[House Prints, 112th Congress]
[From the U.S. Government Publishing Office]


112th Congress
 1st Session                COMMITTEE PRINT
_______________________________________________________________________

                                     

                                     

                                     

                                                                       

 

                          FORUM TO REVIEW THE
                         BIOTECHNOLOGY PRODUCT
                      REGULATORY APPROVAL PROCESS

                               __________

                                A FORUM

                               before the

                        COMMITTEE ON AGRICULTURE

                     u.s. house of representatives

                      one hundred twelfth congress

                             FIRST SESSION

[GRAPHIC] [TIFF OMITTED] TONGRESS.#13


                  U.S. GOVERNMENT PRINTING OFFICE
64-310                    WASHINGTON : 2011
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office, 
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202ï¿½09512ï¿½091800, or 866ï¿½09512ï¿½091800 (toll-free). E-mail, [email protected].  

                            JANUARY 20, 2011
?

                        COMMITTEE ON AGRICULTURE

                   FRANK D. LUCAS, Oklahoma, Chairman

BOB GOODLATTE, Virginia,             COLLIN C. PETERSON, Minnesota, 
    Vice Chairman                    Ranking Minority Member
TIMOTHY V. JOHNSON, Illinois         TIM HOLDEN, Pennsylvania
STEVE KING, Iowa                     MIKE McINTYRE, North Carolina
RANDY NEUGEBAUER, Texas              LEONARD L. BOSWELL, Iowa
K. MICHAEL CONAWAY, Texas            JOE BACA, California
JEFF FORTENBERRY, Nebraska           DENNIS A. CARDOZA, California
JEAN SCHMIDT, Ohio                   DAVID SCOTT, Georgia
GLENN THOMPSON, Pennsylvania         HENRY CUELLAR, Texas
THOMAS J. ROONEY, Florida            JIM COSTA, California
MARLIN A. STUTZMAN, Indiana          TIMOTHY J. WALZ, Minnesota
BOB GIBBS, Ohio                      KURT SCHRADER, Oregon
AUSTIN SCOTT, Georgia                LARRY KISSELL, North Carolina
STEPHEN LEE FINCHER, Tennessee       WILLIAM L. OWENS, New York
SCOTT R. TIPTON, Colorado            CHELLIE PINGREE, Maine
STEVE SOUTHERLAND II, Florida        JOE COURTNEY, Connecticut
ERIC A. ``RICK'' CRAWFORD, Arkansas  PETER WELCH, Vermont
MARTHA ROBY, Alabama                 MARCIA L. FUDGE, Ohio
TIM HUELSKAMP, Kansas                GREGORIO KILILI CAMACHO SABLAN, 
SCOTT DesJARLAIS, Tennessee          Northern Mariana Islands
RENEE L. ELLMERS, North Carolina     TERRI A. SEWELL, Alabama
CHRISTOPHER P. GIBSON, New York      JAMES P. McGOVERN, Massachusetts
RANDY HULTGREN, Illinois
VICKY HARTZLER, Missouri
ROBERT T. SCHILLING, Illinois
REID J. RIBBLE, Wisconsin

                                 ______

                           Professional Staff

                      Nicole Scott, Staff Director

                     Kevin J. Kramp, Chief Counsel

                 Tamara Hinton, Communications Director

                Robert L. Larew, Minority Staff Director

                                  (ii)


                             C O N T E N T S

                              ----------                              
                                                                   Page
Lucas, Hon. Frank D., a Representative in Congress from Oklahoma, 
  opening statement..............................................     1
    Prepared statement...........................................     3
Peterson, Hon. Collin C., a Representative in Congress from 
  Minnesota, opening statement...................................     5
    Prepared statement...........................................     6

                               Witnesses

Vilsack, Hon. Thomas J., Secretary, U.S. Department of 
  Agriculture, Washington, D.C...................................     7
    Prepared statement...........................................    10
    Submitted questions..........................................    51
Conner, Hon. Charles F., President and CEO, National Council of 
  Farmer Cooperatives, Washington, D.C.; accompanied by Bernice 
  Slutsky, Ph.D., Vice President, Science and International 
  Affairs, American Seed Trade Association.......................    37
    Prepared statement...........................................    40

                           Submitted Material

Greenwood, James C., President and CEO, Biotechnology Industry 
  Organization, submitted letter.................................    49


                          FORUM TO REVIEW THE
                         BIOTECHNOLOGY PRODUCT
                      REGULATORY APPROVAL PROCESS

                              ----------                              


                       THURSDAY, JANUARY 20, 2011

                  House of Representatives,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Committee met, pursuant to call, at 10:05 a.m., in Room 
1300, Longworth House Office Building, Hon. Frank D. Lucas 
[Chairman of the Committee] presiding.
    Members present: Representatives Lucas, Goodlatte, Johnson, 
King, Neugebauer, Conaway, Fortenberry, Schmidt, Thompson, 
Rooney, Stutzman, Gibbs, Fincher, Southerland, Crawford, Roby, 
Huelskamp, Ellmers, Hultgren, Schilling, Peterson, Boswell, 
Cardoza, David Scott of Georgia, Walz, Schrader, Pingree, and 
Courtney.
    Staff present: Nicole Scott, Patricia Barr, John Goldberg, 
Debbie Smith, Tamara Hinton, Scott Kuschmider, Clark Ogilvie, 
Keith Jones, and Jamie Mitchell.

 OPENING STATEMENT OF HON. FRANK D. LUCAS, A REPRESENTATIVE IN 
                     CONGRESS FROM OKLAHOMA

    The Chairman. This forum of the Committee on Agriculture to 
review the biotechnology product regulatory approval process 
will come to order.
    First let me welcome all of our returning Members and what 
is almost an unprecedented number of new Members to the House 
Agriculture Committee. In the coming days we will have our 
first business meeting to formally organize the Committee. I 
expect a very busy schedule over the next year as we work 
together on behalf of America's farmers, ranchers and 
agricultural interest.
    And I would like to welcome Secretary of Agriculture Tom 
Vilsack and former Deputy Secretary of Agriculture Chuck 
Conner. We appreciate your participation in today's public 
forum and for assisting the Committee in its oversight 
responsibilities.
    Agricultural biotechnology is important to the future of 
American agriculture. Both of our panelists have a long history 
of work in support of this issue. In fact, Secretary Vilsack in 
his previous capacity as Governor of Iowa was recognized by the 
biotech industry for his efforts. I point to the Secretary's 
support of biotechnology because while we may disagree on some 
of the regulatory alternatives under consideration, I am 
certain the Secretary is committed to the advancement and the 
availability of biotech products.
    We can all agree that the science has consistently 
demonstrated agricultural biotechnology safety and that those 
products have enormous benefits. The regulatory approval 
process for agricultural biotechnology products has run into 
increasingly troublesome delays.
    USDA statutory authority to regulate plant-based products 
of agricultural biotechnology derives from the Plant Protection 
Act, the Act is a pure science statute. Under the Act all plant 
products are subject to regulatory review by USDA' Animal and 
Plant Health Inspection Service, APHIS. APHIS's authority is to 
determine if any new product is a plant pest. If the product is 
found not to be a plant pest, USDA then deregulates it. USDA 
must base its decisions on quantifiable plant pest risk.
    In addition to the APHIS determination, the Food and Drug 
Administration reviews the safety of food and feed from biotech 
plants, and the Environmental Protection Agency reviews 
pesticidal ingredients of biotech plants. This coordinated 
framework has been required since 1992.
    Lately, despite repeated conclusions that individual 
applications of biotechnology do not pose plant pest risk, 
activist organizations have successfully sued USDA under the 
National Environmental Policy Act, NEPA, in a review process 
that confers no statutory authority to regulate. Regulatory 
authority as mentioned above derives from the Plant Protection 
Act, and that Act does not authorize regulation on the basis of 
rhetorical concerns advanced by activist groups. Unfortunately, 
we now have a growing list of products that have been held up 
by the factors the agency has no authority to address.
    Herbicide tolerance in alfalfa has been subjected to an 
extensive multiyear review. It began in the summer of 2005 when 
USDA found that Roundup Ready' alfalfa had no 
significant environmental impacts and deregulated it. Following 
the lawsuit filed in the summer 2006, a judge in the 9th 
Circuit Court revoked USDA's deregulation decision pending 
completion of an Environmental Impact Study. The USDA told the 
court it could accomplish this EIS in 24 months, but 47 months 
later USDA has now published a final EIS wherein the agency has 
reached the same conclusion it did 5 years previously.
    This should be the end of the debate. A product that has 
been repeatedly found to be safe should be deregulated. 
Unfortunately, we now have a new problem. Since USDA has 
determined that there is no plant pest risk, the only option 
under the statute is full deregulation, but USDA is considering 
two additional options. One would have USDA retain full 
regulatory authority. The Secretary has acknowledged that this 
is not preferred.
    The third option would be to only partially deregulate the 
product. We are concerned that Option 3 would have a negative 
impact on all U.S. agriculture. Concerns have been raised that 
this option was developed to prevent future lawsuits by 
addressing coexistence between conventional and organic 
production. That is a political objective and is outside of the 
scope of the legal authority. I believe USDA has the authority 
to make its own decisions. I also believe that the recent 
Supreme Court case on alfalfa came to this very same 
conclusion. For example, when the courts have arbitrarily 
intervened and the rulings would have resulted in disastrous 
economic consequences, USDA has acted. In this regard, because 
this is still in litigation, we understand that APHIS may be 
authorized to partially deregulate sugarbeets pending 
completion of a final EIS.
    Beyond that I support farmer's choice. Farmers of most 
major commodities are choosing to grow biotech crops versus 
non-biotech or organic. More than 90 percent of corn, soybeans, 
cotton, sugarbeets, alfalfa are biotech crops. All farmers 
should have the ability to choose their cropping systems.
    With regard to organic agriculture, I recognize the 
tremendous marketing potential and that consumer demand is 
increasing for those products. However, as we seek to find 
solutions to the challenges of identity preservation, I cannot 
support strategies that pit producer against producer. I agree 
with the Secretary's public statements about grower choice, 
which is why it is troubling that USDA seems inclined to pursue 
a path that limits grower choice.
    It is important to note that nowhere in the Organic Foods 
Production Act has Congress limited access to organic producers 
to the advantages of agricultural biotechnology. It was only 
after intense lobbying by the organic industry that the 
proposed organic standards regulations were modified to include 
restrictions. Organic producers with full knowledge of the 
compliance cost associated with the standards chose to impose 
the standards on themselves. The National Organic Standards 
Marketing Program, approved by USDA, imposes very strict 
standards on those who choose to grow crops that will be 
certified organic and carry the USDA organic certified label. 
We all agree that the label carries with it marketing benefits, 
costs, and responsibilities. I am sensitive to the difficulties 
organic producers face, but I cannot support proposals that 
shift the financial burden from those who chose to produce 
organic to those producers who chose a different cropping 
system.
    Mr. Secretary, once again I thank you for your time today. 
I expect you will be spending a bit of time with us in this 
Committee in the coming months, and it is my hope that we can 
all work together to find solutions to the challenges rural 
America faces.
    [The prepared statement of Mr. Lucas follows:]

Prepared Statement of Hon. Frank D. Lucas, a Representative in Congress 
                             from Oklahoma

    Let me first welcome all of our returning Members and what is an 
almost unprecedented number of new Members to the House Agriculture 
Committee. In the coming days, we will have our first business meeting 
to formally organize the Committee. I expect a very busy schedule over 
the next year as we work together on behalf of America's farmers, 
ranchers, and agricultural interests.
    I would like to welcome Secretary of Agriculture Tom Vilsack and 
former Deputy Secretary of Agriculture Chuck Connor. We appreciate your 
participation in today's public forum and for assisting the Committee 
in its oversight responsibilities.
    Agricultural biotechnology is important to the future of American 
agriculture. Both of our panelists have a long history of work in 
support of this issue. In fact, Secretary Vilsack, in his previous 
capacity as Governor of Iowa, was recognized by the biotech industry 
for his efforts.
    I point to the Secretary's support of biotechnology because while 
we may disagree on some of the regulatory alternatives under 
consideration, I am certain the Secretary is committed to the 
advancement and availability of biotech products. We can all agree that 
the science has consistently demonstrated agricultural biotechnology's 
safety and that those products have enormous benefits.
    The regulatory approval process for agricultural biotechnology 
products has run into increasingly troublesome delays. USDA's statutory 
authority to regulate plant based products of agricultural 
biotechnology derives from the Plant Protection Act. The Act is a pure 
science statute.
    Under the Act, all plant products are subject to regulatory review 
by USDA's Animal and Plant Health Inspection Service (APHIS). APHIS's 
authority is to determine if any new product is a plant pest. If the 
product is found to not be a plant pest, USDA then deregulates it. USDA 
must base its decisions on quantifiable plant pest risk.
    In addition to the APHIS determination, the Food and Drug 
Administration reviews the safety of food and feed from biotech plants 
and the Environmental Protection Agency reviews pesticidal ingredients 
of biotech plants. This coordinated framework has been required since 
1992. Lately, despite repeated conclusions that individual applications 
of biotechnology do not pose plant pest risks, activist organizations 
have successfully sued USDA under the National Environmental Policy Act 
(NEPA). NEPA is a review process that confers no statutory authority to 
regulate. Regulatory authority, as mentioned above, derives from the 
Plant Protection Act and that Act does not authorize regulation on the 
basis of rhetorical concerns advanced by activist groups. 
Unfortunately, we now have a growing list of products being held up by 
factors the agency has no authority to address.
    Herbicide tolerance to alfalfa has been subjected to an extensive 
multi-year review. It began in the summer of 2005 when USDA found that 
Roundup Ready' alfalfa had no significant environmental 
impacts and deregulated it. Following a lawsuit filed in the summer of 
2006, a Judge in the 9th Circuit Court revoked USDA's deregulation 
decision pending completion of an Environmental Impact Statement (EIS). 
USDA told the court it would complete the EIS in 24 months. But, 47 
months later, USDA has now published a final EIS wherein the agency has 
reached the same conclusion it did 5 years previously.
    This should be the end of the debate. A product that has been 
repeatedly found to be safe should be deregulated.
    Unfortunately, we now have a new problem.
    Since USDA has determined that there is no plant pest risk, the 
only option under the statute is full deregulation. But, USDA is 
considering two additional options. One would have USDA retain full 
regulatory control. The Secretary has acknowledged this is not 
preferred. The third option would only partially deregulate the 
product.
    We are concerned Option 3 would have negative impacts on all U.S. 
agriculture. Concerns have been raised that this option was developed 
to prevent future lawsuits by addressing coexistence between 
conventional and organic production. That is a political objective and 
is outside the scope of legal authority.
    I believe USDA has authority to make interim decisions. I also 
believe the recent Supreme Court case on alfalfa came to this same 
conclusion. For example, when courts have arbitrarily intervened and 
their rulings would have resulted in disastrous economic consequences, 
USDA has acted. In this regard, because this is still in litigation, we 
understand that APHIS may be authorized to partially deregulate 
sugarbeets pending completion of a final EIS.
    Beyond that, I support farmer's choice. Farmers of most major 
commodities are choosing to grow biotech crops versus non-biotech or 
organic. More than 90 percent of corn, soybeans, cotton, sugarbeet, and 
alfalfa are biotech crops. All farmers should have the ability to 
choose their cropping system.
    With regard to organic agriculture, I recognize the tremendous 
marketing potential and that consumer demand is increasing for these 
products. However, as we seek to find solutions to the challenges of 
identity preservation, I cannot support strategies that pit producer 
against producer. I agree with the Secretary's public statements about 
grower choice, which is why it's troubling that USDA seems inclined to 
pursue a path that limits grower choice.
    It is important to note that nowhere in the Organic Foods 
Production Act has Congress limited access for organic producers to the 
advantages of agricultural biotechnology. It was only after intense 
lobbying by the organic industry that the proposed organic standards 
regulations were modified to include restrictions.
    Organic producers, with full knowledge of the compliance costs 
associated with the standard, chose to impose these standards on 
themselves. The National Organic Standards (NOS) marketing program, 
approved by USDA, imposes very strict standards on those who choose to 
grow crops that will be certified ``organic'' and carry the USDA 
organic-certified label. We all agree the label carries with it market 
benefits, costs, and responsibilities.
    I am sensitive to the difficulties organic producers face, but I 
cannot support proposals that shift the financial burden from those who 
choose to produce organic to other producers who choose a different 
cropping system.
    Mr. Secretary, once again I thank you for your time today. I expect 
you will be spending a bit of time with this Committee in the coming 
months. It is my hope that we can all work together to find solutions 
to the challenges rural America faces. I now yield to our Ranking 
Member, Representative Peterson for any comments he would like to make.

    The Chairman. I now yield to Ranking Member Peterson for 
any comments that he would like to make. Mr. Ranking Member.

OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE 
                   IN CONGRESS FROM MINNESOTA

    Mr. Peterson. Thank you, Mr. Chairman. And first of all, I 
want to congratulate you on taking over the chairmanship of the 
Committee and we wish you well, and we are going to do our part 
to help you be successful and make this Committee work.
    We also want to welcome the returning Members and the new 
Members of the Committee. You will find that this is one of the 
few bipartisan committees in the Congress and it does not 
happen by accident. It takes a lot of work and we work at it 
very hard to make sure that we listen to each other and 
understand each other, and I think we come up with better 
solutions because of it.
    So I look forward to working with all of you, and I want to 
welcome the Secretary to the Committee and Mr. Conner. I 
recognize the Committee is not formally organized and we are 
jumping into a complex topic, but this Department has some 
decisions to make so I think today's discussion is appropriate.
    As many people know, USDA's release of the final EIS on 
Roundup Ready' alfalfa on December 16th lays out two 
options, including a partial deregulation, so-called Option 3. 
It is worth noting that the recently completed EIS on alfalfa 
is one step in a drawn out process that has taken decisions 
about alfalfa production largely out of the hands of the 
agriculture community and moved them into the courtroom, 
litigated by lawyers and decided by judges who have no 
connection to agriculture and in a lot of cases no 
understanding of agriculture, which concerns me.
    I understand the concerns of those who think that 
restrictions listed under Option 3 could have a negative long-
term consequences for biotech product development and approval. 
It is a highly unusual step that arguably creates more 
questions than answers with respect to the science-based 
regulatory process, trade policy with respect to biotechnology, 
and perhaps even the reexamination of previously approved 
biotech traits.
    So I look forward to discussing those issues with the 
Secretary today. But I don't think we are completely looking at 
the big picture unless we recognize that endless litigation is 
a fact of life it appears under the current biotech approval 
process. And if the only answer to the alfalfa question is one 
that leads us right back into the courtroom, where USDA's track 
record in recent years is very poor, then I am not sure how 
that benefits biotechnology in the long run.
    On the sugarbeet issue, in particular the folks that I have 
talked to have just about had it with these lawsuits that is 
causing big problems, big concerns for us in my part of the 
world and other places where they produce sugarbeets. I have 
talked to the Secretary about this enough times to know that he 
has about had it with, too, with these lawsuits.
    Along those lines, there has been a lot of discussion about 
the Secretary's efforts to bring stakeholders together to 
discuss agriculture's coexistence amongst those who understand 
agriculture rather than the courts. Now whether or not these 
folks can reach an agreement remains to be seen, and I do 
recognize that having these discussions while the Department is 
trying to reach a conclusion on the alfalfa issue is causing 
problems for a lot of people.
    I also don't know if I share the Secretary's optimism 
because some folks apparently will use every tool possible to 
try to shut down biotech crops. But I really think he is 
genuinely looking for an answer that doesn't involve endless 
litigation.
    You know, one of the issues that I would like to find out 
about today is the process whereby we got into this. How did 
the decision get made that we were going to just do an 
Environmental Assessment instead of an Environmental Impact 
Statement in the first place? You know, it appears that you 
gave our opponents ammunition by taking a shortcut. I don't 
know. And so I would be interested in finding out how that 
decision was made. What was the thought going into it, both on 
alfalfa and sugarbeets. You know, who was involved? Who weighed 
in? Just how was that whole process developed, because I think 
it is unfortunately unrealistic to think that we are going to 
be able to avoid this and it just appears that you are going to 
go have to do an EIS on these deals, and you might as well do 
it sooner rather than later, or we are going to just get back 
into this loop.
    Some have expressed concerns about this partial 
deregulation, that it is beyond the scope of the Plant 
Protection Act. I think I share some concerns in that regard. 
It may be that we decide out of this process that there needs 
to be changes in that Act so that we can deal with this. I 
think that would be an appropriate discussion for this 
Committee to have.
    So I look forward to hearing from the Secretary, hearing 
from former Deputy Secretary Conner, and I thank the Chairman 
for the time.
    [The prepared statement of Mr. Peterson follows:]

  Prepared Statement of Hon. Collin C. Peterson, a Representative in 
                        Congress from Minnesota

    Good morning. Thank you Chairman Lucas for holding today's forum 
and welcome, Secretary Vilsack and Mr. Conner, to the Committee. I 
recognize that the Committee has not formally organized and we are 
jumping into a complex topic, but the Department has some decisions to 
make very soon and I welcome today's discussion.
    As many people know, USDA's release of the final Environmental 
Impact Statement on Roundup Ready' alfalfa on December 16 
lays out two options, including a partial deregulation option, the so-
called Option 3.
    It is worth noting that the recently completed EIS on alfalfa is 
one step in a drawn out process that has taken decisions about alfalfa 
production largely out of the hands of the agriculture community and 
moved them into the courtroom, litigated by lawyers and decided by 
judges who have no connection to agriculture.
    I understand the concerns of those who think the restrictions 
listed under Option 3 could have negative long-term consequences for 
biotech product development and approval. It is a highly unusual step 
that arguably creates more questions than answers with respect to the 
science-based regulatory process, our trade policy with respect to 
biotechnology, and perhaps even the re-examination of previously 
approved biotech traits. I look forward to discussing those issues with 
the Secretary today.
    But I don't think we are completely looking at the big picture 
unless we recognize that endless litigation is a fact of life under the 
current biotech approval process. And if the only answer to the alfalfa 
question is one that leads us right back into the courtroom, where 
USDA's track record in recent years is very poor, then I'm not sure how 
that benefits biotechnology in the long run.
    On the sugarbeet issue in particular, the folks I have talked to 
have just about had it with these lawsuits. And I have talked to the 
Secretary enough times to know that he has about had it, too.
    Along those lines, there has been a lot of discussion about the 
Secretary's efforts to bring stakeholders together to discuss 
agricultural coexistence among those that understand agriculture rather 
than the courts.
    Now whether or not these folks can reach an agreement remains to be 
seen, and I do recognize that having these discussions while the 
Department is trying to reach a conclusion on the alfalfa issue is 
causing problems for a lot of people. I also don't know if I share the 
Secretary's optimism because some folks will use every tool possible to 
try and shut down biotech crops. But I think that he is genuinely 
looking for an answer that doesn't involve endless litigation.
    Some have expressed concerns that a partial deregulation is beyond 
the scope of the Plant Protection Act. I look forward to hearing from 
the Secretary on this particular question today.
    Again, I thank the Chairman for calling today's forum and look 
forward to hearing from our panelists.

    The Chairman. And the chair thanks the Ranking Member and 
would note that the chair would request other Members to submit 
their opening statements for the record so that the forum 
participants may begin their statements to ensure that there is 
ample time for questions. And with that we would like to 
welcome our first panelist to the table, the Honorable Tom 
Vilsack, the Secretary of the United States Department of 
Agriculture here in Washington, D.C. Mr. Secretary, thank you 
for coming.

STATEMENT OF HON. THOMAS J. VILSACK, SECRETARY, U.S. DEPARTMENT 
                OF AGRICULTURE, WASHINGTON, D.C.

    Secretary Vilsack. Thank you, Mr. Chairman, and thank you, 
Representative Peterson and Members of this Committee, for the 
opportunity to appear before you today to discuss a very 
important topic to American agriculture, the complex issues 
surrounding biotechnology and USDA's role in regulating it.
    Today's meeting considers a topic that is critically 
important to U.S. agriculture. Over the last 2 decades we have 
experienced rapid development and widespread adoption by 
producers of new technologies like biotechnology. Biotechnology 
has already delivered significant benefits to farmers and 
consumers, and it holds tremendous promise for agriculture here 
in the United States, and I might say around the world.
     Over the past 20 years, due to improved plant breeding 
practices in biotechnology, yields have increased and new 
varieties have been developed that will resist pests and 
drought, and reduce the amount of water and fertilizer needed 
to raise a crop. Recognizing the benefits of these products 
today, more farmers are planting biotech varieties of crops.
    We believe at USDA that biotechnology stands to play a 
significant role in our effort to support our drive towards 
energy independence, conserve our natural resources and meet 
the world's growing demand for food, feed, fiber and fuel.
    At the same time there has also been strong growth in the 
organic sector and in non-genetically engineered production, 
all to meet the requirements of specific and expanding markets.
    The growth of these markets is great for U.S. agriculture. 
It means farmers, ranchers, and growers have a range of ways to 
meet consumer needs and preferences both here and around the 
world. It means they can grow their operations in the best way 
for their operation while contributing to the success and 
vitality of rural America.
    The growth and promise of biotechnology, the fact that it 
can provide critical assistance in meeting domestic and global 
challenges, including food security and climate change, is due 
in large part to the innovative culture of American 
agriculture.
    I need to state clearly and emphatically, I have no doubt 
about the safety of the products our regulatory system at USDA 
has approved over the last 2+ decades and that we will continue 
to approve in the weeks, months, and years ahead.
    The rapid adoption of GE crops has coincided with the rapid 
expansion of demand for organic and non-GE products, resulting 
in real practical difficulties for some non-GE producers to 
meet the needs of their markets. These conflicts have produced 
ongoing litigation and resulted in uncertainty for producers 
and technology innovators.
    We are at a critical juncture and a crucial juncture in 
American agriculture where the issues causing the litigation 
and uncertainty must be addressed so that the potential 
contributions of all sectors of agriculture can be fully 
realized.
    As part of USDA's efforts to expand U.S. agriculture, we 
must ensure that our regulatory oversight is timely, 
consistent, effective, and grounded in sound science. We must 
ensure that we keep pace with the latest scientific 
developments and do so transparently. The Plant Protection Act 
gives the Secretary of Agriculture, through the Animal and 
Plant Health Inspection Service, the authority to prohibit or 
restrict the importation, exportation, and the interstate 
movement of plants, plant products, certain biological control 
items, noxious weeds, and plant pests. It is under these 
authorities that APHIS regulates the importation, interstate 
movement, and safe field testing of GE products.
    In regulating biotechnology products, APHIS works closely 
with the U.S. Food and Drug Administration and the U.S. 
Environmental Protection Agency as part of the Coordinated 
Framework for Regulation of Biotechnology. The three agencies 
work together to ensure that development, testing and use of 
biotechnology products occurs in a manner that is safe for 
plants and animal health, human health and the environment.
    USDA's biotechnology program has been in place since 1986, 
and APHIS has developed a framework for regulating 
biotechnology that is rigorous and based on sound science. 
Since the program began APHIS has overseen the adoption of 
numerous biotechnology products, with 26,000 field trials grown 
under our notification procedures and 3,000 field trials 
conducted under our permitting process, which encompasses field 
trials at 86,000 different locations. In addition, we have 
deregulated over 75 products.
    It is not a static program. To farmers, ranchers, and 
growers it is one that has grown and evolved as technology, 
often driven by the needs and demands of producers, has 
changed. As we move forward we must be cognizant of the needs 
of all producers in all types of production.
    We are at a crossroads with the Department's ability to 
handle the demands of the industry and producers. The length of 
time it takes APHIS to complete the petition process has 
increased dramatically, and we are engaged in a process 
improvement program to reduce the amount of time. However, the 
combination of increased number and the complexity of the 
petitions combined with time consuming litigation has really 
slowed us down. I fear that if we don't address these issues 
comprehensively, innovation will be discouraged, not 
encouraged.
    The procedural and legal challenges related to GE 
sugarbeets and GE alfalfa have taken years. APHIS made its 
initial decision, as the Chairman indicated, to deregulate GE 
alfalfa in June of 2005. Yet here we are nearly 6 years later 
with the process not yet concluded. GE sugarbeets were granted 
non-regulated status in March of 2005, and the case is still in 
litigation in Federal court. As these cases continue the market 
uncertainty increases and those involved in agriculture lack 
sufficient guidance for planning and determining how to react 
or which products to use.
    The situation needs to be resolved. The legal challenges 
and the resulting effects have created uncertainty for all 
growers. Growers need to be able to order seed, to make 
planting decisions, but have difficulty when the legal 
challenges cause so much uncertainty. There are companies and 
researchers who have devoted significant resources to 
developing safe products that can help us meet our food 
security needs that find themselves fighting in court awaiting 
to see how a judge's decision in a separate case will affect 
theirs.
    I strongly believe that these decisions regarding these 
critical issues should not be decided solely by the courts. 
Litigation creates uncertainty and often results in winners and 
losers. To help minimize that uncertainty, as well as other 
impacts in the cost of litigation, we are committed at USDA to 
seeking solutions that will end or limit litigation and thereby 
benefit agriculture as a whole.
    On December 16, 2010, the USDA released its final 
Environmental Impact Statement, EIS, on the potential 
environmental effects of granting genetically engineered 
alfalfa non-regulated status. This is the line of alfalfa that 
has been genetically engineered to be resistant to the 
herbicide commonly known as Roundup.
    The EIS provides an exceptionally comprehensive evaluation 
and analysis of the potential environmental impact of granting 
or denying the petition for non-regulated status. In addition 
to the draft EIS's two alternatives of either granting or 
denying non-regulated status, the final EIS examined a third 
alternative that was included in response to ideas presented 
during the comment period. This third alternative looks at the 
impacts of establishing geographic restrictions and isolation 
distances for GE alfalfa's production, and it mirrors a healthy 
and productive conversation between GE, non-GE and organic 
interest that is already underway in the industry and continues 
to evolve. Every interest engaged in the conversation shares 
the goal of protecting the right of every producer to grow on 
their land what they believe and decide is best. Every interest 
engaged in this conversation, to my knowledge, recognizes the 
fundamental property right interest inherent in this 
discussion, and I believe that many participants have found the 
discussion important and beneficial.
    Now some have questioned the need for this discussion, and 
have suggested that USDA is moving away from a science-based, 
rules-based decision making process. I want to reassure 
everyone on the Committee that USDA will continue to adhere to 
a scientific risk-based decision-making process and that our 
decisions will continue to be driven by science.
    I look forward to our discussion here and I hope you share 
my belief that farmers, ranchers, and growers are in the best 
position to decide what is best for their operation.
    Again, I would like to thank the Chairman and the Committee 
for the opportunity to appear before you this morning. I look 
forward to trying to answer as many questions as I can.
    [The prepared statement of Mr. Vilsack follows:]

     Prepared Statement of Hon. Thomas J. Vilsack, Secretary, U.S. 
              Department of Agriculture, Washington, D.C.

    Chairman Lucas, thank you and thank you to Representative Peterson 
and Members of the Committee for the opportunity to appear before you 
today to discuss an important topic to American agriculture--the 
complex issues surrounding biotechnology and USDA's role in regulating 
it.
    Today's meeting considers a topic that is critically important to 
U.S. agriculture. Over the last 2 decades, we have experienced the 
rapid development, and the widespread adoption by producers, of new 
technologies like biotechnology. Biotechnology has already delivered 
significant benefits to farmers and consumers and it holds tremendous 
promise for agriculture here in the United States, and around the 
world. Over the past twenty years, due to improved plant breeding 
practices and biotechnology, yields have increased and new varieties 
are being developed that will resist pests and drought, and reduce the 
amount of water and fertilizer needed to raise a crop. Recognizing the 
benefits of these products, today, more farmers are planting biotech 
varieties of crops. We believe that biotechnology stands to play a 
significant role in our effort to support our drive toward energy 
independence, conserve our natural resources, and meet the world's 
growing demand for food, feed, fiber, and fuel.
    At the same time, there has also been strong growth in the organic 
sector, and in non-genetically engineered production, all to meet the 
requirements of specific and expanding markets.
    The growth of all these sectors is great for U.S. agriculture. It 
means farmers, ranchers, and growers have a range of ways to meet 
consumer needs and preferences both here and around the world. It means 
they can grow their operations in the way best for their operation 
while contributing to the success and vitality of rural America.
    The growth and promise of biotechnology--the fact that it can 
provide a critical assist in meeting domestic and global challenges, 
including food security and climate change--is due in large part to the 
innovative culture of American agriculture. I need to state clearly and 
emphatically--I have no doubt about the safety of the products our 
regulatory system at USDA has approved over the last 2+ decades and 
that it will continue to approve in the months and years ahead.
    The rapid adoption of GE crops has coincided with the rapid 
expansion of demand for organic and other non-GE products, resulting in 
real, practical difficulties for some non-GE producers to meet the need 
of their markets. These conflicts have produced ongoing litigation and 
resulted in uncertainty for producers and technology innovators. We are 
at a crucial juncture in American agriculture where the issues causing 
the litigation and uncertainty must be addressed, so that the potential 
contributions of all sectors of agriculture can be fully realized.
USDA's Biotechnology Regulatory Program
    As part of USDA's efforts to expand U.S. agriculture, we must 
ensure that our regulatory oversight is timely, consistent, effective, 
and grounded in sound science. We must ensure that we keep pace with 
the latest scientific developments, and that we do so transparently. 
The Plant Protection Act gives the Secretary of Agriculture, and 
through delegated authority the Animal and Plant Health Inspection 
Service (APHIS), the ability to prohibit or restrict the importation, 
exportation, and the interstate movement of plants, plant products, 
certain biological control organisms, noxious weeds, and plant pests. 
It is under these authorities that APHIS regulate the importation, 
interstate movement, and safe field testing of GE organisms. In 
regulating biotechnology products, APHIS works closely with the U.S. 
Food and Drug Administration and the U.S. Environmental Protection 
Agency, as part of the Coordinated Framework for Regulation of 
Biotechnology. The three agencies work together to ensure the 
development, testing, and use of biotechnology products occurs in a 
manner that is safe for plant and animal health, human health, and the 
environment.
    USDA's biotechnology program has been in place since 1986, and 
APHIS has developed a framework for regulating biotechnology that is 
rigorous and based on sound science. Since the program began, APHIS has 
overseen the safe adoption of numerous biotechnology products, with 
26,000 field trials grown under our notification procedures and 3,000 
field tests conducted under our permitting process, which encompasses 
field trials at 86,000 different locations. In addition, we have 
deregulated over 75 products.
    It is not a static program. To farmers, ranchers, and growers, it 
is one that has grown and evolved as technology--often driven by the 
needs and demands of producers--has changed. As we move forward, we 
must be cognizant of the needs of all producers and all types of 
production.
Challenges Facing the Biotechnology Review Process
    We are also at a crossroads with the Department's ability to handle 
the demands of industry and producers. The length of time it takes 
APHIS to complete the petition process has increased dramatically, and 
we are engaged in a process improvement process to reduce the amount of 
time. However, the combination of an increased number and complexity of 
the petitions combined with the time consuming litigation has really 
slowed us down. I fear that if we don't address these issues 
comprehensively, innovation will be discouraged not encouraged.
    The procedural legal challenges related to GE sugarbeets and GE 
alfalfa have taken years. APHIS made its initial decision to deregulate 
GE alfalfa in June 2005. Yet here we are nearly 6 years later with the 
process not yet concluded. GE sugarbeets were granted non-regulated 
status in March 2005, and the case is still in litigation in Federal 
court. As these cases continue, the market uncertainty increases, and 
those involved in agriculture lack sufficient guidance for planning and 
determining how to react or which products to use.
    The situation needs to be resolved. The legal challenges, and the 
resulting effects, have created uncertainty for all growers. Growers 
need to order seed and make planting decisions, but have difficulty 
when the legal challenges cause so much uncertainty. There are 
companies and researchers who have devoted significant resources to 
developing safe products that can help us meet our food security needs, 
but find themselves fighting in the courts, or waiting to see how a 
judge's decision in a separate case will affect them.
    I strongly believe that the decisions regarding these critical 
issues should not be decided solely by the courts. Litigation creates 
uncertainty and often results in winners and losers. To help minimize 
that uncertainty, as well as the other impacts and costs of litigation, 
USDA is committed to seeking solutions that will end or limit 
litigation and thereby benefit agriculture as a whole.
Roundup Ready Alfalfa
    On December 16, 2010, the USDA released its final Environmental 
Impact Statement (EIS) on the potential environmental effects of 
granting genetically engineered alfalfa non-regulated status. This is 
the line of alfalfa that has been genetically engineered to be 
resistant to the herbicide commonly known as Roundup.
    The EIS provides an exceptionally comprehensive evaluation and 
analysis of the potential environmental impacts of granting or denying 
the petition for non-regulated status. In addition to the draft EIS's 
two alternatives of either granting or denying non-regulated status, 
the final EIS examined a third alternative that was included in the 
response to ideas presented during the comment period. This third 
alternative analyzes the impacts of establishing geographic 
restrictions and isolation distances for GE alfalfa's production, and 
it mirrors a healthy and productive conversation between GE, non-GE, 
and organic interests that is already underway in the industry and that 
continues to evolve. Every interest engaged in the conversation shares 
the goal of protecting the right of every producer to grow on their 
land what they believe and decide is best. And, I believe that many 
participants have found the discussion important and beneficial.
    Some have questioned the need for this discussion and have 
suggested USDA is moving away from a science based, rules based 
decision making process. I want to reassure everyone that USDA will 
continue to adhere to a scientific, risk based decision making process 
and that our decisions will continue to be driven by science. I look 
forward to our discussion here and I hope you share my belief that 
farmers, ranchers, and growers are in the best position to decide what 
is best for their operations.
    Again, I would like to thank the Committee for the opportunity to 
appear before you this morning and I look forward to answering any 
questions that you may have.

                                 Charts



 Thank you, Mr. Secretary. The chair would like to remind Members they 
   will be recognized for questioning in the order of seniority for 
  Members who were here at the start of the forum. After that Members 
will be recognized in the order of arrival. I will repeat that one more 
time. We will recognize you in the order of seniority if you were here 
   at the beginning of this process and after that in your order of 
    arrival. I appreciate the Members' understanding.Mr. Secretary, 
before I get to the questions I would like to comment on the suggestion 
in your statement that there are some questioning the value of having a 
conversation of coexistence, and I want to clarify that concern that we 
are hearing that this is not a conversation that is taking place, but 
the concern is with the forum and the timing of those conversations. 
The USDA currently is engaged in a decision making process on a 
petition to deregulate a specific crop. What is of concern here is the 
report that this conversation started with a comment something to the 
effect of from USDA, and I think it is a pretty accurate quote, our 
preference is to have you all help us do it as best we can. But if that 
is not possible then we will do the best we can.
    I would hope that you would recognize that at a time when you have 
a company waiting for a decision that could cost the industry millions 
of dollars, thousands of jobs, comments like that create more of an 
atmosphere of, well, less than cooperation, a sense of cooperation. I 
would hope that you and your entire staff would bear in mind that you 
have instructed your staff that this is not acceptable.
    Equally important, and the focus of today's forum, is the question 
of whether the issues and options raised in the discussion of 
coexistence are political issues that fall outside your legal mandate 
to determine the safety of those products under and Plant Protection 
Act. On this issue I promise you a series of, I hope, relatively 
painless questions.
    With that said, Mr. Secretary, how many biotech varieties have been 
fully deregulated by USDA; in other words, approved without any of the 
coexistence restrictions that are envisioned within the so-called 
Option 3 for partial regulation of alfalfa?
    Secretary Vilsack. Mr. Chairman, I believe we have approved 75 
products. I am not familiar with the conditions or circumstances of all 
of the approvals, but I think we have approved 75. There have been some 
that were withdrawn before we got to the approval process, but I think 
it is 75.
    The Chairman. That is an impressive number, Mr. Secretary. How many 
of those varieties contain a similar glyphosate tolerance gene as that 
which has been incorporated into the Roundup Ready' alfalfa 
product under consideration?
    Secretary Vilsack. I would have to ask, if I could, Mr. Chairman, 
Cindy Smith.
    The Chairman. Of course.
    Secretary Vilsack. We are going to guess, if that is all right, Mr. 
Chairman, roughly ten percent.
    The Chairman. And is it correct that each review of the currently 
available Roundup Ready varieties of crop seed that USDA has 
deregulated were determined by USDA to be substantially equivalent to 
their conventional counterparts?
    Secretary Vilsack. I think that is a correct statement.
    The Chairman. Is it correct that each review of the biotech alfalfa 
product conducted by USDA has concluded that the product is 
substantially equivalent to conventional alfalfa?
    Secretary Vilsack. That is safe to say, Mr. Chairman.
    The Chairman. I promise you I am not Perry Mason, but I do 
appreciate your answers. It appears to many observers--and I guess that 
dates me, doesn't it, referring to Perry Mason--it appears to many 
observers that--and that was a weak attempt at humor--that the partial 
deregulation option presented by USDA will have a much broader impact 
on all of U.S. agriculture, our international negotiations and further 
development of these important products. Please explain if you could, 
Mr. Secretary, your thinking on how a partial deregulation alternative 
would promote these mutually stated goals.
    Secretary Vilsack. Mr. Chairman, this has been a long and torturous 
process that alfalfa has gone through. As you indicated, this started 
in 2005. Since then, courts have come in and have essentially directed 
us to perform a more extensive evaluation under an Environmental Impact 
Statement. And if I might take your question and just try to briefly 
address the Ranking Member's question. We are instructed under the NEPA 
process to consider two approaches. One is the Environmental 
Assessment, the other is the Environmental Impact Statement. We had 
prior to the last several years used the EA fairly successfully in 
moving this process forward to get to the 75 products that have been 
deregulated.
    Recently there have been questions about the comprehensive nature 
of those assessments which have led courts to direct us to do more 
extensive reviews in the form of an Environmental Impact Statement. We 
have done that, and our belief is that the reason for the courts 
directing us to do that is that they believe that those Environmental 
Impact Statements ought to, ``inform the process,'' going forward.
    We produced an extensive EIS in connection with alfalfa, it is 
roughly 2,300 pages, and in it we identified a number of issues. When 
we put the draft EIS out for comment, we received a number of comments 
back, and in an effort to try to be responsive to those comments we 
took a look at various alternatives. We now have an opportunity for 
review of the final EIS and that in turn creates another opportunity 
for us to be informed as we end up making a decision. The review period 
has to occur for at least 30 days, and it is our intention to make a 
decision as close to the end of that 30 day period as possible, because 
we understand and appreciate that folks need to know what they can 
plant, what they can't plant, and we are on track to do that.
    When we proposed the various alternatives, what happened is it 
created and generated a dialogue between differing interests, and I 
think that it has been a positive experience for those who have 
participated in that dialogue. Now why do I say that? Because I think 
it has allowed us to better understand the unique nature of alfalfa. It 
has better allowed us to understand the greater awareness of 
stewardship contracting that is taking place in the market. It has 
allowed us to have questions raised about the process of verifying 
those stewardship contracts, and it has underscored the importance of 
trying to build more of a trusting relationship between various 
interests of agriculture, all of which are positive, and perhaps most 
positive of all is it has helped us at USDA begin to look at ways in 
which we can use tools outside of this process to help further create 
this sense of cooperation. So, for example, issues have been raised 
during this discussion about the purity of seed and whether or not 
there will be in fact an assurance that we will continue to have purity 
of seed so that anybody who wants to do organic, anyone who wants to do 
identity preserved non-GE will always have that option. We can play a 
role in that. So it has been an informative process.
    The Chairman. Mr. Secretary, I ask one last question with the 
indulgence of my colleagues here. You have obviously been a biotech 
supporter for decades. Looking once again at this international 
negotiations issue, looking at the kind of efforts that this country 
and your Department have been a part of for decades, does it concern 
you that if ultimately the segregated concept is what the Department 
decides to do, does it worry you what that does to our decades of 
persuading our trading partners and our friends around the world that 
if you use sound science, if you follow established rules that these 
products are absolutely safe and this segregation business is not 
necessary, does that cause you personal angst?
    Secretary Vilsack. It would cause me angst, Mr. Chairman, if the 
decision we made was not science-based and not rules-based, because 
that has been the consistent approach of this government for a 
considerable period of time and it is something that we have been 
critical of in other international forums.
    Let me say in terms of my experience with biotechnology in other 
countries, we developed when I first came into office an overall 
strategy for how we might be better positioning biotechnology in the 
international community. That involves better public diplomacy, it 
involves better articulation of the benefits of biotechnology. It 
involves identifying countries in areas of the world that are more 
receptive of biotechnology and encouraging them to speak to their 
counterparts, whether it is in Africa or Asia, about the important role 
that biotechnology can play in food security. And so we are looking at 
this strategically and comprehensively. And I think that is one of the 
reasons why I think this forum is important because it gives us yet 
another opportunity, a public opportunity to talk about the benefits of 
biotechnology, and also talk about the need for American agriculture to 
have choices and diversity.
    The Chairman. Thank you, Mr. Secretary. And before I turn to my 
colleague, the Ranking Member, for his questions I would note to the 
underclassmen the first bell has rung. There will be a second bell. At 
the second bell I advise you to work your way to the floor since the 
new management seems to be very focused on time limitations on those 
votes.
    Mr. Ranking Member.
    Mr. Peterson. Thank you, Mr. Chairman. So the reason the decisions 
were made apparently is because the Environmental Assessment was 
working, and so they decided that with the case of sugarbeets and 
alfalfa that was probably going to be okay, and so that is why they did 
the Environmental Assessment instead of the EIS.
    Secretary Vilsack. Obviously I was not the Secretary at the time 
those decisions were made, Representative, but I believe that it is 
reasonable to assume that if the process had worked and had not been 
subject to question and had not been overturned in the past it was 
reasonable for people to say that is the approach we should take. What 
your question, and what this discussion underscores, is the more 
petitions we get, and we now have 23 pending, the more complex the 
issues become, the more awareness folks have about the various 
alternatives, the more diversification that is taking place in 
agriculture, the more markets that are being created, the greater the 
need is for us to have a comprehensive conversation about this and to 
figure out if there are ways in which we can streamline the process. I 
don't think there is anybody in this room that believes 6 years is 
appropriate. I know I don't, and I know that I indicated to 
Administrator Smith that I want to shorten that time if at all 
possible.
    We are going to continue to follow the rules. If we think an EA is 
appropriate, then I think we are required to follow the rules. If we 
think an EIS is more appropriate under the framework, we will use an 
EIS.
    Mr. Peterson. Do you think that these folks that oppose biotech, do 
you think they picked on sugarbeets and alfalfa because they are small 
crops and they are easy to pick on? Do you think that was----
    Secretary Vilsack. I wouldn't know the motivation and wouldn't want 
to question the motivation of anyone involved in this, Representative, 
but I would simply say this, EISs are very expensive and very time 
consuming. And we have to figure out a way either beefing up the 
capacity of APHIS in terms of more people and more resources to handle 
these petitions on a more timely basis, or develop a better way of 
dealing with the industry so the industry can provide assistance and 
help in putting EISs together and having us critically review them. 
There has got to be a way to reduce this time.
    Mr. Peterson. Do you think you have the authority to implement 
Option 3?
    Secretary Vilsack. I think that the statute indicates that we have 
three decisions that can be made with reference to any petition. One is 
to say we are going to continue to regulate it, another is to say we 
are not going to regulate it at all, and the third is we are going to 
deregulate it in part. So I think we have those three authorities. I 
think that is fairly clear under the statute. We have to make sure that 
whatever option we choose we do it in a way that is consistent with the 
science. We understand that, we appreciate that, and we know that that 
is our responsibility.
    Mr. Peterson. So at this point, the Department, you don't think you 
need any additional authority or this Committee needs to be involved in 
looking at the Act to make changes to try to accommodate what you are 
trying to do?
    Secretary Vilsack. I wouldn't say that you don't need to look at 
the Act. I mean, the reality is this Act was enacted I believe in the 
early 1980s, and we have seen a tremendous expansion of this technology 
and we have seen these conflicting interests being raised. I think that 
certainly merits a review. I am not in a position today to suggest 
specific changes, but I think the clearer the direction is to us in 
terms of the Environmental Assessment, the EIS, do you want to continue 
to give us options? If so, we are going to continue to make decisions 
pursuant to that framework. Are there ways in which we have a set of 
regulations that are pending right now relative to noxious weed? That 
might be something that you would want to take a look at as well.
    Mr. Peterson. Thank you. Thank you, Mr. Chairman.
    The Chairman. Thank you, Ranking Member. And we are now at the 
second bell on the floor votes. Mr. Secretary, if you would indulge us, 
we are going to recess for a few minutes, go vote, and come right back, 
sir.
    Secretary Vilsack. I will be here.
    The Chairman. Thank you very much.
    [Recess.]
    The Chairman. The forum will reconvene. I will now recognize the 
gentleman from Virginia, Mr. Goodlatte, for 5 minutes.
    Mr. Goodlatte. Thank you, Mr. Chairman.
    Mr. Secretary, welcome. We are delighted to have you back. I want 
to follow up on the line of questioning from the Ranking Member, Mr. 
Peterson. To review the timeline, USDA did an Environmental Assessment 
resulting in the determination of substantial equivalence. USDA then 
got sued. After the suit, the agency took 4 years to complete an 
Environmental Impact Statement that, while though admittedly a more 
comprehensive document, came to the exact same conclusion. This seems 
to me to be an expensive and time-consuming process to come to the same 
conclusion. To the extent that we are scrutinizing the current 
statutory framework, shouldn't we be looking at ways to eliminate 
unnecessary procedural steps?
    Secretary Vilsack. Representative, I share with you the concern 
about the time, and I share with you the concern about the length of 
time it has taken, which is why, if I could--if you could put the chart 
up that shows the process that we have; no, not that one, the process. 
It is hard to see, but I think you have copies of this. This is the 
process that we have to go through with reference to an EIS, which is 
one of the reasons why it takes time. And the concern I have is that we 
are now faced with 23 applications, and the number of applications is 
increasing at a rate of five to ten a year. So we have to figure 
something out to continue to do what we need to do and what we are 
directed to do under NEPA, and what we are directed to do under the 
Plant Protection Act. We have to figure out a way to do it more 
quickly.
    Mr. Goodlatte. Would you be willing to work with this Committee to 
look at legislative solutions to that?
    Secretary Vilsack. We are willing to work with committees, we are 
willing to work with the industries. We are willing to work within 
USDA, as we are in process improvement. The statute directs us to make 
decisions within 6 months and it would be great if we did that, but we 
haven't. And I am deeply concerned that the length of time, part of 
which is resulting in litigation, the length of time is just, it makes 
it more difficult to innovate.
    Mr. Goodlatte. Thank you. Let me ask another timing issue. I have 
been a supporter of biotech for a long time. I have been out to the 
gentleman from Illinois' district and looked at some of the amazing 
things that a company in his district is doing. I am not opposed to the 
conversations that have occurred at your request with the biotech and 
organic industry. I think that is good. I am concerned about the timing 
of those conversations, however, roughly a month before Roundup 
Ready' alfalfa needs to be approved to meet their spring 
2011 planting deadline.
    We are mixing a marketing issue of the standards different 
industries have regarding the level of adventitious presence, AP, that 
is acceptable in their alfalfa crops, basically concerns of the organic 
industry, with the plant pest safety review that is the focus of APHIS' 
approval of biotech products.
    Can you explain why those conversations were not held earlier, and 
how we separate those two issues to preserve our science-based 
regulatory system? When we start confusing issues related to marketing, 
people want to distinguish their organic crops from regular crops and 
the products that come from those. I certainly understand that, but 
that is a separate issue from the safety issue that is APHIS' 
responsibility, and we need to move ahead.
    Secretary Vilsack. Let me, first of all, reassure the Committee 
that we understand the time constraints that we are under, the 
importance of making a decision in a timely fashion, and we intend to 
make that decision in a timely way. We have a review period that 
expires, I believe, on January 24, and I have directed staff to make 
all efforts to get a final record of decision prepared as quickly after 
the 24th as possible, and we will do that.
    There are so many complexities to this issue, Representative, that 
there needs to be an extended conversation about a variety of issues. 
Part of what has occurred as a result of this dialogue is that in a 
number of areas, the parties have come together. They had not, many of 
them had not talked to each other before. They have come together. They 
have identified areas where they agree. They have identified areas 
where they clearly disagree, and they have also identified areas where 
there needs to be further dialogue. And what we have to do at USDA is 
figure out a process consistent with the Administrative Procedure Act, 
or outside of government, to have some kind of formal process by which 
this conversation will continue, because there are a multitude of 
issues that need to be looked at so that we streamline the process, we 
encourage innovation and, at the same time, we respect the property 
rights of every farmer who wants to farm how they see fit.
    Mr. Goodlatte. I understand. But you need to keep the marketing 
issues separate from the safety issues. And we should not be--when the 
safety issues have been addressed, we should not hold up farmers who 
are depending upon being able to plant during the spring planting 
period from being able to move forward and do that, and I think that is 
the problem.
    Secretary Vilsack. Just to be clear about this, the time period, we 
had to wait--by our rules and regulations we had to wait at least 30 
days after the final EIS was submitted to allow folks to review and 
provide whatever additional input that they wanted to provide. So this 
30 day period is still running and will expire on the 24th of January.
    Mr. Goodlatte. But we could act then and still be in time to plant 
crops.
    Secretary Vilsack. And it is the intent that we will act very, very 
shortly after that.
    Mr. Goodlatte. Thank you Mr. Secretary. I have one last question, 
with the forbearance of the Chairman. I am the new Chairman of the 
Subcommittee on Intellectual Property, Competition, and the Internet on 
the Judiciary Committee, and I have been watching the anti-trust 
hearings that your agency has conducted with the Department of Justice. 
You focused one of those hearings on the seed industry and need for 
more competition.
    I would recommend that this agency commit more resources to 
ensuring that when we have new entrants to the seed industry, instead 
of having them navigate a system that has resulted in significant 
losses and an agency that took 46 months to complete a court-ordered 
Environmental Impact Statement, we must do more to encourage this type 
of investment, and I fear we are sending the wrong signals.
    Secretary Vilsack. Well, that is one of the reasons why we 
instructed the APHIS staff to take a look at process improvement, to 
streamline the process. That is one of the reasons why we are taking a 
look at how we might be able to work with the various industries to 
facilitate the Environmental Impact Statement. It is one of the reasons 
why we are proposing a change in regulations that would, for some, 
limit the amount of work that we had to do in this area. So, I mean 
there are a number of things that we are doing right now, 
Representative, to try to shorten the process. We don't disagree with 
you that it has taken too long and we are trying to figure out ways to 
shorten it.
    Mr. Goodlatte. Thank you very much, Mr. Secretary.
    The Chairman. The chair now turns to the gentleman from Oregon, Mr. 
Schrader.
    Mr. Schrader. Thank you, Mr. Chairman. Thanks for being here, Mr. 
Secretary, good to see you.
    If you could just comment briefly, I am a big supporter of 
genetically engineered products here in our country. To me it seems 
pretty obvious it is the only way we are going to be able to feed the 
world. To me it seems like an avenue for energy independence, 
particularly for our ag community to be able to compete in that arena.
    Could you comment very briefly on those two issues as far as the 
role that GE crops play?
    Secretary Vilsack. Well, Representative, one of the things that I 
have been trying to encourage folks outside of the United States to 
recognize is that we have a growing world population that continues to 
expand. The amount of land capable of producing crops is not 
necessarily going to grow. The chances are that it could very well 
shrink with urbanization and the spreading of cities. And that is why 
we are looking at a multitude of ways to try to deal with this issue of 
do we have food security, will we have food security, how will we 
accomplish it. One way to do that is by figuring out how to increase 
productivity of crops. And there is no question that biotechnology has 
increased productivity.
    In my lifetime, for a variety of reasons, including biotechnology, 
corn production has increased 300 percent, wheat production nearly 200 
percent, and soybean production over 200 percent. So it is a 
productivity issue.
    It is also an issue relative to the environment. I think there is 
genuine concern about water quality, genuine concern about issues 
concerning soil, and biotechnology is one strategy that we are looking 
at to reduce the amount of pesticides and chemicals that are required 
in order to continue to have the productivity. So there are 
environmental issues.
    And clearly, our capacity to be more productive has resulted in our 
ability to export. And I think this year is a good example of the 
dramatic impact that exports can have on farm income and on job growth. 
One billion dollars of ag exports equals 8,000 to 9,000 jobs, and this 
year we are looking at a record amount of ag exports. So there is an 
economic concern, there is a food security concern, and there are 
environmental concerns.
    Mr. Schrader. Thank you very much.
    If I listen to your testimony and read some of the concerns from 
the different trade groups, and listen to some of my farmers back in 
the Willamette Valley in Oregon, I see this as actually a little bigger 
issue. It would appear that the courts, either willingly or 
unwillingly, are being thrust into the role of agriculture decision 
maker when they, frankly, don't have a lot of expertise in that area. 
But I see beyond genetically engineered crops that allow us to feed the 
world and provide a better environment. It would appear that this issue 
of coexistence goes beyond that.
    And I will give you an example. In my valley there is a big concern 
about the growth in the canola industry for ethanol and other great 
products. But at the same time, there is actually a pest that is common 
in canola, that if it was to take root would also affect a lot of the 
brassicas that are grown in the valley in my area. So beyond just the 
GE issues, to me this coexistence thing is sort of real, and I don't 
know how we get at that; perhaps giving you more authority, as has been 
alluded here. But it seems to me we have a choice. Either the courts 
will dictate how this is done, or USDA will hopefully come up with some 
better solutions that are more ag-friendly as to how this should be 
done. Could you comment on that?
    Secretary Vilsack. Well, I think this is a conversation that is 
really important to American agriculture. I think it is also important 
to rural development. If you give farmers and growers and ranchers a 
multitude of choices, then they are in a position to figure out what is 
the very best choice for their operation, the very best choice for 
their family and their community.
    I think we at USDA need to be in the business of trying to figure 
out how we can facilitate and make those choices easier, and how we 
recognize and respect the property rights of individual farmers. That 
requires us to help create a level of trust between the various aspects 
of agriculture so that they feel, as is the case with some of these 
products, where they feel it is appropriate and necessary to talk about 
the various--to communicate. I mean, one of the keys here to different 
production systems being able to work side by side or in the same 
community is the capacity to communicate. I think that happens at the 
local level. I think farmers go across the road and talk to their 
neighbor. I think we have to figure out how to replicate that in a more 
global sense, and that means creating some kind of forum, some kind of 
process where we can deal with these complex issues. Whether it is 
legislation or regulation, or the market or a combination, I think we 
have to have this conversation, and that is my goal here is to let's 
have the conversation, because I don't know that anybody disagrees that 
we have to have that. And we have to figure out a way to do it and 
build those lines of trust. And you know, maybe we were unartful in 
this process, but at least we are all talking about it.
    Mr. Schrader. Thank you. I yield back.
    Secretary Vilsack. Thank you. The chair now turns to the gentleman 
from Illinois, Mr. Johnson.
    Mr. Johnson. Thank you, Mr. Chairman. Let me, by way of a 
parenthetical, just add one option to my distinguished colleague and 
good friend from Oregon's options as to how best to control this arena. 
He has alluded to the Department and the courts. I would add to the mix 
our market system, our free enterprise system, our system that has 
served this country for about 250 years and made the agricultural 
sector the envy of the world. And I would suggest, as a philosophical 
matter, that the more we go down the path of unnecessary regulation and 
the more we exceed what I think is either statutory and/or commonsense 
authority, the more we are going to diminish our agricultural sector 
and its spot in the sun.
    And I think you would agree, Mr. Secretary, in a time of a failing 
world economy and a difficult economy here at home, we can look to our 
agricultural sector as one that has not only been a bright spot but 
whose progeny throughout the economy has been very, very good for us. 
Just a parenthetical comment.
    Let me just ask a couple of questions and then just follow a stream 
of consciousness, if you will, that will carry me through my 5 minutes. 
You had indicated in response to a question before that you believe 
that the Department has statutory authority to regulate plant-based 
biotech crops. Can you specifically point to the portion of the United 
States Code that gives you that authority?
    Secretary Vilsack. CFR Part 340, section 340.6.
    Mr. Johnson. Which provides?
    Secretary Vilsack. Essentially indicates----
    Mr. Johnson. Not essentially. It provides what?
    Secretary Vilsack. The regulations direct the Department to have 
one of three options that it considers.
    Mr. Johnson. Do you want to provide that for us for the Committee, 
because there are certainly a good many people, including myself, a 
good many others in this sector, who do question the statutory 
authority of the Department. Not directing this to you, Mr. Secretary, 
but I think it is endemic of a problem throughout our system today 
where, when we go home, as we are in about 25 minutes, for the weekend, 
then the government is controlled by people who are unelected and whose 
statutory authority is somewhat questionable. So I do question that 
authority. And I would like to see your, at least your indication of 
what you believe that authority is.
    Let me ask if the Department has calculated in any way, the 
economic impact that these new regulations on alfalfa, on farmers, 
specifically, what the impact is now and what it will be down the line.
    Secretary Vilsack. There has not been a specific economic analysis, 
Representative, if you are talking about a thorough and a complete 
analysis that would normally require our Chief Economist to get 
engaged. There has been a recognition that what is being discussed in 
the various alternatives is, in some parts of the country, in a sense, 
already being done by the industry.
    When you talk about stewardship contracting, for example, and you 
distinguish between the various pollinators that are involved with 
alfalfa and you distinguish various zones and ranges of protection, 
that is already in a number of stewardship contracts that are being 
considered. So what we are talking about is an extension of that.
    Now, there has been some indication during the course of the review 
process, feedback to us, that a significant percentage, as much as 20 
percent of the country, could potentially be impacted by this. I have 
not had a chance to verify whether that is accurate or not.
    Mr. Johnson. So the answer is there may have been some vague 
assessment, but you certainly can't provide that for us today.
    Let me go back to your answer to a previous question when I asked 
you the question as to the basis for the Department's statutory 
authority. When I went to law school, I believed, and I still believe, 
although I haven't practiced for a while, that the CFR to which you 
made reference is not the statute. Those are regulations. I am talking 
about the specific statutory language passed by the Congress that 
enables you to extend your authority. CFR is not statutory language, 
Mr. Secretary.
    Secretary Vilsack. Well, it is the Plant Protection Act.
    Mr. Johnson. Well, what you quoted for us was not statutory 
authority. It was regulatory action, and that is my very point. 
Regulatory actions are not statutory authority. And my concern is that 
we are now extending into significant new areas the path that can lead 
from alfalfa to wheat to corn to soybeans, which would have dramatic 
impacts, dramatic, staggering impacts on American agriculture. And I 
would suggest that this is being done with at least questionable 
statutory authority, and I would like you to provide for us what that 
authority is. And if, in fact, you think this Congress needs to 
buttress up or limit or expand that area, then we certainly would have 
an opportunity to look at it. But I think this body, and not unelected 
bureaucrats, ought to be the people who are making those regulations 
and laws for American agriculture.
    Secretary Vilsack. Congressman, I would be happy to provide you 
portions of the Plant Protection Act under subtitle A, section 411 and 
others. I would be happy to provide that to you.
    USDA's authority to regulate genetically modified crops is derived 
from the Plant Protection Act (PPA), and the Animal and Plant Health 
Inspection Service (APHIS) currently carries out its biotechnology 
regulatory program under 7 USC 7701-7786 of the PPA. Additionally, 
APHIS prepared and published a proposed rule (the comment period is now 
closed), which solicited comments on the question of whether its 
biotechnology regulations should include use of the PPA's noxious weed 
authority.
    Mr. Johnson. My last question is, do you believe--and I do 
appreciate your being here with us. I appreciate your previous calls, 
your courtesy to me. I think your Department is doing its very best. We 
may have a little philosophical difference about what ``very best'' 
means, but I do appreciate your good faith.
    And my last question is, do you believe that these new regulations 
that we are looking at could well become a precedent for a whole wide 
variety of new biotech crops, or are you going to limit this to 
alfalfa?
    The Chairman. The gentleman's time has expired. If the Secretary 
would like to answer, of course.
    Secretary Vilsack. Honestly, one of the things that I have learned 
in this process is how unique and significant the various crops are 
that are being subject to this review and regulatory process. I would 
not want to hazard an opinion today that anything we do on any of these 
decisions, whether it is sugarbeets or whether it is alfalfa or whether 
it is corn, or whatever it might be, is necessarily precedent setting. 
I think what we have to follow is the precedent that is fairly clear, 
and that is that we have to do this in a timely way. We have to do it 
in a science-based way, and we have to do it within the framework of 
the rules as they exist and as you all have legislated, and that is 
what we intend to do.
    The Chairman. The chair now recognizes the gentleman from Iowa, Mr. 
Boswell, for 5 minutes.
    Mr. Boswell. Thank you, Mr. Chairman. I too would like to join with 
Mr. Peterson in congratulating you on your chairmanship, and knowing 
something of your background, I think that we will communicate, and I 
realize that, not too much different than I, back home is a lady named 
Linda that is kind of looking after the herd. But anyway, so much for 
that. I appreciate it.
    Mr. Secretary, we went through, in our state, a process of farmers 
market, and we have seen it balloon and go on and on and on, and I am 
leading up to a point I want to make here. Unbeknownst to me, 
unexpected, one of my granddaughters, in a very urban setting, has 
started a market, door-to-door organic food, and it looks like she is 
going to make it. Recently, another grandchild came out of an urban 
setting in a different place and said they would like to try some 
farming, but he wants to garden; truck batch is what we call it. So I 
took an old feed lot and I plowed him up an acre. I don't know how that 
is going to work out just yet.
    I have been kind of maintaining for a while that there is the 
market out there for those that want the organic-type foods, and more 
power to them. We don't object to that. But I feel like that we must 
keep our course on genetically approved science. I have been saying 
this for years with Iowa State University there, that we have to use 
the science to feed this population, like Mr. Schrader said. It is 
growing at a speed that we can't really get a grip on, it seems to me. 
And we are going to see some demands that we don't even think about, so 
we have to use the science. I feel that reasonable people can sit down 
and work this out. There is a place for each. And I am going to stay 
with that hope. I am kind of an eternal optimist since I am a farmer, 
so I am going to keep that going.
    But I think that we have to keep the science in this. And we have 
to work this out because the demands of this hungry world are growing 
at a pace that is almost unbelievable. And so we have quite a 
challenge.
    And with that, I just wonder what your reaction is. One of our 
questions about, if you choose Option 3, what do the other agencies 
feel about this; the coexistence of this in general? In particular, how 
does the proposed partial deregulation fit with the trade policies 
taken on biotech by our negotiators in the WTO? Do you have any comment 
on that?
    Secretary Vilsack. Representative, we are very sensitive to the 
issues that you have raised about trade and about a rules-based and 
science-based system. As long as the review process has not expired, I 
don't think it would be appropriate for me to suggest what we are going 
to decide or what the nature of our decision is going to be. But I do 
want to reassure this Committee that we understand and appreciate all 
of the issues that you are raising with your question, and we will take 
those, and should take those into consideration in the decisions that 
we make.
    The trade question is complicated because there are a number of 
trade issues here in addition to the WTO. There are markets that we--
with non-GE products and organic products that are also subject to 
trade discussions and subject to trade agreements, market agreements, 
and so forth, that are pretty profitable for folks, and we want to make 
sure we preserve those export opportunities.
    The one message I have gotten from this Committee that has been 
very consistent, whether it is a Republican or Democratic speaking to 
me, is that you want us to focus on exports because you see this as a 
way of increasing farmer income. And I agree, and we have done that and 
will continue to do that. That is the reason this conversation is so 
important because it creates options. It allows farmers to do with 
their land what they wish to do. And we have to figure out how we build 
the level of trust and the communication process, whether it is inside 
or outside of government, how we do that in a way that allows the 
genetically engineered crop to be grown in one area, the organic crop 
to be grown in another area, the non-GE crop to be grown, and how they 
can all sort of live in the same world, because these are great market 
opportunities, all of them. They are all great market opportunities.
    Mr. Boswell. I appreciate that. I think they are beholden to all of 
us to try to say to the folks engaged, talk to each other. And there 
seems to me like good sense tells me there is room for each. But I am 
signed on to the letter we sent you, a bunch of us sent you a while 
back. And we have to use the science, or I don't see how we feed this 
world we live in.
    Secretary Vilsack. There is no disagreement on that.
    Mr. Boswell. Okay. Thank you very much. I yield back.
    The Chairman. I now recognize the gentleman from Texas, Mr. 
Conaway, for 5 minutes.
    Mr. Conaway. Thank you, Mr. Chairman.
    Mr. Secretary, before I get to the question I thought I was going 
to ask you, your response to Mr. Johnson's question about the economic 
impact on alfalfa, that you had no idea what this might or might not 
do, is startling. Did I misunderstand that?
    Secretary Vilsack. With respect, that is not quite what I said.
    Mr. Conaway. Okay. Help me understand.
    Secretary Vilsack. He asked if there was an economic analysis, and 
I wasn't certain whether he was talking about an extensive economic 
analysis that would be the Chief Economist's office. We obviously 
understand and appreciate because, in the marketplace today, there are 
stewardship contracts already in place. And part of the stewardship 
contracts, I mean, there is a double-edged sword here. The economic 
analysis can go two ways. If you don't have protections, how does that 
impact and affect the capacity of non-GE crops and organic crops to the 
market?
    Mr. Conaway. You have made those assessments; you have that 
information available to you, that you have some sense of what the 
economic impact is of the various routes you go?
    Secretary Vilsack. We have an understanding and appreciation of the 
impact. But it can't be just one aspect of this. You have to look at 
the economic impact on all production.
    Mr. Conaway. Yes. Well, I was thinking that 8 years of testing on 
alfalfa already and 6 years of this process, surely during that 
Environmental Assessment, Environmental Impact Statement, somehow you 
figured out there were some economic issues involved in the deal.
    Secretary Vilsack. Well, part of the Environmental Impact Statement 
is to take a look at a variety of issues. That is why it is 2,300 pages 
in length.
    Mr. Conaway. I am not sure length represents good.
    Secretary Vilsack. I am not suggesting it was good or bad. I am 
just suggesting it was lengthy.
    Mr. Conaway. Okay. A couple of days ago our President, in an op-ed, 
and I think an Executive Order, began to talk about the impact that 
regulations have on jobs, on everything. Where does all of this--where 
does that Executive Order have an impact on what you are doing with 
this and the broader issues, if you are trying to deal with 
regulations?
    Secretary Vilsack. I think it supports the directive I gave to 
APHIS some time ago to take a look at ways in which we could streamline 
the process in terms of getting approvals. I think it falls four square 
with the proposals we are making in terms of revising our rules to 
create more flexibility, to short-circuit some of the process in areas 
where there is probably little or no disagreement, to focus our 
attention and resources on where the risk may be greatest. I think it 
is very consistent with the President's directive, very consistent.
    Mr. Conaway. Okay. What I heard you say is that we are going to 
work on our processes. What I was hoping the President intended was to 
look at the impact that your regulations have on whatever it is you are 
trying to regulate, and that impact would be the minimum amount needed 
to do whatever it is you need to do. I understand streamlining your own 
stuff and trying to shorten that. Great. But the impact on the 
industries ought to have somewhere in that, I think that is what he was 
alluding to.
    Secretary Vilsack. You are right. Time is money, so the process 
does matter. And we are dealing with a variety of sectors of 
agriculture here that are impacted by this decision. So it is not just 
one aspect of agriculture that is impacted. It is not just GE, it is 
not just non-GE, it is not just organic. It is actually all three.
    Mr. Conaway. Okay. There have been reports that, as a part of one 
of the solutions, I guess the partial regulatory solution would involve 
a compensation fund. Can you give us any sense of who runs that fund, 
who funds that fund, and who gets money out of that fund?
    Secretary Vilsack. Just to be clear about this, I don't know that 
that has been discussed as part of the discussion relative to alfalfa 
specifically. It is part of the discussion, as is indemnification 
agreements which are already being discussed in other crop areas in 
this discussion about how we coexist, as well as insurance products. I 
mean, there are a variety of options that are being looked at in ways 
to try to address any economic issues that might be forthcoming.
    Mr. Conaway. Who would house the fund? Hypothetically, who would 
house it and who would fund it and who would get money out of it?
    Secretary Vilsack. None of those questions have been asked or 
answered. The point of this is that these are preliminary 
conversations.
    Mr. Conaway. Well, actually they have been asked at least once. I 
just asked it. Go ahead. I am sorry.
    Secretary Vilsack. This is a serious conversation, and I appreciate 
the opportunity to talk about this, and if I can just take 30 seconds 
of the Committee's time. When I was up in North Dakota, I had an 
opportunity to visit with sugarbeet growers, and these poor guys are 
just sort of scratching their head. All they want to do is farm. And 
they are confused and concerned about the complexity of the process 
that they find themselves in. And we talked about ways in which a 
system of trust could be created so that everybody could do, on their 
land, what they wanted to do without interference and without being 
damaged.
    I mean, the reality is if you have an organic crop, whatever it 
might be, and something happens to that organic crop that makes it no 
longer organic, there is an economic consequence of that. And the same 
is true with identity-preserved non-GE.
    And so we started just talking about ways in which that issue could 
be looked at without going into great detail, without trying to figure 
out every aspect, all ``t''s crossed and ``i''s dotted, compensation 
funds, indemnification agreements, insurance products. All of that 
needs to be part of an extended conversation that we need to have in 
this country so that everybody can do what they want without worrying 
about necessarily being economically damaging to their neighbor or 
being damaged as a result of something somebody else does. And this is 
not picking sides. This is trying to figure out how do we have all 
aspects of agriculture be able to prosper in this country.
    And we would be happy to work with folks who want to look at any of 
those options, or there may very well be a better fourth option or 
fifth option or sixth option. The point of this is, let's at least have 
a discussion about it to see what works, what doesn't work, what is a 
good idea, what is a bad idea. And that is essentially where this is, 
Congressman. It is not a well----
    Mr. Conaway. Let me set the record straight. I didn't intend to 
make light of the seriousness of this issue by correcting your 
statement. That was not my intent. If you want to put us on that kind 
of a footing, we can. While the discussions go on, ad infinitum, while 
your processes go on, ad infinitum, I understand, you are saying all 
the right things. You are saying exactly what everybody wants said, 
except the farmers are out there waiting on a decision. We have a batch 
of Roundup Ready' alfalfa seed that will go bad, I am told, 
before too much longer, while we have these discussions, these extended 
discussions on these issues. So I agree, we need to get this done. But 
sooner rather than later, and let's don't use the constant conversation 
of delay from making a decision and moving forward.
    Secretary Vilsack. Representative, as you know, there is a 30 day 
review period, and we are still in that period. So we have----
    Mr. Conaway. But the conversation you were proposing would seem to 
me to be much, much longer than 30 days in terms of third, fourth, 
fifth and sixth options.
    Secretary Vilsack. Well, that is a conversation that is larger than 
one crop.
    Mr. Conaway. Right.
    The Chairman. Both gentlemen's time has expired. I turn now to the 
gentleman from Pennsylvania, Mr. Thompson, for his 5 minutes.
    Mr. Thompson. Thank you, Mr. Chairman. Thank you, Mr. Secretary. It 
is always good to see you. Thanks for joining us for this forum.
    As you know, I have been following the issue of Roundup 
Ready' alfalfa for some time. I spearheaded two 
Congressional letters on the SU. One I sent, actually going back to 
November 2009, asking you and your agency to prioritize the completion 
of the Environmental Impact Statement for the Roundup Ready' 
alfalfa. And I sent a second letter in July of 2010, asking you to 
issue a partial deregulation of the crop as a result of the Supreme 
Court case in favor of the alfalfa. And a partial deregulation would 
have put the crop back on the market while the USDA completed the EIS 
process.
    Now it is 2011 and we are still talking about getting this product 
back on the market. The EIS process took 46 months to complete. And in 
the middle of extremely low dairy prices, this product obviously would 
have been helpful to my farmers and dairy farmers all across the 
nation, many who grow alfalfa on their farms.
    We have had historically low milk prices during the last few years. 
Many dairy farmers grow their own alfalfa for use for their dairy, and 
alfalfa growers have self-reported $100 increase in profits an acre 
when using Roundup Ready' alfalfa because of the increased 
yields as a result of the decreased weed pressure.
    And I think it is important that we look at this toll for farmers 
and we think of the dairy industry specifically and how we must commit 
our resources that help them during this crisis.
    Now I understand that lawsuits are certainly one of the reasons we 
don't have that product available to farmers. And one of the reasons 
some groups are successful in their cause to oppose the introduction of 
biotech crops is because USDA has been slow to respond to the rulings 
of these court cases. This technology obviously will no doubt have a 
positive impact on dairy farms, and I am very concerned that many dairy 
farms may not be able to reach their demand if Roundup 
Ready' alfalfa is not deregulated in time for planting 
season.
    Actually, it is--I guess the fact I represent Punxsutawney, it is 
appropriate to say this feels like Groundhog Day to me. I mean, 
November 2009 that was my letter, preparing for the purchase of seed 
for the 2010 planting season, and here we are in 2011.
    Has USDA--and I know you reflected a little bit on the economic 
impact already. But just to clarify, has USDA been taking economic 
impacts like this into account when coming to their decision?
    Secretary Vilsack. The decision we have to make, Congressman, is 
consistent with the Plant Protection Act. There are two different 
issues here. There is the Plant Protection Act, which is really 
designed and directing our decision making process. There is the, in 
this case, the court-ordered EIS under NEPA which is a completely 
different process. We were trying to comply with the court order in 
terms of completing the EIS in a way that was comprehensive enough that 
didn't lead necessarily to yet more litigation and more delay. I am 
certainly sympathetic with your concerns about the dairy industry. That 
is the reason why we put a dairy council together. It is the reason why 
we took steps in 2009 to help that industry out, and we are looking 
forward to the diary council's recommendation in March of this year, 
working with this Committee to make sure that we create greater 
stability in that industry.
    There are a variety of things that probably need to be done in 
order, and that may be a subject of another conversation between the 
two of us and this Committee, and I look forward to that.
    Mr. Thompson. The court challenges, I haven't looked in great 
detail with that, that raised these red flags and delayed this process. 
Were they specifically related to the questioning of the science or the 
safety, or was it more market issues and competing market issues?
    Secretary Vilsack. It was compliance with NEPA, whether or not an 
Environmental Assessment was adequate; and, if not, requiring and 
directing that an Environmental Impact Statement, which is far more 
extensive and comprehensive, needed to be done. That is what we have 
done. That is what we recently filed.
    Mr. Thompson. Okay, one other last question. It seems to me that if 
the third option is put into place, it would create a regulatory 
nightmare for USDA. Maybe that is just my projection. But how do you 
see USDA actually administering such a policy? And frankly, how much 
time do you project would be required to fully implement the third 
option, which that time for implementation I see just as additional 
delay and financial burden on our dairy farmers, or farmers in general, 
from accessing this scientifically proven, safe technology.
    Secretary Vilsack. Congressman, any decision we make, we will be 
prepared to fully and appropriately implement and do in a way that will 
not interfere with the capacity of folks to farm on a timely basis. We 
are well aware of the time constraints that we are under relative to 
seed. You know, the reality is, as you well know, the safety of these 
products has never been under question and it isn't under question at 
all. And in my opening statement I made that, and I want to make that, 
clear. The safety of this product has not been questioned in the 
lawsuits. It has been a process and a procedural set of issues.
    Mr. Thompson. Thanks, Mr. Secretary. I appreciate your time. Thank 
you, Mr. Chairman.
    Mr. Conaway [presiding.] The gentleman from Indiana, Mr. Stutzman, 
5 minutes.
    Mr. Stutzman. Thank you, Mr. Chairman. And thank you, Mr. 
Secretary, for being here.
    I am new to Washington and it is good to be here, and I enjoy the 
conversation so far. But I am getting up to speed on this particular 
issue. But just listening to the conversation today, I guess I just 
have a couple of questions more on practice.
    Being a practicing farmer in northeast Indiana, we actually were 
raising organic crops, but also raised seed corn. And so, I definitely 
understand that there is a push for raising organic crops. And I 
believe that and I think it is good practice. But I know for our 
particular operation, it got to the point where it became an economic 
decision as well.
    And I guess my question would be, more towards some of the 
proposals that have been tossed out, and maybe you could comment on 
them, maybe in particular with genetic seeds, modified seeds, that 
there be buffer zones potentially. Could you touch on that a little bit 
and where that conversation is going, because we have had a lot of 
those conversations back at the state legislative level about CAFOs and 
setbacks. And it really does create a lot of problems.
    Secretary Vilsack. Well, the industry itself, within the industry, 
has had these conversations. And initially, the industry focused on 
alfalfa on best management practices and with a contractual 
relationship between the provider and the producer. Over time, it 
evolved into something beyond best management practices, or in addition 
to best management practices, which are stewardship contracts which 
reflect sort of the unique nature of alfalfa and the pollination that 
takes place and the type of pollinators you use. And in some cases, 
set-back distances or zones, if you will, were created in some areas. 
In some states there are actually areas where there has been agreement 
that no GE crop will be grown because of the potential impact.
    So those conversations were taking place, have taken place. And 
what is taking place now is an extension of those conversations in 
which those who were not necessarily party initially to the 
conversations are now talking to each other. And what we know is that 
there is now a real desire to ensure that there will always be seed 
available for whatever production system you want to embrace. What 
prompted a lot of concern was, as GE alfalfa is utilized and as its use 
is expanded, will we get to a point where that will, at some point in 
time, today or tomorrow, jeopardize the ability to have seed to produce 
organic or non-GE? That is a constructive conversation to have, because 
it informs USDA in terms of the tools we might be able to bring to bear 
in terms of germplasm and seed purity that might reassure folks that we 
are not going to lose our capacity, whatever choice you might want to 
make as a farmer. So that has sort of been the nature.
    And the question then is, if you have a stewardship arrangement, 
the design of it, the verification of it, the industry is in the 
process verifying and auditing, is that sufficient? Is it adequate? 
Some folks say yes, some folks say no. But there has been a 
conversation about that and there has been a good exchange of 
information, and I think the beginning of a trusting relationship in 
terms of certain elements have been brought together that weren't 
together before all of this.
    Mr. Stutzman. So did I catch you right that there are several 
states that already have taken action in setbacks or----
    Secretary Vilsack. There are areas. California is one area, one 
state where there are areas that have been designated as sort of off 
limits. But there are also stewardship contracts where producers agree 
to operate under a certain set of conditions.
    Mr. Stutzman. Privately?
    Secretary Vilsack. This is a private arrangement, a contractual 
arrangement. And that raises the issue of, okay, how was that designed, 
is that adequate given the pollination system that you use? Is that 
adequate? Is it 3 miles, is it 5 miles, is it 900 yards? What distance 
is appropriate? And what supports that, and how do you verify that that 
is being done?
    And that then gets you into a whole complicated discussion of 
tolerance levels and the like. It is a set of complicated questions, 
complicated issues, that I think people are taking very seriously.
    Mr. Stutzman. Well, I know in our operation we are starting to move 
out of some of the organic production just because of weed pressure and 
because of rotation in crops and things like that. And I know that if 
we were starting to deal with setbacks, it would definitely limit our 
flexibility in the crops that we would be raising on certain land. So 
that is always a fear of mine, that you start talking setbacks or 
buffer zones, it would----
    Secretary Vilsack. I think every area of the country, every 
operation is, in a sense, somewhat the same and somewhat unique at the 
same time. And that is what makes this so complex is the tremendous 
diversity and opportunity we have in this country to actually be able 
to do all of this. And the question is how do we do it all, 
successfully, without interfering with each other.
    Mr. Stutzman. Thank you, Mr. Chairman.
    Mr. Conaway. The gentleman's time has expired. The gentleman from 
Iowa, Mr. King, 5 minutes.
    Mr. King. Thank you, Mr. Chairman.
    Mr. Secretary, I thank you for your testimony. And I did hear most 
of it. I didn't hear all the exchange between some of the Members so I 
don't want to go over new territory. But I wanted to ask you if you 
would speak to the issue of the message that comes out of here with the 
position that seems to be shaping with the USDA and GMO products. How 
does that echo through Europe where we are constantly seeking to export 
our products over there? And I have charged them myself with using that 
as trade protectionism.
    In your discussions with the U.S. Trade Representative, could you 
give us a sense of how that sounds and what that looks to you from 
where you sit, Mr. Secretary?
    Secretary Vilsack. Well, Congressman, obviously the decision we 
make, if it is within a--if it is justified by the science and it is 
within the rules that we have, I think that is very consistent with the 
positions we have taken on the international scene. The conversation 
that we are having today, the conversation that has been taking place 
in various places throughout the last 30 days, is very helpful in the 
sense that it allows us to begin to; A, celebrate the diversity of 
American agriculture; and, B, also gives us another opportunity to 
reinforce the positive aspects of biotechnology, which we need to do 
more of on the international stage.
    Mr. King. Do you see the Europeans starting to perhaps back away a 
little bit from their relatively hard line on GMOs?
    Secretary Vilsack. I want to be optimistic about that, Congressman. 
The resistance has been pretty consistent and pretty longstanding. I 
think everyone in this world who is serious about agriculture sees what 
we all see, which is six billion, seven billion, eight billion, nine 
billion people. How are we going to feed them? And we can't feed them 
unless we make the best use of all of our resources and that we do it 
in a way that doesn't necessarily overtax our capacity, our water 
resources, which is also an issue, and doesn't compromise our ability 
to have clean water with pesticides and chemicals. So biotechnology is 
part of the answer.
    Mr. King. Well, Mr. Secretary, let me say something and it is 
perhaps better that I say it, and I am not seeking to put words in your 
mouth, just my own. But as I observe what has gone on in Europe with 
the GMO protectionism there, it looks to me like it started out to be a 
political movement that wasn't based on sound science, that got some 
foundation there, and it penetrated through the politics of Western 
Europe, and now it becomes a trade protectionism tool that was spawned 
by a political movement. I won't ask you to respond to that, but I 
wanted to put my view into the record.
    Then I would ask you if the Department has examined the loss of 
economic growth or the economic impact of not having a clear-cut, I 
will say, approval for GMO alfalfa in particular, Roundup Ready.
    Secretary Vilsack. Well, we have had a conversation about this 
before, and I want to make sure I am clear about this. There is an 
indication and an understanding that what is being done in the industry 
today and what is proposed in Option 3 could very well result in some 
areas of the country not being conducive to the growing of a certain 
type of alfalfa.
    On the other hand, there is also a recognition of the economic 
impact that if we don't do this well, that those who are producing non-
GE crops for export, those who are producing organic crops for domestic 
and export consumption may also be harmed. So it is a process where 
there are economic analyses on all three areas.
    Mr. King. Do you happen to have a number that would tell us that if 
there was no conflict between GMO alfalfa and organic alfalfa, if there 
happened to just be no conflict, what is the potential economic 
improvement that we would have from the increased production in the GMO 
alfalfa, if it could be raised any place where it were chosen, without 
an impact on the organic?
    Secretary Vilsack. I don't have that number. And I know that, I 
don't know that it is--I don't know how easy it would be to calculate 
that, because of the fact that people are making decisions every year 
to change their operation.
    Having said that, here is what I can say with certainty; that we 
need the biotechnology and we need the GE crop production. I can say 
with certainty that there is going to continue to be interest on the 
part of U.S. agriculture in adopting and embracing biotechnology. At 
the same time that is happening, there is also a very robust market 
being created, both domestically and abroad, for non-GE crops and for 
organic crops, which creates great opportunities and options for 
farmers. And that is a positive thing for this country.
    Mr. King. I thank you, Mr. Secretary.
    And then just in conclusion, you will be aware of press reports of 
Deputy Secretary Kathleen Merrigan and her record and the way she is 
viewed as having been instrumental in obstructing the approval of 
bioengineered veterinary drugs and also in preventing the inclusion of 
genetically engineered crops under the organic rubric. That I take from 
Forbes Magazine.
    And you understand our concern when we have an individual with all 
of that influence in that position and this subject that affects all of 
the agriculture across the country.
    Secretary Vilsack. I would understand that concern on every Member 
of this Committee with the exception of two, you and Congressman 
Boswell, because you both know me. This decision, at the end of the 
day, is the Secretary's decision.
    Mr. King. Thank you, Mr. Secretary. I appreciate your testimony and 
particularly your response to that final question. Mr. Chairman, I 
yield back the balance of my time.
    Mr. Conaway. Mr. Schilling from Illinois is recognized for 5 
minutes.
    Mr. Schilling. Thank you, Mr. Chairman. Mr. Secretary, good to see 
you, being from Illinois.
    Actually, the questions, like Mr. Stutzman, I am also new to this 
arena, so I just really look forward to serving on this Committee. The 
questions that I did have have already been addressed, so I really just 
appreciate being here and hope to be effective on this Committee.
    Mr. Conaway. Does the gentleman yield back?
    Mr. Schilling. I yield back.
    Mr. Conaway. The gentleman from Arkansas, Mr. Crawford, is now 
recognized.
    Mr. Crawford. Thank you, Mr. Chairman.
    Mr. Secretary, thank you for being here today. I represent the 
First District of Arkansas which, if you know anything about Arkansas, 
we refer to that area as the Delta. And in the Delta we have large 
economies of scale primarily geared toward rice, cotton, and soybean 
production, so this is a sensitive issue for my constituents.
    But let me ask you this. If I were a large-scale alfalfa producer 
and one of my neighbors decided to plant organic alfalfa, neighbor 
adjacent to me, who is responsible for implementing that buffer zone?
    Secretary Vilsack. It would depend on the arrangement that you had 
with the producer of the seed. It could very well be that there is a 
contractual arrangement that you have that creates some responsibility. 
It could very well be that your neighbor needs to know what you are 
doing and needs to understand the impact. I mean, you could reverse 
that question. And that is why we are having this conversation, so that 
there is a clear path and a clear way to know how to respond to that 
question.
    It kind of depends on the circumstances, Congressman. I am not 
trying to be evasive, but it really does depend on your contractual 
relationship and also what your neighbor knows about your operation and 
what decisions your neighbor makes relative to the distance that he or 
she locates, and it depends on pollination. I mean, it depends on a lot 
of issues. So it is very hard to answer that question.
    Mr. Crawford. Okay. With regard to Roundup Ready technology, 
glyphosate-tolerant plants have been on the market for a number of 
years. Is it safe to say, then, the USDA and the FDA have deemed that 
these products are safe for the environment and for human health?
    Secretary Vilsack. There is no question, Congressman, about the 
safety of these products.
    Mr. Crawford. And then final question, has there been a calculation 
that you are aware of how much land would be taken out of production to 
accommodate the needs for buffer zones?
    Secretary Vilsack. Well, obviously that depends on the degree to 
which folks accept this technology, but there has been at least an 
estimate that roughly 20 percent of the land might not be amenable 
under Option 3. That is obviously not true under Option 2.
    Mr. Crawford. And so in those buffer zones that land is taken out 
of production, does that become a conservation program?
    Secretary Vilsack. No, it could very well be other products. It 
could be other crops or it could be other types of--other types of 
crops, it could be livestock or it could be whatever other options are 
available. It is not that you would have to take the land out of 
production totally. It is that you would not be able to plant certain 
types of crops relative to alfalfa in that zone. You wouldn't be able 
to plant GE alfalfa in that zone, as is the case already in some parts 
of the country. We have some areas of the country today where that is 
the case, where producers understand that they cannot use certain 
technologies because of the impact it may have on surrounding crops.
    Mr. Crawford. Okay. I misspoke, and I do have one final question. 
We talk about the economic impact as it applies to farmers, but what 
about the economic impact as it applies to the investment and 
biotechnology? If these products become less appealing to farmers and 
therefore their value goes down, are we going to see a disruption in 
investment in the biotechnology community?
    Secretary Vilsack. This chart reflects, Congressman, all the 
pending regulations.
    If you could put the other chart up. Despite all the difficulties 
we have talked about today, you can see the number of petitions for 
deregulation that have escalated over the course of the last several 
years. One of the great things about American agriculture, as I said in 
my statement, is how innovative it is. One of the under appreciated 
aspects of American agriculture is its innovation. It is one of the 
reasons why it is productive and I think it is one of the reasons why 
we are seeing some success today.
    So I am confident that we are going to be able to figure out ways 
in which we can enhance innovation. That is what this whole process at 
the end of the day ought to be about, and it certainly from my 
perspective what it is about, how do we create innovation, how do we 
foster innovation, and how do we make sure that farmers have choice.
    Mr. Crawford. Thank you, Mr. Secretary. I yield back.
    Mr. Conaway. Mr. Secretary, have there been any organic 
certifications lost as a result of biotech plants crossing over?
    Secretary Vilsack. Let me check with the staff on that.
    We don't know of any. I am going to go back to the office and 
double-check that and make sure.
    Mr. Conwawy. If you wouldn't mind providing that. You do those 
certifications, your shop does, right?
    Secretary Vilsack. Yes.
    Mr. Conwawy. So if you would provide that for the record, I would 
appreciate it. I yield back to the real Chairman. Thank you for being 
here.
    Secretary Vilsack. No. While the National Organic Program 
Regulation (7 CFR Part 205 et seq.) excludes the use of products 
resulting from genetic modifications, USDA-AMS does not consider 
inadvertent trace presence in itself to be a violation.
    NOP regulations do not require withdrawal of crops or land in the 
case of inadvertent GE contamination, but some producers have 
reportedly done so voluntarily.
    The Chairman [presiding.] Secretary, once again thank you for 
coming and sharing your insights and your observations with us. 
Obviously we have a good many conversations that lie ahead and I look 
forward to that and I hope do you too.
    Secretary Vilsack. Thank you, Mr. Chairman. Thank you.
    The Chairman. Since our next panel is coming to the table we would 
like to welcome them, the Honorable Charles F. Conner, President and 
CEO of National Council of Farmer Cooperatives, in Washington, D.C.; 
and accompanied by Bernice Slutsky, Ph.D., Vice President, Science and 
International Affairs, American Seed Trade Association, in Alexandria, 
Virginia. Whenever you are ready.

   STATEMENT OF HON. CHARLES F. CONNER, PRESIDENT AND CEO, NATIONAL 
   COUNCIL OF FARMER COOPERATIVES, WASHINGTON, D.C.; ACCOMPANIED BY 
   BERNICE SLUTSKY, Ph.D., VICE PRESIDENT, SCIENCE AND INTERNATIONAL
                AFFAIRS, AMERICAN SEED TRADE ASSOCIATION

    Mr. Conner. Thank you, Mr. Chairman, for the opportunity to be here 
today. I know the hour is late. I have provided a full statement to the 
Committee, and I would ask that that be distributed to Members of the 
Committee for this forum, and I will attempt to summarize those remarks 
very briefly.
    I am here today on behalf of 3,000 farmer owned cooperatives and a 
broader coalition of very diverse agricultural industry groups with an 
interest in this issue, Mr. Chairman, and we thank you for holding this 
forum today. This is especially timely, given the Department of 
Agriculture's pending decision relative to herbicide tolerant alfalfa, 
and the long reaching effects of that decision.
    I noted earlier Mr. Schrader's remarks, Mr. Chairman, about the 
importance of biotechnology in terms of meeting future food needs of 
this country. I would take that a step further, Mr. Chairman, and say 
that, as I said to Secretary Vilsack at our meeting on December 20th, 
without biotechnology our country would be in some very difficult 
straits relative to our current supply and demand estimates already 
today. We need this technology, Mr. Chairman, and we should be 
encouraging it.
    The development and adoption of these products and the promise of 
new products will make possible the continued availability of safe 
food, feed, and fiber products to consumers to the U.S. and worldwide. 
With 23 biotech crops, Mr. Chairman, in the regulatory pipeline and 
more on the way, it is clear that USDA's pending decision relative to 
alfalfa will have broad implications going forward in the future.
    The acceptance of biotech crops would not have been possible 
without a strong risk-based regulatory approval process that has been 
in place since 1986, and has been based solely on sound scientific 
principals. It has served us well.
    In 2005, Mr. Chairman, APHIS prepared an Environmental Assessment 
for Roundup Ready' alfalfa, as required by the National 
Environmental Policy Act, NEPA, and deregulated the crop under the 
Plant Protection Act. The crop was grown by U.S. farmers quite 
successfully, I might add, for 2 years before a NEPA court suit 
reversed that APHIS decision. I would add for the record, Mr. Chairman, 
that when I say successful I am talking about successful from the 
producers' standpoint. And some of our data suggests that farmers 
producing Roundup Ready' alfalfa were as much as $110 an 
acre better off as a result of growing that Roundup Ready' 
alfalfa. Again, this is technology that we need and need quickly.
    In 2007, the U.S. District Court of the northern region of 
California, San Francisco, required APHIS to prepare a full 
Environmental Impact Statement, due only, Mr. Chairman, to procedural 
concerns over APHIS meeting its NEPA obligations. I want to be clear, 
there was no finding of any deficiency under the Plant Protection Act 
and there was certainly no risk in health or safety identified, and I 
think Secretary Vilsack has echoed that point today.
    In December of 2010, USDA announced the completion of the court-
ordered EIS and said it would make a final regulatory decision under 
the Plant Protection Act possibly later this month. However, in 
preparing this EIS, USDA did choose in an unprecedented way, Mr. 
Chairman, to include an option referred to as Alternative 3, that of 
deregulating Roundup Ready' alfalfa. Alternative 3 includes 
a series of unprecedented conditions such as isolation distances of up 
to 5 miles, other geographic restrictions that would not allow farmers 
to plant, we estimate, on as much as 20 percent or more of the current 
alfalfa acres in this country, and that acreage is as high as 50 
percent in the western part of this country with the restrictions that 
are suggested under Option 3.
    Having made the latter determination, it is clear that USDA is 
obligated, in our opinion, to unconditionally deregulate the crop, the 
alfalfa crop, and has no authority to impose these arbitrary 
restrictions as suggested under their preferred Option 3, in their 
words. Combined with broader policy statements in the EIS, the 
imposition of the conditions on a crop that poses no plant risk sets a 
dangerous precedent for the continued safe development, availability, 
and marketability of new biotech tools. Therefore, we fully support 
alfalfa growers having access to Roundup Ready' alfalfa for 
this spring's planting without conditions posed by the USDA or any 
government agency.
    I certainly can appreciate Secretary Vilsack's commitment to 
address some of the roadblocks that have been placed in the path of 
valuable biotech crops. We all understand that. Where I respectfully 
disagree with the Secretary is on the proper means of removing those 
roadblocks.
    In addition to my experience with the Roundup Ready' 
alfalfa lawsuit while I was at the Department, I happened to be Acting 
Secretary during another lawsuit filed with regard to Roundup Ready 
sugarbeets. It is my belief that attempting to mediate disputes between 
interest groups in conjunction with a specific regulatory decision for 
a biotech product would set a precedent that is in direct conflict with 
the longstanding adherence and the rule of law relative to science-
based regulation for biotech crops in the United States. In fact, the 
U.S. Government has continually supported and defended science-based 
regulatory regimes. And we discussed that plenty already this morning. 
But it is fair to say we are the standard for the world and we continue 
to press the world to move to our standard of safety and safety and 
soundness.
    One of the terms we have heard a lot over the last several month is 
``coexistence.'' Coexistence with respect to biotech's crops, as has 
been stated, Mr. Chairman, is indeed a marketing issue. It is 
absolutely not a safety issue. Despite claims to the contrary, 
Alternative 3 will hurt the ability of growers to choose what they want 
to plant, in this case, as I have pointed out, impact their bottom 
line, profitability.
    Market needs, communication, and workable solutions by the industry 
and growers, not government mandates, are the key to ensuring the 
multiple production systems can continue to exist side by side as they 
have for so long already.
    It has been suggested that extraordinary regulatory action is 
needed to address the burdens that have been imposed by recent NEPA 
lawsuits challenging APHIS's decision making. Those who are totally 
opposed to biotechnology, Mr. Chairman, have sought relief in Federal 
courts under NEPA for nearly 30 years and more recently have challenged 
regulatory actions taken by APHIS. In those very few cases where their 
suits have been successful it has always been based upon the court 
finding of procedural violation and no court has ever held that the 
biotech crops present any kind of health or safety risk to the 
environment, and certainly APHIS has never been directed by any court 
to regulate coexistence as has been proposed under this so-called 
Option 3.
    In closing, we urge the Administration and this Committee to 
maintain the integrity of this regulatory process for the benefit of 
U.S. growers and our consumers. We must remember that we are working 
towards the use of biotechnology in a manner that promotes continued 
opportunity, profit making opportunities for all of our farmers and for 
better marketing opportunities for consumers around the world.
    We look forward to working with you, Mr. Chairman, and this 
Congress and Secretary Vilsack on these issues, and I thank you for the 
opportunity to appear here today.
    [The prepared statement of Mr. Conner follows:]

   Prepared Statement of Hon. Charles F. Conner, President and CEO, 
       National Council of Farmer Cooperatives, Washington, D.C.

    Chairman Lucas, Mr. Peterson and Members of the Committee, thank 
you for holding today's forum on the biotechnology product regulatory 
approval process. I am Chuck Conner, President and Chief Executive 
Officer of the National Council of Farmer Cooperatives (NCFC). NCFC 
represents the nearly 3,000 farmer-owned cooperatives across the 
country whose members include a majority of our nation's more than two 
million farmers. These farmer cooperatives allow individual farmers the 
ability to own and lead organizations that are essential for the 
vitality of the agriculture sector and rural communities.
    I applaud the Committee for holding this forum in recognition of 
the need to gain insight, provide transparency and highlight the 
concerns of America's farmers. This is timely given the U.S. Department 
of Agriculture's pending decision on herbicide-tolerant alfalfa and the 
long-reaching effects of that decision. These are the very reasons so 
many grower groups and related organizations urged the Committee to 
host this session. Additionally, NCFC is a member of a broad coalition 
of agriculture and related industry groups on biotechnology--that group 
will submit additional comments for the record.
    My comments today will focus on three issues:

   First, the USDA regulatory process for agricultural 
        biotechnology approvals to date;

   Second, the regulatory status of Round up Ready alfalfa and 
        ``co-existence'' issues; and

   Third, litigation and court cases over biotechnology product 
        approvals.

    American agriculture has long been at the forefront of meeting the 
world's ever expanding needs for food, feed and fiber. The availability 
of corn, cotton, soybeans, sugarbeets, canola, alfalfa, and other crops 
enhanced through biotechnology will continue to assist the U.S. farmer 
in providing for the world's growing population.
    In addition, crops enhanced by biotechnology currently on the 
market bring value to agriculture, consumers and the environment. For 
example, some of these plants have been engineered to allow the 
application of herbicides such as glyphosate over the top of crops 
growing in the field, reducing tillage and runoff. Others have been 
protected against harmful insect pests and diseases, thereby reducing 
the need for chemical spraying.
    The development and adoption of these products, and the promise of 
new products, makes possible the continued availability of safe food, 
feed and fiber products to consumers in the U.S. and worldwide. With 23 
crops in the regulatory pipeline, and more on the way, it's clear that 
USDA's pending decision on herbicide-tolerant alfalfa will have a far-
reaching impact.
    The acceptance of biotech crops would not have been possible 
without the existence of a risk-based regulatory process based on sound 
scientific principles. That process has been in place since the 
adoption of the Coordinated Framework for Regulation of Biotechnology 
by the United States was announced in 1986. Every biotechnology crop on 
the market today has successfully completed review under the Framework 
and has been found to be safe. We support the integrity of the U.S. 
regulatory requirements for biotechnology-derived crops.
    Under the authority of the Plant Protection Act implementing 
regulations, USDA's Animal and Plant Health Inspection Service (APHIS) 
is the agency that reviews all biotechnology crops before they can be 
field tested or commercialized. APHIS has overseen tens of thousands of 
field tests that have made it possible for over 70 biotechnology crops 
to reach the market through its deregulation process. In making 
deregulation decisions under the Plant Protection Act, APHIS has 
consistently relied upon its independent evaluation of the potential 
for new products that could pose a plant pest risk. Under its authority 
it considers factors that are relevant to a plant pest risk 
determination. Though the National Environmental Policy Act (NEPA) must 
be addressed in making a deregulation decision, it is important to 
remember that NEPA is a procedural statute. NEPA directs APHIS to 
assess potential environmental impacts of its actions, but that is 
where NEPA's jurisdiction ends. NEPA does not give USDA any authority 
beyond the Plant Protection Act and APHIS's implementing regulations.
    In 2005, APHIS prepared an Environmental Assessment for glyphosate-
tolerant alfalfa and made a deregulation decision. The crop was on the 
market and successfully grown by U.S. farmers for 2 years before a NEPA 
law suit reversed APHIS' decision. In an order issued by the United 
States District Court for the Northern District of California in San 
Francisco in 2007, APHIS was required to prepare a full Environmental 
Impact Statement (EIS) because the court found that APHIS failed to 
follow the proper procedures in meeting its NEPA obligations. There was 
no finding of any deficiency under the Plant Protection Act or of any 
risk to health or safety.
    In December 2010, USDA announced the completion of the court-
ordered EIS. In subsequent meetings, the Secretary has indicated he 
will make a final regulatory decision by late January 2011. In 
preparing the EIS, USDA chose to include the option, referred to as 
``Alternative 3,'' of deregulating glyphosate-tolerant alfalfa with 
unprecedented regulatory conditions in an attempt to address concerns 
between growers planting glyphosate-tolerant alfalfa and those planting 
conventional and organic alfalfa. USDA designated this as one of its 
``preferred options.'' The conditions include isolation distances of up 
to 5 miles and other geographic restrictions that would not allow 
farmers to plant glyphosate-tolerant alfalfa on an estimated 20 percent 
of alfalfa acres (50 percent of the alfalfa acreage in the western 
states); limitations on harvest periods and equipment usage; seed bag 
labeling; seed coloration; and the listing of seed production field 
locations on a national database.
    The EIS for glyphosate-tolerant alfalfa states USDA's conclusion 
that it does not pose a plant pest risk. Having made that 
determination, USDA should immediately deregulated glyphosate-tolerant 
alfalfa without additional regulatory conditions. Combined with broader 
policy statements in the EIS, the imposition of conditions on a crop 
that poses no plant pest risk sets a dangerous precedent for the 
continued safe development, availability and marketability of new 
biotechnology products. Broad policy changes related to how USDA makes 
regulatory decisions on new biotechnology crops should not be made in 
the context of an environmental review for a specific crop. Attempting 
to mediate disputes between interest groups in the context of a 
specific regulatory decision for a product such as glyphosate-tolerant 
alfalfa would set a precedent that is in direct conflict with the long-
standing adherence to science-based regulation of biotechnology crops 
in the U.S. as well as this Administration's commitment to upholding 
the public's trust in the integrity of the scientific process.
    Now that an EIS has been prepared and APHIS has found, for the 
second time, that there is no plant pest risk, we fully support alfalfa 
growers having access to glyphosate-tolerant alfalfa for planting this 
spring. The best way to ensure production of this valuable crop is for 
USDA to grant full deregulation without further delay. We urge the 
Secretary to fully deregulate glyphosate-tolerant alfalfa, and hope 
that the U.S. Government will vigorously defend that action in any 
court challenge. The alfalfa industry, with its partners, has 
demonstrated it has stewardship measures in place that meet all 
requirements of the re-deregulation that does not require additional 
regulatory oversight.
    We appreciate Secretary Vilsack's commitment to address some of the 
roadblocks that have been placed in the path of valuable new 
biotechnology crops including herbicide-tolerant alfalfa and sugarbeets 
by NEPA litigation. Where we respectfully disagree with the Secretary 
is on his approach to removing these roadblocks.
    One of the terms we've heard most over the last several months is 
``coexistence.'' The ability of growers to choose what they want to 
plant cannot be achieved through the process laid out in the alfalfa 
deregulation decision if the Department adopts Alternative 3. The 
ability of multiple production systems to exist side-by-side is based 
on market needs, communication, and workable solutions developed by 
industry and growers. Growers have always worked closely with the seed 
industry and state seed certifying agencies to meet their respective 
stewardship obligations through contractual agreements and other 
mechanisms.
    Characterizations of disputes between farmers with different 
cropping systems may have been overstated in the last several months. 
Farmers, processors and markets have been and are managing potential 
conflicts with best practices and private contractual agreements. Where 
the terms of private contracts call for the exclusion of safe, 
deregulated biotechnology crops, those contracts should not be the 
basis for the imposition of regulatory conditions on the production of 
those biotechnology crops. Coexistence of all crops is a marketing 
issue, not a safety issue.
    It has been suggested that extraordinary regulatory action is 
needed to address the burdens that have been imposed by recent NEPA 
lawsuits challenging APHIS's decisions. Those who are opposed to 
biotechnology have sought relief in the Federal courts under NEPA for 
nearly 30 years and more recently have challenged regulatory actions 
taken by APHIS. In those few cases where their suits have been 
successful, it has always been based on the court finding a procedural 
violation--no court has ever held that a biotechnology crop presents a 
risk to health, safety or the environment, nor has any court ever 
directed APHIS to regulate coexistence. The answer is to take whatever 
steps are needed to adequately address APHIS's procedural 
responsibilities under NEPA so that, when and if a decision is 
challenged, it can be successfully defended with little or no adverse 
impact on agricultural production or innovation. We look forward to 
discussing these issues with the Secretary and the Administration 
further.
    APHIS has already implemented a number of key reforms to address 
the court's concerns with its NEPA compliance. This ability to learn, 
evolve and improve is one of the great strengths of the U.S. regulatory 
process for biotechnology. The best insurance for mitigating the 
adverse effects of the current round of NEPA court cases will be the 
continued preparation of enhanced Environmental Assessments for 
biotechnology crops and, where circumstances warrant, an Environmental 
Impact Statement. We continue to support efforts to secure adequate 
resources for the continued enhancement of APHIS's regulatory program 
and the defense of its decisions.
    The U.S. Government has consistently supported and defended 
science-based regulatory regimes. In many international forums, U.S. 
policy is the standard for science- and risk-based regulation. The U.S. 
successfully argued against the European Union in a World Trade 
Organization dispute over the approval of biotechnology products. The 
interests of growers, businesses and consumers depend on trade 
agreements with countries that import commodities and products that we 
produce. The injection of non-science-based criteria into our 
government's regulatory process will only serve to undermine those 
international efforts.
    As former Acting Secretary and Deputy Secretary at USDA, I am very 
familiar with the biotechnology product regulatory approval process. We 
were threatened by lawsuits when I was at USDA--in fact, the alfalfa 
case was filed while I was Deputy Secretary. I believed then and I 
believe now in science-based risk assessments for the regulation of all 
crops.
    In closing, we urge the Administration and this Committee to 
maintain the integrity of the regulatory process for the benefit of 
U.S. growers and our consumers. We must remember that we all are 
working toward the use of biotechnology in a manner that promotes 
continued opportunities for all farmers and consumers around the world. 
We look forward to working with the Secretary on this issue.
    Thank you again for convening this forum and for your continued 
interest in this matter.

    The Chairman. Thank you, Mr. Conner.
    In 2006, the World Trade Organization dispute settlement 
body ruled in favor of the United States, Canada, and Argentina 
in the EU biotech case, upholding the principle of regulating 
based on sound science.
    How does the current debate with respect to coexistence 
affect similar cases that the U.S. may be a party to in the 
future?
    Mr. Conner. I don't think there is any question, Mr. 
Chairman, that we are concerned about the precedent that would 
be set under this so-called Option 3 should the Department 
choose to go anywhere near that direction in their final 
determination relative to alfalfa. Our WTO case was won very 
strongly against the EU on the basis that these are decisions 
based upon safety and soundness, based upon environmental 
impact, not based upon in any way a precautionary principle of 
any kind, not based in any way upon consumer preferences of any 
kind, based upon safety and soundness. And we won that case, we 
won it strongly. I think it is hard to back up that case if 
indeed we go in that direction in some of our regulatory 
procedures going forward, and I think Option 3 takes us down 
that path and should not.
    The Chairman. Mr. Conner, the EU has long been an advocate 
for including the so-called precautionary principle in 
international agreements.
    Are there similarities, as you see it, to be drawn between 
the debate about coexistence and the precautionary principle?
    Mr. Conner. I think so, Mr. Chairman. The precautionary 
principle is really a manifestation, if you will, of policies 
where politics trumps science in a regulatory decision-making 
process. That is not the system we want to go to. We want to 
emphasize that we think USDA should stick to a science-based 
regulatory process.
    The Chairman. So I guess, Mr. Conner, the question then 
becomes in your opinion--and you have been around this process 
a little bit.
    Mr. Conner. A long time.
    The Chairman. You have an little understanding, a little 
history of observation. If USDA decides on deregulation with 
conditions under the so-called Option 3, will the United States 
in effect be defending the precautionary principle in the 
future? Will we be defending what we have argued against for 
decades, I guess is really the point?
    Mr. Conner. I don't think there is any question, Mr. 
Chairman, that a decision to move forward with Alternative 3 is 
going to have significant consequences, no question about it. 
It will send a message we believe to our trading partners that 
the United States has shifted its policy away from promoting 
sound science relative to these decision making processes and 
now including politics in that decision making process. And the 
precedent that that sets, the future of that for these pending 
biotech products, as well as everything that is going to come 
down the pike that we don't even know about yet, but that are 
going to be absolutely necessary in order for us to meet our 
food and fiber needs on the planet in the future is going to be 
threatened if we go in this direction.
    The Chairman. The U.S. Government invests significant 
resources towards outreach in developing countries to assist 
them in developing functional science-based regulatory systems.
    What impact do you anticipate in countries that are 
beginning to see the value in agricultural biotechnology if the 
USDA regulates biotechnology products based on, I guess the 
polite phrase would be, socioeconomic concerns rather than 
plant pest basis?
    Mr. Conner. Mr. Chairman, there is no question that 
agricultural biotechnology is not just a thing for the United 
States of America. It has been widely accepted all over the 
planet, it is now grown we believe in 25 countries. I am 
advised over 335 million acres of biotech crops are planted on 
the globe this year. I am further advised that most of the 
majority of those countries planting biotech crops are what we 
would refer to as developing countries. So this is not a 
developed country issue either. Most are in developing 
countries.
    Why is this happening? It is simple. They see biotechnology 
as the means by which they feed their people, and I think that 
is the right assessment, that is the right call, and we again 
are going to need these products grown all over the planet in 
order to meet the future food needs of the population that I 
think everyone acknowledges is going to be here in the not too 
distant future.
    The Chairman. One last question, Mr. Conner, and my time is 
about to expire, you have been a part of the process on all 
sides. You have observed everything, you have been subject to 
these lawsuits in the past. Earlier the question was asked 
about whether the legal framework with which it is possible for 
these kind of procedural lawsuits to take place is occurring.
    Is there some structural change here we need to be 
addressing in the way the law works as opposed to implementing 
the law perhaps?
    Mr. Conner. It is a great question, Mr. Chairman, if I 
could answer it perhaps this way. I don't think I would favor 
at this stage a change in the Plant Protection Act, at this 
stage in the process. I say so because I believe that USDA has 
the authority and the flexibility under that Act to regulate 
accordingly. I think one thing I would point out to the 
Committee is the fact that perhaps you have been left with the 
notion that we are regulating the approval of new biotech 
plants the exact same way we did perhaps a decade or 2 decades 
ago, and that is not the case. APHIS has put in place a number 
of reforms over the last decade relative to the approval of 
these plants. I personally believe many of those reforms will 
help expedite this process, probably not as fast as it should 
be, but I think it does provide them again the flexibility to 
make those kind of changes, make the call, make the 
determination ultimately of safety of those products.
    And I will say as well, Mr. Chairman, this was a problem 
when I served at USDA, I think it continues to be a problem. 
APHIS is an agency where we probably need to focus a little bit 
upon their resources. They are called upon to do a great deal 
with very, very limited resources. I think I would propose 
leaving the Act alone, giving APHIS some additional resources 
that they need to see these approval processes move forward 
more quickly, before I would consider legislative changes.
    The Chairman. If my colleagues will tolerate me for one 
more moment in this forum environment. The question about 
Environmental Assessment versus Environmental Impact Statement, 
could you shed some light on that?
    Mr. Conner. Well, one the changes that APHIS has made to 
the current approval process is they have altered what are 
called the Environmental Assessments for approval of products. 
And they have also altered the means by which then they 
determine whether Environmental Assessment is necessary, sort 
of lower impact situation, or whether they need to go to the 
full blown Environmental Impact Statement. Again that is not to 
say that all the problems have been solved, but they have 
recognized that some of these issues need to be addressed. They 
have made those changes. The Act provides them with that 
authority.
    If I could, if you would indulge me, Mr. Chairman, Mr. 
Peterson raised earlier the notion of why didn't we just simply 
make the decision to do the EIS on all of these products, going 
forward. And again there has probably been circumstances where 
we should have initiated the EIS from the very beginning I 
suspect, but I would just note that when you look at the 75 or 
76 plants that have been approved and are used again widely in 
so many crops across America today, there is absolutely no way 
that we would have the resources or have had the resources to 
do a full EIS on all 76 of those plants. And as I told some 
folks informally earlier, there is probably not enough plant 
scientists in our entire university system in America to do 
that kind of analysis.
    So we need to continue to focus upon those times when 
Environmental Assessment is necessary and all that is needed 
versus those times when we need to go up to that next level and 
make that call, and I again I think APHIS is getting much 
better and more tuned into when one of those is appropriate.
    The Chairman. Thank you, Mr. Conner. I now turn to my 
colleague from Iowa, Mr. Boswell.
    Mr. Boswell. Thank you, Mr. Chairman. Mr. Conner, welcome 
back.
    Mr. Conner. Mr. Boswell, thank you.
    Mr. Boswell. You have been in this room a few times.
    Mr. Conner. A few times, yes, indeed.
    Mr. Boswell. And our association with you in the co-op 
business, as I served as a very activist Chairman of the local 
through the farm crisis and so on, I appreciate what you are 
doing today. Thank you for your efforts.
    Listening to this conversation between you and Chairman 
Lucas I guess leads me to the question, in your mind does the 
Secretary have the authority to implement the partial 
deregulation, do you think?
    Mr. Conner. I am not a lawyer, Mr. Boswell.
    Mr. Boswell. I am not either.
    Mr. Conner. Well, we may be able to communicate with each 
other then. I will just tell you having served in the capacity 
as one who oversaw the regulatory process for this and many, 
many other products I think it is my view, and the one that I 
currently share, that once they have completed all of the 
process in terms of the assessment of the safety of these 
products--which they have on Roundup Ready' 
alfalfa--I do not believe that they have the regulatory 
authority to do anything other than just simply deregulate the 
product, which is the so-called Option 2 that the Department 
has presented and is under consideration through January 24th.
    Mr. Boswell. Okay. Thank you. You heard my earlier 
statement that I am a long time supporter of science and 
biotech. I actually believe, as I have heard you state, that to 
feed this hungry world, growing population I don't know how 
else we do it. At the same time across the country in my state 
and other places the farmer's market, the interest in organic 
foods, and so on, has really exploded. And it is a great 
opportunity for jobs and giving people what they want. And so I 
kind of maintain the idea with this grand need we have that 
there is room for both. And I do believe that. I think we need 
to work with both, get them to communicate together and so on. 
And I know when I go to my towns, my medium sized cities, my 
capital city, the interest in the organic food is a big item, 
it is very big. At the same time as I have been exposed to the 
world, kind of like you have and some of the rest of us, and 
this population growth, I just think we have to continue the 
science and so on.
    I guess I ask do you share my hope and belief that they can 
work this out and coexist and everybody do well? Do you share 
that feeling?
    Mr. Conner. I do, Mr. Boswell. I share it wholeheartedly 
and I will tell you many of the farmer owned cooperatives that 
I represent are engaged in conventional as well as organic 
production and they have seen tremendous growth in both. I 
think there has been coexistence in the past and it is a 
testament to our farmers, to the agriculture system we have in 
this country that when you walk into a grocery store today and 
no matter what you are looking for it is there and available in 
just about every shape and size imaginable. It is a remarkable 
system, it really is.
    Mr. Boswell. Well, I appreciate that. I thought you 
probably did. Mr. Chairman, I just wonder if we see a need 
here. It seems like that we almost see people developing sides. 
I don't think--maybe there needs to be a side. Maybe we need to 
figure out how to facilitate communication because it seems 
like everybody on the Committee feels that we have to do 
science and at the same time just this exchange that I have had 
with Mr. Conner, there is a desire and need and a use out there 
for organic side. And a lot of our co-ops, I think you have had 
reminders, they do do it. Is there a role that we can play to 
help the communication on that to realize there is room for 
both?
    The Chairman. The gentleman is always full of wisdom and 
good ideas and that is a part of our agenda on this Agriculture 
Committee is to address the needs of all agriculture.
    Mr. Boswell. Well, anyway, thank you for your time and we 
will move forward. That is all we can do.
    I yield back.
    The Chairman. The gentleman yields back. We now turn to the 
gentleman from Texas, Mr. Conaway.
    Mr. Conaway. Thank you, Chairman and Mr. Conner, for being 
here. As I heard discussion on Option 3, or Alternative 3, I 
can see this monster bureaucracy coming together to try to set 
back standards or buffer zones or all these other things for 
every single product that is on that list. Aren't those 
decisions as to whether or not local land use, aren't those 
decisions really better left to the states and local 
municipalities and local entities rather than some effort on 
the part of USDA to try to figure out that rule for the entire 
country?
    Mr. Conner. Well, Mr. Conaway, I think we would say that 
private party interests should be the ones in charge of this, 
because there is precedent for private party interests looking 
after these issues of coexistence, quite successfully I might 
add. In the case of alfalfa, in particular, I know some of the 
members I represent are quite anxious out there to fulfill a 
market for organic alfalfa seed, a market that exits, a market 
that I think they are prepared to be there in a big way and 
believe that through private contractual arrangements they can 
more than fulfill that market to the benefit of the co-op as 
well as the producers that are growing that high value crop.
    Again, one of the problems, the rub here is, and I go back 
to Secretary Vilsack's statement, I think virtually the last 
sentence that he made here, and I just read from this: ``I look 
forward to our discussion here and I hope you share my belief 
that farmers, ranchers, growers are in the best position to 
decide what is best for their operations.'' And so I concur 
with that statement.
    Mr. Conaway. Right. I do, too.
    Mr. Conner. I think there is not a role for the Federal 
Government to be stepping in the middle of these private 
contractual arrangements relative to coexistence, and I believe 
they will take care of themselves.
    Mr. Conaway. Well, the interesting thing is that the 
Secretary said all the right things, and very political about 
everything, and hugged all sides and those kinds of things. But 
at the end of the day if he pulls the trigger on Option 3 then 
that last statement is inaccurate.
    Mr. Conner. It is inaccurate. That is correct.
    Mr. Conaway. Because that is not how you would go about 
that. How much of this is a definitional issue? In other words, 
from a scientific standpoint is the milk coming out of a cow 
that is fed organic alfalfa versus Roundup Ready' 
alfalfa, are there any minute differences chemically in that 
milk that is discernable, measurable?
    I see Dr. Slutsky is shaking her head. It is hard for the 
stenographer to record that.
    Mr. Conner. Why don't you go ahead on that? You are more of 
the science person here.
    Dr. Slutsky. No. I mean from a chemical point of view, no. 
From the point of view of the organic standard, which is a 
process-based standard, I think that there might be some issues 
if you could call that milk organic, but from a safety, 
chemical perspective, no, there is no difference.
    Mr. Conaway. Okay. So USDA sets the standards for what is 
or is not organic, correct?
    Dr. Slutsky. Yes.
    Mr. Conaway. So I would expect that 100 years from now 
genetically engineered seeds, as an example, will be the new 
organic, given the strains that everybody talks about, growing 
populations, shrinking land mass, those kinds of things. Should 
there be a suggestion that USDA look at the standards for 
organic given it is just really a marketing issue and not a 
health and safety issue, that USDA should look at those 
standards to see if it really does make sense given the growth 
in population of the world, given the impact that in this 
instance Roundup Ready' alfalfa has on the ability 
to produce more of it on less land or the same land? Are we 
hung up with just the phrase organic meaning something that we 
grew ourselves in the backyard with whatever? Is there an 
opportunity to have that conversation at some point?
    Mr. Conner. I will say, Mr. Conaway, from our standpoint we 
have no problem with those current organic standards and again 
farmer-owned co-ops are in the business of meeting those 
standards and doing so to the benefit of their own farmer 
owners, whether that is milk, fruit and vegetables, no matter 
what.
    Mr. Conaway. Mr. Conner, in the meantime talk continues and 
you have guys out there who are really spring loaded to plant 
Roundup Ready' alfalfa who aren't going to be able 
to do that as it currently stands. So we can continue to have 
these conversations at 10,000 feet and you have guys out there 
who really need to make some decisions on the ground and so we 
will keep up the conversation.
    I yield back, thank you, sir.
    Mr. Conner. And again our point of view is that is a 
different statement than USDA making a regulatory decision 
under the Plant Protection Act, favoring one of those over 
another. We don't believe there should be any favoring one way 
or the other. Let the commercial interests solve those issues 
as they have in the past.
    The Chairman. The gentleman's time has expired, all time 
has expired. I would like to thank the panel for their 
participation and their insights also. Clearly we have a lot of 
work ahead of us in the coming season on a variety of topics, 
and I suspect we will look at this one many more times. Thank 
you very much.
    The forum is adjourned.
    [Whereupon, at 12:45 p.m., the Committee was adjourned.]
    [Material submitted for inclusion in the record follows:]

      Submitted Letter by James C. Greenwood, President and CEO, 
                  Biotechnology Industry Organization




Hon. Frank D. Lucas,                 Hon. Collin C. Peterson,
Chairman,                            Ranking Minority Member,
House Committee on Agriculture,      House Committee on Agriculture,
Washington, D.C.;                    Washington, D.C.



    Dear Chairman Lucas and Ranking Member Peterson:

    The Biotechnology Industry Organization (BIO) wishes to express its 
appreciation to the U.S. House of Representatives Committee on 
Agriculture for the January 20, 2011 public forum to review the 
agricultural biotechnology regulatory authorization process. Like the 
participants in the forum, BIO strongly believes that science-based 
decisions by the U.S. Department of Agriculture (USDA) are critical for 
agricultural biotechnology products to meet future food production 
challenges. While BIO is pleased that USDA ultimately decided to fully 
deregulate glyphosate-tolerant alfalfa, we are concerned that USDA 
previously considered imposing restrictions as a means to regulate 
coexistence even though the product did not present a risk to health, 
safety or the environment. We further continue to be concerned that 
coexistence is mentioned specifically in the Record of Decision as one 
of USDA's purposes in the context of regulating agricultural 
biotechnology products.
    BIO is the world's largest biotechnology organization, providing 
advocacy, business development and communications services for more 
than 1,100 members worldwide. BIO members are involved in the research 
and development of innovative healthcare, agricultural, industrial and 
environmental biotechnology. Corporate members range from 
entrepreneurial companies developing their first product to Fortune 100 
multi-nationals. We also represent state and regional biotechnology-
derived associations, service providers to the industry, and academic 
centers.
    USDA's regulatory system has helped demonstrate the safety and 
acceptance of biotech-derived crops. The Plant Protection Act (PPA) has 
provided USDA with the scientific basis for regulating and deregulating 
biotechnology-derived crops. Based on its authority under the PPA, USDA 
has overseen tens of thousands of field tests of biotechnology-derived 
plants and deregulated over 70 of these crops. This system has brought 
significant benefits to farmers, consumers and the environment without 
any evidence of adverse effects to health, safety or the environment.
    The National Environmental Policy Act (NEPA) also requires USDA's 
Animal and Plant Health Inspection Service (APHIS) to consider 
potential environmental impacts. Under the NEPA process, USDA prepares 
an environmental assessment (EA) to identify whether there is the 
potential for significant impacts on the human environment. A draft EA 
is released for public comment before it is finalized by the agency. If 
the EA concludes there is no significant impact, no further 
environmental review is necessary. If the EA concludes that there is 
the potential for significant environmental impacts, then the agency is 
to undertake a full Environmental Impact Statement (EIS). The agency 
prepares a draft EIS for public comment prior to finalizing it. The 
process of drafting, receiving public comment and finalizing an EIS can 
take two to three years or more.
    In each case, USDA has made an independent, science-based 
evaluation of the potential environmental impacts of its deregulation 
decision as required by NEPA. Any USDA movement away from the 
scientific justifications used in America's agricultural biotechnology 
policy would set a dangerous precedent for blocking future agriculture 
technologies, create legal uncertainty for pre-existing regulatory 
decisions, and undermine the United States' commitment to defend our 
exports from non-tariff barriers.
    Fortunately, USDA's January 27, 2011, announcement and Record of 
Decision authorizing full deregulation of glyphosate-tolerant alfalfa 
followed science-based conclusions under the PPA and complied with 
USDA's NEPA responsibilities through the issuance of an EIS. BIO 
appreciates that USDA has amplified its NEPA compliance efforts in 
response to a handful of recent Federal Court decisions and, in the 
case of glyphosate-tolerant alfalfa, complied with the Court's order to 
prepare an EIS. However, we are still concerned that USDA considered 
using the EIS as a means to regulate coexistence for alfalfa, which 
would have been inappropriate since no plant risks were identified and 
therefore USDA would have exceeded the statutory authority under the 
PPA. To be clear, no court has ever directed USDA to regulate 
coexistence or change its coexistence policy, nor has any court held 
that a biotechnology-derived crop has presented a risk to health, 
safety or the environment. We are relieved that USDA did not issue 
restrictions, based on NEPA, to the deregulation of glyphosate-tolerant 
alfalfa.
    BIO supports coexistence in American agriculture. American 
agriculture has an impressive track record of successfully addressing 
the economic and market-based issues associated with coexistence, 
whether neighbor-to-neighbor or through state seed certifying agencies 
or other local, state or regional initiatives. The Federal Seed Act and 
National Organic Program, both administered by USDA's Agricultural 
Marketing Service, currently provide measures for addressing seed 
production, handling and commingling. In the field of agricultural 
biotechnology, growers have worked closely with the seed industry to 
meet their respective stewardship obligations through contractual 
arrangements and other mechanisms. That is where matters of coexistence 
and stewardship are addressed most effectively and efficiently.
    We also would like to take this opportunity to clarify another 
point for the record. If the United States is to reap the benefits of 
agricultural biotechnology, we need more timely and science-based 
authorizations of the innovative biotech products that are in the 
technology pipeline. When the plant biotechnology industry submitted 
its first products for authorization in 1995, USDA granted 
authorizations in a relatively expedient fashion--141 days, on average, 
in 1996 (see Figure 1 below). Since then, the length of time for 
authorization has increased on average by more than 700 percent. And 
the delays for achieving authorization are increasing at a time when we 
know even more about the safety of this technology and the benefits it 
holds.
Figure 1: Average Number of Days to Achieve Authorizations by Year, 
        1996-2010
        
        

    _reg.html).In addition, delays have increased in the permitting 
process. While the specified time period for the approval of permit 
applications by regulation is 120 days, the fact is, many permits are 
taking as long as 400 days to approval. Overall, 23 permits have taken 
more than 250 days for approval, or two times the target time of 120 
days (2003-2009). Any additional delays and unpredictability to the 
authorization process will cause U.S.-based biotech companies to lose 
investment, hinder public research and innovation, and cause American 
producers to lose out on new technologies that can help enhance their 
production capabilities while producers in other countries are gaining 
a competitive advantage. Efficiently and sustainably increasing global 
agricultural production, including through the development and adoption 
of new technologies, will be paramount to meeting future population 
needs for food, feed, fuel and materials.
    Again, we thank you for the Committee's public forum highlighting 
the need for USDA to maintain a science-based regulatory system and 
evaluation process that demonstrates the safety and acceptance of 
biotech-derived crops.
            Sincerely,
            
            
President and CEO.
                                 ______
                                 
                          Submitted Questions
Questions Submitted by Hon. Collin C. Peterson, a Representative in 
        Congress from Minnesota
Response from Hon. Thomas J. Vilsack, Secretary, U.S. Department of 
        Agriculture
    Question 1. Please explain in detail the public comment process 
that lead to the exclusion of genetically modified traits from food 
products certified under the Organic Foods Production Act.
    Answer. The Organic Foods Production Act of 1990 (OFPA) does not 
prohibit genetic engineering. In some measure, this was because Deputy 
Secretary Kathleen Merrigan, at the time, was working for the U.S. 
Senate Committee on Agriculture, Nutrition and Forestry. While the 
Deputy is widely known for her work in drafting OFPA, she also has a 
history of advocacy for biotechnology.
    The Organic Foods Production Act of 1990 (OFPA) does not prohibit 
genetic engineering. In some measure, this was because Deputy Secretary 
Kathleen Merrigan, at the time, was working for the U.S. Senate 
Committee on Agriculture, Nutrition and Forestry. While the Deputy is 
widely known for her work in drafting OFPA, she also has a history of 
advocacy for biotechnology.
    When the first proposed rule to implement OFPA was published in 
1997, it did not prohibit genetic engineering and, instead, USDA asked 
the public to provide guidance on this topic. USDA received a record-
breaking 275,603 public comments, the vast majority demanding that USDA 
prohibit ``GMOs.'' Deputy Secretary Merrigan became Administrator of 
the Agricultural Marketing Service in 1999, after these comments were 
received, and she was responsible for overseeing the development of the 
second proposed and final rule. Working with Secretary Glickman at the 
time, they concluded that because the organic standard is not a safety-
based standard, but rather is a process-based marketing claim, and 
because existing state, private, and international standards prohibited 
genetic engineering, USDA would follow suit. The prohibition is defined 
under the term ``excluded methods'' and the final rule has been in full 
force since October 1, 2002.

    Question 2. As biotech traits evolve from field crops to industrial 
processes to perhaps those that do not require the insertion of a plant 
pest gene, what are the limitations of the current regulations and 
statues in ensuring an effective and efficient regulatory structure?
    Answer. At USDA we continue to examine the issues and weigh the 
options available to revise our regulations to ensure an effective and 
efficient, science-based regulatory structure. This will require 
conversations and partnerships with a wide range of stakeholders, 
including other Federal agencies such as the Food and Drug 
Administration (FDA), Environmental Protection Agency (EPA), and other 
agencies with interests in agricultural biotechnology.

    Question 3. Is the option for ordering Environmental Impact 
Statements for each pending trait under consideration? If so, how 
feasible is that option given the current workload at APHIS?
    Answer. We do not anticipate preparing an environmental impact 
statement for each deregulation decision. That will continue to be 
determined on a case-by-case basis.

    Question 4. It took roughly 46 months for your agency to complete 
the final EIS on glyphosate-tolerant alfalfa. Is this the same amount 
of time it will take to complete the EIS on glyphosate-tolerant 
sugarbeets, or for any other trait for which an EIS would be ordered? 
Have you taken steps to shorten this process, if possible?
    Answer. USDA is currently working on the EIS for GE sugar beets, 
and we expect to have it complete by May 2012, which would be less than 
the 46 months for the GE alfalfa EIS. Where possible, we have taken 
steps to shorten the process for completing the EIS for GE sugar beets, 
while satisfying applicable law.

    Question 5. When do you expect to come to a decision on Alpha-
Amylase Maize Event 3272, also known as corn amylase?
    Answer. USDA announced its decision to deregulate alpha-amylase 
corn on February 11, 2011.

    Question 6. Option No. 3 in the final EIS for glyphosate-tolerant 
alfalfa proposed planting and growing restrictions that do not show up 
in the draft EIS, plus appeared to be more restrictive than industry 
practices. Can you explain from where you drew your conclusions on the 
restrictions presented in that option?
    Answer. In developing the restrictions we considered:

   Comments received on the draft EIS.

   The restrictions and best management practices recommended 
        in the petition for partial deregulation submitted by Forage 
        Genetics.

   The Association of Official Seed Certifying Agencies (AOSCA) 
        Alfalfa Seed Stewardship Program (ASSP).

                                  
