[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
EXAMINING FDA'S ROLE IN THE REGULATION OF GENETICALLY MODIFIED FOOD
INGREDIENTS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
DECEMBER 10, 2014
__________
Serial No. 113-186
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
______
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois FRANK PALLONE, Jr., New Jersey
JOSEPH R. PITTS, Pennsylvania BOBBY L. RUSH, Illinois
GREG WALDEN, Oregon ANNA G. ESHOO, California
LEE TERRY, Nebraska ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
PHIL GINGREY, Georgia JIM MATHESON, Utah
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio JOHN BARROW, Georgia
CATHY McMORRIS RODGERS, Washington DORIS O. MATSUI, California
GREGG HARPER, Mississippi DONNA M. CHRISTENSEN, Virgin
LEONARD LANCE, New Jersey Islands
BILL CASSIDY, Louisiana KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky JOHN P. SARBANES, Maryland
PETE OLSON, Texas JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia BRUCE L. BRALEY, Iowa
CORY GARDNER, Colorado PETER WELCH, Vermont
MIKE POMPEO, Kansas BEN RAY LUJAN, New Mexico
ADAM KINZINGER, Illinois PAUL TONKO, New York
H. MORGAN GRIFFITH, Virginia JOHN A. YARMUTH, Kentucky
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah
PHIL GINGREY, Georgia GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey JOHN BARROW, Georgia
BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin
BRETT GUTHRIE, Kentucky Islands
H. MORGAN GRIFFITH, Virginia KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
C O N T E N T S
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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 2
Prepared statement........................................... 3
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 4
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 6
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 7
Witnesses
Michael M. Landa, Director, Center for Food Safety and Applied
Nutrition, U.S. Food and Drug Administration (FDA)............. 9
Prepared statement........................................... 12
Alison Van Eenennaam, Ph.D., Cooperative Extension Specialist,
Animal Genomics and Biotechnology, Department of Animal
Science, University of California, Davis....................... 45
Prepared statement........................................... 48
Answers to submitted questions............................... 125
Scott Faber, Senior Vice President of Government Affairs,
Environmental Working Group.................................... 71
Prepared statement........................................... 73
Answers to submitted questions............................... 130
Kate Webb, Assistant Majority Leader, Vermont House of
Representatives................................................ 84
Prepared statement........................................... 86
Answers to submitted questions............................... 133
Stacey Forshee, Fifth District Director, Kansas Farm Bureau...... 90
Prepared statement........................................... 92
Answers to submitted questions............................... 136
Tom Dempsey, President and CEO, Snack Food Association........... 97
Prepared statement........................................... 99
Answers to submitted questions............................... 138
Submitted Material
Statement of the Corn Refiners Association....................... 122
EXAMINING FDA'S ROLE IN THE REGULATION OF GENETICALLY MODIFIED FOOD
INGREDIENTS
----------
WEDNESDAY, DECEMBER 10, 2014
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:16 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Joe Pitts
(chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Burgess, Shimkus,
Murphy, Blackburn, Lance, Guthrie, Griffith, Bilirakis,
Ellmers, Pallone, Engel, Capps, Schakowsky, Matheson, Green,
Butterfield, Barrow, Castor, Sarbanes, and Waxman (ex officio).
Also present: Representative Pompeo.
Staff present: Nick Abraham, Legislative Clerk; Clay
Alspach, Chief Counsel, Health; Gary Andres, Staff Director;
Leighton Brown, Press Analyst; Karen Christian, Chief Counsel,
Oversight; Noelle Clemente, Press Secretary; Brad Grantz,
Policy Coordinator, Oversight and Investigations; Sydne
Harwick, Legislative Clerk; Brittany Havens, Legislative Clerk;
Peter Kielty, Deputy General Counsel; Carly McWilliams,
Professional Staff Member, Health; Tim Pataki, Professional
Staff Member; Chris Sarley, Policy Coordinator, Environment and
Economy; Macey Sevcik, Press Assistant; Adrianna Simonelli,
Clerk; Heidi Stirrup, Health Policy Coordinator; John Stone,
Counsel, Health; Tom Wilbur, Digital Media Advisor; Ziky
Ababiya, Democratic Staff Assistant; Eric Flamm, Democratic FDA
Detailee; Debbie Letter, Democratic Staff Assistant; Karen
Lightfoot, Democratic Communications Director and Senior Policy
Advisor; Karen Nelson, Democratic Deputy Committee Staff
Director for Health; and Rachel Sher, Democratic Senior
Counsel.
Mr. Pitts. The subcommittee will come to order. Before we
begin, I would like to take a moment to address the guests in
our audience. First of all, thank you all for coming. We think
engaged citizens are a welcome and valuable part of the
political process, and I only wish every hearing drew this much
interest.
The purpose of this hearing is to examine FDA's role in
regulating genetically-modified food ingredients, and it is an
opportunity for this committee to ask questions and have a
thoughtful discussion on this issue. The number of people in
this audience and in the hallway this morning demonstrates the
strong interest in this topic, and we welcome that interest and
your attendance here today. I do want to remind our guests that
the chair is obligated, under the rules of the House and rules
of the committee, to maintain order, preserve decorum in the
committee room, and I know that we all may not agree on this
topic, but I ask that we all abide by these rules and be
respectful of our audience members, our viewers and our
witnesses, and the chair appreciates the audience's cooperation
in maintaining order as we have a full discussion on this
important issue this morning.
The chair will now recognize himself for an opening
statement.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. The genetically-modified organisms, or GMOs, is
a term that refers to ingredients sourced from crops that have
been genetically engineered to express certain traits or
characteristics. A number of people have an instinctive
distrust of food that has been genetically modified, and are
asking questions about its safety. Others see great promise for
better nutrition and the alleviation of hunger around the
world.
There are real sensitivities around this issue, and all
issues regarding the food we eat and feed our children and our
grandchildren. It is our job as policymakers, particularly as
it relates to the public health, to establish a factually and
scientifically sound foundation prior to taking any action that
would impact consumers and our economy, and this hearing
provides a great opportunity to put rhetoric aside and do just
that.
GMOs have been a part of the U.S. food supply since the
mid-1990s. In fact, as much as 90 percent of our corn, sugar
beet, and soybean crops are now genetically engineered, and
about 70 percent of processed foods contain such ingredients.
The U.S. Food and Drug Administration oversees the safety and
the labeling of all food products from plant sources, including
those from genetically-engineered crops. These products must
meet the same safety requirements as foods from traditionally
bred crops. The Food and Drug Administration currently has a
consultation process in place in which developers of the
underlying technologies address any outstanding safety or other
regulatory issues with the agency prior to marketing their
products. FDA has completed approximately 100 of such
consultations. No products have gone to market until FDA's
safety-related questions have been resolved.
According to FDA Commissioner Margaret Hamburg, FDA has
``not seen evidence of safety risks associated with
genetically-modified foods.'' Further, FDA has no basis for
concluding that bioengineered foods are different from other
foods in any meaningful way, and the World Health Organization
has stated that ``no effects on human health have been shown as
a result of consumption of such foods.'' In fact, they can grow
faster, resist diseases and drought, lower reliance on
pesticides, cost less, and prove more nutritious. Even
President Obama has stated that ``advances in the genetic
engineering of plants have provided enormous benefits to
American farmers'' and that ``investment in enhanced
biotechnology is an essential component of the solution to some
of our planet's most pressing agricultural problems.''
Nonetheless, there have recently been a number of state
initiatives calling for the mandatory labeling of food products
that contain GMOs, and we will hear today from a number of
witnesses who can speak to such actions and the impact they
would have.
Food labeling is a matter of interstate commerce and is,
therefore, clearly a federal issue that rightfully resides with
Congress and the FDA. I am concerned that a patchwork of 50
separate state labeling schemes would be impractical and
unworkable. Such a system would create confusion among
consumers and result in higher prices and fewer options.
Finally, I want to commend Representative Mike Pompeo and
Representative Butterfield for their leadership on these
issues, and I look forward to learning more about H.R. 4432,
the Safe and Accurate Food Labeling Act of 2014, and I would
seek unanimous consent of the committee that Mr. Pompeo, who is
on the full committee but not on the Health Subcommittee, be
able to sit with us today in this hearing.
Without objection, so ordered.
I would like to welcome all of our witnesses for being here
today. I look forward to your testimony.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
The Subcommittee will come to order.
The Chair will recognize himself for an opening statement.
Genetically modified organisms, or GMOs, is a term that
refers to ingredients sourced from crops that have been
genetically engineered to express certain traits or
characteristics. A number of people have an instinctive
distrust of food that has been genetically modified, and are
asking questions about its safety. Others see great promise for
better nutrition and the alleviation of hunger around the
world.
There are real sensitivities around this issue, and all
issues regarding the food we eat and feed our children and
grandchildren. It is our job as policymakers, particularly as
it relates to the public health, to establish a factually and
scientifically sound foundation prior to taking any action that
would impact consumers and our economy. This hearing provides a
great opportunity to put rhetoric aside and do just that.
GMOs have been a part of the U.S. food supply since the
mid-1990s. In fact, as much as 90 percent of our corn, sugar
beet, and soybean crops are now genetically engineered and
about 70 percent of processed foods contain such ingredients.
The U.S. Food and Drug Administration oversees the safety
and labeling of all food products from plant sources, including
those from genetically-engineered crops. These products must
meet the same safety requirements as foods from traditionally
bred crops. The FDA currently has a consultation process in
place in which developers of the underlying technologies
address any outstanding safety or other regulatory issues with
the agency prior to marketing their products. FDA has completed
approximately 100 of such consultations. No products have gone
to market until FDA's safety-related questions have been
resolved.
According to FDA Commissioner Margaret Hamburg, FDA has
``not seen evidence of safety risks associated with genetically
modified foods.'' Further, FDA has no basis for concluding that
bioengineered foods are different from other foods in any
meaningful way, and the World Health Organization has stated
that ``no effects on human health have been shown as a result
of consumption of such foods.'' In fact, they can grow faster,
resist diseases and drought, lower reliance on pesticides, cost
less and prove more nutritious.
Even President Obama has stated that ``advances in the
genetic engineering of plants have provided enormous benefits
to American farmers'' and that ``investment in enhanced
biotechnology is an essential component of the solution to some
of our planet's most pressing agricultural problems.''
Nonetheless, there have recently been a number of state
initiatives calling for the mandatory labeling of food products
that contain GMOs. We will hear today from a number of
witnesses who can speak to such actions and the impact they
would have.
Food labeling is a matter of interstate commerce and is
therefore clearly a federal issue that rightfully resides with
Congress and the FDA. I'm concerned that a patchwork of 50
separate state labeling schemes would be impractical and
unworkable. Such a system would create confusion among
consumers and result in higher prices and fewer options.
Finally, I want to commend Rep. Mike Pompeo (R-KS) and Rep.
G.K. Butterfield (D-NC) for their leadership on these issues,
and I look forward to learning more about H.R. 4432, the Safe
and Accurate Food Labeling Act of 2014.
I would like to welcome all of our witnesses for being here
today. I look forward to your testimony.
Mr. Pitts. And at this time, I yield 5 minutes to the
ranking member for his opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairman Pitts.
Today's topic is one of thoughtful consideration of this
committee. Many Americans are interested in the regulation and
labeling of foods with genetically-modified ingredients, and
while it is an emotional issue for many, the facts can lead
reasonable people to different conclusions.
For policymakers, there are a number of considerations
involved, so I am glad that we are able to convene a panel to
share the range of perspectives on the issues, and I hope we
can engage in an honest and respectful discussion.
Genetically-modified foods have been in our food supply for
decades. In fact, some estimate that over 70 percent of
processed foods contain GMOs, however, they are not labeled as
such. In the wake of growing concerns from consumers, the Food
and Drug Administration issued a policy statement on its
regulatory oversight and labeling policies for GM foods in
1992, and in 2001, issued draft guidance on voluntary industry
labeling.
I fully understand why consumers want to know what goes
into the food they serve their families. For people to make
informed decisions about what they eat, they need information,
and that is why we required food labels to include nutrition
facts, and that is why they must use common rather than
technical names for ingredients whenever possible so that this
information is, in fact, useful. It is also why several states
have enacted their own regulations mandating the labeling of
these foods. Three states have put new laws on their books,
while many more have considered doing so, either through ballot
initiative or state legislation. None of the state labeling
laws have gone into effect yet.
While such laws give voice to the many who are concerned, I
am troubled by the net effect of the inconsistent state
standards. America's agricultural production and food
distribution chains necessarily cross state lines, and
conflicting regulations could cause difficulties, resulting in
higher cost for consumers.
Like the advances in medical technology that we deal with
as a subcommittee, innovations in biotechnology have a real
potential to address current problems and improve the quality
of life for people across the globe. And as representatives of
the American people, we must also be sure that the application
of these technologies does not put consumers at risk, and that
information is available to those seeking it out. In the end,
the science must remain the arbiter of any safety concerns, and
our regulations must reflect a rigorous evaluation of the
evidence.
So again, I am glad that we are having this hearing. I look
forward to the panel's testimony. I hope that we can weigh the
merits of all recommendations presented, and evaluate just how
any regulatory approach would best serve the interests of the
American people.
I would like to yield the remainder of my time to the
gentleman from North Carolina, Mr. Butterfield.
Mr. Butterfield. Thank you, Mr. Pallone, for yielding.
Thank you, Mr. Chairman, for your kind words, and thank all of
you for coming today.
Mr. Chairman, access to safe and affordable food is very
important to every consumer in America. I think at least we can
agree on that fact. I begin this conversation by saying that I
represent an agricultural district in North Carolina. It is
also a low-income district, and so I have a very keen interest
in this subject. A large portion of my North Carolina district
is agriculture. Farmers all across my state and across my
district remind me that North Carolina farmers don't just grow
crops for North Carolinians, they grow crops for America. And
so the food supply chain is vast. It is interconnected. The
work necessary to get an apple or an ear of corn to the produce
section at the supermarket is absolutely staggering. From sea,
to farmer, to wholesaler, to processor, to packer, to
distributor, even to the store shelf itself, it is easy to
appreciate the intricate system that feeds America, and I am
beginning to learn more and more about this.
But several states have proposed regulations, and that I
worry, if enacted, would cause significant disruption to the
Nation's food supply. It would cause confusion, it would cause
uncertainty among consumers, and ultimately will result in
increased costs at the checkout line. Depending on what state
regulations mandate, separate supply chains will likely have to
be developed, beginning at the farm, and at every state--step,
all the way to the supermarket.
The new infrastructure requirements are as daunting as they
are costly, and you can bet that all of those costs will be
passed on to the consumer, with studies showing that the
average cost topping $500 a year. For many of my constituents,
that would be impossible.
So I have worked with my friend, Mr. Pompeo, and others to
propose what I believe is a measured approach that gives
consumers certainty while taking into account the delicate
balance and sheer size and complexity of the food supply chain
that employs many Americans.
The proposal, my friends, is very simple. The FDA, our
Nation's foremost food safety authority, should have the
authority to require labeling on genetically-modified foods,
and establish federal standards so that consumers, regardless
of where they live or work, will clearly understand the
options.
Finally, I would say, Mr. Chairman, that I will be the
first to say that this proposal is not perfect. This proposal
is not perfect. It will certainly evolve as it progresses. We
don't legislate in a vacuum, but I believe a national, a
national labeling standard makes the most sense for our highly-
integrated and interdependent food supply. I am confident that
we will take what we learn from today's hearing, as well as the
input we are sure to receive, to inform out work as we move
forward. We need commonsense legislation.
Thank you very much. I yield back.
Mr. Pitts. Gentleman's time has expired.
The chair now recognizes the vice chairman of the full
committee, the gentlelady from Tennessee, Mrs. Blackburn, for 5
minutes for an opening statement.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman.
The people who are going to be harmed the most by the anti-
GMO activist movement are those who can least fight against it.
For example, there is a rice, it is called golden rice, which
was developed with genetic engineering. One of the benefits to
this rice, and the reason that it is called golden rice, is
that it has a level of vitamin A that is not found in other
rice. Golden rice has fed millions of starving people around
the world, and additionally, prevented blindness and death
because of the presence of vitamin A. The rice has been shown
to be safe by multiple tests, and yet the anti-GMO activists
have opposed its use simply because they do not like the idea
of genetically-modified food.
Farmers have genetically modified food for centuries.
Farmers would breed cattle to get the best traits. Crops were
developed which are most resistant to drought, pests, and
weeds. George Washington Carver did research and taught at
Tuskegee for over 40 years. While there, he developed
techniques to improve soil, give farmers alternative cash
crops, improve the nutrition of people living in the south. He
did this by experimenting with different varieties of peanuts
and sweet potatoes. Of course, different varieties are simply
products with different genetic makeup.
To bring reason to this discussion of different varieties
of food, my colleagues and I have introduced legislation, H.R.
4432, the Safe and Accurate Food Labeling Act of 2014,
introduced by Representative Pompeo and myself, along with
Representatives Matheson and Whitfield, would prohibit
genetically-modified plants intended for food use to be sold
without first complying with a safety review process at the
FDA. Under this Bill, if the FDA were to find a difference
between the new product and a comparable non-GMO food that
might affect safety, the FDA would require a label. The bill
would do the following. Number one, advance food safety.
Address the questions that consumers have about the safety of
GMO food by requiring the FDA to conduct a safety review of all
new GMO traits before they are introduced to the marketplace.
Number two, inform consumers. Help consumers make sense of GMO
labeling claims and their choices in the marketplace by asking
the FDA to establish federal standards for companies that want
to voluntarily label their product for the absence of or the
presence of GMO food ingredients. Number three, provide
consistency. Improve food labels using the term natural by
requiring the FDA to define the term for its use on food and
beverage products, thus creating a consistent legal framework
to guide food labels and inform consumer choice. Fourth,
eliminate confusion, which is what all good legislation should
do, and remove the uncertainty of the 50 state patchwork.
Thank you for holding the hearing, and at this time, I
yield my remaining time to Mr. Pompeo.
Mr. Pompeo. Thank you for yielding, Mrs. Blackburn. Thank
you to you and to Mr. Butterfield for being cosponsors of this
bill. You can see today that we are engaged in a bipartisan
effort to get to the facts and the science surrounding this
incredibly important issue. I want to thank all the witnesses
for coming. I especially want to thank Stacey Forshee, fellow
Kansan. It is her second trip to Washington to help do good
work on behalf of consumers all across the country. Thank you
for being here today.
Look, at the end of the day, this is a Bill that is needed
to make sure that folks all across America can afford food. We
in America have known for a long time that absent innovation
and technology, the food prices will rise dramatically. We
won't be able to feed the next billion people in the world
either, something that I think we take great pride in here in
America. Studies have shown that absent this legislation, the
average family's food bill will go up by $500, and while I know
there are some for whom that is not a lot of money, there are a
lot of folks that I represent for whom that it is an awful lot
of money, and who are living day-to-day and paycheck to
paycheck, and who care deeply to make sure that their food
prices, one of the things that they have to make hard decisions
about from time to time, doesn't get even more difficult in
this economy that we know is struggling so much. And it is also
to help folks who are the producers of this food, to make sure
that they have a way to get this product from their cattle
ranch or their farm, or wherever it may be, to our store
shelves in a way that they can do profitably, so that they can
continue to invest in their products, so that America continues
to be the leader in world production of food in an affordable
way.
The science is not debatable here. There has been lots of
research, lots of studies. Even those who oppose this bill
don't make much of a case about the science. And that is what
FDA is all about; it is about getting the science right. This
bill gives them the opportunity to continue to review that, and
I think it is really good policy and will make our food supply
chain enviable all around the world.
I yield back.
Mr. Pitts. The chair thanks the gentleman.
Now recognize the ranking member of the full committee, Mr.
Waxman, 5 minutes for an opening statement.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman.
Today's hearing is on a topic about which many Americans
have strong feelings. Twenty years ago, the first genetically-
engineered food, the slow-ripening Flavr Savr tomato, went on
the market. Today, the vast majority of corn and soybeans and
cotton and canola and sugar beets and papaya grown in the U.S.
are genetically engineered. All of these foods have been
assessed by the Food and Drug Administration in a voluntary
consultation process, and FDA has found no significant
differences between them and their traditionally-bred
counterparts.
Some 70 to 80 percent of packaged foods contain ingredients
from genetically engineered, or GE, plants. Yet, despite their
ubiquity and FDA's OK, many consumers remain uncomfortable with
these foods and want mandatory labeling so they can avoid them.
As we consider the questions on GE foods at today's
hearing, I will examine them in the context of some important
principles I have long supported. First, I believe it is
critical that our actions be based on science. As with so many
other matters pertaining to products we use and consume every
day, we need to rely on the expertise of FDA and other
scientific regulatory agencies. Second, when we consider
requiring labeling on food, that label should provide useful,
science-based information to consumers. I certainly believe
that food labels should enable consumers to make informed
choices. I fought hard to pass legislation that gave consumers
useful information about the nutritional content of food.
Third, unless there is a compelling policy reason otherwise, we
should maintain the ability of states to make a decision that
is different from the Federal Government. All three of these
concepts are at play here today, and I think we should examine
each carefully.
On the first concept, what does the science tell us about
GE foods? From what I understand, genetic engineering is not an
inherently dangerous technology. Certainly, when it is used to
give new properties to plants, we need to make sure those new
properties don't affect the safety or nutrition of food from
those plants, but if FDA has done that and finds that GE food
does not differ in any significant way from traditional food,
why should there be a label that marks it as different? If
there are safety questions about a food, then it shouldn't be
allowed on the market at all.
I look forward to hearing more from FDA and other witnesses
on this today. Nevertheless, I understand that people may still
want information about how their foods are produced. So let us
look at the second concept of whether there is a way to give
them meaningful and useful science-based information. On the
one hand, I am concerned that people have the information they
want or need. On the other hand, I am concerned that mandatory
GE labeling could be inherently misleading. Mandatory labeling
could lead consumers to believe that if the government is
requiring a GE label, it must mean that GE foods are riskier or
somehow fundamentally different from non-GE foods, and to date,
scientists have concluded that they are not.
Furthermore, given that up to 80 percent of packaged foods
contain GE ingredients, if we require labels, most food on the
shelves would have a label declaring the presence of GE
ingredients. I am not sure what good that does us. Under our
current system, if consumers want to avoid GE foods, they can.
They can buy organic foods which, by law, cannot contain GE
ingredients. Or they can search out the foods that
manufacturers have certified and labeled as non-GE. That more
targeted information may, in fact, be more useable, and I would
like to hear what our witnesses think about that.
Now let us turn to the third principle of preserving the
ability of states to make decisions that are right for their
citizens, absent a compelling policy reason to the contrary.
Even if there is not a compelling reason to require GE labeling
at the federal level, that doesn't necessarily mean Congress
should tell Vermont and other states that they cannot require
such labeling. I have always believed states should have the
right to act in the best interests of their residents. And I
want to hear from our industry witnesses why the Vermont
legislation, and potentially similar legislation in other
states, is so harmful to some legitimate public interest that
Congress should override them. Absent a compelling reason
otherwise, I support letting states make their own laws and
govern themselves.
I remain open to hearing the view of all of our witnesses
today on these three points, and any other points pertaining to
this issue. I think today's hearing will be very interesting
and informative, and I thank the chairman for holding it.
Mr. Pitts. Chair thanks the gentleman.
That concludes the opening statements of the Members. As
always, the written opening statements of the Members will be
made a part of the record.
I have a unanimous consent request here, a statement from
the Corn Refiners Association, to enter into the record.
Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. We have two panels today, and I would like to
call our first panel, and I will introduce him at this time. We
have Mr. Michael Landa, Director, Center for Food Safety and
Applied Nutrition of the U.S. Food and Drug Administration.
Thank you for coming today. You will have 5 minutes to
summarize your testimony. Your written testimony will be placed
into the record.
So at this point, Mr. Landa, you are recognized for 5
minutes for your summary.
STATEMENT OF MICHAEL M. LANDA, DIRECTOR, CENTER FOR FOOD SAFETY
AND APPLIED NUTRITION, U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Mr. Landa. Good morning, Chairman Pitts, Ranking Member
Pallone, and members of the subcommittee. I am Michael M.
Landa, Director of the Center for Food Safety and Applied
Nutrition at the Food and Drug Administration. Thank you for
the opportunity to be here today to discuss FDA's regulatory
program for genetically engineered, or GE, foods.
Over the last 20 years, FDA has reviewed data and
information on more than 150 plant-derived GE foods. These
range from herbicide-tolerant soybeans to canola oil with a
modified fatty acid profile. Based on our evaluations, we are
confident that the GE foods in the U.S. marketplace today are
as safe as their conventionally-bred counterparts. The
selection and genetic improvement of plants for agricultural
use has been going on for thousands of years.
Mr. Pitts. Could you pull the mic a little closer to you
please?
Mr. Landa. Sorry.
Mr. Pitts. Yes, thank you.
Mr. Landa. That better?
Mr. Pitts. That is better, thank you.
Mr. Landa. Typically, plant breeding has involved cross-
breeding and hybridization. Many of the foods that are already
common in our diet, such as hybrid corn or nectarines, are
obtained from plant varieties that were developed using such
conventional genetic techniques, but during the breeding
process, undesirable traits, such as poor yield or poor disease
resistance, may appear. These unwanted traits can often be
eliminated through additional breeding and selective
reproduction, but the process is painstaking and time-
consuming.
Today, by inserting one or more specific genes into a
plant, scientists are able to produce a plant with new,
advantageous characteristics. These techniques give scientists
the ability to isolate specific genes of interest, and
introduce them and their corresponding traits into plants
without introducing undesirable genes or traits. This important
improvement over traditional plant breeding can reduce the time
needed to develop a new variety, and expand the range of new
proteins and other substances that can be introduced into
plants.
Any of these genetic modification techniques has the
potential to change the composition of food in a manner
relevant to food safety. FDA, however, has well-established
scientific procedures for evaluating the safety of new foods,
including any new substances in food, and our guidelines help
developers address any safety concerns prior to marketing.
FDA regulates the safety of all foods, including those
derived from GE plants, under the Federal Food, Drug, and
Cosmetic Act, to be called the Food and Drug Act. Foods
developed from genetically-engineered plant varieties, such as
fruits, vegetables, grains and their byproducts, are subject to
the same safety requirements as foods derived from non-GE
plants. The Agency relies primarily on two sections of the Food
and Drug Act to ensure the safety of food and food ingredients
produced by genetic engineering--the adulteration provisions in
Section 402 of the Act, and the food additive provisions in
Section 409.
Food growers, manufacturers, and distributors are
responsible for taking the steps necessary to ensure that their
food products are safe. The law places primary responsibility
for ensuring safety of food on industry. To help developers of
food derived from GE plants comply with their obligations under
the Food and Drug Act, and FDA's regulations, the Agency
encourages them to participate in a voluntary consultation
process prior to commercial distribution. Since the process was
created, developers of GE plants have completed the process
more than 100 times as they sought to introduce plants into the
U.S. market. Typically, the consultation begins early in
development when the Agency advises the company on what tests
would be appropriate to assess the safety of the new food.
After the studies are completed, a summary of the data
reflecting safety and nutritional assessment are provided to
FDA for its review. FDA expects developers of GE foods to
analyze the composition of the foods from their new crop
varieties to ensure that any changes compared to the foods'
conventionally-derived counterpart are appropriately considered
and addressed before marketing such foods. As part of our
review and analysis, we consider whether any newly-introduced
protein is likely to be allergenic or toxic, and whether levels
of important nutrients or anti-nutrients have been changed in a
way that is important to food safety or nutrition. We also
consider whether any newly-introduced protein requires
premarket approval as a food additive.
Examples of the information evaluated by FDA include the
name of the food and the crop from which it is derived, the
source, identities, functions and stability of introduced
genetic material, the purpose of the modification and its
expected effect on the composition and characteristics of the
food, the identity and function of any new substances
introduced by the genetic material, a comparison of the
composition and characteristics of the GE food to that of food
derived from the parental variety, and information on whether
the genetic modification altered the allergenic or toxic
potential of the food.
Let me just speak for a minute or so about FDA regulation
of labeling. We regulate labeling including labeling of GE
foods under the Food and Drug Act and our regulations. The Act
establishes that a food is misbranded if its labeling is false
or misleading in any particular. The Act also provides that
labeling is misleading if it, one, fails to reveal facts that
are material with respect to representations made or suggested
in the labeling, or two, fails to reveal facts that are
material with respect to consequences that may result from use
of the food, whether that is a labeled use or a customary use.
Historically, FDA has taken the position that the use of
genetic engineering in the development of food is normally not,
by itself, material information within the meaning of the Food
and Drug Act. Federal courts have held that absent a material
fact or a difference in food derived from a GE source, the Act
does not require labeling indicating that the food has been
developed through genetic engineering.
In closing, let me reiterate that the consultation process
for foods derived from GE plants is working well, and provides
for a rigorous food safety evaluation of such foods. The Agency
will continue to be vigilant, ensuring the safety and integrity
of the food supply.
And with that, I am happy to answer any questions.
[The prepared statement of Mr. Landa follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The chair thanks the gentleman.
We will now begin questioning. I will recognize myself 5
minutes for that purpose.
Mr. Landa, you state in your testimony that FDA has
reviewed and evaluated data and information on over 150
genetically-engineered foods. Based on these reviews and the
data that has been compiled over the past 20 years, is the
Agency more or less confident today in the safety of the
underlying technology?
Mr. Landa. I think its confidence remains strong. It has
been and remains strong.
Mr. Pitts. How do you know that genetically-engineered
foods are no different in terms of safety than their
conventional counterparts?
Mr. Landa. Well, we know this based on the reviews we
conduct. We are looking at the genetic material, we are looking
at products of that material, new proteins, for example, at
their safety. We look at potential toxicity and allergenicity.
We look at chemical composition to see whether it is different
from the conventional counterpart. We look at the safety of the
whole food, if you will, and we look to see whether there are
any differences in the nutrients that might require disclosure,
for example.
Mr. Pitts. And how long, typically, does your evaluation
take?
Mr. Landa. I will have to get back to you with detailed
information, if I may.
Mr. Pitts. All right. Are there any material differences
between genetically-engineered ingredients and those derived
from traditionally-bred crops?
Mr. Landa. In general, no. We have found that there have
not been such differences.
Mr. Pitts. Does the FDA support the various state,
legislative and ballot measures that would require the labeling
of genetically-engineered foods, or would these initiatives
interfere with FDA's authority over food production or
labeling?
Mr. Landa. We haven't reviewed the initiatives. We don't
have any view about them and, therefore, we don't know whether
they would interfere or not.
Mr. Pitts. Would state-specific labeling requirements
change anything as far as your evaluation is concerned?
Mr. Landa. I do not believe so.
Mr. Pitts. All right. Let me ask if there currently is a
lack of consensus about the validity of the research and
science behind the safety of foods derived from genetically-
engineered plant varieties.
Mr. Landa. I think there is not. That is, I think there is
a consensus.
Mr. Pitts. There is a consensus----
Mr. Landa. Yes.
Mr. Pitts [continuing]. In the scientific community?
All right, at this time, I will recognize Mr. Pallone 5
minutes for his questions.
Mr. Pallone. Thank you, Mr. Chairman.
Mr. Landa, some who oppose mandatory GE labeling argue that
such labeling would be inherently misleading. They argue that
such a requirement would easily be taken to imply that the
government considered food from GE plants to be so
fundamentally different from food from non-GE plants as to
warrant a special designation. And I guess I agree that if the
GE designation had to look like a warning, it would be
misleading. However, in the next panel, Mr. Faber testifies
that his organization is not asking for anything like a warning
label, but rather a modest disclosure on the back of the
package. And I guess I would like to get your view based on
your experience with food labeling whether it would be possible
to design the size and wording of a mandatory GE designation in
such a way as to be innocuous, in other words, those who look
for it could find it, those who don't care about genetic
engineering would have no reason to pay attention to it. I am
not asking whether FDA could require such a label, nor whether
you think any form of mandatory GE labeling would be
appropriate from a scientific perspective, just that if
Congress were to decide that the best way to avoid multiple
state GE labeling requirements would be to impose a federal GE
labeling requirement, do you think it would be possible to do
so in a way that would be neutral and would not tarnish the
product. And also as part of your answer, if you could describe
the FDA's experience with irradiation labeling and whether we
could learn from that experience.
Mr. Landa. I certainly have not thought about the question
you posed with respect to the nature of a statement about GE
labeling. I don't think the Agency has considered that question
because our focus has been on whether there is a difference----
Mr. Pallone. The material. The material definition.
Mr. Landa [continuing]. Allowing us to require disclosure.
I think one way of looking at that question is whether there
are data on similar efforts, or whether one could design a
study to answer that question so that people would look at
different formulations of labeling, and you would learn what
they would take away from those different formulations.
Mr. Pallone. I mean I--the reason I asked the question, I
know you--I guess you don't really feel you can answer it at
this point, is because, you know, a lot of people that approach
me that would like the labeling requirement don't necessarily
make the argument that there is a scientific difference, but
just that they should--or that it is bad, but just that they
should know.
Mr. Landa. No, I understand, but one might, for example--
again, I think maybe one could develop different formulations
and do experimental studies surrounding them, the types of
studies that are typically done over the internet with panels
that are set up, they are large numbers, to see what people
would take away from a different mock label.
Mr. Pallone. OK. Now, I know you say that the FDA's
consultation process is--right now is obviously voluntary, but
what does that mean in practice? In other words, if it is
voluntary why would companies choose to use it? Do you have an
estimate of how many manufacturers choose not to use it? In
other words, what are the pros and cons of this voluntary
approach?
Mr. Landa. Well, we think for people intending to
commercialize product, we think those people do come to us for
several reasons. One, there is the basic statutory requirement
on companies to market food that is safe. Another is that we
learn a great deal from EPA and from APHIS and from others
about what is going on in this area, which is another incentive
for people also to come to us. And finally, we think that
growers are going to be reluctant to use seeds where there
isn't a no-questions letter from us because if, at the end of
that growing season, they have a crop that turns out to be
either unlawful or unmarketable because questions have arisen,
better to start with a product that has been through the
consultation process. So we think there are lots of drivers
that make the voluntary process one that people do subscribe
to, at least people who are intending to commercialize.
Mr. Pallone. Now, you say that you--the FDA hasn't required
the genetically-engineered label because they don't believe the
information is material. Does the FDA have the authority under
the Act to change its assessment that information is not
material? Do you think you have the authority to do that?
Mr. Landa. Yes, certainly in a given case. And let me also
say, the policy I have been describing and we have been
discussing, it has been in place for roughly 20 years, but we
have been asked to change it. We have before us several citizen
petitions asking to change our view on the law with respect to
materiality, and asking us to change our view with respect, in
some cases I think, to the facts. And we are considering those
petitions. We haven't responded yet, but we certainly have the
authority to change a position as long as the change is
appropriately grounded in the science and interpretation of the
law.
Mr. Pallone. Thank you.
Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman.
Now recognize the vice chairman of the full committee, Mrs.
Blackburn, 5 minutes for questions.
Mrs. Blackburn. I thank you, Mr. Chairman.
Mr. Landa, thank you so much for your time. I have to tell
you, I find this an absolutely fascinating debate, and am so
appreciative that you would take the time and the FDA would
take the time to talk with us on it.
I grew up in south Mississippi with a grandmother who, when
she went to college at the turn of the century, the 19th
century, chose to audit agriculture classes. So then buying a
farm and with her savings from being a teacher, and married,
she has five boys from--and then my mother, five more boys. Big
farm. During the Depression, she helps feed our hometown. So
being someone who enjoys growing things, as I was, and very
active in 4H club, which I was, and going on to be a part of a
crop judging team, I learned to appreciate what goes into
having good-looking food, because we eat with our eyes. I also
grew to appreciate yield per acre, that I would learn from my
grandmother, and having foods that would be more drought-
resistant, that would take less chemicals, that would take less
pesticides, things of that nature, and the importance of that
so that you had a good-looking and good-tasting food product
that did not, as readily and easily, spoil.
So I come to this debate from that background, and today
even in my district, I visited a lot of the farmers' markets,
and every once in a while someone will come up and talk about
genetically-engineered food or genetically-modified food, and I
enjoy asking them what that means to them. And I have found it
so fascinating that it means something different to nearly
everyone that I talk to, because we don't have that federal
standard, if you will. And I hope that you all at the FDA are
going to be able to work with us on this. Basically, everything
we eat is genetically-modified, whether it is corn or wheat or
any variety of tomatoes, which were mentioned earlier, it all
has been genetically modified. If you want to go back and eat
original wheat or barley, it is not going to give you very much
of a yield, and it is not going to be the desirable product
that you are looking for today. So we have to realize that as a
part of this debate.
So moving forward, let us go back to Mr. Pallone's question
on the labeling. I would love to hear from you what you all at
the FDA, what your team thinks should be conveyed in those
labels to the consumer, what should be there about health,
about safety, and about nutritional content of those products?
Mr. Landa. Well, the statute tells us as a general matter
that labeling is not to be false or misleading. That is sort of
the basic proposition. And since then, there have been many
changes to the law, including NLEA, which has directed us to
write the nutrition facts label or nutrition facts panel, which
has information about macronutrients and micronutrients. And,
in fact, we are in the process now of updating that label. We
proposed earlier this year to do that, and we are reviewing
comments on it.
Mrs. Blackburn. And when do you anticipate having those
recommendations?
Mr. Landa. I would certainly hope that the Agency could
issue final rules updating nutrition facts by 2016. It is a
complicated--it is called informal rulemaking, which is less
difficult than formal rulemaking, but it is still a----
Mrs. Blackburn. OK.
Mr. Landa [continuing]. Very resource-intensive process.
Mrs. Blackburn. I am about to run out of time. I want to
get to a couple of other things. I am certain you all go
through reams of information on analyzing data on the GE foods,
and I wonder how often do your FDA analysts go back in and
request additional information when you have a submission?
Mr. Landa. I don't know. I can't answer that, but we will
get that information for you.
Mrs. Blackburn. OK. Does the FDA distinguish foods based on
the method of breeding or the material composition of the food?
Mr. Landa. Not for labeling purposes, unless there is a
material fact.
Mrs. Blackburn. OK. Are you satisfied that your agency is
capable of understanding genetic engineering and determining
whether or not a plant is safe?
Mr. Landa. Yes.
Mrs. Blackburn. Thank you.
I yield back.
Mr. Pitts. Chair thanks the gentlelady.
Now recognize the ranking member of the full committee, Mr.
Waxman, 5 minutes for questions.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Landa, in many of the articles on GE foods, people
claim that the science is unsettled, controversial or new, with
the implication that there may be unknown risks and, therefore,
consumers are justified in being uneasy with GE foods. And yet
from your testimony, we get a different impression. However,
while you point out that genetic engineering is just one of
many techniques used in plant breeding, I don't think FDA has a
consultation process for any of the others.
How new is the science behind GE foods, and what are the
risks from them, and if genetic engineering is not especially
risky, why do you encourage companies to go through your
consultation process prior to marketing foods from GE plants?
Mr. Landa. I think it is largely that there certainly is
some possibility, for example, of a material difference. I
think we identified one with a product where there wasn't a
safety issue, but there was a difference in how the food
performed in the consumer's hands. I think it had to do with
friability. And we have completed over 100 consultations. There
have been a handful that have not gone to completion where we
were asked to stop the review, or the submitter withdrew. I
think in general, the process, which has been in place for some
time, was one that enabled us to learn and also to build
confidence, and we would hope to transmit some confidence in
this technology.
Mr. Waxman. Is this a new area of science?
Mr. Landa. No. Certainly, it is decades old.
Mr. Waxman. As you know, many consumers believe they have a
right to know whether a food was manufactured using
genetically-engineered ingredients, irrespective of all the
science in the world showing them to be no different from non-
GE ingredients. I would like to understand more about such a
requirement and how it would fit in with FDA's traditional
stance toward labeling requirements if Congress were to respond
to this consumer demand and pass a law requiring the label--
labeling of genetically-engineered foods.
How would mandatory labeling of genetically-engineered
foods compare with existing labeling requirements, such as to
reveal the presence of allergens in a food, or that a food has
been irradiated? Would FDA be concerned about a new law that
requires the labeling of GE foods, and if so, why?
Mr. Landa. There isn't any administration position on such
legislation. It would be obviously new for us. We would
implement it as best we could. I suppose the question it would
raise would be what is sort of the limiting principle. If what
animates this is right to know, the question then becomes what
is it that people do not have a right to know on the food
label, and I am not sure how one answers that question.
Mr. Waxman. There are just some foods that are irradiated.
Why would anybody irradiate their food? Why would a
manufacturer want to irradiate food?
Mr. Landa. For safety reasons.
Mr. Waxman. To keep the food from spoiling?
Mr. Landa. Spices. Spices are irradiated, for example.
Mr. Waxman. OK. Now, is there any harm from that? Any----
Mr. Landa. No.
Mr. Waxman [continuing]. Consequences that are problematic?
Mr. Landa. No.
Mr. Waxman. Yet, we require labeling. Why do we require
labeling on foods that have been irradiated?
Mr. Landa. It has been thought that irradiation could as a
process change some properties of the food and so that was the
thinking behind that.
Mr. Waxman. But there is no evidence of that?
Mr. Landa. I would have to go look at what we said at the
time we issued the labeling requirement.
Mr. Waxman. Now, why is this any different? You don't think
there is a problem. You said there may be a problem but you
don't know of a problem. What is the difference between
informing people that their spices have been irradiated if they
want to know that information, even though you don't think it
is particularly helpful for them to know it?
Mr. Landa. I think at the time with irradiation, we thought
that there was a possibility of a change in characteristics of
the food which people would not know about. We do not think
that is the case with genetic engineering.
Mr. Waxman. Do you think we should remove the labels from
irradiated foods?
Mr. Landa. The Agency has issued a proposal to do that. It
has not finalized that.
Mr. Waxman. OK, thank you, Mr. Chairman.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman from Illinois, Mr. Shimkus, 5
minutes for questions.
Mr. Shimkus. Thank you, Mr. Chairman.
Thank you for being here. I--a question I have is, I
understand the state debate, but does--do you know of any state
that has the capability to do the research and the findings to
the same standard as the FDA?
Mr. Landa. I don't, but I wouldn't have any reason to know
that one way or another.
Mr. Shimkus. Yes. I can tell you I am from a big state of
Illinois, and we can't do it. There may be one--maybe--well,
maybe California has some capability, but my guess is smaller
states, they don't have nearly the ability to do the research
that you all do. And I think that is part of this whole should
states be able to have their own labeling restrictions and
requirements because, as we have found, it is really based upon
emotion and not based upon a scientific evaluation.
Let me ask about--do you distinguish foods based upon the
method of breeding, or the material composition of the food?
Mr. Landa. We don't require labeling based on method of
production alone.
Mr. Shimkus. Why not?
Mr. Landa. Because we have found that it is not material to
safety or nutritional composition.
Mr. Shimkus. Yes, and I appreciate that. Let me--in the
case of sugar, right, we--sugar processors require to label
whether refined table sugar comes from--I am--I guess the
questions is, are sugar processors required to label whether
refined table sugar comes from a certain species or plant?
Mr. Landa. I am sorry, I don't----
Mr. Shimkus. So if you have--are we--you don't require fine
table sugar to label whether it comes from sugar beets or from
cane.
Mr. Landa. No.
Mr. Shimkus. Why?
Mr. Landa. Again, I think it is a question of materiality,
to safety or nutrition.
Mr. Shimkus. So if we were--would the consumers be any--
would they get any benefit if that labeling requirement for
fine table sugar also had a requirement, well, this is beet-
produced fine table sugar or sugar cane fine table sugar.
Mr. Landa. Again, what we focus on is the attribute of the
food as the consumer would----
Mr. Shimkus. And----
Mr. Landa [continuing]. Would eat it.
Mr. Shimkus [continuing]. For the genetically-engineered
ingredients in foods today, is there any evidence that they
vary in their objective characteristics in any meaningful or
uniform way?
Mr. Landa. No, not as a class.
Mr. Shimkus. Can you explain why FDA's regulatory focus is
on the food or food product as opposed to the process in which
it was grown?
Mr. Landa. Because, of course, in the end, it is the food
that we eat.
Mr. Shimkus. Right. Yes, and I appreciate--I think you are
going to keep getting the same questions from members here on
trying to understand--you are Food and Drug Administration, you
all come before us on a lot of different aspects. You are our
trusted advisors. We respect the job that you do. I know this
is a very difficult and emotional debate for some folks on both
sides because it deals with some individual consumers, it deals
with the agricultural community that many of us represent. We
have to have an impartial, you know, observer based upon health
and safety effects to the consuming public. We appreciate the
work you do.
Mr. Chairman, thank you, and I yield back.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentlelady from California, Mrs. Capps, 5
minutes for questions.
Mrs. Capps. I thank you, Mr. Chairman, and thank you, Mr.
Landa, for your appearance here with us today, and your
testimony.
I understand that FDA's position that under the Food, Drug
and Cosmetic Act, the breeding methods by which a plant was
developed is not material information about food from that
plant. However, in their testimony, Mr. Faber and
Representative Webb point out that many consumers do believe
that foods labeled as natural--in quotes, ``natural'', are not
genetically engineered, and sometimes buy such foods because of
that belief. They also say that many such foods do contain GE
ingredients.
I can understand FDA's reluctance to wade into the argument
as to what constitutes natural, but if many consumers believe
that the term natural implies non-GE, and are making purchasing
choices based on that belief, shouldn't the use of that term on
a food label be considered a representation that the food is,
in fact, non-GE? I know that is kind of a packed question, and
I am going to continue just for a little bit more to give you
plenty to deal with. This is my only question, actually. And if
so, wouldn't the use of the term natural on a food containing
GE ingredients be, as the statute says, failing to reveal facts
and material in light of such representation if it does not
state that it contains GE ingredients? Gets convoluted. In
other words, and this is the question, even though the use of
genetic engineering may not be material information, per se,
doesn't it become material information in those circumstances
in which the rest of the labeling of the GE food implies that
the food does not contain GE ingredients?
If you can sort that out, kudos to you, but this is the
topic I wish to hear from you. And take your time because for
the next few minutes.
Mr. Landa [continuing]. There is a short answer to this,
which is that we have pending several citizen petitions related
to the question of what is natural, including one going to the
very question I think you are getting at which is, is the food
that contains a genetically-engineered ingredient, or
ingredient derived from a genetically-engineered plant, a food
that may properly be labeled as natural. There is a big debate
about that. We have been petitioned to say yes. I am sure we
have been petitioned to say no. We have been petitioned to
establish a definition for natural, and we are considering
those petitions. That is really all I can say at the moment.
Mrs. Capps. Is there any--can you shed any light on this
topic for the sake of our constituents as to where you are
going in your--I mean I agree, it is very confusing.
Mr. Land. One possibility, and we have not committed to
this, but to take you back a little bit, the Agency embarked on
an effort to define natural years ago. That did not result in a
codified definition. It resulted in a statement and a preamble
that natural can't be either added or synthetic, I think was
the language. We have been asked on many occasions to develop a
definition. I personally have been asked on many occasions. I
have always said that we really don't have the resources to do
that.
We now have petitions before us. I think if we decide to
reconsider this issue, it will necessarily have to be a public
process. Whether we would embark on rulemaking, which has to be
a public process, or guidance, there will be some public
process if we decide to revisit this.
Mrs. Capps. Well, I actually applaud that. I think the
public is already engaged, I believe that, and would be
welcoming--this is my opinion now, but from what my
constituents are telling me, that they are already engaged, and
a signal from FDA that--maybe you don't have black-and-white
kind of answers to give, that you are seriously considering
this, and maybe that we can carry on this kind of conversation
throughout the country. It appears to me the consumers are
clearly confused by the current labeling system. I mean we can
perhaps all agree on that; it is complicated today. And they
are making purchasing decisions based on, sometimes I believe,
misleading or unclear labeling. And I am not blaming,
necessarily, here, but it leads to a state of confusion. And I
hope that you can find the resources in FDA to take a broader
look at what is happening with respect to consumers'
experiences so that they can have confidence in this system
that we have and work with you to strengthen the labeling
system to reduce the kind of confusion that we are talking
about.
With that, I will yield back. Thank you.
Mr. Landa. Thank you.
Mr. Pitts. Chair thanks the gentlelady, and now recognizes
the gentleman from Virginia, Mr. Griffith, 5 minutes for
questions.
Mr. Griffith. Thank you, Mr. Chairman.
OK, I eat a fair number of odd foods, and a number of those
are labeled non-GMO. Is there a distinction between genetically
modified and genetically engineered?
Mr. Landa. I think as a technical matter, GMO refers to an
organism, as opposed to genetic engineering which we think of
as having to do with sort of modern biotechnology.
Mr. Griffith. OK. In that regard, one of the concerns that
I have, and I want to know if it is a concern for you, is that
I come from a family where just about half of us have some kind
of food allergy. If you are changing proteins around and you
have things that are, for the general public, generally
recognized as safe, are you able in what you all do to be able
to distinguish if a protein that someone may be allergic to has
been added to a product which they may not know that protein
has just been included?
Mr. Landa. That is part of the evaluation process, and if
there were to be an addition that might prompt an allergic
reaction that one would not expect, we would require a label
disclosure.
Mr. Griffith. So you would pick out those things which
people arehighly allergic to, or which there is a significant
percentage of folks that have a problem with, and you say, OK,
you can't put the strawberry ingredient into this tea?
Mr. Landa. Or we would require disclosure.
Mr. Griffith. Or disclosure.
Mr. Landa. Most likely would be the----
Mr. Griffith. And I apologize if I missed this in one of
your earlier answers, are you all looking at the possibility
of--for those people who may be concerned, saying or labeling a
product as something that is, in fact, as opposed to saying it
is genetically engineered or genetically modified in some way,
having those companies that want to, obviously you pay more for
it, but have some process where they can actually say we have
used all products that are not genetically engineered or
modified?
Mr. Landa. We have had draft guidance since about 2001 on
voluntary labeling. So there isn't any prohibition on a
voluntary label that your food does not contain----
Mr. Griffith. OK.
Mr. Landa [continuing]. GE ingredients. So the basic
requirement is that statement not be false or misleading.
Mr. Griffith. OK. And I appreciate that. You indicated
earlier that it was pretty much a consensus that this was not
something that was dangerous, if I understood your testimony
correctly, and yet I know there are a number of countries
around the world that have concerns about products, and
sometimes will ban our exports if they think that there has
been some crosspollination or something. Can you explain why
they are concerned?
Mr. Landa. I think different countries have different
regulatory systems. There are obviously different cultures with
different attitudes towards different aspects of foods, from
production to consumption to preparation and everything else.
Mr. Griffith. Other than culture, have any of those
countries had studies that indicated there was some danger to
the general human----
Mr. Landa. Not to my knowledge, no.
Mr. Griffith. All right. I appreciate that. And I think you
said earlier you are looking at finalizing some guidance by
2016?
Mr. Landa. The nutrition facts?
Mr. Griffith. Yes, sir.
Mr. Landa. Yes.
Mr. Griffith. All right. And I am going to switch just
briefly, because I have a little bit of time left, into a
different subject but it is tangentially related, and that is,
what do you do about the grocery stores that are fixing food
and selling things, and they have to do nutrition facts, and
then you get into the whole allergens and then the GE or GMO
foods? How do you deal with all of that as a part for grocery
stores that fix the food----
Mr. Landa. The processed food is subject to nutrition
facts.
Mr. Griffith. Right.
Mr. Landa. What we have called restaurant-type food made
and sold in a grocery store is now subject, or will be when it
becomes effective, to menu labeling requirements.
Mr. Griffith. I will just tell you, I think that even
though I am concerned about it, and I might not eat the food if
I didn't know what was in it, I am not sure how a grocery store
is going to be able to comply with that when they may be using
all kinds of different ingredients, and somebody walks up and
says can I have X, Y or Z, it may be easier for--like a
McDonald's where they have certain ingredients and every one of
them has a label, a grocery store may not have that capability.
Mr. Landa. Well, we are talking about standard menu items.
Mr. Griffith. Standard menu items, so if it is some kind of
specialty item they would have an exemption?
Mr. Landa. Right.
Mr. Griffith. All right.
Mr. Landa [continuing]. Again, the requirement is 20 or
more establishments, a restaurant and similar retail
establishments is the language in the statute, and it is
standard menu items.
Mr. Griffith. All right, I appreciate that.
Thank you very much, and I yield back.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman, Mr. Butterfield, 5 minutes for
questions.
Mr. Butterfield. Thank you very much, Mr. Chairman.
Let me just remark on the statement made by Mrs. Blackburn
a few minutes ago about this being a fascinating debate. Mr.
Chairman, this is certainly a fascinating debate by any
measure.
In my former life, I served as a trial judge down in North
Carolina, and every day for 15 years I had to look at the
evidence and had to decide the facts. That was my job
description, and I did it for 15 years. And I have tried to do
that in this debate. And I have read large amounts of well-
informed publications over the last several months, and I for
one, I am just convinced that GE plants are as safe as any
other foods.
But, Mr. Landa, I need to interpose this question to you.
Do you have any evidence that foods derived from GE plants are
as safe as other foods? I have heard you mention it throughout
your testimony, but is there any scintilla of evidence that
would suggest that these foods are unsafe?
Mr. Land. I I heard you correctly. Is there any evidence
that suggeswant to make surets that these foods are unsafe?
Mr. Butterfield. Yes. Yes. That GE foods are unsafe.
Mr. Landa. Not to our knowledge, no.
Mr. Butterfield. All right. And how long does your agency,
and how large is the division that handles this task?
Mr. Landa. Well, the office that handles that task has
maybe 135 or 140 people, but those people also handle a variety
of tasks related to food additives, generally recognized as
safe substances.
Mr. Butterfield. But these are not politicians, these are
career employees at your agency?
Mr. Landa. Correct.
Mr. Butterfield. Yes. Have you encountered anyone, anyone
who advocates a 50-state approach to mandatory labeling?
Mr. Landa. I am not sure I----
Mr. Butterfield. You have talked to a lot of people, both
formally and informally, about this, and----
Mr. Landa. Anyone who advocates----
Mr. Butterfield. Who advocates a----
Mr. Landa [continuing]. That we have 50 separate----
Mr. Butterfield. Fifty separate sets----
Mr. Landa [continuing]. Sets of requirements?
Mr. Butterfield [continuing]. Of regulations, plus the
District of Columbia.
Mr. Landa. I have not.
Mr. Butterfield. I happen to find it to be----
Mr. Landa. I don't know that I have a reason to encounter
such a person, but no.
Mr. Butterfield. It seems to me illogical and irrational
and I am wrong from time to time, but I don't see how that
would ever work, even in California.
I yield back.
Mr. Pitts. Chair thanks the gentleman.
Chair recognizes the gentlelady from Illinois, Ms.
Schakowsky, 5 minutes for questions.
Ms. Schakowsky. Thank you, Mr. Chairman.
I am trying to sort out the science here. I have lots of
passionate constituents who are very concerned about GE
products. I have experts that we will hear on the next panel
who have great scientific credentials themselves, who will
argue about consumer information being provided about GE
products.
I want to follow up on another word. Mrs. Capps was talking
about natural, I want to ask you about material difference. And
you said that the FDA could change its view that GE status of
food is not material, which it is--that is the position right
now, there is no material difference, and that the Agency is
evaluating citizens' petitions that report to do that. So can
you elaborate on why the FDA has not believed this is a
material difference, and have the courts said anything about
it, what kind of different information might change your mind?
Mr. Landa. Well, we haven't found any differences in
relation to safety or nutritional composition. Again,
considering these foods as a class, any differences in safety
or nutritional composition, or any other attribute of the food.
Ms. Schakowsky. Can I ask you one thing? What about food
allergies? Since we are putting in a--into the DNA something
from perhaps a peanut into something else.
Mr. Landa. In that case we would require disclosure. That
would be material.
Ms. Schakowsky. And would that prevent, in this
consultation process, from that particular formulation going to
market?
Mr. Landa. No. What would happen is there would be a
disclosure of the allergic potential of the food.
Ms. Schakowsky. I see.
Mr. Landa. That would be a material fact.
Ms. Schakowsky. OK, and a seed that--I know Mr. Pitts said
you can use less pesticide. That is sometimes true, although
the FDA has just approved use of a seed that would make it more
tolerant of a lot more pesticide. Does the FDA have any
concerns about that?
Mr. Landa. I am not familiar with that matter, I am sorry.
Ms. Schakowsky. 2.4-D and Glyphosate. Anyway, OK. So in
material, meaning even in the peanut issue, then a disclosure
would be required because of safety?
Mr. Landa. Typically, with respect to allergens, yes. First
of all, there is a 2004 statute that requires disclosure of
what we call the big eight allergens, but if you were to find
another allergen, typically, we would require disclosure of it
rather than ban the food.
Ms. Schakowsky. And who does the research? I have to tell
you, my constituents who are against GMOs will say Monsanto,
DuPont, and can we really trust these companies that benefit so
much?
Mr. Landa. The data that are supplied to us are supplied by
the companies doing the consulting, and sometimes they will do
the studies, sometimes they will pay to have the studies done.
I will say that is true across all FDA-regulated products. FDA
does research, but it does not do research on the scale that
would be required to support voluntary submissions, much less
marketing applications.
Ms. Schakowsky. Let me ask one more question. Does the Food
and Drug Administration have the authority to implement a
mandatory premarket approval process of any food to ensure that
it is safe for consumers?
Mr. Landa. We proposed a number of years ago a mandatory
notification program for the types of products we have been
talking about this morning. That proposed rule is still in
existence. We have not found the need to finalize it, given
what we think is how well the voluntary program works, but that
proposal necessarily maintained that we had the authority to
establish a mandatory program.
Ms. Schakowsky. I yield back. I can put some more questions
in writing. Thank you.
Mr. Pitts. Chair thanks the gentlelady.
Just for clarification, when you say it requires
disclosure, does that mean on a label?
Mr. Landa. On a label. I am sorry, yes. Thank you for that
question. Yes.
Mr. Pitts. Yes. OK. Thank you.
Gentleman, Mr. Matheson, is recognized 5 minutes for
questions.
Mr. Matheson. Well, thanks, Mr. Chairman.
And, Mr. Landa, I appreciate you coming here today.
You just said this with Mr. Butterfield, but I just want to
be clear, from the FDA perspective to date, you have found no
scientific evidence that there is a health and safety issue
with genetically-engineered foods?
Mr. Landa. That is correct.
Mr. Matheson. OK. I appreciate that. If there is this
consumer demand for wanting to know, if there is a producer of
a non-GMO food in the organic industry, they can label their
product as such that it is non-GMO, is that correct?
Mr. Landa. So long as the labeling is not false or
misleading, that is correct.
Mr. Matheson. So if the marketplace wants this, there is a
private sector opportunity for the organic food industry to
provide that information to consumers if they so choose?
Mr. Landa. That is correct.
Mr. Matheson. Does the FDA have any regulatory authority
over that type of labeling?
Mr. Landa. It is the general authority that labeling must
not be false or misleading.
Mr. Matheson. How long has the FDA been involved in
managing food labeling?
Mr. Landa. Well, the false or misleading provision dates
from either 1906 or 1938.
Mr. Matheson. Long time.
Mr. Landa [continuing]. I am not sure which.
Mr. Matheson. We will stipulate it is a long time. And how
is the FDA's role in terms of, if I am in the food industry,
and there are a lot of different people in it, how does the
FDA's role give signals to the food industry for how they do
labeling? They look to you for guidance, they look to you for
consistency, is that correct?
Mr. Land. Correct. They look to the statute, they look to
regulations we issue, they look to guidance we issue, and they
certainly, when they have particular questions, companies will
call our experts in labeling.
Mr. Matheson. So how do your guidances work? How do you
come up with those labeling guidances and how do they work?
Mr. Landa. Typically, on a significant issue, we would
issue what is called a draft guidance. We would call for
comment on it. We would analyze the comments we receive, and
issue it in final, with or without changes, or perhaps decide
not to issue it at all, or to reissue it with substantial
changes and calling for more comment.
Mr. Matheson. And the food industry relies on that. That is
where they get their direction for how they do labeling is from
your guidances?
Mr. Landa. First the statute, then the regulations----
Mr. Matheson. Got you.
Mr. Landa [continuing]. And then guidance, yes.
Mr. Matheson. How do food manufacturers--I want to address
this issue about a national system versus a 50-state patchwork
system. How do food manufacturers, from the big guys to the
little guys, how do they benefit from a national system?
Mr. Landa. There is a benefit to uniformity, but I think
the answer is that they are in a better position to tell you
how much of a benefit that is to them than I am.
Mr. Matheson. How do consumers benefit from a national
system compared to 50 different sets of rules around our
country?
Mr. Landa. You see the same labeling for the same product--
--
Mr. Matheson. There you go. People do cross state lines,
don't they?
Mr. Landa [continuing]. Wherever you purchase it.
Mr. Matheson. Yes. Yes. Funny how that works. I go 2,000
miles every week back and forth. Yes, so I think that I would
suggest, not to answer for you, that you are going to confuse
consumers if you have 50 different standards. That would be my
suggestion.
Let me ask you a question. How do you in the FDA resolve a
situation if a product is mislabeled? What do you do if some
manufacturer mislabels a product?
Mr. Landa. Typically, we might call the manufacturer, we
might issue what is called a warning letter----
Mr. Matheson. Yes.
Mr. Landa [continuing]. Depending on how serious we thought
the infraction was. If the label were not corrected, ultimately
we can, through the United States Department of Justice, seize
the product that is misbranded because of a misleading label--
--
Mr. Matheson. Right, so you have just----
Mr. Landa [continuing]. And we can enjoin further
distribution.
Mr. Matheson. You have just defined, as the regulator in
this industry for food labeling, you have just defined you have
the tools in the toolbox you have to address situations or
mislabeled, that is what I would suggest.
There have been claims by some consumer groups that the FDA
is too closely aligned with the industry and it can't be
trusted. How would you respond to that criticism?
Mr. Landa. I have been at FDA for almost 30 years. I work
with people who have been there much longer, by the way. I
believe, and my colleagues believe, that we are civil servants,
that we are engaged in an honorable professional and an
honorable activity. It does not mean we get every decision
right any more than anyone on the planet gets every decision
right, but we try to make decisions to the best of our ability
based on what the science tells us, and based on the law and
the regulations and sound policy.
Mr. Matheson. Well, Mr. Landa, I appreciate that answer,
and I thank you for your civil service. I think there are a lot
of folks in the agencies who are trying to do the right thing,
and appreciate your forthrightness in these questions today.
I will yield back, Mr. Chairman.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman from Texas, Mr. Green, 5
minutes for questions.
Mr. Green. Thank you, Mr. Chairman, and Ranking Member
Pallone for having the hearing today, and our witness for being
here.
Ensuring the safety of my constituents has always continued
to be the top priority as a member of Congress, and I hope that
your testimony today, we can come to a greater understanding of
the vital role that bioengineering plays in our food supply and
the economy.
Mr. Landa, thank you for taking your time to be here, and
like my colleagues, we appreciate your 30 years of service to
the FDA. I find this issue, as heated as it is, often leads to
passionate claims, and I hope your years of experience at FDA
can shed some light on the science of genetically modified
organisms, and the safety process behind their approval.
How many new plants are reviewed by the FDA each year, and
how much time does it take to conduct those reviews?
Mr. Landa. We will have to get back to you on that.
Mr. Green. OK.
Mr. Landa. The number of completed reviews is about now, I
think, 103. I think in five cases submissions were withdrawn or
people asked us to cease the review. We will get back to you
on----
Mr. Green. OK.
Mr. Landa [continuing]. Yearly figures and average times.
Mr. Green. OK. Do you believe changing from the voluntary
reviews to mandatory reviews would change the number of reviews
performed by the FDA each year?
Mr. Landa. I don't know, but I don't see why it would.
Mr. Green. OK. A coordinated frame work was developed by
the White House Office of Science and Technology Policy to
leverage the regulatory safety expertise present in the Federal
Government agencies like the FDA. In the 30 years that the
Agency has been part of this, are you satisfied that your
agency is capable of understanding genetic engineering and
determining whether or not a plant is safe?
Mr. Landa. Yes.
Mr. Green. Do you feel the FDA has the staff and
capabilities to be the voice of authority when it comes to GMO
safety?
Mr. Landa. In connection with foods in my center, yes.
Mr. Green. Food safety. Do you feel that the coordinated
frame work requires adequate safeguards for consumer health and
safety, and gives companies the regulatory certainty they need
to develop new products?
Mr. Landa. Yes.
Mr. Green. Has a GMO plant been deemed unsafe in the past
voluntary review process?
Mr. Landa. I am sorry, I didn't----
Mr. Green. Has a GMO plant been deemed unsafe in the past
voluntary review processes?
Mr. Landa. Not that I am aware of.
Mr. Green. OK. Was a safety issue due--if it did, and it
hasn't been, but is it due to the genetic engineering or is
other factors that you look for when you are inspecting them?
Mr. Landa. Again, I am not aware of any consultation that
has resulted in a finding of lack of safety. The ones we have
completed, we obviously have concluded we don't have any
questions. There were a handful that did not go to completion.
They were either withdrawn or we were asked to stop the review,
and I simply don't know the details of the reasons.
Mr. Green. What happens when you are asked to stop the
review?
Mr. Landa. We stop the review and the products do not go to
market.
Mr. Green. OK. So by just stopping your review, they don't
go to market, OK. So effectively, you are doing what a
regulator is supposed to do.
Was the frame work rooted in congressional enactments like
the Federal Food, Drug, and Cosmetic Act, Federal Meat
Inspection Act, the Federal Insecticide, Fungicide, and
Rodenticide Act, and do you feel that these statutes all, to
some extent, preempt state requirements?
Mr. Landa. It varies enormously across statutes. I simply
can't answer that question.
Mr. Green. And have each of these statutes, including the
one from 1906, been instrumental in consumer protection?
Mr. Landa. I can speak to the Food and Drug Act. I think
the answer to the question is yes. It dates from 1906, was
amended in 1938. Multiple, multiple times since then. I think
in order to protect and promote the public health.
Mr. Green. Do you have any suggestions on how we might look
at some of these Acts and make your job more effective? You can
get back to us if you want because I know--because that is our
job is, if you don't have----
Mr. Landa. We are certainly happy to----
Mr. Green [continuing]. The tools to do it----
Mr. Landa [continuing]. Provide technical assistance
whenever you ask us to do that.
Mr. Green. OK. Thank you.
And, Mr. Chairman, I will yield back my time.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman from Maryland, Mr. Sarbanes, 5
minutes for questions.
Mr. Sarbanes. Thank you.
Thank you, Mr. Landa. This is kind of a random question,
just picking up on your allergy discussion. Presumably, I mean
now you were suggesting that most ingredients, to which there
is an allergy of any significance, you require that that be
disclosed, right?
Mr. Landa. Congress required it in 2004.
Mr. Sarbanes. OK, but FDA would determine at some point
that if the number of people affected by that ingredient, in
terms of an allergy, reached a certain percentage of the
population or something, then it would flip into a banning of
the ingredient? Like sort of where is that line? Just----
Mr. Landa. No, it is not banning, it is a disclosure
requirement. Disclosure in the labeling, as the chairman was
reminding me earlier, so that if we were to conclude that a
food ingredient that is not on the list in the 2004 statute,
that--met a certain threshold, and I can't answer what that
threshold is in terms of percentage of population, we would
require a disclosure of it on the label.
Mr. Sarbanes. So you are talking about meeting a certain
threshold in terms of requiring disclosure. I am asking you
whether there is a threshold that one might meet that would
suggest that----
Mr. Landa. That we would ban it?
Mr. Sarbanes [continuing]. You just ban it. I mean if 95
percent of the population is allergic to a certain ingredient--
--
Mr. Landa. Of course.
Mr. Sarbanes. OK.
Mr. Landa. Let me give you an example. The oldest
adulteration provision in the law says, among other things, if
a food bears or contains a substance that renders the food
ordinarily injurious to health, the food is adulterated. And if
it is adulterated, it is prohibited from interstate commerce.
So sure, of course, if there was an ingredient that caused
illness in 90 percent of the population, people who ate the
food containing the ingredient, we would ban the ingredient.
Mr. Sarbanes. All right.
Mr. Landa. I am sorry. I thought you were sort of----
Mr. Sarbanes. Right.
Mr. Landa [continuing]. Trying to get at the disclosure
question.
Mr. Sarbanes. I got you. So let me switch. I am curious
about when the industry has to go change labels in response to,
say, some consultation exercise where everybody realizes that
that is the right thing to do, or something more prescriptive
that you require--well, first of all, is it the case that these
labels get created and they are sort of static for extended
periods of time, or in your experience, is labeling constantly
being revised and updated, both with respect to content
potentially, but also just in terms of the form of it, the way
it looks on packaging and all of this?
Mr. Landa. I really don't know.
Mr. Sarbanes. Yes.
Mr. Landa. I am just not familiar enough with industry
practice----
Mr. Sarbanes. Can you----
Mr. Landa [continuing]. To answer that question.
Mr. Sarbanes. In your 30 years, when was the last time that
you can remember that something the FDA did, or some
realization that the food industry came to, resulted in a
significant, across-the-board change in labeling?
Mr. Landa. Well, the one that comes immediately to mind is
nutrition facts----
Mr. Sarbanes. Yes.
Mr. Landa [continuing]. Which is a regulation that the
heart of which is now I guess about 20 years old. We required
disclosure of trans fat, 8, 9----
Mr. Sarbanes. So that was pretty significant.
Mr. Landa [continuing]. Eight, 9, 10 years ago, as I
mentioned earlier----
Mr. Sarbanes. Yes.
Mr. Landa [continuing]. With the revising of nutrition
facts.
Mr. Sarbanes. So if you revise what is required in the
nutrition fact panel in this rulemaking period between now and
2016, or whatever it was and you decide there are some
additional things that ought to be in there, then that would
cut across the entire food industry in a significant way in
terms of revising its labels, right?
Mr. Landa. Correct.
Mr. Sarbanes. Thank you.
Mr. Pitts. Gentleman's time has expired.
The chair recognizes gentleman, Mr. Pompeo, 5 minutes for
questions.
Mr. Pompeo. Great, thank you.
Thank you, Mr. Landa, for being here today. Thanks for your
30 years of service. I understand you are closer to the end of
your service than the beginning at this point, and----
Mr. Landa. Yes, thank you.
Mr. Pompeo [continuing]. And thank you for your good work.
Thanks for your testimony this morning too. It has been
interesting to watch. I think lots of folks watching this
hearing this morning have been surprised by the certainty you
are expressing around the science. You used the word initially
that there is a consensus. I thought I would try and parse into
that just a little bit more.
So when you--I have heard consensus, and that can be 70/30
or 80/20 or 90/10, where--tell me how much science there is
that would refute your position with respect to the materiality
of genetically engineered foods being safe.
Mr. Landa. We do not believe, again, as a class that there
is any question about safety, based on the reviews we have
done.
Mr. Pompeo. And that would include just--go ahead.
Mr. Landa. There are obviously people, scientists, who
differ with that point of view. I don't know how many of them
there are.
Mr. Pompeo. But it is a tiny fraction.
Mr. Landa. It certainly is.
Mr. Pompeo. And not folks that the FDA, at least, gives
significant credit to, certainly enough that you would change
your view with respect to the safety of this food. You all have
been very decisive.
Mr. Landa. To date, we have seen nothing to change the view
that we have had for a number of years now.
Mr. Pompeo. And that would include--there were questions
about what other countries have done----
Mr. Landa. Yes.
Mr. Pompeo [continuing]. And how their regulatory practice
would include studies performed all across the world as well.
Mr. Landa. That is correct.
Mr. Pompeo. I have heard some of my colleagues talk about a
patchwork of 50 sets of rules and what that might do. Just so
we are all clear, it wouldn't just be 50 sets of rules, it is
potentially thousands of sets of rules; cities, counties,
townships, neighborhood associations. One--the mind reels with
respect to folks who might want to confirm their theory of a
right to know through some sort of statutory or municipal rule.
Tell me what you think that complexity would do the safety of
the food supply chain.
Mr. Landa. I don't know that it would have an effect on
safety.
Mr. Pompeo. Right the confusion consumers--we were talking
about this, Mr. Matheson, he said he had to go 2,000 miles. You
might only have to go 2 miles to pass into a city that had a
different set of rules. I think there would be massive
confusion, and the impact that that would have on consumers'
ability to understand what they were consuming would be pretty
significant.
Mr. Landa. I suppose it could be. My point was that the
underlying safety of the food would not be----
Mr. Pompeo. Wouldn't change. Absolutely.
You have talked a bit about your premarket consultation
process. Today you said that most of the folks are--entering
this into commercial service have provided that for you. You
said you have gone through 100. A few have been withdrawn. I
want to make sure, no one has run through the stop sign today
where FDA has said, hey, we have a question or a concern, and
they have said, good for you, we still want to introduce this
product to the marketplace.
Mr. Landa. That is correct.
Mr. Pompeo. No one has run through the stop sign. It is----
Mr. Landa. That is correct.
Mr. Pompeo [continuing]. Not your expectation that anyone
ever would because it would be very difficult for a
commercialized food product to have run through an FDA letter
that says, hey, we think we have a health or safety issue.
Mr. Landa. That is our view, yes.
Mr. Pompeo. You talked about petitions for--and actually,
we are going to give you another one if I get this Bill passed
into law, this law contains a provision which would require the
FDA, within 24 months, to propose a regulation with respect to
natural. I agree with some of my colleagues, frankly, on both
sides of the aisle that I think we ought to clear that up so
that consumers have a good idea what that really means. I
understand the difficulty of that task and why you all have not
come to fruition on that yet, but know that if we are
successful in getting this particular Bill passed, you will get
to be successful in your endeavor as well.
So there have been proposals in some cities and some states
about labeling for genetically-engineered products. Have any of
those folks come to you or to the FDA to ask for your wisdom
about what that label ought to look like, or about the safety
or science behind genetically-engineered foods?
Mr. Landa. Not that I am aware of.
Mr. Pompeo. So to the best of your knowledge, none of the
states have come to you to say, hey, what do you--what does the
FDA think about this?
Mr. Landa. Not that I am aware of. It is certainly
conceivable that someone from----
Mr. Pompeo. Sure.
Mr. Landa [continuing]. A state would have come somewhere
in the agency, but not that I am aware of.
Mr. Pompeo. And I guess my last question is, this Bill
proposes that we would make the review process at FDA mandatory
as opposed to voluntary. Assuming that we provide the resources
to the FDA, such that they can handle all of the requests for
review, do you think that is an improvement, that is, do you
think it is the case that each of these products ought to be
submitted for FDA review before commercialization?
Mr. Landa. Yes, and we think that is happening now.
Mr. Pompeo. Right. Thank you.
I yield back, Mr. Chairman.
Mr. Pitts. Chair thanks the gentleman.
That concludes the questions of the members who are
present. I am sure we will have follow-up questions, other
questions from members. We will submit those to you in writing.
We ask that you please respond promptly. Thank you very much
for coming this morning.
We are going to take, while the staff sets up the second
panel, a 3-minute recess. The subcommittee is in recess.
[Recess]
Mr. Pitts. The subcommittee will come to order. We will ask
our guests to please take their seats, and I will introduce the
second panel at this time.
First of all, Dr. Alison Van Eenennaam, Cooperative
Extension Specialist in Animal Genomics and Biotechnology,
Department of Animal Science, from the University of California
Davis. Secondly, Mr. Scott Faber, Senior Vice President of
Government Affairs for the Environmental Working Group.
Representative Kate Webb, Assistant Majority Leader in the
Vermont House of Representatives. Ms. Stacey Forshee, the Fifth
District Director of the Kansas Farm Bureau. And finally, Mr.
Tom Dempsey, President and CEO of the Snack Food Association.
Thank you all for coming. We appreciate your patience. You
will each have 5 minutes to summarize your testimony. Your
written testimony will be made a part of the record.
So, Dr. Van Eenennaam, I think is the way you pronounce
your name, right? I am sorry for the mispronunciation. We will
start with you. You are recognized for 5 minutes for your
summary.
STATEMENTS OF ALISON VAN EENENNAAM, PH.D., COOPERATIVE
EXTENSION SPECIALIST, ANIMAL GENOMICS AND BIOTECHNOLOGY,
DEPARTMENT OF ANIMAL SCIENCE, UNIVERSITY OF CALIFORNIA, DAVIS;
SCOTT FABER, SENIOR VICE PRESIDENT OF GOVERNMENT AFFAIRS,
ENVIRONMENTAL WORKING GROUP; REPRESENTATIVE KATE WEBB,
ASSISTANT MAJORITY LEADER, VERMONT HOUSE OF REPRESENTATIVES;
STACEY FORSHEE, FIFTH DISTRICT DIRECTOR, KANSAS FARM BUREAU;
AND TOM DEMPSEY, PRESIDENT AND CEO, SNACK FOOD ASSOCIATION
STATEMENT OF ALISON VAN EENENNAAM, PH.D.
Ms. Van Eenennaam. All right. Good morning, Mr. Chairman,
and members of the subcommittee. My name is Alison Van
Eenennaam, and I am a biotechnology and genomics cooperative
extension specialist at the University of California in Davis,
and I appreciate the opportunity to speak on this topic here
today.
I work in the public sector as a scientist performing
research and education on biotechnology, and one of the reasons
I am testifying here today is that I was the taskforce chair
and the lead author of the CAST Issue Paper number 54,
entitled, The Potential Impacts and--of Mandatory Labeling for
Genetically-Engineered Food in the United States, that was
released in April of this year, and it is included as an
attachment to this testimony. And it basically explores the
scientific, legal and economic aspects of requiring food
labeling in the United States, based on the use of a breeding
method, that is, genetic engineering, rather than on some
specific attribute of the food product itself. And it also
looks at the implications of state versus national labeling
laws, and the potential economic impacts, and so I think it is
very germane to today's discussion.
As a scientist speaking here today, I do want to clarify
that GE food, commonly, but less precisely, referred to as
genetically-modified food, is food derived from crops produced
using a breeding method, based on the movement of useful genes
from one species into another using recombinant DNA technology.
This method is used routinely in medicine, and many
pharmaceuticals such as insulin and food processing aids, such
as renin used in cheese production, have been made by GE
microbes.
Although most commercialized crops that have been developed
using GE thus far have been made to resist insects or
herbicides, this breeding method can be used for many purposes.
And public sector scientists in Hawaii and New York, for
example, use GE to produce a virus-resistant papaya, a papaya
that virtually saved the Hawaiian papaya industry. Other
introductions include drought-tolerant corn, virus-resistant
squash, and consumer traits like a non-browning apple, a low-
acrylamide potato, and crops that produce improved oils for
nutrition.
Land grant university researches in California, Florida,
and Texas are working to use genetic engineering to develop
oranges that are resistant to Citrus Greening Disease,
something that is devastating the Florida orange industry, and
grape varieties that are resistant to Pierce's Disease.
In New York, researchers are using a wheat gene to develop
an American chestnut tree that is resistant to the imported
chestnut blight. These disease-resistant GE applications focus
on controlling disease with genetics rather than with
chemicals, and importantly, they don't involve the use of
chemical pesticides, an issue that often gets conflated with GE
as a breeding method.
In 2013, genetically-engineered crops were cultivated
worldwide by 18 million farmers, and in the United States, GE
varieties were planted on 95 percent of sugar beet acreage, 93
percent of soy, and over 90 percent of both cotton and corn
acreage.
What has been the impact of this widespread adoption? As a
scientist, I look to the peer reviewed independent literature,
especially meta-analyses and review articles that present a
summary of many independent studies. In 2014, German university
professors published a comprehensive analysis of 147 studies
that have assessed the impact of the adoption of genetically-
engineered crops. They found the benefits were significant and,
in summary, on average, GE technology adoption reduced chemical
pesticide use by 37 percent, increased crop yields by 22
percent, and increased farmer profits by 68 percent. This would
explain their widespread adoption by farmers globally.
As a result of this widespread use in American agriculture,
many food products in the United States include ingredients
that might be from corn oil or sugar that have been derived
from GE crop varieties. And it has been said before, it has
been estimated 70 to 80 percent of processed foods likely
contain such ingredients.
Importantly, many highly-processed ingredients, such as
sugar and oil, contain no detectable traces of DNA or protein,
and hence, there is no way to test these refined products to
determine their genetic origin; meaning, labeling of these
products would require entire supply chain tracking and
segregation to keep track of the products derived from
genetically-engineered crops, a very expensive and complicated
proposition.
There is a broad scientific consensus about the safety of
food produced from GE crop varieties, and solid data to support
that consensus. A 2013 review article, written by independent
Italian public sector scientists, reviewed over 1,700 safety
records of GE crop safety published this past decade, and
concluded that the scientific research conducted so far has not
detected any significant hazards directly connected with the
use of GE crops.
The American Association for the Advancement of Science,
the world's largest and most prestigious scientific society,
stated in 2012 the science is quite clear; crop improvement by
the modern molecular techniques of biotechnology is safe. The
World Health Organization, the American Medical Association,
the U.S. National Academy of Sciences, the British Royal
Society, and every other major scientific body and regulatory
agency in the world that has examined the evidence has come to
the same conclusion.
To date, no material differences in composition or safety
of commercialized crops developed using GE has been identified
that would justify a label based on the use of GE as a breeding
method in the development of that crop variety. While this
conclusion will not satisfy those who consider the insertion or
manipulation of genes in a laboratory a material difference,
per se, the science of food safety does not support mandatory
process-based labeling of GE food and, by extension, is not
required by the Food and Drug Administration.
Thank you for the opportunity to speak here this morning,
and I would be pleased to take questions from the subcommittee.
[The prepared statement of Ms. Van Eenennaam follows:]
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Mr. Pitts. The chair thanks the gentlelady.
Now recognize Mr. Faber 5 minutes for his opening
statement.
STATEMENT OF SCOTT FABER
Mr. Faber. Thank you, Mr. Chairman. Mr. Chairman, Ranking
Member Pallone, members of the committee, thank you for the
opportunity to testify. First, let me thank you for the
tremendous work you and your staff performed on the Sunscreen
Innovation Act. We greatly appreciate your work on that
important piece of legislation. And let me thank you for
dedicating your time to this important issue. As you can tell,
people are incredibly passionate about their food.
Consumers simply want the right to know what is in their
food and how it is produced. More than 90 percent of consumers,
regardless of age, gender, income, or even party affiliation,
routinely tell pollsters that they want--simply want the right
to know what is in their food. But this isn't simply a question
of right to know. It is also a question of consumer confusion.
As Mrs. Capps mentioned earlier, misleading claims like natural
claims have led to significant consumer confusion. Roughly 60
percent of consumers, when buying a package with a natural
claim, believe that all natural foods are GMO-free. And we
believe that a factual, informative, nonjudgmental disclosure
on the back of the package would help address this confusion.
Now, let me be very, very clear. We are not seeking a
warning of any kind; we are simply seeking a factual,
nonjudgmental disclosure on the back of the package, and we are
confident, as Mr. Pallone suggested earlier, that food
companies, farmers, FDA, consumer groups can work together to
craft a disclosure that provides consumers basic information
without rendering a judgment on the technology.
And fortunately, FDA has the authority to require such a
disclosure, and as Mr. Waxman alluded to earlier, has used this
authority in the past. And that is fortunate because we would
greatly, greatly prefer a national GMO labeling solution. But
in the absence of leadership from FDA, we believe that states
should and can act or require a mandatory disclosure. Congress
has long recognized a role for the states, a leading role for
the states, in food labeling, and that is why the NLEA was
carefully crafted to not preempt state labeling laws, such as
the GMO disclosure laws that have been passed by states like
Vermont.
Now, you have certainly heard arguments made today, and
will hear more arguments made by this panel, that GMO labeling
will increase food prices, but you don't have to work for the
Grocery Manufacturers Association or work for the food industry
to know that food companies change their labels all the time to
highlight new claims or new innovations.
You will also hear today that GMO labeling will create
costly new farm and food--the need for costly new farm and food
segregation systems, but those systems have been in place for
decades, to address allergens and to meet growing demand for
non-GMO and organic choices, all the way from the farm to the
elevator, to the processor, to the retailer. In fact, the snack
food industry has launched more non-GMO project offerings in
the last decade than any other segment of the food industry.
You will also hear--and also have heard, and will hear
again, that we need GMO crops to feed the world. First, let me
say, no one, no one is seeking a ban on GMO crops, and let me
point out also that many farm groups, including the National
Farmers Union, support mandatory GMO labeling. But it is also
worth noting that we have run the experiment for the last 20
years, and so far yields of conventional crops have kept pace
with yields of GE crops.
Now, I agree with testimony you will hear from Ms. Forshee
that farmers should have choices, but so should consumers. We
need a national GMO labeling system that works for farmers,
that works for food companies, but that also works for
consumers. Unfortunately, H.R. 4432 does not provide a national
mandatory labeling system. In fact, H.R. 4432 narrows FDA's
ability to work with us, to work with farmers, to work with the
food industry to craft such a system. It fails to restrict the
misleading natural claims that have fueled so much consumer
confusion, and it preempts state laws that are ultimately
designed to protect consumers from this confusion.
Mr. Chairman, people simply want to know what is in their
food, they want to be able to make choices for their families,
and I hope that you will work with us to give consumers the
right to know whether or not their food contains genetically-
modified food ingredients.
Thank you.
[The prepared statement of Mr. Faber follows:]
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Mr. Pitts. The chair thanks the gentleman.
Now recognize Representative Webb 5 minutes for opening
statement.
STATEMENT OF KATE WEBB
Ms. Webb. Thank you, Mr. Chair, and committee. My name is
Kate Webb. I am a Representative and Assistant Majority Leader
from the good state of Vermont, and I was the lead sponsor on
Act 120, a law that simply gives consumers the right to know if
the food they purchase in Vermont is genetically engineered.
The law is at risk should H.R. 4322 become law. Because Vermont
is involved in litigation regarding this very issue, I want to
be clear that I am not a lawyer, not a scientist, and not here
as a representative of my state or my government. I am here as
a Vermont citizen to tell you of the importance of this right
to the citizens of my state, and other states whose citizens
seek this simple request for transparency.
Vermont's Act 120, an act relating to the labeling of foods
produced with genetic engineering, was signed into law this May
to great fanfare and celebration on our State House steps. This
Bill grew from grassroot efforts of tens of thousands of
Vermonters seeking to have a right to make an informed choice
about the food they purchase. This desire was not limited to a
handful of Vermonters. Survey upon survey has shown that more
than 75 percent of Vermonters were in favor of such labeling.
I personally became involved in this legislation in 2012,
and over the next 3 years, we developed draft legislation to
gain the fundamental right to know how our food is produced;
drafts that traveled through six legislative committees who
received testimony from over 100 people, including scientists,
lawyers, academics, consumers, manufacturers, and food
producers on both sides of the issue. Act 120, in its final
form, is the result of many hours, weeks and years of work, and
it passed the Senate, I want you to hear this, the Senate on a
vote of 28 to 2. It passed the House on a vote of 114 to 30.
These are large numbers.
Why is it that Vermont wants this right? It is about
transparency and truth in labeling. Even though the World
Health Organization defines genetically-modified food as foods
derived from organisms whose genetic material has been modified
in a way that does not occur naturally. And Monsanto defines
genetically-engineered organisms as plants or animals that have
had their genetic makeup altered to exhibit traits that are not
naturally theirs. However, many genetically-engineered products
continue to carry the word natural, or variations of this word,
on their labels. I believe this is misleading, and Act 120
would prohibit the use of this term for products produced or
partially produced with genetic engineering.
Because GE is a relatively new and evolving science,
consumers concerned about unintentional environmental and
health effects want the right to exercise this precaution.
And finally, we heard testimony that without labeling,
members of many religious communities could not tell if
products they purchased violated their faith's dietary
prohibitions. There is nothing in our law that restricts anyone
from producing or selling genetically-engineered products.
There is nothing in our law that says that it is good or bad.
Business and farming will go on as business and farming does.
One of the great strengths of a capitalist democracy is not
only do we cast a vote at the polls, we also do by--so by
selecting the products we purchase. Transparency allows us to
see how things work, be it government, financial institutions
or the food we eat. This transparency allows us to make
informed decisions, and ultimately build trust.
States have historically, and continue today, to lead the
way on food labeling. Forty-one states regulated the use of
sell-by and use-by data on--dates on food labels. Before
Congress mandated our current federal county of origin--country
of origin label, which also doesn't state whether it is good or
bad, nor does our Bill, these requirements existed in Alabama,
Mississippi and Arkansas, who required labeling disclosure
about the source and production of catfish. And many states
regulate the labeling of cottage foods. I believe Tennessee and
Mississippi do this. And many states are already regulating the
labeling of bottled water before the FDA set standards of
identity.
While the USDA and AMS issue voluntary grading standards
for some agricultural products, many states also issue these
grading labels. Vermont's legislature did so with maple syrup
this year.
Mr. Chairman, our state is already involved in litigation
with the Grocery Manufacturers Association, among others, and
if this will help to answer if Vermont and any other state has
the constitutional right to label.
I urge you to defeat H.R. 4432 and promote federal
labeling. Thank you.
[The prepared statement of Ms. Webb follows:]
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Mr. Pitts. Chair thanks the gentlelady.
Ms. Forshee, you are recognized 5 minutes for your opening
statement.
STATEMENT OF STACEY FORSHEE
Ms. Forshee. Chairman Pitts and Ranking Member Pallone, and
all the other committee members, it is an honor and privilege
to sit in front of you today. My name is Stacey Forshee. My
husband, David, and I are fifth generations to farm in Cloud
County, Kansas, in north central Kansas. We live in--near the
small community of Delphos, and just to put it in perspective,
I am 20 miles away from my nearest grocery store.
I am a member of the Cloud County Farm Bureau Association.
I serve on the Board of Directors for Kansas Farm Bureau for a
10-county area. I am also a part of the Cloud County Community
College Ag Advisory Board, CloudCorp Board of Directors, and I
also sit on my Concordia High School Booster Club Board. But my
most important job is as wife of my husband, David, for 24
years, who I farm right alongside, as well as my--our children,
Kendra, Lauren and Wyatt. But raising our children on our farm
hasn't always exactly been easy, but we are very proud of what
we have accomplished.
Today, we farm approximately 2,000 acres that we grow corn,
soybeans, alfalfa, wheat and other feed crops for our cattle.
We operate a feed cow calf operation that has about 700 cows,
that my husband is home finishing calving for me right now, but
the majority of them will calf in the spring.
We also operate a small feed lot that enables us to feed
our own cattle, and actually, much of what we grow, sometimes
we are able to feed them. We also custom feed other producers'
cattle. We have a custom hay-grinding operation where we grind
area cattlemen's hay for them, and we also buy and sell quality
alfalfa and we have supplied dairies and feedlots throughout
Kansas.
But first, and most importantly, I am a mom and I am a
consumer, and a farmer, so I would never want my children to
eat anything, or anybody else's children to consume something
that was bad for them, that was unsafe. And as a farmer, my
family would never want anything to enter the food supply that
we raised or that we grew that would be proven to be unsafe.
And there has been, very many--all the credible studies have
shown that genetically-modified ingredients and products are
safe.
On our farm, we use this biotechnology to be able to
conserve moisture. We also have found that by using this
technology, up to 40 percent we can save on fuel, on fertilizer
and on pesticides. We have seen that drop over the last 24
years. We also are stewards of the land. The environment is
very important to us, so the less we use of all of these things
are very important, and we owe that to biotechnology.
Labeling a safe product, to me as a consumer, just does not
make any sense. So I just feel that this, making a mandatory
label is going to mislead consumers into thinking that it is
unsafe, which we have heard today that that is wrong.
With the future projections of our growing world, farmers
and ranchers around the world are going to have to double their
food production to meet those growing demands, and on my farm,
biotechnology is a way that we feel like we can make this
happen.
On our farm, we also have the ability to store more than
20,000 bushels of grain. So when we harvest our crops, we store
that grain in different bins. Due to crop insurance
regulations, there are certain things that we need to abide by,
but we can store all one kind of grain in one bin. And the same
is true for my local elevators and all our rural communities.
For us, we do this so that we can market that crop later, or
feed it to our livestock, but it would cost billions of dollars
in infrastructure and new technology to be able to just
absolutely trace a biological trait from my farm to the
consumer's table.
As a mother and a farmer, I urge Congress to pass this H.R.
4432, the Safe and Accurate Food Labeling Act. For me to be
able to continue to farm like I do, and to meet the growing
future's needs, I really urge you to do this.
And I really thank you for your time.
[The prepared statement of Ms. Forshee follows:]
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Mr. Pitts. Chair thanks the gentlelady, and now recognizes
Mr. Dempsey 5 minutes for your opening statement.
STATEMENT OF TOM DEMPSEY
Mr. Dempsey. Thank you. First, I would like to thank the
subcommittee, Chairman Pitts and Ranking Member Pallone, for
holding this hearing to provide a balanced review of one of the
most critical issues facing the food industry today, the
labeling of genetically-modified organisms, or GMOs.
My name is Tom Dempsey. I have served as the President and
Chief Executive Officer of the Snack Food Association, the SFA,
since 2013. Prior to joining SFA, I was the President of one of
the largest privately owned snack food brands in the United
States.
Today at SFA, I represent over 400 companies who produce
snacks ranging from potato chips to granola bars. My members
include both billion dollar, multi-category companies, and
small, family-owned businesses in the second and third
generation of management. More than half of SFA members have
sales of less than $100 million a year, and many are the
primary employers in their community.
While voters have rejected ballot initiatives calling for
mandatory GMO labeling in 4 states, the state of Vermont
recently approved the Nation's first mandatory labeling law.
Mandatory GMO labeling at the state level would impact nearly
every aspect of my members' business, upping costs by requiring
increased product inventory, added complexity for packaging and
distribution processes, and extensive new regulatory and
training requirements.
Absent a federal solution, manufacturers will have
essentially three options to comply with a state GMO: redesign
their packaging, reformulate products so that no labeling is
required, or halt sales to that state. Each option is
difficult, costly, time-intensive, and at worst, could
eliminate jobs and consumer choice in the marketplace. Smaller
companies may not have these options at all. A patchwork of GMO
labeling laws would pose significant burdens on the
manufacturing process itself. They would require separate
storage for GMO and non-GMO products throughout the entire
supply chain, beginning with the farmer, and extending through
various states of production and distribution. Aside from new
administrative and recordkeeping burdens, snack makers will be
forced to clean and boil the sheeting, baking, frying, and
seasoning lines between GMO and non-GMO production to ensure
there is no contamination. This could take up to 2 hours, and
would lead into a loss in valuable production time. Duplicative
food labeling for the same stock keeping unit, or SKU, assigned
to each product line is also a problem. Film, which is our
industry's term for snack packaging, would need to be changed
mid-production, and 2 separate inventories of the same finished
product must be kept. Significant lead times and costs would go
into bag changes. The cost in plate charges, new film,
administrative oversight could be more than $750,000 for 800
SKUs, and the process could take 20 to 26 weeks.
GMO and non-GMO products must continue to be segregated
from the factory to the grocery store, resulting in increased
distribution costs and heightened opportunity for mistakes.
To be clear, the hardest hit by this will be the one plant
operators with a single line of production. These costs could
put family-owned businesses out of business, thereby increasing
consolidation in the industry. While it is sometimes assumed
that companies could remove the GMO ingredients from their
products, this is unrealistic because the availability of non-
GMO crops is limited. Over 80 percent, although I heard today
90 percent, of the corn, cotton, and soybean crops in the
United States are produced with biotechnology, all products
which are staple items in the snack production. Our members
will not have the opportunity to increase their contract with
farmers or mills for non-GMO corn for a minimum of 2 years.
Transitioning to GMO-free production will not happen overnight.
Some manufacturers may choose to end distribution in states
that require GMO labeling, resulting in fewer product options
for consumers, and causing a ripple effect in the grocery
industry. Even if manufacturers notify grocers of their intent
to stop selling in a state, manufacturers could run the risk of
being fined if retailers do not comply or if mistakes happen in
the distribution process. Fewer players in the aisle could mean
less incentive to keep quality high and prices low. Fewer
products could disproportionately cause job losses for some in
the distribution chain. Ultimately, a patchwork of state GMO
laws will hit consumers the hardest, and would result in either
increased costs at the grocery store, or less availability of
products in their stores.
In addition, it is important to note that consumers already
have options to purchase non-GMO foods, and these options
continue to expand. For over a decade, both the USDA's natural
organic program and the independent non-GMO project have
certified foods that are organic and GMO-free respectively. The
process to gain these certification seals is not only rigorous
but expensive. Many SFA members have already made the
significant investment to display these voluntary labels.
Forcing companies to re-label more than 80 percent of the
products does nothing but add cost, confusion and may limit
choices to consumers.
SFA does not have a single member company that
manufactures, distributes, and sells in just one state, which
makes state labeling law incredibly complex. Multiply these
challenges by 5, 10, or even 25 states, and an insurmountable
burden is placed on the supply chain. SFA supports the Safe and
Accurate Food Labeling Act, which eliminates the proposed
patchwork of state laws by creating one federal GMO standard,
and provides much-needed consistency for manufacturers and
consumers alike.
Thank you for your time.
[The prepared statement of Mr. Dempsey follows:]
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Mr. Pitts. Chair thanks all of our witnesses for your
testimony.
I will begin the questioning. Recognize myself 5 minutes
for that purpose.
Dr. Van Eenennaam, is there currently a lack of consensus
about the validity of research and science behind the safety of
foods and ingredients derived from genetically-engineered
crops?
Ms. Van Eenennaam. Well, as I stated in my testimony, there
is clear consensus among all of the leading scientific
organizations throughout the world, and the meta-analysis of
over 1,700 studies, about \1/3\ of which are done by the public
sector that do not have any industry funding, somewhere in that
vicinity, have all come to the same conclusion that there are
no unique risks posed by the use of this particular breeding
method in the production of genetically-engineered crops.
Consensus doesn't mean unanimity, so there are scientists
that you will hear that say that that is not true, but to your
question earlier, it is as strong of a consensus, it is
probably stronger than on global warming, it is 99 to 1, or
something in that vicinity. And I think if you get consensus of
all of the major scientific societies in the world, then that
is a pretty strong consensus.
Mr. Pitts. The first generation of biotechnology products
has brought tremendous benefits to farmers, as we have heard.
What do you see as the potential for a consumer facing benefits
of the next generation of biotechnology products?
Ms. Van Eenennaam. So certainly, and I might argue the
consumer has had some benefit from the first generation also
because of the decreased insecticide use associated with Bt
crops, for example, has knock on benefits for the environment
and the consumer, and also costs. But there are direct benefit
traits being developed for consumers. For example, altered
nutritional profiles of crops for improved human health, and
particularly in developing nations, there are efforts to bio-
fortify crops to improve the nutritional profile of staple
crops of the world's poor to improve their nutrition. And so
there is a huge interest amongst public sector scientists and
also public-private partnerships to try to use this technology
to improve foodstuffs and improve the nutritional composition
of crops for both developed and developing countries.
Mr. Pitts. As a scientist, could you put in laymen's terms,
you said this requires use of less pesticides. How does that
occur, how do they make that occur?
Ms. Van Eenennaam. Well, for example, the insect-protected
crops have a protein in them that basically targets Lepidoptera
caterpillars so that when they eat the crop, they perish, but
it is safe for humans. And so it basically enables farmers not
to have to put insecticide on that crop. And so, for example,
especially in the developing world, there has been a dramatic
production in insecticides, over \1/2\--they have doubled--
decreased their insecticide use by over \1/2\, and they have
doubled their yields as a result of protecting the crops from
the insects, and not having to use more dangerous insecticides
to protect those crops. And so it is kind of breeding the crop
to be protected from insects and, therefore, you can decrease
your insecticide use.
And even in the U.S., it has decreased the use of
insecticides on Bt corn over tenfold since the adoption of this
technology.
Mr. Pitts. Thank you.
Mr. Faber, how would you describe or define natural?
Mr. Faber. Yes, that is a great question, Mr. Chairman. I
think commonsense definition of natural for an ordinary
consumer would not include genetically-modified ingredients. In
fact, one of the major providers of the technology, Monsanto,
itself does not define biotech traits to be something that
should be described by natural. And I think you are getting it
right at the heart of the matter, which is that consumers go to
the store, they see an all-natural or natural disclosure, and
roughly 60 percent, depending on its study, 58 percent, 64
percent in others, believe that that food is GMO-free.
What is important here is that we want consumers to be
using their buying power to shape their lives and the world
around them. If they are confused about what they are buying,
they are not able to use their buying power to really make
good, informed choices.
Mr. Pitts. Thank you.
Representative Webb, when would your law become effective?
Is it effective now?
Ms. Webb. We are involved in rulemaking now. Rules should
be out July 2015 and in effect July 2016.
Mr. Pitts. All right. Ms. Forshee or Mr. Dempsey, how would
this labeling requirement affect your snack food companies if
they did not wish to comply?
Mr. Dempsey. Well, as I said, there are three options. They
can reformulate, they could label, or they could cease sales
within Vermont. And I think each individual company is going to
have to make that decision based upon the number of businesses
and SKUs that have to be relabeled.
Mr. Pitts. And finally, Ms. Forshee, has biotechnology
impacted the way you farm, say, in the past decade?
Ms. Forshee. Well, I would say that we are able--with that
kind of technology, we are able to use a practice of no-till
which allows us to conserve moisture and not spray the crops
nearly as much as--I mean there is a whole notion of--that
farmers just dump pesticides and herbicides on their crops, but
we don't. It is very costly to do that kind of an application,
spray any kind of an application, and so we are very--what I
want to say, we use GPS to do that so that there is just the
right amount put on the crop and no more. And so the less we
can do that, the more it is going to help our bottom dollar too
for yield. So we have seen higher yields as well on our farm in
the last 24 years----
Mr. Pitts. And with----
Ms. Forshee [continuing]. As a result of that.
Mr. Pitts. With no-till, less run-off--water run-off?
Ms. Forshee. That is correct. And also though the
biotechnology traits in our crops, it all comes together as
one.
Mr. Pitts. Thank you. My time has expired.
The chair recognizes the ranking member, Mr. Pallone, 5
minutes for questions.
Mr. Pallone. Thank you, Mr. Chairman.
Mr. Faber and Representative Webb, you both believe that
industry should be required to label all foods that contain GE
ingredients, and you both also characterize such labeling
requirements as a modest disclosure or a simple request. And,
Mr. Faber, you also state that food companies frequently change
their labels to make new claims or to highlight new
innovations. And I think an accurate summary of your position
on this is that it simply is not a big deal for companies who
use GE ingredients to label their products as such. Now, Mr.
Dempsey, on the other hand, makes the argument that mandatory
labeling for GE foods would dramatically increase the cost of
the food because it would require manufacturers to segregate
the food or use multiple labeling films, a number of things.
I guess in my view, on the one hand, if it is truly not
that burdensome for industry to label their food, then why
shouldn't they be required to do so. On the other hand, if the
labeling requirement could result in higher food costs, maybe
that is not a risk that we want to take.
So let me just ask you these questions in light of that.
First, Mr. Faber or Representative Webb, can you elaborate on
why you believe a mandatory labeling requirement is simple for
industry, and how do you respond to the assertion by Mr.
Dempsey and others in industry that complying with that
requirement would be an elaborate and expensive prospect?
Briefly if you can----
Mr. Faber. Right.
Mr. Pallone [continuing]. Because I want to ask him a
question too.
Mr. Faber. Absolutely. So very briefly, so we have heard
reference from Mr. Pompeo and Mr. Butterfield to this $500 cost
associated with food labeling. That study assumes two things,
and one thing in particular is that disclosure would ultimately
equal disparagement, that consumers would see a disclosure,
they would stop eating food made with genetically-modified food
ingredients, and that would cause costly supply change
disruptions or force consumers to buy organic. What we know
about how consumers use labels is they tend to look for certain
attributes. You may look for fiber, I may look for calories. We
tend not to read the whole package. We use that information to
make particular decisions about our food choices. So the notion
that American consumers are going to broadly reject foods with
a modest, nonjudgmental disclosure I think is unfounded. We
know that in part because we have labeling in 64 other
countries, including countries like Brazil, where there has
been a disclosure for--since 2001, and consumers more or less
eat the way they have for the last 13 years. So I think we can
all be confident that if we craft the disclosure in the right
way, to your earlier point, Mr. Pallone, that we can give
consumers information without rendering a judgment that
ultimately leads to significant changes in buying behavior.
The other thing I will just quickly say again is that
companies are already finding ways to make both non-GMO and GMO
foods. We have segregation throughout the supply chain. We
preserve identity of these grains throughout the supply chain,
in part because the marketing needs, but also because of
quality and allergen needs. So there is already an
infrastructure in place that allows us to segregate non-GMO and
GMO, and other kinds of grains and oils.
Mr. Pallone. All right. I am going to go to Mr. Dempsey now
because I want you to respond to those claims and specifically
respond to the assertion that food companies are changing their
labels so they can easily do this. What do you--how do you
respond to what----
Mr. Dempsey. Well----
Mr. Pallone [continuing]. Mr. Faber was saying?
Mr. Dempsey [continuing]. Certainly, food companies change
their labels but not on a wholesale banner, and do all of them
all at the same time. So you run into a big situation of X
number of SKUs that have to be done all at the same time to
comply with a law that goes into effect in 2016. Small
businesses would be hit very hard because of that. They have
historically been ones who change their labels very seldomly.
And in central Pennsylvania, I can probably think of five or
six companies that are using the same graphics, same bags that
they have had for many years; the only changes, those being
mandated by the FDA. So I think the real burden comes on the
small family-owned, small operators who have SKUs that are
genetically modified and have to label them, and rather than
using what the market has now, and that is the option of a non-
GMO or GMO-free certification, to notify and give consumers
transparency, which gives the manufacturer the option of doing
it.
Mr. Faber. Can I add just one quick thing?
Mr. Pallone. Well, maybe I will ask Representative Webb, we
have 40 seconds----
Ms. Webb. Yes.
Mr. Pallone [continuing]. If you want to say something.
Ms. Webb. I would say that we are in rulemaking process
now. We have manufacturers that are weighing in on how that
label will be written. We are hoping that our labeling will be
something that other states can use. The standards between
Maine, Connecticut and Vermont, the legislation is similar. We
are also a small state. We have 630,000 people in our entire
state. People already drive to New Hampshire to avoid the sales
tax, so if the industry chooses not to sell in Vermont, I am
sure that we can get our Doritos over the state lines.
Mr. Pallone. All right.
Mr. Faber. And I would like just to add, that not only do
companies change their packaging all the time, the average
lifespan of a label is about a year, we ask companies to change
their disclosures. We ask them to change them for trans fat, we
ask them to change them for allergen labeling, and we are about
to ask them to change their labels as part of a refresh of the
nutrition facts panel. So there are periods in the history of
labeling where we ask companies to disclose a little bit more
about what is in the food. This is the perfect time, since we
are in the midst of an NFP rulemaking, to think about how can
we make this disclosure in a way that is nonjudgmental.
Mr. Pallone. Thank you.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman from Virginia, Mr. Griffith, 5
minutes for questions.
Mr. Griffith. Well, and I would have to say that from
listening to the testimony today, that I am convinced we have
to have a national policy. And we can argue, Representative
Webb, about what that policy ought to be, and, Mr. Faber, we
can argue about what that policy ought to be but I think it
needs to be national. It may be relatively easy for Vermonters
to cross the stateliness to get their Doritos, but I would have
to submit that in parts of my district, and I represent the
southwestern portion of Virginia, the Allegheny Highlands of
Virginia, and Southside Virginia. It is a large district, it
may be larger than Vermont, certainly has more people in it,
but there are parts of that where, if you wanted to go and get
some other product, you would have to drive several hours.
There are other parts where you just walk across the street,
and so if you had a grocer on one side of the street, and you
looked at the labeling in that state and on Tennessee on State
Street, and you said, I don't know about this genetic
engineering, and you walk across the street, it might be the
very same product but it might not have that label on in
Virginia. So I am convinced we have to have a national label.
And just a few miles up the road from State Street, where
you literally are on the main street of the town, and you are
one state on one side and in another state on the other side of
the street, is probably one of your members, Mr. Dempsey,
Shearer Foods has a potato chip facility there and they
obviously ship to a number of states from that Bristol,
Virginia, plant.
Mr. Dempsey. That is correct.
Mr. Griffith. And so that concerns me that they would have
to have different labels for all the states that they operate
in, but I am particular concerned about if we don't have a
national policy, concerned that the consumer gets confused into
what is it I am buying. Well, if I buy it in Virginia, it is a
different product than what I am buying in Tennessee. I don't
know whether you have any towns like that in Vermont that
straddle the state line, but I have a number of them. Bristol,
Virginia/Tennessee, Bluefield, Virginia/West Virginia, the
Martinsville area has towns if you didn't know where you were,
you would be out of Henry County and into North Carolina in a
heartbeat traveling down 220. And so I think we have to be
very, very concerned about that, and I do think it is
important.
And then the other thing is your rulemaking process, I know
your Attorney General is in charge of that, but what experience
does Vermont have, Representative Webb, in food labeling? I
mean is this something that they have done before in some kind
of a large way, and what are they doing in that process to try
to label these foods?
Ms. Webb. Well, as I previously stated, we did make some
changes to our maple syrup labeling.
Mr. Pitts. Can you poke your----
Ms. Webb. I am not on?
Mr. Pitts. Yes.
Mr. Griffith. Yes. You did say that about maple syrup, and
what was the difference? I just assumed it was a parochial
difference.
Ms. Webb. Our labeling had been grade A, grade B. We chose
to go with the standards that they are using in Quebec because
they are a larger producer than our brave little state.
Mr. Griffith. And grade A, grade B, what do they use in
Quebec?
Ms. Webb. Goodness. I am not----
Mr. Griffith. Because I have to tell you the truth----
Ms. Webb. Yes.
Mr. Griffith [continuing]. My wife disagrees with me----
Ms. Webb. Total difference.
Mr. Griffith [continuing]. I can't tell the difference
between A and B----
Ms. Webb. Yes.
Mr. Griffith [continuing]. So I always buy B because it is
cheaper.
Ms. Webb. Yes. I like B too.
Mr. Griffith. Yes. But what is the Quebec standard so I
will know what I am looking at when I go to----
Ms. Webb. I----
Mr. Griffith [continuing]. The store?
Ms. Webb. I would have to look it up.
Mr. Griffith. You would have to look it up. All right, I
appreciate that. That was----
Ms. Webb. We just recently----
Mr. Griffith. That was not fair to ask you today anyway----
Ms. Webb. Yes.
Mr. Griffith [continuing]. I apologize. I do think it is
complicated, and I would ask folks who are here today, or who
are watching at home, if you have suggestions on how you might
make some reasonable changes to Mr. Pompeo's Bill, he may or
may not accept them, but I would ask that you submit those to
the committee so that we can take a look at those changes
because I am convinced we have to have a national standard. And
I would like to know, if I am buying something that is labeled
natural, and I do that on a fairly regular basis, I would like
to know that there is something standard about it, and so I
would like to see us move in that direction as well.
Mr. Faber. And, Mr. Griffith, we would be thrilled to work
with you and with our colleagues in the food industry, and to
craft a national disclosure that is mandatory, that works for
the consumer, but that also works for food manufacturers who
have to operate in 50 states, I think if people of goodwill
could find a way to develop a disclosure that is truly
nonjudgmental, and I would welcome the opportunity to do that.
Mr. Griffith. Well, and I appreciate that. I will tell you
that in thinking about this over the years, as you may have
heard earlier, I do read labels fairly carefully----
Mr. Faber. Yes, I know.
Mr. Griffith [continuing]. And I am convinced now that
genetically-modified or genetically-engineered foods are so
prevalent that we probably need to go the other way, and for
those of us that may want to purchase something, that the
labeling requirement ought to be on those who can certify that
their food, in fact, does not have this product in it, as
opposed to the reverse.
Mr. Faber. That is right. And you and I may agree or
disagree about whether or not there are more herbicides or
fewer herbicides, or--I think the bottom line here is that
consumers want to be able to make those choices themselves. And
it ultimately boils down not just to an issue of transparency,
but an issue of trust. If we give parents, consumers the basic
information, we should trust them to do their homework and make
those choices for themselves.
Mr. Griffith. I appreciate that.
And with that, Mr. Chairman, I see my time is up and yield
back.
Mr. Pitts. The chair thanks the gentleman.
Now recognize the gentlelady from California, Mrs. Capps, 5
minutes for questions.
Mrs. Capps. Thank you very much, Mr. Chairman. And to our
witnesses, thank you for being at this hearing and your
testimony.
I think we are finding ourselves in general agreement that
a good federal standard for GE labeling is preferable to a
confusing patchwork of state labeling rules, which it appears
that we have today, but there still is disagreement about what
exactly that standard should be. I want to be clear, I don't
believe this is even a debate about whether or not GE foods are
safe, it is a debate about whether or not consumers have the
right to know what is in their food, and I think I am just
echoing what some of you just have said. I firmly believe that
consumers do have the right to make informed decisions about
the food they eat, and I believe we pretty much all agree on
this point.
Just to get it on the record, however, what about now a
simple yes or no question so we can get this on the record. And
I will start with Dr. Van Eenennaam, and right down the line,
yes or no, do you think consumers should have the right to know
what is in their food?
Ms. Van Eenennaam. I can't give you a yes-or-no answer to
that.
Mrs. Capps. You can't say yes or no?
Ms. Van Eenennaam. No, because I don't think the labeling
is about what is in the food, it is about the process used to
make the food, and that is a really subtle difference.
Mrs. Capps. I hear you.
Ms. Van Eenennaam. So sugar from genetically-engineered
sugar beet is the same as sugar from non-genetically-engineered
sugar cane sugar.
Mrs. Capps. All right, I wanted to go faster than that, but
we will give you----
Ms. Van Eenennaam. Well, I mean because I think we are not
discussing about a label of what is in the food----
Mrs. Capps. But----
Ms. Van Eenennaam [continuing]. We are talking about a
label of how it was produced.
Mrs. Capps. Well, I think that could be under the umbrella,
but that, yes, we do need to do this and we also need to talk
about how to do it and what should be in it. But I will just go
right along.
Mr. Faber. Yes, of course consumers should have the right
to know what is in their food.
Mrs. Capps. Yes.
Ms. Webb. Absolutely.
Ms. Forshee. Yes.
Mr. Dempsey. It depends on how easy it is to give them the
right to know. I think that is a too simple--a yes/no is too
simple of a response.
Mrs. Capps. All right, I got an answer. Unfortunately,
consumers currently do not have access to all the information
they are looking for when it comes to GE foods, and consumers
are often further confused, confused enough by not knowing what
is in it, and then confused by what the information that they
find on the packaging.
So I will now zero in on you, Mr. Faber. Why do you think
there is currently so much consumer confusion when it comes to
GE labels?
Mr. Faber. Well, consumers have been deluged with
misleading claims for many, many years, especially claims like
natural. They perceive those claims, natural, all-natural, to
mean something that they don't. They perceive those claims to
mean GMO-free, and they are using their buying power in a way
that they think is improving the world around them, when it is
actually not.
Mrs. Capps. And it is not. So you agree that the current
voluntary system is not working?
Mr. Faber. And the voluntary system isn't serving consumers
and codifying the voluntary system as H.R. 4432 would just
continue to create more and more consumer confusion.
Mrs. Capps. That was my next question, so I can just let
you underscore it again. One of the arguments in favor of H.R.
4432 is that it will reduce this confusion. You disagree?
Mr. Faber. We strongly disagree. I think if we lived in a
world where consumers perfectly understood what natural, non-
GMO, organic and other claims meant, then a voluntary system
might make sense, but we don't live in that world.
Mrs. Capps. Right.
Mr. Faber. We live in a world where consumers are
extraordinarily confused about what they are buying at the
point of sale.
Mrs. Capps. Well, I think we would also agree that this is
certainly a complicated topic, and any labeling system must be
implemented carefully and in close consultation with the
industry, actually with all the stakeholders, but the current
system, I believe and I think there is some agreement here, is
not working for consumers. So I am concerned that the bill we
have before us, I guess I agree with you, Mr. Faber, that it
just largely codifies the inadequate rules that we now have.
But I have 50 seconds left to ask you, and you agree that
consumers are making decisions with their wallets, and they
choose to avoid GE products, not because of food safety
concerns, I want to bring up and let you respond to, but
because of their environmental impact as well. So that is a
further aspect, at least for many of my constituents. What are
some of the environmental concerns that consumers are now
having with the GE crops?
Mr. Faber. Thank you. Thank you, Mrs. Capps. There are many
reasons that people want the right to know what is in their
food. One is that the widespread adoption of GE corn and GE
soybeans in the U.S. has increased the amount of herbicides
that we use, and as those herbicides have become less effective
due to weed resistance, has forced farmers to turn to even more
toxic herbicides like 2.4-D----
Mrs. Capps. I got you.
Mr. Faber [continuing]. Mentioned by Ms. Schakowsky
earlier.
Mrs. Capps. And so, again, you think consumers should be
able to take this kind of information into account as well when
making food choices?
Mr. Faber. Consumers overwhelmingly tell you, tell us, tell
consumer attitudes experts, they simply want to have that
information so they can make those choices for themselves.
Mrs. Capps. Thank you very much.
I yield back.
Mr. Pitts. Chair thanks the gentlelady.
Now recognize the gentleman from Florida, Mr. Bilirakis, 5
minutes for questions.
Mr. Bilirakis. Thank you, Mr. Chairman, I appreciate it so
very much, and thank you for holding this hearing.
I have a couple of questions. Dr. Eenennaam, can you
describe the current issue with Citrus Greening, affecting
orange trees throughout the country? What is the role of GM
technology in helping to fight this devastating disease?
Ms. Van Eenennaam. Well, Florida industry in particular is
being hit by this particular disease, and as plant breeders
looking for options as to how we might go about trying to solve
the issue, and there are several land grant universities, I am
aware of Florida and Texas and California, all looking at both
conventional breeding if that is an option, but also genetic
engineering options. And I think that is the power of the
technology is you can bring in a gene from another species to
enable those trees to be resistant to the Citrus Greening
Disease, and that is really, I think, the opportunity that
exists to utilize this technology to develop disease-resistant
plants that are able to withstand devastating diseases like
Citrus Greening Disease or Pierce's Disease. And I think many
public sector scientists see this as a real opportunity to
develop plants that are healthier, don't require any pesticidal
inputs or anything, it is just basically breeding, to make
those trees healthier and able to withstand that disease.
Mr. Bilirakis. Thank you very much.
Ms. Van Eenennaam. I think that is a really important--
depending what the application of the genetically-engineered
crop is depends on the environmental impacts. For example, the
disease-resistant papaya doesn't require any inputs, and it
enables those crops to grow. And so I think that you have to
look at the application as to whether or not it has an
increased or decreased effect on pesticide use. And it is
application-specific and location-specific and country-
specific.
Mr. Bilirakis. Thank you so much, doctor. And I am from the
State of Florida, so I have a real interest.
Ms. Forshee, how much fuel does it take to plant and
harvest your field? I know you talked about this a little bit,
you alluded to it in your statement.
Ms. Forshee. How much what? I am----
Mr. Bilirakis. How much fuel does it take to plant and
harvest your field?
Ms. Forshee. Well, I would say that--from planting to
harvesting?
Mr. Bilirakis. Well, approximately.
Ms. Forshee. Right. I would say right now on my farm, we
are not tilling the land. We are no-till farming. So we use
fuel in our tractor when we plant the crop, which probably for
a couple of hours of planting, you know, maybe like on an 80-
acre farm would maybe consume about--I would say maybe \1/4\ of
a tank of fuel to maybe \1/2\ a tractor tank of fuel. So maybe
75 to 100 gallons there. And then we harvest the crop. I mean,
you know, sometimes there does need to be an application if
there is a weed problem, so I would say total, from planting to
harvesting, maybe a couple hundred gallon, where before, if we
were having to work the ground and, you know, really, you know,
put strain on our tractors and equipment, it would double if
not, you know, triple that fuel consumption.
Mr. Bilirakis. Thank you very much.
Ms. Forshee. Thank you.
Mr. Bilirakis. Thank you. Mr. Faber, if genetic
modification were the only way to fight a particular disease,
would the Environmental Working Group still oppose this type of
technology?
Mr. Faber. Thank you for the question. We do not oppose
genetic engineering, genetically-modified food ingredients. We
think there are actually many promising applications of
genetically-modified food ingredients. Dr. Van Eenennaam
mentioned several of them. This isn't a question about the
technology, this is a question of whether or not to require
labeling; it is really a question of transparency, should
people have this information to make their own choices for
their own families. I am an optimist. I am optimistic that the
promises that were made by the providers of this technology
will ultimately be realized that will have traits that produce
more nutritious food, that will see significant yield
increases. All of those promises haven't yet been realized, but
that is not what is at stake here in this question of whether
or not to preempt Act 120, or whether or not to craft a
national disclosure system. The real issue is should people
have the right to decide for themselves, and does FDA have the
authority now, I believe they do, to work with us to craft some
kind of informative, fact-based, nonjudgmental disclosure on
the back of the package.
Mr. Bilirakis. OK, thank you very much.
I yield back, Mr. Chairman.
Mr. Pitts. Chair thanks the gentleman.
The chair now recognizes Mr. Matheson 5 minutes for
questions.
Mr. Matheson. Thank you, Mr. Chairman.
Mr. Dempsey, in your industry when people manufacture,
makes the product, perhaps someone else is a distributor,
perhaps someone else is the grocery store owner, if you have a
product that was supposed to be made for the state of Maine,
and it accidently went by a truck to Vermont and got put on a
shelf, and Vermont charges $1,000 a day fine, who is going to
pay the fine out of the manufacturer, the distributor or the
grocery store owner?
Mr. Dempsey. My understanding with the Vermont law the way
it is currently crafted is the manufacturer is responsible for
that on $1,000 a day per SKU.
Mr. Matheson. Even if the distributor may be a separate
third-party entity that----
Mr. Dempsey. Yes.
Mr. Matheson [continuing]. Mistakenly went blunder?
Mr. Dempsey. Yes, in fact, the way I understand the law,
the retailer is absolutely exempt from that fine.
Mr. Matheson. Representative Webb, do you think that is a
correct interpretation of the law?
Ms. Webb. Is that to me? The retailer would be responsible
if the product was an agricultural product such as corn that
was----
Mr. Matheson. I am talking about a pack of potato chips
that got made some place else, and accidentally the distributor
took it across state lines.
Ms. Webb. I would have to check on that.
Mr. Matheson. OK.
Ms. Webb. I am happy to get back to you.
Mr. Matheson. Seems to me in this hearing we are talking
about this consumer right to know. I find it interesting, this
is on an issue where everyone has acknowledged there is no
health or safety risk here. I find this--it is the old clich
AE1e, a solution in search of a problem. Now, we do have a
problem with mislabeling where people say something is natural,
and no one can decide what natural is. And I think that Mr.
Pompeo's legislation rightly encourages the FDA to move forward
on that issue, and give clarity that issue, and I think that is
important. I think that is something we have consensus across
the board here, but whether or not we should be doing labeling
on a component of food that has no demonstrated health or
safety risk, that is a tougher one for some of us to swallow, I
think.
Mr. Faber. Mr. Matheson, could I?
Mr. Matheson. No, I am going to ask you a question instead.
I only have 5 minutes. You have indicated you think we should
have a natural--national labeling system, but in addition to
being a lobbyist for the Environmental Working Group, you are
the executive director of Just Label It campaign.
Mr. Faber. That is correct.
Mr. Matheson. And the Just Label It campaign has spent a
lot of money in a lot of states pushing state-based initiatives
to set up individual state systems. Do you want state systems
or do you want a national system, and why are you encouraging
this effort at the state level?
Mr. Faber. Yes, and as I testified--and thank you for the
question, as I testified, we would greatly prefer a national
solution. We believe that FDA has the authority to craft a
national solution. FDA has used that authority to require
disclosures unrelated to safety and health, to your earlier
point. When food is unsafe in the United States, at least since
1906, we don't label it, we take it off the shelves.
Mr. Matheson. We also make sure that----
Mr. Faber. But we----
Mr. Matheson. But why are you pursuing it in each state?
Tell me--what is the agenda here?
Mr. Faber. In the absence----
Mr. Matheson. If I hear there is another agenda here----
Mr. Faber. There is no agenda here, except to----
Mr. Matheson [continuing]. But pursuing it at the state
level.
Mr. Faber [continuing]. Protect consumers. I wish that the
Administration today would work with us to craft a national
solution. In the absence of that leadership, we think it is
appropriate for states to step in and help protect consumers
from----
Mr. Matheson. See, I appreciate that that is your
statement. I tend to question the logic of that. I think if you
want a national standard, going out and stirring things up in
every state to do a patchwork system that everyone around here
said is a bad idea----
Mr. Faber. Well----
Mr. Matheson [continuing]. Doesn't make much sense to me.
Mr. Faber. Let----
Mr. Matheson. I don't want to get in a debate with you, but
I don't see the consistency in that, and I think there may be
other agendas involved in terms of pursuing it at the state
level.
Congress can help this as well if you want to engage
Congress. This committee is holding hearings. I think we would
have a conversation if there ought to be some national standard
or not, and I welcome this hearing. I welcome Chairman Pitts
scheduling this because I think this is an issue that deserves
a lot of discussion, but there is another effort going on and,
boy, a lot of effort and resources being spent in these
different states on state ballot initiatives, and I question
what the motivation is, and if that really gets us to where
anybody in this room really wants to be, maybe some people want
to be there with that patchwork of 50 stats, 50 different
rules, or as Mr. Pompeo said, maybe we shouldn't limit it to
states. It could be counties, it could be cities, it could be a
lot more than 50. I think we ought to figure out what we are
really trying to do here, and what the agendas are. And I think
we ought to look for a national standard, at best, and I would
suggest a national standard ought to be on science-based
decision making about health and safety risks to consumers, to
the integrity of our food supply chain, and that is what I
encourage this--I think most people on a bipartisan basis would
agree, that is the motivation for this committee in looking at
this issue.
With that, Mr. Chairman, I will yield back the balance of
my time.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman from Maryland, Mr. Sarbanes, 5
minutes for questions.
Mr. Sarbanes. Thank you.
Mr. Faber, do you know if the Nutritional Fact Panel that
is now required for products, did the FDA conclude that needed
to be there for safety reasons, or was that something that the
Congress just decided, in response to the demand they heard
from the public, ought to be on products?
Mr. Faber. That is a terrific question. So the basis for
the Nutrition Facts Panel was to try to promote nutrition and
health.
Mr. Sarbanes. Yes.
Mr. Faber. The NLEA clearly preempted states from changing
the NFP, the Nutrition Facts Panel, from adding things to the
ingredient line, or from regulating certain kinds of claims
like health claims, but the NLEA was also carefully crafted to
preserve for the states other roles in food labeling, and
states have already stepped into that role in many ways. And
Mrs. Webb talked about this, whether it is grading butter and
cheese in Wisconsin, or use-by and sell-by dates in 41
different states. I am not arguing for a patchwork quilt, but I
think we should recognize that Congress, more than 20 years
ago, explicitly recognized----
Mr. Sarbanes. Yes.
Mr. Faber [continuing]. The longstanding role that states
have played in food labeling, especially with regards to
addressing consumer deception, and helping consumers understand
what they are buying.
Mr. Sarbanes. Mr. Dempsey, if the choice were between a
situation where there were 50 different labeling regimes, or 1
uniform labeling requirement, but that requirement was that you
had to indicate whether there was genetically-engineered
ingredients included, which would be the better one from your
standpoint?
Mr. Dempsey. We would want a federal standard that would
place the FDA as a mandatory resource for determining what was
genetically modified and what was not genetically modified, and
we would want the labeling to be voluntary, similar to what we
already have with organic. If someone wants an organic product,
they go through an organic certification by the USDA, and we
put organic on that. We do not put non-organic on the balance
of the products. So it seems to me that forcing a mandatory
labeling law onto products that are the predominant ones on the
supermarket shelf goes against commonsense, and goes against
convention and practice that we already have in the food
industry.
Mr. Sarbanes. Well, leaving this side of the debate about
whether it makes commonsense or not, would it be preferable to
having 50 different labeling----
Mr. Dempsey. Certainly preferable.
Mr. Sarbanes. OK. Now, if there was such a label, could it
be as simple as some would say, may contain genetically-
engineered ingredients? And I don't know what the Vermont one
says, but could you envision a national, Ms. Webb, standard
that would essentially say something like that?
Ms. Webb. We do allow for may----
Mr. Sarbanes. Yes.
Ms. Webb [continuing]. Contain.
Mr. Sarbanes. Yes. Because as I am thinking about the
disruption to the supply chain, it would seem to me that the
burden, frankly, would end up being on those who want to be
able to establish that their product is completely free of GE,
to sort of police that supply chain. So just from a pricing
standpoint, the genetically-engineered products, even if they
had whatever extra cost you might attribute to that requirement
added in, would end up being a lot less expensive potentially
than the others. I am not asking a question, I am just kind of
musing here about it.
So I guess what I am trying to sort out is, I don't think
the public's reaction to knowing that something is genetically
engineered is going to create some huge distortion in the
current nature of demand out there. I think many will say,
maybe genetically engineered, I get that. They will do price
comparisons. They will look at fiber, they will look at other
things and they will make a decision on buying a product. And I
am not also convinced that the industry can't handle the supply
chain issues in a way that is significantly less expensive than
the numbers that are being invoked, but it is a very
complicated issue. I come from the perspective that there
should be a right to know there, but within the context of
that, I am ready to explore how industry can manage that right
to know as efficiently and manageably as possible. Yes, you
just want to----
Mr. Dempsey. It seems to me there is a right to know----
Mr. Sarbanes. Yes.
Mr. Dempsey [continuing]. And the right to know is to look
and shop for, as an organic shopper or a GMO shopper, for those
seals that go through a certified and rigorous----
Mr. Sarbanes. Yes.
Mr. Dempsey [continuing]. Certification process. That is
the lack of transparency, if you ask me. It is also from our
members' perspective gives a marketing advantage to it, and in
most cases, these products are more expensive than the, if you
will, conventional products that are on the shelf. So I mean
there is information out there if the intelligent, educated
consumer wants to find that product.
Mr. Faber. And unfortunately, consumers are looking at
those claims, natural and organic, and many of them are getting
it exactly backwards. They are thinking the natural claim that
might be on a multigrain tortilla snack chip is the one that is
GMO-free, and they look at the organic certification and they
don't quite know what that means. And so that is why we think
addressing the use of the word natural, and having a modest,
nonjudgmental disclosure would help cure that consumer
confusion. Consumers are extraordinarily busy, they are looking
for a simple way to know what they are buying so they can use
their buying power to shape the market.
Mr. Sarbanes. Thank you.
I yield back.
Ms. Webb. May I add also that in deference to Mr. Dempsey's
concern for smaller businesses, the cost for a small business
to go through the non-GMO project is prohibitive for them,
which is why we were looking at the expense to go to the larger
industry, rather than for people trying to get----
Mr. Pitts. Gentleman's time has expired.
Chair recognizes the gentleman from Texas, Mr. Green, 5
minutes for questions.
Mr. Green. Thank you, Mr. Chairman.
Coming from Texas though, when you say it is a multigrain
tortilla chip, you know, corn is corn, but I know my daughter
keeps telling me multigrain chips are much better.
Mr. Dempsey, can you elaborate on how you feel the Vermont
Act 120 would lead to a consolidation in the industry and many
small businesses force to close, and also are the multi-
category, multinational players the only companies that can
currently have the capability to change their supply chain and
bear these type of costs?
Mr. Dempsey. Smaller companies, the ones I would define as
smaller companies, are companies with one plant, one line.
Mr. Green. Yes.
Mr. Dempsey. And as I said in my statements, closing those
lines takes significant time out of the production process that
would not be able to go right from non-GMO to GMO product. So
then the companies have to decide whether they participate in
the non-GMO labeling or the GMO labeling as it is in Vermont.
They will have to make a decision on what products qualify to
go into Vermont without labeling, and which ones don't. And a
lot of those will determine both the distribution networks,
some of those are DSD, some of those are warehouse, how do you
leave open your, if you will, your company to fines if the
wrong product gets into Vermont.
Mr. Green. OK. Mr. Faber, according to the non-GMO foods,
the U.S. market perspective, GMO foods are expected to account
for up to 40 percent of the market by 2017, representing a
value of about $264 billion. You state that consumers deserve a
choice of knowing what is in their food, but isn't the market
already voluntarily moving in that direction?
Mr. Faber. Well, today, only about 3 percent of SKUs are
certified as GMO-free by the non-GMO project, and so consumers
are much likely today to see a natural claim on their
multigrain tortilla chip----
Mr. Green. Yes.
Mr. Faber [continuing]. Than to see the little butterfly
that means it has been a non-GMO certified multigrain tortilla
chip. So consumers are much more likely today, and in the near
future, to think that they are using their buying power to
avoid GMOs, if that is what they choose to do, than they would
if they are relying on that certification.
Mr. Green. Do you think there are any costs shifted to
consumers due to the mandatory labeling laws and how they might
change the operation of our food supply?
Mr. Faber. I don't believe that they will--even if we had a
modest informational GMO disclosure tomorrow, that you would
see dramatic change in buying behavior, and we know because we
have GMO labeling in some form or another in 64 other
countries, including countries where people eat more or less
like us. Brazil is a great example where they have had a GMO
disclosure since 2001, and where consumers have conferred a
benefit to the GMO disclosure, and that is why they have not
seen any significant change in buying behavior. So I am
confident that if we had a GMO disclosure tomorrow, that the
food industry would take all the money they have been spending
to fight these ballot initiatives, which is now more than $100
million, and invest it into a topnotch consumer education
campaign to persuade consumers that GMOs have all the benefits
that we have heard about during this hearing.
Mr. Green. Well, and I guess that is my concern that, we
heard from the FDA and, with their resources and, of course, we
decide their resources to do the inspections, but there has
been no proof that GMOs are actually bad to consume, and we
also know, and I assume we will have testimony, but this is not
the Ag Committee, but some of the GMOs have actually expanded
our possibilities for food production, not only in our own
country, because obviously we eat very well, but in parts of
the world where starvation is an issue, whether it be the GMO
rice product that you can, and those have been shown that they
they don't harm humans, but it does help the nutrition issues.
Mr. Faber. And as I said earlier, no one is arguing that
farmers should be prohibited from planting GMOs, and GMO traits
may indeed provide benefits to farmers or nutritional benefits
someday. I think the real question here is whether or not
people should be able to decide for themselves, and whether or
not FDA has the authority to do so. As Mr. Waxman was talking
about earlier, FDA has compelled disclosures simply because of
consumer interest, and up until 1992, for the years between
1938 and 1992, understood that word material that we talked
about earlier really to mean relevant. Was it information that
a consumer would want to have in order to make an educated
choice.
Mr. Green. Thank you for your patience, Mr. Chairman. I
know I ran over time a little bit.
Mr. Pitts. Chair thanks the gentleman.
Now recognize Mr. Pompeo 5 minutes for questions.
Mr. Pompeo. Thank you, Mr. Chairman.
Ms. Forshee, thank you again for traveling out here to be
here. You talked about the costs that would increase your small
business to operate. I assume you wouldn't just eat those
costs, you would attempt to pass them on as best you could to
your customers?
Ms. Forshee. Yes, just like any small business. I think I
left off the fact that we have one full-time hired man as well,
so, not only do we farm, but farming is a business----
Mr. Pompeo. Yes.
Ms. Forshee [continuing]. And that is exactly right, that
would have to be passed down.
Mr. Pompeo. I appreciate that. I have a lot of ground, I
want to try and get some yes-or-no answers. We haven't been
successful so far today. I am confident I will be the first to
do so.
Earlier today, we had an FDA witness testify, a very senior
FDA official testify. He said that GE foods in the U.S.
marketplace today are safe as their conventional counterparts.
We will start on my left, your right, and tell me if you agree,
yes or no, with that statement.
Ms. Van Eenennaam. Yes.
Mr. Faber. I believe so.
Mr. Pompeo. That is a yes, for the record.
Ms. Webb. Yes.
Mr. Pompeo. Just yes, yes.
Ms. Forshee. Yes.
Mr. Dempsey. Yes.
Mr. Pompeo. Yes. We have total unanimity. That is
fantastic. That is one of the first times in this committee we
have had that in my 4 years here, so that is all good news.
And, Mr. Faber, you were talking about misinformation out
there. I can tell you you are part of the problem. Your
organization is part of the problem. Mr. Matheson asked you
about it. You say you don't want a patchwork. You have spent
millions of dollars stirring up trouble to create just that
patchwork of regulation, and you are continuing to do so today.
I am confident that the phones are ringing in my office as a
result of your efforts to stir up this very challenge. And so I
would just urge you to work to get to the right place. This
piece of legislation requires the FDA to define natural, the
very thing that you spent so much time in your testimony
speaking to. So I am with you.
Mr. Faber. Yes.
Mr. Pallone. I want that to occur. But when you put up
things and you call this piece of legislation the dark act,
saying we are denying consumers the right to know, there is
nothing in this legislation that denies any consumer any
capacity to know precisely what it is they are eating. If any
willing provider deems it appropriate, and finds customer
demand to provide information to their customers about the
nature of that product, no one's right to know is being
impinged today, nor would it be if this bill became law.
So as you are out there working to defeat this legislation,
I hope you will be honest in the way you talk to America about
this because it is very important that folks have the right to
know. This Bill would never impinge on that. So I am sure today
you will go out and issue something that says that this is not
the dark act. I look forward to reading that on my Web site.
Mr. Dempsey, you were talking about this. One to 10 on a
scale, how does this impact the businesses that you represent
if we fail to get this law put into place and a patchwork of
rules becomes the norm in America?
Mr. Dempsey. Ten being the most difficult scenario?
Mr. Pompeo. Sure.
Mr. Dempsey. Ten for sure.
Mr. Pompeo. And so if it is a 10, what is it for the
smallest businesses in America?
Mr. Dempsey. Multiply that times 10.
Mr. Pompeo. Thank you.
Ms. Webb, how many FDA-level quality scientists are
employed by the state of Vermont today that are reviewing these
sets of food rules?
Ms. Webb. I have no idea.
Mr. Pompeo. So you----
Ms. Webb. We are not trying to compete with the FDA or be
the FDA.
Mr. Pompeo. So are there any folks that are experts in food
safety applied today by the state of Vermont that is trying to
put forth a set of rules that I promise you the citizens you
represent think have something to do with food safety?
Ms. Webb. I would have to get back to you on that.
Mr. Pompeo. You don't know. I would appreciate you getting
back with the committee and answering that question.
I want to come back to choice, Ms. Forshee, and this really
comes to you. You are both the producer and the consumer.
Today, if you decided, for whatever reason, because you had
some personal preference with respect to non-GMO foods, do you
think you could walk into a store somewhere, I guess not near
you, 20 miles, but somewhere in Kansas and find that set of
products on the shelves, or if you didn't, contact the
providers of those foods and say I want you to label that? Do
you think you could pull that off?
Ms. Forshee. No. I mean----
Mr. Pompeo. Yes.
Ms. Forshee [continuing]. I don't believe so.
Mr. Pompeo. Yes.
Ms. Forshee. I really don't.
Mr. Pompeo. Yes.
Ms. Forshee. I mean I feel that it is safe----
Mr. Pompeo. Yes.
Ms. Forshee [continuing]. And that is what I care about is
knowing that it is safe, but no.
Mr. Pompeo. I appreciate that.
Mr. Chairman, I yield back.
Mr. Pitts. All right, the chair thanks the gentleman.
That concludes the questions of the members present. I am
sure we will have follow-up questions. We will send them to you
in writing. We ask that you please respond promptly.
And members will have 10 business days to submit questions
for the records. That means they should submit their questions
by the close of business on Monday, December 29.
Thank you very much for your testimony, for your
willingness to come today, in a very important and informative
hearing.
Without objection, the subcommittee is adjourned.
[Whereupon, at 1:13 p.m., the subcommittee was adjourned.]
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