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AGRICULTURE BIOTECHNOLOGY: 

A LOOK AT FEDERAL REGULATION 

AND STAKEHOLDER PERSPECTIVES 

HEARING 

BEFORE THE

COMMITTEE ON AGRICULTURE, 

NUTRITION, AND FORESTRY 

UNITED STATES SENATE 

ONE HUNDRED FOURTEENTH CONGRESS 

FIRST SESSION 

OCTOBER 21, 2015 

Printed for the use of the 

Committee on Agriculture, Nutrition, and Forestry 

( 

Available via the World Wide Web: http://www.fdsys.gov/ 

COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY 

PAT ROBERTS, Kansas, Chairman 

THAD COCHRAN, Mississippi 

MITCH MCCONNELL, Kentucky 

JOHN BOOZMAN, Arkansas 

JOHN HOEVEN, North Dakota 

DAVID PERDUE, Georgia 

JONI ERNST, Iowa 

THOM TILLIS, North Carolina 

BEN SASSE, Nebraska 

CHARLES GRASSLEY, Iowa 

JOHN THUNE, South Dakota 

DEBBIE STABENOW, Michigan 

PATRICK J. LEAHY, Vermont 

SHERROD BROWN, Ohio 

AMY KLOBUCHAR, Minnesota 

MICHAEL BENNET, Colorado 

KIRSTEN GILLIBRAND, New York 

JOE DONNELLY, Indiana 

HEIDI HEITKAMP, North Dakota 

ROBERT P. CASEY, JR., Pennsylvania 

JOEL T. LEFTWICH, MAJORITY STAFF DIRECTOR

ANNE C. HAZLETT, MAJORITY CHIEF COUNSEL

JESSICA L. WILLIAMS, CHIEF CLERK

JOSEPH A. SHULTZ, MINORITY STAFF DIRECTOR

(II) 

(III) 

C O N T E N T S 

Page 

HEARING(S): 

Agriculture Biotechnology: A Look at Federal Regulation and Stakeholder 

Perspectives .......................................................................................................... 1 

Wednesday, October 21, 2015 

STATEMENTS PRESENTED BY SENATORS 

Roberts, Hon. Pat, U.S. Senator from the State of Kansas, Chairman, Committee on Agriculture, Nutrition, and Forestry ................................................. 1 

Stabenow, Hon. Debbie, U.S. Senator from the State of Michigan ..................... 2 

Panel I 

Gregoire, Michael, Associate Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Washington, DC ...................... 4 

Jordan, William, Deputy Director, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, DC ...................................................... 6 

Mayne, Susan, Ph.D., Director, Center for Food Safety and Applied Nutrition, 

Food and Drug Administration, College Park, MD ........................................... 7 

Panel II 

Lidback, Joanna, Producer, The Farm at Wheeler Mountain, Barton, VT ......... 35 

Thomas, Daryl E., Senior Vice President, Herr Foods, Inc., Nottingham, PA ... 36 

Hirshberg, Gary, Chairman and Co-Founder, Stonyfield Farm Inc., Concord, 

NH ......................................................................................................................... 38 

Jaffe, Gregory, Project Director, Biotechnology, Center for Science in the 

Public Interest, Washington, DC ........................................................................ 40 

Kleinman, Ronald E., M.D., Physician in Chief, MassGeneral Hospital for 

Children, Boston, MA .......................................................................................... 42 

APPENDIX 

PREPARED STATEMENTS: 

Gregoire, Michael ............................................................................................. 56 

Hirshberg, Gary ................................................................................................ 61 

Jaffe, Gregory ................................................................................................... 65 

Jordan, William ................................................................................................ 76 

Kleinman, Ronald E. ........................................................................................ 84 

Lidback, Joanna ................................................................................................ 87 

Mayne, Susan ................................................................................................... 94 

Thomas, Daryl E. .............................................................................................. 111 

DOCUMENT(S) SUBMITTED FOR THE RECORD: 

Hirshberg, Gary: 

‘‘It’s time for Congress to require GMO labeling’’ The Register’s Editorial . 118 

QUESTION AND ANSWER: 

Gregoire, Michael: 

Written response to questions from Hon. Pat Roberts .................................. 120 

Written response to questions from Hon. Debbie Stabenow ......................... 121 

Written response to questions from Hon. Joni Ernst .................................... 122 

Written response to questions from Hon. Patrick J. Leahy .......................... 122 

Page

IV 

Gregoire, Michael—Continued 

Written response to questions from Hon. David Perdue ............................... 123 

Written response to questions from Hon. John Thune .................................. 124 

Hirshberg, Gary: 

Written response to questions from Hon. Sherrod Brown ............................ 126 

Written response to questions from Hon. Heidi Heitkamp ........................... 127 

Written response to questions from Hon. Patrick J. Leahy .......................... 128 

Written response to questions from Hon. Joni Ernst .................................... 130 

Jaffe, Gregory: 

Written response to questions from Hon. Sherrod Brown ............................ 144 

Written response to questions from Hon. John Thune .................................. 145 

Jordan, William: 

Written response to questions from Hon. Pat Roberts .................................. 147 

Written response to questions from Hon. Joni Ernst .................................... 148 

Written response to questions from Hon. Heidi Heitkamp ........................... 149 

Written response to questions from Hon. Patrick J. Leahy .......................... 150 

Written response to questions from Hon. David Perdue ............................... 150 

Written response to questions from Hon. Ben Sasse ..................................... 151 

Written response to questions from Hon. John Thune .................................. 152 

Kleinman, Ronald E.: 

Written response to questions from Hon. Joni Ernst .................................... 234 

Written response to questions from Hon. John Thune .................................. 234 

Lidback, Joanna: 

Written response to questions from Hon. Joni Ernst .................................... 235 

Written response to questions from Hon. Heidi Heitkamp ........................... 235 

Written response to questions from Hon. Patrick J. Leahy .......................... 236 

Written response to questions from Hon. John Thune .................................. 237 

Mayne, Susan: 

Written response to questions from Hon. Pat Roberts .................................. 239 

Written response to questions from Hon. Debbie Stabenow ......................... 241 

Written response to questions from Hon. Joni Ernst .................................... 241 

Written response to questions from Hon. Patrick J. Leahy .......................... 241 

Written response to questions from Hon. John Thune .................................. 243 

Thomas, Daryl E.: 

Written response to questions from Hon. Joni Ernst .................................... 244 

Written response to questions from Hon. Heidi Heitkamp ........................... 244 

Written response to questions from Hon. Patrick J. Leahy .......................... 245 

Written response to questions from Hon. John Thune .................................. 249 

(1) 

AGRICULTURE BIOTECHNOLOGY: 

A LOOK AT FEDERAL REGULATION 

AND STAKEHOLDER PERSPECTIVES 

Wednesday, October 21, 2015 

UNITED STATES SENATE, 

COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY, 

Washington, DC 

The committee met, pursuant to notice, at 10:04 a.m., in room 

106, Dirksen Senate Office Building, Hon. Pat Roberts, Chairman 

of the committee, presiding. 

Present or submitting a statement: Senators Roberts, Boozman, 

Hoeven, Perdue, Ernst, Tillis, Sasse, Grassley, Thune, Stabenow, 

Leahy, Brown, Klobuchar, Bennet, Gillibrand, Donnelly, Heitkamp, 

and Casey. 

STATEMENT OF HON. PAT ROBERTS, U.S. SENATOR FROM THE 

STATE OF KANSAS, CHAIRMAN, U.S. COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY 

Chairman ROBERTS. Good morning. I call this meeting of the 

Senate Committee on Agriculture, Nutrition, and Forestry to order. 

I have said many times that one of our committee’s main goals 

is to conduct thorough oversight of issues within our jurisdiction. 

We have a responsibility to ensure that government agencies carry 

out laws passed by Congress in an efficient and effective manner. 

Today’s hearing is an important step in the committee’s work as 

we hear from the three agencies tasked with regulating agriculture 

biotechnology: USDA’s Animal and Plant Health Inspection Service, the Environmental Protection Agency, and the Food and Drug 

Administration. We will also hear from witnesses that represent 

different perspectives in the value chain of agriculture and food 

production: A farmer, a food manufacturer, as well as representatives of other consumer opinions and a medical professional. 

We have all heard about our growing global population, currently 

at seven billion and estimated to reach over 9.6 billion in the next 

several decades. We have seen too many examples in recent years 

where shortfalls in grain and other food items or increases in prices 

at the consumer level have helped to trigger outbreaks of civil unrest and protest in places like the Middle East and Africa. 

In light of these global security threats, today’s farmers are being 

asked to produce more safe and affordable food to meet the demands at home and around the globe. At the same time, they are 

facing increased challenges to production, including limited land 

and water resources, uncertain weather, and pest and disease 

2 

issues. Over the past 20 years, agriculture biotechnology has become a valuable tool in ensuring the success of the American farmer in meeting the challenge of increasing yield in a more effective, 

safe, and responsible manner. 

So, as we review these issues, we must continue to be guided by 

the best available science, research, and innovation. Today, I look 

forward to our government witnesses highlighting the steps their 

agencies have taken to ensure that agriculture biotechnology is 

safe—safe to other plants, safe to the environment, and safe to the 

food supply. We do have a regulatory system that makes biotechnology crops among the most tested in the history of agriculture. 

The multi-agency approach referred to as the Coordinated 

Framework for the Regulation of Biotechnology was established 

with a science and risk-based approach back in the 1990s, and the 

White House Office of Science and Technology Policy has recently 

initiated a process to review the regulatory system. Now, their objective is a long-term strategy to ensure that the federal regulatory 

system can assess any risks associated with products of biotechnology while supporting innovation and protecting health and 

the environment, maintaining public confidence in the regulatory 

process, increasing transparency and predictability, and reducing 

unnecessary costs and burdens. That is a mouthful. That is quite 

a mission statement. 

Today, we will also hear from representatives of the value chain 

of agriculture and food production. This includes witnesses with 

firsthand experience farming and in food production and it includes 

perspectives of those that deal with hunger and health issues on 

a daily basis. 

Increasingly, many Americans have taken an interest in where 

their food comes from and how it is made. Throughout this discussion, I hope we remember the importance of focusing on science 

and consider our role to help ensure a safe, affordable food supply 

for consumers at home and all around the globe. 

I thank each witness for providing testimony before the committee on such an important issue, and I ask consent to include 

other statements and information submitted to the committee 

along with the hearing record. 

With that, I recognize our distinguished Ranking Member, 

former Chairperson Senator Stabenow, for any remarks that she 

would like to make. 

STATEMENT OF HON. DEBBIE STABENOW, U.S. SENATOR 

FROM THE STATE OF MICHIGAN 

Senator STABENOW. Well, thank you very much, Mr. Chairman, 

and I also want to thank the administration officials that are here 

and all of the food industry leaders for testifying today. Your comments, your perspectives are very important to us and I look forward to hearing your testimony. 

I agree that throughout the history of our country, American agriculture has been at the forefront, developing cutting-edge technology, from John Deere’s invention of the steel plow, to Norman 

Borlaug’s use of novel plant breeding techniques to create highVerDate Nov 24 2008 16:19 May 17, 2016 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\USERS\MW42035\DESKTOP\DOCS\98991.TXT MICAH
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yielding wheat that has helped prevent hunger and famine around 

the world. 

Today, that same spirit of innovation is helping drive agriculture 

production and efficiency to amazing new heights. A growing global 

population, coupled with the effects of climate change and the 

stress placed on much of our natural resources, has created a sense 

of urgency for new innovations if we are to maintain our nation’s 

agricultural leadership. 

That is one reason why I support the use of biotechnology in agriculture. Biotechnology has proven to be safe, beneficial, and I believe will play a major role in helping to solve these dual global 

challenges of climate change and global food security. 

I also recognize the desire by a growing number of American consumers to know more about the food they eat. This growing demand for information is one reason why in the 2014 farm bill we 

had unprecedented investments in areas like organic production 

and local food systems, which help ensure consumers have increased choices. 

As we know, several states have passed laws to disclose more 

about the production of food, and I believe this issue will only continue to build steam in the months and years ahead. I share the 

concern about the difficulty in doing business across our country if 

50 different states have 50 different standards and requirements, 

and, frankly, it will not work. However, we also need to recognize 

and respect the interests of many American consumers who care 

deeply about where and how their food is produced. 

In order to address legitimate concerns from our farmers, our 

food companies, our consumers, I believe we need to work together, 

and I am committing myself, Mr. Chairman, to do that in a bipartisan way, to develop and pass a bill that can pass the Senate by 

the end of the year. This needs to move quickly in order to address 

these issues, and I believe they need to meet the following tests. 

First, a solution that addresses the problem of a 50-state patchwork of regulations. 

Second, a national system of disclosure and transparency for consumers who wish to know more about their food. 

Third, an approach that does not stigmatize biotechnology. 

Nearly 30 years ago, the White House Office of Science and Technology Policy established the Coordinated Framework for the Regulation of Biotechnology. Since its inception, this framework has 

helped establish what sound oversight of agricultural biotechnology 

must be. With the continued development and increased use of biotechnology and other science-based breeding techniques, it makes 

sense that these standards are revisited, and I applaud the administration for taking that step earlier this summer. Ensuring that 

the Coordinated Framework is updated to reflect the latest research and science on biotechnology will help instill additional confidence about the safety and soundness of the use of these technologies. 

As we look at updating the rules to reflect advancements in biotechnology, it makes sense that we examine the way in which consumers have access to the information they need to make informed 

decisions about the food they eat and purchase for their families. 

4 

As members of this committee, we recognize that American farmers and ranchers are the best in the world and they use the most 

sophisticated farming practices to produce the most abundant and 

safest food supply in the world. We should strive to build confidence in these technologies so that all consumers can better understand their benefits and recognize and appreciate the role of innovation in American agriculture today. 

Mr. Chairman, I look forward to working with you on this issue. 

I know this is a very important hearing today. 

Chairman ROBERTS. I want to thank the distinguished Ranking 

Member, and we will be moving with legislation as quickly as possible. 

Welcome to our first panel of witnesses before the committee this 

morning. Our first panelist is Mr. Gregoire, who serves as the Associate Administrator of APHIS. In addition to a focus on the agency’s policy, budget, and administrative responsibilities, he manages 

the biotechnology and regulatory services as well as the plant protection and quarantine issue areas. Welcome, and I look forward to 

your statement. 

STATEMENT OF MICHAEL GREGOIRE, ASSOCIATE ADMINISTRATOR, ANIMAL AND PLANT HEALTH INSPECTION SERVICE, U.S. DEPARTMENT OF AGRICULTURE, WASHINGTON, DC 

Mr. GREGOIRE. Thank you very much, Chairman Roberts and 

Senator Stabenow and members of the committee. Thank you for 

the opportunity today to appear before you and discuss an important topic to American agriculture, that is the complex issues surrounding biotechnology and the federal government’s role in regulating it. 

I am Michael Gregoire, Associate Administrator of USDA’s Animal and Plant Health Inspection Service. APHIS is responsible for 

ensuring that new biotechnology products do not inadvertently 

harm plant health in the U.S. 

APHIS regulates the importation, the interstate movement, and 

field testing of genetically engineered organisms. Our specific role 

is to ensure that new GE crops do not pose a risk to plant health, 

such as causing disease or damage to other crops or plant products 

in the United States. 

If a GE product requires USDA’s oversight, developers must 

apply for an APHIS permit and adhere to APHIS regulations to 

maintain adequate confinement of a regulated organism during 

field trials. After developers have the scientific information which 

they believe is sufficient for us to conclude that a GE organism is 

unlikely to pose a plant pest risk, they can petition APHIS for nonregulated status. 

We then prepare an appropriate plant pest risk assessment and 

environmental analysis that informs our decisions. If our officials 

conclude then that a GE organism does not pose a plant pest risk, 

APHIS deregulates the product and that organism may be freely 

moved or planted without further APHIS oversight and permits or 

other regulatory requirements. 

Over the years, APHIS has—over the recent years, APHIS has 

undertaken a process to significantly improve the timeliness of our 

biotechnology regulatory decisions. We have been able to provide a 

5 

more timely review process that does not sacrifice the thoroughness 

or the quality of our scientific reviews while also giving the public 

an additional opportunity to provide us with input. 

APHIS has completed 30 of the 37 pending and new petitions 

since implementing our new process in March of 2012, and we plan 

to complete three more by the end of this year. Since March of 

2012, we have also cut the time down for review of new petitions 

from between three to five years to just over 18 months, and we 

are on a course to get that down to more like 15 months, on average. 

Again, APHIS’s authority to regulate GE products is based on 

their potential plant pest risk. We regulate based on the specific 

product and the environment into which it is being introduced, not 

the production process that created the organism. Developers may 

seek a written determination from us if they are unsure whether 

or not their product requires regulatory oversight. 

We work regularly with the Food and Drug Administration and 

EPA to ensure that the development, testing, and use of biotechnology products happens in a way that is safe for plant and 

animal health, human health, and the environment. We regularly 

communicate with our colleagues in FDA and EPA to ensure that 

any safety or regulatory issues that may arise are appropriately resolved. We have great confidence in the safety of the GE crops that 

have been approved under the U.S. regulatory system. 

Recently, the Executive Office of the President released a memo 

that directed our three agencies to work with them to update the 

Coordinated Framework of 1986, and we are working very closely 

with our colleagues on this review and update. 

Complementing the interagency effort to update the Coordinated 

Framework is our renewed effort in USDA to revise and update 

APHIS’s regulations. We plan to align our regulations with current 

authorities and regulate GE organisms that pose a plant pest or 

weed risk in a manner that balances oversight and risk and that 

is based on the best available science. We plan to continue to engage the public throughout the rulemaking process and will provide 

ample opportunities for public input in that process. 

To summarize, USDA is committed to a sound, science-based and 

modern approach to the regulation of products derived from biotechnology. We will continue to work with our federal partners and 

stakeholders as we build upon the many years of our work in this 

area. 

Mr. Chairman, that concludes my opening remarks. 

[The prepared statement of Mr. Gregoire can be found on page 

56 in the appendix.] 

Chairman ROBERTS. Thank you very much for your statement. 

Our next witness is Mr. Bill Jordan. He joins us today as the 

Deputy Director for EPA’s Office of Pesticide Programs, and I understand that he has plans to retire at the end of the year, after 

a distinguished career in public service. Maybe we can talk you out 

of that here this morning. 

[Laughter.] 

Chairman ROBERTS. He has worked in several capacities in the 

Office of Pesticide Programs since 1988 and previously served in 

the EPA’s Office of General Counsel. 

6 

I look forward to your testimony and your experience, sir. 

STATEMENT OF WILLIAM JORDAN, DEPUTY DIRECTOR, OFFICE OF PESTICIDE PROGRAMS, U.S. ENVIRONMENTAL PROTECTION AGENCY, WASHINGTON, DC 

Mr. JORDAN. Good morning, and thank you, Chairman Roberts 

and Ranking Member Stabenow and members of the committee. I 

appreciate the chance to testify about EPA’s role in regulating 

products of biotechnology. 

EPA administers two strong laws, FIFRA and the Food, Drug, 

and Cosmetic Act, to regulate pesticides, a term that includes genetically engineered plants that express pesticidal properties. We 

call a pesticide like that a plant incorporated protectant, or PIP, for 

short. I will be talking a lot about PIPs. 

Under FIFRA, we register pesticides to ensure that they are used 

in a way that is safe for humans and the environment, and in order 

to obtain a registration, an applicant must demonstrate that the 

pesticide will not cause unreasonable adverse effects on humans or 

the environment. 

EPA also regulates the safety of pesticide residues in food under 

the FFDCA by establishing maximum residue limits, called tolerances. Here, we may establish a tolerance only if there is a reasonable certainty that no harm will result from exposure to pesticide 

residues. 

As described more fully in my written testimony, EPA’s regulation of PIPs and other pesticides is guided by several principles. 

First, our decisions are based on the best available science. 

Second, we operate with consistency and fairness in a transparent manner. 

Third, we collaborate with our partners at USDA and FDA. 

I want to emphasize the important role that science-based risk 

assessment plays in our regulatory process. When making decisions 

about PIPs, the Agency knows we must be fully informed by the 

best available information and expert advice. So, EPA requires applicants for registrations and tolerances to provide extensive data 

on their PIPs. EPA’s staff experts carefully review all of this information to see if a product meets the safety standards in our statutes. EPA also has sought advice from external independent experts on biotechnology through nearly two dozen meetings of the 

FIFRA Scientific Advisory Panel. At the end of the day, we are 

very confident that we can stand behind our conclusions that the 

PIP products we approve meet the demanding protective standards 

of FIFRA and FFDCA. 

We have approved 86 PIP registrations. Most of these are for 

products that produce a protein that is toxic to particular kinds of 

insects, but has practically no effect on humans or other species. 

Growers have widely adopted PIP products. Today, tens of millions 

of acres are being planted with EPA-approved varieties of PIPs. 

A number of groups, including the National Academy of Sciences, 

have studied how the introduction of PIPs has affected the use of 

synthetic chemical pesticides. These experts concluded that by 

planting PIPs, growers have reduced by many millions of pounds 

their reliance on broad spectrum synthetic insecticides. The result 

is less exposure to such pesticides for workers and non-target wildVerDate Nov 24 2008 16:19 May 17, 2016 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 C:\USERS\MW42035\DESKTOP\DOCS\98991.TXT MICAH
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life, less ground and surface water contamination, and less pesticide residue in food. In addition, PIPs solve pest problems that 

conventional chemical pesticides have not, as shown with the plum 

pox example described in my written testimony. 

The use of PIPs in agriculture has already produced real benefits, but we cannot say that future products will always be risk 

free. Therefore, before a new PIP is introduced into the environment, it is important that EPA have sufficient data and opportunity to evaluate the potential for risks. In addition, because PIPs 

have proven to be effective and safer alternatives to conventional 

pesticides, EPA believes they should be managed in a way that preserves the technology long into the future. That will likely require 

controls on the use of PIPs to prevent the development of pest resistance. 

In sum, EPA recognizes the potential benefits that products of 

modern biotechnology can bring to agriculture and the environment, and we also believe the country needs a strong, effective, and 

efficient regulatory system that embodies the principles of sound 

science, transparency, and collaboration. We believe we have such 

a system at EPA, and working with our colleagues at FDA and 

USDA, we look forward to continuing to fulfill our responsibility for 

ensuring the safety of products of modern biotechnology. 

I would be happy to answer questions later. 

[The prepared statement of Mr. Jordan can be found on page 76 

in the appendix.] 

Chairman ROBERTS. We thank you, Mr. Jordan. 

We have both of our witnesses finishing exactly on time. We may 

set a record here this morning. 

[Laughter.] 

Chairman ROBERTS. Our third witness, Dr. Susan Mayne—I did 

not mean to put that on your shoulders—— 

[Laughter.] 

Chairman ROBERTS. —comes to us from the FDA Center for Food 

Safety and Applied Nutrition. Dr. Mayne has served as the Director of FDA’s Center for Food Safety and Applied Nutrition since 

January 2015. In this role, she leads the Center’s efforts related to 

the composition, the quality, the safety and labeling of foods, food 

and color additives, and cosmetics. Previously, Dr. Mayne was the 

C.-E.A. Winslow Professor of Epidemiology and Chair of the Department of Chronic Disease of Epidemiology at the Yale School of 

Public Health, as well as Associate Director of the Yale Cancer 

Center. 

Welcome. I look forward to your testimony and your insight. 

STATEMENT OF SUSAN MAYNE, PH.D., DIRECTOR, CENTER 

FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND 

DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND 

HUMAN SERVICES, COLLEGE PARK, MARYLAND 

Ms. MAYNE. Thank you, Chairman Roberts and Ranking Member 

Stabenow and members of the committee. 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 information on more 

than 150 plant-derived GE foods, ranging from herbicide-tolerant 

8 

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 conventional counterparts. 

The selection and genetic improvement of plants for agricultural 

use has been going on for thousands of years, typically through 

cross-breeding and hybridization. Many of the foods that are common in our diet, such as hybrid corn or nectarines, are obtained 

from plant varieties that were developed using such conventional 

genetic cross-breeding techniques. 

Since the late 1980s, 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 and traits. 

Any of these genetic modification techniques has the potential to 

change the composition of a food in a manner that is relevant to 

food safety. FDA, however, has well established scientific procedures for evaluating the safety of new foods, including any new 

substances in a food, and our guidelines help developers address 

any safety concerns prior to marketing. 

FDA regulates the safety of all foods within our authority, including those derived from GE plants, under the Federal Food, 

Drug, and Cosmetic 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. Food growers, manufacturers, and distributors are responsible for taking the steps necessary to ensure 

that their products are safe. 

To help developers of food derived from GE plants comply with 

their safety obligations, the agency encourages participation in our 

voluntary consultation process prior to commercial distribution. 

Since the consultation process was created, developers of GE plants 

have completed the process more than 100 times. Typically, the 

consultation begins early in the development, when the agency advises the developer on what tests would be appropriate to test safety. After the studies are completed, a summary of the data reflecting safety and nutritional composition are provided to FDA for 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 food’s conventionally derived counterpart 

are appropriately considered and addressed before marketing. 

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 any important nutrients have been changed in a 

way that is important to food safety or nutrition. We also consider 

whether any newly introduced protein requires pre-market 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 sources, 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 

9 

new substances introduced by the genetic material; a comparison 

of the composition and characteristics of the GE food to that of the 

parental variety; and information on whether the genetic modification altered the allergic or toxic potential of the food. 

FDA also regulates the labeling of food, including GE foods, 

under the Act and our regulations. The Act establishes that a food 

is misbranded if its labeling is false or misleading. Labeling is misleading if it fails to reveal facts that are material with respect to 

representations made or suggested in the labeling or if it fails to 

reveal consequences that may result from the use of the food. 

FDA has taken the position that the use of genetic engineering 

in the development of a food is normally not by itself material information within the meaning of the Act. Federal courts have held 

that FDA’s position that the use of genetic engineering by itself 

does not constitute a material fact or require labeling to indicate 

that the food has been developed through genetic engineering is entitled to deference. 

Finally, I want to note that FDA is engaged with our colleagues 

at USDA and EPA to implement the activities laid out in the 2015 

memorandum on modernizing the regulatory system for biotechnology products. On October 30, at our campus in Silver 

Spring, Maryland, FDA will host the first of three public meetings 

to involve the public in this modernization effort. 

In closing, I want to assure you that FDA’s consultation process 

for foods derived from GE plants works well and provides for a rigorous food safety evaluation of GE foods. The agency will continue 

to be vigilant in ensuring the safety and integrity of the nation’s 

food supply. Thank you. 

[The prepared statement of Ms. Mayne can be found on page 94 

in the appendix.] 

Chairman ROBERTS. We thank you. 

This is for all witnesses with regards to my question. Based on 

the best available science at your agency, do you believe that biotechnology is safe? Additionally, how does the regulatory scrutiny 

for agriculture biotechnology compare to the regulatory review 

process for other food ingredients at your respective agencies? Mr. 

Gregoire. 

Mr. GREGOIRE. Yes. Thank you, Mr. Chairman. We are very confident in the safety of the products that we have reviewed through 

our regulatory process. The genetically engineered crops that we 

review in terms of the plant risks that we review, they get more 

scrutiny than would, say, conventional bred crops. 

Chairman ROBERTS. Mr. Jordan. 

Mr. JORDAN. We, too, at EPA are very confident in the judgments 

that we have made about the safety of the PIP products that we 

have reviewed. The PIP products, pesticides and conventional pesticides, must meet the same rigorous safety standard, and we require companies to give us as much data as we need in order to 

make that decision. So, both conventional pesticides and PIPs are 

rigorously examined. 

Chairman ROBERTS. Dr. Mayne. 

Ms. MAYNE. As I indicated before, we have had a long established pre-market consultation process. To our knowledge, all of the 

firms that are intending to commercialize GE plants in the U.S. 

10 

have consulted with FDA prior to marketing. As I indicated, we review newly inserted DNA protein product, allergenicity, potential 

toxicity. We look for key nutrient changes, toxicants, et cetera. So, 

our process is rigorous. Our process is thorough. It is consistent 

with how we regulate food in general under the Federal Food, 

Drug, and Cosmetic Act. 

Chairman ROBERTS. A second question for all witnesses. When 

the White House Office of Science and Technology Policy announced the review of the Coordinated Framework for the Regulation of Biotechnology in July, key objectives included ensuring public confidence in the regulatory system and preventing unnecessary 

barriers to future innovation and competitiveness. How can the 

three agencies and the administration, as well as this committee, 

do a better job, especially conveying to the public their belief in 

science and risk-based work of the agency experts? Will this process help convey more confidence to the public? Mr. Gregoire. 

Mr. GREGOIRE. Yes, Senator, I believe it will. The process that 

we have undertaken will look at clarifying roles and responsibilities of the three agencies in the regulatory oversight. It will position us for the future products of biotechnology and we will also be 

getting outside expert review of the future landscape of biotechnology. So, the purpose is really to make the overall system 

more clear and transparent and predictable, both for developers 

and for the public. 

Chairman ROBERTS. Mr. Jordan. 

Mr. JORDAN. I agree with Mr. Gregoire and I would only add that 

the process going forward by which we intend to update the Coordinated Framework and develop a long-term strategy will include, as 

Dr. Mayne has noted, opportunities for public input. We are hoping 

to learn from that feedback how to do our job as well as we possibly 

can. 

Chairman ROBERTS. Dr. Mayne. 

Ms. MAYNE. So, I concur with that. We are—FDA is committed 

to work with the other agencies to update the Coordinated Framework after we have had public input into the process. We will be 

looking towards long-term strategies to thinking about how we can 

assure that this is working as effectively as possible into the future. We look forward to the input from independent analyses, from 

National Academies and others, as to how we can do this most effectively. 

Our goal through this process is to provide clarity to the regulatory process to encourage innovation while we are managing 

risks, and we look forward to that process. 

Chairman ROBERTS. Speaking for all members on this committee, 

we will continue our oversight responsibilities in a partnership effort with you. This is the first time, I think, for Senator Stabenow, 

for ten years that we have had a hearing on biotechnology. So, I 

guess we are a little late, but we are here. 

Senator Stabenow, please. 

Senator STABENOW. Well, thank you very much, Mr. Chairman, 

and again, thanks to each of you for your testimony. 

I would like to just expand a little bit more on what the Chairman was talking about in terms of the 1986 Coordinated Framework that you are now involved in updating, and I think the objecVerDate Nov 24 2008 16:19 May 17, 2016 Jkt 000000 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 C:\USERS\MW42035\DESKTOP\DOCS\98991.TXT MICAH
11 

tive is a really important one, quote, ‘‘ensure public confidence in 

the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving transparency, 

coordination, predictability, and efficiency of regulations.’’ So, that 

is a lot and it is also very, very important to do. 

I wonder if you could expand a little bit as you look at how you 

have seen technologies evolve in recent years and how that will inform you as you are looking to update the plan. I wonder if each 

of you might. Mr. Gregoire, you might go first. 

Mr. GREGOIRE. Yes. Thank you for that question. Certainly, the 

science has advanced greatly since the Coordinated Framework 

was put into place and the technology is changing rapidly. There 

are a lot of new plant breeding techniques that have been developed that allow developers to confer traits with more precision 

more quickly than conventional breeding and at less cost. So, there 

are many different advances in this technology. 

Senator STABENOW. Thank you. 

Mr. Jordan. 

Mr. JORDAN. Thank you, Senator. One of the changes that we at 

EPA think is very encouraging is that technology developers have 

been able to combine different genetically engineered traits into a 

single plant, making the plant’s ability to resist different kinds of 

insects and to deal with pest resistance more effective. I think, is 

a notable advance in the technology in recent years. 

As Mr. Gregoire has indicated, companies, technology developers, 

are extraordinarily innovative in terms of the ability that they—the 

variety of products that they are bringing to us, and because those 

products are different, then we need to be able to be clear, first, 

about which agency has responsibility for regulating them, and 

then to look carefully at how the different types of products may 

present different issues in terms of risk and environmental effects. 

Senator STABENOW. Dr. Mayne. 

Ms. MAYNE. So, the science has evolved and continues to evolve, 

the techniques for doing this type of genetic engineering, and our 

scientists attend the same conferences, read the same scientific 

journals, and do all they can to stay abreast of advances in science 

and technology. 

In some cases, we have to stay abreast of all the science, but that 

also presents opportunities, and one example is that through the 

genomic revolution, we now have the ability to have sequences on 

all kinds of different things. We now have the ability to, for example, screen proteins against known sequences for proteins that have 

allergenic potential. So, we have better tools now to identify things 

like potential allergenicity through advances in science and technology. 

Senator STABENOW. Thank you. 

Just a comment, Mr. Chairman. One of the things that I find 

frustrating on this issue, and I have said it to so many people who 

are involved in doing the technology and so on, is really breaking 

this down in a way that the public can understand that does not 

sound scary, because the reality is, and I will never forget reading 

a great book called Our Daily Bread about Norman Borlaug, and 

we now have a statue of him in Statuary Hall, and to look at what 

he did both in the field and laboratory and starting in 1944 with 

12 

the Rockefeller Foundation. Then he spent decades doing basically 

what can be done in a lab now. It is speeding up what he did. That 

is how I view this. 

So, he spent decades trying to create a situation where there was 

broader and more stable disease resistance and higher yields. He 

was called the Father of the Green Revolution. He got a Nobel 

Peace Prize for literally saving millions of people by feeding people 

around the globe because of the work he did. Now, because we can 

do this in a laboratory faster rather than taking decades, it has 

now become a whole other thing that we talk about. 

So, one of my frustrations is the fact that this is not explained 

well at all, or understood. Is there anything that all of you are 

doing that will help sort of break this down? I mean, this is about 

how we—just as we do better medical research in a lab than we 

used to do, with technology, we are now doing better plant science 

and seed science than we used to do because of technology. We, I 

think in general, as a country, and industries have not explained 

this very well, and it is very unfortunate. 

So, I do not know if there is anything that you are involved in 

that will help make that more clear about what that means in 

terms of how science is positive in this sense or not, but it certainly 

would be helpful. I do not know if anybody wants to respond to 

that or not. That is more of an editorial comment, Mr. Chairman, 

but if anyone would want to respond. I do not know if the Framework does anything to translate this into real world for people and 

why this is positive in terms of health and safety, but is that anywhere in the Framework or not? I do not know. 

Ms. MAYNE. Well, I would just—— 

Chairman ROBERTS. Feel free. 

Ms. MAYNE. I would just say, at the end of this process, I would 

hope that the public would have greater confidence and that we 

will continue to try to communicate the strength of the science, as 

you hear today, that we have confidence in the safety of these products, in the case from FDA, for the food supply. 

Senator STABENOW. Thank you. Thank you, Mr. Chairman. 

Chairman ROBERTS. Thank you, Senator. Your sense of frustration folds very neatly into our challenge here on the committee. 

This is the first time in ten years that we have had a hearing on 

biotechnology, and we have experts that have testified basically to 

the American public that biotechnology is safe. Each of us have our 

megaphones that we can talk to our farmers and ranchers and all 

of agriculture, and, for that matter, the food industry. But, it is a 

challenge and I thank you for bringing that up. 

Senator Thune. 

Senator THUNE. Thank you, Mr. Chairman, and thank you for 

being a pioneer on this subject. It is important. It is the first one— 

I did not realize, the first one in ten years, but it is an important 

subject, so thank you to you and Ranking Member Stabenow for 

bringing this issue in front of us. 

It goes without saying that biotechnology has provided my home 

State of South Dakota and its number one industry, agriculture, 

with dramatic yield increases, drought tolerant crops, sustainability, and economic benefits that far exceed expectations from ten 

or 20 years ago. Farmers in South Dakota and across the United 

13 

States take great pride not only in the amount of the crops that 

they produce, the number of people they feed, but most importantly 

in the safety of the food supply they provide, not only for the 

United States and global populations, but also for their own families. 

Now, based on testimony that is provided and going to be provided at today’s hearing, I am greatly concerned that just like 

many other areas of regulatory overreach, future regulation of our 

biotechnology crops, especially regarding the approval process, 

could become much more cumbersome and complicated and send 

the wrong message to our trading partners overseas, which could 

be very detrimental to my home state, as it depends heavily on export markets. 

Additionally, the uncertainty that is created by states individually passing mandatory GMO labeling laws would be devastating 

to producers, as our supply chains are much too complex to meet 

the needs of 50 different states. 

So, I start with that. I have a couple of questions I would like 

to ask, and I want to direct this one first to Mr. Jordan, because 

opponents of biotechnology have been raising questions about the 

safety of glyphosate herbicide with certain GM crops, notwithstanding its 40-year history of safe use, and the fact, by the way, 

that no regulatory agency in the world considers glyphosate to be 

a carcinogen. 

In April of this year, EPA issued a desk statement regarding 

glyphosate and the IARC conclusion. In this statement, EPA stated, in part, and I quote, ‘‘In 2014, EPA reviewed over 55 epidemiological studies conducted on the possible cancer and non-cancer effects of glyphosate. Our review concluded that this body of research 

does not provide evidence to show that glyphosate causes cancer 

and it does not warrant any change in EPA’s cancer classification 

for glyphosate. This is the same conclusion reached in 2004 by the 

United Nations Food and Agriculture Organization and affirmed 

this year by Germany’s pesticide regulatory officials.’’ That is the 

end of the quote. 

So, I just want to ask you the question, can you confirm that this 

is the most recent public statement EPA has issued addressing the 

safety of glyphosate? 

Mr. JORDAN. Yes, sir, that is the most recent statement that we 

have issued on that, and I helped write it with the input of the experts at EPA. We are currently reviewing the IARC report and we 

expect by the end of this year, possibly sooner, to have another 

statement addressing that document. 

Senator THUNE. You in your testimony, when discussing regulation of plant incorporated protectants, or what you referred to as 

PIPs, that, quote, ‘‘Our decisions are based on the best available 

science. We operate with consistency and fairness in a transparent 

manner and we collaborate fully with our regulated partners in the 

Coordinated Framework,’’ end quote. Then you went on to say that 

the EPA believes we have a responsibility to convey to the public 

that our decisions are consistent, scientifically solid, and fully protective of human health and the environment. 

Based on the collaborative efforts of EPA, FDA, and USDA 

APHIS using sound science to ensure food safety, especially for 

14 

foods derived from genetically engineered plants, do you believe 

consumers need mandatory labeling of foods produced from GMO 

plants? 

Mr. JORDAN. Sir, I believe that the genetically engineered plants 

that we have reviewed do not pose any risk in the food supply. It 

is not EPA’s purview to address labeling questions, but that lies 

with FDA. 

Senator THUNE. Okay, and thank you for that nice segue there. 

Dr. Mayne, you provide in your testimony the FDA is supportive 

of voluntary labeling that indicates whether foods have or have not 

been developed through genetic engineering, provided that such labeling is truthful, not misleading. You also provide in your testimony that, and I quote, ‘‘FDA’s voluntary pre-market consultation 

process provides for a rigorous food safety evaluation of foods derived from genetically engineered plants. As a result of these premarket consultations, we are confident that foods derived from GE 

plants in the U.S. marketplace today are as safe as their conventional counterparts,’’ end quote. 

So, if you are confident that foods derived from GE plants are 

just as safe as foods derived from conventional counterparts, does 

not the whole idea that you put forward of labeling send a mixed 

message? 

Ms. MAYNE. So, if we were to require mandatory labeling, that 

would be a different interpretation. As I indicated previously, there 

is no basis for us to require labeling based upon a material difference in the products, and federal courts have upheld that position. We recognize consumers want to know this information, and 

that is why FDA has issued guidance on voluntary labeling procedures for industry. So, mandatory labeling also has some enforcement challenges, and so it is not grounded in science or in the basis 

of our authority to require mandatory labeling. 

Senator THUNE. I would like to continue that line of questioning, 

Mr. Chairman. My time has expired, so I will perhaps get it on another round or submit some questions for the record. 

Chairman ROBERTS. The Chair would inform the distinguished 

Senator that he will be granted any time after the members 

present have their questions. You have flown at 2,000 feet. We 

have been flying at 30,000 feet, so, obviously, those are some very 

pertinent questions. 

Let us recognize the former distinguished Chairman of the committee, Senator Leahy, who I am sure has very interesting questions. Senator Leahy. 

Senator LEAHY. I have just been fascinated by all the questions 

already asked. Mr. Chairman, and Ranking Member Stabenow, I 

appreciate you holding this hearing, bringing together a diverse 

panel of witnesses. As I have mentioned to you both, I have to go 

off to another scheduled event and so I will not be able to stay 

much longer. 

I just wanted to, before I left, welcome a fellow Vermonter, Joanna Lidback of Barton, to the committee. She and her husband 

have worked very hard on this subject. We also had a chance to 

talk about the foliage in Vermont. That is a view off my front lawn. 

Senator STABENOW. Rub it in. 

[Laughter.] 

15 

Senator LEAHY. It probably is different in Kansas, but—— 

Chairman ROBERTS. Did you want to hold that up and—— 

Senator LEAHY. No, no, no. It would sound too much like bragging and we never do that in Vermont even though we have the 

best—— 

Chairman ROBERTS. I cannot see anything for the trees. 

Senator LEAHY. We do not brag about it, because even though we 

do have the best foliage in the world, but—— 

[Laughter.] 

Senator LEAHY. —but we will not brag. I know that—Joanna, I 

do appreciate the amount of time you spent talking to my staff and 

others. I know you are going to bring a unique perspective on biotechnology to the hearing. I also note that she, like other farmers 

in Vermont and throughout our country, take great pride in providing safe, nutritious food for all of us, and this is a complicated 

issue. I hope we are going to hear from even more witnesses, to reflect the broad scope of issues at play. 

Mr. Gregoire, you mentioned in your testimony that the USDA 

regulates GE crops under its plant pest authority provided by the 

Plant Protection Act, but the Plant Protection Act, when it was 

considered by Congress back in 2000, did not include any language 

relevant to GE crops. In the legislative record, I have gone back, 

I do not see anything in it that says Congress intended to address 

GE crops. So, it is a kind of narrow hook, suggesting the remote 

possibility that GE crops could become a plant pest. We have many 

new GE crops that are not made using plant pests in their development, so they fall outside USDA’s regulatory authority. Will the 

proposed rule on risk-based regulation address this, or are we trying to put a square peg in a round hole? 

Mr. GREGOIRE. Thank you, Senator, for that question. You are 

correct that the Plant Protection Act does not specifically address 

biotechnology or genetically engineered crops, nor does it define 

any plant breeding methodology per se. What that Act provides the 

Secretary is very broad authority to prevent the introduction and 

dissemination of plant pests and noxious weeds in the U.S. to protect the health of our agriculture industry. That is really the focus 

of the mission of our agency, and it is through this lens that we 

look at the products of biotechnology as we would look at any other 

organism that might present a plant pest—— 

Senator LEAHY. The reason I get this, we seem to have conflicting agencies. Those who oppose the labeling and regulations 

often point to the FDA’s policy statement from 1992 that GE foods 

can be marketed without labeling because they are not materially 

different from other foods. But that is in sharp contrast to the U.S. 

Patent and Trademark Office, which holds that GE foods are novel 

for patent purposes. 

So, I ask both Dr. Mayne and Mr. Gregoire, is it defensible to 

maintain that GE foods are not materially different from other 

foods when the U.S. PTO recognizes them as a novel invention? 

Help a layman out here. I am new to all this kind of thing—— 

Mr. GREGOIRE. Well—— 

Senator LEAHY. —after 40 years. 

Mr. GREGOIRE. So, some of the things that we look at in our reviews for a new GE crop are: does the trait that has been put into 

16 

this plant cause disease or damage to other plants or plant products? Does the trait make the plant more weedy? Things of that nature. Again, what we are trying to get at is not so much how it was 

transformed, but if the product of the technology has potential to 

cause physical damage or harm to other agriculture, and what we 

have found in every one of the 117 deregulations that we have 

done, is that those plants are essentially no different in those regards than their conventional counterparts. 

Senator LEAHY. Dr. Mayne, what do you have to say about the 

U.S. PTO? 

Ms. MAYNE. Again, from the materiality difference, we look to 

see whether these foods are any different from their conventional 

counterparts with regard to issues of food safety and nutrition. So, 

we do not look at the production method. That is not what we consider in the materiality. What we look at is the food itself and are 

the characteristics of the food itself materially different from the 

conventional counterparts. As a class, we have concluded that they 

are not materially different. 

If they were, if there were a material difference, then we would 

want that labeled. So, for example, if there was a different nutritional content, we would indicate that, for example, high oleic acid 

soybean. 

Senator LEAHY. Thank you. 

Thank you, Mr. Chairman, and I would ask consent to submit 

some questions for the record. 

Chairman ROBERTS. Without objection. I would offer only the 

comment that every member is certainly free to put a picture of 

their state on the front of their briefing book, but comments therein will be limited to raising them on high and mentioning them for 

ten seconds. 

[Laughter.] 

Chairman ROBERTS. I would also offer the opinion that neither 

one of us should be talking about foliage. 

[Laughter.] 

Senator LEAHY. I think we are referring to a different type. 

Chairman ROBERTS. Yes. 

[Laughter.] 

Chairman ROBERTS. Senator Boozman. 

Senator BOOZMAN. Thank you, Mr. Chairman, and I thank the 

panel for being here. We appreciate all that you all do to ensure 

that our food is safe. 

Chairman ROBERTS. Yes. 

Senator BOOZMAN. Again, thank you to the Chairman and Ranking Member for having this very, very important hearing. 

Mr. Jordan, all of you have—well, first of all, all of you have stated that the biotech crops are safe, and Mr. Jordan, in your testimony, you mention that PIPs have had positive impacts in the environment and that they are safer than conventional pesticide. Can 

you elaborate on the benefits you have seen from PIPs? 

Mr. JORDAN. Certainly. First and foremost, farmers are adopting 

the PIP technology because it works. It is effective at controlling 

the pests. So it meets their needs. 

Secondly, PIPs, the ones that we have reviewed and that have 

been so widely adopted, use a genetic material from a bacterium 

17 

called Bacillus thuringiensis. It is a common soil microbe that actually has been adapted to use in the organic program, and it produces a protein that is harmful to the insects that eat corn or soybeans or other crops, and it kills those insects but it has virtually 

no effect on any other species. So, it is safer than conventional 

broad spectrum pesticides, chemical pesticides that not only affect 

the target insect, but also other insects and sometimes other species in humans, as well. By using PIP plants, there has been less 

use of those conventional pesticides and that means less pesticide 

residues in our food and our water, less exposure for workers and 

wildlife. 

Senator BOOZMAN. Thank you, Mr. Jordan. 

Dr. Mayne, I have heard from folks asking about the FDA’s premarket consultation process. To me, it would seem to be in the developer’s interest to consult with the FDA both for safety and trade 

reasons. Can you walk us through the FDA pre-market consultation process. 

Ms. MAYNE. Certainly. So, the way the process works is we encourage the plant developers to come in to us early in the process, 

in part because we can help to identify the types of data that might 

be needed to review the safety of that process. So, it is a voluntary 

consultation process. They can come to us multiple times to get the 

package of data information together that they would submit to the 

agency and then we would review that evidence for safety. 

Senator BOOZMAN. So, you have got confidence in the process. 

Ms. MAYNE. We do have confidence in the process. 

Senator BOOZMAN. How long does it take? 

Ms. MAYNE. So, the time is variable, depending upon, like, when 

do we start the clock when they first come to us. But once the 

package is together and once they have submitted that information 

to us, generally, it takes between one and two years to complete 

the final consultation. 

Senator BOOZMAN. Yes. Has any developer of a biotech plant ever 

not followed your pre-market consultation process? 

Ms. MAYNE. In terms of our consultation process, we are not 

aware of anyone that has not gone through the consultation process 

that has then commercialized a product into the U.S. market. 

Senator BOOZMAN. How does the regulatory scrutiny that biotech 

crops undergo compare to the regulatory process for other food ingredients? 

Ms. MAYNE. Again, we use the same safety standards, the same 

legal standards for conventional as well as for food produced 

through genetic engineering. 

Senator BOOZMAN. Mr. Gregoire, does the USDA have full authority to regulate any plant in the U.S. if it is shown to be a pest, 

even if it is a biotech crop? 

Mr. GREGOIRE. Yes, Senator. The Plant Protection Act gives the 

Secretary very broad authority to take measures to control, prevent, mitigate the introduction or dissemination of plant pests in 

the U.S. So, regardless of how that may have been created, we do 

have that authority and that ability. 

Senator BOOZMAN. Very good. Thank you, Mr. Chairman. Thanks 

to the panel. So far, your information has been very, very helpful. 

We appreciate you coming. 

18 

Chairman ROBERTS. I thank the Senator, very pertinent questions. 

Senator Heitkamp. 

Senator HEITKAMP. Thank you, Mr. Chairman. 

I am going to take this in a little different direction because I 

do not think there is anyone on this committee who has not reviewed the science and who does not believe everything that you 

are saying. This is not a new issue. During the 1990s, I served on 

something called Trade and the Environment Policy Advisory Committee for the USTR where European labeling of genetically engineered foods was starting to surface as an issue in terms of a trade 

barrier. We know that there has been a growing and brewing controversy around this kind of technology, for good or bad. 

You take a look at the fight that we are fighting right now on 

vaccines, the fight that we are fighting on pasteurized milk. You 

can go down the list. All these technologies that have really helped 

create more food, helped keep our food safe and are being challenged all the time. 

I have a question that goes to maybe not the regulatory scheme, 

but goes to why it is that we have this controversy given the unanimous consent of all of the regulatory agencies that these products 

are safe. What is it that we are not doing in terms of making the 

information that you provide more accessible to the average consumer so that they understand? We are up against a huge social 

media network where things get said that should be challenged, 

but yet we do not seem to find the way to challenge them. 

My question for all of you is how can you make the information 

that you utilize to make these determinations more accessible to 

the American public in a way that they understand and that they 

have confidence in the work that you have done. We would start 

with the FDA. 

Ms. MAYNE. So, that is a challenging question. It is a communications issue, and we do work with a very talented communications team every time we have new information that we put out 

onto the market. I have only been at the agency for nine months, 

but I can tell you, for example, we recently finished a consultation 

process on two new genetically engineered products. One was an 

Arctic apple. The other was a potato. We put the information out 

in the media, and to my surprise, we did not have much media attention. 

So, I am thinking that the times are changing and perhaps we 

are getting more embracing of the genetic engineering and the 

technology and how it can be used. But, it is really a communications challenge and we need to go to our most trusted communicators to communicate that to our public. 

Senator HEITKAMP. Dr. Mayne, if it were getting more acceptable 

we would not be in this room with a room full of people. 

Ms. MAYNE. Yes. 

Senator HEITKAMP. I think that is pretty clear. There is something about what we are not communicating in terms of the science 

that is not getting through. 

Mr. Jordan, can you offer any comments? 

Mr. JORDAN. I will try. It is a very challenging issue, and I think 

the general decline in confidence in all parts of government plays 

19 

a role in this. For what it is worth, we at EPA believe that doing 

our work transparently, making available all of the information, all 

of our analysis that underlies our decisions, seeking outside experts 

who do not have government affiliations to weigh in on difficult 

issues is the way that we as government can demonstrate that we 

are doing a responsible, effective job of making decisions. 

Senator HEITKAMP. Except what people hear is ‘‘blah, blah, blah, 

blah, blah.’’ 

Mr. JORDAN. I know that. 

Senator HEITKAMP. I think that is a serious problem as it relates 

to what we are trying to do, because we are talking about how do 

we provide consumer information, information consumers want, 

versus what consumers need. That really is what we are talking 

about here, and I believe the science is so strong in this area that 

these are products that will not have an adverse effect in any way 

on health, in fact, can improve health by making it more accessible 

worldwide, food products worldwide. But, yet, we seem to be losing, 

I think, the fight, not just on labeling, but losing the fight on how 

we are going to make these products more acceptable. 

I think, Mr. Gregoire, maybe you can offer some comments, as 

well. 

Mr. GREGOIRE. Yes. Thank you. It is certainly very, very challenging to explain to the public very complex scientific issues. Some 

of the things that we do, all of the analyses that we do are made 

available to the public. Any regulatory decisions we make, we call 

attention to those decisions either with a press release or an e-mail 

to our stakeholders to let them know the decisions that we have 

made and how we have made those. We do have an annual stakeholder meeting where members of the public can—— 

Senator HEITKAMP. I am out of time. I just want to make one 

final point, if I can. The data that you are presenting and the information you are presenting is not presented in a way that is accessible to the public. It is easier to say this is bad than explain why 

this is good, especially when the technology is so elevated. I would 

really challenge all of you to think about how you discuss your 

findings with the public so that we can advance this beyond regulation and all the discussion but actually have a conversation with 

consumers. 

Senator BOOZMAN. [Presiding.] Senator Hoeven. 

Senator HOEVEN. Thank you, Mr. Chairman. 

The availability, the affordability, and the quality of our food, 

though often taken for granted, is a linchpin of every American’s 

personal security. There is a tremendous amount of interest in 

what is in our food and how it is produced and, specifically, genetically engineered plants and the food that is produced them. 

I want to thank Chairman Roberts for holding this hearing because I do think it is important for the American public to understand what is being done to ensure the safety of the food that 

Americans eat. I also think it is important to hear about how fundamental biotech ag products are to our ability as a nation to provide for our food security. 

I have been working with our Chairman, Chairman Roberts, and 

with the Ranking Member, Senator Stabenow, on putting together 

bipartisan consensus legislation to address the issue of labeling of 

20 

food made with genetically engineered, or GMO, products. I have 

had a lot of good conversation with my colleagues on both sides of 

the aisle and I am hoping that today’s hearing can further those 

discussions. 

So, with that in mind, my first question for each of you is, from 

a scientific perspective, is there anything that makes genetically 

engineered crops less safe for humans or the environment than traditional plant breeding techniques, such as cross-breeding? Mr. 

Gregoire, if you would start. 

Mr. GREGOIRE. Yes. We have not found that to be the case with 

any of the products that have gone through our regulatory system, 

and we have confidence in the safety of the GE plants that we have 

approved. 

Senator HOEVEN. Mr. Jordan. 

Mr. JORDAN. For EPA, the products that we have looked at are 

safe. They pose no greater risks than the conventional crops that 

are not genetically engineered. 

Senator HOEVEN. Dr. Mayne. 

Ms. MAYNE. Similarly, the products that have been through our 

consultation process, we have determined are as safe as the conventional counterparts. 

Senator HOEVEN. A second question would be how can your agencies better communicate the safety of products that you have vetted? How can you better communicate? Mr. Gregoire. 

Mr. GREGOIRE. I mentioned some of the things we do, and that 

is to be transparent in our decision making and share the analyses 

that inform the regulatory decisions that we make. I think the undertaking that is the review of the Coordinated Framework will 

help with this, as well, because one of the objectives there is to 

make the system more clear, transparent, and understandable for 

both the public and for developers. 

Senator HOEVEN. Mr. Jordan. 

Mr. JORDAN. We at EPA are doing many of the same things that 

Mr. Gregoire mentioned, making our decisions and the basis for 

them public, giving the public lots of opportunities to engage us if 

they either do not understand or disagree, and we always respond 

to the comments. We will use the Coordinated Framework to revisit our activities and see if we can do a better job. 

Senator HOEVEN. Dr. Mayne. 

Ms. MAYNE. I would say the same, that as part of the Coordinated Framework, we should make it a deliverable to try to figure 

out how we can better enhance communication around this complicated topic. Having the involvement of external review from the 

National Academies may be helpful to us in that regard. 

Senator HOEVEN. What recommendations would you have, if any, 

for food labeling in regard to GMOs? Mr. Gregoire. 

Mr. GREGOIRE. So, the labeling belongs with our colleagues in 

the Food and Drug Administration. We do recognize that having a 

multitude of disparate laws and statutes among the different states 

and local governments can be confusing to consumers, and developers and food companies and the USDA wants to be helpful in 

this process. 

Senator HOEVEN. Mr. Jordan. 

21 

Mr. JORDAN. EPA has no authority or responsibility for food labeling and our agency has not taken a position on that issue. 

Senator HOEVEN. Dr. Mayne. 

Ms. MAYNE. From an FDA perspective, our goal is to make sure 

that the labeling is truthful and not misleading, and that is our 

goal. As we indicated previously, we have issued voluntary guidance as to how manufacturers can label their foods with regard to 

either the presence or absence of ingredients from genetically engineered products. 

Senator HOEVEN. Do you have any other recommendations? 

Ms. MAYNE. Truthful and not misleading. 

Senator HOEVEN. Okay. Thank you. 

Thank you, Mr. Chairman. 

Chairman ROBERTS. [Presiding.] Senator Bennet. 

Senator BENNET. Thank you, Mr. Chairman. Thank you for holding this important hearing, and it is good to try to establish a 

shared understanding of the facts, and I think that is a very important place to start. For all the reasons Senator Thune said, this has 

been very important to the West and to Colorado, to increase the 

yields of some of our most important crops like corn and sugar 

beets. 

This is for you, Mr. Gregoire. However, I have heard concerns 

that biotech crops can sometimes accidentally mix with non-GMO 

crops in neighboring fields. This includes organics, which consumers expect to meet very specific standards. How is APHIS 

working to avoid contamination—working with our farmers to 

avoid contamination of non-GMO crops and develop best practices 

for growing all types of crops? 

Mr. GREGOIRE. Thank you for that question, Senator. So, there 

are two aspects of this. While GE crops are under regulation, and 

in field trials our regulations are designed to keep them confined 

and so that this problem does not occur, I think the greater issue 

is once we have deregulated and the products have become commercialized that we see these issues of gene drift and so on. 

The Secretary has recognized this is an important issue for our 

stakeholders. Our policy in USDA is that we support all forms of 

agricultural production, be it conventional, biotech, or GE. That 

should be the farmers’ choice with what they grow. 

Given that, the Secretary and the Department have undertaken 

a number of measures, working with stakeholders to identify ways 

that we can strengthen coexistence among the different agricultural production systems. APHIS and other USDA agencies have 

been part of that effort, and so we have announced things in 

USDA, like additional research to prevent gene flow, for example, 

looking at crop insurance programs, looking at best management 

practices that we can share with producers to mitigate these kinds 

of issues. So, it is not just APHIS, but the Secretary is using the 

resources throughout USDA to address this issue. 

Senator BENNET. How big a risk do you think it currently is? Is 

it a risk that is growing, and are the recommendations that you are 

making actually getting out to the country, or is this still internal 

in the bureaucracy of the agency? 

Mr. GREGOIRE. No, much of this has already been shared. We are 

still in discussions with stakeholders about additional measures 

22 

that the Department can take to strengthen coexistence. There are 

a lot of measures that the industry has undertaken themselves to 

deal with these issues, as well. 

Senator BENNET. Dr. Mayne, every year, as you have testified 

here, more GMOs successfully move through the FDA’s food safety 

review process. While the studies that have been cited today have 

concluded that GMOs are safe, some of my constituents have concerns about the changing landscape of biotechnology, evolution of 

biotechnology, especially when the FDA does not conduct its own 

tests of the GMO foods. In your view, are the current practices for 

evaluating GMO foods at the FDA keeping pace with innovation in 

biotechnology, and how are you thinking about that coming challenge? 

Ms. MAYNE. So, I would say, at this point, yes, we are keeping 

pace with changes in biotechnology, and one of the things we will 

be looking at as part of the Coordinated Framework is more horizon scanning. What do we need to do in the future, and what types 

of challenges might we anticipate coming at us in the future and 

how do we best prepare to deal with those challenges. So, that will 

be one of the things we will be looking at. 

Senator BENNET. I am just—as you—what was that term you 

used, horizon scanning? 

Ms. MAYNE. Horizon scanning, yes. 

Senator BENNET. So, as you think about the coordination the 

White House has asked you to do, maybe I will close just by asking 

each of you what you think that interagency work—what kind of 

horizon scanning that is going to make possible beyond the question that I just asked Dr. Mayne. What are some things that are 

going to be at the forefront of the discussion you have? 

Mr. JORDAN. Senator, I think that there are a couple of things 

that have already begun. First and most important is conversations 

between the regulatory agencies—FDA, USDA, and EPA—and 

parts of the executive branch engaged in research that includes 

work with new breeding technologies. As the researchers discover 

what they can get done, knowing about that as a regulator is helpful to us because it helps us both prepare for eventual commercial 

products and also give feedback to the researchers if there is an 

issue that they might encounter once those products become subject to the regulatory process. 

Senator BENNET. Thank you, Mr. Chairman. 

Chairman ROBERTS. Senator Ernst, and Senator, I understand 

that Iowa Public Television is covering this event, and I know that 

you will be at your best. 

Senator ERNST. It is wonderful. Thank you very much, Mr. 

Chair. I appreciate that. 

Well, thank you, folks, for joining us here today in this committee hearing. I just came from the Armed Services Committee, 

and, of course, we focus very much on national security, and Senator, I believe you mentioned national security and food security in 

your opening statement, so, thank you for doing that. 

The Director of National Intelligence, DNI, released a report last 

week pointing out the national security threats posed by global 

food insecurity. If we fail to embrace biotechnology as a safe, affordable, and timely way to bring better food production methods 

23 

to developing and unstable nations, we are ultimately putting our 

military and our country at greater risk. How can this administration and your agency specifically work to help the public better understand the science supporting biotechnology so we can better address the national security challenges laid out by DNI? I would 

open that up to our entire first panel. 

Mr. GREGOIRE. Well, I have mentioned some things that we are 

already doing in terms of being transparent in our decision making, 

and the Coordinated Framework review that we have undertaken 

is, at least in part, designed to get at this issue. Beyond that, I 

think we just need to really redouble our efforts to communicate 

better about our processes and the science behind them. 

Senator ERNST. Thank you. 

Mr. JORDAN. Government needs to speak clearly, to answer questions responsibly, to lay out fully all of the information that we 

have, and I hope and expect that anyone who gives that fair consideration will conclude, as we have, that our decisions are protecting 

public health, the environment, and the food is safe. 

Senator ERNST. Okay. Thank you, Mr. Jordan. 

Dr. Mayne. 

Ms. MAYNE. I would say just to continue to educate as best we 

can, using plain language techniques as best we can to communicate what the science really indicates with regard to the processes and how we review these commodities for safety. 

Senator ERNST. Well, I appreciate that. I do think that—and 

many of us use this phrase in our own home communities, but— 

since many of us are from agricultural areas, but we do feed and 

fuel the world, and I do believe that that is very important to 

maintain stability around the globe and making sure that populations are fed. So, I appreciate your answers today. But, it is 

something that we need to continue working on. I believe that 

GMOs are safe. I believe we should have them available to the 

globe, so thank you very much. We appreciate it. 

Chairman ROBERTS. Senator Klobuchar. 

Senator KLOBUCHAR. I think I am going to defer to Senator 

Casey. He has another commitment. Then I will go after that. 

Chairman ROBERTS. Senator Klobuchar has yielded to Senator 

Casey. Senator Casey is recognized. 

Senator CASEY. I want to thank Senator Klobuchar, and I will be 

brief, so whatever time I have used, I will double that and give it 

back to her on another day. 

[Laughter.] 

Senator CASEY. So, thanks very much, and I will be brief, Mr. 

Chairman. I have to run, and we are all going in different directions for hearings and meetings. So, I will only pose one question. 

It will be for the whole panel. 

But, let’s start by talking about a number which I think stares 

a lot of us in the face. Some of us had mentioned, as Senator Ernst 

did, national security. Here is a number which I think—I will call 

it the 34 percent/70 percent number. According to the Food and Agriculture Organization of the United Nations in an October 2009 

paper entitled, ‘‘How to Feed the World in 2050,’’ they conclude 

that by 2050, the world’s population will reach 9.1 billion, which 

is 34 percent higher than today. That is the 34 percent number. In 

24 

order to feed this larger population, food production must increase 

by 70 percent. So, if those numbers are correct, we have a major 

challenge we confront. 

So, I guess, one of the basic questions I would ask is in light of 

the fact that all three of you represent part of the executive branch, 

and of July of this year, the Executive Office of the President 

issued a memorandum, as others have referred to, directing three 

organizations which have the primary regulatory responsibility for 

this area, meaning biotechnology. The Executive Order asked that 

an update of the Coordinated Framework for the Regulation of Biotechnology be undertaken. 

I would ask you, in succession, and maybe we can start left to 

right, what is the current status of this work, and are there areas 

where both—or, I should say, all three, APHIS, EPA, and FDA, can 

increase collaboration? Maybe we will start on my left. I am sorry. 

We will start with APHIS. 

Mr. GREGOIRE. Yes. Well, the review has just gotten underway 

and there are three focus areas. One is to clarify the roles and the 

responsibilities of the respective agencies. The second is to take a 

strategic look at how we can prepare for the future products of biotechnology. The third is to get an outside expert study of the future 

landscape of the products of biotechnology. 

So, there is work that has gotten underway in each of those three 

areas. APHIS is cooperating fully. We have put some of our best 

scientific staff on this work. FDA is hosting a public meeting later 

this month. APHIS anticipates hosting one of the future meetings 

after this first one. 

Senator CASEY. Okay. Mr. Jordan. 

Mr. JORDAN. There will be three public meetings, and EPA gets 

the third one, so that each of us will actively reach out to stakeholder communities and draw them into this conversation about 

how to improve coordination, improve clarity and transparency. 

One thing that the July memorandum accomplished that no one 

has spoken to yet is the creation of a formal coordination mechanism, a committee, and it is a mouthful. It is the Emerging Technology Interagency Policy Coordination Committee. But, it gives us 

a formal opportunity, a regularly scheduled place to bring our 

issues together and talk about them. We already do have such conversations among our staffs at FDA and USDA and EPA, but making this more formal, I think, will be a good thing. 

Senator CASEY. Thank you. 

Doctor, if you could limit it to 30 seconds. Sorry about that. 

Ms. MAYNE. Well, I echo what they said. We are putting together 

formal mechanisms to get together on a regular basis, which had 

already been happening, but now we have a clear mandate on 

tasks that we should be thinking about. As you heard, FDA is preparing for a public meeting which will be held October 30. So, we 

are engaged in a process to get public comment on things that we 

should be considering as the three key agencies responsible here. 

Senator CASEY. That is great. Thanks for being so brief. 

Mr. Chairman, before I relinquish the microphone, on the second 

panel that I may or may not be back for, I want to make sure that 

I highlight one of our witnesses, do a quick bio here for Mr. Daryl 

Thomas. He is a Pennsylvanian, of course, He started his career at 

25 

Herr Foods as a salesperson. He served in both the Navy and the 

Army National Guard. His first job, I believe, at Herr’s was to 

manage their quality assurance program. After getting a Bachelor’s 

degree, he got a Master’s of Science degree in food marketing from 

St. Joe’s, a great university where my daughter attended some 

years after Daryl did. 

Daryl serves now as Herr’s Senior Vice President of Sales and 

Marketing. He is married to his wife, Martha. They have three 

sons, Daryl, Jeremiah, and Hans, and Hans, I am told, is married 

to Daryl’s daughter-in-law Emily. They reside in Southern Lancaster County. 

Thank you for letting me introduce him quickly. Not bad. 

Chairman ROBERTS. Well, thank you, Senator Casey. That means 

that I will not have to read that again. 

[Laughter.] 

Chairman ROBERTS. But I will if you want me to. 

Senator CASEY. I will come back and read it if I can. 

Chairman ROBERTS. All right, that is fine. Thank you so much. 

Senator Tillis. 

Senator TILLIS. Thank you, Mr. Chair. I want to thank all of the 

panelists for being here. 

I know that this question may have been asked in a different 

way, but I tell you, back in North Carolina, there are a lot of misconceptions about biotechnology and the safety of the food supply. 

So, if you are sitting at a diner or a barbecue joint in North Carolina and somebody asks you a question about biotechnology-driven 

breeding techniques versus other ones, what would you tell them? 

Are they any more or less safe? I will start down the line with Ms. 

Mayne. 

Ms. MAYNE. As I have said, they are as safe. It is—— 

Senator TILLIS. As safe. 

Ms. MAYNE. It is a different way to accomplish incorporating desirable genes into plants. 

Senator TILLIS. But, in your opinion, there is no science to suggest that they are any less safe? 

Ms. MAYNE. That is our opinion, any less safe than their conventional counterparts. 

Senator TILLIS. Mr. Jordan, what would you tell the person at 

that diner table? 

Ms. MAYNE. Senator, I would say we have looked at these products six weeks to Wednesday and we are convinced, and so, too, are 

outside experts, that these things are safe. 

Senator TILLIS. Mr. Gregoire. 

Mr. GREGOIRE. I would just emphasize the very thorough review 

that they get by the U.S. Government agencies before they are 

commercialized. 

Senator TILLIS. So, we have senior people from three very important agencies, FDA, EPA, and USDA, all saying that the science 

suggests this is safe and that while we always want to scan the horizon, as Ms. Mayne said, till it for any other potential threats, 

there is no evidence to suggest that the crops that we have in the 

field today, the techniques that we are using for breeding, are in 

any way unsafe and a threat to our food supply. 

26 

I have another question. This may be an unfair question for you, 

Mr. Gregoire, but I do want to get it out there so that we can research it. Let us say we roll back the clocks. Some believe that all 

of these techniques are bad and that we should basically eliminate 

them. Has there been any research done to determine what that 

would look like in terms of the impact on our production or our 

food supply today? So, roll back the clock. Get rid of all the gains 

that we have made in terms of agriculture output. Let’s go back to 

a pre-biotech era to get some idea of what that would really mean 

to our food supply. 

I know, for example, in Iowa, about 95 percent of the corn grown 

there is a product of biotechnology. If we really look back—I think 

that there are really some who would think that would be a good 

idea—I am just trying to get an idea of how that would affect us. 

Mr. GREGOIRE. I do not know if that question has been put to us 

in that particular way. I can tell you, though, that biotech crops 

have been widely adopted by producers in the U.S. Upwards of 90 

percent now of corn, cotton, soybeans, and sugar beets are now genetically engineered. So, had that not been the case—I think we 

probably have some reports and statistics that we might be able to 

share with the committee from the Economic Research Service in 

USDA that might be helpful to provide for the record. 

Senator TILLIS. I guess there are some that say the baseline regulations our agencies are using to oversee biotech and breeding 

techniques have not really been updated since the 1980s. Are they 

broken and do we need to fix them, or are they sufficient for you 

all to do your respective jobs? Dr. Mayne, we will start with you. 

Ms. MAYNE. I feel they are sufficient for us to do our current 

jobs. 

Senator TILLIS. Mr. Jordan. 

Mr. JORDAN. EPA administers two laws. We think they work 

very well. 

Senator TILLIS. Mr. Gregoire. 

Mr. GREGOIRE. I believe that our regulatory system in APHIS 

has served the country very well in terms of protecting plant 

health. We are pursuing updating our regulations so that we are 

in a good position in the future, going forward. We have got many 

years of experience now. We would like to apply the lessons learned 

over these many years of regulation and also, account for the new 

science and the technology. 

Senator TILLIS. Well, the flip side of that question would be, if 

it does not look like we need any more or new regulations or processes put into place, what, in your opinion, could we do based on 

our knowledge of the science to stream for regulators? There was 

a lot less certainty in the 1980s than there is today based on the 

science that has been developed over that period of time. Are there 

things that we could do to actually ease the regulatory burden and 

potentially make the processes that people have to go through for 

approval more efficient, less burdensome, and more likely that we 

are increasing productivity and producing better outcomes for agriculture? 

Mr. GREGOIRE. Two points on that, Senator. One is that we have 

made a real effort in APHIS over the last three years to improve 

the timeliness of our regulatory decisions. We appreciate that ConVerDate Nov 24 2008 16:19 May 17, 2016 Jkt 000000 PO 00000 Frm 00030 Fmt 6633 Sfmt 6633 C:\USERS\MW42035\DESKTOP\DOCS\98991.TXT MICAH
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gress has provided additional resources for our program to do that. 

We have pretty much eliminated the backlog in petitions that we 

are dealing with and we have reduced the time frame that had gotten up to more than three years, on average, down to about 18 

months, and I think we can get it down to about 15 months. 

As we start talking about a new regulatory system, or an updated regulatory system, those are the kind of questions that we 

will be looking at and talking to stakeholders about, as well. 

Senator TILLIS. Thank you, and thank you, Mr. Chair. 

Chairman ROBERTS. Senator Tillis, are you not going to ask Mr. 

Jordan the same question? I mean, he does come from the EPA. 

Senator TILLIS. Well, I just wanted to make sure that the Marine 

Chairman would be okay for me going into overtime, but I would 

like to ask that question of Mr. Jordan and Dr. Mayne, if I may. 

Chairman ROBERTS. I am very interested in their response. 

Senator TILLIS. Thank you. 

Mr. JORDAN. Thank you, Senator. Congress has passed an 

amendment to the Federal Insecticide, Fungicide, and Rodenticide 

Act referred to as the Pesticide Registration Improvement Act, 

PRIA. Everything has an acronym. It sets deadlines for EPA to review and make decisions on applications for all sorts of pesticides, 

including PIPs. Our deadline for PIPs varies, depending on the 

type of product, from 12 to 18 months, and it provides us resources 

to do that. That is on the same timeline as USDA’s reviews are 

now taking place and the FDA reviews. So, we are able to align our 

review schedules with those of other agencies, share information, 

and that is an efficiency for the companies as well as for the agencies. 

Ms. MAYNE. Just quickly, I would say that from an FDA perspective, the fact that our process is voluntary but has worked very 

well is an efficient way for us to enforce the Act. 

Senator TILLIS. Thank you, Mr. Chair. 

Chairman ROBERTS. Senator Klobuchar will be recognized next, 

but Mr. Jordan, the Department of Labor is in the business now 

of issuing regulations on the pesticide application process to many 

farmers and ranchers and that has caused quite a fuss. Are you 

working with the Department of Labor folks? I am very hopeful the 

answer is, yes, in a positive way, with the question raised by Senator Tillis on regulations that we feel are not necessary and are 

very burdensome. 

Mr. JORDAN. Senator, the Department of Labor and EPA do work 

together on safety when it comes to pesticide issues. Yes, we are 

looking for streamlined and streamlining regulatory processes and 

avoiding undue burdens. 

Chairman ROBERTS. Well, in that arm wrestling contest, I hope 

that you speak up loud and clear. 

Dr. Mayne, do you have any comment about that? 

Ms. MAYNE. No specific comment on that. 

Chairman ROBERTS. Senator Klobuchar. 

Senator KLOBUCHAR. Thank you very much, Mr. Chairman. 

Dr. Mayne, you just mentioned the FDA pre-market approval 

process and the voluntary process. Do you think there is anything—as we look at—and I know a lot of the White House effort 

on coordinating and making sure things are not falling through the 

28 

cracks is about safety, but it is about consumer confidence, as well. 

Do you think there should be any statutory changes to that process 

or do you think it works? 

Ms. MAYNE. I mean, as I indicated, it is a voluntary process. We 

do believe it has worked well. We are unaware of any product that 

has come into the U.S. market, been commercialized, that has not 

gone through the voluntary process. There are many incentives for 

a developer to go through the process. So, our experience is that 

it has been working well. 

Senator KLOBUCHAR. Okay. Senator Casey asked all of you about 

the Coordinated Framework among the agencies that are represented here today, and you answered the process questions about 

what was happening. Are there any preliminary results that have 

come out of that which you could share with us? Mr. Gregoire. 

Mr. GREGOIRE. You are referring to the coordinated review? 

Senator KLOBUCHAR. Yes. 

Mr. GREGOIRE. No, it has really just gotten underway—— 

Senator KLOBUCHAR. Yes. 

Mr. GREGOIRE. —so it is a little too early to say. 

Senator KLOBUCHAR. Okay. Do you know when we will have 

some preliminary results? 

Mr. JORDAN. The different agencies are pressing ahead quickly. 

As we mentioned, there is a public meeting on October 30. There 

is also a Federal Register notice inviting the public to comment 

both on how to update the Coordinated Framework and ideas for 

consideration as part of the long-range strategies that our three 

agencies are working on. We are aiming to pull that information 

together and have something fairly early next year, but it will 

probably be an updated version of the public—of the Coordinated 

Framework for public comment. 

Senator KLOBUCHAR. Okay. Mr. Gregoire, I know you were 

asked—all of you have been asked about the advances in biotech 

research in the last ten years and how your own processes have 

evolved with new products coming in. Since biotech crop varieties 

first became commercially available in the mid-1990s, APHIS has 

approved more than 14,000 field trials of plants, it is my understanding. How has your division evolved in order to handle the 

workload, and can you comment on some of the challenges you 

faced with the development of the new crops. 

Mr. GREGOIRE. Well, the program has certainly grown and Congress has increased the funding for our biotechnology regulatory 

services program rather substantially a few years ago. We feel like 

we have the resources we need to do the job, to provide the regulatory oversight and to make our decisions in a timely sort of a 

way. So, the workload and staffing has been a challenge, but I 

think we have met that challenge, and keeping up with the science, 

and our scientists, like the scientists from the other agencies, do 

a lot to keep abreast of the changes in plant breeding technology 

and so on. So, that is a very important sort of thing, too. 

Senator KLOBUCHAR. Okay. My state, as you know, is the nation’s fifth largest agriculture producing state, about 79,000 farms. 

I think you also know agriculture is cyclical in nature and producers face natural and market challenges. Your agency helps producers deploy farm management practices, which have been inVerDate Nov 24 2008 16:19 May 17, 2016 Jkt 000000 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 C:\USERS\MW42035\DESKTOP\DOCS\98991.TXT MICAH
29 

creasingly sophisticated over the years. Can you comment on if and 

how you have seen biotech develop in that context of farm management. 

Mr. GREGOIRE. Well, it is certainly a technology that has been 

widely adopted. Our role is not so much an extension kind of a role, 

working with individual producers on this. We review the products 

for the safety for plant health and that is generally the procedure 

that all the developers go through before it is widely commercialized. We have, as the Department and USDA, shared information on best practices for things like weed management and coexistence and so on. 

Senator KLOBUCHAR. All right. Thank you. 

Chairman ROBERTS. The Chair recognizes no stranger to the 

Iowa Public Television audience, the distinguished Senator, Senator Grassley. 

Senator GRASSLEY. Well, after a comment like that, I am going 

to have to thank you for holding this very, very, very important 

hearing. I think it is important that we do review regulation from 

time to time to ensure that our policies and regulations are functioning. 

Biotechnology holds great promise for agriculture, and as the 

population grows around the world, and it is going to continue to 

grow very dramatically, food security will become a more important 

issue for—and a very critical issue for people around the world. 

Biotechnology will help us continue to meet future requirements, 

and I was glad to read what Director Mayne said in her testimony. 

The science says that there is no difference between foods derived 

from plants that utilize biotechnology in foods. 

I also often run into this issue of safety or what consumers want 

to eat when European parliamentarians come around to our job, 

and you know how farmers around the country are. It is a very imprecise test of when a grain is ready to harvest, but sometimes you 

take a bean or a kernel of corn and put it between your teeth and 

see if it is ready to harvest. I always tell them I have been doing 

this for 20 years and I am alive. I am a living laboratory for the 

safety of biotechnology. 

[Laughter.] 

Senator GRASSLEY. I have one question of the panel, but I would 

like the three of you to do it. You may think I am asking this question that I expect you to know about the regulatory process in other 

countries. That is not what my question is about. It is about what 

other countries do, and it comes from the fact that China rejected 

several shipments of dried distiller grain because of an unapproved 

biotech trait that they said was present. This caused disruption in 

the grain trade that is still being sorted through by lawyers. 

From a scientific standpoint, I would like to have each of you tell 

me how sensitive is testing for GMO traits by other countries that 

they can find traces of GMO traits on a large ocean-going vessel. 

Mr. GREGOIRE. I do not know if I could put a number to it, Senator, other than to say there are very sensitive tests that are available to detect even trace amounts of a product in a large shipment. 

Senator GRASSLEY. Okay. 

Mr. GREGOIRE. We certainly recognize and are focused on the 

issues of trade with China. The Secretary has personally done a lot 

30 

in this realm. There was a recent bilateral between the U.S. and 

China. That was during President Xi’s visit. Both sides committed 

to further improving the biotech approval process and reaffirmed 

the importance of a timely, transparent, predictable, and sciencebased approval for biotech products. The Foreign Agricultural Service in USDA is very focused on these kinds of issues and APHIS 

plays a supporting role to them to try to address these issues and 

trade disruptions. 

Senator GRASSLEY. Mr. Jordan, will you respond, please, and 

then Dr. Mayne. 

Mr. JORDAN. Certainly. With regard to the sensitivity of analytical methods, my understanding is, like Mr. Gregoire’s, that the 

methods are very sensitive and capable of detecting very low level 

presence of genetically engineered traits in large shipments. I am 

sure many others are aware, we recognize that when we have approved something here in the United States and it then goes to a 

country where it is not approved, that which could be the source 

of trade problems. That is why we at EPA work with our colleagues 

at the Foreign Agricultural Service and USDA to provide information about our regulatory decisions to other governments. That is 

why we participate in international organizations to develop worldwide standards that would ensure consistent outcomes when different countries are looking at the same kinds of products. 

Senator GRASSLEY. Dr. Mayne. 

Ms. MAYNE. From a food safety point of view, I would say we do 

engage in a dialogue with other countries, including China. We 

similarly had a meeting with some of the high-level Chinese food 

safety experts just recently. 

The other thing I will reiterate is the food safety approaches we 

use are consistent with the CODEX international guidelines. So, 

we are adhering to international standards when we consider how 

we review the safety of these commodities. 

Senator GRASSLEY. Okay. Thank you, Mr. Chairman. 

Chairman ROBERTS. Thank you, Senator Grassley. 

Dr. Mayne, when you are working with China, are you getting 

the static that they are putting up about that one shipment? I hope 

it is just one, but it could be more. I understand the shipment was 

turned away in China, but it did sell the product to another country. So, that is an interesting thing. But, is this coming from your 

experience from the scientists involved that you work with, obviously, on a collaborative basis, or does this come from higher up? 

Where is the problem, as you see it? 

Ms. MAYNE. I do not—I cannot comment on the specific problem. 

What I can say is we are engaged in a dialogue with Chinese officials about how to assure food safety, and that is a commitment we 

have broadly, not just with genetically engineered foods. But, we 

work with Chinese officials to try to assure a safe food supply. 

Chairman ROBERTS. Tell them we have your back. 

Senator Brown. 

Senator BROWN. Thank you, Mr. Chairman. 

I would like to ask a question of the whole panel, and I guess 

I will start with USDA, if I could. If Congress were to task each 

of your agencies, USDA and EPA and FDA, to task each of your 

agencies with developing a label, whether voluntary or mandatory, 

31 

what are some of the factors you would look at to ensure a label 

that is truthful and not misleading? If you would, just give us your 

thoughts on that. 

Mr. GREGOIRE. Well, APHIS has really not had any involvement 

or experience with food labeling. That is in FDA’s realm. I will say, 

though, that we hear from stakeholders about concerns they have 

with the potential proliferation of different laws and statutes that 

might be coming out from the different states and local governments. We would be happy, if the committee is going to be looking 

at the House bill, to provide technical assistance on looking at that 

bill with our scientific people and attorneys in USDA. 

Senator BROWN. Mr. Jordan. Even though nor does EPA write 

the labels, but if you would give thoughts on the kind of input you 

would want to see result in a voluntary or mandatory label that is 

useful, not misleading, to consumers. 

Mr. JORDAN. That is an area that I have not personally worked 

on, nor has my agency. My sense is that public perception and understanding of different types of labeling would be an important 

consideration as to how they would take particular words and 

whether they would form an impression that was inconsistent with 

the reality, so whether it was misleading in FDA’s terms. 

There would be issues about definition of what is a genetically 

engineered ingredient. Would a product from livestock that fed on 

grain sources that were genetically engineered, would the livestock 

products be covered? Some definitions of what constitutes genetically engineered materials would also be an important consideration. 

Senator BROWN. Dr. Mayne. 

Ms. MAYNE. So, FDA issued draft guidance in 2001 on how companies could voluntarily label products. We have examples in that 

draft guidance. We received over 155,000 comments on that draft 

guidance. So, we have received public input on how to get voluntary labels out through this process and we are hoping to finalize the final guidance before the end of the year. 

Senator BROWN. Mr. Jordan, let me ask you a question, a bit unrelated. Farmers obviously face challenges in the field every year, 

expected, unexpected challenges. One challenge that has become 

concerning is weed and pest resistance. Does EPA consider weed 

and pest resistance during its risk analysis of FIFRA registered 

products, and how has consideration of resistance changed in the 

past three or four or several years? 

Mr. JORDAN. Thank you, Senator. EPA does consider pest resistance, both weed resistance and insect resistance, as we make our 

regulatory decisions about pesticides. Over the last several years, 

I would say that we have changed our position. In the past, we relied on the marketplace and farmers and education programs directed at farmers to encourage them to follow the kinds of behaviors that would prevent resistance from arising or would slow its 

spread. In certain cases, we recognize that it has not worked as 

well as we had hoped and wanted, and so we have begun to work 

with the companies that register pesticides to get them to play a 

greater role and to look at more effective ways of getting growers 

to adopt practices that address pest resistance. 

Senator BROWN. Thank you. Thank you, Mr. Chairman. 

32 

Chairman ROBERTS. Senator Gillibrand. 

Senator GILLIBRAND. Thank you, Mr. Chairman. I appreciate this 

hearing. 

Dr. Mayne, you said that you hope to issue the final guidance at 

the end of this year, is that correct? 

Ms. MAYNE. That is correct. 

Senator GILLIBRAND. Apart from the 150,000 comments you received, how is the FDA engaging with producers for this option? 

Ms. MAYNE. With the industry? 

Senator GILLIBRAND. Correct. 

Ms. MAYNE. We have consulted with industry. Industry also has 

the ability to submit comments into the docket on any proposed 

thing that we put out there. So, industry is part of the dialogue. 

Senator GILLIBRAND. Great. While all domestic producers who 

have brought GE crops to market have been through the voluntary 

FDA consultation process, I am not confident that this is always 

the case, particularly as foreign biotech companies expand. Has 

FDA worked with foreign companies that are interested in marketing their GE products in the U.S.? 

Ms. MAYNE. We have. In fact, some of the more recent approvals 

have come in for other countries. For example, the Arctic apple was 

a Canadian company that we have worked with, and we have 

worked with companies from other countries, as well. 

Senator GILLIBRAND. Do you think that the current FDA review 

process has sufficient time where we could continue to import a 

growing number of parts—a growing share of our food? What safeguards do you have in place so that you have an appropriate review process for GE products coming in? Do you have a way to scan 

the horizon and really do the oversight that you want to do? 

Ms. MAYNE. So, with imports, obviously, if we are aware of a developer that is making a—or working on a new application in another country, we would encourage them to come into our process. 

So, we work with Foreign Agricultural Service and others to be 

aware of crops that would be being developed overseas. 

But, the ultimate answer is that the importers have the same responsibility to assure that their foods are safe that are brought into 

the U.S. market as any other crop. So, we have our import authorities to ensure the safety of all foods, including any genetically engineered foods, coming from other countries. 

Senator GILLIBRAND. Mr. Gregoire, the USDA draws its authority 

to regulate GE products from the Plant Protection Act, which obviously is concerned with potential plant pests. While some older genetic engineering tools relied on plant pest bacteria and viruses to 

modify the DNA, many newer tools do not. Does APHIS have sufficient authority to regulate GE crops that are developed with the 

new engineering editing tools? 

Mr. GREGOIRE. Thank you, Senator. We do. We do have sufficient 

authority. I do not think there are any gaps in our ability to deal 

with risks to animal and plant health. The Plant Protection Act 

gives us a very, very broad authority in this area. Again, just as 

a core principle, the coordinated framework is the underpinning of 

our regulations; the focus is not so much on the method by which 

a plant is transformed but the product of the transformation and 

what risks that product might pose. 

33 

Senator GILLIBRAND. Can you explain whether a gene that is inserted into a plant with a gene gun is any more or less concern 

than one that is inserted by bacteria? 

Mr. GREGOIRE. No, it is not. It really, again, goes to what trait 

is being put in what organism and how that would be put into the 

environment. Those are the things that we would really be focused 

on looking at. 

Senator GILLIBRAND. Do you think you need any more refined 

authority to do that? 

Mr. GREGOIRE. I do not think we need any more statutory authority to do that. 

Senator GILLIBRAND. This question, I do not think because it is 

not your area of expertise, but I saw that the USDA announced a 

way for companies to receive a voluntary label from USDA certifying that their product is GE-free. For the record, if you do not 

know the answer, can you have someone describe the process to receive this label and how it differs from the organic label that is also 

provided by USDA. Also, what is the USDA doing to promote the 

new label and what effect do you think it will have on consumer 

choice? Are producers showing an interest in this new label? 

Mr. GREGOIRE. Those programs are run by the Agricultural Marketing Service. That is one of our sister agencies, and I think it 

would be best if we just responded to—— 

Senator GILLIBRAND. That would be great. 

Mr. GREGOIRE. —to that question for the record. 

Senator GILLIBRAND. That would be wonderful. 

Mr. GREGOIRE. Thank you. 

Senator GILLIBRAND. I just want to go back to Dr. Mayne for one 

second. At the end of your consultation process from producers, you 

issue a letter that says, no further questions, on your determination. How come you do not end that process with a letter that says 

your product is safe? 

Ms. MAYNE. So, the consultation process is a service that we provide to industry to help assure that they are meeting their compliance obligations to have a safe food. It is voluntary, and to date, 

it has worked well. 

Senator GILLIBRAND. But, you do not make an assessment or 

whether it is safe? 

Ms. MAYNE. Well, what we do is we consult on the safety. So, we 

consult as to whether or not we believe that anything has any antigenic or allergenic potential, any toxic potential. But it is ultimately industry’s responsibility to assure the safety of that product. So, we consult with them on this. 

Senator GILLIBRAND. Okay. So, you do not determine if it is safe. 

You just create a dialogue to make sure they are doing their job. 

Ms. MAYNE. Well, correct. We review the science. We review the 

data to make sure that we have no further questions about the 

safety. If we were to have to attest to that safety specifically, then 

that would shift some of that burden to FDA—— 

Senator GILLIBRAND. To you. 

Ms. MAYNE. —with obvious resource implications. 

Senator GILLIBRAND. Got it. Thank you. 

Thank you, Mr. Chairman. 

34 

Chairman ROBERTS. I think we now are going to move to the second panel. We thank the witnesses from the first panel. You have 

provided excellent testimony. You have shown a great deal of patience and we thank you very much. 

We would ask the second panel to come forth and be seated, 

please. 

[Pause.] 

Chairman ROBERTS. Welcome to our second panel of witnesses 

before the committee this morning. 

Joanna Lidback, a dairy producer from Vermont. Our foliage expert, Senator Leahy, introduced this witness. It is important for us 

to hear directly from farmers on the issue before the committee, 

and Joanna Lidback operates the Farm at Wheeler Mountain in 

Northeastern Vermont along with her husband, Adam. They milk 

Jerseys and Holsteins and manage a grass-based cropping and 

grazing program and run a Jersey beef direct sales business. Mrs. 

Lidback also works as a business consultant with a Farm Credit 

Association. Welcome. I look forward to your testimony. 

In the interest of time, I am going to introduce all the witnesses. 

Our second witness is Daryl Thomas. Senator Casey has already 

introduced this witness. Mr. Thomas is the Senior Vice President 

for Sales and Marketing from Herr Foods, Inc., from Pennsylvania. 

I regret not introducing you twice, but in the interest of time, I 

would like to move to Gary Hirshberg, co-founder and Chairman of 

Stonyfield Farm from New Hampshire. Senator Stabenow is scheduled to introduce this witness, and I would refer to her at this 

point. 

Senator STABENOW. We actually do not—I think you have the introduction, Mr. Chairman, if you would like to proceed. 

Chairman ROBERTS. I would be delighted. Mr. Hirshberg is the 

co-founder and Chairman of Stonyfield Farm, an organic yogurt 

producer. He is here on behalf of Just Label It, a national campaign to label genetically engineered foods. Welcome and thank you 

for joining us. 

Our fourth witness is Greg Jaffe, the Director of the Project on 

Biotechnology, Center for Science in the Public Interest, from 

Washington, DC Mr. Jaffe is the Director of the Project on Biotechnology at the Center for Science in the Public Interest, a nonprofit consumer organization. Previously, he served in the Department of Justice’s Environmental and Natural Resources Division 

and with the EPA. I appreciate you sharing your testimony with 

us. 

Mrs. Lidback. 

Mrs. LIDBACK. Thank you. Chairman Roberts, Ranking Member 

Stabenow, and other members—— 

Chairman ROBERTS. Mrs. Lidback, I am sorry. I did not introduce 

Dr. Ronald Kleinman. We would not want to do that to the good 

Doctor. 

I apologize. You are the Physician in Chief at the Massachusetts 

General Hospital for Children from Massachusetts. Dr. Kleinman 

is the Physician in Chief at the Massachusetts General Hospital for 

Children, the Chair of the Department of Pediatrics at the Massachusetts General Hospital, and the Charles Wilder Professor of Pediatrics at Harvard Medical School. 

35 

His major areas of interest include gastrointestinal immunology, 

nutrition support of infants and children, and nutrition and public 

health. We also look forward, sir, to your statement and experience. 

Now, Mrs. Lidback, the Chair has corrected my egregious error 

and we look forward to your testimony. 

STATEMENT OF JOANNA LIDBACK, PRODUCER, THE FARM AT 

WHEELER MOUNTAIN, WESTMORE, VERMONT, ON BEHALF 

OF AGRI–MARK DAIRY COOPERATIVE AND NATIONAL COUNCIL OF FARMER COOPERATIVES 

Mrs. LIDBACK. Well, thank you again. Chairman Roberts, Ranking Member Stabenow, and other members of the committee, thank 

you for inviting me here to talk about agricultural biotechnology. 

I am testifying on behalf of Agri-Mark Dairy Cooperative and the 

National Council of Farmer Co-Ops. 

I live with my husband and our two young boys on a 50-cow 

dairy in the beautiful Northeast Kingdom of Vermont. In addition 

to selling our milk to the co-op, we grow hay, raise Jersey steers 

to sell beef locally, and we market a small amount of composted 

manure. We farm about 200 acres of land, including 50 acres of 

pasture where we graze our herd. 

My husband and I are both proud to be first-generation farmers. 

Starting out on our own to build a dairy operation has been trying 

at times, but all of the hard work we have endured could never 

outweigh the chance to raise our boys in a farming lifestyle, all the 

while producing food for our little corner of the world. 

When we started building our operation, we knew that environmental and economic sustainability would be important in order to 

pass the farm along to our sons someday. We needed to diversify 

our operation and use modern technology at the same time to have 

a positive impact on our farm and our community. My husband always says, as a farmer and a small farmer at that, we have so 

much working against us, we need to make use of all the things 

that will work for us. 

Biotech crops are essential to sustaining our dairy and keeping 

our feed prices affordable. To compare, a non-GMO basic feed 

would cost us $555 per ton and the same conventional feed that we 

currently purchase is $305 per ton. We purchase 16 tons of grain 

each month, and if you do the math, we would be paying an additional $4,000 a month, or $48,000 per year, for non-GMO feed. I 

do not see how we could profitably farm in the long term with 

those increased feed costs. I am certain our small farm would be 

pushed out of business. 

Biotechnology is also a key to our stewardship of the land. One 

myth I have heard is that biotech crops increase pesticide use. My 

neighbors growing these crops would tell you that the truth is exactly the opposite. In fact, according to the USDA, overall pesticide 

usage in the U.S. peaked in 1982 and has been trending downward 

ever since. 

I am disappointed that my home State of Vermont passed a mandatory GMO labeling law set to take effect next year. The main argument for passing this bill was this idea that consumers have a 

right to know what is in their food. In my opinion, the new label 

36 

would not better inform consumers, but instead, it would serve as 

a warning sign. 

I find the law to be frustrating and full of contradictions. For example, it applies to packaged and processed foods, but not if they 

contain meat. So, a can of vegetable soup would carry a label, but 

that same soup with added meat would not. Restaurant food is exempt. So, a frozen pizza from the grocery store might carry a label, 

but not a restaurant delivery pizza. At this time, dairy is also exempt, but my worry is that, over time, these odd exclusions would 

fall away. 

I believe there are better uses of the state’s time and taxpayer 

resources than imposing regulations on a technology that has been 

proven safe time and time again. I am also concerned about the impact this law will have on the cost and availability of food in 

Vermont’s grocery stores and whether or not food companies will 

decide to simply not ship to the state because of the law’s nonsensical labeling requirements. 

With mandatory GMO labels, the cost of food at the grocery store 

will go up. A study out of Cornell University estimates an increase 

of about $500 per family of four per year. That may not seem like 

a lot to us in the room today, but the burden of this increase would 

be felt by those who could least afford it, including people in my 

own community. Eighty percent of the children in our local elementary school qualify for free or reduced price lunch already. These 

are the families who would be hardest hit for no good reason. 

If a small percent of consumers are to drive a GMO labeling requirement, I believe it should be done in a voluntary and cohesive 

way at the federal level. Again, I do not believe those consumers, 

who can least afford it, should have to bear the burden for such a 

small percent of consumers that are pushing for mandatory labeling. 

We know more now about growing food and caring for animals 

than we ever have and this helps us achieve a level of productivity 

that previous generations of farmers would envy. I am proud of 

how far the American farmer has come, just as I am proud of how 

far we have come on our own farm. I look forward to the day when 

our boys are grown and tell us they are ready to take over the 

farm. I know they will carry the values my husband and I have instilled in them, to be good stewards of the land, animals, and community, and I hope they still have the ability to use the latest tools 

and technology to help them do so. 

Thank you. 

[The prepared statement of Mrs. Lidback can be found on page 

87 in the appendix.] 

Chairman ROBERTS. We thank you for your testimony, Mrs. 

Lidback. 

Mr. Thomas. 

STATEMENT OF DARYL E. THOMAS, SENIOR VICE PRESIDENT 

OF SALES AND MARKETING, HERR FOODS, INC., NOTTINGHAM, PENNSYLVANIA 

Mr. THOMAS. I, too, would like to thank this committee, Chairman Roberts, and Ranking Member Stabenow for holding this 

hearing. I greatly appreciate the opportunity to be here. 

37 

My name is Daryl Thomas and I am with Herr Foods. Herr’s is 

a family-owned snack food company that was started in 1946 by 

my father-in-law. Our corporate headquarters are located in Pennsylvania and we operate two manufacturing facilities and 22 warehouses throughout the Northeast. 

The regulation of foods derived from biotechnology is an important issue facing our industry today, especially since the State of 

Vermont recently approved the nation’s first mandatory GMO labeling law. Absent a federal solution, by July 2016, when 

Vermont’s law takes effect, manufacturers will have three options 

to comply. The first is to redesign packaging. Second is to reformulate products so that no label is required. Or, three, halt sales to 

that state. 

While we have not made a final decision, we are considering several factors that will make it difficult to continue sales in Vermont. 

One factor is the ability of our distribution chain to segregate products for Vermont, since it is the food manufacturer who is liable if 

mislabeled products make it onto store shelves. We recently received a note from one of the largest grocery wholesalers in the nation. The letter informed us that they will not take additional steps 

to segregate or otherwise specifically direct a shipment of Vermontonly products into Vermont. 

Discussions about mandatory GMO labeling laws reducing consumers’ choices are becoming much less theoretical and much more 

real. If the number of products on store shelves decreases, not only 

will consumers lose choices, but the lack of choice and competition 

could drive up cost. For some households, that might be easy to absorb. For others, it could be significantly more difficult. 

You might wonder, so, why does not Herr’s just change all of our 

ingredients to be non-GMO or at least change the ingredients in 

Vermont? It sounds simple, but it would actually be very difficult. 

The first problem would be sourcing the ingredients. Soybeans, cotton, and corn are three top ingredients used by manufacturing companies such as Herr’s, and more than 80 percent of these crops 

grown in the U.S. are genetically modified. As a mid-sized company, it would be difficult to compete for the limited supplies of 

these ingredients. 

There is also the issue of food product verification. In today’s environment of increased litigation, we would want a third-party 

verification when we label a product as non-GMO. At Herr’s, we 

use third-party certification for our non-GMO popcorn product, and 

in addition to the cost, the process took approximately six months. 

To do this for all 411 of our products would be both time and cost 

prohibitive. 

The fact that states seem to be considering different standards 

for what is deemed genetically modified for labeling purposes only 

compounds this problem. For individual states to define the term 

GMO, set labeling protocol, and legislate fines for noncompliance, 

our food distribution system could be crippled. Segregation of nonGMO products from some states and GMO-containing products for 

the rest of the country would be even more difficult. 

Just the additional cost of different packaging for one state 

versus another would be virtually insurmountable. To change the 

label on a bag can cost up to $5,500 per product. To do this for our 

38 

entire product line would cost Herr’s more than $2.2 million for 

every state with a different law. That is a cost our family-owned 

business simply cannot afford. Mandatory labels are unnecessary to 

provide consumer choice. For those consumers who do not want 

GMO products, there are already voluntary labeled products available to them in the form of organic foods and non-GMO certified 

foods. We support giving consumers transparency and choice, but 

transparency should not be defined by different states. 

The second question I considered in preparation for today is why 

does Herr’s not just label all products as GMO if we cannot 

change—if non-GMO if we cannot—or as GMO if we cannot change 

our ingredients? My answer is simple. Mandatory labels on food 

products are reserved for critical information about nutrition and 

safety. GMO ingredients do not change the nutritional profile or 

safety of our products. 

While it might not be the intent of mandatory GMO labels to 

imply inferior food or safety or nutrition, some groups have made 

unfound negative claims about genetically modified crops. The fact 

is that we have the safest, most abundant, and most affordable 

food supply in the world. I fear that a mandatory GMO label could 

be used by some to unfairly question the safety of our products. 

Let me be clear. I am not here to testify about the safety of 

GMOs. That has already been confirmed by the FDA. I am here to 

advocate for a federal solution to a critical issue that could force 

hundreds of family-owned companies like ourselves to make distribution decisions that would negatively impact the sales, jobs, 

and food choices. 

In conclusion, Herr’s is extremely concerned about mandatory labeling for products containing GMO. We urge the Senate to pass 

a national set voluntary standard before the law in Vermont can 

take effect. 

Again, thank you for the time to be here and I look forward to 

answering your questions. 

[The prepared statement of Mr. Thomas can be found on page 

111 in the appendix.] 

Chairman ROBERTS. Thank you, Mr. Thomas. 

Mr. Hirshberg. 

STATEMENT OF GARY HIRSHBERG, CHAIRMAN AND COFOUNDER, STONYFIELD FARM INC., CONCORD, NEW HAMPSHIRE, ON BEHALF OF JUST LABEL IT 

Mr. HIRSHBERG. Thank you, Chairman Roberts and Ranking 

Member Stabenow, for the opportunity to testify today. My name 

is Gary Hirshberg. I am the co-founder, Chairman, and former 30- 

year CEO of Stonyfield Farm. I also serve or have served as a director and advisor for numerous conventional and organic food 

companies now owned by firms such as Coca-Cola, Hormel, and 

General Mills, among others. 

Today, however, I am appearing as Chairman of Just Label It, 

a coalition of more than 700 businesses and organizations dedicated to a mandatory disclosure system for products containing genetically modified organisms, or GMOs. 

I have seen firsthand a remarkable and encouraging shift in consumer interest in food in the last 20 years. Consumers, especially 

39 

millennials, are demanding transparency as never before. Consumer interest in food and farming is a trend that should be welcomed, because our food choices have enormous impact on our 

health and on the health of our environment. 

Grown in demand for sustainably-grown food is also good for agriculture, because two decades of double-digit annual growth in 

these categories is creating billions of dollars of new revenue, creating millions of jobs, and creating new opportunities for farmers, 

especially younger farmers. 

When I started Stonyfield, most consumers had no idea what organic meant. Now, annual organic sales are nearing $40 billion, 

and most of the nation’s largest food manufacturers are actively engaged in this category. 

Our position is simple. Consumers have the right to know what 

is in their food and how it is grown, the same right held by citizens 

in 64 other nations. Recent polling and consumer data tell us that 

nine out of ten Americans, regardless of age, income, race, or party 

affiliation, want the right to know whether the food they eat and 

purchase for their families contains GMOs. Consumers give many 

reasons for wanting these disclosures, but chief among them is the 

extent to which GMO crops have increased the use of herbicides 

linked to serious health problems. 

Let me be very, very clear. We strongly support a national GMO 

disclosure system that provides factual information. We do not support a warning or a disclosure system that renders a judgment on 

GMOs, and we are certainly not seeking a ban on GMO crops. 

Rather, we support a value-neutral disclosure that respects the 

rights of consumers to make their own choices. 

Actual experience shows that food prices have not increased in 

the 64 nations that have adopted GMO labels, nor do consumers 

in these countries view GMO disclosures as warnings. At the same 

time that GMO disclosures have been adopted around the globe, 

GMO crop acreage has steadily increased, from 27 million acres in 

1997, when the first GMO label was introduced, to 448 million 

acres in 2014. 

The world’s second-largest producer of GMO crops, Brazil, implemented mandatory labeling in 2003, yet less than one percent of 

food sales in Brazil are organic, and Brazilians have accepted GMO 

foods in the marketplace. Claims that a mandatory disclosure 

would disrupt GMO expansion were disproved by actual marketplace experience. 

I know from my own experience that food companies change our 

labels all the time to highlight new innovations and that food companies and farmers already segregate GMO and conventional ingredients to serve our markets at home and abroad. 

I also know from experience that a value-neutral disclosure will 

not cause sudden shifts in consumer behavior. In fact, a recent fiveyear study of consumer data confirmed that American consumers 

will not view a GMO disclosure as a warning. 

The Just Label It coalition and I welcome the opportunity to 

work with the committee and with farmers, food manufacturers, 

and other stakeholders to craft a disclosure that is national, that 

is factual, that is mandatory, that works for consumers, and that 

40 

works for farmers and the food industry. You should not have to 

live in Vermont to know what is in your food and how it is grown. 

The Des Moines Register in a 2014 editorial entitled, ‘‘It’s Time 

for Congress to Require GMO Labeling’’ put it very simply. Quote, 

‘‘Congress should set a nationwide standard of disclosure and then 

let the individual consumers decide whether the presence of GMOs 

in a product is something that concerns them. But keeping consumers in the dark is never the right thing to do,’’ unquote. 

In the absence of such a system, we urge the Senate to reject efforts to block state GMO disclosures or limit the administration’s 

authority to develop a national solution. Such efforts contradict 

Congress’s longstanding view that states should be able to require 

simple factual disclosures on food labels and that the FDA and 

USDA should have the authority to require disclosures that help 

consumers make informed decisions. 

Farmers should, of course, have choices, and so, too, should consumers. The fastest creators of new on-farm and factory jobs are 

the companies and brands that are most transparently responsive 

to consumer desires. The 21st century consumer demands food that 

is, above all, transparent, and Congress as well as the food industry should honor and support and most certainly not block this fundamental right. 

Thank you for the opportunity to testify and I look forward to 

your questions. 

[The prepared statement of Mr. Hirshberg can be found on page 

61 in the appendix.] 

Chairman ROBERTS. We thank you, Mr. Hirshberg. 

Mr. Jaffe. 

STATEMENT OF GREGORY JAFFE, BIOTECHNOLOGY PROJECT 

DIRECTOR, CENTER FOR SCIENCE IN THE PUBLIC INTEREST, WASHINGTON, DC 

Mr. JAFFE. Thank you, Chairman Roberts and Ranking Minority 

Member Stabenow and other committee members for inviting me 

as a witness on behalf of the Center for Science in the Public Interest. 

It is appropriate to review and possibly modify the roles of the 

Food and Drug Administration, the USDA, and the EPA in ensuring those crops’ safe use. While current GE crops grown in the U.S. 

are safe and beneficial, the federal regulatory oversight system 

needs improvements to ensure safety for future products and to 

provide consumers with confidence about their safety. 

I am here today as the Director of CSPI’s Biotechnology Project. 

CSPI is a nonprofit consumer organization that was established 44 

years ago. CSPI works primarily on food safety and nutrition issues 

and publishes Nutrition Action Health letter to educate consumers 

on issues surrounding diet and health. CSPI does not receive any 

funding from industry or from the federal government. Our funding 

primarily comes from our members and donors, as well as from 

independent philanthropic foundations. 

CSPI has long advised consumers, journalists, and policymakers 

that foods and ingredients made from currently grown GE crops 

are safe to eat. The current crops have also provided tremendous 

benefits to farmers and the environment in both the U.S. and 

41 

around the world. However, actions by developers selling GE seeds 

and by farmers growing GE crops have led to the highly troublesome development of insects and weeds that are resistant to widely 

used pesticides. 

Today, I will limit my oral testimony primarily to legislative 

changes at FDA and USDA. CSPI believes that FDA should determine the safety of all GE food crops before foods from those crops 

enter our food supply. FDA should review the safety data submitted by the developer, conduct its own analysis of those data, 

and provide the developer and the public with its opinion of whether foods from that GE crop are safe to eat by humans and animals. 

This new regulatory process would further ensure safety of future 

crops and allay consumer concerns about biotechnology. 

While GE crop developers in the United States have always completed the consultation process, there is no guarantee that they will 

continue complying with the consultation process in the future. 

Similarly, it is unclear whether GE crop developers in India or 

China would consult with FDA, especially since they may be exporting finished food products. 

CSPI believes that a mandatory pre-market approval process by 

FDA should have the following four components. First, all genetically engineered crops, irrespective of their intended use, should go 

through that approval process. 

Second, the mandatory approval process should be legally included in the Food, Drug, and Cosmetic Act as opposed to being established in an agency policy that could change at any time. 

Third, after FDA has received public comments and completes its 

safety review, FDA must provide the developer and the public with 

its opinion about the GE crop’s safety. 

Finally, until FDA determines if the GE crop meets that safety 

standard, it would be illegal to market foods or ingredients made 

from that crop. 

USDA regulates GE crops under its plant pest authority provided 

by the Plant Protection Act. To date, USDA has granted 117 petitions for non-regulated status and never once found a commercial 

GE crop that is a plant pest that requires continued oversight. Developers and USDA spend significant resources determining that a 

GE crop is not a plant pest when they could use those resources 

to analyze and address real impacts from GE crops, such as development of resistant weeds and pests or gene flow to wild relatives 

and non-GE farms. 

In the last few years, a large loophole has emerged that allows 

developers of GE crops to avoid USDA’s lengthy and expensive regulatory process. If a GE plant variety is developed without using 

any component of a listed pest, then USDA has no authority to regulate that crop, even its experimental trials. USDA’s decision to exempt certain crops is not based on a scientific analysis that the 

particular crops are not risky and need no regulation, but instead 

the decision is solely because the crop is not captured by the narrow legal hook USDA uses to regulate GE crops. 

Such arbitrary and non-scientific decisions undermine the regulatory system and its reputation with the public in the United 

States and our trading partners abroad. Congress should pass new 

legislation that would require USDA to regulate all gene crops, 

42 

whether developed here or abroad, and ensure that the review addresses the real and potential risks and impacts of those crops instead of expending resources addressing nonexistent plant pest 

risks. 

I appreciate the time the committee has given me to testify today 

and I look forward to your questions. 

[The prepared statement of Mr. Jaffe can be found on page 65 

in the appendix.] 

Chairman ROBERTS. We thank you, Mr. Jaffe. 

Dr. Kleinman. 

STATEMENT OF RONALD E. KLEINMAN, M.D., PHYSICIAN IN 

CHIEF, MASSGENERAL HOSPITAL FOR CHILDREN, BOSTON, 

MASSACHUSETTS 

Dr. KLEINMAN. Chairman Roberts, Ranking Member Stabenow, 

thank you very much for asking me to appear today. As a pediatrician, I know that food safety is critically important to moms and 

to children and I am called upon to help parents understand facts 

and the fictions around food and nutrition, including GMOs. 

Plant biotechnology has been with us safely for 20 years or more. 

Not a single human illness or adverse effect has been documented. 

GM technology allows us to move a handful of carefully selected 

genes and traits among species and to achieve characteristics that 

conventional breeding will not permit. Commercial GM crops undergo testing and safety assessment that far exceeds the little, if 

any, testing of conventional varieties, despite the fact that GM 

technology is far more precise. Genes, DNA, RNA, and resulting 

proteins are a part of every living thing and, thus, every whole food 

we consume. Undue concern regarding a few carefully selected 

genes makes no biological sense when considered against the hundreds of thousands of untested genes and gene products in the natural diet. 

In my professional opinion, existing GM crops are safe, based on 

the fundamental science of DNA, RNA, and protein in foods, upon 

extensive safety and compositional testing, and upon an extensive 

body of scientific studies, both short-and long-term. 

Our current system for the review and safety assessment of GM 

crops by the FDA and EPA is robust and comprehensive. They are 

the most studied foods in history. The science and risk-based regulatory system we have in place is robust and provides a solid food 

safety and environmental affirmation to the American people. 

The nutritional value of GM crops is assured via extensive 

compositional testing. Food labeling on GM content conveys no useful nutrition or safety information to consumers. It is often misleading and will simply present confusing and confounding information to consumers, including the parents that I personally advise. 

Nutritional enhancement through GM technology is a reality. 

Globally, vitamin A deficiency afflicts millions of children annually 

with blindness, stunting, or death. The GM Golden Rice which provides this essential nutrient remains on the shelf is an incalculable 

tragedy. 

In the developed world, we know that adult heart disease has its 

origins in the diet of children. Existing, approved, but currently unVerDate Nov 24 2008 16:19 May 17, 2016 Jkt 000000 PO 00000 Frm 00046 Fmt 6633 Sfmt 6633 C:\USERS\MW42035\DESKTOP\DOCS\98991.TXT MICAH
43 

available GM offerings for heart health include vegetable oils very 

low in saturated fats and plant-derived oils providing benefits of 

long chain fatty acids found mainly in fish, the latter being underconsumed, expensive, and in short supply. 

Globally, we must sustainably feed a growing population while 

conserving limited land, water, and other resources. GM crops have 

resulted in dramatic reductions in chemical insecticide use, support 

conservation tillage to retain soils and conserve water, and reduce 

fuel use and carbon footprint. Traits in development include improved water and nitrogen utilization and, therefore, enhanced 

yield, which, in combination with breeding and hybrid technology, 

will be essential to providing ongoing food security. 

Much of the recent controversy surrounding GM crops revolves 

around the concomitant use of glyphosate. Improved techniques 

allow detection of minute quantities of chemicals in body fluids, but 

presence does not equal risk. Measurement of glyphosate demonstrates that intakes in the general population are far below allowable daily intakes determined to be safe by the EPA and by 

similar agencies globally. Reports of glyphosate in breast milk have 

not been replicated using validated techniques. 

The recent opinion from the IARC that glyphosate is a probable 

human carcinogen is not supported by the data and flies in the face 

of comprehensive assessments from multiple agencies globally. 

Older allegations suggesting that glyphosate and GMOs are somehow associated with food allergy, autism, and other medical conditions are wholly unfounded speculation. Thus, concerns regarding 

glyphosate residues are unsupported and the fear-mongering surrounding them unjustifiable. 

Despite the obesity problem, hunger remains a challenge in the 

U.S. today. Roughly one in five children live in households that are 

food insecure. This is often driven by economic limitations and 

often afflicting the most vulnerable children and the elderly. Suboptimal nutrition remains common in adults, with excessive intakes of saturated fats and inadequate intakes of long chain omega 

fatty acids. In the developing world, malnutrition and food security 

remain daunting challenges. 

Enhanced sustainable food production is essential in both the developed and developing world. Advancing agricultural technology, 

including GM technology, is and will remain essential to meeting 

global production demands, and to not just meeting, but optimizing 

global nutrition. 

So, in summary, this is essential not just for personal health, but 

for community health, global economic development, social order, 

and transnational security. Thank you very much. 

[The prepared statement of Dr. Kleinman can be found on page 

84 in the appendix.] 

Chairman ROBERTS. I thank you, Doctor. 

I am going to start with you. As a pediatrician, you obviously 

highlighted concerns related to both sound science and nutrition, 

and you talked about visiting with parents. Can you talk about 

your conversations with mothers about biotech, and can you speak 

about the importance of accurately trying to communicate to the 

public about science, especially as it relates to what you highVerDate Nov 24 2008 16:19 May 17, 2016 Jkt 000000 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 C:\USERS\MW42035\DESKTOP\DOCS\98991.TXT MICAH
44 

lighted—food production, malnutrition, and hunger around the 

world? 

Dr. KLEINMAN. Those are fairly broad questions, but I will do my 

best. As far as conversations with parents, I enjoy an open dialogue 

with all the parents that I talk to. I am often talking to them about 

nutrition and I usually start by asking what they have read on the 

Internet and what kinds of questions they have that they would 

like me to address. 

At the end of those conversations, I always assure them that the 

food supply in the United States is safe as it is currently regulated 

and assessed and that issues raised about GMOs have not stood 

the test of scientific investigation over a very long period of time. 

I think this whole issue of explaining GMOs to parents is complicated and not easily addressed in a couple of sentences. If I were 

to ask everyone in this room to raise their hand if they took a 

course in DNA chemistry or molecular biology, there would not be 

a lot of arms up in the air, and I think that is highlighted by two 

questions that I have seen on surveys about labeling GMOs. 

The first is the question of whether people feel GMOs should be 

on the food label, and a substantial number of people will say yes 

to that question. 

The second question, however, I think, highlights the issue, because when you ask those same people if we should label all foods 

that contain DNA, the same number of people raise their hands. 

All fruits and vegetables, meat, fish and fowl contain DNA. We consume DNA on a daily basis in significant quantities, and we also 

have a significant amount of foreign DNA in our own bodies. The 

germs that inhabit our intestine all have DNA, and there are thousands of trillions of those germs. 

So, that is the challenge. It is simplifying this in a way that reassures people that we have a safe food supply, explaining that the 

efforts to ensure that the food is safe are adequate and appropriate, 

and that these new technologies do not change that risk at all and 

that they have been carefully assessed over a period of 20 years to 

give us that guarantee. 

The last thing I will say is that it is not easy standing up and 

defending GMO today. This has become really an era in which ad 

hominem attacks on those who disagree with others are very difficult to tolerate. We see now the use of the Freedom of Information Act, for example, directed against a whole range of academic 

investigators, scientists who have spent careers looking at GMOs 

and how they behave, both with the environment and with human 

health, and many of these people are now being subjected to severe 

personal attacks and Freedom of Information Act requests. 

So, I think we have a big challenge before us, but I hope that 

many who counsel parents directly, who have a forum and can 

speak to this in a public way, will be able to work with government 

agencies like we heard this morning the members of the first panel 

discuss so that we can assure the population of the United States 

that they have nothing to fear from GMOs as they are currently 

used. 

Mrs. LIDBACK. Chairman Roberts, may I add a quick comment? 

Chairman ROBERTS. Certainly. 

45 

Mrs. LIDBACK. I talk about biotech crops with my pediatrician all 

the time, and he is very much in support of me being here and 

sharing my perspective and my message about biotech crops. 

Thank you. 

Chairman ROBERTS. I appreciate that very much. 

I have exhausted my time limit, but it was for good purpose. Doctor, thank you so much for a very eloquent and persuasive response, and I thank you for what you are doing. 

Dr. KLEINMAN. Thank you. 

Chairman ROBERTS. As a matter of fact, I know of three individuals that you could visit with. They happen to be my kids and 

grandchildren. So, maybe we can work that out. Thank you. 

I had other questions, but I think I will yield to the distinguished 

Ranking Member. 

Senator STABENOW. Thank you very much, Mr. Chairman, and 

thank you to all of you for your important testimony. 

Mr. Hirshberg, I wanted to start with you today because you 

have long been a leader in the call for mandatory labeling of genetically modified food. You talked about in your testimony that 

this was a direct result of your experience running a large food 

company, so I wondered if you could talk about what motivated you 

to be where you are today as an advocate in bringing together businesses and leaders on this issue. 

Mr. HIRSHBERG. Thank you, Senator. When we started 32 years 

ago, my company, there was, of course, no organic industry, and 

the world has changed dramatically since that time. We now have, 

as I mentioned, a $40 billion sector. This growth in this sector has 

been strictly and completely a result of responding to consumer demand for transparency about what is in our foods and how they are 

grown. The company and the industry, indeed, have evolved to be 

engaged in highly robust contact with consumers, because, frankly, 

that has been our strength, our competitive strength. 

But, by 2011, questions about GMOs really dominated 

Stonyfield’s social media. This is before the creation of ‘‘Just Label 

It’’ and certainly before any of these state efforts. What we have 

deduced, and only deduced since then, and I think you have heard 

ample evidence of it today, is complete and utter confusion out 

there. 

We have had a voluntary labeling guidance from the FDA since 

2001, and yet confusion runs amok, questions of does not natural 

prohibit GMOs, et cetera, and I could go into many more examples. 

But, in the interest of time, I would simply say that despite the 

voluntary labeling system, it has not addressed the confusion. In 

fact, I might even go further and say that I believe that the trust 

issue that has been talked about with many of the Senators’ questions today could be addressed by simply going ahead and having 

a value-neutral label. I think it would put the trust issue to rest, 

because we would be stating a fact to consumers. 

In any case, to your point, these questions and this confusion is 

really, in our view in industry, a logical consequence of the rapid 

success of GMOs, which has certainly been talked about today. 

Two-thirds of acreage planted in the U.S. is now GMO, as has been 

mentioned. 

46 

But it also came to a head for me when HTA—herbicide tolerant 

alfalfa—was approved in 2011 and we came to understand the 

quarter-billion pounds of glyphosate that has been referenced 

today, now being used per year, super weeds as a result in over 60 

million acres and the need to use 2,4–D, et cetera. Indeed, herbicide use has gone up. That is a fact. It is USDA survey data. So, 

we recognize that this extraordinary change in U.S. agriculture has 

happened in less than a generation with no citizen or consumer 

input and that 64 other nations had solved this problem with mandatory disclosure. 

So, from our vantage point, we recognize that the FDA has the 

authority under the Federal Food, Drug, and Cosmetic Act to implement mandatory labeling, just as they have with many other 

foods and many other attributes. We organized ‘‘Just Label It’’ to 

seek mandatory disclosure to address this confusion and choice and 

to engage the marketplace. 

I would say quickly that I share the same opinion as you have 

heard from many of my co-panelists today. America needs help now 

resolving this. This is crafting a disclosure system that is valueneutral. I certainly do not support, nor have we supported, the 50- 

state patchwork solution. That would be a nightmare for all of us. 

Thank you. 

Senator STABENOW. Thank you. Just as a follow-up, because I 

was going to ask you—— 

Chairman ROBERTS. Dr. Kleinman wanted to—— 

Senator STABENOW. Oh, yes. Dr. Kleinman, did you want to respond? 

Dr. KLEINMAN. If I might just add to that briefly, we all applaud 

an effort towards transparency, and transparency in the production 

process seems to be a laudable goal. But these efforts that we are 

talking about today are purely restricted to transparency about 

GMOs. There are some 3,000 fruits and vegetables today that are 

produced from seeds that are developed using chemical and radiation mutagenesis. We do not talk at all about labeling those. 

There are fruits and vegetables that are produced using exploited 

labor. We do not talk at all about labeling that. 

I am not going to go on and on about this, I promise, but how 

much do we put on that label? What is the difference between need 

to know and right to know? I think Senator Heitkamp was getting 

at that in her question that she addressed to the first panel. So, 

I will stop there. 

Senator STABENOW. Yes, thank you very much. 

I did want to do just a quick follow-up with Mr. Hirshberg, 

though, because I wanted to get your perspective on how we provide consumers the right to know. People want to know about their 

food and are more engaged, and that is a good thing, that people 

are more engaged in this whole process. I mentioned in the farm 

bill part of our reason, part of my push to make sure we were doing 

more around choices for people was to really address that important desire. 

But, how do we do that without stigmatizing biotechnology or 

having this interpreted as a food safety warning? That is the concern from industry’s standpoint, when you have heard all of the 

47 

issues as it relates to safety. Yet, at the same time, consumers 

have a right to know. 

Mr. HIRSHBERG. Yes. Well, I will be brief, but we fully support 

and agree with you. You cannot stigmatize. Farmers need choice. 

Consumers need choice. From the beginning, as I said before, before any state initiative had been launched, we were advocating for 

factual value-neutral presence disclosure, mandatory so that the 

playing field is level. As we have seen with the NLEA and other 

valuable legislation, when you have a level playing field, it really 

stimulates innovation and is fair to emerging smaller operators. 

National, again, not the 50-state solution. Acceptable to farmers, 

acceptable to consumers, and acceptable for industry. 

In other words, all stakeholders need to agree, this works, and 

we are open, from Just Label It’s perspective, to any system. The 

focus has been on labels, but certainly there is a lot of discussion 

about technology. Any discussion. Our plea is to bring the stakeholders together for a constructive discussion about a value-neutral 

solution. We have not been prescriptive intentionally because we 

know many stakeholders need to weigh in. 

I will quickly say in closing, in response to you, that to us, the 

European standard makes the most sense. It is two words. They 

are innocuous. They are value-neutral in the ingredient panel. It 

seems to be similar. But we are open to technology. We have a lot 

of questions about how scanners would work and so on and so 

forth, but again, we need to be open. 

This is a problem that need to be solved, as the Senators know, 

and you have heard ample evidence of it today. This discussion is 

raging in 35 states. Vermont is not the only state that has taken 

this up. Three other states have passed. Several more will be passing. So, it really needs to be solved at the national level, and it 

really does need to be non-disparaging. Thank you. 

Senator STABENOW. Thank you. 

Thank you, Mr. Chairman. 

Chairman ROBERTS. Senator Hoeven is next. Senator Donnelly, 

welcome to this discussion, and I will recognize you next. But I am 

going to take the Chairman’s prerogative here to ask Mr. Thomas, 

hearing Mr. Hirshberg, how could your company manage any additional cost to implement what he is talking about? 

Mr. THOMAS. Well, obviously, there would be costs. I am impressed with how much agreement that there is across these different persons testifying. 

You know, I think we would support a government determined 

standard for non-GMO or GMO particularly declared foods. I think 

I would disagree with the point of doing it as a mandatory label. 

I believe that the vast testimony that we have heard this morning 

supports that our foods are safe. I understand that there is great 

consumer interest and curiosity around this issue. To respond with 

a determination of it is GMO or it is not GMO, I think, does not 

really aid the consumers’ curiosity and maybe even lack of information that they have had thus far. I think it would tend to make it 

more misunderstood because you would have it interpreted as a 

pass/fail indicator on packaging. 

48 

So, I support the voluntary use of it. I think the market is working pretty well right now and that there are many products that 

are—— 

Chairman ROBERTS. But who would pay the cost? I mean, how 

would you handle the cost? 

Mr. THOMAS. Well, ultimately, the cost gets passed on to the consumer or else you go out of business, so to analyze products, to 

change all of our packaging, I mean, over time, it can be absorbed 

as a cost of doing business, but—— 

Chairman ROBERTS. What I am worried about is—well, I am 

worried about that, but I am worried about any mandate that 

comes from Washington, with all due respect—— 

Mr. THOMAS. Right. 

Chairman ROBERTS. —how ably described or what flag you are 

waving. 

Mr. THOMAS. Ultimately, those costs do get passed through to the 

end user. 

Chairman ROBERTS. I am worried about them going back down 

to the farmer and the rancher. 

Mr. HIRSHBERG. Mr. Chairman, may I respond? We, as was mentioned earlier today, I believe, we change our labels almost annually. If you look across the food industry, every time a Disney 

movie comes out or a Super Bowl hero comes through, companies 

change their labels. It is a routine part of business. So, the act of 

changing the label itself has never been passed along to either our 

end user or our supply. It is just a normal—— 

Chairman ROBERTS. Well, with all due respect, Mr. Hirshberg, a 

Disney label is a little bit different than what we are talking about 

on a pass/fail kind of test mentioned by Mr. Thomas on the safety 

of our food supply. 

I am going to move on and mention, Mr. Hoeven—I do not mean 

to cut you off—Mr. Hoeven, Senator Hoeven, dear friend and colleague, please proceed. 

Senator HOEVEN. Thank you, Mr. Chairman. 

I would like to ask each of the witnesses, do you believe that genetically engineered plants are safe, starting with Mrs. Lidback. 

Mrs. LIDBACK. Yes, I do. 

Senator HOEVEN. Mr. Thomas. 

Mr. THOMAS. Yes, I do. 

Senator HOEVEN. Mr. Hirshberg. 

Mr. HIRSHBERG. The evidence is clear from the earlier panel that 

this is our federal policy and I am not qualified to disagree with 

it. I would only say that there is significant debate and discussion 

that has not been included in today’s discussion. 

Senator HOEVEN. Mr. Jaffe. 

Mr. JAFFE. For the current crops that are grown in the United 

States, yes. 

Senator HOEVEN. Dr. Kleinman. 

Dr. KLEINMAN. Yes, they are safe, and I think that this has been 

demonstrated and agreed to by over 240 international oversight 

agencies and scientific groups. 

Senator HOEVEN. For both Mr. Thomas and Mr. Jaffe, if there is 

not labeling, and it is not a food safety issue but consumers still 

want to know more about GMO as it pertains to any food they are 

49 

purchasing, what are the ways they would do that? Maybe, Mr. 

Thomas, you could start on that. 

Mr. THOMAS. Well, there is—I think the market is responding to 

the interest in some of these organic or natural products and there 

are products that have been flooding the market. They are pretty 

clearly labeled. Those products are made with great intention. They 

are sourced, the ingredients are sourced. They are formulated with 

great intention to deliver those products to market. So, companies 

are taking advantage of commercializing that interest and are putting big call-outs on the packaging. So, I think the determinant or 

whether a product is or is not is already well underway. I think 

it could be polished a little bit through the voluntary program we 

have talked about here. 

You know, social media today, there is certainly a lot of information that is out there, and one of the things that I would say that 

as we get communication from our customers, the questions are 

more broad than—we are not being flooded by inquiries as to specific products and what have you. I think they are getting their information from the media and broader sources than individual companies. 

Senator HOEVEN. Mr. Jaffe. 

Mr. JAFFE. So, I think transparency is very important to consumers and I think consumers are looking for information about 

lots of things regarding their foods. I think that, little by little, the 

industry needs to move to have increased transparency so that if 

consumers want to find out more details about the foods that they 

are buying, they can find that out. 

In terms of specifically knowing about genetically engineered ingredients in foods, I would alert the committee to Wegman’s supermarket chain. They have done a really excellent job in a Q&A 

about GMOs and why they support the farmers who are growing 

them, where they are in their supermarket, which products people 

can find contain GMOs and which products they can buy to avoid 

them. Wegman’s did what I thought was an extremely good job of 

being both neutral, explaining the regulatory system, the safety, as 

well as where they are and why they support farmers growing 

those crops. 

Senator HOEVEN. Mr. Jaffe, how do they do that? How is that 

provided? 

Mr. JAFFE. It is on their website. 

Senator HOEVEN. On their website. 

Mr. JAFFE. They have a series of frequently asked questions. But, 

also, if you are a customer of Wegman’s, you know they have a 

quarterly magazine and in that quarterly magazine, Danny 

Wegman, the chairman or CEO—I am not sure of his position— 

wrote a letter about Wegman’s position on GMOs. They also put it 

on their blog. So, they—— 

Senator HOEVEN. So, it is on their website—— 

Mr. JAFFE. —they expressed it in a number of ways. 

Senator HOEVEN. It is on their website, but not specifically on all 

their food products, or is there a reference on the food product to 

the website? 

Mr. JAFFE. I do not think they are on their food products. 

50 

Senator HOEVEN. Okay. Mr. Hirshberg, when you talk about a 

value-neutral label, please, what is that? Describe it. 

Mr. HIRSHBERG. Thank you, sir. Again, as I mentioned, in Europe and throughout most of the world, the standard is including 

two words in the ingredient label. If it is a genetically engineered 

soy or genetically engineered corn, it would be identified as such. 

As was mentioned in the earlier panel, we have tremendous scientific ability now to test and sense even minute amounts. You 

might recall the discussion earlier about the large shipping containers. So, these programs just simply identify the presence, the 

factual presence in the supply chain. 

Senator HOEVEN. Dr. Kleinman, do you have any recommendations about how the federal government could better communicate 

and convey the safety of GMO products? 

Dr. KLEINMAN. I do not think the way to do that is to put a mandatory requirement for GMOs on labels. I think, certainly, that a 

well designed effort within the agencies that we heard from this 

morning towards this effort would be very welcome. I do not think 

that currently exists, and I think it is extremely important. It is 

analogous to what Mr. Jaffe was just describing at Wegman’s. It 

is very possible to create information for the Internet, in brochures, 

in various other forms of media, and the government can play a 

role in that just as producers and distributors can do that. 

So, I think this is a concerted effort by all of us who have an opportunity to educate the consumers to take that opportunity and to 

run with it. In particular, I think, as I said, creating a specific effort in government towards communication is very important. 

Senator HOEVEN. Thank you. 

Chairman ROBERTS. Senator Donnelly. 

Senator DONNELLY. Thank you, Mr. Chairman. 

Mrs. Lidback, you come from a very beautiful area. I think I represent a beautiful state, too. I know you have young kids on the 

farm, and protecting the environment is important to you, as it is 

to the farmers in my state. You testified biotech goes hand-in-hand 

with various conservation practices, things like cover crops and no 

till as well as significantly reduced pesticide use. Can you speak in 

more detail to the ways you have seen the genetically engineered 

crops change the way you farm and how it helps the environment 

in regards to similar things like cover crops and no till? 

Mrs. LIDBACK. Okay. Thanks for the question, Senator. I can 

speak to how my neighbors farm. We actually only grow grass. We 

do not grow biotech crops. But, I can tell you that they spray less 

pesticides, which in turn means that they are going over the 

ground less. There is less soil impaction and less soil erosion. 

The no till cropping, a neighbor—actually, she just posted on 

Facebook about using glyphosate in order to convert one of her 

hilly fields into—from grass into corn for next year, and the first 

step is to spray glyphosate to get rid of the grass, and then they 

will use no till planting because of the hilly nature of their field 

so it helps to prevent soil erosion. 

Cover crops were once thought to not be an option for our area 

because of the cold weather, but more and more folks, specifically 

farmers that I work with directly, are utilizing cover crops along 

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est rates of GE crops grown—corn grown for silage in the country, 

and so they are utilizing that seed with cover cropping and no till, 

given the need of their farm, trying to make the best of their resources. 

Senator DONNELLY. Thank you. 

Mr. Thomas, one of my great passions is small business and family businesses. I must say, I have consumed your products and they 

are of extraordinarily high quality—on numerous occasions. But, 

when I look at a company like yours, we have talked to a number 

of Indiana firms who have come into our office and said, here are 

the challenges we face. Here are the challenges that this will cause. 

We have some ice cream companies. I have heard there is an ice 

cream company in Vermont, Mr. Hirshberg. I do not know if that 

is true or not, but we have some ice cream companies in Indiana, 

too, and they said, we have 68 varieties times 50 different labels. 

If it gets to a certain point, it becomes unworkable for us. 

What are the kind of challenges you anticipate? I know you have 

talked about it a little bit before, as to how difficult this will be on 

a firm like yours. Is it a series of accumulating challenges that you 

are looking at, then? 

Mr. THOMAS. I think it depends on if it would be state by state 

or a mandatory enforcement that was done in a short period of 

time. Obviously, that would accelerate our changing of packaging, 

and the costs that I alluded to are real. To change 411 SKUs of 

our product would cost close to $2 million. So, those are real costs. 

I think, obviously, there would be great incentive, I think, if it 

was a mandatory practice because people would, probably look 

more at how they land on the non-GMO. I am not making a judgment whether that is the right thing to do or not. 

So, there are costs in segmenting the product. Now you have to 

segment. Your manufacturing processes become a lot more complicated as you have to protect one product from the others to prevent cross-contamination. So, through complexity, higher raw material costs, changing of packaging, all those things contribute increased costs of manufacturing. 

Senator DONNELLY. Thank you. 

Mr. THOMAS. Also marketing. 

Senator DONNELLY. Thanks. 

Mr. Jaffe, one of the things I have looked at has been barriers 

to international agricultural trade caused by varying approval processes for GE foods. Indiana grain producers are suffering because 

of drawn-out approvals for their products within the United States 

and also overseas in, like, the Chinese regulatory systems. You discussed the need for a U.S. regulatory system consistent with those 

in other countries. So, the question is, do you believe it is possible 

for an updated U.S. regulatory policy to reduce trade barriers in 

countries like China, and how would current regulations need to 

shift in order to do that and to promote our trade? 

Mr. JAFFE. So, the short answer is, I think that having FDA 

more involved in the oversight of GE crops with an approval process where they give their opinion about safety will actually help 

both our exporting of crops and ensuring the safety of our importing of foods. 

52 

I can give the example, so, right now, as was said in the earlier 

testimony on the first panel, FDA does not give its opinion about 

the foods and it does not explain why those GE crops are safe. So, 

therefore, China, for example, has nothing to rely upon from our 

country. They have to start from scratch in doing their own food 

safety assessment. 

I have worked, for example, in Vietnam, and Vietnam has now 

passed a regulation to implement their regulatory system that says 

if there are five countries that follow the OECD guidelines and approved a GE food, for grain, for an import, then they do not have 

to go through and approve it. It is automatically approved in that 

country. We are seeing that kind of regulation occurring in other 

countries around the world. 

The problem is, the U.S. does not have an approval for GE food, 

so we may not count as one of those five. I think if we want to get 

streamlined processes, we have to put our own opinion on the table 

first for those crops so that others can rely upon it. Our FDA is 

independent. It is one of the most well respected regulatory agencies around the world. Yet here, as you heard in the first panel, 

it avoids coming forward and saying that it thinks that these crops 

are safe. So, I think that would help consumer confidence in the 

U.S. but would also help the export of our grain products. 

[I have since found out that Vietnam does count the FDA 

voluntary consultation submission as an approval for purposes of allowing an engineered crop into its country for 

food of feed purposes.] 

It would also help the imports in the sense that China will, sooner or later, have BT rice, genetically engineered rice, and when 

they do that, we are not going to grow it in our country, but we 

will import the rice noodles, and will they go through that consultation process? I am not convinced of it. So, I think there are 

big advantages here. 

Senator DONNELLY. Thank you to the panel, and Mrs. Lidback, 

come back with your family some day and enjoy this process without being behind a table. 

Chairman ROBERTS. Senator Stabenow. 

Senator STABENOW. Well, Mr. Chairman, I just want to thank 

you for the hearing and everyone on the panel and members. Obviously, there is a great deal of interest in this. 

I want to just indicate as we close that we have been talking a 

lot about science today, and I believe in science, and because I believe in science, I know that climate change is real. Because I believe in science, I believe that genetically modified foods are safe. 

I hope we will continue to focus on science and I am also hopeful 

that we can come together in a bipartisan way that addresses the 

legitimate and growing concerns of consumers about having information about their food. Thank you. 

Chairman ROBERTS. Thank you, Senator. 

Today, we have heard clearly from the regulators that agriculture biotechnology is safe, and foods consisting of such ingredients are safe. As this committee and the Senate moves forward to 

address issues on labeling or other regulations, it seems to me we 

must keep in mind the role of government and the mandates imposed by the government, mandates at any level of government, 

53 

should be based on science and address the concerns of health and 

safety. Mandating regulations based on any metric with any yardstick other than science, health, and safety exceeds the role of government. 

If producers and manufacturers want to meet consumer demand 

for food product information not based on science, health, and safety, then they have every right and opportunity today to meet those 

demands, and it is important to meet those consumer demands, because I can assure you the most effective tool consumers have to 

change our food system is in their pocketbooks. 

To my fellow members, we would ask any additional questions 

you may have for the record be submitted to the committee clerk 

five business days from today, or by 5:00 next Wednesday, October 

28. 

Thank you to the panel and all the patience that you have demonstrated. 

The committee is adjourned. 

[Whereupon, at 1:03 p.m., the committee was adjourned.] 

(55) 

A P P E N D I X 

OCTOBER 21, 2015 

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(117) 

DOCUMENTS SUBMITTED FOR THE RECORD 

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QUESTIONS AND ANSWERS 

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