This is the accessible text file for GAO report number GAO-09-60 
entitled 'Genetically Engineered Crops: Agencies Are Proposing Changes 
to Improve Oversight, but Could Take Additional Steps to Enhance 
Coordination and Monitoring' which was released on December 5, 2008.

This text file was formatted by the U.S. Government Accountability 
Office (GAO) to be accessible to users with visual impairments, as part 
of a longer term project to improve GAO products' accessibility. Every 
attempt has been made to maintain the structural and data integrity of 
the original printed product. Accessibility features, such as text 
descriptions of tables, consecutively numbered footnotes placed at the 
end of the file, and the text of agency comment letters, are provided 
but may not exactly duplicate the presentation or format of the printed 
version. The portable document format (PDF) file is an exact electronic 
replica of the printed version. We welcome your feedback. Please E-mail 
your comments regarding the contents or accessibility features of this 
document to Webmaster@gao.gov. 

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately. 

Report to the Committee on Agriculture, Nutrition, and Forestry, U.S. 
Senate: 

United States Government Accountability Office: 
GAO: 

November 2008: 

Genetically Engineered Crops: 

Agencies Are Proposing Changes to Improve Oversight, but Could Take 
Additional Steps to Enhance Coordination and Monitoring: 

GAO-09-60: 

GAO Highlights: 

Highlights of GAO-09-60, a report to the Committee on Agriculture, 
Nutrition, and Forestry, U.S. Senate. 

Why GAO Did This Study: 

Genetically engineered (GE) crops—including crops engineered to resist 
pests or tolerate herbicides—are widespread in the United States and 
around the world. Taking direction from the 1986 Coordinated Framework 
for Regulation of Biotechnology, the U.S. Department of Agriculture 
(USDA), Environmental Protection Agency (EPA), and Food and Drug 
Administration (FDA) regulate GE crops to ensure that they are safe. 
The unauthorized mixing of some GE crops with non-GE crops has caused 
controversy and financial harm. GAO examined (1) unauthorized releases 
of GE crops, (2) coordination among the three agencies, and (3) 
additional actions they have proposed to improve oversight. GAO 
gathered data from agencies and stakeholders; used criteria from prior 
GAO work to assess coordination; and reviewed agency proposals. 

What GAO Found: 

Unauthorized releases of GE crops into food, animal feed, or the 
environment beyond farm fields have occurred, and it is likely that 
such incidents will occur again. While there is no evidence that the 
six known releases into the food or feed supply or into crops meant for 
the food or feed supply affected human or animal health, some resulted 
in lost trade opportunities. Moreover, the total number of unauthorized 
releases into the environment is unknown. USDA and EPA have the 
authority to inspect fields in which GE crops are tested, but crop 
developers have detected most violations. USDA and EPA have taken 
enforcement actions in response to violations, ranging from warning 
letters to significant penalties. The agencies have used lessons 
learned from unauthorized releases to make regulatory and policy 
changes. For example, USDA increased inspections of field trial sites 
for GE crops producing pharmaceutical compounds; EPA discontinued a 
policy under which a GE crop containing a pesticidal agent could be 
approved for animal feed, but not for food; and FDA established a 
voluntary early food safety evaluation program for certain GE crops 
intended for food use to help mitigate the impact should unauthorized 
releases occur during field trials, although it has not made these 
evaluations available to the public. 

USDA, EPA, and FDA routinely coordinate their oversight and regulation 
of GE crops in many respects, but could improve their efforts. 
Specifically, USDA and FDA do not have a formal method for sharing 
information that could enhance FDA’s voluntary early food safety review 
for certain GE crops in the field trial stage and support USDA’s 
oversight. Also, the three agencies do not have a coordinated program 
for monitoring the use of marketed GE crops to determine whether the 
spread of genetic traits is causing undesirable effects on the 
environment, non-GE segments of agriculture, or food safety, as 
recommended by the National Research Council and others. 

USDA, EPA, and FDA have proposed regulatory changes intended to improve 
their oversight of GE crops. In 2007, USDA assessed a wide array of 
regulatory alternatives that could redefine, on the basis of risk, 
which GE crops it regulates and how it will respond to unauthorized 
releases. USDA’s fiscal year 2009 budget request also seeks funding for 
a voluntary system to help GE crop developers employ best management 
practices to reduce the risk of unauthorized releases. Furthermore, the 
2008 Farm Bill required USDA to take actions on lessons learned from 
its investigation of an unauthorized release of GE rice. EPA has 
proposed several changes to its regulations for GE crops that produce 
pesticides, including one change that would distinguish between 
pesticidal agents produced in GE crops and those applied topically to 
crops. In 2001, FDA proposed to require that GE food developers notify 
the agency before marketing their products. However, as of July 2008, 
FDA had not taken action to finalize the proposed rule, believing its 
current approach calling for voluntary notice is sufficient. 

What GAO Recommends: 

GAO recommends that (1) FDA make public the results of its early food 
safety assessments of GE crops; (2) USDA and FDA develop an agreement 
to share information on GE crops with traits that, if released into the 
food or feed supply, could cause health concerns; and (3) USDA, EPA, 
and FDA develop a risk-based strategy for monitoring the widespread use 
of marketed GE crops. FDA agreed with the first recommendation, and, 
with USDA, agreed in part with the second. The agencies agreed in part 
with the third recommendation. We stand by the recommendations. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-09-60]. For more 
information, contact Lisa Shames at (202) 512-3841, or shamesl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

Unauthorized Releases of GE Crops Have Caused Financial Losses, and the 
Agencies Have Taken Steps to Reduce the Likelihood of Future Releases: 

Routine Interagency Coordination of Programs Occurs, but Opportunities 
Exist for Further Coordination among the Agencies: 

Agencies Are Considering Regulatory Changes and Other Initiatives to 
Improve Oversight and Further Limit the Impact of Potential 
Unauthorized Releases: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Objectives, Scope, and Methodology: 

Appendix II: Comments from the U.S. Department of Agriculture: 

Appendix III: Comments from the Department of Health and Human Services 
(FDA): 

Appendix IV: U.S. Legal Framework for Regulation of GE Crops: 

Appendix V: Summary Information on USDA Notifications and Permits for 
Field Trials of GE Crops: 

Appendix VI: Information on the Commercialization of GE Crops: 

Appendix VII: Six Documented Incidents of Unauthorized Release of GE 
Crops into the Food and Feed Supply: 

Appendix VIII: GE Regulatory Issues and Alternatives Discussed in 
USDA's DEIS and Proposed Rule: 

Appendix IX: GAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Tables: 

Table 1: Key Statutes Relevant to the Regulation of GE Plants: 

Table 2: Summary of the Six Known Unauthorized Releases of Regulated GE 
Crops into the Food and Feed Supply, 2000-2008: 

Table 3: USDA Data on Incidents from January 2003 through August 2007: 

Table 4: Key Legislation That Is Relevant to the Regulation of GE 
Crops: 

Table 5: GE Crops Granted Nonregulated Status by USDA and their 
Marketing Status in the United States and Other Countries: 

Table 6: GE Regulatory Issues and Alternatives Discussed in USDA's DEIS 
and Proposed Rule: 

Figures: 

Figure 1: Use of Biotechnology to Create a Pest-Resistant Plant: 

Figure 2: USDA Enforcement Actions, 2003 through 2007: 

Figure 3: Annual Number of Notifications and Permits Approved by USDA, 
1987 through 2007: 

Figure 4: Number of Field Trials by the Genetic Characteristic Tested, 
1987 through 2007: 

Abbreviations: 

APHIS: Animal and Plant Health Inspection Service: 

BQMS: Biotechnology Quality Management System: 

Bt: Bacillus thuringiensis: 

DEIS: draft programmatic environmental impact statement: 

EPA: Environmental Protection Agency: 

FDA: Food and Drug Administration: 

FFDCA: Federal Food, Drug, and Cosmetic Act: 

FIFRA: Federal Insecticide, Fungicide, and Rodenticide Act: 

GE: genetic engineering: 

IES: Investigative and Enforcement Services: 

OECD: Organisation for Economic Cooperation and Development: 

OSTP: Office of Science and Technology Policy: 

PPA: Plant Protection Act: 

PVCP: plant virus coat protein: 

USDA: U.S. Department of Agriculture: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

November 5, 2008: 

The Honorable Tom Harkin: 
Chairman: 
The Honorable Saxby Chambliss: 
Ranking Member: 
Committee on Agriculture, Nutrition, and Forestry: 
United States Senate: 

The genetic engineering of agricultural crops is seen as both promising 
and controversial, with potentially significant implications for the 
United States' and other countries' food security and economic well- 
being, the environment, and international relations and trade. 
Proponents cite the potential for enhanced crop yields; more 
environmentally friendly food production; more nutritious foods; and 
the increased use of plants to inexpensively produce pharmaceutical 
compounds, such as human or veterinary drugs, or industrial compounds, 
such as substances used in paper production or detergent manufacturing. 
Opponents argue that not enough is known about the safety of 
genetically engineered (GE) crops and food, and that they should be 
more rigorously controlled than conventional alternatives. This debate 
has been exacerbated by several well-publicized cases of unauthorized 
release of GE crops into the food supply. For example, in August 2006, 
the U.S. Department of Agriculture (USDA) announced that trace amounts 
of a regulated variety of GE rice had been commingled with supplies of 
conventional rice. This announcement led several U.S. trading partners 
to refuse U.S. rice exports, potentially disrupting the $1.3 billion 
U.S. rice export market and leading to financial losses for U.S. 
farmers and exporters. Furthermore, there also is concern that genetic 
traits could spread from crops into the environment with unintended 
consequences for plants and animals. This debate may intensify in the 
future as genetic modifications to crops become more complex, and as 
pressures build to increase agricultural yields to meet the growing 
demand for food and biofuel. 

Currently, the United States accounts for about 50 percent of the GE 
crops planted globally. In 2008, GE varieties accounted for about 80 
percent of the corn, 92 percent of the soybeans, and 86 percent of the 
cotton planted in the United States. In 2005, GE varieties accounted 
for about 93 percent of the canola. To date, the most common 
characteristics, or traits, engineered into these crops have been 
resistance to insect pests and the ability to tolerate specific 
herbicides. The global value of GE seeds sold in 2007 was estimated at 
$6.9 billion. Food industry sources indicate that over 70 percent of 
processed foods sold in the United States contain ingredients and oils 
from GE crops. Increasingly, some countries--including Argentina, 
Brazil, Canada, and India--have embraced GE crops and food to, among 
other things, increase yields. Other countries--including many in the 
European Union and some in Africa--have resisted GE crops and food, 
citing safety and economic concerns. 

Three federal agencies have primary responsibility for regulating GE 
crops and food in the United States: USDA, the Environmental Protection 
Agency (EPA), and the Food and Drug Administration (FDA). USDA is 
responsible for assessing whether GE crops pose a risk as "plant pests" 
that could directly or indirectly harm plants. To accomplish this, USDA 
regulates the importation, interstate movement, and release of GE crops 
into the environment, the latter of which could occur when a developer 
tests the crop in a field trial. USDA may, upon finding a GE crop does 
not pose a potential plant pest risk, grant a petition to extend 
"nonregulated" status to the crop, meaning that it can be moved or 
released without agency oversight. USDA also has the authority to 
regulate GE plants as noxious weeds; a noxious weed is any plant or 
plant product that can injure or cause damage to, among other things, 
crops, livestock, interests of agriculture, public health, or the 
environment. EPA is responsible for regulating all pesticides, 
including those produced by plants that have been genetically modified 
to protect themselves from insects, bacteria, and viruses. USDA and, to 
a lesser extent, EPA exercise oversight of the thousands of field 
trials in which developers have tested new varieties of GE plants since 
1987. FDA has primary responsibility for ensuring the safety of most of 
the nation's food supply and encourages companies to voluntarily submit 
safety data on a new food or feed derived from GE crops before it is 
marketed. The President's Office of Science and Technology Policy 
(OSTP) published the final version of the Coordinated Framework for 
Regulation of Biotechnology (Coordinated Framework) in 1986. This 
document outlines the federal government's policy for ensuring the 
safety of GE organisms, including relevant laws and definitions. It was 
developed in response to concerns that products resulting from genetic 
engineering might pose greater risks than those resulting from 
traditional breeding techniques. 

In this context, you asked us to examine (1) unauthorized releases of 
GE crops into the food or feed supply, or the environment; (2) the 
degree of coordination among the three key agencies that regulate GE 
crops under the 1986 Coordinated Framework--USDA, EPA, and FDA; and (3) 
additional actions these agencies have proposed to improve the 
oversight of GE crops and reduce the potential for unauthorized 
releases. 

In conducting this work, we spoke with and reviewed documents provided 
by officials at USDA, EPA, and FDA as well as OSTP, which is charged 
with coordinating federal government policy on biotechnology. We also 
reviewed scientific and technical studies and other literature and 
spoke with officials in academia, private industry, and consumer 
groups. We reviewed applicable laws and regulations as well as 
available public comments on several agency-proposed GE regulations or 
initiatives as of October 2008. In addition, we reviewed information on 
all known unauthorized releases of GE crops into the food or feed 
supply as of September 2008, and on potentially unauthorized releases 
of GE crops into the environment for the period of January 2003 through 
August 2007. We assessed the agencies' coordination efforts, using 
criteria that we have developed in prior work on agency collaboration 
and coordination.[Footnote 1] We did not assess the federal regulation 
of GE animals. Furthermore, we did not assess U.S. efforts to reduce 
barriers to international trade in GE agricultural commodities. A more 
detailed description of our objectives, scope and methodology is 
presented in appendix I. We conducted this performance audit from July 
2007 to November 2008 in accordance with generally accepted government 
auditing standards. These standards require that we plan and perform 
our audit to obtain sufficient, appropriate evidence to provide a 
reasonable basis for our findings and conclusions based on our audit 
objectives. We believe that the evidence obtained provides this 
reasonable basis. 

Results in Brief: 

Federal agencies have documented six unauthorized releases of GE crops 
into the food and feed supply or into crops meant for the food or feed 
supply and additional releases into the environment, as of September 
2008, and the ease with which genetic material from crops can be spread 
makes future releases likely. While the agencies maintain that there is 
no evidence that any of the known releases have adversely affected 
human or animal health or the environment, several releases resulted in 
food recalls or lost trade opportunities that caused financial losses. 
Moreover, the actual number of unauthorized releases is unknown. 
Specifically, while USDA and EPA regulations subject crop developers to 
periodic inspections by federal or state personnel to ensure that 
developers have taken adequate measures to isolate regulated GE crops 
from other crops, USDA does not have the resources to inspect all 
sites, and EPA and the states have not made inspections a priority. In 
most cases, crop developers have self-reported known unauthorized 
releases and other violations of regulations. USDA and EPA have taken 
enforcement actions--ranging from issuing warning letters to assessing 
significant financial penalties--against GE crop developers who 
violated regulations. USDA, EPA, and FDA have also taken steps in 
response to these incidents to reduce the potential for future 
unauthorized releases and to mitigate the impact of any releases. For 
example, USDA has increased the frequency of inspections of field trial 
sites for GE crops producing pharmaceutical and industrial compounds; 
EPA has discontinued a policy under which a GE crop containing a 
pesticidal agent could be approved for animal feed, but not for food; 
and FDA has established a voluntary early food safety evaluation of GE 
crops that might pose a new risk to help mitigate the impact of 
unauthorized releases, although FDA has not yet fulfilled a commitment 
to publish the results of those evaluations. 

As called for by the Coordinated Framework and measured against other 
established criteria, the three federal agencies routinely work 
together to regulate GE crops. For example, the agencies have agreed on 
their respective roles and responsibilities and developed mechanisms 
for making policy decisions, sharing information, and responding to 
incidents. However, the agencies could enhance their coordination by 
leveraging resources and developing mechanisms to monitor and evaluate 
results. For example, USDA and FDA do not have a formal method for 
sharing information that could enhance FDA's voluntary early food 
safety evaluation of certain GE crops in the field trial stage and 
USDA's oversight of those field trials. Sharing such information could 
better leverage resources to address food safety issues for GE crops at 
the field trial stage. In addition, USDA, EPA, and FDA do not have a 
coordinated program for monitoring and evaluating the use of marketed 
GE crops to determine whether they are causing (1) undesirable effects 
to the environment or economic harm to non-GE segments of agriculture 
through the unintentional spread of GE traits or (2) food safety 
concerns, such as the unintentional introduction of pharmaceutical or 
industrial compounds into the food supply. Several organizations, such 
as the National Research Council, have made such recommendations 
regarding the monitoring of GE crops. 

USDA, EPA, and FDA have proposed several regulatory changes intended to 
improve the oversight of GE crops and reduce the potential for 
unauthorized release. For example, in July 2007, USDA released a draft 
programmatic environmental impact statement (DEIS) that assessed 
proposals to modify many aspects of how the agency regulates GE crops, 
such as how it will respond to the unauthorized release of low levels 
of GE crops and how it will address the food safety risks posed by GE 
crops that produce pharmaceutical or industrial compounds when setting 
requirements for field trials. In October 2008, USDA released for 
public comment its proposed amendments to those regulations. In 
addition, USDA's fiscal year 2009 budget request seeks funding to 
establish a voluntary system to encourage GE crop developers to employ 
best management practices for field trials and the handling of 
regulated materials, including third-party audits of their field trial 
plans and records. The Food, Conservation, and Energy Act of 2008 (2008 
Farm Bill) directs USDA to consider regulatory and procedural changes 
based on the agency's Lessons Learned and Revisions Under Consideration 
for APHIS' Biotechnology Framework, a document resulting from lessons 
learned from its investigation of the unauthorized release of GE rice 
into the food supply in 2006, as well as from its years of regulatory 
experience, and to take action to, among other things, enhance the 
availability of genetic samples from developers and the quality and 
completeness of records by developers. For its part, EPA is working on 
three proposed changes to regulations, including one that would make a 
distinction between pesticidal agents produced in GE crops and 
pesticides made from chemicals that are applied topically to crops, 
noting that currently approved GE-based pesticides are less toxic and, 
therefore, generally present less risk. FDA proposed in 2001 to 
require--rather than to encourage, as it does now--developers of GE 
food products to consult with the agency about the safety of the food 
before it is marketed. However, as of July 2008, FDA had not taken 
action to finalize the proposed rule. FDA officials told us that such a 
rule may no longer be needed because the voluntary consultation process 
is working well and fully protects the public health. 

To ensure that the federal government addresses emerging risks 
associated with new developments in GE crops, we are recommending that 
FDA post on its Web site the results of its early food safety 
evaluations, and that USDA and FDA develop a formal agreement to share 
information concerning GE crops with novel genetic traits that could 
cause, or are likely to cause, health concerns if unintentionally 
released into the food or feed supply. We are also recommending that 
USDA, EPA, and FDA develop a coordinated strategy for monitoring the 
marketed use of GE crops for unintended consequences to the 
environment, non-GE segments of agriculture, or food safety. 

In commenting on a draft of this report, USDA, EPA, and FDA generally 
agreed with the report's findings. On the first recommendation, FDA 
said it intends to make every effort to fulfill its commitment to post 
to its Web site the results of completed and future early food safety 
evaluations. However, FDA also said that activities of greater public 
health priority have been the focus of its limited resources. 
Nevertheless, we believe that posting the results of these evaluations 
would be a low-cost way to increase public transparency and mitigate 
the impact of unintended releases of GE crops. Regarding the second 
recommendation, USDA and FDA agreed, in part, saying that they would 
explore the development of a formal agreement for sharing information 
on GE crops with novel genetic traits. However, they also said that 
they should focus their resources on issues that present or are likely 
to present public health concerns, rather than perceived concerns. We 
modified this recommendation to remove the reference to "perceived 
health concerns" and instead emphasize that the agreement would cover 
GE crops that present or are likely to present public health concerns. 
Concerning the third recommendation, USDA, EPA, and FDA agreed, in 
part, to the development of a coordinated strategy to do risk-based 
monitoring of marketed GE crops for unintended consequences. However, 
USDA emphasized that its current regulations limit it to monitoring 
only regulated crops that pose a potential plant pest risk; EPA stated 
that GE crops that produce pesticides do not require any further post- 
market monitoring; and FDA said post-market monitoring of food and feed 
derived from GE crops is not necessary and random sampling to detect GE 
crops producing pharmaceutical or industrial substances in food and 
feed would present significant technical challenges and greatly affect 
resources. Nevertheless, the agencies agreed to enter into discussions 
to develop a coordinated strategy should such monitoring be necessary 
in the future. Given that in the United States (1) GE crop varieties 
are grown extensively, (2) most processed foods contain ingredients 
from GE crops, (3) it is inherently difficult to prevent the spread of 
plant genetic material in the environment, (4) there may be an 
increasing use of GE crops to produce an even wider array of 
pharmaceutical and industrial compounds in the future, and (5) genetic 
modifications are becoming increasingly complex in response to 
pressures to increase yields for food and biofuel, we continue to 
believe the agencies should develop a coordinated strategy for risk- 
based monitoring of marketed GE crops. 

USDA's and FDA's comments are presented in appendixes II and III, 
respectively. EPA provided its comments orally. EPA and FDA also 
provided technical comments that we have incorporated as appropriate. 

Background: 

Genetic engineering refers to the technology of modifying the genetic 
makeup of crops, animals, or microorganisms by introducing genes for 
specific traits. For centuries, people have crossbred related plants or 
animal species to develop useful new varieties or hybrids with 
desirable traits, such as better taste or increased productivity. 
Traditional crossbreeding, however, can be very time-consuming because 
it may require breeding several generations to obtain a desired trait 
and breed out numerous unwanted characteristics. Genetic engineering 
techniques allow for faster development of new crop or livestock 
varieties, since the genes for a given trait can be readily 
incorporated into a plant or animal species to produce a new variety 
incorporating that specific trait. In addition, genetic engineering 
increases the range of traits available for developing new varieties by 
allowing genes from totally unrelated species to be incorporated into a 
particular crop or animal variety. 

Seed developers have experimented with engineering a wide variety of 
traits into plants, including insect resistance; herbicide tolerance; 
resistance to viruses, bacteria, and fungi; enhanced product quality, 
such as increased oil content, delayed ripening, and altered color; and 
other properties, such as increased tolerance to drought or cold. For 
example, as shown in figure 1, scientists produced insect-resistant 
plants by identifying a gene responsible for insect resistance in an 
organism, isolating and copying the gene, and then inserting the gene 
into the target plant's DNA. 

Figure 1: Use of Biotechnology to Create a Pest-Resistant Plant: 

[Refer to PDF for image] 

This figure illustrates the use of biotechnology to create a pest-
resistant plant, as follows: 

* The microorganism Bacillus thuringiensis (Bt) produces an 
insecticidal substance. 

* Bt gene is inserted into corn (maize) DNA. 

* The resulting corn variety (Bt corn) produces its own insecticide, 
reducing the need for farmers to spray pesticides. 

Sources: GAO and Art Explosion (clip art). 

[End of figure] 

In 1986, OSTP published the Coordinated Framework, which outlined the 
regulatory approach; relevant laws; and regulations for, and a 
definition of, GE organisms. This document states that existing 
statutes provide a basic network of agency jurisdiction over genetic 
engineering both for research and products. The statutes most relevant 
to the regulation of GE crops are shown in table 1, with additional 
details provided in appendix IV. In 1992, OSTP elaborated on the 
Coordinated Framework with a policy announcement that (1) called for 
the oversight of GE organisms only when there is evidence of 
"unreasonable" risk, that is, when the reduction in risk obtained by 
oversight is greater than the cost of oversight, and (2) expected 
federal agencies to focus on the characteristics and risks of 
biotechnology products, not on the process by which these products are 
created. 

Table 1: Key Statutes Relevant to the Regulation of GE Plants: 

Statute: Plant Protection Act[A] (PPA); 
Relevance to the regulation of GE crops: Authorizes the Secretary of 
Agriculture to regulate the importation or movement in interstate 
commerce of plants and articles, including GE crops, that might 
introduce or disseminate a plant pest or noxious weed. 

Statute: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); 
Relevance to the regulation of GE crops: Authorizes the EPA 
Administrator to register pesticides and regulate the distribution and 
use of nonregistered pesticides, which would include those genetically 
engineered into plants. 

Statute: Federal Food, Drug, and Cosmetic Act (FFDCA); 
Relevance to the regulation of GE crops: Authorizes the Secretary of 
Health and Human Services (delegated to FDA) to regulate food, animal 
feed, additives, and human and animal drugs, which would include those 
derived from biotechnology such as GE crops; In addition, authorizes 
the Administrator of EPA to establish tolerances or tolerance 
exemptions for pesticidal chemical residues. 

Statute: National Environmental Policy Act of 1969; 
Relevance to the regulation of GE crops: Requires all federal agencies 
to consider the likely environmental effects of actions they are 
proposing, and if those actions would significantly affect the 
environment, provide an environmental impact statement. Such statements 
could be required for actions related to the regulation of GE crops. 

Source: GAO. 

[A] In 2000, the Plant Protection Act incorporated many authorities of 
the Federal Plant Pest Act, the Plant Quarantine Act, and the Federal 
Noxious Weed Act of 1974 and repealed all but a few provisions of those 
acts. 

[End of table] 

Responsibility for implementing the Coordinated Framework fell 
primarily to three agencies--USDA, EPA, and FDA--with USDA designated 
as the lead agency for plants and animals. Each agency has specific 
requirements for certain activities with GE crops, and not all three 
agencies are necessarily involved in overseeing each activity or use of 
a GE crop. The applicability of these requirements to GE crops depends 
upon several factors, including the type of trait engineered into the 
plant and the proposed use of the crop. Specific responsibilities of 
the agencies are described in the following text. 

USDA Oversees the Movement and Environmental Releases of Regulated GE 
Crops: 

USDA regulations require persons seeking to import, move interstate, or 
release into the environment GE crops to first submit a notification to 
the agency or obtain a permit, depending on the risk that the GE crop 
poses, with notification being the more administratively streamlined 
option: 

* Notification: USDA regulations provide that GE crops may be released 
into the environment or moved under a notification, rather than with a 
permit, if they meet the following six criteria. 

1. The GE crop species is not listed in regulation as a noxious weed or 
considered by the Administrator of USDA's Animal and Plant Health 
Inspection Service to be a weed for the area of release. 

2. The introduced genetic material is "stably integrated" in the crop's 
genome. 

3. The function of the introduced genetic material is known and does 
not result in plant disease. 

4. The introduced genetic material does not cause the production of an 
infectious entity, produce a substance that is likely to be toxic to 
nontarget organisms, or produce a product intended for pharmaceutical 
or industrial use. 

5. The introduced genetic sequences do not pose a significant risk of 
the creation of a new plant virus. 

6. The crop has not been modified to contain certain genetic material 
from animal or human pathogens. 

USDA regulations also require that activities conducted under a 
notification meet certain performance standards. Namely, regulated GE 
crops must be handled in such a way that they do not persist in the 
environment or get mixed with nonregulated plant materials. A general 
technique for avoiding mixing is to isolate the GE crops from non-GE 
crops, and USDA has described in guidance documents a number of steps 
that developers may take, such as bagging or netting the plants to 
contain the seeds, planting border rows, or using sterile male 
varieties. 

* Permit: The USDA permit process is for those GE crops that cannot be 
introduced under notification, such as plants engineered to produce 
pharmaceutical or industrial compounds or modified with genetic 
material that causes the production of an infectious entity or toxic 
substance. Permits spell out specific requirements for conducting the 
activity, with the permit conditions for GE crops that produce 
pharmaceutical or industrial compounds typically being the most 
restrictive. For example, permit conditions for these types of GE crops 
require that the fallow zones around field trial sites be larger than 
for other types of crops, that farmers use dedicated machinery 
(harvesters or planters) and storage facilities, and that the permit 
holder implement a training program for its personnel. 

Permits or notifications are also required for the interstate movement 
or importation of regulated GE crops. For example, the requirements 
relevant to these permits address such matters as the points of origin 
and destination, packaging, and record keeping. 

From fiscal years 1987 through 2007, USDA issued almost 19,000 
notifications and almost 4,300 permits for environmental releases, 
importation, and interstate movement. Over 13,000 of the notifications 
and permits were for releases into the environment, also known as field 
trials.[Footnote 2] A single permit or notification for a field trial 
may cover more than one location at which a GE crop can be tested. (See 
app. V for details on the yearly rate at which USDA has issued permits 
and acknowledged notifications for field trials and on the types of 
genetic characteristics those trials covered.) 

USDA regulations also allow for persons, including GE crop developers, 
to petition the agency to deregulate a GE crop. If USDA deregulates the 
crop, it is no longer subject to regulatory control under the Plant 
Protection Act, unless USDA finds it to be a plant pest or noxious weed 
on the basis of new data or analysis. Petitioning USDA is the typical 
route to commercialization, since it allows planting with less 
restrictive conditions than those imposed by a permit or the 
notification process. However, according to USDA officials, a GE crop 
developer could market a product that is still regulated. As of July 
2008, USDA had received 113 petitions for deregulation and approved 73. 
(See app. VI for more details on deregulated and marketed GE crops.) 

EPA Regulates Pesticides Produced in GE Crops: 

EPA is responsible for regulating the genetic materials engineered into 
a crop to produce pesticides that ward off insects, bacteria, and 
viruses, as well as the pesticide that the crop ultimately produces 
(known as a "plant-incorporated protectant," but referred to in this 
report as a "GE pesticide"). As with conventional chemical or 
biological pesticides, EPA regulates the sale, distribution, and use of 
GE pesticides, and producers must register them before they are put 
into commercial use. Since 1995, EPA has registered 29 GE pesticides 
engineered into 3 crops--corn, cotton, and potatoes--5 of which have 
since been voluntarily canceled. (See app. VI for more details about 
EPA's process for registering GE pesticides.) 

EPA requires persons seeking to conduct field trials of GE crops 
containing pesticides on more than 10 cumulative acres to apply for an 
experimental use permit. These crops generally have shown promise in 
previous small-scale field trials (less than 10 cumulative acres) 
regulated by USDA and are potential candidates for future 
commercialization. To receive a permit, applicants must submit data to 
EPA on the descriptions and specific results of any appropriate prior 
testing of the product conducted by the applicants to determine 
toxicity, effects on the environment, and other matters associated with 
the GE pesticide. According to EPA, it requires that applicants 
demonstrate that regulated genetic material will not spread into other 
plants. In the absence of such a showing, EPA will impose containment 
measures which may be similar to those that USDA requires to address 
potential environmental risks. If it can be reasonably expected that 
the field trial will result in pesticide residues in food or feed, the 
applicant must submit evidence that a tolerance or tolerance exemption 
has been established or submit a petition for the establishment of a 
tolerance or tolerance exemption, or certify that the food or feed is 
disposed of in a manner that ensures it will not endanger man or the 
environment. 

Although EPA establishes tolerances, FDA, not EPA, is responsible for 
enforcing tolerances for pesticide residues on foods derived from GE 
crops. If EPA determines that there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide residue, it 
may grant an exemption from the requirement for a tolerance. FDA may 
take enforcement actions if residue of a GE pesticide enters into the 
food supply without a tolerance or exemption from tolerance. From 
fiscal years 1997 through 2007, EPA issued 65 experimental use permits 
for field trials of GE pesticides, or about 6 such permits per year. As 
of June 1, 2008, there were 8 active permits for GE pesticides, 
covering about 26,000 acres. According to EPA, it generally considers 
small-scale field trials to have adequate containment measures if they 
are conducted under USDA authorization and are in compliance with USDA 
requirements and meet EPA's requirement that no pesticide residues can 
be in the food or feed supply unless there is a tolerance or tolerance 
exemption in place. 

FDA Encourages Developers to Consult on Food Safety Issues before 
Marketing GE Crops, and Regulates GE Pharmaceutical Products: 

FDA is responsible for ensuring the safety of most of the food supply, 
with the exception of meat, poultry, and egg products, which are under 
USDA's authority. FDA established its basic policy regarding the review 
of GE foods in its 1992 Statement of Policy: Foods Derived from New 
Plant Varieties, which explained that substances introduced into food 
or feed by way of breeding were potential food additives if they were 
not generally recognized as safe or if they were pesticides, and 
described the kinds of assessments FDA expected companies to perform to 
assure themselves that foods and feeds from new plant varieties were as 
safe as comparable foods and feeds already on the market, and otherwise 
did not raise regulatory concerns. In 1995, FDA established its 
voluntary consultation process, through which companies developing 
foods and feeds from GE plants voluntarily notify the agency and submit 
a safety assessment report containing a summary of test data and other 
information on the foods before they are marketed. The company 
evaluates, for example, whether the level of allergens, toxins, 
nutrients, and antinutrients--compounds that inhibit the absorption of 
nutrients--in the GE food is comparable to the level of these 
substances in the food's conventional counterpart, and whether the GE 
food contains any new allergens or toxins. FDA assists the company with 
questions related to the regulatory status of the food. If FDA has no 
further questions about the safety of the food or feed, it provides the 
company with a letter to that effect. Although the consultation process 
is voluntary, it is FDA's experience that companies do not commercially 
market their GE crops until they have received this letter. As of July 
2008, FDA had completed 72 voluntary consultations on GE crops intended 
for use in animal feed, human food, or both. FDA does not track which 
of these GE crops have been marketed; industry data indicate that many 
have been, but that some are no longer commercially available. (See 
app. VI for more details about GE crops that developers have marketed.) 

For plants engineered for a nonfood use, such as those that produce a 
pharmaceutical compound, FDA subjects the pharmaceutical product to the 
drug or biologic review and approval process. In 2002, in collaboration 
with USDA, FDA published draft guidance to the biotechnology industry 
that outlined some of the steps industry should take to ensure that 
regulated products do not become mixed with the food or feed supply and 
manufacturing information that should be submitted to FDA with 
applications for marketing approval. 

Unauthorized Releases of GE Crops Have Caused Financial Losses, and the 
Agencies Have Taken Steps to Reduce the Likelihood of Future Releases: 

Federal agencies have documented the unauthorized releases of regulated 
GE crops into the food supply and the environment. While none of these 
releases are known to have affected human or animal health or the 
environment, some releases into the food supply had substantial 
financial consequences. Specifically, there have been six known 
releases of GE crops into the food or feed supply or into crops meant 
for the food or feed supply; with the first occurring in 2000. While 
these releases have not harmed human or animal health, several had 
significant financial consequences, including product recalls and 
destruction and lost trade opportunities. USDA data indicate that there 
have been more unauthorized releases of regulated crops into the 
environment, but the agency says that they have not caused 
environmental harm. USDA and EPA have taken enforcement actions in 
response to violations, including several large financial penalties. 
All three agencies have taken steps in response to known unauthorized 
releases to reduce the potential for future unauthorized releases or to 
mitigate their impact. 

Known Unauthorized Releases of GE Crops Apparently Have Not Caused 
Health Effects, but Several Caused Financial Losses: 

There have been six known incidents of the unauthorized release of 
regulated GE crops into the food supply or into crops meant for the 
food supply--four involving GE varieties of corn and the remaining two 
involving a GE variety of rice. (See table 2.) These incidents 
apparently have not caused health effects, but several led to financial 
losses for farmers and exporters. While the specific causes of 
unauthorized releases vary by incident, from cross-pollination of 
regulated and conventional crops to the mislabeling of bags of seeds, 
they highlight the challenges of containing regulated GE crops given 
the porous nature of biological systems and the potential for human 
error. (See app. VII for a detailed description of each of these 
incidents.) According to USDA, large-scale annual field testing of GE 
crops occasionally results in materials from these trials being 
detected at low levels in commercial commodities and seeds. Most 
officials we asked, including representatives from the biotechnology 
industry, agricultural commodity growers, and consumer advocacy 
organizations, also told us that future unauthorized releases of low 
levels of regulated GE material are likely to occur. 

Table 2: Summary of the Six Known Unauthorized Releases of Regulated GE 
Crops into the Food and Feed Supply, 2000-2008: 

Year: 2000; 
Product: StarLink; 
Crop: Corn; 
Trait: Insect resistance and herbicide tolerance; 
Cause: Cross-pollination, commingling of corn after harvest; 
Detection: Third-party testing. 

Year: 2002; 
Product: Prodigene; 
Crop: Corn; 
Trait: Pharmaceutical protein; 
Cause: Cross-pollination and uncontrolled volunteers[A]; 
Detection: USDA inspection. 

Year: 2004; 
Product: Syngenta Bt10; 
Crop: Corn; 
Trait: Insect resistance; 
Cause: Misidentified seed; 
Detection: Third-party testing. 

Year: 2006; 
Product: Liberty Link Rice 601; 
Crop: Rice; 
Trait: Herbicide tolerance; 
Cause: Not determined; 
Detection: Third-party testing. 

Year: 2006; 
Product: Liberty Link Rice 604; 
Crop: Rice; 
Trait: Herbicide tolerance; 
Cause: Not determined; 
Detection: Third-party testing. 

Year: 2008; 
Product: Event 32; 
Crop: Corn; 
Trait: Insect resistance; 
Cause: Under investigation; 
Detection: Developer testing. 

Source: GAO analysis of USDA and EPA data. 

[A] "Uncontrolled volunteers" refers to plants from a previous season's 
field trial that grow on their own without being deliberately planted. 

[End of table] 

The regulated materials in these six incidents were detected at 
different points in the food and feed supply. For example, in the 
StarLink corn incident--a GE corn containing a pesticidal protein that 
was approved only for animal feed and not for human food--trace amounts 
of the pesticidal protein were detected in consumer products, such as 
taco shells and corn bread. The presence of the pesticidal protein in 
human food rendered it adulterated. Therefore, FDA requested food 
processors to recall potentially affected food products. In the 
Prodigene corn incident, USDA discovered that the regulated crop had 
been mistakenly harvested and commingled with soybeans in a grain silo. 
USDA ordered the soybeans and GE corn destroyed before they were sold 
commercially. 

With the exception of Prodigene corn, the regulated material in all of 
the incidents involved traits of herbicide tolerance and insect 
resistance familiar to federal regulators. In addition, the regulated 
materials found in Syngenta Bt10, Liberty Link Rice 601 (LLRICE 601), 
Liberty Link Rice 604 (LLRICE 604), and Event 32, were very similar to 
GE material that had already been reviewed by EPA, FDA, or both, and 
deregulated by USDA. Shortly after each of these four incidents, EPA, 
FDA, or both, issued statements attesting to the safety of the low- 
level presence of the regulated GE crops in the food and feed supply. 

While USDA, EPA, and FDA have determined that none of these six 
incidents of unauthorized release harmed human or animal health, some 
cases led to financial losses, particularly from lost sales to 
countries that would not accept crops containing the regulated GE 
varieties. For example, in response to the detection of regulated GE 
rice in commercial rice supplies in the United States in 2006, several 
of the leading importers of U.S. rice either banned the import of 
certain varieties of rice imports or imposed new testing requirements 
on rice traders. However, it is difficult to quantify the financial 
losses resulting from these unauthorized releases because many factors 
may determine the final sale price of commodity agriculture. Of the few 
estimates available, one by a group of economists estimated that the 
StarLink incident resulted in $26 million to $288 million in lost 
revenue for producers in market year 2000/2001. (According to USDA, 
U.S. cash receipts for corn totaled about $15.2 billion in 2000.) 
Similarly, a separate study by university economists estimated that the 
presence of StarLink in the food supply in 2000 caused a 6.8 percent 
drop in the price of corn, lasting for 1 year. More recently, an 
environmental advocacy group estimated that the worldwide costs 
resulting from the LLRICE incidents, including the costs associated 
with the loss of export markets, seed testing, elevator cleaning, and 
food recalls in countries where the variety of rice had not been 
approved, ranged from $741 million to $1.285 billion. 

USDA Says That Unauthorized Releases of GE Crops Have Not Caused 
Environmental Harm: 

In addition to known unauthorized releases to the food supply, USDA 
data indicate there have been other potentially unauthorized releases 
of GE crops into the environment. However, USDA has concluded that 
these releases have not caused harm. Most of the reports of such 
incidents were self-reported by the developers, rather than identified 
through USDA inspections. In 2007, USDA analyzed its record of over 700 
violations or potential violations that occurred from January 2003 
through August 2007 and found 98 that indicated a possible release into 
the environment, as shown in table 3. 

Table 3: USDA Data on Incidents from January 2003 through August 2007: 

Total number of permits and notifications: 6,983; 

Number of violations or potential violations: 712; 

USDA categories of violations that could indicate a release to the 
environment: Persistence in the environment[B]; 
Number of violations or potential violations identified by USDA[A]: 7. 

USDA categories of violations that could indicate a release to the 
environment: Production and/or persistence of progeny (offspring); 
Number of violations or potential violations identified by USDA[A]: 4. 

USDA categories of violations that could indicate a release to the 
environment: Animal-related release, incursion, destruction, or 
consumption; 
Number of violations or potential violations identified by USDA[A]: 33. 

USDA categories of violations that could indicate a release to the 
environment: Weather-related release, incursion, or destruction; 
Number of violations or potential violations identified by USDA[A]: 17. 

USDA categories of violations that could indicate a release to the 
environment: Movement of propagules into the environment[C]; 
Number of violations or potential violations identified by USDA[A]: 16. 

USDA categories of violations that could indicate a release to the 
environment: Isolation distance or other flower control insufficiency; 
Number of violations or potential violations identified by USDA[A]: 21. 

Source: USDA. 

[A] An incident may involve more than one violation or potential 
violation. 

[B] A GE crop that is persistent in the environment is one that 
produces a sustained population in agricultural or nonagricultural 
habitats without human intervention. 

[C] Propagules are any part of a plant that can be detached from the 
organism and propagated in order for it to grow into a new plant. 

[End of table] 

A concern associated with the release of a GE crop into the environment 
is that its pollen containing its genetic characteristics may spread to 
wild relatives. This is known as "gene flow." There is the potential 
for the traits of insect resistance or herbicide tolerance to transfer 
to weedy relatives of a crop, which could give the weeds a competitive 
advantage or require a different herbicide for their control. The turf 
grass known as "creeping bentgrass" is an example of this concern. The 
Scotts Company has tested herbicide-resistant creeping bentgrass in the 
hopes that it can be marketed for use on golf courses and lawns. In 
2003, several environmental organizations and individuals filed suit 
against the Secretary of Agriculture and other officials for, among 
other things, permitting field tests of GE creeping bentgrass without 
adequately determining whether the crop was a plant pest that could 
spread to wild relatives or preparing an environmental impact statement 
or environmental assessment pursuant to the National Environmental 
Policy Act. Evidence presented in the case showed that the GE bentgrass 
at the field test site had pollinated wild relatives. The court found 
in February 2007 that there was no evidence that USDA considered 
whether the permitted field tests had the potential to significantly 
affect the environment when it decided that an environmental impact 
statement or assessment was not necessary. The court held that USDA 
could not process future permits without first considering whether the 
field tests involve either new species or organisms or novel 
modifications that raise new issues and, if either one exists, whether 
the field tests likely would significantly affect the quality of the 
human environment. 

Agency Inspections Have Led to Some Enforcement Actions and Penalties: 

USDA and EPA have the authority to conduct inspections of field trials 
and other activities, and the agencies do so under their respective 
regulations to help ensure compliance. USDA does not inspect all field 
trial sites where GE crops are tested; instead, it uses a risk-based 
approach to select sites for inspection. In response to violations, 
USDA has taken enforcement actions, such as issuing enforcement letters 
and assessing financial penalties. EPA, on the other hand, has 
delegated primary enforcement authority--including inspection 
responsibilities--to the states, but, according to EPA, neither the 
agency nor the states have made these inspections a priority. In 
response to violations, EPA has assessed several large financial 
penalties, but otherwise has taken few enforcement actions. However, 
USDA, EPA, and FDA have taken other actions in response to incidents of 
the unauthorized release of GE crops to reduce the likelihood of future 
releases or minimize their impact. 

USDA Follows a Risk-Based Approach to Inspect Field Trial Sites: 

USDA policy is to use a risk-based approach to selecting which field 
trials covered by permits and notifications it will inspect. The 
agency's most stringent policy applies to permits for field trials of 
GE crops engineered to produce pharmaceutical or industrial compounds. 
For those GE crops, USDA's policy calls for up to 7 inspections of 
permitted field trials, both during and after the growing season. For 
permits other than those for pharmaceutical or industrial compounds, 
USDA's policy is to inspect every permit at least once in each state in 
which a field trial is done. For example, if a permit allows for 15 
field trial sites to be planted in 7 states, at least 1 inspection will 
be done in each of the 7 states. According to USDA officials in charge 
of the inspection program, the agency has met the inspection goals for 
permitted field trials in recent years. 

USDA policy does not call for inspecting all field trials done under a 
less stringent notification. For fiscal years 2005 through 2007, USDA 
selected for inspection about one-third of the field trials conducted 
under the notification procedure on the basis of the developer's past 
compliance record, the size of the field trial, the number of field 
trial sites covered by the notification, and the type of crop being 
tested, among other factors. A developer may conduct notification field 
trials at many sites, but USDA does not necessarily inspect all of 
those sites. 

During inspections, USDA officials check records, make visual or 
photographic observations, and conduct interviews to determine 
regulatory compliance, including whether regulated material might have 
been inadvertently released. However, these officials told us that they 
do not have the resources to develop methods to conduct genetic testing 
of the area surrounding a field test site as part of routine inspection 
to determine with certainty whether regulated genetic material has 
escaped the control of the biotechnology developer. Instead, USDA 
relies on biotechnology developers to voluntarily provide them with the 
genetic testing methodology and representative samples necessary to 
detect regulated articles when USDA has reason to believe they may have 
been released from a site. According to USDA officials, to date, 
developers have been cooperative when asked to provide a testing 
methodology and representative samples, although doing so is not a 
requirement of the regulation. 

Although USDA's inspection program has detected some violations of 
regulations, it generally has found a high rate of compliance. Over the 
3-year period from fiscal years 2005 through 2007, USDA inspected field 
trials conducted under 489 permits and found that 18 (about 4 percent) 
were out of compliance. USDA also found high compliance levels at field 
trials operated under a notification; it completed 754 inspections over 
the same period and found 17 instances of noncompliance (about 2 
percent). Holders of USDA permits and notifications are required to 
self-report, and most incidents have been identified by self-report, 
rather than by inspection. 

USDA Has Taken Enforcement Actions in Response to Violations and Has 
Assessed Financial Penalties: 

From calendar years 2003 through 2007, USDA's typical enforcement 
action in response to regulatory violations generally was to issue an 
order requiring the developer to take corrective action; in a small 
number of other cases, USDA also obtained a civil monetary penalty from 
the developers. USDA handled 320 incidents representing violations or 
potential violations reported during this period. These incidents 
included those self-reported by the developer and those detected by 
USDA inspections. USDA resolved more than half of the incidents with an 
acknowledgment letter or notice indicating that the developer had 
returned to compliance or that the alleged incident was not, in fact, a 
violation. The remaining incidents led to guidance letters or notices 
of noncompliance, warning letters, or referrals to USDA's Investigative 
and Enforcement Services (IES) (see figure 2).[Footnote 3] 

Figure 2: USDA Enforcement Actions, 2003 through 2007: 

[Refer to PDF for image] 

This figure is a pie-chart depicting the following data: 

USDA Enforcement Actions, 2003 through 2007: 
Acknowledgment letter or notice of compliance: 54%; 
Guidance letter or notice of compliance: 36%; 
Referred to USDA’s IES: 5%; 
Warning letter: 5%. 

Source: GAO analysis of USDA data. 

Note: Starting in 2005, guidance letters were changed to notices of 
noncompliance. 

[End of figure] 

According to USDA officials, the agency refers serious incidents to 
IES, and only incidents that have been referred to IES have resulted in 
fines. We reviewed case files associated with the 17 referrals to IES. 
Over half were initiated in 2005 to address nationwide noncompliance by 
the Scotts Company in its development of GE creeping bentgrass. Those 
violations included allowing GE grasses to form pollen that might have 
pollinated plants outside of the field trial site, exceeding the 
allowable acreage in a field trial, missing records for particular 
field trial sites, allowing unauthorized movement of regulated GE grass 
to locations outside of the field trial site, and lacking adequate 
borders around field trial sites. In 2007, the company entered into a 
consent decision with USDA and agreed to conduct three compliance 
workshops and pay a $500,000 fine, which is the maximum allowable under 
the statute. 

Also among the referrals to IES was the 2004 Syngenta Bt10 corn 
incident, for which USDA levied a $375,000 fine. Seven other incidents 
that IES investigated in 2005 through 2007 resulted in financial 
penalties ranging from $2,500 to $40,000. The seven violations included 
failure to list a field trial site for a drought-resistant corn in its 
permit; report that a storm blew regulated bentgrass outside of the 
field trial site; and maintain the identity of regulated eucalyptus 
trees being grown in a field trial. In four of these seven incidents, 
the violator self-reported the incident. 

EPA Has Delegated Its Inspection Responsibilities to the States: 

EPA has delegated its primary enforcement authority, including 
responsibility for most inspections of field trials conducted under 
experimental use permits, to state agencies. However, according to EPA 
officials, neither EPA nor the states consider monitoring field trial 
permits for GE pesticides a high priority, partly because all of the GE 
pesticides currently being grown in field trials have already been 
evaluated for food, feed, and environmental risks and received a 
tolerance or a tolerance exemption, indicating they are relatively low 
risk.[Footnote 4] EPA does not collect information on how many 
experimental use permits the states inspected. Furthermore, EPA does 
not collect detailed information on the results of inspections. EPA can 
initiate its own investigation when there is reason to believe that an 
applicant is not meeting permit requirements. EPA officials told us 
that they exercised this option for two field trials conducted by two 
companies in Hawaii. In those instances, EPA targeted these field 
trials for inspection because the permit holders did not have a 
tolerance for the GE pesticide they were testing. EPA inspectors found 
permit violations that could have resulted in the unauthorized release 
of a GE pesticide. EPA officials said that, following these incidents, 
the agency stopped issuing experimental use permits for field trials of 
GE pesticides that do not have a tolerance or an exemption from 
tolerance. 

EPA Has Assessed Several Large Financial Penalties, but Has Taken Few 
Other Enforcement Actions Related to GE Pesticides: 

EPA has assessed several large financial penalties since it began to 
regulate GE pesticides in 1986. Otherwise, however, the agency has 
taken few enforcement actions. As of August 2008, EPA had issued 
financial penalties on four occasions for violations of pesticide laws 
and regulations involving GE pesticides, ranging from $8,800 to $1.5 
million. Two of these occasions were related to violations of field 
trial permit conditions in 2002. During the inspections in Hawaii of 
field trials of GE pesticides being grown without a pesticide 
tolerance, EPA inspectors found that one permit holder had planted 
experimental corn in an unapproved location, and that another permit 
holder did not have an appropriate buffer surrounding the field trial. 
The permit holders were fined $9,900 and $8,800, respectively. In 
addition, as part of its settlement, EPA required the first company to 
perform tests to confirm that the experimental gene grown in the field 
trial had not been transferred to adjacent fields. In 2003, EPA imposed 
an additional $72,000 penalty on that company for failing to 
immediately report to the agency the results of an initial test that 
suggested that an inadvertent release of an unregistered pesticide had 
occurred. Subsequent testing conducted by the company revealed that the 
initial test had been incorrect, but EPA still fined the company for 
failing to report the initial test results. On the remaining two 
occasions, EPA issued fines of $165,200 in 1996 and $1.5 million in 
2006 in response to separate incidents of the unauthorized sale and 
distribution of a registered pesticide. The latter fine related to the 
unauthorized release of Bt10 corn, as we have previously discussed. 
Other enforcement options available to EPA include calling for the 
destruction of products, as it did with Bt10 corn, or stopping the sale 
of a product, as it did in the case of Event 32 corn. 

Agencies Have Taken Actions in Response to Incidents of Unauthorized 
Release to Reduce Their Likelihood or Minimize Their Impact: 

In response to incidents of unauthorized release, USDA, EPA, and FDA 
have taken several actions to either reduce the likelihood that 
regulated crops would be unintentionally released into the food supply 
or the environment or to minimize the impact of such occurrences. In 
some cases, these actions were a response to specific incidents. For 
example, the StarLink corn incident led to two significant policy 
changes in the way that EPA regulates GE pesticides. First, EPA decided 
to stop issuing split registrations--in which a product is approved for 
animal feed but not for human consumption. StarLink had been the first-
-and the only--GE pesticide to receive a split registration. Second, 
EPA began requiring developers of GE pesticides receiving a tolerance 
or an exemption from tolerance to develop a quick-detection method for 
the modified gene and provide it to EPA as part of the product's 
registration. In addition, in March 2003, not long after the Prodigene 
incident, USDA published a request for comments in the Federal Register 
that included a description of more stringent permit conditions for 
environmental releases of plants that produce pharmaceutical and 
industrial compounds. USDA also announced that it would increase the 
number of USDA field trial site inspections, stating that a field test 
may have five inspections during the growing season and two additional 
inspections post-harvest to look for volunteer plants. In addition, 
USDA would restrict what can be grown on a test site and fallow zone in 
the next growing season. 

Other actions have been a response to releases in general. In an August 
2002 Federal Register notice, OSTP articulated three principles 
regarding field trials of GE crops: (1) the level of confinement under 
which field tests are conducted should be consistent with the risks 
posed; (2) if the risk is unacceptable or unknown, field trial 
confinement requirements should be rigorous to prevent unauthorized 
releases, and the occurrence of any genes and gene products from those 
field tests in commercial seed, commodities, and processed food and 
feed would be prohibited; and (3) in other instances where risks are 
low, field trial requirements should still minimize unauthorized 
releases of gene products, but a low level of GE crops in the 
environment could be found acceptable if available data find that they 
meet applicable regulatory standards. Following that announcement, 
USDA, EPA, and FDA published notices concerning their responsibilities 
regarding field trials and the low-level presence of regulated GE 
material. Specifically: 

* In March 2007, USDA published its current policy for responding to 
low levels of regulated GE plant materials that may occur in commercial 
seeds or grain. For example, USDA may determine that remedial action is 
not necessary when (1) the regulated material is derived from plants 
that meet all of the criteria to qualify for USDA's notification 
process and (2) the regulated GE crop is similar to another GE crop 
that has already been deregulated by USDA. USDA also stated that it 
could take enforcement action against violators of regulations, even if 
it decided that no remedial actions were necessary to address the low- 
level presence of regulated GE material in commerce. 

* In May 2007, EPA released guidance for small-scale field testing and 
the low-level presence of GE pesticides in food. EPA stated if there is 
any reasonable expectation that residues of the GE pesticide being 
tested could enter the food supply, even at low levels, all crops 
affected by such tests must either be destroyed or be kept from the 
food or feed supply while additional studies using the crop are 
conducted, or the applicant must obtain a tolerance or tolerance 
exemption, regardless of the size of the field trial. EPA's policy also 
noted the FFDCA provision that a food containing pesticide residues may 
not be moved in interstate commerce without an appropriate tolerance or 
tolerance exemption. EPA also described methods that developers can use 
to isolate GE pesticides from the food or feed supply. 

* In June 2006, FDA issued guidance recommending that developers of 
certain GE crops intended for food use, but still in the field trial 
stage, engage in what the agency called a voluntary early food safety 
evaluation, whereby developers would consult with FDA about new GE 
materials produced in these plants before they might inadvertently 
enter the food supply.[Footnote 5] If FDA had already reviewed the GE 
material and had no safety concerns, the agency did not expect 
developers to participate. FDA has conducted seven such evaluations 
since 2006. FDA officials said the agency does not use data from USDA's 
permits database to identify field trials that might be candidates for 
FDA's early food safety assessments; instead FDA relies on developers 
for notification. In this guidance, FDA stated that "consistent with 
confidentiality requirements," it would make the developers' 
submissions and FDA's responses easily accessible to the public via the 
Internet. However, FDA has not done so. Agency officials indicated that 
they intend to fulfill this commitment to make submissions available 
online, but FDA has not had the resources to post the submissions. 

Routine Interagency Coordination of Programs Occurs, but Opportunities 
Exist for Further Coordination among the Agencies: 

USDA, EPA, and FDA have organizational structures and mechanisms in 
place to coordinate their oversight and regulation of biotechnology, 
but opportunities exist for further coordination and collaboration 
among the agencies. Using as criteria practices we have identified in 
prior work that can enhance and sustain collaboration among federal 
agencies, we found that agencies have agreed on roles and 
responsibilities and have established compatible policies, procedures, 
and other means to operate across agency boundaries. However, the 
agencies could enhance their coordination by further leveraging 
resources, developing mechanisms to monitor and evaluate results, and 
implementing other practices. While we have identified areas for 
improvement, most of the officials with whom we spoke did not indicate 
that they had major concerns about the adequacy of interagency 
coordination, nor did they identify changing the Coordinated Framework 
as a high priority. 

Agencies Could Enhance Coordination by Further Leveraging Resources, 
Developing Mechanisms to Monitor and Evaluate Results, and Implementing 
Other Practices: 

GAO has previously identified a set of eight practices that can enhance 
and sustain collaboration among agencies.[Footnote 6] Seven of these 
practices are as follows: 

* Defining and articulating a common outcome. 

* Agreeing on roles and responsibilities. 

* Establishing mutually reinforcing or joint strategies. 

* Identifying and addressing needs by leveraging resources. 

* Establishing compatible policies, procedures, and other means to 
operate across agency boundaries. 

* Reinforcing agency accountability for collaborative efforts through 
agency plans and reports. 

* Developing mechanisms to monitor, evaluate, and report on the 
results. 

We evaluated the degree of coordination and collaboration among USDA, 
EPA, and FDA in their oversight of GE crops according to each of these 
practices. 

Defining and Articulating a Common Outcome: 

The three agencies are working toward the broad common outcome that was 
originally described in the Coordinated Framework. The document sought 
to achieve a balance between developing regulations adequate to ensure 
health and environmental safety and maintaining sufficient regulatory 
flexibility to avoid impeding the growth of the nascent biotechnology 
industry. To arrive at this outcome, the Coordinated Framework 
attempted to distinguish those organisms that require a certain level 
of federal review from those that do not. In general, the Coordinated 
Framework and subsequent policy statements from OSTP direct federal 
agencies to exercise oversight of GE organisms only when there is 
evidence of unreasonable risk--that is, when the value of the reduction 
in risk obtained by additional oversight is greater than the additional 
regulatory costs. Although the types of GE crops that each agency 
regulates vary, all three agencies have striven to achieve this common 
outcome through the development of risk-based regulatory systems. For 
example, USDA's two-tiered permit system, which we previously 
described, allows for GE crops that present less risk to be eligible 
for the more streamlined notification procedure, rather than a permit. 
USDA and EPA have begun other initiatives--which we discuss later in 
this report--intended to make their oversight of GE crops more risk- 
based. Similarly, because FDA considers most transferred genetic 
material to be generally recognized as safe, it does not expect 
transferred genetic material to be subject to its food additive 
regulation.[Footnote 7] 

Agreeing on Roles and Responsibilities: 

The agencies have generally agreed on their roles and responsibilities 
as they are outlined in the Coordinated Framework, which states that 
existing laws provide the basic network of agency jurisdiction and that 
jurisdiction over a GE product should be determined by its use. When 
these responsibilities overlap, the Coordinated Framework establishes a 
lead agency. When incidents of unauthorized release have occurred, the 
three federal agencies have taken actions related to their roles and 
responsibilities to protect health and environmental safety. For 
example, after the most recent unauthorized release, which involved a 
regulated GE corn known as Event 32, USDA issued emergency action 
notifications for the unauthorized movement of a regulated article, and 
EPA issued a "Stop Sale Order" to the developer of the GE corn because 
it is illegal to distribute any pesticide not registered under FIFRA. 
The three agencies also issued a joint statement in which USDA 
concluded that Event 32 poses no plant pest or environmental concerns; 
EPA determined that the pesticidal material produced by Event 32 is 
identical to that found in an approved GE pesticide and, therefore, it 
is covered by an existing tolerance exemption; and FDA concluded there 
were no food or feed safety concerns. 

Establishing Mutually Reinforcing or Joint Strategies: 

The three agencies have taken steps that establish mutually reinforcing 
strategies. For example, in 2002, OSTP proposed a mutually reinforcing 
joint strategy to address how agencies should respond to a low-level 
presence of regulated GE material in the environment or commercial 
agriculture. Following OSTP's proposal, USDA issued a notice in the 
Federal Register stating its policy for responding to any occurrences 
of low-level presence of regulated GE crop materials; EPA released 
guidance for small-scale field testing and the low-level presence in 
food of GE pesticides; and FDA issued guidance to recommend that 
developers of certain GE crops intended for food use but still in the 
field test stage engage in what it called a voluntary early food safety 
evaluation, as we have previously described. However, OSTP's proposal 
was limited in scope to GE crops intended for food or feed use; 
pharmaceutical and industrial compounds were not a part of the joint 
strategy. Food plants, such as corn and soybeans, are used to produce 
these compounds. 

Identifying and Addressing Needs by Leveraging Resources: 

In 2002, USDA and EPA's Office of Pesticide Programs signed an 
agreement intended to leverage agency resources to improve coordination 
of federal oversight of GE crops that are engineered to tolerate 
herbicide treatments. Under the current regulatory framework, USDA 
regulates the herbicide-tolerant GE crop, while EPA regulates 
herbicides that are engineered into crops. In the 2002 agreement, USDA 
agreed to supply EPA with a list of herbicide-tolerant plants being 
field tested each year to ensure that EPA is aware of forthcoming 
products, and to provide EPA with a copy of petitions USDA receives 
from persons seeking nonregulated status for herbicide-tolerant crops. 
USDA also agreed to ask each applicant to submit a voluntary 
stewardship plan for the management of pest-resistance and weedy 
volunteer crops in herbicide-tolerant crop rotations and to consult 
with EPA on the viability of these stewardship plans. For its part, EPA 
agreed to supply USDA with current lists of herbicides registered for 
use on the crop in question and any readily available information about 
their efficacy. 

However, we found that USDA and FDA could better leverage agency 
resources to address food safety issues for GE crops at the field trial 
stage. Specifically, FDA currently relies on GE crop developers to 
notify the agency that they are engaged in field trials of a plant with 
a novel trait or protein that might benefit from a voluntary early food 
safety evaluation. As the federal agency that reviews all applications 
for field trials of GE crops, USDA could alert FDA to field trials of 
such plants. At the same time, FDA could provide USDA with its 
evaluation of important food safety information, such as similarities 
between a new protein and known allergens and toxins and the overall 
stability of the protein, which USDA could use when making risk 
determinations for field trials of GE crops. Food safety concerns are 
one of several factors USDA takes into account when considering, for 
example, what types of permit conditions are needed for the 
environmental release of a GE crop, or whether activities associated 
with the crop should qualify for an exemption from the permit 
requirement. Currently, however, there are no formal mechanisms for 
coordinating the FDA early food safety evaluations with USDA's data on 
permits or notifications. 

Establishing Compatible Policies, Procedures, and Other Means to 
Operate across Agency Boundaries: 

Although the specific procedures that the agencies use to regulate 
biotechnology vary according to each agency's legal authorities, the 
agencies hold interagency meetings to coordinate policies and share 
scientific information related to biotechnology across agency 
boundaries. There are currently two interagency groups that meet 
regularly to coordinate the federal government's oversight of 
agricultural biotechnology. One group is responsible for implementing 
the administration's policy on agricultural biotechnology and the other 
is a technical working group that provides agency officials involved in 
the day-to-day implementation of regulations with an opportunity to 
discuss emerging issues. These groups are as follows: 

* The Interagency Agricultural Biotechnology Working Group. This 
working group, cochaired by OSTP and the National Economic Council, was 
formed in 2001 to provide a forum for senior-level officials in 
relevant executive branch agencies--USDA, EPA, and FDA, the Office of 
Management and Budget, and the U.S. Trade Representative--to address 
agricultural biotechnology policy.[Footnote 8] According to OSTP, the 
Biotechnology Working Group meets once a month or once every 2 months, 
as needed. Since its inception, the group has worked on several 
interagency initiatives, including coordinating negotiations between 
federal agencies to develop a coherent policy to address the low-level 
presence in food or feed of regulated GE crops. More recently, the 
group provided a forum for senior-level officials to discuss proposed 
regulatory revisions, such as the publication of USDA's Draft 
Programmatic Environmental Impact Statement and an EPA Advance Notice 
of Proposed Rulemaking, to address compliance issues for producers of 
GE pesticides. Also according to OSTP, when a major unauthorized 
release occurs, this group also provides a venue for officials to 
circulate information to ensure that the participating agencies are up 
to date on recent developments, and that the federal government's 
response is well-coordinated. 

* The Interagency Coordinated Framework Technical Working Group. This 
working group was formed in 2003 to provide USDA, EPA, and FDA 
officials involved in the day-to-day implementation of regulations with 
an opportunity to meet monthly via conference call to discuss emerging 
issues. The group's past activities have included agency briefings on 
new GE products passing their respective approval or consultation 
processes, sharing information about upcoming rulemakings, and 
discussing lawsuits concerning the regulation of GE agricultural 
products. 

Reinforcing Agency Accountability for Collaborative Efforts through 
Agency Plans and Reports: 

The agencies' strategic planning documents and performance reports do 
not specifically focus on the Coordinated Framework or the broad 
principles underlying the current regulatory system. However, these 
documents do address emerging issues related to biotechnology and 
recognize the need for interagency collaboration where appropriate. For 
example, USDA and FDA defined and measure their progress toward the 
shared goal of supporting international capacity building for 
agricultural biotechnology and promoting science-based oversight. In 
its strategic plan for 2005 through 2010, USDA established the goals of 
providing technical assistance and training to help countries adopt 
U.S. approaches to agricultural trade policy and helping foreign 
countries improve their regulatory structure for adopting biotechnology 
and agricultural biotechnology products. To measure its progress, USDA 
set a target of helping 15 countries make improvements to their trade 
policy and regulatory framework by 2010. Similarly, as part of its 
yearly report to stakeholders, FDA's Center for Food Safety and Applied 
Nutrition identified as priorities for 2007 its serving as the head of 
U.S. delegations and providing technical experts to two international 
task forces: (1) the Organisation for Economic Co-operation and 
Development's (OECD) Task Force on the Safety of Novel Foods and Feeds, 
which has worked to harmonize oversight of foods derived from 
biotechnology, and (2) the Codex Alimentarius Ad Hoc Intergovernmental 
Task Force on Foods Derived from Biotechnology, which has worked to 
develop a food safety assessment procedure for the low-level presence 
of regulated GE crops.[Footnote 9] FDA also established the goal of 
providing technical assistance to the U.S. government on food 
biotechnology issues. EPA has been involved in similar initiatives, 
including participation on the previously mentioned task forces formed 
by OECD and Codex Alimentarius; however, EPA did not discuss these 
initiatives in the planning documents and reports that we reviewed. 

Developing Mechanisms to Monitor, Evaluate, and Report on the Results: 

USDA and EPA have established mechanisms to help evaluate and report on 
matters related to the oversight of GE crops. Among the mechanisms 
established, USDA formed the USDA Advisory Committee on Biotechnology 
and 21st Century Agriculture in 2003 to provide information and advice 
to the Secretary of Agriculture on issues related to agricultural 
biotechnology. Since its inception, the committee has presented four 
consensus reports to the Secretary, including most recently a report on 
the issues that USDA should consider regarding the coexistence of GE, 
organic, and conventional crops. In addition, in response to USDA's 
requests, the National Research Council of the National Academy of 
Sciences has provided the agency with three science-based analyses of 
emerging issues in biotechnology, including GE crops.[Footnote 10] EPA 
also has an advisory committee--the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) Scientific Advisory Panel--that, while not 
specific to biotechnology, has provided recommendations and peer 
reviews related to EPA's oversight of GE pesticides on a number of 
occasions. The FIFRA Scientific Advisory Panel, for example, played an 
important role in evaluating the health risks associated with the GE 
pesticide in StarLink corn. 

However, several organizations have concluded that the agencies need 
better monitoring to detect unintended environmental or economic 
consequences and improve their risk analysis and management of marketed 
GE crops. In 2002, the National Research Council concluded that 
"screening of all crops with added genetic variation must be conducted 
over a number of years and locations because undesirable economic and 
ecological traits may only be produced under specific environmental 
conditions."[Footnote 11] The council's report contained numerous 
recommendations regarding the monitoring of GE crops after they have 
been deregulated, including a recommendation that the federal 
government establish a long-term monitoring effort to assess potential 
environmental changes associated with the commercialization of GE 
crops, and that there be an open and deliberative process involving 
stakeholders to establish monitoring criteria. Similarly, in 2006, the 
National Science and Technology Council[Footnote 12] cited the 
monitoring for ecosystem effects associated with the use of GE products 
as an area where the federal government could improve its risk 
assessments, noting that the ecological consequences are difficult to 
predict and that the variety of GE crops and organisms introduced in 
the environment is likely to grow.[Footnote 13] 

As an example of an unintended environmental consequence, EPA officials 
said that the widespread use of herbicide-tolerant GE crops could 
accelerate the development of herbicide-tolerant weeds. In this regard, 
weed scientists from Iowa State University and the University of 
Wisconsin said that federal support for mapping the occurrence of 
herbicide tolerance would be helpful. Another possible unintended 
consequence of the widespread use of crops containing the GE pesticide 
Bt is that Bt could lose its effectiveness against insect pests. As a 
condition of registering a Bt pesticide with EPA, registrants must 
require that users of the product follow certain insect-resistance 
management techniques, including planting "refuges" with non-Bt crops. 
[Footnote 14] Registrants determine whether these requirements are met 
through surveys of farmers. However, some stakeholders with whom we 
spoke raised doubts about the effectiveness of having the registrant of 
a GE pesticide perform compliance monitoring activities. 

Another concern stemming from the widespread use of GE crops is the 
economic impact they might have on farmers growing conventional or 
organic crops. For example, some growers of non-GE crops fear that 
seeds or pollen containing engineered traits from neighboring fields 
may commingle with their crops, thereby making those crops harder to 
sell to customers who prefer not to consume GE products. In this 
regard, in February 2007, the U.S. District Court for the District of 
Northern California ruled that USDA needed to conduct an environmental 
impact statement to analyze, among other things, the impact that 
deregulating a particular GE alfalfa might have on farmers growing 
organic or conventional alfalfa. In a 2008 report to the Secretary of 
Agriculture, USDA's Advisory Committee on Biotechnology and 21st 
Century Agriculture concluded that fostering coexistence between GE and 
non-GE crops is an important and worthwhile goal and acknowledged that 
the proximity of GE crops to conventional and organic crops sometimes 
causes commingling, preventing some retail consumers from finding 
products that are free of GE crops.[Footnote 15] The committee 
recommended that the Secretary "take note" of several factors that can 
cause commingling, such as the failure to adequately contain regulated 
GE crops. 

Despite these recommendations and observations from various sources, we 
found that USDA, EPA, and FDA do not have a mechanism to monitor, 
evaluate, and report on the impact of the commercialization of GE crops 
following the completion of the agencies' evaluation procedures. USDA, 
the agency with the most comprehensive authority regarding GE crops, 
has no systematic program of postmarket oversight. Once GE crops are 
deregulated, they are not subject to regulatory control under the Plant 
Protection Act, unless USDA finds them to be a plant pest or noxious 
weed on the basis of new data or analysis. EPA places conditions on the 
use of marketed GE pesticides, but its oversight is largely limited to 
the data it collects through the biotechnology developers that register 
the products. Without monitoring, undesirable agricultural and 
environmental problems could result from the unintended transfer of 
genetic material from deregulated GE crops to non-GE crops and other 
plants, and these problems could have significant financial 
implications. 

Similarly, FDA generally does not monitor the use of GE crops in food 
or feed once they have been marketed. According to FDA officials, the 
agency does not routinely monitor the food supply for the presence of 
regulated GE crops because these crops may legally be present in food 
and feed, unless they contain an unapproved pesticide or food additive. 
In addition, as we have previously reported, monitoring the long-term 
health effects of GE food is generally neither necessary nor feasible, 
according to scientists and regulatory officials that we contacted. 
[Footnote 16] In their view, such monitoring is unnecessary because 
there is no scientific evidence, or even a hypothesis, suggesting that 
long-term harm (such as increased cancer rates) results from these 
foods. Furthermore, there is consensus among these scientists and 
regulatory officials that technical challenges make long-term 
monitoring infeasible. Experts cited, for example, the technical 
inability to track the health effects of GE foods separately from those 
of their conventional counterparts. In addition, little is known about 
the long-term health effects of consuming most foods, meaning there is 
no baseline information against which to assess the health effects 
caused by GE foods. However, some stakeholders have expressed food 
safety concerns about the potential transfer of genetic material from 
food crops used to produce pharmaceutical and industrial compounds (see 
the following section on regulatory changes and other initiatives). 
While as of July 2008, the use of food crops to produce these compounds 
had not moved beyond limited field trials, in the future they may be 
produced on a larger scale for commercialization, increasing the 
potential for gene transfer to other crops and possible entry into the 
food and feed supply. This prospect suggests that some form of limited, 
directed monitoring of the food supply may be needed to ensure that 
these compounds are not present. 

Officials Generally Did Not Cite Interagency Coordination as a Major 
Concern or Call for Revisions to the Coordinated Framework: 

In general, the officials from 22 stakeholder groups with whom we spoke 
did not indicate that interagency coordination was a major concern. 
Five officials told us that coordination among the agencies had 
improved over time. Nevertheless, some officials identified areas where 
interagency coordination could be improved. Most notably, five said 
that stronger central leadership, possibly residing in a high-ranking 
official, was needed to bring together the relevant agencies and to 
provide a unified government response to emerging issues and incidents 
as they occur. Two of these officials noted that such leadership 
existed in the past but has been inconsistent. 

Similarly, the officials with whom we spoke generally did not identify 
changing the Coordinated Framework as a high priority. Of those that 
expressed an opinion, 10 officials told us that the framework has 
worked well and withstood the tests of time. On the other hand, four 
officials told us that the Coordinated Framework needed to be revised. 
Two of these four individuals, representing consumer advocacy 
organizations, said that using existing laws to govern biotechnology, 
as called for in the framework, was inadequate because agencies have 
had to "creatively interpret" or "bend over backward" to apply laws 
that do not specifically address biotechnology. They supported the 
creation of new laws specific to biotechnology. Meanwhile, six of the 
officials with whom we spoke did not have an opinion on the adequacy of 
the Coordinated Framework. 

Agencies Are Considering Regulatory Changes and Other Initiatives to 
Improve Oversight and Further Limit the Impact of Potential 
Unauthorized Releases: 

In recent years, USDA, EPA, and FDA have considered changes to which GE 
crops they regulate and how they will regulate them with the intention 
of improving oversight and reducing the impact of unintended releases 
of GE crops. In particular, in its July 2007 draft programmatic 
environmental impact statement (DEIS) and its October 2008 proposed 
rule, USDA is considering significant changes that could affect, among 
other things, which GE crops it regulates, requirements for 
pharmaceutical and industrial crops, and the agency's response to 
unauthorized releases. Proposals in the DEIS drew mixed views from 
stakeholders who submitted comments to the agency; the public comment 
period for the proposed rule was ongoing as we completed this report. 
Several of these proposed changes in the DEIS related to USDA's 
consideration of food safety and public health concerns, and some 
stakeholders have commented that USDA did not clearly state how it 
would coordinate human health assessments with FDA and EPA. USDA is 
also seeking funding to implement a voluntary quality management system 
designed to improve industry compliance with its field trial 
regulations. In addition, USDA has identified several operational 
lessons from its investigation of the LLRICE release that, if acted 
upon, could improve oversight. For its part, EPA has proposed amending 
several of its GE pesticide regulations, and stakeholders who submitted 
comments to the agency generally supported these proposals. Finally, 
FDA proposed in 2001 to make its voluntary premarket notification 
procedure mandatory; however, as of July 2008, the agency had not taken 
action to finalize the proposed rule, despite support from key 
stakeholders that we interviewed. 

USDA Is Considering Significant Changes in How It Regulates GE crops: 

In July 2007, USDA published a DEIS outlining 10 issues related to 
biotechnology that may be the subject of future revisions to 
regulation. These 10 issues address such matters as which GE crops USDA 
should regulate, the permitting and notification process, the 
restrictions placed on GE crops that produce pharmaceutical compounds, 
and the agency's response to the low-level presence of regulated GE 
plant material. For each issue, USDA presented and assessed alternative 
regulatory approaches, including a no-action alternative and a 
preliminary preferred alternative. (See app. VIII for a list of the 10 
issues and the alternatives that USDA assessed for each issue.) 

The agency received 77 comments on the DEIS from stakeholders, such as 
individuals and organizations representing academia, the biotechnology 
industry, public interest groups, agricultural producers, and 
government agencies. USDA also received many comments from private 
citizens, 265 of which were submitted individually and another 23,379 
that were in form letters forwarded by 2 public interest groups. We 
analyzed the comments from the 77 stakeholders as well as a random 
sample of 51 of the 265 comments submitted individually by private 
citizens.[Footnote 17] Using the public comments and other 
considerations, USDA issued proposed amendments to its regulations in 
October 2008. According to USDA, differences between the proposed rule 
and the DEIS are primarily a matter of reorganizing and realigning some 
materials and their corresponding regulatory alternatives, using more 
descriptive terms in some criteria listed in the alternatives, and 
choosing between regulatory alternatives that fall within the analysis 
of the DEIS. Changes arising from this rulemaking process could 
represent the most extensive overhaul to the regulations since USDA 
originally implemented them in 1987. We selected 4 of the 10 issues 
addressed by the DEIS that we believe are particularly relevant to 
incidents of the unauthorized release of GE crops and analyzed the 
comments USDA received. While USDA has requested comments on the 
proposed rule, we were not able to review them for this report. 
[Footnote 18] 

Issue 1: Broadening Regulatory Scope to Include GE Crops Posing Noxious 
Weed Risk: 

This issue examines the question of which GE crops to regulate. Two 
alternatives USDA assessed in relation to this issue--including the one 
that the agency indicated was its preliminary preferred alternative-- 
would expand USDA's oversight to all GE plants, not only those that 
pose a risk to plants. These alternatives could also have allowed USDA 
the authority to consider the effect of GE crops on public health and 
the environment, rather than just the effect on other plants. 

In our review of the stakeholder comments submitted to USDA, we found 
that 42 of the 44 stakeholders who indicated their preference supported 
expanding USDA's oversight. However, stakeholders had varied reactions 
to a key difference between the two alternatives--whether USDA should 
make regulatory decisions on an "event" or "trait" basis. Regulating by 
event would mean regulating each individual insertion or deletion of a 
gene or gene fragment from a cell. Regulating by trait would mean 
evaluating the characteristic (e.g., herbicide tolerance) manifested in 
the crop as a result of genetic engineering, and potentially making 
decisions for multiple events that exhibit the same trait. Some of 
those who favored regulating by event, which USDA indicated was its 
preliminary preferred alternative, believed it would be more 
protective. Some of those who favored regulating by trait indicated it 
would reduce the regulatory burden on developers. In its October 2008 
rulemaking, USDA proposed to regulate GE plants on the basis of (1) 
known plant pest and noxious weed risks of the parent plants, (2) the 
traits of the GE plant, or (3) the possibility of unknown risks as a 
plant pest or noxious weed when insufficient information is available. 
Under the proposal, if adopted, USDA would encourage GE plant 
developers to consult the agency if they are uncertain whether a GE 
plant would be subject to regulation. 

At the same time that USDA assessed the impact of expanding the reach 
of its regulatory oversight, it also assessed the impact of excluding 
certain classes of GE crops from regulatory oversight on the basis of 
risk. USDA included this exclusion--which 31 of the 37 stakeholders who 
expressed a preference supported--as part of its preliminary preferred 
alternative in the DEIS. Some stakeholders who commented on the DEIS 
and other observers have suggested that USDA could exclude from 
regulation plant pests from which disease-causing genes have been 
deleted. An example of a plant pest that is often used in genetic 
engineering is a bacterium known as Agrobacterium tumefaciens that can 
cause a plant disease known as crown-gall. When used in genetic 
engineering, its disease-causing genes are first removed. In the 
proposed rule, USDA stated that it anticipates that the range of GE 
plants subject to oversight will decrease as the agency reaches the 
conclusion that they do not pose increased or unfamiliar plant pest or 
noxious weed risks. The proposed rule also contains a procedure whereby 
the agency may approve petitions for conditional exemptions from permit 
requirements. 

Issue 2: Use of Risk-Based Categories for New Products: 

Two of the alternatives under this issue that USDA considered in the 
DEIS would have expanded its current two-tier system of notifications 
and permits to further classify GE crops according to risk. Currently, 
USDA's policy allows for GE plants that meet specific eligibility 
criteria, such as cases in which the function of the introduced genetic 
material is known and does not result in plant disease, to be 
introduced under the notification process, while plants that do not 
meet the criteria must use the more stringent permit option. Under the 
two alternatives, USDA would have clarified and increased the number of 
tiers in which GE plants (and other GE organisms) could be placed. The 
DEIS proposed four tiers that would account for the potential of a GE 
plant to pose plant pest, noxious weed, or food safety risks. The tiers 
would impose different procedural requirements and permit conditions on 
GE crop developers. According to USDA, an expanded tier system would 
increase transparency and help focus agency resources on unfamiliar or 
high-risk crops. Almost all stakeholders (45 of 48) who expressed a 
preference preferred 1 of the alternatives that would expand the 
current 2-tiered system, with the remaining 3 stakeholders preferring 
that USDA abolish all categories and evaluate all field trial 
applications on a case-by-case basis. USDA's October 2008 proposed rule 
is consistent with the DEIS in that it would eliminate the notification 
procedure. USDA would continue to issue three types of permits for 
interstate movement, importation, and environmental release. The 
permits for environmental release of GE plants would be sorted into one 
of four categories on the basis of risk. 

Issue 4: Regulation of Crops Producing Pharmaceutical and Industrial 
Compounds: 

USDA also assessed in its DEIS several alternatives for modifying its 
approach to issuing field trial permits for GE crops not intended for 
food or feed--namely, those engineered to produce pharmaceutical and 
industrial compounds. Currently, USDA imposes more stringent 
confinement and inspection requirements on these crops than it does for 
other types of GE crops. If unintentionally released into the food or 
feed supply, GE crops producing pharmaceutical and industrial compounds 
may pose risks to human health, trade, and the environment that are not 
posed by other types of GE crops, such as herbicide-resistant or insect-
tolerant crops. USDA outlined a number of possible alternatives, such 
as prohibiting outdoor field tests of these crops or allowing only 
nonfood crops, such as tobacco, to be engineered to produce those 
compounds under the assumption that they would not be consumed 
inadvertently. Its preferred alternative was to continue to allow food 
and feed crops to be used for the production of pharmaceutical and 
industrial compounds, imposing confinement requirements as appropriate. 

About half (27 of 52) of those stakeholders who expressed a preference, 
including all of the biotechnology developers and the majority of the 
academics and governmental organizations, preferred that USDA continue 
to allow food and feed crops (such as corn) to be used for the 
production of pharmaceutical and industrial compounds, but impose 
confinement requirements on the basis of the risk posed by the organism 
and consider food safety in setting permit conditions. However, 12 
preferred that USDA prohibit outdoor field testing of GE crops 
engineered to produce pharmaceutical or industrial compounds if the 
type of crop used also has food or feed uses because of concerns that 
outdoor testing would increase the probability of those compounds 
spreading into the food or feed supply. Another 10 preferred that USDA 
prohibit outdoor field testing of any GE crop that produces these 
compounds. The remaining 3 advocated prohibiting the use of food and 
feed crops, regardless of whether the crop is grown in an outdoor field 
test or in a contained facility. Of all of the issues discussed in the 
DEIS, this is the one that most concerned private citizens. The Union 
of Concerned Scientists and the Center for Food Safety forwarded almost 
23,400 comments from private citizens urging USDA to ban the outdoor 
production of pharmaceutical and industrial compounds in food crops. In 
its proposed rule, USDA concluded that its proposed permitting 
procedures and the use of stringent permit conditions can effectively 
minimize the risks that might be associated with the environmental 
release of GE plants that produce pharmaceutical or industrial 
compounds, including GE plants that are normally food crops. 

Issue 7: Allowance for Low-Level Presence of Regulated GE Material in 
Crops, Food, Feed, or Seed: 

Under this issue, USDA's DEIS evaluated alternatives that would 
establish criteria for determining that an unauthorized release of a 
low level of regulated GE crops outside of a field trial site is 
"nonactionable"--that is, determining when a GE crop poses a low risk 
to health or the environment. Currently, the agency's policy is to 
respond to incidents of low-level presence on a case-by-case basis, 
assessing the specific health and environmental risks posed by the 
regulated material and taking remedial action only when necessary. In 
its DEIS, USDA proposed specific criteria under which the agency would 
not take remedial action in response to unauthorized releases that pose 
minimal risk, contending that these criteria would reassure the public 
and other countries of the safety of any regulated GE crops detected at 
low levels in commercial plants or seeds. The majority of stakeholders 
(34 of 46) who expressed a preference supported establishing criteria 
for determining when a release is nonactionable. A number of academic 
stakeholders attributed the market disruptions that followed 
unauthorized releases to a perception of risk created by the current 
regulations, which treat all releases alike. Some stakeholders also 
noted that tolerances have been developed to allow for low levels of 
contaminants, such as pesticides or insect parts, in the food supply, 
and that USDA should be able to develop similar tolerances for GE crops 
that pose no known risk to human health. In addition, some stakeholders 
supported the relaxation of confinement standards in some instances, 
arguing that the low-level presence of genes moving from a GE plant to 
a non-GE plant should not, in itself, be a concern because gene flow is 
a pervasive and naturally occurring process. 

However, other stakeholders (7 of 46), namely public interest groups 
and agricultural producers, supported the most stringent of the 
proposed alternatives, which would impose confinement requirements on 
all GE crops comparable to those now imposed on pharmaceutical and 
industrial crops and would consider all low-level presence to be 
actionable. These stakeholders argued that trace amounts of regulated 
material could jeopardize organic agriculture, particularly in export 
markets that have tighter standards, and that USDA does not have 
sufficient scientific data on the long-term effects of GE crops to make 
the determination that low levels are safe. The private citizens whose 
comments we analyzed and who expressed a preference also preferred this 
alternative. 

USDA's October 2008 proposed amendment to its regulations is generally 
consistent with the preliminary preferred alternative in the DEIS. USDA 
proposes to investigate each incident of low level presence 
individually before making a decision on what, if any, remedial action 
is needed. USDA would use specific criteria enumerated in the proposed 
regulations to rate the risk involved in the incident. However, those 
criteria would not fully determine the agency's response; USDA would 
evaluate other relevant information and order remedial action if it 
appears necessary. 

Stakeholders Raised Concerns That USDA Did Not Clearly State How It 
Would Coordinate Human Health Assessments with EPA and FDA: 

Four of the 10 issues described in USDA's DEIS referred to the agency's 
consideration of food safety and public health concerns associated with 
GE crops, and some stakeholders thought it was unclear whether it would 
be USDA's, EPA's, or FDA's responsibility to perform the necessary 
evaluations. These 4 issues are as follows: 

* In issue 1, regarding the broadening of USDA's scope of oversight of 
GE crops, as we have previously discussed, USDA's preliminary preferred 
alternative in its DEIS as well as its proposed regulatory amendment 
would use the agency's authority to consider the effect that GE crops 
could have on public health. To date, USDA has regulated GE crops on 
the basis of their risk as a plant pest--it takes into consideration 
human health data when responding to petitions to deregulate GE crops 
to meet NEPA requirements, but FDA has primary responsibility for food 
safety. Under its proposed rule, USDA would use its authority under the 
Plant Protection Act to regulate GE crops as potential noxious weeds, 
which would enable it to regulate crops on the basis of their effect on 
public health. For example, it could consider public health in setting 
the conditions for field trials of GE crops and could require that all 
food safety issues be resolved prior to deregulation. However, the 
agency did not provide specific details in either the DEIS or the 
proposed rule on how it intends to evaluate human health effects or 
determine when food safety issues have been resolved. 

* In issue 2, USDA's preliminary preferred alternative in the DEIS, as 
well as its proposed regulatory amendment, would include human health 
as a criterion for determining which category a GE crop would fall into 
under the proposed risk-based system. For example, according to the 
DEIS, to qualify for the lowest risk tier, a GE food would need an EPA- 
issued pesticide tolerance or an alternative evaluation of its toxicity 
and allergenicity. In general, under its preferred alternative, USDA 
would consider the toxicity and allergenicity of GE crops when imposing 
confinement requirements on field test sites. However, USDA did not 
specify which agency would evaluate toxicity or allergenicity. 

* In issue 4, USDA's DEIS described several alternatives for regulating 
crops engineered to produce pharmaceutical and industrial compounds, 
including one alternative that would use evaluations of food safety to 
determine the appropriate confinement measures, and another alternative 
that would require that food safety concerns be addressed prior to the 
use of a food or feed crop for the production of such compounds. 
However, USDA did not describe the role that FDA or EPA, the agencies 
that have primary responsibility for regulating pharmaceutical and 
industrial compounds, respectively, would have in providing health 
assessments of GE crops used for these purposes. 

* In issue 7, USDA indicated in the DEIS that one potential criterion 
for determining whether the low-level presence of a regulated GE crop 
in the food supply or the environment is nonactionable would be if food 
safety issues have been adequately addressed. However, in the DEIS, 
USDA did not indicate how it would use food safety assessments from 
other agencies, such as FDA or EPA, in deciding whether a low-level 
presence is nonactionable. In its October 2008 rulemaking, USDA 
proposed that for food and feed crops, one of the following three 
conditions must be true for the agency to determine that a low level 
presence is nonactionable: (1) EPA has established a tolerance or an 
exemption from tolerance for any GE pesticide expressed by the GE 
plant, (2) key food safety issues of the new protein or other substance 
have been addressed, or (3) no new protein or substance is produced. 

A range of stakeholders, including academics, state officials, and 
public interest groups, commenting on the DEIS expressed concern that 
if USDA decides to evaluate the public health consequences of new GE 
crops, its oversight responsibilities would overlap with those of EPA 
and FDA. Several stakeholders encouraged USDA to coordinate its 
regulatory activities with those of EPA and FDA when addressing human 
health concerns. USDA acknowledged that addressing all of the food 
safety issues discussed would likely increase these agencies' workload. 
USDA's DEIS did not describe how it would incorporate other agencies' 
programs, such as FDA's early food safety evaluations of novel 
proteins, into its oversight. In addition, FDA's early food safety 
evaluations do not apply to crops intended exclusively for the 
production of pharmaceutical or industrial compounds. FDA officials 
said they had no plans to perform such evaluations in the future. 

In its October 2008 proposed rule, USDA acknowledged FDA's authority in 
the food safety area, but also emphasized the need for mutual agency 
support. USDA stated that it would evaluate permit applications for new 
GE organisms, including plants, to determine if they could present 
risks to the public health. If so, USDA would contact FDA. The decision 
to regulate food and feed from the GE organism would be FDA's. USDA 
also stated that it would take into account existing food safety 
evaluations when evaluating GE organisms. 

USDA Seeks to Establish a Voluntary Biotechnology Quality Management 
System to Help Improve Industry Compliance with Field Trial 
Regulations: 

USDA also is seeking $4.0 million in additional funding for fiscal year 
2009 to establish a quality management system to improve developers' 
compliance with field trial regulations.[Footnote 19] USDA has 
concluded that there is a lack of quality management systems among GE 
plant developers, and, in September 2007, the agency announced that it 
would establish a voluntary program called the Biotechnology Quality 
Management System (BQMS) to help universities, small businesses, and 
large companies develop policies and practices that will enable them to 
proactively address potential compliance problems before they 
materialize. Participants would identify vulnerabilities in their 
processes, develop quality control measures to minimize the risk of 
unauthorized releases, and demonstrate--through recordkeeping and a 
documented management system--their ability to manage the safe 
introduction of GE crops into the environment. In addition, USDA would 
(1) work with permit holders to ensure that quality management plans 
are developed and in place, (2) develop standardized quality assurance 
and best practices guidance documents, and (3) provide outreach to the 
regulated community. USDA's Agricultural Marketing Service would manage 
the audit component of the program and accredit third-party auditors. 
However, BQMS would not replace USDA's existing regulatory compliance 
and inspection process. 

An issue raised by several members of USDA's advisory panel on 
biotechnology was whether BQMS's benefits would justify its likely 
costs to the government and regulated community. One particular concern 
was that the program, while called voluntary, would become an expensive 
de facto mandatory program for developers with limited resources, such, 
as universities, if agencies used participation in the program as a 
criterion for awarding federal funding for GE research. Another concern 
was whether there would be adequate incentives to encourage 
participation. However, in its 2008 report on coexistence, the advisory 
committee also concluded that programs like BQMS may help address 
factors that inhibit coexistence among different agricultural 
production systems, including the production of GE, conventional, and 
organic crops. 

USDA Has Identified Lessons Learned from the LLRICE Incidents That 
Could Improve Oversight: 

In October 2007, USDA issued a compilation of proposed changes intended 
to enhance its oversight of GE crops on the basis of lessons learned 
from its investigation of the LLRICE incidents and its 20 years of 
experience in GE crop regulation. The lessons learned related to a 
range of issues, including inadequate record keeping by permit and 
notification holders, delays in obtaining representative samples of GE 
seed, developers' lack of corrective action plans, incomplete access to 
agreements made among GE crop developers and entities they have 
contracted with to conduct field trials, and the sufficiency of 
isolation distances between field trial sites and other crops. USDA 
also noted that it lacked the authority to subpoena anything other than 
documents--for example, the agency could not subpoena seeds or plant 
parts. The recently enacted 2008 Farm Bill contains language directing 
the Secretary of Agriculture to take action on the lessons learned 
within 18 months. According to USDA, its October 2008 proposed 
rulemaking would address many of the Farm Bill requirements, 
particularly as it relates to recordkeeping and reporting. The 2008 
Farm Bill also expanded USDA's subpoena authority to cover "tangible 
things that constitute or contain evidence." 

EPA Has Proposed Amending Its Regulations for GE Pesticides: 

EPA is considering amending its regulations governing GE pesticides. In 
April 2007, EPA proposed two related rules intended to create a more 
risk-based system for regulating a certain type of GE pesticide known 
as a plant virus coat protein (PVCP).[Footnote 20] In the first rule, 
EPA proposed to exempt from regulation PVCPs that present minimal risk 
to human health or the environment. In the second rule, the agency 
proposed to exempt from regulation the residues produced by GE 
pesticides that are based on viral coat proteins. Under these rules, 
developers would be able to self-determine whether a new PVCP-based GE 
pesticide is exempt from EPA's pesticide registration requirements and 
the requirement of a pesticide tolerance on the basis of specific risk- 
based criteria established by EPA. Stakeholders commenting on EPA's 
proposed rules had mixed views on the scope of the agency's proposals. 
In addition to those that supported the exemptions proposed by EPA, 
there were stakeholders from scientific associations that favored 
extending the exemption to plant virus genes other than virus coat 
proteins, as well as those that favored limiting the exemption to 
certain types of PVCP GE pesticides. On the other hand, some comments 
from food industry and safety organizations expressed concern about 
EPA's proposed exemptions, citing scientific uncertainty. 

Also in April 2007, EPA published an advance notice of proposed 
rulemaking describing possible revisions that would help EPA account 
for the differences between GE pesticides and conventional pesticides 
and help ensure that developers of GE pesticides comply with necessary 
requirements. According to EPA, current regulations for agricultural 
pesticides were written before GE pesticides were defined, and may not 
adequately address the distinction. As such, they may not apply to the 
unique characteristics of GE pesticides produced in a GE crop on a 
farm. Specifically, EPA is considering amending regulations governing 
the (1) registration of GE pesticide production facilities, (2) 
reporting and record-keeping requirements, (3) issuance of experimental 
use permits, and (4) requirements for labeling. 

Most stakeholders supported these proposals to distinguish between GE 
pesticides and other pesticides. For example, most stakeholders favored 
modifying the current definitions in FIFRA relating to GE pesticides, 
either by excluding farmers and seed processors from the current 
definition of pesticide "producer" and "establishment" or by including 
other parties, such as companies that license a GE pesticide for 
inclusion in plants, facilities that produce seeds containing GE 
pesticides, and any laboratory or greenhouse where a pesticide is 
engineered into a plant. However, some stakeholders had varied views 
about changes to labeling requirements for GE pesticides. Under current 
practices, according to EPA officials, seed labels do not need to 
identify that the seed contains a registered pesticide that might have 
certain use restrictions. Instead, EPA requires as a condition to 
registration that registrants ensure that growers comply with any 
planting restrictions associated with the seed. For example, growers 
are expected to sign a contract with the registrant of the pesticide 
agreeing to certain planting restrictions as well as routine 
"compliance assurance visits." While some (4) felt this system was 
adequate, others (3) thought a legally enforceable label would help 
promote growers' compliance with planting restrictions. 

FDA Proposed in 2001 to Make Premarket Notification Mandatory: 

In 2001, FDA proposed a rule that would require companies to notify the 
agency before marketing GE crops as food or feed products to complement 
its voluntary consultations. Among the reasons that FDA cited for 
proposing this change were concerns expressed by consumers and public 
interest groups about the limits to the transparency and the voluntary 
nature of the consultation process and the potential of genetic 
engineering to create more complex safety issues. Many stakeholders 
with whom we spoke were in favor of this proposal. For example, a 
representative from the Grocery Manufacturers Association/Food Products 
Association said that food safety assessments should be mandatory and 
done early enough so that the public could be assured of product safety 
if regulated articles were unintentionally released into the food 
supply. Similarly, a representative from the rice industry also said 
that food assessments should be mandatory and that if a premarket 
notification had been done for LLRICE, it would have reduced the 
economic impacts of unauthorized releases. However, as of July 2008, 
FDA had not taken action to finalize this proposed rule, and FDA 
officials told us that such a rule no longer may be needed because the 
voluntary consultation process is working well and fully protects the 
public health. 

Conclusions: 

After two decades of experience with field trials, it is widely 
acknowledged that unauthorized releases of regulated material from 
field trial sites are likely to occur in the future, and, accordingly, 
releases are one area of the Coordinated Framework that has been 
reviewed and modernized in recent years. While the OSTP's 2002 policy 
document outlines important first steps for agencies to take to address 
the likelihood of the low-level presence of regulated genetic material 
in the environment or food supply and to mitigate any potential 
economic, environmental, or human health consequences, there are two 
areas where the agencies could improve their implementation of these 
proposals, as follows. 

* First, FDA has yet to make publicly available, as was initially 
intended, the results of its early food safety evaluations of novel 
proteins engineered into plants. In the absence of timely information 
about the actual risks to human health and the environment presented by 
a GE crop in the field trial stage, FDA may be missing an opportunity 
to mitigate the impacts of unauthorized releases, enhance the agency's 
credibility, and improve public confidence. 

* Second, USDA and FDA have not taken steps to fully leverage their 
resources to address food safety issues for certain GE crops at the 
field trial stage. While the agencies have acted to implement the 
proposals in OSTP's 2002 policy document to address field trials of GE 
crops, a lack of coordination of key information among the agencies may 
prevent them from making the most effective use of their resources. 
Specifically, the agencies do not have a formal mechanism for sharing 
information that could enhance their oversight of GE crops in the field 
trial stage that contain new proteins and that, if released into the 
food supply, could cause health concerns. FDA currently relies on crop 
developers to voluntarily notify the agency that they are engaged in 
field trials of a plant that might benefit from an early food safety 
evaluation. Because USDA, the federal agency that reviews all 
applications for field trials of GE crops, does not have a formal 
mechanism to alert FDA to field trials of such plants, FDA is less 
likely to be aware of developers' activities and to encourage them to 
participate in an evaluation. At the same time, without a formal 
mechanism for sharing the results of FDA's evaluations, USDA may lack 
important food safety information that it could use when making risk 
determinations for field trials of GE crops and when setting 
confinement and remediation measures. 

To date, government oversight of GE crops has largely focused on 
assessing and preventing risks posed by GE crops in the testing phase, 
assuming that after GE crops enter commercial production, the need to 
oversee them diminishes. However, as the volume and variety of GE crops 
being grown increases, many stakeholders, including the National 
Research Council and the National Science and Technology Council, are 
becoming concerned that widespread use of GE crops can have unintended 
consequences that should be monitored. The consequences could include 
negative effects on the environment, non-GE segments of agriculture, or 
food safety. Among the practices we have identified as important to 
enhancing collaboration among agencies is developing mechanisms to 
monitor, evaluate, and report on the results of agency decisions. Such 
mechanisms should be applied to decisions that lead to the commercial 
use of GE crops. However, such a monitoring program should be based on 
risk. Not all GE crops that are marketed may warrant monitoring, and 
the duration of monitoring may not need to be indefinite. 

Recommendations for Executive Action: 

To improve transparency and mitigate the impact of an unauthorized 
release into the food or feed supply of a regulated GE plant that has 
completed an early food safety evaluation, we recommend that the FDA 
Commissioner fulfill the agency's commitment to post the results of 
completed early food safety evaluations on its Web site and add the 
results of future evaluations within 120 days of receiving the 
submission from the plant developer. 

To reduce the risk and impact of unauthorized releases, we recommend 
that the Secretary of Agriculture and the FDA Commissioner develop a 
formal agreement to share information concerning GE crops with novel 
genetic traits that, if unintentionally released into the food or feed 
supply, present or are likely to present public health concerns and, as 
a result, also could have negative financial consequences for the food 
and agriculture industry. With information from USDA about permits or 
notifications for field trials of such GE crops, FDA could identify 
which GE crops might benefit from an early food safety evaluation and 
encourage the developers of those crops to participate in evaluations. 
With assistance from FDA, USDA could make meaningful and transparent 
use of the health evaluation data available through FDA's early food 
safety evaluations in its risk assessment of GE crops. 

To help ensure that unintended consequences arising from the marketing 
of GE crops are detected and minimized, we recommend that the Secretary 
of Agriculture, the EPA Administrator, and the FDA Commissioner develop 
a coordinated strategy for monitoring marketed GE crops and use the 
results to inform their oversight of these crops. Such a strategy 
should adopt a risk-based approach to identify the types of marketed GE 
crops that warrant monitoring, such as those with the greatest 
potential for affecting the environment or non-GE segments of 
agriculture, or those that might threaten food safety through the 
unintentional introduction of pharmaceutical or industrial compounds 
into the food supply. The strategy should also identify criteria for 
determining when monitoring is no longer needed. In developing a 
strategy, the agencies should draw upon the analysis and conclusions of 
the National Research Council and the National Science and Technology 
Council. 

Agency Comments and Our Evaluation: 

We provided a draft of this report to USDA, EPA, and the Department of 
Health and Human Services (FDA) for review and comment. USDA and FDA 
provided written comments; these comments are reproduced in appendixes 
II and III, respectively. EPA provided its comments orally. The 
agencies generally agreed with the report's findings. FDA and EPA also 
provided technical comments that we have incorporated as appropriate. 
In addition, we provided a draft of this report to the Office of the 
United States Trade Representative for informal review and comment. 
This Office responded that it had no comments on the report. 

Concerning our first recommendation, FDA said that it intends to make 
every effort to fulfill its commitment to post the results of completed 
early food safety evaluations on its Web site and add the results of 
future evaluations within 120 days of receiving the submission from the 
plant developer. However, FDA also said that activities of greater 
public health priority have been the focus of its limited resources. 
While acknowledging these priority and resource considerations, we 
continue to believe that implementing this recommendation would be a 
relatively low-cost way to increase public transparency and trust and 
mitigate the impact of the unintended release of GE crops subject to 
early food safety evaluations. 

Regarding our second recommendation, USDA and FDA agreed, in part, that 
developing a formal agreement could enhance the sharing of information 
concerning GE crops with novel genetic traits that, if unintentionally 
released into the food or feed supply, could cause health concerns and 
have negative financial consequences. For example, USDA stated that 
information obtained from FDA under this agreement could assist USDA in 
its decisions on confinement conditions and deregulation of certain GE 
organisms. FDA also said that it would be useful to explore possible 
mechanisms for sharing information with USDA. However, the agencies 
said they should focus their resources on issues that present or are 
likely to present public health concerns rather than issues that pose 
only "perceived" concerns. In addition, regarding the financial 
consequences of unintended releases, FDA said this possibility falls 
outside the scope of its authority to protect and promote the public 
health. However, we note that USDA, which bears some responsibility for 
promoting and expanding agricultural markets, may be concerned with 
these consequences. Because sharing such information would be 
beneficial, we retained the reference to the financial consequences of 
unintended releases in the recommendation. As we reported, the known 
unintended releases of GE crops into the food or feed supply apparently 
have not caused health effects, but several led to financial losses. 
Nonetheless, we modified this recommendation to remove the reference to 
"perceived health concerns" and instead emphasize that the agreement 
would cover GE crops that present or are likely to present public 
health concerns. 

USDA, EPA, and FDA agreed, in part, with the third recommendation that 
they develop a coordinated strategy to monitor marketed GE crops for 
unintended consequences. USDA stated that it supports having 
discussions with EPA and FDA regarding monitoring strategies for 
marketed deregulated GE crops. While USDA agreed that monitoring a 
partially deregulated GE crop might be appropriate where a potential 
plant pest risk is identified, USDA said its current regulations limit 
it to monitoring only regulated crops, and only for plant pest risks. 
We note that USDA maintains authority under the Plant Protection Act to 
regulate GE crops that it previously deregulated if it obtains new 
information indicating the crop is a plant pest. We also note that USDA 
has authority under the Plant Protection Act to regulate GE crops as 
noxious weeds, if warranted. Finally, in light of known unauthorized 
releases that led to financial losses, we believe that USDA should 
contribute to monitoring for other unintended consequences, such as 
economic impacts on other agriculture sectors, such as organic crops, 
that may become contaminated by GE crops. Also regarding monitoring 
strategies for marketed deregulated crops, EPA said that it intends to 
discuss such coordination issues with USDA and FDA to be better 
prepared in case a situation should arise in the future that warrants 
monitoring and is willing to continue working with the other agencies 
to determine whether additional monitoring mechanisms are worthy of 
consideration, how such monitoring would be conducted, and what 
resources would be required. However, EPA opined that GE crops that 
produce pesticides do not require any post-market monitoring beyond 
what is currently in place. For example, EPA noted that companies are 
required by FIFRA to report any adverse effects associated with GE 
pesticides and, in some cases, EPA has required companies holding 
registrations for GE pesticides to conduct studies on their effects. 
While acknowledging these monitoring mechanisms already in use, we 
still believe the agencies need a coordinated strategy for monitoring 
marketed GE crops that could include, in part, these mechanisms. FDA 
said that post-market monitoring of foods derived from GE crops is not 
necessary, but that it would consider risk-based monitoring should 
marketed GE crops intended for food or feed warrant such scrutiny in 
the future. FDA also indicated that it plans to discuss coordination 
issues with the other agencies to be better prepared should such a 
situation arise. In making this recommendation, our concern, in part, 
was the potential for GE crops producing pharmaceutical or industrial 
substances to be inadvertently present in the food or feed supply. In 
that regard, FDA opined that random sampling to detect pharmaceutical 
or industrial substances would present significant technical challenges 
and greatly affect resources and would be less effective than USDA's 
current system of strict permit conditions and inspections targeted to 
GE crops used to produce these substances. However, given that in the 
United States (1) GE crop varieties are grown extensively, (2) most 
processed foods contain ingredients from GE crops, (3) it is inherently 
difficult to prevent the spread of plant genetic material in the 
environment, (4) there may be an increasing use of GE crops to produce 
an even wider array of pharmaceutical and industrial compounds in the 
future, and (5) genetic modifications are becoming increasingly complex 
in response to pressures to increase yields for food and biofuel, we 
stand by our recommendation that the agencies should develop a 
coordinated strategy for risk-based monitoring of marketed GE crops. 

As agreed with your offices, unless you publicly announce the contents 
of this report earlier, we will plan no further distribution until 30 
days from the report date. At that time, we will send copies of this 
report to the appropriate congressional committees; the Secretary of 
Agriculture; the Administrator of EPA; the Secretary of Health and 
Human Services; the Commissioner of FDA; the Director, Office of 
Management and Budget; and other interested parties. Copies of this 
report will be made available to others upon request. In addition, this 
report will be available at no charge on GAO's Web site at [hyperlink, 
http://www.gao.gov]. 

If you or your staffs have any questions about this report, please 
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this report. Key contributors to this report are 
listed in appendix IX. 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Objectives, Scope, and Methodology: 

At the request of the Chairman and Ranking Member, Senate Committee on 
Agriculture, Nutrition, and Forestry, we evaluated federal oversight of 
genetically engineered (GE) crops. Specifically, our objectives were to 
examine (1) unauthorized releases of GE crops into food, feed, or the 
environment; (2) the degree of coordination among the federal agencies 
that regulate GE crops under the 1986 Coordinated Framework for 
Regulation of Biotechnology (Coordinated Framework); and (3) additional 
actions the agencies have proposed to improve the oversight of GE crops 
and reduce the potential for unauthorized releases. The focus of our 
work was on the federal regulation of GE crops. We did not assess 
regulation of GE animals or other nonplant organisms. In addition, we 
did not assess U.S. efforts to reduce barriers to international trade 
in GE agricultural commodities. 

In general, to achieve our objectives, we interviewed officials or 
obtained documentation from relevant federal agencies, including the 
U.S. Department of Agriculture (USDA); Environmental Protection Agency 
(EPA); Food and Drug Administration (FDA), and Office of Science and 
Technology Policy (OSTP) which is within the Executive Office of the 
President, as well as from agriculture and food industry and consumer 
organizations. Industry organizations included the American Farm Bureau 
Federation, American Seed Trade Association, American Soybean 
Association, Association of Official Seed Certifying Agencies, Grocery 
Manufacturers' Association/Food Products Association, National 
Association of Wheat Growers, National Corn Growers Association, 
National Grain and Feed Association, North American Export Grain 
Association, Organic Trade Association, U.S. Soybean Export Council, 
and USA Rice Federation. Consumer organizations included the Center for 
Food Safety, Center for Science in the Public Interest, Consumers 
Union, and Union of Concerned Scientists. In addition, we interviewed 
officials or obtained documentation from the Biotechnology Industry 
Organization; biotechnology companies, such as Arborgen and Monsanto; 
academics involved in genetic engineering research; the National 
Research Council; and the Pew Initiative on Food and Biotechnology. 

More specifically, to examine unauthorized releases of GE crops into 
food, feed, or the environment, we reviewed government documents, 
academic literature, and media accounts related to known incidents of 
releases. We also discussed these incidents and their potential 
environmental, financial, health, and trade implications with industry, 
consumer, and academic officials. Furthermore, to examine the federal 
government's role in preventing unauthorized releases and mitigating 
their impact, we reviewed relevant laws and regulations and discussed 
their implementation with USDA, EPA, and FDA officials. At USDA, we 
also reviewed data on field trial permits and inspections done during 
fiscal years 2005 through 2007, and data on suspected violations and 
enforcement actions taken during fiscal years 2003 through 2007. In 
addition, we reviewed case files on potential incidents of unauthorized 
releases reported during fiscal years 2003 through 2007 that were 
referred for investigation. We also reviewed a random sample of other 
case files that were resolved without an investigation during this 
period. In addition, at EPA, we reviewed data on field trial permits 
issued from fiscal year 1997 through May 2008, and documentation on the 
four enforcement actions taken from fiscal year 1996 through August 
2008. Since EPA had delegated enforcement authority, including the 
responsibility for doing field trial inspections to all 50 states 
except Wyoming, the agency was unable to provide us with summary data 
on the number of completed inspections involving GE pesticides. 

To determine the degree of coordination among agencies that regulate GE 
crops, we reviewed the Coordinated Framework's guidance for interagency 
coordination. We then discussed with agency officials their 
implementation of this guidance and reviewed documents that they 
provided, such as interagency memorandums of understanding and agendas 
or minutes for interagency meetings. We also considered the views of 
nongovernmental organizations regarding the adequacy of this 
coordination, including those published by the National Research 
Council and the Pew Initiative on Food and Biotechnology. In addition, 
for criteria, we applied selected practices previously identified by 
GAO for enhancing and sustaining interagency collaboration.[Footnote 
21] These practices include defining and articulating a common outcome; 
agreeing on roles and responsibilities; establishing mutually 
reinforcing or joint strategies; identifying and addressing needs by 
leveraging resources; establishing compatible policies, procedures, and 
other means to operate across agency boundaries; developing mechanisms 
to monitor, evaluate, and report on results; and reinforcing agency 
accountability for collaborative efforts through agency plans and 
reports. We did not address an eighth practice--that is, reinforcing 
individual accountability for collaborative efforts through performance 
management systems--because doing so was beyond the scope of our work. 

Related to the coordination issue and other aspects of the Coordinated 
Framework, we also compared the guidance contained in the framework and 
in related policy statements subsequently issued by OSTP with 
regulations and proposed rules promulgated by USDA, EPA, and FDA since 
1986. In addition, we discussed the framework's relevance with 
industry, consumer, and academic officials. Although the framework is a 
broad policy document addressing all aspects of biotechnology, our 
analysis was limited to those sections that pertain specifically to the 
regulation of GE crops. 

To determine the additional actions proposed by the agencies to improve 
oversight of GE crops and reduce the potential for unauthorized 
releases, we reviewed relevant proposed rules published in the Federal 
Register. These proposed rules included the following: 

* USDA, Proposed Rule: Importation, Interstate Movement, and Release 
Into the Environment of Certain Genetically Engineered Organisms, 73 
Fed. Reg. 60,008 (Oct. 9, 2008). 

* USDA, Introduction of Genetically Engineered Organisms, Draft 
Programmatic Environmental Impact Statement, (July 17, 2007). 

* EPA, Proposed Rule: Exemption from the Requirement of a Tolerance 
under the Federal Food, Drug, and Cosmetic Act for Residues of Plant 
Virus Coat Proteins that are Part of a Plant-Incorporated Protectant 
(PVC-Proteins), 72 Fed. Reg. 19,640 (Apr. 18, 2007). 

* EPA, Proposed Rule: Exemption Under the Federal Insecticide, 
Fungicide, and Rodenticide Act for Certain Plant-Incorporated 
Protectants Derived From Plant Viral Coat Protein (PVCP-PIPs) Gene(s) 
Supplemental Proposal, 72 Fed. Reg. 19,590 (Apr. 18, 2007). 

* EPA, Advance Notice of Proposed Rulemaking: Plant-Incorporated 
Protectants; Potential Revisions to Current Production Regulations, 72 
Fed. Reg. 16,312 (Apr. 4, 2007). 

* FDA, Proposed Rule: Premarket Notice Concerning Bioengineered Foods, 
66 Fed. Reg. 4,706 (Jan. 18, 2001). 

USDA issued its October 9, 2008 proposed rule after we had sent our 
draft report to the agencies for review and comment. We modified our 
draft to reflect the publication of the proposed rule, and added brief 
descriptions of some aspects of it. However, we were not able to 
thoroughly analyze the proposed rule or interview agency or other 
stakeholder officials about its contents. 

We also reviewed public comments submitted with respect to each of 
these proposed rules except USDA's October 2008 proposed rule. (The 
deadline for commenting on that proposed rule is November 24, 2008.) In 
general, these comments are posted to each rule's official electronic 
docket found at Regulations.gov. To summarize the comments on USDA's 
draft programmatic environmental impact statement (DEIS), we divided 
the respondents into seven constituent categories: academics, 
agricultural producers, biotechnology developers, consumer and public 
interest groups, food industry representatives, government officials, 
and unaffiliated private citizens. A GAO analyst then coded the 
responses from the first six constituent categories on the basis of 
stakeholders' explicit or implied preference for various alternatives 
discussed in the draft statement. The coding scheme included a means of 
indicating when a stakeholder's preference was not apparent on the 
basis of the written comments. To ensure that decisions about how to 
code the comments were reliable, a second GAO analyst also reviewed the 
comments. We used the same technique to code a random sample of 51 of 
the 265 comments submitted individually by unaffiliated private 
citizens. 

To summarize the views of stakeholders who commented on EPA's proposed 
rules, we coded all stakeholders' comments on the basis of their 
general response to the rules as well as their specific responses to 
relevant issues identified by EPA. Because of the limited number of 
responses--generally about 12--posted in each docket, we did not 
stratify respondents into different categories. Regarding FDA's 
proposed rule, we could not easily stratify and summarize the 
associated comments, which, according to FDA, numbered over 124,000. 
Specifically, as of August 2008, FDA had not entered these comments 
into an electronic docket that we needed to perform this analysis. 
Instead, we reviewed a limited, judgmental sample of these comments to 
gain a general understanding of the issues that stakeholders raised. 

Furthermore, to determine additional actions proposed by USDA, we 
interviewed agency officials and reviewed documentation they provided 
related to two initiatives--that is, USDA's (1) proposal for a 
voluntary Biotechnology Quality Management System (BQMS) and (2) 
summary of lessons learned from its investigation of the unauthorized 
release of a GE rice variety, LibertyLink Rice (LLRICE), and other 
similar incidents. BQMS, which USDA plans to fully implement in fiscal 
year 2009, provides guidance to GE crop developers for analyzing their 
field trial operations to identify possible problems and mitigation 
measures that could reduce the potential for an unauthorized release. 
Also, we attended meetings in November 2007 and March 2008 of USDA's 
Advisory Committee on Biotechnology and 21st Century Agriculture at 
which the BQMS proposal was discussed. 

We conducted this performance audit from July 2007 to November 2008 in 
accordance with generally accepted government auditing standards. These 
standards require that we plan and perform our audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides this reasonable basis. 

[End of section] 

Appendix II: Comments from the U.S. Department of Agriculture: 

Note: GAO comments supplementing those in the report text appear at the 
end of this appendix. 

USDA: 
United States Department of Agriculture: 
Office of the Secretary: 
Washington, D.C. 20250: 

October 31, 2008: 

Mr. Jim Jones, Assistant Director: 
United States Government Accountability Office: 
441 G Street, NW: 
Washington, DC 20548: 

Dear Mr. Jones: 

The United States Department of Agriculture (USDA) appreciates the 
opportunity to review and provide comments on the GAO Draft Report, 
"Genetically Engineered Crops: Agencies Are Proposing Changes to 
Improve Oversight, but Could Take Additional Steps to Enhance 
Coordination and Monitoring," (GAO 09-60). We have addressed the 
Recommendations for Executive Action that pertain to USDA. 

GAO Recommendation: 

To reduce the risk and impact of unauthorized releases, we recommend 
that the Secretary of Agriculture and the Commissioner of FDA develop a 
formal agreement to share information concerning GE crops with novel 
genetic traits that, if unintentionally released into the food or feed 
supply, could cause real or perceived health concerns and have negative 
financial consequences for the food and agriculture industry. With 
information from USDA about permits or notifications for field trials 
of such GE crops, FDA could identify which GE crops might benefit from 
an early food safety assessment and encourage the developers of those 
crops to participate in assessments. With assistance from FDA, USDA 
could make meaningful and transparent use of the health assessment data 
available through FDA's early food safety assessments in its risk 
assessment of GE crops. 

USDA Response: 

USDA agrees, in large part, with this Recommendation. Under the 
Coordinated Framework, USDA and the U.S. Food and Drug Administration 
(FDA) have worked effectively to share information on this and related 
issues. However, development of a formal agreement between USDA and FDA 
could enhance relevant information sharing. USDA will work with FDA to 
explore the development of an agreement for sharing information to help 
ensure that each agency has relevant information concerning regulated 
GE crops. USDA recently published a proposed rule to revise existing 
regulations regarding the importation, interstate movement and 
environmental release of certain genetically engineered (GE) organisms 
under the Plant Protection Act (PPA) of 2000. During the comment 
period, USDA may receive additional suggestions related to regulations 
regarding the importation, interstate movement and environmental 
release of certain genetically engineered (GE) organisms under the 
Plant Protection Act (PPA) of 2000. During the comment period, USDA may 
receive additional suggestions related to enhancing information sharing 
with FDA. Information that is shared by FDA under an agreement may 
assist USDA in its decisions on confinement conditions and deregulation 
of certain GE organisms. Nonetheless, USDA's regulatory system is 
science-based, and therefore its evaluations and decision making are, 
and will remain, limited to risks involving actual physical harm and 
will not consider perceived, but scientifically unfounded, risks. [See 
comment 1] 

GAO Recommendation: 

To help ensure that unintended consequences arising from the marketing 
of GE crops are detected and minimized, we recommend that the Secretary 
of Agriculture, the Administrator of EPA, and the Commissioner of FDA 
develop a coordinated strategy for monitoring marketed GE crops and use 
the results to inform their oversight of these crops. Such a strategy 
should adopt a risk-based approach to identify the types of marketed GE 
crops that warrant monitoring, such as those with the greatest 
potential for affecting the environment or non-GE segments of 
agriculture, or those that might threaten food safety through the 
unintentional introduction of pharmaceutical or industrial compounds 
into the food supply. The strategy should also identify criteria for 
determining when monitoring is no longer needed. In developing a 
strategy, the agencies should draw upon the analysis and conclusions of 
the National Research Council and the National Science and Technology 
Council. 

USDA Response: 

USDA agrees, in part, with this recommendation. We support a risk-based 
approach to the oversight of regulated GE crops and any monitoring 
activities should also be risk-based in order to evaluate potential 
impacts on human health and the environment. [See comment 2] However, 
our current regulations do not allow for APHIS to base its deregulation 
determinations upon any risks other than plant pest risks. Although 
USDA deregulation determinations are currently informed by the NEPA 
process which analyzes potential impacts on the human environment, 
ultimately USDA must deregulate a GE plant when it makes a 
determination that the GE plant is unlikely to be a plant pest. After 
USDA makes its deregulation determination, it would have no regulatory 
basis for further monitoring of the crop. If; however, USDA makes a 
partial deregulation determination, then we do agree that monitoring of 
the crop may be appropriate in specific circumstances where a potential 
for plant pest risk is identified. [See comment 3] We likewise support 
having discussions with EPA and FDA regarding the possible parameters 
of USDA's involvement in plant pest risk-appropriate monitoring 
strategies for marketed deregulated GE crops should such monitoring be 
warranted in the future. USDA's overall approach towards monitoring was 
explained at length in a 2004 response to two National Research Council 
(NRC) reports, issued in 2000 and 2002. In that response USDA explained 
that an USDA deregulation is issued when the Agency has determined that 
the GE plant varieties do not pose a plant pest risk. This means that 
the Agency has found that unconfined release of these deregulated 
products is just as safe as that of their non-GE counterparts. Thus, 
once USDA has determined that the GE plant crop does not pose a plant 
pest risk, then it must remove the GE organism from its regulatory 
oversight. [See comment3] If USDA determined that monitoring of a 
product was required to mitigate a plant pest risk, USDA could choose 
to not deregulate the product or to partially deregulate it with 
stringent conditions including possible geographical limitations. 
Monitoring requirements could certainly be stipulated in permit 
conditions prior to the deregulation of any regulated GE crop. 

USDA would like to also note that, as described in detail in the 2004 
response to the NRC, there are many USDA programs involved in 
activities related to monitoring. [See comment 4] In particular, USDA 
risk assessors help to establish priorities and review grants for the 
Biotechnology Risk Assessment Grant (BRAG) Program. BRAG is a 
competitive grant program administered by USDA's Cooperative State 
Research, Education, and Extension Service (CSREES) and the 
Agricultural Research Service (ARS). BRAG provides grants for research 
on the effects of introducing genetically modified organisms into the 
environment. CSREES and ARS also oversee other research programs 
related to risk assessment and risk mitigation of GE organisms. The 
response to the NRC also reported that in FY2003, ARS funded 
approximately $23 million in intramural environmental risk assessment 
research. Much of this intramural USDA research was conducted in the 
course of developing improved GE varieties. Approximately $4.4 million 
of this was specifically earmarked for risk assessment and risk 
mitigation research. 

USDA also has several long-term programs that track many aspects of 
U.S. forest, crop, and range lands. The Forest Service's Forest 
Inventory and Analysis periodically gathers data on the status and 
trends in forest areas and locations across the United States. Factors 
examined include the type and size of trees, soil composition, and 
under-story plant diversity. In addition, the National Agricultural 
Statistics Service (NASS) conducts surveys and censuses of the Nation's 
2.1 million farms. NASS focuses on the type of commodity produced, the 
yield, and the cost of production but also collects data on management 
practices. Since 2000, NASS has reported on state-by-state adoption 
rates of the major GE crops (soybeans, corn, and cotton) in major 
producing states and combined adoption rates for other states. Also, 
USDA's National Resource Conservation Service (NRCS) collects data on 
land use, and soil and water characteristics. Land use data are 
collected on 800,000 sites in the United States from satellite images 
every five years. 

Sincerely, 

Signed by: 

Bruce I. Knight: 
Under Secretary: 
Marketing and Regulatory Programs: 

The following are GAO's comments on the U.S. Department of 
Agriculture's letter dated October 31, 2008. 

GAO Comments: 

1. USDA commented that its regulatory system is science-based and 
limited to risks involving actual physical harm rather than perceived, 
but scientifically-unfounded, risks. In light of this comment, we have 
modified the wording of our draft recommendation to remove the 
reference to "perceived health concerns" and instead emphasize that the 
agreement would cover GE crops that present or are likely to present 
public health concerns. 

2. USDA commented that its regulations do not allow for the Animal and 
Plant Health Inspection Service (APHIS) to base its deregulation 
determinations upon any risks other than plant pest risks. As USDA 
notes in its October 9, 2008 proposed rule, the agency's regulations 
could be grounded in more than just its authority to regulate GE crops 
as plant pests. The Plant Protection Act gives the Secretary of 
Agriculture the authority to regulate to prevent the introduction or 
dissemination of noxious weeds. Noxious weeds are defined as any plant 
or plant product that can injure or cause damage to, among other 
things, crops, livestock, interests of agriculture, public health, or 
the environment. In this context, USDA could, for example, monitor 
marketed GE crops for their economic effects on other segments of 
agriculture. 

3. USDA stated that after it makes a decision to deregulate a GE crop 
it has no regulatory basis for further monitoring. However, USDA 
maintains the authority under the Plant Protection Act to regulate a GE 
crop that it has granted deregulated status to if it obtains new 
information indicating that the crop is a plant pest. A coordinated 
inter-agency monitoring program would be one way of obtaining such 
information. 

4. USDA listed several programs that it noted are related to 
monitoring. We did not review the programs that USDA mentioned, but we 
believe that they could provide useful monitoring data related to GE 
crops. We suggest that USDA incorporate them into the recommended 
coordinated strategy. 

[End of section] 

Appendix III: Comments from the Department of Health and Human Services 
(FDA): 

Note: GAO comments supplementing those in the report text appear at the 
end of this appendix. 

Department Of Health & Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

October 21, 2008: 

Lisa Shames, Director: 
Natural Resources and Environment: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, DC 20548: 

Dear Ms. Shames: 

Enclosed are the Department's comments on the U.S. Government 
Accountability Office's (GAO) draft report entitled: "Genetically 
Engineered Crops: Agencies Are Proposing Changes to Improve Oversight, 
but Could Take Additional Steps to Enhance Coordination and Monitoring" 
(GAO-09-60). 

The Department appreciates the opportunity to review and comment on 
this report before its publication. 

Sincerely, 

Signed by: 

Jennifer R. Luong: 
For: Vincent J. Ventimiglia, Jr. 
Assistant Secretary for Legislation: 

Attachment: 

Food and Drug Administration General Comments on the Government 
Accountability Office's (GAO) Draft Report Entitled, "Genetically 
Engineered Crops-Agencies Are Proposing Changes to Improve Oversight, 
but Could Take Additional Steps to Enhance Coordination and Monitoring" 
(GAO 09-60): 

The Food and Drug Administration (FDA) welcomes the Government 
Accountability Office's (GAO) draft report on bioengineered foods and 
appreciates the opportunity to review and provide comments. In addition 
to the FDA's responses to the recommendations, we have provided GAO 
with some technical comments regarding the draft report. FDA believes 
that its current processes for evaluating bioengineered foods and new 
proteins in such foods provides appropriate oversight and protection of 
the food and feed supplies. FDA also believes that it closely and 
effectively coordinates with the United States Department of 
Agriculture (USDA) and the Environmental Protection Agency (EPA) in the 
regulation of genetically engineered (GE) food plants. FDA does agree, 
however, that certain additional actions would increase transparency 
of, and enhance public confidence in, the agency's evaluation 
processes. 

GAO Recommendations: 

To improve transparency and mitigate the impact of an unauthorized 
release into the food or feed supply of a regulated GE plant that has 
completed an early food safety evaluation, we recommend that the 
Commissioner of FDA fulfill the agency's commitment to post the results 
of completed early food safety evaluations on its Web site and add the 
results of future evaluations within 120 days of receiving the 
submission from the plant developer. 

FDA Response: 

FDA agrees that posting the results of completed early food safety 
evaluations on our Web site would improve transparency. As described in 
the Guidance to Industry: Recommendations for the Early Food Safety 
Evaluation of New Non-Pesticidal Proteins Produced by New Plant 
Varieties Intended for Food Use, FDA has stated that the agency plans 
to respond to a complete submission within 120 days of receipt, and to 
make the text of that response letter easily accessible to the public 
via the Internet. FDA intends to make every effort to fulfill the 
commitments made in the guidance document; however, to date other 
activities of greater public health priority have been the focus of the 
agency's, and particularly, the Center for Food Safety and Applied 
Nutrition's, limited resources. [See comment 1] 

GAO Recommendation: 

To reduce the risk and impact of unauthorized releases, we recommend 
that the Secretary of Agriculture and the Commissioner of FDA develop a 
formal agreement to share information concerning GE crops with novel 
genetic traits that, if unintentionally released into the food or feed 
supply, could cause real or perceived health concerns and have negative 
financial consequences for the food and agriculture industry. With 
information from USDA about permits or notifications for field trials 
of such GE crops, FDA could identify which GE crops might benefit from 
an early food safety assessment and encourage the developers of those 
crops to participate in assessments. With assistance from FDA, USDA 
could make meaningful and transparent use of the health assessment data 
available through FDA's early food safety assessments in its risk 
assessment of GE crops. 

FDA Response: 

FDA agrees in part with this recommendation. FDA agrees that it would 
be useful to explore possible mechanisms to facilitate information 
sharing with USDA to reduce the risk and potential public health impact 
of an unauthorized release of a GE crop. In the recent past, USDA and 
FDA have worked effectively to share information when an unauthorized 
release has occurred. However, the agency intends to explore 
development of a formal mechanism to facilitate these exchanges, 
recognizing that such a mechanism may make interagency coordination 
more transparent and thereby enhance public confidence. 

The recommendation suggests that FDA obtain information about GE crops 
that, if unintentionally released into the food or feed supply, could 
cause "perceived health concerns." FDA uses a risk-based approach that 
focuses its resources on issues that either do or are likely to present 
public health concerns, as opposed to those issues that present only 
"perceived health concerns." FDA believes that focusing its resources 
on issues most likely to pose public health concerns provides the 
greatest public health protection. In addition, focusing resources on 
"perceived health concerns" would divert resources from activities 
providing significant public health protection to activities with 
little or no discernible public health benefit. [See comment 2] 

GAO also suggests that FDA obtain information about GE crops that, if 
unintentionally released into the food or feed supply, could have 
"negative financial consequences for the food and agriculture 
industry." While recognizing that the food and agriculture industry may 
experience negative financial consequences in the event of an 
unauthorized release of a GE crop, this issue falls outside the scope 
of FDA's mandate to protect and promote the public health. [See comment 
3] 

GAO Recommendation: 

To help ensure that unintended consequences arising from the marketing 
of GE crops are detected and minimized, we recommend that the Secretary 
of Agriculture, the Administrator of EPA, and the Commissioner of FDA 
develop a coordinated strategy for monitoring marketed GE crops and use 
the results to inform their oversight of these crops. Such a strategy 
should adopt a risk-based approach to identify the types of marketed GE 
crops that warrant monitoring, such as those with the greatest 
potential for affecting the environment or non-GE segments of 
agriculture, or those that might threaten food safety through the 
unintentional introduction of pharmaceutical or industrial compounds 
into the food supply. The strategy should also identify criteria for 
determining when monitoring is no longer needed. In developing a 
strategy, the agencies should draw upon the analysis and conclusions of 
the National Research Council and the National Science and Technology 
Council. 

FDA Response: 

FDA agrees in part with this recommendation. FDA agrees that any 
monitoring strategy should adopt a risk-based approach. FDA does not 
believe that post-market monitoring of foods derived from GE crops 
currently on the market is necessary for the same reasons presented in 
the report (p. 35); there is no scientific evidence or even a 
hypothesis suggesting long-term harm from consumption of these foods. 
FDA would consider specific risk-based monitoring efforts should 
marketed GE crops intended for food or feed warrant such monitoring in 
the future. FDA intends to discuss coordination issues with USDA and 
EPA to be better prepared in case a situation should arise in the 
future that warranted such monitoring. [See comment 4] 

FDA notes GAO's concern regarding the potential for GE crops producing 
pharmaceutical or industrial substances to be inadvertently present in 
the food or feed supply (p. 35). As part of the coordinated effort to 
regulate such crops, USDA establishes strict permit conditions and 
performs rigorous inspections, including an increased rate of 
inspections, so that crops producing substances not intended for use in 
the food or feed supply do not inadvertently become part of the food or 
feed supply. FDA and USDA closely and effectively communicate and 
coordinate when there is a concern about the safety of the food or feed 
supply. FDA believes that random food product or commodity sampling to 
detect GE crops producing pharmaceutical or industrial substances in 
food and feed would present significant technical challenges and 
greatly affect resources, and would not likely be nearly as effective 
as USDA's current system of strict permit conditions and rigorous 
inspections targeted toward these crops. [See comment 5] 

The following are GAO's comments on the Department of Health and Human 
Service's letter dated October 21, 2008. 

GAO Comments: 

1. FDA commented that it intends to make every effort to fulfill its 
commitment to post the results of its early food safety evaluations but 
that its focus has been on higher public health priorities. We 
recognize that FDA has competing priorities and finite resources, but 
we continue to believe that implementing this recommendation would be a 
relatively low-cost way to increase public transparency and trust and 
mitigate the impact of the unintended release of GE crops subject to 
early food safety evaluations. 

2. FDA commented that it uses a risk-based approach that focuses its 
resources on issues that present or are likely to present public health 
concerns as opposed to issues that present only perceived health 
concerns. In light of this comment, as well as USDA's similar comment, 
we modified the wording of the recommendation to emphasize that the 
agencies develop a formal agreement to share information on GE crops 
that present or are likely to present public health concerns. 

3. We acknowledge FDA's statement that the financial consequences of 
unintended releases fall outside it authority to protect and promote 
the public health. However, USDA, which bears some responsibility for 
promoting and expanding agricultural markets, may be concerned with 
these consequences. Thus, while we modified this recommendation to 
emphasize sharing information on GE crops that present or are likely to 
present health concerns, we also retained reference to the financial 
consequences of unintended releases. As we reported, known unintended 
releases of GE crops to the food and feed supply apparently have not 
caused health effects, but several led to financial losses. 

4. FDA commented that it does not believe that post-market monitoring 
of foods derived from GE crops currently on the market is necessary. 
However, in making the recommendation that the agencies develop a 
coordinated monitoring strategy, our concern, in part, is the potential 
for GE crops producing pharmaceutical or industrial substances to be 
inadvertently present in the food or feed supply. Their presence could 
violate the Federal Food, Drug, and Cosmetic Act, could cause harm to 
human or animal health, and would likely cause financial harm to the 
agriculture and food industry. In light of this possibility, as well as 
the likelihood that the use of GE crops to produce these substances 
will increase in the future, we believe that the agencies should 
develop a risk-based coordinated strategy to monitor for their presence 
in the food and feed supply. 

5. FDA commented that USDA establishes strict permit conditions and 
performs inspections to minimize the likelihood that crops producing 
substances not intended for the food or feed supply might inadvertently 
become part of that supply, and that random FDA sampling to detect such 
substances would be difficult, expensive, and not as effective as 
USDA's actions. We acknowledge that USDA imposes strict permit 
conditions and requires frequent inspections of GE crops that produce 
pharmaceutical and industrial substances. However, while USDA may be 
able to reduce the likelihood of unintended releases of these crops, 
FDA has primary authority over the safety of the food and feed supply. 
Because biological substances such as GE crops are inherently difficult 
to control and there may be an increasing use of GE crops to produce an 
even wider array of pharmaceutical and industrial compounds in the 
future, we continue to believe that FDA and the other agencies should 
develop a risk-based coordinated strategy to monitor for their 
unintentional release. Furthermore, in the United States (1) GE crop 
varieties are grown extensively, (2) most processed foods contain 
ingredients from GE crops, and (3) genetic modifications are becoming 
increasingly complex in response to pressures to increase yields for 
food and biofuel. We believe these factors also argue for risk-based 
monitoring. 

[End of section] 

Appendix IV: U.S. Legal Framework for Regulation of GE Crops: 

On June 26, 1986, OSTP published the Coordinated Framework in the 
Federal Register.[Footnote 22] The framework describes the 
comprehensive federal regulatory policy for ensuring the safety of 
biotechnology research and products. According to OSTP, existing 
statutes provide a basic network of agency jurisdiction over research 
and products and help ensure reasonable safeguards for the public. 
While OSTP recognized that the Coordinated Framework might need to 
evolve through administrative or legislative actions, it determined 
that existing laws would adequately address the regulatory needs for 
biotechnology. 

The Coordinated Framework outlined the roles and responsibilities of 
relevant federal agencies, including USDA, EPA, FDA, the Occupational 
Safety and Health Administration, the National Institutes of Health, 
and the National Science Foundation. The framework also identified the 
relevant laws that would govern those agencies' activities regarding 
biotechnology. Table 4 contains summaries of key provisions in the 
primary laws that the agencies have used to regulate GE crops as well 
as a brief explanation of their relevance to biotechnology. Three of 
these laws--administered by USDA, EPA, FDA, or a combination of these 
agencies--include the Plant Protection Act; the Federal Insecticide, 
Fungicide, and Rodenticide Act; and the Federal Food, Drug, and 
Cosmetic Act. In addition, the table contains a summary of the relevant 
provisions of the National Environmental Policy Act of 1969; procedures 
outlined in that law must be followed by USDA, EPA, and FDA, when 
applicable. 

Table 4: Key Legislation That Is Relevant to the Regulation of GE 
Crops: 

Legislation: Plant Protection Act[A]: 

General application to GE organisms: 
With respect to genetic engineering, USDA currently defines as a 
"regulated article" any organism that has been altered or produced 
through genetic engineering if the donor organism, recipient organism, 
or vector or vector agent belongs to any genera or taxa designated in a 
list of plant pests and meets the definition of plant pest or if the 
APHIS Administrator determines it is a plant pest or has reason to 
believe it is a plant pest. Statutory and regulatory requirements that 
apply to plant pests also apply to GE plants that meet the definition 
of plant pests. 
As described in this report, USDA is considering changes to its 
regulations that would also recognize the agency's authority to 
regulate GE plants as noxious weeds. 
Major relevant provisions: 
* Repealed the Federal Plant Pest Act, the Plant Quarantine Act, and 
the Federal Noxious Weed Act of 1974, and several other related 
provisions. Defines a plant pest as any living stage of a protozoan, 
nonhuman animal, parasitic plant, bacterium, fungus, virus or viroid, 
infectious agent or other pathogen, or any article similar to or allied 
with the foregoing items. Prohibits the importation, entry, 
exportation, or movement of any plant pest in interstate commerce, 
unless authorized by the Secretary of Agriculture under permit. 
* Authorizes the Secretary of the U.S. Department of Agriculture to 
allow importation, entry, exportation, or movement of a specific plant 
pest without a permit when he or she finds a permit is not necessary. 
Allows any person to petition to add or remove a plant pest from the 
list of plant pests exempt from the prohibition and directs the 
Secretary to act on the petition. 
* Authorizes the Secretary to issue regulations to prohibit or restrict 
the importation, entry, exportation, or movement in interstate commerce 
of any plant product, biological control organism, noxious weed, 
article, or means of conveyance if he or she determines it is necessary 
to prevent the introduction or dissemination of a plant pest or noxious 
weed. Such regulations could include requiring permits or certificates 
of inspection. Authorizes the Secretary to publish, by regulation, a 
list of noxious weeds prohibited or restricted from entering the United 
States or that are subject to restrictions in interstate movement. 
* Authorizes the Secretary to, among other things, hold, seize, 
quarantine, or destroy any plant, plant pest, noxious weed, biological 
control organism, plant product, article, or means of conveyance, if he 
or she considers it necessary, to prevent the dissemination of a plant 
pest or noxious weed that is new or not widely prevalent in the United 
States, and is moving or has moved through the United States or 
interstate. States that no plant, plant pest, noxious weed, biological 
control organism, plant product, article, or means of conveyance shall 
be destroyed unless, in the opinion of the Secretary, there is no less 
drastic action that is feasible and that would be adequate to prevent 
the dissemination of any plant pest or noxious weed new or not widely 
prevalent in the United States. 
* Authorizes the Secretary, upon a finding that an extraordinary 
emergency exists because of the presence of a plant pest or noxious 
weed that is new or not widely prevalent in the United States, to, 
among other things, hold, seize, quarantine, or destroy any plant, 
plant pest, noxious weed, biological control organism, plant product, 
article, or means of conveyance the Secretary has reason to believe is 
infested with the plant pest or noxious weed, or to quarantine any 
state or portion of a state in which the Secretary finds the plant pest 
or noxious weed. 
* Authorizes the Secretary to inspect, without a warrant, any person or 
means of conveyance moving (1) into the United States to determine if 
the person or means of conveyance is carrying an article subject to the 
act; (2) in interstate commerce upon probable cause that the person or 
means of conveyance is carrying an article subject to the act; or (3) 
in intrastate commerce within a state, portion of a state, or premises 
that is quarantined as part of an extraordinary emergency upon probable 
cause. Authorizes the Secretary to enter any premises in the United 
States for conducting inspections or seizures with a warrant issued 
upon probable cause that there is an article subject to the act on the 
premises. Grants the Secretary power to subpoena the attendance and 
testimony of witnesses, the production of all evidence, and the 
direction to permit inspections of premises related to the 
administration or enforcement of the act. Established criminal and 
civil penalties for violations of the act. 
* Authorizes the Secretary to issue regulations and orders he or she 
considers necessary to carry out the act. Preempts states from 
regulating the movement in interstate commerce of any article subject 
to the act to control or eradicate a plant pest or noxious weed or to 
prevent the dissemination of a biological control organism, plant pest, 
or noxious weed if the Secretary has already issued a regulation, or to 
prevent the dissemination of the biological control organism, plant 
pest, or noxious weed within the United States. 

Legislation: Federal Insecticide, Fungicide, and Rodenticide Act[B]: 

General application to GE organisms: With respect to genetically 
engineered organisms, EPA regulates the pesticides produced in plants, 
as well as the genetic material that produces such pesticides. These 
pesticides are known as "plant-incorporated protectants." The statutory 
and regulatory requirements that apply to pesticides in general--such 
as those concerning registration, labeling, experimental use permits, 
inspections, and enforcement--also apply to plant-incorporated 
protectants produced in GE crops. 
Major relevant provisions: 
* Unless otherwise authorized by the act, prohibits the selling in any 
state of any pesticide that has not been registered under the act, and 
authorizes the Administrator of the Environmental Protection Agency to 
limit, by regulation, the distribution, sale, or use in any state of 
any pesticide that is not registered under the act or is not subject to 
an experimental use permit or an emergency exemption. Establishes 
procedures to register a pesticide with EPA. Directs the Administrator 
to publish guidelines specifying the kinds of information required to 
support the registration of a pesticide. Establishes time frames and 
procedures for the Administrator to review and approve of registration 
applications. 
* Permits any person to apply to the Administrator for experimental use 
permits for pesticides. Directs the Administrator to review those 
applications and either approve the permit or notify the applicant of 
the reasons for not issuing a permit. Limits experimental use permits 
to when the Administrator determines that the applicant needs such a 
permit to accumulate information necessary for registration of a 
pesticide under the act. Allows the Administrator to set a temporary 
tolerance level for pesticide residues before issuing an experimental 
use permit. Allows the Administrator, by regulation, to authorize 
states to issue experimental use permits for pesticides. 
* Authorizes the Administrator to cancel a pesticide registration if it 
appears to the Administrator that the pesticide or its labeling does 
not comply with the act, or suspend registration to prevent an imminent 
hazard during the time proceedings are pending. 
* Prohibits the production of pesticides subject to the act (or an 
active ingredient used in producing a pesticide subject to the act) 
unless the establishment at which such pesticides are produced is 
registered with the Administrator. Authorizes the Administrator to 
prescribe regulations requiring producers to maintain records with 
respect to their operations and the pesticides produced as the 
Administrator determines necessary for the effective enforcement of the 
act, and to make those records available for inspection and copying. 
Requires producers to permit EPA, upon a valid request, access to and 
to copy all records showing delivery, movement, or holding of 
pesticides. Authorizes EPA to enter, at reasonable times, any 
establishment where pesticides are held for distribution or sale to 
inspect and obtain samples. EPA may obtain a warrant from a court of 
competent jurisdiction to enter and inspect an establishment or inspect 
and copy records when there is reason to believe that provisions of the 
act have been violated. 
* States that it is unlawful for any person in any state to distribute 
or sell, among other things, any pesticide that is not registered 
(unless otherwise authorized under the act) or any pesticide that is 
misbranded or adulterated. In addition, the act makes it unlawful for 
any person to, among other things, fail to prepare and maintain 
records, submit reports, or allow inspection under the act. Authorizes 
the Administrator to issue "stop sale, use, or removal" orders whenever 
a pesticide is found by the Administrator in any state and there is 
reason to believe--on the basis of inspections or tests-- that the 
pesticide is in violation of the act, or intended to be sold or 
distributed in violation of the act. States that unsold pesticides (or 
pesticides in unbroken packages) being or having been transported, or 
sold or offered for sale in any state in violation of the act, shall be 
liable for seizure in any district court in a district where found if, 
among other things, the pesticide is misbranded or adulterated or is 
not registered under the act. The act also establishes civil and 
criminal penalties associated with violations of the act. 
* Authorizes the Administrator to exempt federal and state agencies 
from the provisions of the act if the Administrator determines 
emergency conditions exist that require such an exemption. Authorizes 
the Administrator to, by regulation or order, issue requirements and 
procedures for persons who store or transport pesticides the 
registration of which has been canceled or suspended, for persons who 
dispose of stocks of pesticides the registration of which has been 
suspended, and for the disposal of any pesticide the registration of 
which has been canceled. Directs the Administrator to order a recall of 
a pesticide, the registration of which has been suspended or canceled, 
if he or she determines the recall is necessary to protect health or 
the environment. If the Administrator finds that voluntary recall by 
the registrant would be as safe and effective as a mandatory recall, 
the Administrator shall request a plan for that recall, and if the plan 
is adequate, order the registrant to conduct the recall under the plan. 
* Authorizes the Administrator to enter into cooperative agreements 
with states and Indian tribes to delegate the authority to cooperate in 
the enforcement of the act. Allows states to regulate the sale or use 
of federally registered pesticides in the state to the extent the 
regulation does not permit any sale or use prohibited by the act. 
Allows states to provide registration for additional uses of federally 
registered pesticides formulated for distribution and use within that 
state to meet special local needs in accordance with the purposes of 
the act. 
* Authorizes the Administrator to prescribe regulations to carry out 
the provisions of the act, and establishes procedures for developing 
and finalizing those regulations. Authorizes the Administrator to 
exempt, by regulation, any pesticide from the requirements of the act 
if he or she determines the pesticide is adequately regulated by 
another federal agency or, because of its character, it is unnecessary 
to be subject to the act in order to carry out the purposes of the act. 
Authorizes the Administrator, after notice and comment rulemaking, to, 
among other things, declare a pest, any plant or animal life (other 
than man or a bacteria, virus, or other micro-organism on or in living 
man or animals) that is injurious to health or the environment and 
establish standards with respect to the package, container, or wrapping 
in which a pesticide is enclosed. 
* Declares that states shall have primary enforcement authority for 
pesticide use violations during a period for which the Administrator 
determines that the state has adopted adequate pesticide use laws and 
regulations, adopted and implemented adequate procedures for 
enforcement, and will keep records and reports showing the adoption of 
adequate laws and regulations and the adoption and implementation of 
adequate procedures. In addition, declares that states that have 
entered into cooperative agreements with the Administrator to receive 
delegated cooperative enforcement authority will have primary authority 
for enforcement, and that the Administrator will have primary 
enforcement authority for those states that do not. States that 
whenever the Administrator determines that a state with primary 
enforcement authority is not carrying out such responsibility, the 
Administrator will notify the state. After 90 days, if the 
Administrator determines the state's program remains inadequate, the 
Administrator can rescind, in whole or in part, the state's primary 
enforcement authority. 

Legislation: Federal Food, Drug, and Cosmetic Act, as amended[C]: 

General application to GE organisms: 
All domestic and imported foods and feeds under FDA's jurisdiction, 
whether or not they are derived from GE crops, must meet the same 
standards. Any food additive, including any introduced through genetic 
engineering, cannot be marketed before it receives FDA approval. 
However, substances added to foods that are "generally recognized as 
safe" under the conditions of intended use do not require FDA approval 
to be lawfully marketed. In 1992, FDA determined that most substances 
likely to become components of food as a result of genetic engineering 
would be the same or similar to substances commonly found in food. FDA 
encourages developers of GE foods to voluntarily notify the agency 
before marketing the foods. Notification leads to a consultation 
process between the agency and the company regarding the safety of the 
food in question. 
Major relevant provisions: 
* Describes the mission of the Food and Drug Administration to, among 
other things, protect the public health by ensuring that foods are 
safe, wholesome, sanitary, and properly labeled. 
* Defines "food" as articles used for food or drink for man or other 
animals, chewing gum, and articles used for components of any such 
articles. Defines "food additive" as any substance the intended use of 
which results or may reasonably be expected to result, directly or 
indirectly, in its becoming a component or otherwise affecting the 
characteristic of any food, if such substance is not "generally 
recognized as safe," as described in the act and implementing 
regulations, under the conditions of its intended use. However, 
pesticide chemicals and pesticide chemical residues, among other 
things, are not considered food additives. 
* Prohibits the adulteration or misbranding of any food in interstate 
commerce, and the delivery for introduction into or receipt in 
interstate commerce of any adulterated or misbranded food. Gives U.S. 
district courts jurisdiction to, among other things, enjoin violations 
of the prohibitions, or to seize adulterated or misbranded food in 
interstate commerce. Provides criminal penalties for violations of 
these prohibitions. Authorizes FDA to temporarily detain food when 
there is credible evidence or information indicating that such article 
presents a threat of serious adverse health consequences or death. 
* Deems a food to be "adulterated" when, among other things, the food 
bears or contains any poisonous or deleterious substance that may 
render it injurious to health; any pesticide chemical residue, unless 
the quantity of the residue is within the limits of the tolerance set 
by EPA, or an exemption from the requirement of a tolerance is in 
effect; or any food additive that is unsafe. (Generally, food additives 
are considered unsafe unless a regulation is in effect prescribing the 
conditions under which it may be used safely.) Authorizes the 
Administrator of EPA to establish tolerances for pesticide chemical 
residues in or on food if he or she determines the tolerance is safe. 
Authorizes the Administrator to establish exemptions to required 
tolerances if he or she determines the exemption is safe. 
* Requires those who manufacturer, process, pack, distribute, receive, 
hold, or import food (except farms and restaurants) to allow the 
Secretary of Health and Human Services (the Secretary) (delegated to 
FDA), when there is a reasonable belief that an article of food is 
adulterated and presents a threat of serious adverse health 
consequences or death, upon written notice at reasonable times and 
within reasonable limits and in a reasonable manner, to have access to 
and copy all records relating to such article of food needed to assist 
the Secretary (delegated to FDA) in determining whether the food is 
adulterated and presents such a threat. Authorizes the Secretary 
(delegated to FDA) to establish, by regulation, requirements regarding 
the establishment and maintenance of records needed to identify the 
immediate previous sources and immediate subsequent recipients of food 
to address credible threats of serious health consequences or death. 
Directs the Secretary (delegated to FDA) to, by regulation, require 
facilities that manufacture, process, pack, or hold food for 
consumption (not including farms, restaurants, other retail food 
establishments, certain nonprofit food establishments, or certain 
fishing vessels) to register with the Secretary. 
* Authorizes the Secretary (delegated to FDA) to promulgate regulations 
for the efficient enforcement of the act, and to conduct examinations 
and investigations for the purposes of the act. Authorizes the 
Secretary (delegated to FDA), for the purposes of enforcement and upon 
written notice, to enter any factory, warehouse or establishment in 
which food is manufactured, processed, packed, or held for introduction 
in interstate commerce or after such introduction, or to enter any 
vehicle being used to transport or hold such food in interstate 
commerce. Authorizes the Secretary (delegated to FDA), for the purposes 
of enforcement and upon written notice, to inspect, at reasonable 
times, and within reasonable limits, and in a reasonable manner, any 
factory, warehouse, establishment, or vehicle and all pertinent 
equipment, finished and unfinished materials, containers, and labeling 
therein. 
* Authorizes the refusal of admission of any article of food if, among 
other reasons, it appears from examination of samples or otherwise that 
such article is adulterated or misbranded. Directs FDA, under certain 
circumstances and upon credible evidence or information indicating that 
an article of food presents a threat of serious adverse health 
consequences or death, to request the Secretary of Treasury to hold 
such article for up to 24 hours to enable the Secretary (delegated to 
FDA) to inspect, examine, or investigate such article. 

Legislation: National Environmental Policy Act of 1969[D]: 

General application to GE organisms: 
This act requires agencies with oversight responsibility for GE crops 
to consider the likely environmental effects of actions they are 
proposing, and if those actions would significantly affect the 
environment, provide an environmental impact statement. Such statements 
could be required for actions related to the regulation of GE crops. 
For example, USDA's effort to change its biotechnology regulations is 
being conducted under the provisions of the act. USDA also conducts 
environmental analyses when it receives a petition to grant 
nonregulated status to GE crops. 
Major relevant provisions: 
* Directs all federal agencies to include a detailed statement of, 
among other things, the environmental impact, adverse environmental 
effects that cannot be avoided, and alternatives to the proposed action 
in every recommendation or report on proposals for major federal 
actions significantly affecting the quality of the human environment. 
Directs federal agencies to study, develop, and describe appropriate 
alternatives to recommended courses of action in any proposal that 
involves unresolved conflicts concerning alternative uses of available 
resources. 

Source: GAO analysis of relevant provisions of these four statutes. 

[A] Pub. L. No. 106-224, Tit. IV, §§ 401-442, 114 Stat. 438 (codified 
as amended at 7 U.S.C. §§ 7701-7786). 

[B] Pub. L. No. 80-104, 61 Stat. 163 (1947) (codified as amended at 7 
U.S.C. §§ 136-136y). 

[C] Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 
U.S.C. §§ 321-399). 

[D] Pub. L. No. 91-190, 83 Stat. 852 (codified as amended at 42 U.S.C. 
§§ 4321-4370f). 

[End of table] 

[End of section] 

Appendix V: Summary Information on USDA Notifications and Permits for 
Field Trials of GE Crops: 

USDA acknowledges notifications submitted by developers seeking to 
import, move interstate, or conduct field trials of regulated GE 
material, including GE crops, or issues permits. For field trials 
involving low-risk GE materials, such as engineering a well-known 
protein into a new plant variety, the more streamlined notification 
process may be used, assuming other regulatory criteria are met. 
However, for higher-risk items, such as engineering an unfamiliar 
protein into a new plant, a permit may be required that provides, among 
other things, more specific conditions for containment of the GE crop 
during the field trial. 

From 1987 through 2007, USDA approved over 13,000 notifications and 
permits for field trials. Over 90 percent of these approvals were 
notifications. Figure 3 shows the number of notifications and permits 
that USDA approved annually during this period. 

Figure 3: Annual Number of Notifications and Permits Approved by USDA, 
1987 through 2007: 

[Refer to PDF for image] 

This figure is a vertical bar graph depicting the following data: 

Annual Number of Notifications and Permits Approved by USDA, 1987 
through 2007: 

Year: 1987; 
Total number of field trial notifications and permits: 9. 

Year: 1988; 
Total number of field trial notifications and permits: 18. 

Year: 1989; 
Total number of field trial notifications and permits: 38. 

Year: 1990; 
Total number of field trial notifications and permits: 57. 

Year: 1991; 
Total number of field trial notifications and permits: 106. 

Year: 1992; 
Total number of field trial notifications and permits: 150. 

Year: 1993; 
Total number of field trial notifications and permits: 306. 

Year: 1994; 
Total number of field trial notifications and permits: 594. 

Year: 1995; 
Total number of field trial notifications and permits: 684. 

Year: 1996; 
Total number of field trial notifications and permits: 626. 

Year: 1997; 
Total number of field trial notifications and permits: 742. 

Year: 1998; 
Total number of field trial notifications and permits: 1,085. 

Year: 1999; 
Total number of field trial notifications and permits: 984. 

Year: 2000; 
Total number of field trial notifications and permits: 937. 

Year: 2001; 
Total number of field trial notifications and permits: 1,128. 

Year: 2002; 
Total number of field trial notifications and permits: 1,141. 

Year: 2003; 
Total number of field trial notifications and permits: 816. 

Year: 2004; 
Total number of field trial notifications and permits: 960. 

Year: 2005; 
Total number of field trial notifications and permits: 891. 

Year: 2006; 
Total number of field trial notifications and permits: 898. 

Year: 2007; 
Total number of field trial notifications and permits: 902. 

Source: USDA’s Animal and Plant Health Inspection Service. 

Note: USDA created the notification process in 1993; prior to that 
year, it only issued permits. 

[End of figure] 

Over time, GE crop developers have conducted field trial experiments on 
a variety of characteristics engineered into plants. The 
characteristics tested most often have been herbicide tolerance and 
insect resistance. Figure 4 presents data on the number of field trials 
by the type of characteristic being tested from 1987 through 2007. 
Because developers may test more than one characteristic during a field 
trial, the total number of characteristics (over 17,000) exceeds the 
more than 13,000 approved notifications and permits. 

Figure 4: Number of Field Trials by the Genetic Characteristic Tested, 
1987 through 2007: 

[Refer to PDF for image] 

This figure is a vertical bar graph depicting the following data: 

Number of Field Trials by the Genetic Characteristic Tested, 1987 
through 2007: 

Genetic characteristic: Herbicide tolerance; 
Total number of approved field trials: 4,427. 

Genetic characteristic: Insect resistance; 
Total number of approved field trials: 3,774. 

Genetic characteristic: Product Quality; 
Total number of approved field trials: 3,137. 

Genetic characteristic: Agronomic properties; 
Total number of approved field trials: 1,880. 

Genetic characteristic: Virus resistance; 
Total number of approved field trials: 1,298. 

Genetic characteristic: Other; 
Total number of approved field trials: 956. 

Genetic characteristic: Marker gene; 
Total number of approved field trials: 847. 

Genetic characteristic: Fungal resistance; 
Total number of approved field trials: 805. 

Genetic characteristic: Bacterial resistance; 
Total number of approved field trials: 139. 

Genetic characteristic: Nematode resistance[A]; 
Total number of approved field trials: 44. 

Source: Virginia Tech’s Information Systems for Biotechnology. 

[A] Nematodes are wormlike organisms. 

[End of figure] 

[End of section] 

Appendix VI: Information on the Commercialization of GE Crops: 

If field tests of a new GE crop are successful--for example, the 
desired trait, such as herbicide resistance, is expressed, and there 
are no unresolved safety issues--developers may seek to commercialize 
the product. In general, to do this, developers must petition USDA to 
deregulate the GE crop. In turn, to grant this "nonregulated" status, 
USDA must determine that the crop does not constitute a "plant pest." 
For GE crops engineered to include a pesticidal protectant, the 
developer must also obtain a pesticide registration from EPA. Finally, 
prior to introducing GE crops into the food or feed supply, developers 
are encouraged to consult with FDA on the crops' potential 
allergenicity, toxicity, and antinutrient (interference with nutrient 
absorption) properties. Assuming these regulatory agencies do not act 
to restrict the growth or use of a GE crop, it can enter into the food 
or feed supply and mix with conventional (non-GE) varieties without 
being monitored, traced, or labeled. 

USDA's Deregulation of GE Crops: 

Within USDA, APHIS bears the main responsibility for assessing the 
environmental safety of GE crops. The primary focus of this agency's 
review is to determine whether a plant produced through biotechnology 
is a plant pest. Developers can petition the agency to exempt a GE 
plant from regulation once they have collected sufficient and 
appropriate data regarding the potential environmental impact of a GE 
plant. The agency may choose to grant the petition in whole or in part 
or to deny the petition. As of July 14, 2008, USDA had received 113 
petitions to deregulate regulated GE crops, of which it approved 73. 
(See table 5 at the end of this appendix for information regarding the 
GE crops addressed by those 73 petitions.) Of the remainder, 12 were 
pending, 27 were withdrawn by the petitioner, and USDA identified 1 as 
"incomplete." In general, USDA approval of a petition to deregulate 
allows the developer to market the product in the United States. 

EPA's Registration of GE Pesticides Known as Plant-Incorporated 
Protectants: 

EPA is responsible for regulating genetic modifications in plants that 
protect them from insects, bacteria, and viruses, as well as the 
genetic material that causes the pesticide to be produced. These 
protectants are subject to the agency's regulations on the sale, 
distribution, and use of pesticides. In order for field-testing of 
plants with such protectants to be performed on more than 10 acres of 
land, EPA must grant an experimental use permit. Prior to 
commercialization of a GE plant with such a protectant, EPA reviews the 
application for approval of the protectant, solicits public comments, 
and may seek the counsel of external scientific experts. For 
registrations of new GE pesticides, EPA routinely examines information 
regarding the identification of the new genetic material, toxicity or 
allergenicity concerns, and possible effects on wildlife. EPA also 
evaluates whether the residues of the pesticide in food will be "safe" 
and determines whether a tolerance or tolerance exemption can be 
issued. Since 1995, EPA has registered 29 GE pesticides engineered into 
3 crops--corn, cotton, and potatoes--5 of which have since been 
voluntarily canceled.[Footnote 23] All currently registered GE 
pesticides have received an exemption from the requirement of a 
tolerance, indicating EPA's determination that any level of pesticidal 
residue from these crops is safe for food and feed. 

FDA's Voluntary Consultation Process for GE Food and Feed Crops: 

FDA has primary responsibility for ensuring the safety of most of the 
nation's food supply. The Federal Food, Drug, and Cosmetic Act 
prohibits the adulteration of food in interstate commerce.[Footnote 24] 
In this context, FDA encourages companies developing GE foods to 
voluntarily notify the agency before marketing the foods. Notification 
leads to a two-part consultation process between the agency and the 
company that initially involves discussions of relevant safety issues, 
and subsequently involves the company's submission of a safety 
assessment report containing a summary of test data on the food in 
question.[Footnote 25] The purpose of these test data is to demonstrate 
that the GE food item presents no greater risk of allergenicity, 
toxicity, or antinutrient properties than its conventional 
counterparts. At the end of the consultation, FDA evaluates the data 
and may send a letter to the company stating that the agency has no 
further questions, indicating in effect that it sees no reason to 
prevent the company from commercializing the GE food. Although this 
consultation is voluntary, FDA officials said that they are not aware 
of any GE food or feed products intentionally marketed to date that 
have not gone through the consultation process. As of July 2008, FDA 
had completed 72 voluntary consultations on GE crops intended for use 
in human food, animal feed, or both; not all of these items were 
marketed. 

FDA also has regulatory authority over pharmaceutical products derived 
from GE crops. These products may be marketed--regardless of whether 
the associated GE crops have been deregulated by USDA--only with FDA 
approval of a marketing application. However, as of July 2008, FDA had 
not received any applications to market pharmaceutical products from GE 
crops.[Footnote 26] 

Many GE Crops Have Been Marketed for a Variety of Purposes: 

Many GE crops have been marketed in the United States and other 
countries for a variety of purposes, such as food or feed use. For 
example, in the United States, GE varieties accounted for about 80 
percent of the corn, 92 percent of the soybeans, and 86 percent of the 
cotton planted in 2008. Furthermore, according to food industry 
sources, over 70 percent of the processed foods sold in the United 
States contain ingredients and oils from GE crops. 

However, not all GE crops have been marketed in the United States, and 
others were marketed for several years but then were withdrawn from 
commercial production. Some of the GE crops marketed in the United 
States may also be approved for marketing in other countries. In some 
instances, those countries have placed restrictions on the use of these 
crops. Table 5 provides information on GE crops granted nonregulated 
status by USDA, their approved uses in the United States and other 
countries, and their marketing status in the United States. 

Table 5: GE Crops Granted Nonregulated Status by USDA and their 
Marketing Status in the United States and Other Countries: 

GE crop/Institution: Canola/Aventis; 
Genetic transformation, or "event,"[A] and trait[B]: MS1&RF1 MS1&RF2 
(PGS1); Trait: HT+F; 
Commercialized in the United States[C]: Last sold in 2003; 
Commercial name[D]: SeedLink Canola; 
Approved for: All uses: United States, Australia, Canada, European 
Union; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: 
Approved for: Food: China, Japan, New Zealand, South Africa, South 
Korea; 
Approved for: Feed: China, Japan, South Africa. 

GE crop/Institution: Canola/Aventis; 
Genetic transformation, or "event,"[A] and trait[B]: Topas 19/2 (HCN92, 
HCN10); Trait: HT; 
Commercialized in the United States[C]: Last sold in 2003; 
Commercial name[D]: [D]; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: Australia, Japan; 
Approved for: Planting[E]: Australia; 
Approved for: Food: Australia, China, European Union, Japan, Mexico, 
New Zealand (HCN92), South Africa, South Korea; 
Approved for: Feed: China, European Union, Japan, South Africa. 

GE crop/Institution: Canola/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: MS8xRF3; Trait: 
HT+F; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: [D]; 
Approved for: All uses: United States, Australia, Canada, Japan; 
Approved for: Environment: European Union, South Korea; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: China, European Union, Mexico, New Zealand, South 
Africa, South Korea; 
Approved for: Feed: China, European Union, Mexico, South Africa. 

GE crop/Institution: Canola/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: T45 (HCN28); 
Trait: HT; 
Commercialized in the United States[C]: Last sold in 2005; 
Commercial name[D]: LibertyLink® Canola; 
Approved for: All uses: United States, Australia, Canada; 
Approved for: Environment: Japan, South Korea; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: China, European Union, Japan, Mexico, New Zealand, 
South Korea; 
Approved for: Feed: China, European Union, Japan. 

GE crop/Institution: Canola/Calgene; 
Genetic transformation, or "event,"[A] and trait[B]: PCGN 3828-212/86-
18; PCGN 3828-212/86-23; (23-18-17, 23-198); Trait: OC; 
Commercialized in the United States[C]: PCGN 3828-212-86-23 (last sold 
in 1998); No: PCGN 3828-212-86-18; 
Commercial name[D]: Laurical; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Canola/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: GT200 (RT200); 
Trait: HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: Westar Roundup Ready®; 
Approved for: All uses: United States; 
Approved for: Environment: Canada, Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada, Japan; 
Approved for: Feed: Japan. 

GE crop/Institution: Canola/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: GT73 RT73; Trait: 
HT; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: Roundup Ready Canola®; or; Westar Roundup Ready®; 
Approved for: All uses: United States, Canada, Japan; 
Approved for: Environment: Australia, European Union, South Korea; 
Approved for: Planting[E]: Australia; 
Approved for: Food: Australia, China, European Union, Mexico, New 
Zealand, Philippines, South Korea; 
Approved for: Feed: China, European Union, Mexico, Philippines. 

GE crop/Institution: Chicory/Bejo; 
Genetic transformation, or "event,"[A] and trait[B]: RM3-3 RM3-4 RM3-6; 
Trait: HT+F; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: European Union; 
Approved for: Planting[E]: European Union; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Cotton/Aventis; 
Genetic transformation, or "event,"[A] and trait[B]: LLCotton25; Trait: 
HT; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: LibertyLink Cotton; 
Approved for: All uses: United States; 
Approved for: Environment: South Korea; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, Canada, Japan, Mexico, New Zealand, 
South Korea; 
Approved for: Feed: Canada, Japan, Mexico. 

GE crop/Institution: Cotton/Calgene; 
Genetic transformation, or "event,"[A] and trait[B]: 31807/31808; 
Trait: HT+IR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada, Japan; 
Approved for: Feed: Japan. 

GE crop/Institution: Cotton/Calgene; 
Genetic transformation, or "event,"[A] and trait[B]: BXN; Trait: HT; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, Canada, Japan, Mexico, New Zealand; 
Approved for: Feed: Australia, Canada, Japan. 

GE crop/Institution: Cotton/Mycogen/Dow; 
Genetic transformation, or "event,"[A] and trait[B]: 281-24-236; Trait: 
IR; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada, Mexico; 
Approved for: Feed: Canada. 

GE crop/Institution: Cotton/Mycogen/Dow; 
Genetic transformation, or "event,"[A] and trait[B]: 3006-210-23; 
Trait: IR; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada, Japan, Mexico; 
Approved for: Feed: Canada, Mexico. 

GE crop/Institution: Cotton/DuPont; 
Genetic transformation, or "event,"[A] and trait[B]: 19-51A; Trait: HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Cotton/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON1445 MON1698; 
Trait: HT; 
Commercialized in the United States[C]: Yes: MON1445; No: MON1698; 
Commercial name[D]: Roundup Ready®; 
Approved for: All uses: United States, Argentina (MON1445), Columbia 
(MON1445); 
Approved for: Environment: Australia (MON1445), Japan, Mexico, South 
Africa; 
Approved for: Planting[E]: Australia, Mexico, South Africa; 
Approved for: Food: Australia, Canada, China, European Union (MON1445), 
Japan, Mexico, New Zealand, Philippines; 
Approved for: Feed: Canada, China, European Union (MON1445), Japan, 
Philippines. 

GE crop/Institution: Cotton/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON15985; Trait: 
IR; Commercialized in the United States[C]: Yes; 
Commercial name[D]: Bollgard II®; 
Approved for: All uses: United States, India, South Africa; 
Approved for: Environment: Australia, South Korea; 
Approved for: Planting[E]: Australia; 
Approved for: Food: Australia, Canada, European Union, Japan, Mexico, 
New Zealand, Philippines, South Korea; 
Approved for: Feed: Canada, European Union, Japan, Philippines. 

GE crop/Institution: Cotton/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON531 MON757 
MON1076; Trait: IR; 
Commercialized in the United States[C]: Yes: MON531; No: MON1076; 
MON757[C]; 
Commercial name[D]: Bollgard®; 
Approved for: All uses: United States, Argentina (MON531), Australia 
(MON531), Brazil, China, Colombia (MON531), India (MON531), Mexico, 
South Africa (MON531); 
Approved for: Environment: Indonesia, Japan, South Korea (MON531); 
Approved for: Planting[E]: Indonesia; 
Approved for: Food: Canada, European Union (MON531), Japan, New 
Zealand, Philippines (MON531), South Korea (MON531); 
Approved for: Feed: Canada, European Union (MON531), Japan, Philippines 
(MON531). 

GE crop/Institution: Cotton/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON88913; Trait: 
HT; Commercialized in the United States[C]: Yes; 
Commercial name[D]: Roundup Ready® Flex; 
Approved for: All uses: United States, South Africa; 
Approved for: Environment: Australia; 
Approved for: Planting[E]: Australia; 
Approved for: Food: Australia, Canada, Japan, Mexico, New Zealand, 
Philippines, Singapore, South Korea; 
Approved for: Feed: Canada, Japan, Philippines. 

GE crop/Institution: Cotton/Syngenta Seeds; 
Genetic transformation, or "event,"[A] and trait[B]: COT102; Trait: IR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: [Empty]; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: United States, Australia, New Zealand; 
Approved for: Feed: United States. 

GE crop/Institution: Flax, Linseed/University of Saskatchewan; 
Genetic transformation, or "event,"[A] and trait[B]: FP967; Trait: HT; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: CDC Triffid; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Maize (corn)/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: CBH-351; Trait: 
HT+IR; 
Commercialized in the United States[C]: Last sold in 2000; 
Commercial name[D]: StarLink; 
Approved for: All uses: [Empty]; 
Approved for: Environment: United States; 
Approved for: Planting[E]: United States; 
Approved for: Food: [Empty]; 
Approved for: Feed: United States. 

GE crop/Institution: Maize (corn)/Plant Genetic Systems; 
Genetic transformation, or "event,"[A] and trait[B]: MS3; Trait: HT+F; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Maize (corn)/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: MS6; Trait: HT+F; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Maize (corn)/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: T14 T25; Trait: 
HT; Commercialized in the United States[C]: Yes: T25; T14: Last sold in 
1999; 
Commercial name[D]: Liberty Link™; 
Approved for: All uses: United States, Argentina, Canada, European 
Union (T25), Japan (T25); 
Approved for: Environment: Japan (T14), South Korea (T25); 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia (T25), China (T25), Japan (T14), Mexico, 
New Zealand (T25), Philippines (T25), Russia (T25), South Korea (T25), 
Taiwan (T25); 
Approved for: Feed: Australia (T25), China (T25), Japan (T14), Mexico, 
Philippines (T25), Taiwan (T25). 

GE crop/Institution: Maize (corn)/Dekalb Genetics Corporation; 
Genetic transformation, or "event,"[A] and trait[B]: B16 (DLL25); 
Trait: HT; 
Commercialized in the United States[C]: Last sold in 1999; 
Commercial name[D]: [D]; 
Approved for: All uses: United States, Canada, Japan; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Philippines, South Korea, Taiwan; 
Approved for: Feed: Philippines, Taiwan. 

GE crop/Institution: Maize (corn)/Dekalb Genetics Corporation; 
Genetic transformation, or "event,"[A] and trait[B]: DBT418; Trait: 
HT+IR; 
Commercialized in the United States[C]: Last sold in 1999; 
Commercial name[D]: Bt Xtra™; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: Argentina, Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, Japan, New Zealand, Philippines, South 
Korea, Taiwan; 
Approved for: Feed: Japan, Philippines, Taiwan. 

GE crop/Institution: Maize (corn)/Dow AgroSciences LLC; 
Genetic transformation, or "event,"[A] and trait[B]: DAS-06275-8; 
(TC6275); Trait: IR; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Japan; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Maize (corn)/Dow AgroSciences LLC/Pioneer Hi-Bred 
International Inc.; 
Genetic transformation, or "event,"[A] and trait[B]: 59122 (DAS-59122-
7, Event 22); Trait: HT+IR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: Herculex® RW; 
Approved for: All uses: United States, Canada, Japan; 
Approved for: Environment: European Union; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, European Union, Mexico, New Zealand, 
Philippines, South Korea, Taiwan; 
Approved for: Feed: European Union, Mexico, Philippines, Taiwan. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: GA21; Trait: HT; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: Roundup Ready®; 
Approved for: All uses: United States, Argentina, Canada, Japan; 
Approved for: Environment: South Korea; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, China, European Union, Mexico, New 
Zealand, Philippines, Russia, South Africa, South Korea, Taiwan; 
Approved for: Feed: China, European Union, Philippines, Russia, South 
Africa, Taiwan. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: LY038; Trait: LYS; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: Japan; 
Approved for: Food: Australia, Japan, Mexico, Philippines; 
Approved for: Feed: Australia, Philippines. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON80100; Trait: 
IR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for:: Feed: [Empty]. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON802; Trait: 
HT+IR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: Yieldgard®; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON810; Trait: IR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: Yieldgard®; 
Approved for: All uses: United States, Argentina, Canada, European 
Union, Honduras, Japan, Philippines, South Africa, Uruguay; 
Approved for: Environment: Colombia, South Korea; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, China, Colombia, Mexico, New Zealand, 
Russia, South Korea, Switzerland, Taiwan; 
Approved for: Feed: China, Colombia, Russia, Switzerland, Taiwan. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON863; Trait: IR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: [D]; 
Approved for: All uses: United States, Canada, Japan; 
Approved for: Environment: South Korea; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, China, European Union, Mexico, New 
Zealand, Philippines, Russia, Singapore, South Korea, Taiwan; 
Approved for: Feed: China, European Union, Philippines, Russia, 
Singapore, Taiwan. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON88017; Trait: 
HT+IR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: [D]; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: Japan; 
Approved for: Food: Australia, Japan, Mexico, New Zealand, Philippines, 
South Korea, Taiwan; 
Approved for: Feed: Mexico, Philippines, Taiwan. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON89034; Trait: 
HT+IR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: Canada, Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Japan; 
Approved for: Feed: Canada, Japan. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: NK603; Trait: HT; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: Roundup Ready®; 
Approved for: All uses: United States, Argentina, Canada, Japan, 
Philippines, South Africa; 
Approved for: Environment: South Korea, Uruguay; 
Approved for: Planting[E]: Uruguay; 
Approved for: Food: Australia, China, Colombia, European Union, Mexico, 
New Zealand, Russia, Singapore, South Korea, Taiwan, Thailand; 
Approved for: Feed: China, Colombia, European Union, Russia, Singapore, 
Taiwan, Thailand. 

GE crop/Institution: Maize (corn)/Mycogen (Dow AgroSciences); Pioneer 
(Dupont); 
Genetic transformation, or "event,"[A] and trait[B]: 1507 (TC1507); 
Trait: HT+IR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: Herculex® I; 
Approved for: All uses: United States, Argentina, Canada, Japan; 
Approved for: Environment: Colombia, Uruguay; 
Approved for: Planting[E]: Uruguay; 
Approved for: Food: Australia, China, Colombia, European Union, Mexico, 
New Zealand, South Korea, Philippines, South Africa, Taiwan; 
Approved for: Feed: China, Colombia, European Union, Philippines, South 
Africa, Taiwan. 

GE crop/Institution: Maize (corn)/Pioneer Hi-Bred International Inc.; 
Genetic transformation, or "event,"[A] and trait[B]: 676; 678; 680; 
Trait: HT+F; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Maize (corn)/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON809; Trait: 
HT+IR; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: Japan. 

GE crop/Institution: Maize (corn)/Northrup King; 
Genetic transformation, or "event,"[A] and trait[B]: Bt11; Trait: 
HT+IR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: [D]; 
Approved for: All uses: United States, Argentina, Canada, Philippines, 
South Africa, Uruguay; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, China, European Union, Japan, Mexico, 
New Zealand, Russia, South Korea, Switzerland, Taiwan; 
Approved for: Feed: Australia, China, European Union, Japan, Mexico, 
Switzerland, Taiwan. 

GE crop/Institution: Maize (corn)/Syngenta Seeds; 
Genetic transformation, or "event,"[A] and trait[B]: MIR604; Trait: IR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: Agrisure RW Rootworm-Protected Corn; 
Approved for: All uses: [Empty]; 
Approved for: Environment: United States, Japan, Philippines; 
Approved for: Planting[E]: Japan; 
Approved for: Food: United States, Australia, Japan, Mexico, New 
Zealand, Philippines, South Korea; 
Approved for: Feed: Mexico, Philippines. 

GE crop/Institution: Maize (corn)/Ciba Seeds; 
Genetic transformation, or "event,"[A] and trait[B]: 176; (Bt 176); 
Trait: HT+IR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: NaturGard™ KnockOut™; 
Approved for: All uses: United States, Argentina, Australia, Canada, 
European Union; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: China, Japan, New Zealand, Philippines, South 
Africa, South Korea, Switzerland, Taiwan; 
Approved for: Feed: China, Japan, Philippines, South Africa, 
Switzerland, Taiwan. 

GE crop/Institution: Papaya/Cornell University; 
Genetic transformation, or "event,"[A] and trait[B]: 55-1/63-1; Trait: 
VR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: SunUp, Rainbow; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Papaya/USDA-Agricultural Research Service; 
Genetic transformation, or "event,"[A] and trait[B]: ARS-PLMC5-6(C5); 
Trait: VR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: [Empty]; 
Approved for: Environment: United States; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Potato/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: BT6 BT10 BT12 BT16 
BT17 BT18 BT23; Trait: IR; 
Commercialized in the United States[C]: BT6: Last sold in 2001; No: 
BT10, BT12, BT16, BT17, BT18, and BT23; 
Commercial name[D]: Russet Burbank NewLeaf®; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Japan, Mexico, Philippines (BT16); 
Approved for: Feed: Mexico, Philippines (BT16). 

GE crop/Institution: Potato/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: ATBT04-6 ATBT04-27 
ATBT04-30 ATBT04-31 ATBT04-36 SPBT02-5 SPBT02-7; Trait: IR; 
Commercialized in the United States[C]: ATBT04-6: Last sold in 2000 
ATBT04-31: Last sold in 2000 ATBT04-36: Last sold in 2000 SPBT02-5: 
Last sold in 2001 SPBT02-7[C]; No: ATBT04-27, ATBT04-30; 
Commercial name[D]: Atlantic and Superior NewLeaf®; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: Russia (SPBT02-5); 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, Japan, New Zealand, Philippines (SPBT02-
5), Russia (SPBT02-5), South Korea (SPBT02-5); 
Approved for: Feed: Australia, Philippines (SPBT02-5). 

GE crop/Institution: Potato/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: RBMT22-082; Trait: 
IR+VR; 
Commercialized in the United States[C]: Last sold in 2000; 
Commercial name[D]: [Empty];
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, Japan, Mexico, New Zealand; 
Approved for: Feed: Australia. 

GE crop/Institution: Potato/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: RBMT21-129 RBMT21-
350; Trait: IR+VR; 
Commercialized in the United States[C]: RBMT21-350: Last sold in 2000; 
RBMT21-129: Last sold in 2000; 
Commercial name[D]: Russet Burbank NewLeaf® Plus; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, Japan, Mexico, New Zealand, Philippines, 
South Korea; 
Approved for: Feed: Australia, Philippines. 

GE crop/Institution: Potato/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: RBMT15-101 SEMT15-
02 SEMT15-15; Trait: IR+VR; 
Commercialized in the United States[C]: RBMT15-101: Last sold in 2001; 
SEMT15-02[C]; SEMT15-15[C]; 
Commercial name[D]: NewLeaf® Y; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, Japan, Mexico, New Zealand, Philippines, 
South Korea; 
Approved for: Feed: Australia, Mexico, Philippines. 

GE crop/Institution: Rice/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: LLRICE06 LLRICE62; 
Trait: HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: Liberty Link®; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada, Mexico, Russia (LLRICE62); 
Approved for: Feed: Canada, Mexico. 

GE crop/Institution: Rice/Bayer CropScience; 
Genetic transformation, or "event,"[A] and trait[B]: LLRICE601; Trait: 
HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: [Empty]; 
Approved for: Environment: United States; 
Approved for: Planting[E]: United States; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Soybean/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: A2704-12 A2704-21 
A5547-35; W62 W98; Trait: HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: Liberty Link®; 
Approved for: All uses: United States (all 5); 
Approved for: Environment: Canada (A2704-12), Japan (A2704-12); 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia (A2704-12, A2704-21, A5547-35), Canada 
(A2704-12), European Union (A2704-12), Japan (A2704-12), Mexico (A2704-
12, A2704-21, A5547-35), New Zealand (A2704-12, A2704-21, A5547-35), 
Russia (A2704-12), South Africa (A2704-12); 
Approved for: Feed: Canada (A2704-12), European Union (A2704-12), Japan 
(A2704-12), Mexico (A2704-12, A2704-21, A5547-35), South Africa (A2704-
12). 

GE crop/Institution: Soybean/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: A5547-127; Trait: 
HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: Liberty Link®; 
Approved for: All uses: United States; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Japan, Mexico, Russia; 
Approved for: Feed: Japan, Mexico. 

GE crop/Institution: Soybean/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: GU262; Trait: HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Soybean/DuPont Canada Agricultural Products; 
Genetic transformation, or "event,"[A] and trait[B]: G94-1 G94-19 G168; 
Trait: OC; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: Japan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, Japan, New Zealand; 
Approved for: Feed: Japan. 

GE crop/Institution: Soybean/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: GTS40-3-2; Trait: 
HT; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: [D]; 
Approved for: All uses: United States, Argentina, Brazil, Canada, 
Japan, Mexico, Paraguay, Romania, Uruguay; 
Approved for: Environment: South Korea; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, China, Czech Republic, European Union, 
Malaysia, New Zealand, Philippines, Russia, South Korea, Switzerland, 
Taiwan, Thailand; 
Approved for: Feed: China, Colombia, Czech Republic, European Union, 
Malaysia, Philippines, Russia, Switzerland, Taiwan, Thailand. 

GE crop/Institution: Soybean/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: MON89788; Trait: 
HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: Roundup Ready 2 Yield®; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: Japan, Philippines, Taiwan; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Japan, Philippines, Taiwan; 
Approved for: Feed: Japan, Philippines, Taiwan. 

GE crop/Institution: Squash/Asgrow (United States); Seminis Vegetable 
Inc. (Canada); 
Genetic transformation, or "event,"[A] and trait[B]: CZW-3; Trait: VR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: [D]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Squash/Upjohn (Seminis Vegetable Seeds); 
Genetic transformation, or "event,"[A] and trait[B]: ZW20; Trait: VR; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: [D]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Sugarbeet/AgrEvo; 
Genetic transformation, or "event,"[A] and trait[B]: T120-7; Trait: HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Japan; 
Approved for: Feed: Japan. 

GE crop/Institution: Sugarbeet/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: H7-1; Trait: HT; 
Commercialized in the United States[C]: Yes; 
Commercial name[D]: [D]; 
Approved for: All uses: United States, Canada; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, European Union, Mexico, New Zealand, 
Philippines, Russia, Singapore, South Korea; 
Approved for: Feed: European Union, Philippines, Singapore. 

GE crop/Institution: Sugarbeet/Novartis Seeds; Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: GTSB77; Trait: HT; 
Commercialized in the United States[C]: No; 
Commercial name[D]: InVigor™; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Australia, Japan, New Zealand, Philippines, Russia; 
Approved for: Feed: Australia, Philippines. 

GE crop/Institution: Tobacco;/Vector; 
Genetic transformation, or "event,"[A] and trait[B]: Vector21-41; 
Trait: NIC; 
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty]; 
Approved for: All uses: [Empty]; 
Approved for: Environment: United States; 
Approved for: Planting[E]: United States; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Tomato/Agritope Inc.; 
Genetic transformation, or "event,"[A] and trait[B]: 351N; Trait: DR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Tomato/Calgene; 
Genetic transformation, or "event,"[A] and trait[B]: FLAVR SAVR[F]; 
Trait: DR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: FLAVR SAVR™; 
Approved for: All uses: United States; 
Approved for: Environment: Japan, Mexico; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada, Japan, Mexico; 
Approved for: Feed: Japan, Mexico. 

GE crop/Institution: Tomato/Calgene; 
Genetic transformation, or "event,"[A] and trait[B]: N73 1436-111; 
Trait: DR; 
Commercialized in the United States[C]: Last sold in 1997; 
Commercial name[D]: FLAVR SAVR™; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Tomato/DNA Plant Technology Corporation; 
Genetic transformation, or "event,"[A] and trait[B]: 1345-4; Trait: DR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada, Mexico; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Tomato/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: 5345; Trait: IR; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Tomato/Monsanto; 
Genetic transformation, or "event,"[A] and trait[B]: 8338; Trait: DR; 
Commercialized in the United States[C]: No; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: [Empty]; 
Approved for: Feed: [Empty]. 

GE crop/Institution: Tomato/Zeneca + Petoseed; 
Genetic transformation, or "event,"[A] and trait[B]: B, Da, F; Trait: 
DR; 
Commercialized in the United States[C]: [C]; 
Commercial name[D]: [Empty]; 
Approved for: All uses: United States; 
Approved for: Environment: [Empty]; 
Approved for: Planting[E]: [Empty]; 
Approved for: Food: Canada, Mexico; 
Approved for: Feed: [Empty]. 

Source: GAO analysis of data from USDA, EPA, FDA, the Biotechnology 
Industry Organization, the AGBIOS Company, and the International 
Service for the Acquisition of Agri-Biotech Applications. 

[A] Some events have a synonymous name; those event names are shown in 
parentheses. 

[B] HT (herbicide tolerance), IR (insect resistance), VR (virus 
resistance), DR (delayed ripening/altered shelf life), OC (modified oil 
content), LYS (enhanced lysine content), NIC (nicotine reduction), and 
F (fertility restored). 

[C] In some cases, we were not able to determine from the cited sources 
whether the GE crop had been marketed. 

[D] In some cases, we were not able to determine from the cited sources 
whether the GE crop had a specific commercial name other than its event 
name. 

[E] Has been approved for planting/cultivation, but is not necessarily 
in commercial production at the present time. 

[F] Thirty-three lines of FLAVR SAVR™ tomato were granted nonregulated 
status by USDA. 

[End of table] 

[End of section] 

Appendix VII: Six Documented Incidents of Unauthorized Release of GE 
Crops into the Food and Feed Supply: 

As of August 2008, there were six documented incidents of the 
unauthorized release of GE crops into the food or feed supply, or into 
crops meant for the food or feed supply. Although federal agencies 
determined that these incidents did not harm human or animal health, 
they did cause financial losses in some cases, primarily from lost 
sales to countries that would not accept food or feed containing any 
amount of regulated GE varieties. The six incidents are discussed in 
the following text. 

StarLink Corn - 2000: 

The first known unauthorized release of GE crops into the food supply 
occurred in 2000 and involved a GE corn variety known by its trademark 
name, StarLink. StarLink was engineered for insect resistance and 
herbicide tolerance by Aventis CropScience. USDA deregulated StarLink 
in 1998, and FDA accepted Aventis' data showing that, other than its 
new pesticidal protein, StarLink was essentially the same as other 
commercially available corn varieties. However, EPA granted only a 
"split-registration" to the pesticidal protein in StarLink corn, 
thereby allowing residue of the protein in animal feed but not allowing 
it in the human food supply because of concerns that it may be an 
allergen.[Footnote 27] In 2000, trace amounts of StarLink corn were 
found in commercially available taco shells. According to USDA and 
other sources, StarLink corn intended for animal feed, as well as corn 
grown in adjacent fields that cross-pollinated with StarLink, likely 
became commingled with corn approved for human consumption during 
harvesting, transportation, and storage. 

Federal agencies took a number of actions to divert Starlink corn from 
the food supply. For example, APHIS began purchasing bushels of 
StarLink corn at a 25-cent premium, with Aventis agreeing to reimburse 
the agency for the costs. In addition, the food industry initiated 
recalls of over 300 products that could have contained the regulated 
protein. FDA also issued guidance for sampling and testing corn for the 
presence of this protein. These actions dramatically reduced the amount 
of the protein in the food supply. USDA testing done in 2006 and 2007 
found no trace of the protein in the samples tested. 

The StarLink incident had financial consequences, particularly in major 
U.S. export markets. In 2001, USDA reported that corn sales to Japan-- 
the largest importer of U.S. corn--were down more than 20 percent from 
the previous year, and exports to South Korea were down more than 70 
percent, although USDA noted that some of this drop resulted from other 
factors, such as larger-than-expected corn production and exports from 
Argentina and Brazil. One study estimated that the StarLink incident 
resulted in $26 million to $288 million in lost revenue for producers 
in market year 2000/2001.[Footnote 28] (U.S. cash receipts for corn 
totaled about $15.2 billion in 2000.) In addition, this study estimated 
that the federal government bore indirect costs of $172 million to $776 
million through USDA's Loan Deficiency Payments Program, which offers 
producers short-term loans and direct payments if the price of a 
commodity falls below the loan rate. During marketing year 2000/2001, 
in which StarLink was first detected in the food supply, corn prices 
fell below the loan rate, causing USDA to make additional income 
support payments to producers. In a separate study that compared the 
change in the price of corn with the change in the price of a 
substitute good, sorghum, researchers estimated that the presence of 
StarLink in the food supply caused a 6.8 percent drop in the price of 
corn, lasting for 1 year.[Footnote 29] However, according to USDA, 
declining corn prices may have been caused by other factors as well, 
such as increases in supply due to favorable weather conditions or 
reductions in demand. 

Prodigene Corn - 2002: 

Prodigene, a biotechnology company, was responsible for two incidents 
in 2002 of the unauthorized release of GE corn designed to produce a 
protein to be used in pig vaccine, according to USDA officials. In the 
first incident, USDA ordered the company to destroy 155 acres of 
conventional corn that might have been cross-pollinated by this GE 
corn. In the second incident, USDA inspectors found a small number of 
GE corn plants growing among conventional soybeans. USDA ordered 
Prodigene to remove and destroy them; however, before the company did 
so, the soybeans were harvested and sent to a grain elevator containing 
500,000 bushels of soybeans. USDA detected the problem before the 
soybeans were shipped from the elevator, and the agency ordered all of 
the soybeans destroyed. Although none of this GE corn was found in the 
food or feed supply, FDA issued a statement saying that the small 
amount of regulated material present in the soybeans would have posed 
no risk for human health. 

Prodigene entered a consent decision with USDA in which Prodigene paid 
a $250,000 fine and reimbursed USDA for the destruction of the 500,000 
bushels of soybeans. The company also placed $1 million in a trust fund 
to cover future mitigation efforts, implemented a new compliance 
program, and agreed to third-party audits of its field trial 
procedures. Despite these measures, Prodigene was involved in another 
incident involving GE corn in 2004. During a field trial inspection, 
USDA found evidence that additional GE corn may have been released to 
the food or feed supply. The agency ordered corrective measures and 
reached another settlement with Prodigene in 2007 that included a civil 
penalty and an agreement that neither the company nor any of its 
successors would apply for a GE notification or permit in the future to 
conduct further field trials. 

Bt10 Corn - 2004: 

In 2004, Syngenta, a biotechnology developer, notified EPA that the 
company inadvertently had distributed corn seed containing an 
unregistered GE pesticide known as Bt10. Pesticides must be registered 
with EPA before commercialization. Syngenta previously determined that 
Bt10 was not suitable for commercialization and chose instead to 
register with EPA a similar pesticidal product known as Bt11. However, 
the company mislabeled some seed containers and, thus, inadvertently 
bred and sold lines of Bt10 as Bt11. Syngenta estimated that the Bt10 
variety may have been planted on as many as 37,000 acres of corn, or 
about 1/10 of 1 percent of the annual corn acreage planted in the 
United States from 2001 through 2004. 

In response to this incident, federal agencies took several actions. 
For example, although EPA determined that the protein in Bt10 was 
identical to the one in Bt11 and had established a tolerance exemption 
for Bt11, finding that there were no potential health hazards, it fined 
Syngenta $1.5 million for the sale of an unregistered GE pesticide. 
[Footnote 30] FDA also concluded that the presence of Bt10 corn in the 
food and feed supply posed no food safety risks. In addition, USDA 
fined Syngenta $375,000 for moving and planting a regulated GE plant 
without the proper permit. In addition to the fines, Syngenta 
identified and destroyed all affected plants and seeds as requested by 
EPA and USDA, and the company developed additional quality control 
mechanisms to help ensure its compliance with federal regulations. 

The Bt10 incident disrupted U.S. corn exports. For example, the 
European Union implemented emergency inspection measures for U.S. corn 
from October 2005 to March 2007. In another case, South Korea required 
that all imports of U.S. corn be tested and certified as being free of 
Bt10. However, an agricultural trade group said U.S. corn exporters did 
not suffer a significant loss of market share due to the Bt10 incident 
because Syngenta paid for testing corn samples and diverting corn 
associated with positive samples to approved markets. 

Liberty Link Rice 601 and 604 - 2006: 

In July 2006, another biotechnology developer, Bayer CropScience 
(Bayer), informed USDA that it had detected regulated genetic material 
in a variety of conventional long-grain rice known as Cheniere. USDA 
launched an investigation in August that identified the regulated 
material as LLRICE 601, a GE rice variety that Bayer engineered to 
tolerate its Liberty Link brand of herbicide. USDA investigators 
determined that LLRICE 601 and Cheniere had been grown at a research 
facility affiliated with Louisiana State University between 1999 and 
2001. However, they were unable to determine conclusively that the 
commingling of GE and non-GE seeds, or cross-pollination took place at 
this facility. 

Meanwhile, in response to the LLRICE 601 incident, some state and 
agricultural trade organizations instituted protocols for testing other 
rice varieties for regulated genetic material. For example, in December 
2006, the Arkansas State Plant Board notified USDA that another long- 
grain rice variety, known as Clearfield 131 and marketed by the BASF 
Company, had tested positive for regulated genetic material. USDA 
investigators later determined that this genetic material came from 
another, regulated GE rice variety, LLRICE 604, also engineered by 
Bayer. As a result, USDA issued an emergency action notification to 
halt the distribution and planting of Clearfield 131. LLRICE 604 and 
Clearfield 131 also had been grown at the Louisiana State University 
research facility. However, after a year-long investigation, USDA 
concluded that there was insufficient information to make a conclusive 
link or seek an enforcement action against either Bayer or this 
research facility. 

On November 24, 2006, USDA granted nonregulated status to LLRICE 601 on 
the basis of its genetic similarity to another GE rice previously 
approved for commercialization. However, LLRICE 604 remains regulated. 
In addition, FDA published statements shortly after each incident 
saying that the low-level presence in food or feed of the regulated 
genetic material from these LLRICE varieties did not pose any human 
health concerns. Nevertheless, despite these actions, the LLRICE 
incidents affected the export market for U.S. long-grain rice, which in 
recent years accounted for as much as 50 percent of total U.S. rice 
sales. Specifically, several foreign countries either banned certain 
varieties of U.S. rice or imposed new testing requirements on imports 
from the United States. For example, Japan banned the importation of 
U.S. long-grain rice. In another case, the European Union introduced 
emergency measures for the testing of U.S. rice, resulting in numerous 
shipments of U.S. rice being turned away from European ports. In 
effect, this ended rice trade between the United States and the 
European Union, which had accounted for as much as 10 percent of U.S. 
long-grain rice exports in recent years. 

Furthermore, citing market disruptions caused by the LLRICE incidents, 
rice producers from five states filed a class action lawsuit against 
Bayer. As of August 2008, the plaintiffs had not yet presented 
estimates of rice producers' losses as a result of these incidents, but 
an attorney representing the plaintiffs expects the demand for total 
compensatory damages to be about $1 billion. These LLRICE incidents 
also potentially cost the BASF Company millions of dollars in lost 
sales of its Clearfield 131 rice. One environmental advocacy group 
estimated in 2007 that the worldwide costs resulting from the LLRICE 
incidents, including the costs associated with the loss of export 
markets, seed testing, elevator cleaning, and food recalls in countries 
where the variety of rice had not been approved, ranged from $741.0 
million to $1.285 billion.[Footnote 31] 

Event 32 Corn - 2006: 

In February 2008, USDA, EPA, and FDA issued a joint public statement 
announcing that Dow AgroScience (Dow), a biotechnology developer, had 
discovered low levels of a regulated GE corn seed, called Event 32, in 
three lines of commercially available GE corn seed sold under the brand 
name Herculex. Dow engineered Event 32 to produce a pesticidal 
substance. According to Dow, approximately 72,000 acres were planted 
with corn seed containing low levels of Event 32 in 2006 and 2007. 
Dow's investigation of this incident concluded that the mixing of Event 
32 and Herculex seed probably occurred at a single research testing 
field. As of August 2008, USDA's investigation was still ongoing. 

Event 32 closely resembles another Dow GE corn variety, called Event 
22, that is commercially available. Like Event 32, Dow engineered Event 
22 to produce a pesticidal substance. Before commercialization, Event 
22 was reviewed and granted nonregulated status by USDA, received a 
pesticide registration from EPA, and completed a food safety 
consultation with FDA. Given this history and the similarities between 
Event 32 and Event 22, the three agencies, according to USDA, affirmed 
that there were no public health risks posed by the low-level presence 
of Event 32 in food and feed. In addition, USDA and EPA concluded there 
were also no environmental risks. Nonetheless, USDA issued an 
"emergency action notification" for Event 32 seed, and EPA issued a 
stop-sale order. As of August 2008, these agencies were conducting 
investigations to determine whether any violations had occurred. 
According to Dow, it voluntarily recalled unplanted seed containing 
Event 32. Dow also provided USDA with the testing method it used to 
detect Event 32. However, USDA said this test may not be sensitive 
enough to detect the low levels of Event 32 expected in the commercial 
seed supply. 

The Event 32 incident did not lead to detectable economic impacts. To 
preclude trade disruptions, USDA provided relevant information to U.S. 
trading partners, including information on the similarities between 
Event 32 and Event 22, noting that the latter GE variety is accepted by 
a number of countries, including Japan, the largest purchaser of U.S. 
corn. 

[End of section] 

Appendix VIII: GE Regulatory Issues and Alternatives Discussed in 
USDA's DEIS and Proposed Rule: 

USDA's DEIS, announced in the Federal Register on July 17, 2007, 
presents various issues and alternatives for regulating GE organisms, 
including crops. Table 6 summarizes these issues and alternatives; 
alternatives in bold type indicate USDA's preliminary preferred options 
in the DEIS. USDA invited public comments on these issues and 
alternatives by September 11, 2007. On October 9, 2008, after 
considering the comments on the DEIS and other factors, USDA published 
a proposed rule that, if adopted, would amend its regulations for GE 
organisms, including plants. According to USDA, differences between the 
proposed rule and the DEIS are primarily a matter of reorganizing and 
realigning some materials and their corresponding regulatory 
alternatives, using more descriptive terms in some criteria listed in 
the alternatives, and choosing between regulatory alternatives that 
fall within the analysis of the DEIS. The proposed rule contains a 
table that provides a comparison between the proposed changes in the 
rule and DEIS. Specifically, it indicates which of the DEIS 
alternatives most closely match the proposed rule. We have included 
that information in table 6. 

Table 6: GE Regulatory Issues and Alternatives Discussed in USDA's DEIS 
and Proposed Rule: 

Issue: 1 - Broadening Regulatory Scope to Include GE Crops Posing 
Noxious Weed Risk; 
USDA is considering the broadening of its regulatory scope beyond GE 
organisms that may pose a plant pest risk to include GE crops that may 
pose a noxious weed risk and GE organisms that may be used to control 
noxious weeds or plant pests (biological control agents). 
Do regulatory requirements for these organisms need to be established?; 
Alternatives considered (USDA's preliminary preference indicated): 
1. No action--continue to regulate GE organisms as potential plant 
pests, and use genetic transformation as the trigger for regulation 
(event by event); 
2. (USDA's preliminary preference) Expand the scope of what is 
regulated by adding considerations of noxious weed risk and regulating 
GE biological control organisms in addition to evaluating plant pest 
risks, and use genetic transformation as the trigger for regulation. 
Continue to regulate event by event; 
3. Expand the scope of what is regulated by adding considerations of 
noxious weed risk and regulating GE biological control organisms in 
addition to evaluating plant pest risks. Use novelty of the trait in 
the species as the trigger for regulation; 
4. Exclude specific classes of highly familiar organisms and highly 
domesticated, nonweedy crop plants and, potentially, those regulated by 
another federal agency from regulation; 
USDA's explanation: The second alternative would eliminate potential 
gaps that may occur as genetic engineering techniques continue to 
advance. The fourth alternative would allow USDA and a developer to 
focus resources on GE crops that have a higher potential risk; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 2 or 3[A]. 

Issue: 2 - Use of Risk-Based Categories for New Products; 
USDA is considering revisions to the regulations to increase 
transparency and to address advances in technology that may create new 
products and concerns; 
Should a new system of risk-based categories be designed to deal with 
new products and new concerns? If so, what criteria should be used to 
establish the risk-based categories? 
Alternatives considered: 
1. No action--continue to use a two-tiered system (notifications and 
permits); 
2. Abolish categories and treat all future proposals for the 
introduction of GE organisms on a case-by-case basis; 
3. Establish a tiered permitting system for all organisms based on 
newly devised criteria; 
4. (USDA's preliminary preference) Establish a tiered permitting system 
for plants based on newly devised criteria and evaluate permit 
applications for introductions of nonplant organisms on a case-by-case 
basis; 
USDA's explanation: The fourth alternative would be more transparent, 
allowing developers and the public to see that organisms are to be 
regulated on the basis of risk and familiarity; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 4. 

Issue: 3 - Regulatory Flexibility to Allow Commercialization Despite 
Minor Unresolved Risks; 
USDA is considering ways to provide regulatory flexibility for future 
decisions by accommodating commercialization of certain GE organisms 
while continuing, in some cases, to regulate the organisms on the basis 
of minor unresolved risks. Other regulated articles could be treated as 
they have been under the current system, in which all regulatory 
restrictions are removed. 
What environmental factors should be considered in distinguishing 
between these kinds of decisions? 
Alternatives considered: 
1. No action--continue with current system granting full nonregulated 
status to crops that removes them from all regulatory obligations; 
2. (USDA's preliminary preference) Continue to allow for the option of 
granting full nonregulated status and develop appropriate criteria and 
procedures through which crops can be removed from permitting, but some 
degree of agency oversight, as necessary, to mitigate any minor risks 
is retained; 
USDA's explanation: Under the second alternative, the added flexibility 
of being able to retain some oversight may be useful for some types of 
GE organisms that might be developed in the future; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 2. 

Issue: 4 - Regulation of Crops Producing Pharmaceutical and Industrial 
Compounds; 
Are there changes that should be considered relative to environmental 
review of, and permit conditions for, GE crops that produce 
pharmaceutical and industrial compounds? 
Alternatives considered: 
1. No action--continue to allow food and feed crops to be used for the 
production of pharmaceutical and industrial compounds and to allow 
field testing under very stringent conditions; 
2. (USDA's preliminary preference) Continue to allow food and feed 
crops to be used for the production of pharmaceutical and industrial 
compounds. The agency would impose confinement requirements, as 
appropriate, based on the risk posed by the organism and would consider 
food safety in setting conditions; 
3. Do not allow crops producing substances not intended for food uses 
to be field tested, that is, these crops could be grown only in 
contained facilities; 
4. Allow field testing only if the crop has no food or feed uses; 
5. Allow field testing of food/feed crops producing substances not 
intended for food uses only if food safety has been addressed; 
USDA's explanation: Under the second alternative, the use of highly 
stringent confinement measures can be used to protect the environment 
from significant impact and the consideration of food safety will 
further enhance human safety; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 2. 

Issue: 5 - Regulation of Nonviable Plant Material; 
The definition of noxious weeds in the Plant Protection Act includes 
not only plants, but also plant products. On the basis of that 
authority, USDA is considering the regulation of nonviable plant 
material (i.e., plant materials, such as stems and leaves, that do not 
propagate new plants); 
Is the regulation of nonviable material appropriate and, if so, in 
which cases should we regulate? 
Alternatives considered: 
1. No action--do not regulate nonviable GE material; 
2. (USDA's preliminary preference) Regulate nonviable GE plant material 
in certain circumstances, on the basis of the risks posed; 
3. Regulate all nonviable GE plant material; 
USDA's explanation: The second alternative is preferred because, in 
most cases, nonviable plant material will not pose a risk. However, in 
some cases, oversight might be required to ensure the safe handling and 
disposal of this material; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 2. 

Issue: 6 - New Mechanism for Regulating Nonfood/Nonfeed Crops Producing 
Pharmaceutical and Industrial Compounds; 
USDA is considering establishing a new mechanism involving USDA, the 
states, and the producer for commercial production of plants not 
intended for food or feed in cases where the producer would prefer to 
develop and extract pharmaceutical and industrial compounds under 
confinement conditions with governmental oversight, rather than USDA 
granting nonregulated status to these plants. 
What should be the characteristics of this mechanism? 
Alternatives considered: 
1. No action--continue to authorize field tests of crops not intended 
for food or feed use under permit. Require application and review of 
these permits on an annual basis; 
2. (USDA's preliminary preference) Allow for special multiyear permits, 
with ongoing oversight. The new system would maintain these crops under 
regulation, but USDA oversight would be exercised in a different manner 
than under the current system of permits; 
USDA's explanation: Under the second alternative, the new system would 
be just as protective of the environment as the current system, but in 
a manner that is more efficient; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 1[B]. 

Issue: 7 - Allowance for Low-Level Presence of Regulated GE Material in 
Crops, Food, Feed, or Seed; 
The current regulations have no provision for the low-level presence of 
regulated articles in commercial crops, food, feed, or seed of GE plant 
material that has not completed the required regulatory processes; 
Should low-level occurrences of a regulated article be exempted from 
regulation? 
Alternatives considered: 
1. No action-- allow field testing to continue using current 
confinement strategies to reduce the likelihood of regulated articles 
occurring in commercial commodities or seeds; 
2. Establish criteria under which occurrence of regulated articles 
would be allowable, that is, considered not actionable by USDA. Do not 
allow field testing of crops that do not meet all of these criteria, 
including addressing food safety issues if applicable (i.e., if the GE 
plant is a food crop); 
3. (USDA's preliminary preference) Establish criteria under which 
occurrence of regulated articles would be allowable, that is, 
considered not-actionable by USDA. Allow field testing and impose 
confinement strategies based on whether a plant meets the criteria; 
4. Impose a very strict confinement regime on all field tests, as is 
currently done for pharmaceutical and industrial crops, that would 
further reduce the likelihood of regulated articles occurring in 
commercial commodities or seeds; 
USDA's explanation: The agency's analysis indicates that material 
meeting the safety-based criteria of the third alternative would not 
pose a risk for significant environmental impact; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 3. 

Issue: 8 - Risk Assessment for Imported GE Commodities; 
Should USDA provide expedited review or exemption from review for 
certain low-risk, imported GE commodities intended for food, feed, or 
processing that have received all necessary regulatory approvals in 
their country-of-origin and are not intended for propagation in the 
United States? 
Alternatives considered: 
1. No action--continue to evaluate commodity importation requests on a 
case-by-case basis; 
2. (USDA's preliminary preference) Establish criteria that will be 
applied to determine the appropriate level of risk assessment for 
imported GE commodities. This alternative could include a decision to 
exempt certain organisms or to allow importation under conditions that 
minimize environmental release; 
3. Disallow importation of any commodity pending full USDA approval for 
deregulation; 
4. Accept any importation of a product from a foreign country that has 
evaluated the safety of the product and approved it for unconfined 
environmental release; 
5. Accept any importation of a product from a foreign country that has 
evaluated the safety of the product and approved it for unconfined 
environmental release using a review process equivalent to USDA's; 
USDA's explanation: Under the second alternative, the proposed 
exemption criteria should ensure that exempted GE commodities would not 
result in significant environmental impacts, even if an environmental 
release should accidentally occur; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 1[C]. 

Issue: 9 - Interstate Movement of Well-Studied, Low-Risk GE Material; 
Currently, GE Arabidopsis (a mustard plant commonly used in genetics 
research) is exempt from interstate movement restrictions because they 
are well-understood and extensively used in research; 
Should the movement of GE Arabidopsis or other GE organisms be exempted 
from movement restriction? 
Alternatives considered: 
1. No action--require interstate movement authorizations for all 
organisms on the list in current regulations; 
2. (USDA's preliminary preference) Exempt a class of GE crops or 
organisms that are well-studied and present little or no environmental 
risk from permit requirements for interstate movement as is currently 
done for Arabidopsis; 
3. Create a process to apply for an interstate movement exemption for a 
particular species; 
USDA's explanation: Regarding the second alternative, an expansion of 
the exempted list to include other well-studied research organisms 
would present little or no risk of significant environmental impact; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 3[D]. 

Issue: 10 - Container Requirements for Shipping GE Material; 
What environmental considerations should be evaluated if USDA were to 
move from prescriptive container requirements for shipment of GE 
organisms to performance-based container requirements, supplemented 
with guidance on ways to meet the performance standards? 
Alternatives considered: 
1. No action--retain current list of approved containers and issue 
variances when necessary; 
2. (USDA's preliminary preference) Switch to performance-based 
standards for all transport containers; 
3. Expand current list of approved containers and issue variances when 
necessary; 
USDA's explanation: Under the second alternative, having performance-
based standards would eliminate the need for variances, reduce the 
burden on applicants, and increase the efficient use of agency 
resources while protecting the environment; 
Alternative(s) in DEIS that correspond to proposed change(s) to 
regulations: 2. 

Source: USDA's DEIS, "Introduction of Genetically Engineered 
Organisms." The DEIS's availability for review was announced in the 
Federal Register on July 17, 2007. (72 Fed. Reg. 39,021). 

[A] According to the proposed rule, USDA would regulate GE plants 
either on the basis that (1) the parent plant from which the GE plant 
was derived is a plant pest or noxious weed, (2) the trait introduced 
by genetic engineering could increase the potential of the GE plant to 
be a plant pest or noxious weed, (3) the risk that the GE plant poses 
as a plant pest or noxious weed is unknown, or (4) the Administrator of 
APHIS determines that the GE plant poses a plant pest or noxious weed 
risk. As such, aspects of both DEIS alternatives 2 and 3 are 
incorporated into the proposed rule. 

[B] According to the proposed rule, USDA concluded that the current 
permitting procedures and the use of stringent permitting conditions 
would effectively minimize the risk associated with the environmental 
release of pharmaceutical or industrial compounds. 

[C] USDA stated in the proposed rule that it is not proposing criteria 
to evaluate risks of GE imported commodities that would allow it to 
conduct expedited reviews, but it does not rule out the possibility of 
developing such a system in the future. 

[D] According to the proposed rule, USDA would retain existing 
conditional exemptions from permitting requirements for the interstate 
movement of certain GE organisms but is not proposing new exemptions. 
Instead, the agency is proposing a petition process for approving 
additional exemptions. 

[End of table] 

[End of section] 

Appendix IX: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Lisa Shames (202) 512-3841 or Shamesl@gao.gov: 

Staff Acknowledgments: 

In addition to the individual named above, James R. Jones, Jr., 
Assistant Director; Kevin S. Bray; Ross Campbell; Gloria Hernandez- 
Saunders; Thomas J. McCabe; Alison D. O'Neill; Ilga Semeiks; and John 
G. Smale, Jr., made key contributions to this report. Important 
contributions were also made by Carol L. Kolarik and Peter E. Ruedel. 

[End of section] 

Related GAO Products: 

Genetically Modified Foods: Experts View Regimen of Safety Tests as 
Adequate, but FDA's Evaluation Process Could Be Enhanced. [hyperlink, 
http://www.gao.gov/products/GAO-02-566]. Washington, D.C.: May 23, 
2002. 

International Trade: Concerns Over Biotechnology Challenge U.S. 
Agricultural Exports. [hyperlink, 
http://www.gao.gov/products/GAO-01-727]. Washington, D.C.: June 15, 
2001. 

Intellectual Property: Deposits of Biological Materials in Support of 
Certain Patent Applications. [hyperlink, 
http://www.gao.gov/products/GAO-01-49]. Washington, D.C.: October 16, 
2000. 

Biotechnology: Information on Prices of Genetically Modified Seeds in 
the United States and Argentina. T-RCED/NSIAD-00-228. Washington, D.C.: 
June 29, 2000. 

Biotechnology: Information on Prices of Genetically Modified Seeds in 
the United States and Argentina. RCED/NSIAD-00-55. Washington, D.C.: 
January 21, 2000. 

[End of section] 

Footnotes: 

[1] GAO, Results-Oriented Government: Practices That Can Help Sustain 
Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21, 
2005). 

[2] Not all field trials authorized under USDA permits or notifications 
are carried out. A GE crop developer may decide not to plant the field 
trial if, for example, the seeds have not performed as expected in 
laboratory testing, the necessary quantity of seeds is not available, 
or the weather is not favorable. 

[3] As of July 10, 2008, USDA had not resolved 32 additional incidents. 
IES is located within USDA's Animal and Plant Health Inspection 
Service. 

[4] A tolerance from EPA establishes the maximum amount of pesticidal 
residue allowed on food or feed. 

[5] The guidance does not apply to GE pesticides, which are regulated 
by EPA. Nor does the guidance apply to plants used to produce 
pharmaceutical compounds. 

[6] See [hyperlink, http://www.gao.gov/products/GAO-06-15]. GAO also 
identified an eighth practice--that is, reinforcing individual 
accountability for collaborative efforts through performance management 
systems--that we do not address in this report because it was beyond 
the scope of our work. 

[7] FDA has subjected only one substance added to a GE crop--a protein 
added to a tomato engineered for delayed ripening--to its food additive 
review process, and this was done at the request of the developer. 

[8] The National Economic Council is a part of the White House's Office 
of Policy Development. The council advises the President on matters 
related to U.S. and global economic policy. 

[9] Codex Alimentarius sets international food safety standards. 

[10] The council has published three relevant reports at the request of 
USDA: Ecological Monitoring of Genetically Modified Crops: A Workshop 
Summary (2001); Environmental Effects of Transgenic Plants: The Scope 
and Adequacy of Regulations (2002); and Biological Confinement of 
Genetically Engineered Organisms (2004). The National Research Council 
is part of the National Academy of Science--a private, nonprofit 
organization comprising distinguished scientists and engineers with a 
mandate from Congress requiring it to advise the federal government on 
scientific and technical matters. 

[11] Environmental Effects of Transgenic Plants. 

[12] The council is a cabinet-level organization that includes 
representatives from USDA, EPA, FDA, and other federal agencies. 

[13] National Science and Technology Council, Agricultural 
Biotechnology Risk Analysis Research in the Federal Government: Cross 
Agency Cooperation (2006). 

[14] Planting a "refuge" of crops that do not contain the pesticide Bt 
near crops that do contain Bt is intended to reduce the likelihood that 
insect populations will develop a resistance to Bt. 

[15] Advisory Committee on Biotechnology and 21st Century Agriculture, 
What Issues Should USDA Consider Regarding Coexistence among Diverse 
Agricultural Systems in a Dynamic, Evolving, and Complex Marketplace? 
(March 2008). 

[16] GAO, Genetically Modified Foods: Experts View Regimen of Safety 
Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced, 
[hyperlink, http://www.gao.gov/products/GAO-02-566] (Washington, D.C.: 
May 23, 2002). 

[17] Under the Administrative Procedure Act, agencies generally provide 
"interested persons" with an opportunity to comment on proposed rules, 
and agencies generally respond to the issues and matters raised in 
those comments in their final rules. The comments we analyzed are from 
stakeholders who chose to submit comments to USDA; therefore, they are 
not necessarily representative of all stakeholders who might have 
insights or opinions regarding biotechnology regulation. 

[18] The deadline for public comments on the proposed rule is November 
24, 2008. After considering these comments, the agency plans to issue a 
final rule accompanied by a Final Environmental Impact Statement. 
However, the dates for these publications are uncertain. 

[19] In its fiscal fear 2009 budget request, the administration is 
requesting a 38 percent increase in funding--from $11.7 million to 
$16.2 million--and a 28 percent increase in staffing--from 74 staff 
years to 95 staff years--for USDA's Biotechnology Regulatory Services. 

[20] Virus coat protein GE pesticides are derived from the genetic 
material that plant viruses commonly use for protection. 

[21] GAO, Results-Oriented Government: Practices That Can Help Sustain 
Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21, 
2005). 

[22] 51 Fed. Reg. 23,302 (June 26, 1986). The announcement followed 
publication of a proposed coordinated framework in 1984. 49 Fed. Reg. 
50,856 (Dec. 31, 1984). 

[23] Because states have primary responsibility for pesticide use 
within their borders, once a pesticide is registered with EPA, the 
producer may also be required to register the pesticide with state 
authorities. State registration may involve more stringent requirements 
on how the pesticide is used. 

[24] See 21 U.S.C. § 331. A food is deemed adulterated if, among other 
things, it contains any added poisonous or deleterious substance that 
may render the food injurious to health or if it contains an unapproved 
food additive. See 21 U.S.C. § 342. 

[25] FDA established its basic policy regarding the review of GE foods 
in its 1992 Statement of Policy: Foods Derived from New Plant 
Varieties. In 1997, FDA supplemented its 1992 policy with the current 
Guidance on Consultation Procedures, clarifying procedures for the 
initial and final consultations. 

[26] According to FDA, 10 Investigational New Drug applications for 
pharmaceutical products derived from GE crops have been submitted. As 
of July 2008, only two of the applications were active, and neither 
involved the use of food plants. 

[27] In December 2000, an EPA science advisory panel concluded that the 
pesticidal protein in StarLink had a medium probability of being a 
potential allergen. However, the Centers for Disease Control and 
Prevention, in a 2001 study of this protein's allergenicity conducted 
for FDA, reported that "although the study participants may have 
experienced allergic reactions, based upon the results of this study 
alone, we cannot confirm that a reported illness was a food-associated 
allergic reaction." 

[28] T. Schmitz, A. Schmitz, and C. Moss, "The Economic Impact of 
Starlink Corn," Agribusiness, vol. 21, no. 3 (2005). 

[29] C. Carter and A. Smith, "Estimating the Market Effect of a Food 
Scare: The Case of Genetically Modified StarLink Corn," Review of 
Economics & Statistics, vol. 89, no. 3 (2007). 

[30] The initial penalty exceeded $6 million, but Syngenta qualified 
for a 75 percent reduction due to mitigating circumstances, including 
its voluntary disclosure of the incident and cooperation with EPA 
during the subsequent investigation. 

[31] Neal E. Blue, Risky Business: Economic and Regulatory Impacts from 
the Unintended Release of Genetically Engineered Rice Varieties into 
the Rice Merchandising System of the U.S., Greenpeace International 
(November 2007). 

[End of section] 

GAO's Mission: 

The Government Accountability Office, the audit, evaluation and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the performance 
and accountability of the federal government for the American people. 
GAO examines the use of public funds; evaluates federal programs and 
policies; and provides analyses, recommendations, and other assistance 
to help Congress make informed oversight, policy, and funding 
decisions. GAO's commitment to good government is reflected in its core 
values of accountability, integrity, and reliability. 

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each 
weekday, GAO posts newly released reports, testimony, and 
correspondence on its Web site. To have GAO e-mail you a list of newly 
posted products every afternoon, go to [hyperlink, http://www.gao.gov] 
and select "E-mail Updates." 

Order by Phone: 

The price of each GAO publication reflects GAO’s actual cost of
production and distribution and depends on the number of pages in the
publication and whether the publication is printed in color or black and
white. Pricing and ordering information is posted on GAO’s Web site, 
[hyperlink, http://www.gao.gov/ordering.htm]. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
TDD (202) 512-2537. 

Orders may be paid for using American Express, Discover Card,
MasterCard, Visa, check, or money order. Call for additional 
information. 

To Report Fraud, Waste, and Abuse in Federal Programs: 

Contact: 

Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]: 
E-mail: fraudnet@gao.gov: 
Automated answering system: (800) 424-5454 or (202) 512-7470: 

Congressional Relations: 

Ralph Dawn, Managing Director, dawnr@gao.gov: 
(202) 512-4400: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7125: 
Washington, D.C. 20548: 

Public Affairs: 

Chuck Young, Managing Director, youngc1@gao.gov: 
(202) 512-4800: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7149: 
Washington, D.C. 20548: