Alika Atay, et al v. County of Maui, et al

Filing

FILED OPINION (SIDNEY R. THOMAS, CONSUELO M. CALLAHAN and MARY H. MURGUIA) AFFIRMED. Judge: CMC Authoring, FILED AND ENTERED JUDGMENT. [10202129] [15-16466, 15-16552]

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Home / Data Products / Adoption of Genetically Engineered Crops in the U.S.

Adoption of Genetically Engineered Crops in the U.S.
This data product summarizes the adoption of herbicide-tolerant and insect-resistant crops
since their introduction in 1996.
The tables below for corn, cotton, and soybeans provide data obtained by USDA's National
Agricultural Statistics Service (NASS) in the June Agricultural Survey for 2000 through 2016.
Many people are interested in information about global genetically engineered (GE) acreage.
USDA does not collect these data. Estimates are produced by the International Service for the
16
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ited
See more on recentctrends in GE adoption, and documentation to the data.

Data Set
Genetically engineered varieties of corn, upland cotton, and
soybeans, by State and for the United States, 2000-16

7/14/2016

7/14/2017

CSV (comma separated values) format of all data

7/14/2016

7/14/2017

Adoption of Genetically Engineered Crops in the U.S.
Overview
Recent Trends in GE Adoption
Documentation

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2001

2002

2003

2004

2005

016
14, 2
r
mbe
Nove
on
ived
arch
6466
15-1
o.
ui, N
f Ma
o

All GE varieties 3/
Stacked gene varieties
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Percent of all corn planted
Percent of all corn planted
17
16
22
28
33
36
19
40
52
59
52
55
53
78
83
88
87
55
74
80
84
82
86
85
89
91
93
93
11
12
13
16
21
26
12
30
55
55
56
56
60
73
78
76
75
40
59
78
79
83
85
84
85
88
88
86
30
32
41
45
54
60
18
37
53
57
61
61
64
72
83
80
80
64
78
84
86
90
90
91
91
95
93
92
33
38
43
47
54
63
12
21
35
38
40
42
51
69
72
79
79
68
82
90
91
90
92
90
91
95
95
95
12
17
22
35
33
40
10
19
33
42
44
52
52
71
76
74
70
44
60
72
75
80
87
86
90
93
92
91
37
36
44
53
63
66
16
28
40
41
46
48
47
78
81
78
80
73
86
88
88
92
93
88
91
93
93
93
28
32
34
42
49
55
7
13
22
37
45
36
48
71
79
75
81
59
62
70
77
79
85
86
92
93
89
93
34
34
46
52
60
69
15
25
35
42
45
52
55
74
77
82
77
76
79
86
91
91
93
91
93
96
96
95
75
20
22
31
41
37
39
43
69
68
70
66
83
88
89
93
93
97
96
94
96
97
95
9
11
9
9
13
18
5
20
37
35
36
37
43
63
69
68
66
26
41
66
67
71
74
76
85
86
85
86
48
47
66
75
79
83
34
43
58
65
60
64
62
82
80
83
78
86
93
95
96
95
96
94
96
97
97
98
72
13
20
27
33
40
42
44
53
62
67
71
77
79
78
84
85
88
85
89
91
89
90
18
18
26
32
38
46
10
22
35
37
38
41
53
63
72
70
70
50
64
75
77
80
86
86
84
92
92
90
17
20
27
36
46
44
10
14
22
28
31
36
41
61
66
68
68
55
67
74
78
82
86
85
88
91
90
90
25
26
34
40
47
52
15
28
40
46
47
49
52
71
76
77
76
61
73
80
85
86
88
88
90
93
92
92

unty
v. Co
y
n Ata
ted i
ci

Illinois
1
1
1
1
2
5
Indiana
*
*
*
1
2
4
Iowa
2
1
3
4
8
11
Kansas
1
1
2
5
5
10
Michigan
*
2
2
3
4
5
Minnesota
2
4
4
7
11
11
Missouri
2
1
2
1
4
6
Nebraska
2
2
4
5
6
12
North Dakota 2/
15
Ohio
*
*
*
*
1
2
South Dakota
2
3
10
17
21
22
Texas 2/
9
Wisconsin
1
1
2
2
2
6
Other States 1/
1
1
2
2
6
6
U.S.
1
1
2
4
6
9
* Less than 1 percent.
1/ Includes all other States in the corn estimating program
2/ Estimates published individually beginning in 2005.
3/ Values may not equal sum of components due to rounding.
Source: USDA, Economic Research Service using data from USDA, National Agricultural Statistics Service, June Agricultural Survey.
2000-2001: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 29, 2001.
2001-2002: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 28, 2002.
2002-2003: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2003.
2003-2004: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2004.
2004-2005: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2005.
2005-2006: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2006.
2006-2007: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 29, 2007.
2007-2008: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2008.
2008-2009: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2009.
2009-2010: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2010.
2010-2011: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2011.
2011-2012: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 29, 2012.
2012-2013: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 28, 2013.
2013-2014: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 30, 2014.
2014-2015: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 30, 2015.
2015-2016: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 30, 2016.

State

2000

Genetically engineered (GE) corn varieties by State and United States, 2000-2016
Insect-resistant (Bt) only
Herbicide-tolerant only
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Percent of all corn planted
Percent of all corn planted
Illinois
13
12
18
23
26
25
3
3
3
4
5
6
24
19
13
10
15
14
14
4
3
1
2
12
15
15
15
15
17
18
7
5
4
4
Indiana
7
6
7
8
11
11
4
6
6
7
8
11
13
12
7
7
7
7
9
2
2
4
2
15
17
16
17
20
22
15
10
8
8
9
Iowa
23
25
31
33
36
35
5
6
7
8
10
14
32
22
16
14
15
13
12
5
4
5
3
14
19
15
15
14
16
15
14
8
8
9
Kansas
25
26
25
25
25
23
7
11
15
17
24
30
23
25
25
24
22
28
20
7
5
4
4
33
36
30
29
28
22
19
15
18
12
12
Michigan
8
8
12
18
15
15
4
7
8
14
14
20
16
19
15
13
11
11
8
4
2
2
3
18
22
24
20
25
24
26
15
15
16
18
Minnesota
28
25
29
31
35
33
7
7
11
15
17
22
28
26
19
23
18
16
19
3
2
2
3
29
32
29
24
28
29
22
10
10
13
10
Missouri
20
23
27
32
32
37
6
8
6
9
13
12
38
30
27
23
15
27
18
5
4
5
4
14
19
21
17
19
22
20
16
10
9
8
Nebraska
24
24
34
36
41
39
8
8
9
11
13
18
37
31
27
26
22
15
16
6
4
4
3
24
23
24
23
24
26
20
13
15
10
15
39
North Dakota 2/
21
29
29
24
22
22
26
17
5
6
6
4
34
37
34
30
34
32
36
20
22
21
25
Ohio
6
7
6
6
8
9
3
4
3
3
4
7
8
9
12
15
13
24
13
6
3
3
2
13
12
17
17
22
13
20
16
14
14
18
South Dakota
35
30
33
34
28
30
11
14
23
24
30
31
20
16
7
6
6
7
9
2
3
1
4
32
34
30
25
29
25
23
12
14
13
16
42
Texas 2/
21
27
22
20
21
18
22
20
16
12
10
8
37
37
31
30
27
24
21
20
17
12
11
Wisconsin
13
11
15
21
22
22
4
6
9
9
14
18
22
19
14
13
13
18
10
3
3
3
3
18
23
26
27
29
27
23
18
17
19
17
Other States 1/
10
11
14
17
19
6
8
12
17
21
19
19
20
20
20
20
21
20
18
6
6
4
5
25
33
32
30
30
30
26
21
19
18
18
U.S.
18
18
22
25
27
26
6
7
9
11
14
17
25
21
17
17
16
16
15
5
4
4
3
21
24
23
22
23
23
21
14
13
12
13

State

Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 7 of 150

14
4
32
30
36

2000

28
2
29
47
61

2001

26
1
30
49
47

2002

46
3
47
46
61

2003

45
7
58
60
58

2004
54
42
5
55
64
59
16
54
75
14
46
34

2005

Stacked gene varieties
All GE varieties 3/
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Percent of upland cotton planted
Percent of upland cotton planted
.
.
.
.
.
92
95
60
60
65
60
76
75
70
82
83
90
90
95
98
91
94
97
98
98
98
97
98
78
90
95
94
96
94
45
47
64
64
76
73
77
63
74
80
84
70
95
98
97
98
98
99
98
99
99
99
40
33
39
52
53
57
8
6
8
11
8
25
16
28
34
26
38
24
61
60
73
83
80
80
77
77
71
78
85
93
93
94
95
96
64
68
73
70
69
72
78
83
92
92
93
82
95
97
97
97
96
98
98
99
98
99
91
85
91
93
95
94
68
68
73
63
73
65
64
63
84
87
86
80
96
98
93
95
97
97
98
99
99
98
86
88
92
97
96
98
69
62
66
63
68
76
82
85
86
87
94
78
97
98
93
89
98
98
99
99
99
99
95
97
25
23
19
51
29
29
33
38
48
56
48
99
99
98
98
98
98
98
96
98
94
84
86
93
91
95
98
60
64
62
68
76
79
72
87
89
89
93
76
93
95
96
97
96
96
94
97
97
96
96
93
67
71
73
80
82
83
84
87
92
97
94
98
97
97
98
98
97
96
99
99
98
49
51
53
58
63
70
18
28
31
35
51
49
58
60
74
75
75
46
80
78
81
91
86
91
85
93
91
90
84
86
88
91
88
90
45
42
48
49
52
57
60
81
87
78
85
74
89
90
90
92
94
95
95
98
96
97
69
71
73
76
79
83
39
42
45
48
58
58
63
67
79
79
80
61
87
86
88
93
90
94
90
96
94
93

38

45

48

46

2007-2008: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2008.
2008-2009: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2009.
2009-2010: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2010.
2010-2011: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2011.
2011-2012: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 29, 2012.
2012-2013: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 28, 2013.
2013-2014: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 30, 2014.
2014-2015: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 30, 2015.
2015-2016: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 30, 2016.

36

016
14, 2
r
6
6
4
6
8
mbe
36
33
32
38
45
20
24
22
27
30
Nove
on
ived
1/ Includes other States in the cotton estimating program
arch
2/ Estimates published individually beginning in 2005.
6466
3/ Values may not equal sum of components due to rounding.
15-1
Source: USDA, Economic Research Service using data from USDA, National Agricultural Statistics Service, June Agricultural Survey.
o.
2000-2001: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 29, 2001.
ui, N
2001-2002: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 28, 2002.
f Ma
2002-2003: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2003. o
unty
2003-2004: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2004.
v. Co
2004-2005: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2005.
ay
2005-2006: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2006.
in At
2006-2007: U.S. Dept. of Agriculture, National Agricultural Statisticsed
t Service (NASS), Acreage. June 29, 2007.
ci

Alabama 2/
Arkansas
California
Georgia
Louisiana
Mississippi
Missouri 2/
North Carolina
Tennessee 2/
Texas
Other States 1/
U.S.

State

Genetically engineered (GE) upland cotton varieties by State and United States, 2000-2016
Insect-resistant (Bt) only
Herbicide-tolerant only
State
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Percent of upland cotton planted
Percent of upland cotton planted
Alabama 2/
10
10
10
18
13
11
18
17
12
9
4
6
28
25
25
15
18
7
4
11
4
6
3
2
Arkansas
33
21
27
24
34
42
23
29
37
25
15
12
28
32
30
28
20
18
10
22
13
7
7
21
16
4
5
2
7
12
13
12
12
8
California
3
11
6
9
6
8
17
27
26
27
39
40
9
4
7
8
19
9
21
9
15
10
3
40
51
45
54
56
46
43
40
28
35
37
Georgia
18
13
8
14
13
29
32
43
55
32
23
11
19
17
19
20
20
18
13
5
3
1
1
13
10
5
7
8
6
7
10
4
5
5
Louisiana
37
30
27
30
26
21
13
14
9
15
7
10
13
17
19
20
19
26
24
19
4
5
10
13
11
6
10
3
6
9
16
11
7
2
Mississippi
29
10
19
15
16
14
13
15
22
16
23
23
7
16
19
14
12
15
9
2
2
1
3
22
19
13
16
9
7
7
12
11
11
2
Missouri 2/
20
32
13
12
18
22
22
33
6
21
6
12
59
40
63
68
29
47
47
32
54
27
36
34
North Carolina
11
9
14
16
18
17
29
37
27
29
27
24
19
13
19
15
14
10
16
2
3
1
2
19
16
14
13
7
7
8
5
5
7
1
Tennessee 2/
13
16
10
10
7
8
9
7
4
2
1
1
8
10
17
14
10
8
6
6
5
5
1
3
Texas
7
8
7
8
10
14
33
35
40
39
40
35
18
16
16
15
13
18
11
8
4
5
4
34
36
31
31
27
19
22
17
15
11
11
Other States 1/
17
18
19
18
22
21
33
35
32
24
18
21
27
22
24
24
21
24
5
3
10
3
24
24
20
20
17
16
16
11
9
8
8
9
U.S.
15
13
13
14
16
18
26
32
36
32
30
27
18
17
18
17
15
17
14
8
5
5
4
26
28
23
23
20
15
17
15
12
10
9

Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 8 of 150

unty
v. Co
y
n Ata
ted i
ci

2002
68
71
83
75
83
72
71
80
72
85
61
73
89
78
70
75

2001
60
64
78
73
80
59
63
63
69
76
49
64
80
63
64
68

84
77
88
84
87
73
79
89
83
86
74
74
84
84
76
81

2003
92
81
87
89
87
75
82
93
87
92
82
76
95
82
82
85

2004
92
81
89
91
90
76
83
96
89
91
89
77
95
84
84
87

2005

All GE varieties
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Percent of all soybeans planted
92
92
94
94
96
95
94
97
99
97
96
87
88
87
90
89
92
90
92
91
93
94
92
94
96
94
95
96
93
90
92
93
92
91
94
95
94
96
97
97
93
97
96
97
85
92
95
94
95
96
94
93
94
96
95
81
87
84
83
85
91
91
90
91
94
95
88
92
91
92
93
95
91
93
94
95
96
96
96
97
94
98
98
95
98
99
99
99
93
91
92
89
94
91
91
90
91
87
89
90
96
97
96
94
97
95
96
95
95
96
90
92
94
94
94
94
98
94
96
94
95
82
87
89
83
86
85
86
89
90
91
91
93
97
97
98
98
98
98
97
97
96
96
85
88
90
85
88
91
92
89
95
93
94
86
86
87
87
90
92
93
92
94
94
94
89
91
92
91
93
94
93
93
94
94
94

016
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o

Source: USDA, Economic Research Service using data from USDA, National Agricultural Statistics Service, June Agricultural Survey.
2000-2001: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 29, 2001.
2001-2002: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 28, 2002.
2002-2003: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2003.
2003-2004: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2004.
2004-2005: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2005.
2005-2006: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2006.
2006-2007: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 29, 2007.
2007-2008: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2008.
2008-2009: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2009.
2009-2010: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2010.
2010-2011: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS), Acreage. June 30, 2011.
2011-2012: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 29, 2012.
2012-2013: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 28, 2013.
2013-2014: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 30, 2014.
2014-2015: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 30, 2015.
2015-2016: U.S. Dept. of Agriculture, National Agricultural Statistics Service (NASS). Acreage. June 30, 2016.

1/ Includes all other States in the soybean estimating program.

Genetically engineered (GE) soybean varieties by State and United States, 2000-2016
Herbicide-tolerant only
State
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2000
Percent of all soybeans planted
Arkansas
43
60
68
84
92
92
92
92
94
94
96
95
94
97
99
97
96 43
Illinois
44
64
71
77
81
81
87
88
87
90
89
92
90
92
91
93
94 44
Indiana
63
78
83
88
87
89
92
94
96
94
95
96
93
90
92
93
92 63
Iowa
59
73
75
84
89
91
91
94
95
94
96
97
97
93
97
96
97 59
Kansas
66
80
83
87
87
90
85
92
95
94
95
96
94
93
94
96
95 66
Michigan
50
59
72
73
75
76
81
87
84
83
85
91
91
90
91
94
95 50
Minnesota
46
63
71
79
82
83
88
92
91
92
93
95
91
93
94
95
96 46
Mississippi
48
63
80
89
93
96
96
96
97
94
98
98
95
98
99
99
99 48
Missouri
62
69
72
83
87
89
93
91
92
89
94
91
91
90
91
87
89 62
Nebraska
72
76
85
86
92
91
90
96
97
96
94
97
95
96
95
95
96 72
North Dakota
22
49
61
74
82
89
90
92
94
94
94
94
98
94
96
94
95 22
Ohio
48
64
73
74
76
77
82
87
89
83
86
85
86
89
90
91
91 48
South Dakota
68
80
89
91
95
95
93
97
97
98
98
98
98
97
97
96
96 68
Wisconsin
51
63
78
84
82
84
85
88
90
85
88
91
92
89
95
93
94 51
Other States 1/
54
64
70
76
82
84
86
86
87
87
90
92
93
92
94
94
94 54
U.S.
54
68
75
81
85
87
89
91
92
91
93
94
93
93
94
94
94 54

Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 9 of 150

Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 10 of 150
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74 ° F Rain
Hilo HI

Papaya: A GMO success
story
Published June 10, 2013 - 12:05am

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Editor’s note: This is the second story in a four-part series that
examines the controversial topic of genetically modified
organisms, or GMOs. The series began Sunday and concludes
Wednesday.
By TOM CALLIS

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Tribune-Herald staff writer
Dennis Gonsalves doesn’t have to travel far to see the fruits of his
labor.
The 70-year-old scientist, now retired and living in Hilo, is a short
drive from Puna and the papaya farmers he came to know closely
more than 20 years ago.
Growing up in Kohala during the plantation days, Gonsalves went

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Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 11 of 150
to the University of Hawaii at Hilo, hoping to return with an
education and a job as a boss for one of the sugar companies.
2016-11-14 08:38

Life took him in another direction. Finding a passion in scientific
research, he ended up as a plant pathologist at Cornell University,
where he helped make genetic history through the creation of the
virus-resistant Rainbow papaya, credited with bringing the industry
back from the brink.
“If you drove here in the 1990s, you would see nothing but dead
(papaya) trees,” he said recently as he drove his pick-up truck
toward the farm of Alberto Belmes in Keaau.

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Tucked away behind Highway 130, the farm stretches over 100
acres with a seemingly endless forest of the tall but slender
papaya trees planted in neat rows and topped with their green
oblong-shaped fruit. Some of the fruits are displaying a yellow
tinge as they ripen, and are being harvested by workers using long
pickers needed to reach the top of trees that are as tall as 15 feet.

2016-11-14 00:05

Each tree is transgenic and can trace their origins back to
Gonsalves’ lab.

2016-11-14 00:05

Alaska Airlines begins new
direct service route from
Washington
2016-11-14 00:05

A hive of activity
The politics of pain: Supply
vs. demand

For Belmes, a Filipino immigrant who said his farm was “wiped
out” by the ringspot virus, genetically-modified papaya has been
nothing short of a life-saver.
“I still would be out of business,” said Belmes, his friendly eyes
now matching the earnest tone in his voice.
“It’s hard to get a job in Hawaii.”
As protests against genetically modified food grow, the Rainbow
papaya is frequently cited by scientists as a transgenic success
story.
Belmes’ farm was one of the first to adopt the Rainbow papaya,
which carries a protein coat gene from the virus, allowing it to
reject the pathogen.

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It didn’t take long to realize its benefits.
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“When we started … everyone was jealous,” Belmes said.
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“I’m so happy we are all Rainbow. Not me and imyself, for
nA
ited
everyone that has a job to go to work.” c

Rainbow papaya makes up about 77 percent of the crop now, with
some farmers still growing the non-transgenic Kapoho Solo to
export to markets, like Japan, that are slow to embrace modified
food.

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But overall, papaya production remains a fraction of its peak.
In 2010, the most recent data available, there were 30.1 million
pounds of papaya harvested in the state, almost all of it on the Big
Island, according to the state Department of Agriculture.

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Hawaii’s largest yield was 80.5 million pounds in 1984. In 1992,
the virus hit Puna, which was growing 53 million pounds of papaya
annually.

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By the time transgenic papaya was commercialized in 1998,
production had been cut in half and most trees were infected,
Gonsalves said.
While production remains significantly below pre-virus levels,
Gonsalves and other scientists believe there wouldn’t be much left
without it.
“There’s no papaya industry. Simple as that,” he said.

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Before being located almost entirely in Puna, papaya had been
mostly grown on Oahu. Those crops were hit by the virus, carried
by aphids, in the 1950s, causing the re-location to the Big Isle. It
was first detected on the island in the 1970s in Hilo before
spreading to Puna.
A hindrance to the growth papaya industry is the acceptance of

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Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 12 of 150
transgenic crops abroad.
Japan, which has historically been a major consumer of Hawaii
papaya, didn’t accept the Rainbow variety until December 2011,
and it still makes up a tiny fraction of exports to the country.

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The Pacific neighbor has also required non-transgenic papaya to
be tested to ensure its genetic purity, Gonsalves said.
Japan imported $1.3 million worth of papaya in 2012, about 16
percent of all of Hawaii’s papaya exports.
Gonsalves expects that to continue to grow over time as
consumers elsewhere begin to accept the Rainbow papaya as
safe, but at the same time, hints that lingering concerns over the
safety of modified food may slow that down.
The transgenic papaya had been thoroughly tested, Gonsavles
said, for impacts on nutrition and allergens. The transgenic and
non-transgenic fruit were found to be “substantially equivalent” in
terms of nutritional value, meaning there are no significant
variations, according to a 2011 study by the Pacific Basin
Agricultural Research Center in Hilo and the University of Hawaii.
There are also no increased risks for allergens, said Gonsalves,
who directed PBARC until his retirement in December, and he
believes health concerns are unwarranted.

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“Some people say, ‘I never eat transgenic papaya.’ Great. But
don’t tell me it’s not safe,” he said.
For some organic farmers who seek to grow non-modified crops,
Rainbow papaya is not a welcomed neighbor.
Geoff Rauch, a Pahoa farmer, said the transgenic fruit makes it
harder to ensure that his produce isn’t modified.
Genetic purity requires vigilance, and presents an additional
challenge for organic farmers, he said.
“Every year, I get it sampled so I can tell (customers) I am growing
non-transgenic papaya,” Rauch said.

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Loren Mochida, director of agriculture operations for W.H.. Co
ay v
Shipman, said he believes transgenic and non-transgenic papaya
in At
cited
growers can co-exist, noting that some commercial growers still
have both varieties on their farms.

“Actually it (Rainbow papaya) helps the organic guys,” he said. “…
It keeps the virus pressure down on the surrounding areas.”
Another study PBARC published in 2011 showed low levels of
pollen drift between Rainbow and non-transgenic papaya as long
as the plants were hermaphrodites.
The study found that between 0.8 percent and 1.3 percent of
tested Kapoho Solo hermaphrodite trees grown adjacent to
Rainbow papaya produced transgenic genes. Nearly all of
commercial plants are hermaphrodites, which self pollinate.
The transfer rate was much higher for female plants at 67.4
percent.
Gonsalves notes that only the seeds carry the new genes, not the
fruit itself.
“If there is cross-contamination, that crop can still be sold as an
organic crop,” he said.
The story of transgenic papaya doesn’t end with the Rainbow
variety or the ringspot virus.
David Christopher, chair of molecular biosciences and
bioengineering at the University of Hawaii at Manoa, said he is
working to develop papaya that is resistant to a fungus that also
frustrates growers.
The pathogen is related to the bacteria that caused Ireland’s
potato famine, he said, and he believes he can eliminate it by

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adding a grape gene to the DNA of papaya.
“If we can (get) consistent results, farmers in humid wet regions
will not have to spray their papayas with chemical fungicides,
leading to a cleaner and safer farming conditions,” he said in an
email.
So far, full resistance hasn’t been reached, but the research is
promising, with field trials possibly a few years away, Christopher
said in a phone interview.
Belmes, who has a few trees killed by the fungus, said he would
be happy to try it.
“Chemicals for spraying is so expensive,” he said.
Gonsalves said farmers also have to let fields go fallow for three
years to combat the fungus.
The fungus is particularly problematic during times of extended
rain, said papaya grower Ross Sibucao.
“In wet weather, at least 20 percent or 30 percent” of trees are
impacted, he said.
“It can get pretty bad.”
The non-transgenic Kapoho Solo is slightly more tolerant of the
fungus than Rainbow, said Gonsalves, though both are hit hard.
Without a resistant variety, traditional cross-breeding becomes an
unlikely solution, Christopher said.
Scientists came across the same problem with tyring to defeat the
virus.
Few plants are related to papaya, making it difficult to cross-breed
resistance.
“Papaya is a problem because it doesn’t have any wild relatives,”
Christopher said.
“It’s really genetically uniform.”

unty
v. Co
aycrossing
Recently, a researcher in Australia had some success
in At
papaya with a ringspot-resistant plant fromed
cit South America known
as calasacha or vasconcellea quercifolia.
But there were problems.
The resistance failed to transfer passed the first generation and
the hybridized plant didn’t produce fruit that was commercially
viable, said Richard Manshardt, a horticulturist with UH-Manoa.
Manshardt said UH scientists also picked up on the research, but
it doesn’t look promising and funding is expected to run out.
“At this point, it doesn’t look like we got anything useful from that
experiment,” he said.
Despite continued controversy over genetically modified food,
Gonsalves believes he and other scientists made the right
decision with papaya.
In presentations, he said he always shows a picture of a woman in
Thailand planting one of his immunized papaya trees. Those trees
were protected from the ringspot virus but couldn’t pass on
resistance to the next generation, preventing them from being a
solution to Hawaii’s problem.
Still, it highlights the point he tries to pass to his audience.
“That to me, it brings us back to why we’re doing something,”
Gonsalves said.
“In the end, we did it to help people.”
Still, he doesn’t see all uses of genetic engineering as being
equally altruistic. He believes its uses need to be looked at case
by case.

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Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 14 of 150
“This is a powerful tool …,” Gonsalves said.
“The big question is, ‘Is it causing harm to the environment,
causing harm to human safety?’
“To my estimation, the answer is we have acted good.”
Email Tom Callis at [e-mail].
————————————
PAPAYA
Record harvest:
80.5 million pounds, 1984
2010 harvest: 30.1 million pounds
TIMELINE
1970s: Ringspot virus found in Hilo
1991: Scientists successfully develop transgenic papaya that is
virus resistant.
1992: Virus hits Puna. Production at 53 million pounds.
1998: Rainbow papaya approved by regulatory agencies for
commercialization. Production in Puna at 26 million pounds.
2012 EXPORTS in value
Total: $8,637,162
Canada: $5,132,901
Japan: $1,376,097
Hong Kong: $264,592
China: $943,543
Germany: $110,973
What is Rainbow papaya?

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Scientists added a gene from the ringpsot virus into a Sunset
papaya.
Called SunUp, this variety was then crossed with Kapoho Solo
papaya, which is preferred for export, to create Rainbow. Rainbow
papaya now accounts for 77 percent of the state’s crop.

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USDA CONCLUDES GENETICALLY ENGINEERED CREEPING BENTGRASS
INVESTIGATION

Agency News Releases

USDA Assesses The Scotts Company, LLC $500,000 Civil Penalty
Radio Newsline and Features

WASHINGTON, Nov. 26, 2007--The U.S. Department of Agriculture's Animal and Plant Health Inspection
2016
Service (APHIS) has concluded an investigation into alleged compliance infractions by The Scotts
r 14,
Company, LLC. The investigation related to regulated genetically engineered glyphosate-tolerant creeping
mbe
ove
bentgrass. Under today's settlement agreement, on N has agreed to pay a civil penalty of $500,000
d Scotts
hivePlant Protection Act of 2000. This is a severe civil penalty
which is the maximum penalty allowed bycthe
ar
466
and underscores USDA's strong -16
. 15 commitment to compliance with its regulations.

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cited APHIS entered into this settlement agreement with Scotts to resolve allegations that the company failed

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"USDA takes compliance with its biotechnology regulations very seriously," said Bruce Knight, under
Mau
ty of
secretaryCoun
for marketing and regulatory programs. "Compliance is, and will always be, our highest priority
v.
anday
in At we will continue our rigorous oversight of regulated genetically engineered plants."
to comply with performance standards and permit conditions for field trials of glyphosate-tolerant
creeping bentgrass and improperly moved genetically engineered grass seed. Scotts already has
implemented measures to comply with performance standards and permit conditions related to these
allegations.

In addition, APHIS alleges that Scotts failed to conduct a 2003 Oregon field trial in a manner which
ensured that neither glyphosate-tolerant creeping bentgrass nor its offspring would persist in the
environment. Scotts currently is taking monitoring and mitigation actions in Oregon to locate and remove
the regulated genetically engineered material that was accidentally released during the 2003 field trial.
These actions were required by APHIS beginning in 2004 to address past allegations that Scotts failed to
notify APHIS of the 2003 accidental release. The current allegations address the ongoing persistence in
the environment related to the accidental release of the regulated genetically engineered glyphosatetolerant creeping bentgrass.
Also, as part of the 2007 settlement agreement, within one year Scotts will conduct three public
workshops for other potential developers of genetically engineered plants and other interested parties.
These workshops will focus on best management practices and technical guidance on the identification
and prompt resolution of biotechnology compliance incidents.
Best management practices will be a major focus of APHIS' biotechnology quality management system
which is scheduled for implementation in spring 2008. APHIS will encourage all genetically engineered
developers--including universities, small businesses and large companies--to participate in the
biotechnology quality management system. The goal of the voluntary program is to help developers
establish policies and quality control practices that proactively address potential issues before they
materialize.
Creeping bentgrass is a perennial grass used largely for golf course greens, tees and fairways. Scotts'
creeping bent grass is genetically engineered to be tolerant to the herbicide glyphosate. Scotts field
tested glyphosate-tolerant creeping bentgrass, under APHIS authorization, in various locations across the
United States.
APHIS oversees the development and introduction through importation, interstate movement and
environmental release of genetically engineered organisms. USDA is committed to ensuring safety in the
oversight of field tests and movements involving regulated genetically engineered organisms.

Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 17 of 150

Additional information about the Biotechnology Quality Management System is available at
http://www.aphis.usda.gov/.
#

Last Date Modified: 11/27/2007

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GENETICALLY ENGINEERED CROPS:
Agencies Are Proposing Changes to Improve Oversight, but Could Take Additional Steps to Enhance Coordination and
Monitoring
GAO-09-60: Published: Nov 5, 2008. Publicly Released: Dec 5, 2008.

VIEW REPORT (PDF, 109 PAGES)
HIGHLIGHTS

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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 nonGE 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.

Additional Materials:
Highlights Page:
(PDF, 1 page)
Full Report:

(PDF, 109 pages)
Unauthorized releases of GE crops into food, animal feed, or the environment beyond farm fields have occurred, and it is
Accessible Text:
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
(HTML text file)
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
Contact:
agencies have used lessons learned from unauthorized releases to make regulatory and policy changes. For example,
Lisa R.,Shames
USDA increased inspections of field trial sites for GE crops producing pharmaceutical compounds; EPA discontinued a
2016
r 14
(202)
policy under which a GE crop containing a pesticidal agent could be approved for animal feed, but not for food; and FDA
mbe 512-3000
ve [e-mail]
established a voluntary early food safety evaluation program for certain GE crops intended for food use to help mitigateNo
d on the
impact should unauthorized releases occur during field trials, although it has not made these evaluationsrchive to the
available
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public. USDA, EPA, and FDA routinely coordinate their oversight and regulation of GE crops in 6466respects, but could
1 many
Office of Public Affairs
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[phone]
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FDA's voluntary early food safety review for certain GE crops in the fieldof Ma
trial stage and support USDA's oversight. Also,
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the spread of genetic traits is causing undesirable effects on the environment, non-GE segments of agriculture, or food
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safety, as recommended by the National Research Council and others. USDA, EPA, and FDA have proposed regulatory
cited
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.

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United States Government Accountability Office

GAO

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

November 2008

GENETICALLY
ENGINEERED
CROPS

cited

GAO-09-60

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

unty
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November 2008

GENETICALLY ENGINEERED CROPS
Accountability Integrity Reliability

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

Why GAO Did This Study

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

What GAO Found

Genetically engineered (GE)
Unauthorized releases of GE crops into food, animal feed, or the environment
crops—including crops engineered
beyond farm fields have occurred, and it is likely that such incidents will
to resist pests or tolerate
occur again. While there is no evidence that the six known releases into the
herbicides—are widespread in the
food or feed supply or into crops meant for the food or feed supply affected
United States and around the
human or animal health, some resulted in lost trade opportunities. Moreover,
world. Taking direction from the
the total number of unauthorized releases into the environment is unknown.
1986 Coordinated Framework for
USDA and EPA have the authority to inspect fields in which GE crops are
Regulation of Biotechnology, the
tested, but crop developers have detected most violations. USDA and EPA
U.S. Department of Agriculture
have taken enforcement actions in response to violations, ranging from
(USDA), Environmental Protection
warning letters to significant penalties. The agencies have used lessons
Agency (EPA), and Food and Drug
learned from unauthorized releases to make regulatory and policy changes.
Administration (FDA) regulate GE
crops to ensure that they are safe.
For example, USDA increased inspections of field trial sites for GE crops
The unauthorized mixing of some
producing pharmaceutical compounds; EPA discontinued a policy under
GE crops with non-GE crops has
which a GE crop containing a pesticidal agent 2016 be approved for animal
4, could
caused controversy and financial
ber 1
feed, but not for food; and FDA established a voluntary early food safety
ovem
N
harm. GAO examined (1) unauthoevaluation program for certain on crops intended for food use to help
ived GE
rized releases of GE crops,
arch
mitigate the impact 466
6 should unauthorized releases occur during field trials,
(2) coordination among the three
15-1
althoughuit No. not made these evaluations available to the public.
a i, has
agencies, and (3) additional actions
of M
unty
they have proposed to improve
. Co
v
USDA, EPA, and FDA routinely coordinate their oversight and regulation of
oversight. GAO gathered data ifrom y
n Ata
cited
GE crops in many respects, but could improve their efforts. Specifically,
agencies and stakeholders; used
USDA and FDA do not have a formal method for sharing information that
criteria from prior GAO work to
assess coordination; and reviewed
could enhance FDA’s voluntary early food safety review for certain GE crops
agency proposals.
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
What GAO Recommends
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
GAO recommends that (1) FDA
recommended by the National Research Council and others.
make public the results of its early
food safety assessments of GE
USDA, EPA, and FDA have proposed regulatory changes intended to improve
crops; (2) USDA and FDA develop
their oversight of GE crops. In 2007, USDA assessed a wide array of regulatory
an agreement to share information
on GE crops with traits that, if
alternatives that could redefine, on the basis of risk, which GE crops it
released into the food or feed
regulates and how it will respond to unauthorized releases. USDA’s fiscal year
supply, could cause health
2009 budget request also seeks funding for a voluntary system to help GE crop
concerns; and (3) USDA, EPA, and
developers employ best management practices to reduce the risk of
FDA develop a risk-based strategy
unauthorized releases. Furthermore, the 2008 Farm Bill required USDA to take
for monitoring the widespread use
actions on lessons learned from its investigation of an unauthorized release of
of marketed GE crops. FDA agreed
GE rice. EPA has proposed several changes to its regulations for GE crops
with the first recommendation,
that produce pesticides, including one change that would distinguish between
and, with USDA, agreed in part
pesticidal agents produced in GE crops and those applied topically to crops.
with the second. The agencies
In 2001, FDA proposed to require that GE food developers notify the agency
agreed in part with the third
before marketing their products. However, as of July 2008, FDA had not taken
recommendation. We stand by the
recommendations.
action to finalize the proposed rule, believing its current approach calling for
voluntary notice is sufficient.
To view the full product, including the scope
and methodology, click on GAO-09-60.
For more information, contact Lisa Shames at
[phone], or [e-mail].

United States Government Accountability Office

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Contents

Letter

1
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
2016
Agency Comments and Our Evaluation
r 14,

Appendix I

Appendix II

ay
in At
cited

mbe
Nove
d on
Objectives, Scope, archiveMethodology
6 and
1646
. 15i, No
Mau
ty of
un
v. Co

3
7

14

24

34
44
46
47
51

Comments from the U.S. Department of Agriculture

56

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

61

Appendix IV

U.S. Legal Framework for Regulation of GE Crops

67

Appendix V

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

74

Information on the Commercialization of GE Crops

76

Appendix III

Appendix VI

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Appendix VII

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

GE Regulatory Issues and Alternatives Discussed in
USDA’s DEIS and Proposed Rule

Appendix VIII

Appendix IX

90

96

GAO Contact and Staff Acknowledgments

Related GAO Products

102

103
2016
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mbe
Nove

Tables
ay
in At
cited

on
ived
arch
6466
15-1
No.
i,
Table of Mau Statutes Relevant to the Regulation of GE Plants
y 1: Key
ount 2: Summary of the Six Known Unauthorized Releases of
v. C
Table

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

9

15
17
68
79
96

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

Page ii

8
20
74
75

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Abbreviations

ay
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cited

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66 a
164
. 15APHIS
NoAnimal and Plant Health Inspection Service
aui,
BQMSof M
Biotechnology Quality Management System
unty
. Co
v

Bt
DEIS
EPA
FDA
FFDCA
FIFRA
GE
IES
OECD
OSTP
PPA
PVCP
USDA

Bacillus thuringiensis
draft programmatic environmental impact statement
Environmental Protection Agency
Food and Drug Administration
Federal Food, Drug, and Cosmetic Act
Federal Insecticide, Fungicide, and Rodenticide Act
genetic engineering
Investigative and Enforcement Services
Organisation for Economic Cooperation and Development
Office of Science and Technology Policy
Plant Protection Act
plant virus coat protein
U.S. Department of Agriculture

This is a work of the U.S. government and is not subject to copyright protection in the
United States. This published product may be reproduced and distributed in its entirety
without further permission from GAO. However, 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.

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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
2016
environment, and international relationsband4trade. Proponents cite the
r1 ,
m e
ove
potential for enhanced crop yields;Nmore environmentally friendly food
on
ved
hifoods; and the increased use of plants to
production; more nutritious
arc
6466
inexpensively o. 15-1 pharmaceutical compounds, such as human or
produce
i, N
Mau
veterinary drugs, or industrial compounds, such as substances used in
ty of
n
Cou
y v. paper production or detergent manufacturing. Opponents argue that not
n Ata
i
cited
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

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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
016
into the environment, the latter of whichbcould2occur when a developer
r 14,
m e
ove
tests the crop in a field trial. USDANmay, upon finding a GE crop does not
d on
hive grant a petition to extend “nonregulated”
pose a potential plant 66 arcrisk,
pest
164
status to the, crop, -meaning that it can be moved or released without
. 15
i No
Mau
agencyfoversight. USDA also has the authority to regulate GE plants as
ty o
n
Cou
y v. noxious weeds; a noxious weed is any plant or plant product that can
n Ata
i
cited
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

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(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 6
criteria that we have
1
4, 20 and coordination.1 We
developed in prior work on agency collaboration
ber 1
vem
did not assess the federal regulationoof GE animals. Furthermore, we did
nN
do
hive
not assess U.S. efforts6toareduce barriers to international trade in GE
6 rc
64
15-1
agricultural ,commodities. A more detailed description of our objectives,
No.
aui
scope of M methodology is presented in appendix I. We conducted this
and
unty
. Co
ay v performance audit from July 2007 to November 2008 in accordance with
in At
cited
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

1

GAO, Results-Oriented Government: Practices That Can Help Sustain Collaboration
among Federal Agencies, GAO-06-15 (Washington, D.C.: Oct. 21, 2005).

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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
16
evaluation of GE crops that might pose a er 14, risk to help mitigate the
new 20
mb
impact of unauthorized releases, n Nove
although FDA has not yet fulfilled a
ed o
commitment to publish6thehiv
arc results of those evaluations.
6

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64
15-1
No.
aui,
As nty of M for by the Coordinated Framework and measured against other
called
u
. Co
v 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

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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
2 16
APHIS’ Biotechnology Framework, a document0resulting from lessons
r 14,
mbe
learned from its investigation ofothe ove
n N unauthorized release of GE rice into
ived
the food supply in 2006, ascwell as from its years of regulatory experience,
ar h
6466
15 1
and to take action -to, among other things, enhance the availability of
No.
i,
Mau
geneticf samples from developers and the quality and completeness of
yo
ount
v. C
Atay records by developers. For its part, EPA is working on three proposed
ed in
cit
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.

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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
16
agreement would cover GE crops that present 20 are likely to present
r 14, or
mbe
public health concerns. Concerning ove third recommendation, USDA,
n N the
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EPA, and FDA agreed,6inapart, to the development of a coordinated
64 6
strategy to do o. 15-1
Nrisk-based monitoring of marketed GE crops for unintended
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consequences. However, USDA emphasized that its current regulations
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Atay limit it to monitoring only regulated crops that pose a potential plant pest
ed in
cit
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.

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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.
16

Seed developers have experimented with er 14, 20
engineering a wide variety of
b
vem
traits into plants, including insect resistance; herbicide tolerance;
n No
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resistance to viruses, bacteria, and fungi; enhanced product quality, such
66 a
64
15-1
as increased, oil. content, delayed ripening, and altered color; and other
No
aui
properties, such as increased tolerance to drought or cold. For example,
of M
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. Co shown in figure 1, scientists produced insect-resistant plants by
ay v as
in At
cited
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.

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

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

Bt gene is inserted into
corn (maize) DNA.

Sources: GAO and Art Explosion (clip art).6
46

6
15-1
No.
aui,
of M

cited

The resulting corn variety (Bt corn)
produces its own insecticide, reducing
the need 16 farmers to spray pesticides.
for

ived
arch

20
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Inu1986, OSTP published the Coordinated Framework, which outlined the
nty
. Co
ay v regulatory approach; relevant laws; and regulations for, and a definition of,
in At
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.

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

Relevance to the regulation of GE crops
a

Plant Protection Act (PPA)

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.

Federal Insecticide, Fungicide, and Rodenticide Authorizes the EPA Administrator to register pesticides and regulate the
Act (FIFRA)
distribution and use of nonregistered pesticides, which would include those
genetically engineered into plants.
Federal Food, Drug, and Cosmetic Act (FFDCA) 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.
National Environmental Policy Act of 1969

ay
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cited

USDA Oversees the
Movement and
Environmental Releases of
Regulated 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
2016
actions related to the regulation of GE crops.er 14,
mb
Nove
Source: GAO.
d on
hive
arc
a
6466
In 2000, the Plant Protection Act incorporated many authorities of the Federal Plant Pest Act, the
15-1
. and the Federal Noxious Weed Act of 1974 and repealed all but a few
Plant Quarantine Act,
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provisions of those acts.
ty of
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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 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.

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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
2016
r 14,
creation of a new plant virus.
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cited

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6. The crop has not 466 arc
been modified to contain certain genetic material
16
. 15- human pathogens.
from animal or
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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

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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.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,
16
it is no longer subject to regulatory control 14, 20 the Plant Protection Act,
r under
mbe
unless USDA finds it to be a plant pest or noxious weed on the basis of
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new data or analysis. Petitioning
arc
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commercialization,1since it allows planting with less restrictive conditions
. 15o
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thanty of Ma imposed by a permit or the notification process. However,
those
n
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n Ata
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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 “plantincorporated 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.)

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.

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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
16
tolerance or tolerance exemption has been 14, 20
r established or submit a
mbe
petition for the establishment ofoa Nove
n tolerance or tolerance exemption, or
ed
certify that the food or 6 archiis disposed of in a manner that ensures it will
feed v
646
not endangerNo. 15-or the environment.
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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.

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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
16
the level of allergens, toxins, nutrients, and 14, 20
r antinutrients—compounds
mbe
ve
that inhibit the absorption of nutrients—in the GE food is comparable to
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the level of these substances
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whether the, GE. 15-1 contains any new allergens or toxins. FDA assists the
food
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company a
ty of with questions related to the regulatory status of the food. If
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n Ata
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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.

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

Known Unauthorized
Releases of GE Crops
Apparently Have Noted in Atay
cit
Caused Health Effects, but
Several Caused Financial
Losses

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
16
4, 20
unauthorized releases or to mitigate theireimpact.
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466
-16known incidents of the unauthorized release of
There have been1six
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regulated GE crops into the food supply or into crops meant for the food
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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.

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

Product

Crop

Trait

Cause

Detection

2000

StarLink

Corn

Insect resistance and herbicide
tolerance

Cross-pollination, commingling
of corn after harvest

Third-party testing

2002

Prodigene

Corn

Pharmaceutical protein

Cross-pollination and
a
uncontrolled volunteers

USDA inspection

2004

Syngenta Bt10

Corn

Insect resistance

Misidentified seed

Third-party testing

2006

Liberty Link Rice 601

Rice

Herbicide tolerance

Not determined

Third-party testing

2006

Liberty Link Rice 604

Rice

Herbicide tolerance

Not determined

Third-party testing

2008

Event 32

Corn

Insect resistance

Under investigation

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.

016

4 2
The regulated materials in these six incidents ,were detected at different
ber 1
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points in the food and feed supply.N
on For example, in the StarLink corn
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incident—a GE corn 466
containing a pesticidal protein that was approved
6
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only for animal .feed and not for human food—trace amounts of the
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pesticidal protein were detected in consumer products, such as taco shells
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Atay and corn bread. The presence of the pesticidal protein in human food
ed in
cit
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

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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
16
4, 20
to $1.285 billion.
ber 1

USDA Says That
Unauthorized Releases of
GE Crops Have Not ited in Atay
c
Caused Environmental
Harm

m
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66 a
-164
In addition to known unauthorized releases to the food supply, USDA data
o. 15
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indicate there have been other potentially unauthorized releases of GE
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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.

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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

Number of
violations or
potential violations
a
identified by USDA

Persistence in the
environmentb

7

Production and/or
persistence of progeny
(offspring)

4

Animal-related release,
incursion, destruction, or
consumption

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33

Weather-related release,
incursion, or destruction
6
Movement of propagules
, 201c
into the mber 14
environment
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other flower control
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insufficiency
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Source:ty o
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v. Co

17
16
21

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.

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

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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
2016
enforcement actions, such as issuing enforcement letters and assessing
r 14,
mbe
financial penalties. EPA, on the otherve
No hand, has delegated primary
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enforcement authority—including inspection responsibilities—to the
6 arc
1646
states, but, according to EPA, neither the agency nor the states have made
. 15i, No
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these inspections a priority. In response to violations, EPA has assessed
ty of
n
Cou
y v. several large financial penalties, but otherwise has taken few enforcement
n Ata
i
cited
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

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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
2016
released from a site. According to USDAbofficials, to date, developers have
r 14,
m e
been cooperative when asked tooprovide a testing methodology and
Nove
d n
hive
representative samples, although doing so is not a requirement of the
arc
6466
regulation. , No. 15-1

ay
in At
cited

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

i
Mau
y of
ount
v. C
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.
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

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noncompliance, warning letters, or referrals to USDA’s Investigative and
Enforcement Services (IES) (see fig. 2).3
Figure 2: USDA Enforcement Actions, 2003 through 2007

Warning letter
Referred to USDA’s IES

5% 5%

54%
54%

cited

unty
. Co
ay v
in At

36%

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66 a
64
15-1
No.
aui,
of M

2016
Guidance letter or
r 14,
mbe of compliance
ove notice
on N

Acknowledgment letter
or notice of compliance
Source: GAO analysis of USDA data.

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

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

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.

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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 primary enforcement authority, including
responsibility for most inspections of field trials conducted under
experimental use permits, to state agencies. However, according to EPA
2016
officials, neither EPA nor the states consider4monitoring field trial permits
r1 ,
mbe
for GE pesticides a high priority, n Nove because all of the GE pesticides
partly
ed o
rchiv
currently being grown6inafield trials have already been evaluated for food,
64 6
15-1
feed, and environmental risks and received a tolerance or a tolerance
No.
i,
Mau
exemption, indicating they are relatively low risk.4 EPA does not collect
y of
ount
v. C
Atay information on how many experimental use permits the states inspected.
ed in
cit
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 Delegated Its
Inspection Responsibilities to
the States

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

4

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

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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 6 occasions, EPA
two
1
4, 20in 2006 in response to
issued fines of $165,200 in 1996 and $1.5 ber 1
million
vem
separate incidents of the unauthorized sale and distribution of a registered
n No
ed o
pesticide. The latter fine archiv to the unauthorized release of Bt10 corn,
66 related
64
15-1
as we have previously discussed. Other enforcement options available to
No.
aui,
EPAty of M
include calling for the destruction of products, as it did with Bt10
un
. Co
ay v corn, or stopping the sale of a product, as it did in the case of Event 32
in At
cited
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

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growing season and two additional inspections postharvest 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
2 16
that they meet applicable regulatory standards. 0
r 14, Following that
mbe
announcement, USDA, EPA, and n Novepublished notices concerning their
o FDA
ived
responsibilities regarding rfield trials and the low-level presence of
a ch
6466
regulated GENo. 15-1 Specifically:
material.
,

in
cited

i
Mau
y of
ount
• v. C
Atay 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.

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•

Routine Interagency
Coordination of cited in Atay
Programs Occurs, but
Opportunities Exist
for Further
Coordination among
the Agencies

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.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
2016
r 14,
submissions.
mbe
ove

on N
ived
arch
6466
15-1
No. FDA have organizational structures and mechanisms in
i
USDA, EPA,, and
Mau
y of
place to coordinate their oversight and regulation of biotechnology, but
ount
v. C

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.

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.

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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.6 Seven of these practices are as
follows:

•

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.

•

Defining and Articulating a
Common Outcome

Defining and articulating a common outcome.

•

in
cited

•

Reinforcing agency accountability for collaborative efforts through agency
2016
r 14,
plans and reports.
mbe
ove

on N
ived
arch
• Developing mechanisms to monitor, evaluate, and report on the results.
6466
15-1
No.
i,
Mau
y of
Wenevaluated the degree of coordination and collaboration among USDA,
ou t
v. C
Atay

EPA, and FDA in their oversight of GE crops according to each of these
practices.

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

6
See 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.

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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.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
2016
lead agency. When incidents of unauthorized4release have occurred, the
r1 ,
mbe
three federal agencies have taken actions related to their roles and
Nove
d on
hive and environmental safety. For example,
responsibilities to protectrc
a health
6466
after the most o. 15-1 unauthorized release, which involved a regulated GE
recent
i, N
Mau
cornyknown as Event 32, USDA issued emergency action notifications for
t of
n
Cou
y v. the unauthorized movement of a regulated article, and EPA issued a “Stop
n Ata
i
cited
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

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.

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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.
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
2016
with a list of herbicide-tolerant plants being1field tested each year to
r 4,
mbe
ensure that EPA is aware of forthcoming products, and to provide EPA
Nove
d on
hive receives from persons seeking
with a copy of petitions USDA
arc
6466
nonregulatedNo. 15-1 for herbicide-tolerant crops. USDA also agreed to ask
status
aui,
eachyapplicant to submit a voluntary stewardship plan for the management
of M
ount
v. C
Atay of pest-resistance and weedy volunteer crops in herbicide-tolerant crop
ed in
cit
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.

Identifying and Addressing
Needs by Leveraging Resources

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

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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 dayto-day implementation of regulations with an opportunity to discuss
emerging issues. These groups are as follows:
16

20
The Interagency Agricultural Biotechnology ,Working Group. This
r 14
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working group, cochaired by OSTP and the National Economic Council,
Nove
d on
hive a forum for senior-level officials in relevant
was formed in 2001 to6provide
arc
4 6
executive branch 5-16
. 1 agencies—USDA, EPA, and FDA, the Office of
i, No
Mau
Management and Budget, and the U.S. Trade Representative—to address
ty of
n
8
Cou
y v. agricultural biotechnology policy. According to OSTP, the Biotechnology
n Ata
i
Working Group meets once a month or once every 2 months, as needed.
cited
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

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.

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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.
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
016
assistance and training to help countries adopt2U.S. approaches to
r 14,
mbe countries improve their
agricultural trade policy and helping ve
Noforeign
d on
hive
regulatory structure for adopting biotechnology and agricultural
rc
66 a
biotechnologyo. 15-164 To measure its progress, USDA set a target of
products.
N
Ma countries make improvements to their trade policy and
helpingf 15 ui,
ty o
n
Cou
y v. regulatory framework by 2010. Similarly, as part of its yearly report to
n Ata
i
stakeholders, FDA’s Center for Food Safety and Applied Nutrition
cited
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.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.

Reinforcing Agency
Accountability for
Collaborative Efforts through
Agency Plans and Reports

9

Codex Alimentarius sets international food safety standards.

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

ay
in At
cited

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.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
16
EPA’s oversight of GE pesticides on a number 20 occasions. The FIFRA
r 14, of
mbe
Scientific Advisory Panel, for example, played an important role in
Nove
d on
hive
evaluating the health riskscassociated with the GE pesticide in StarLink
6 ar
1646
corn.
. 15, No

i
Mau
y of
ount
v. C
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.”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

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.

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stakeholders to establish monitoring criteria. Similarly, in 2006, the
National Science and Technology Council12 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.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
2 16
Bt is that Bt could lose its effectiveness against 0
r 14, insect pests. As a condition
mbe
of registering a Bt pesticide with n Noveregistrants must require that users
o EPA,
i ed
of the product follow certainvinsect-resistance management techniques,
arch
6466
15 1
including planting -“refuges” with non-Bt crops.14 Registrants determine
No.
ui,
whetherMa
y of these requirements are met through surveys of farmers. However,
ount
v. C
Atay some stakeholders with whom we spoke raised doubts about the
ed in
cit
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

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.

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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.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,
16
the agency with the most comprehensive er 14, 20 regarding GE crops,
authority
mb
has no systematic program of postmarket oversight. Once GE crops are
Nove
d on
hive
rc
deregulated, they are notasubject to regulatory control under the Plant
6466
15-1
Protection Act, .unless USDA finds them to be a plant pest or noxious
o
ui, N
weed onMa basis of new data or analysis. EPA places conditions on the
ty of the
n
Cou
y v. use of marketed GE pesticides, but its oversight is largely limited to the
n Ata
i
cited
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.16 In their view, such

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, GAO-02-566 (Washington, D.C.: May 23,
2002).

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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 longterm 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 on6a larger scale for
01
commercialization, increasing the potential 14, 2gene transfer to other
r for
mbe
crops and possible entry into the n Noveand feed supply. This prospect
food
ed o
suggests that some form archiv
of limited, directed monitoring of the food supply
6466
1 -1
may be needed .to5ensure that these compounds are not present.
No
,

y
n Ata

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

i
Mau
y of
ount
v. C

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

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to biotechnology. Meanwhile, six of the officials with whom we spoke did
not have an opinion on the adequacy of the Coordinated Framework.

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
2016
proposed changes in the DEIS related tobUSDA’s consideration of food
r 14,
m e
safety and public health concerns, Nove some stakeholders have
n and
ed o
commented that USDA6did hiv clearly state how it would coordinate
arc not
646
15-1
human health assessments with FDA and EPA. USDA is also seeking
No.
ui,
funding Ma implement a voluntary quality management system designed to
y of to
ount
v. C
Atay improve industry compliance with its field trial regulations. In addition,
ed in
cit
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.

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

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.)

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in
cited

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.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
16
rulemaking process could represent the ber 14,extensive overhaul to the
most 20
m
ove
regulations since USDA originally implemented them in 1987. We selected
on N
ved
hiby the DEIS that we believe are particularly
4 of the 10 issues addressed
6 arc
1646
relevant to incidents of the unauthorized release of GE crops and analyzed
. 15i, No
Mau
thencomments USDA received. While USDA has requested comments on
ty of
u
18
v. Co
Atay the proposed rule, we were not able to review them for this report.

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

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.

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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
016
information is available. Under the proposal,4if2adopted, USDA would
r1 ,
mbe
encourage GE plant developers on Nove
to consult the agency if they are uncertain
ived
whether a GE plant wouldcbe subject to regulation.
ar h
66

ay
in At
cited

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

64
15-1
No.
aui,
fM
At theosame time that USDA assessed the impact of expanding the reach of
unty
. Co regulatory oversight, it also assessed the impact of excluding certain
v its

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.
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

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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
2016
types of permits for interstate movement,eimportation, and environmental
r 14,
mb
release. The permits for environmental release of GE plants would be
Nove
d on
hive
sorted into one of four 6 arc
6 categories on the basis of risk.

Issue 4: Regulation of Crops
Producing Pharmaceutical in Atay
and
cited
Industrial Compounds

64
15-1
No.
aui,
fM
USDAoalso assessed in its DEIS several alternatives for modifying its
unty
. Co
v 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 insecttolerant 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

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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
16
environmental release of GE plants that ber 14, 20 pharmaceutical or
produce
m
ve
industrial compounds, includingoGEoplants that are normally food crops.
nN

Issue 7: Allowance for LowLevel Presence of Regulated
GE Material in Crops, Food, Atay
in
cited
Feed, or Seed

ed
rchiv
66 a
4
5-16
Under this issue,1USDA’s DEIS evaluated alternatives that would establish
No.
aui,
criteriaf for determining that an unauthorized release of a low level of
o M
unty
. Co
v 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.

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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.

in
cited

USDA’s October 2008 proposed amendment to its regulations is generally
consistent with the preliminary preferred alternative in the DEIS. USDA
16
proposes to investigate each incident of ber 14, 20 presence individually
low level
m
before making a decision on what, Nove remedial action is needed. USDA
on if any,
ived
would use specific criteriacenumerated in the proposed regulations to rate
ar h
466
5- 6
the risk involved1in1the incident. However, those criteria would not fully
No.
i,
Mau
determine the agency’s response; USDA would evaluate other relevant
y of
ount
v. C
Atay 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

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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
16
4, 20
engineered to produce pharmaceutical mber 1
and industrial compounds,
ove
including one alternative thated on N use evaluations of food safety to
would
hiv
6 arc
determine the appropriate confinement measures, and another alternative
1646
. 15- that food safety concerns be addressed prior to the use
that wouldurequire
i, No
Ma
y of
ofua tfood or feed crop for the production of such compounds. However,
n
Co
y v. USDA did not describe the role that FDA or EPA, the agencies that have
n Ata
i
cited
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.

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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
2016
the public health. If so, USDA would contact4FDA. The decision to regulate
r1 ,
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food and feed from the GE organism ve
No would be FDA’s. USDA also stated
d on
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that it would take into6account
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64 6
evaluating GE o. 15-1
organisms.
,N

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

i
Mau
y of
ount
v. C

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.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

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.

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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
2016
coexistence among different agriculturalbproduction systems, including
r 14,
m e
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the production of GE, conventional,oand organic crops.
on N

USDA Has Identified
Lessons Learned from theay
in At
cited
LLRICE Incidents That
Could Improve Oversight

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66 a
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No.
aui,
In October 2007, USDA issued a compilation of proposed changes
of M
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. Co
v 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.”

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EPA Has Proposed
Amending Its Regulations
for GE Pesticides

ay
in At
cited

EPA is considering amending its regulations governing GE pesticides. In
April 2007, EPA proposed two related rules intended to create a more riskbased system for regulating a certain type of GE pesticide known as a
plant virus coat protein (PVCP).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 selfdetermine 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
016
other than virus coat proteins, as well asbthose2that favored limiting the
r 14,
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exemption to certain types of PVCP ove pesticides. On the other hand,
n N GE
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some comments from 66 archiv
food industry and safety organizations expressed
164
concern aboutoEPA’s proposed exemptions, citing scientific uncertainty.
. 15,N

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y of
ount
v. C
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,

20

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

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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
ay
in At
cited

Conclusions

2016
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ve
In 2001, FDA proposed a rule that would require companies to notify the
n No
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hivcrops as food or feed products to
rc
agency before marketingaGE
6466
complement No. voluntary consultations. Among the reasons that FDA
its 15-1
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citedyforMa
of proposing this change were concerns expressed by consumers
ount
v. C
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.

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

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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
2016
r 14,
m e
OSTP’s 2002 policy document to addressbfield trials of GE crops, a lack of
Nove
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coordination of key informationoamong the agencies may prevent them
hive
6 arc
from making the most6effective use of their resources. Specifically, the
164
. 15No
agencies doi,not have a formal mechanism for sharing information that
Mau
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could enhance their oversight of GE crops in the field trial stage that
Cou
y v. contain new proteins and that, if released into the food supply, could
n Ata
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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

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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

ay
in At
cited

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.
6

201
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To reduce the risk and impact of n Nove
o unauthorized releases, we recommend
ived
that the Secretary of Agriculture and the FDA Commissioner develop a
arch
6466
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formal agreement5to share information concerning GE crops with novel
No.
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geneticf traits that, if unintentionally released into the food or feed supply,
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ount
v. C
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

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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
16
every effort to fulfill its commitment to post 4, 20results of completed early
r 1 the
mbe
food safety evaluations on its Web Nove and add the results of future
on site
ved
evaluations within 1206days iof receiving the submission from the plant
arch
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15-1
developer. However, FDA also said that activities of greater public health
No.
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priority Ma been the focus of its limited resources. While acknowledging
y of have
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v. C
Atay these priority and resource considerations, we continue to believe that
ed in
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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

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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
016
monitoring only regulated crops, and only rfor,plant pest risks. We note
14 2
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that USDA maintains authority underve Plant Protection Act to regulate
No the
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hive
GE crops that it previously deregulated if it obtains new information
arc
6466
indicating the crop 1 a plant pest. We also note that USDA has authority
. 15- is
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under of MaPlant Protection Act to regulate GE crops as noxious weeds, if
ty the
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y v. warranted. Finally, in light of known unauthorized releases that led to
n Ata
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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 postmarket 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

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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
2016
complex in response to pressures to increase ,yields for food and biofuel,
r 14
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we stand by our recommendation thatethe agencies should develop a
Nov
d on
hive
coordinated strategy for arc
66 risk-based monitoring of marketed GE crops.
64
15-1
No.
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cited

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in At

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 http://www.gao.gov.

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If you or your staffs have any questions about this report, please contact me
at [phone] or [e-mail]. 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.

Lisa Shames
Director, Natural Resources
and Environment

cited

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Appendix I: Objectives, Scope, and
Methodology

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
016
documentation from relevant federal agencies,2including the U.S.
r 14,
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Department of Agriculture (USDA); ove
on N Environmental Protection Agency
ived
(EPA); Food and Drug6Administration (FDA), and Office of Science and
arch
64 6
15 (OSTP) which is within the Executive Office of the
Technology ,Policy-1
No.
i
Mau
President, as well as from agriculture and food industry and consumer
y of
ount
v. C
Atay organizations. Industry organizations included the American Farm Bureau
ed in
cit
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

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Appendix I: Objectives, Scope, and
Methodology

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.
6

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in At
cited

201
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To determine the degree of coordination among agencies that regulate
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GE crops, we reviewed6the Coordinated Framework’s guidance for
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1646
interagency ,coordination. We then discussed with agency officials their
. 15i No
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implementation of this guidance and reviewed documents that they
ty of
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v. Co
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.1 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.

1

GAO, Results-Oriented Government: Practices That Can Help Sustain Collaboration
among Federal Agencies, GAO-06-15 (Washington, D.C.: Oct. 21, 2005).

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Appendix I: Objectives, Scope, and
Methodology

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:
•

in
cited

16

4, Movement, and Release
USDA, Proposed Rule: Importation, Interstate20
ber 1
ovem
Into the Environment of CertainnGenetically Engineered Organisms,
N
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73 Fed. Reg. 60,008 (Oct.a9,h2008).
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6

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15-1
No.
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• USDA, fIntroduction of Genetically Engineered Organisms, Draft
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ount
Programmatic Environmental Impact Statement, (July 17, 2007).
v. C
Atay
•

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

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Appendix I: Objectives, Scope, and
Methodology

the proposed rule or interview agency or other stakeholder officials about
its contents.

in
cited

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
2016
statement. The coding scheme included aemeans of indicating when a
r 14,
mb
stakeholder’s preference was notnapparent on the basis of the written
Nove
do
hive
comments. To ensure 66 arcdecisions about how to code the comments
that
64
15-1
were reliable, a. second GAO analyst also reviewed the comments. We used
i, No
M u
thensame a
ty of technique to code a random sample of 51 of the 265 comments
u
v. Co
Atay 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

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Appendix I: Objectives, Scope, and
Methodology

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.

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

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.

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

See comment 1.

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See comment 2.

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

See comment 3.

See comment 3.

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See comment 4.

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

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

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, 2016agency’s regulations
the
14,
could be grounded in more thanovember authority to regulate GE crops
just its
N
as plant pests. The Plantived on
Protection Act gives the Secretary of
arch
Agriculture the 16466
authority to regulate to prevent the introduction or
15No. of noxious weeds. Noxious weeds are defined as any
dissemination
i,
Mau
ty of
ounplant or plant product that can injure or cause damage to, among other
v. C
things, crops, livestock, interests of agriculture, public health, or the
Atay
ed in
cit
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.

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

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.

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

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See comment 1.

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

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See comment 2.

See comment 3.

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

See comment 4.

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

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

GAO Comments

v.
Atay
ed in
cit

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 present2only perceived health
016
14,
concerns. In light of this comment, mbewell as USDA’s similar
as r
Nove
comment, we modified hivedwording of the recommendation to
the on
rc
emphasize that 16466 a
the agencies develop a formal agreement to share
15
. on- GE crops that present or are likely to present public
information
i, No
Mau
ty of
n
Cou 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

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

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 to2control and there may be
016
r 14,
an increasing use of GE crops to produce an even wider array of
mbe
Nove
pharmaceutical and industrial compounds in the future, we continue to
d on
hive
believe that FDA 466 athe other agencies should develop a risk-based
and rc
16
. 15coordinated strategy to monitor for their unintentional release.
i, No
Mau
Furthermore, in the United States (1) GE crop varieties are grown
ty of
n
Cou
y v.
extensively, (2) most processed foods contain ingredients from GE
n Ata
i
cited
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.

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

Appendix IV: U.S. Legal Framework for
Regulation of GE Crops
On June 26, 1986, OSTP published the Coordinated Framework in the
Federal Register.1 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
16
biotechnology. Table 4 contains summaries14, 20 provisions in the
r of key
mbe
primary laws that the agencies haveoused to regulate GE crops as well as a
N ve
d on
hive
brief explanation of their rc
6 arelevance to biotechnology. Three of these
1646
laws—administered by USDA, EPA, FDA, or a combination of these
. 15i, No
Mau
agencies—include the Plant Protection Act; the Federal Insecticide,
ty of
n
Cou
y v. Fungicide, and Rodenticide Act; and the Federal Food, Drug, and
n Ata
i
cited
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.

1

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).

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

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

Major relevant provisions

a

Legislation: Plant Protection Act

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.

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
20 if6
organism, noxious weed, article, or means of conveyance 1 he or she determines it is
r 14,
As described in this report, USDA is
necessary to prevent the introduction or dissemination of a plant pest or noxious weed.
mbe
considering changes to its regulations that Such regulations could include requiring permits or certificates of inspection. Authorizes
Nove
d on
would also recognize the agency’s authority the Secretary to publish, by regulation, a list of noxious weeds prohibited or restricted
hive
6 arc
to regulate GE plants as noxious weeds.
1646
from entering the United States or that are subject to restrictions in interstate movement.
. 15i, No
M u
Authorizes a Secretary to, among other things, hold, seize, quarantine, or destroy any
ty of the
n
Cou
y v. 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
n Ata
i
cited
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.

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Appendix IV: U.S. Legal Framework for
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General application to GE organisms

Major relevant provisions
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,6or noxious weed within the
201
r 14,
United States.
mbe
Nove
Legislation: Federal Insecticide, Fungicide, and Rodenticide Actb
d on
hive
arc
Unless otherwise authorized by the act, prohibits the selling in any state of any pesticide
With respect to genetically engineered
6466
15-1
.registered under the act, and authorizes the Administrator of the
that has not ui, No
been
organisms, EPA regulates the pesticides
Ma
Environmental Protection Agency to limit, by regulation, the distribution, sale, or use in
produced in plants, as well as the genetic
ty of
n
any
material that produces such pesticides. y v. Cou state of any pesticide that is not registered under the act or is not subject to an
n Ata
experimental use permit or an emergency exemption. Establishes procedures to register
These pesticides are known as ed i
“plantcit
a pesticide with EPA. Directs the Administrator to publish guidelines specifying the kinds
incorporated protectants.” The statutory
of information required to support the registration of a pesticide. Establishes time frames
and regulatory requirements that apply to
and procedures for the Administrator to review and approve of registration applications.
pesticides in general—such as those
concerning registration, labeling,
Permits any person to apply to the Administrator for experimental use permits for
experimental use permits, inspections, and pesticides. Directs the Administrator to review those applications and either approve the
enforcement—also apply to plantpermit or notify the applicant of the reasons for not issuing a permit. Limits experimental
incorporated protectants produced in GE
use permits to when the Administrator determines that the applicant needs such a permit
crops.
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.

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

General application to GE organisms

Major relevant provisions
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 the2Administrator in any state and
016
r 14,
there is reason to believe—on the basis of inspections or tests—that the pesticide is in
mbe
e
violation of the act, or intended to be soldNovdistributed in violation of the act. States that
on or
unsold pesticides (or pesticides hivunbroken packages) being or having been
in ed
arc
transported, or sold or16466 for sale in any state in violation of the act, shall be liable
offered
. 15- court in a district where found if, among other things, the
for seizure in iany district
No
au ,
pesticideM misbranded or adulterated or is not registered under the act. The act also
ty of is
n
Cou
y v. establishes civil and criminal penalties associated with violations of the act.
n Ata
i
Authorizes the Administrator to exempt federal and state agencies from the provisions of
cited
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.

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

General application to GE organisms

Major relevant provisions
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 amendedc
All domestic and imported foods and feeds 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
under FDA’s jurisdiction, whether or not
they are derived from GE crops, must meet properly labeled.
016
the same standards. Any food additive,
14, 2
Defines “food” as articles used for food or drink forrman or other animals, chewing gum,
mbe
including any introduced through genetic
and articles used for components of any such articles. Defines “food additive” as any
Nove
engineering, cannot be marketed before it substance the intended use of which results or may reasonably be expected to result,
d on
hive
arc
receives FDA approval. However,
directly or indirectly, in1its 66
64becoming a component or otherwise affecting the
substances added to foods that are
. 15characteristici,of any food, if such substance is not “generally recognized as safe,” as
No
“generally recognized as safe” under the
Mau
described in the act and implementing regulations, under the conditions of its intended
ty of
conditions of intended use do not require Coun However, pesticide chemicals and pesticide chemical residues, among other things,
. use.
FDA approval to be lawfully marketed. tIn v are not considered food additives.
A ay
ed in
1992, FDA determined that most
cit
substances likely to become components of 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
food as a result of genetic engineering
would be the same or similar to substances misbranded food. Gives U.S. district courts jurisdiction to, among other things, enjoin
commonly found in food. FDA encourages violations of the prohibitions, or to seize adulterated or misbranded food in interstate
developers of GE foods to voluntarily notify commerce. Provides criminal penalties for violations of these prohibitions. Authorizes
FDA to temporarily detain food when there is credible evidence or information indicating
the agency before marketing the foods.
Notification leads to a consultation process that such article presents a threat of serious adverse health consequences or death.
between the agency and the company
Deems a food to be “adulterated” when, among other things, the food bears or contains
regarding the safety of the food in question. 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.

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

General application to GE organisms

Major relevant provisions
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),2for6 purposes of enforcement
01 the
r 14,
and upon written notice, to enter any factory, warehouse or establishment in which food
mbe
is manufactured, processed, packed, or held e introduction in interstate commerce or
Nov for
d on
after such introduction, or to entervany vehicle being used to transport or hold such food
hi e
arc
in interstate commerce.6466
1 Authorizes the Secretary (delegated to FDA), for the purposes of
. 15- written notice, to inspect, at reasonable times, and within
enforcement andoupon
i, N
Mau
reasonable limits, and in a reasonable manner, any factory, warehouse, establishment,
ty of
n
Cou
y v. or vehicle and all pertinent equipment, finished and unfinished materials, containers, and
n Ata
i
labeling therein.
cited
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 1969d
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.

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.

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

a

Pub. L. No. 106-224, Tit. IV, §§ 401-442, 114 Stat. 438 (codified as amended at 7 U.S.C. §§ 77017786).
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).

cited

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

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.
16
4, 20
Figure 3: Annual Number of Notifications and Permits Approved by USDA, 1987 through er 1
mb 2007
Nove
d on
hive
Total number of field trial notifications and permits
6 arc
1646
1,200
. 151,128 1,141
i, No
Mau
1,085
ty of
n
Cou
984
y v.
1,000
937
n Ata
i
cited

960
891

898

902

2005

2006

2007

816

800

742
684
626

594

600

400
306

200
106

0

9

18

38

1987

1988

1989

1990

150

57
1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

Year
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.

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

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

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
Total number of approved field trials
5,000
4,427

4,500
4,000

3,774

3,500
3,137
3,000
2,500
1,880

2,000
1,500
1,000

1,298
956

847

805

500

139

44
Ne
res mat
ist ode
an
ce a

Ba
res cter
ist ial
an
ce

res Fung
ist al
an
ce

Ma
rke
ge r
ne

r
he
Ot

res Vir
ist us
an
ce

Ag
ro
pro nom
pe ic
rti
es

Pr
od
qu uct
ali
ty

res Inse
ist ct
an
ce

0
He
r
tol bicid
era e
nc
e

ay
in At
cited

unty
v. Co

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Genetic characteristic
Source: Virginia Tech’s Information Systems for Biotechnology.
a

Nematodes are wormlike organisms.

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Appendix VI: Information on the
Commercialization of GE Crops

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
ay
in At
cited

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

2016
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o
Within USDA, APHIS bears the main ve
on N responsibility for assessing the
ived
hcrops. The primary focus of this agency’s
environmental safety of GE
6 arc
1646
review is to ,determine whether a plant produced through biotechnology is
. 15i No
Mau
a plant fpest. Developers can petition the agency to exempt a GE plant
ty o
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v. Co
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 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,

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Appendix VI: Information on the
Commercialization of GE Crops

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.1 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 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.2 In this context, FDA
encourages companies developing GE foods to voluntarily notify the
2 16
agency before marketing the foods. Notification0leads to a two-part
r 14,
mbe
consultation process between the agency and the company that initially
Nove
d on
hive safety issues, and subsequently involves
involves discussions of6relevant
arc
1646
the company’sosubmission of a safety assessment report containing a
. 15i, N
M u
summary a test data on the food in question.3 The purpose of these test
ty of of
n
Cou
y v. data is to demonstrate that the GE food item presents no greater risk of
n Ata
i
cited
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

FDA’s Voluntary
Consultation Process
for GE Food and Feed
Crops

1
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.
2

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.

3

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.

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Appendix VI: Information on the
Commercialization of GE Crops

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.4

Many GE Crops Have
Been Marketed for a
Variety of Purposes

ay
in At
cited

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
16
2008. Furthermore, according to food industry 20
r 14, sources, over 70 percent of
mbe
the processed foods sold in the United States contain ingredients and oils
Nove
d on
hive
rc
from GE crops.
66 a

64
15-1
No.
aui,
However, not all GE crops have been marketed in the United States, and
of M
unty
. Co
v 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.

4

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.

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Appendix VI: Information on the
Commercialization of GE Crops

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

GE crop/
Institution

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
named
Statesc

All uses

Environment

United
States,
Australia,
Canada,
European
Union

Japan

United
States,
Canada

Australia,
Japan

Plantinge Food

Feed

Canola

Aventis

Last sold in 2003

MS1&RF1
MS1&RF2
(PGS1)

SeedLink
Canola

Trait: HT+F

Aventis

d

Topas 19/2
Last sold in 2003
(HCN92, HCN10)
Trait: HT

AgrEvo

MS8xRF3

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T45
(HCN28)

PCGN 3828212/86–18
PCGN 3828212/86–23
(23-18-17, 23198)

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United
States,
Australia,
Canada,
Japan

European
Union, South
Korea

Last sold in 2005

LibertyLink®
Canola

United
States,
Australia,
Canada

Japan, South
Korea

PCGN 3828-21286-23 (last sold in
1998)

Laurical

Westar
Roundup
Ready®

United
States

Australia,
China,
European
Union,
Japan,
Mexico, New
Zealand
(HCN92),
South Africa,
South Korea

China,
European
Union,
Japan,
South Africa

China,
European
Union,
Mexico, New
Zealand,
South Africa,
South Korea
China,
European
Union,
Japan,
Mexico, New
Zealand,
South Korea

China,
European
Union,
Mexico,
South Africa

Canada,
Japan

Japan

United
States,
Canada

Trait: HT

Calgene

Australia

d

Yes
cited

Trait: HT+F

AgrEvo

China,
China,
Japan, New Japan,
Zealand,
South Africa
South Africa,
South Korea

China,
European
Union,
Japan

No: PCGN 3828212-86-18

Trait: OC
Monsanto

GT200 (RT200)

No

Trait: HT

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Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution
Monsanto

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named
GT73
RT73

Roundup
Ready
Canola®

Trait: HT

or

Environment

Plantinge Food

Feed

United
States,
Canada,
Japan

Australia,
European
Union, South
Korea

Australia

China,
European
Union,
Mexico,
Philippines

United
States

Yes

All uses

European
Union

European
Union

Westar
Roundup
Ready®

Australia,
China,
European
Union,
Mexico, New
Zealand,
Philippines,
South Korea

Chicory
Bejo

c

RM3-3
RM3-4
RM3-6
Trait: HT+F

Cotton
Aventis

LLCotton25

ed

LibertyLink
United chiv
ar
466
Cotton
-16States
15

Yes

Trait: HT

cited
Calgene

31807/31808

unty
. Co
ay v
in At

BXN

281-24-236

United
States

Japan

Canada,
Japan

c

United
States

Japan

Australia,
Australia,
Canada,
Canada,
Japan,
Japan
Mexico, New
Zealand

No

United
States

Canada,
Mexico

Canada

No

United
States

Canada,
Japan,
Mexico

Canada,
Mexico

No

United
States

Trait: IR
Mycogen/Dow

3006-210-23
Trait: IR

DuPont

19-51A

Canada,
Australia,
Japan,
Canada,
Mexico
Japan,
Mexico, New
Zealand,
South Korea

c

Trait: HT

Mycogen/Dow

South Korea

o.
ui, N
f Ma
o

Trait: HT+IR
Calgene

2016
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Trait: HT

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Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution
Monsanto

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named
MON1445
MON1698

Yes: MON1445

Roundup
Ready®

No: MON1698

Trait: HT

All uses

Plantinge Food

Feed

Australia,
Mexico,
South
Africa

Australia,
Canada,
China,
European
Union
(MON1445),
Japan,
Mexico, New
Zealand,
Philippines

Canada,
China,
European
Union
(MON1445),
Japan,
Philippines

Australia, South Australia
Korea

Australia,
Canada,
European
Union,
Japan,
Mexico, New
Zealand,
Philippines,
South Korea

Canada,
European
Union,
Japan,
Philippines

Canada,
European
Union
(MON531),
Japan,
Philippines
(MON531)

Environment

United
States,
Argentina

Australia
(MON1445),
Japan, Mexico,
(MON1445), South Africa
Columbia
(MON1445)

Monsanto

MON15985

Yes

Bollgard II®

Trait: IR

Monsanto

MON531
MON757
MON1076
Trait: IR

Monsanto

MON88913

unty

Co
Yes: MON531
y v.

United
States,
India,
South
Africa

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Bollgard®

United
States,
Argentina
(MON531),
Australia
(MON531),
Brazil,
China,
Colombia
(MON531),
India
(MON531),
Mexico,
South
Africa
(MON531)

Indonesia,
Japan, South
Korea
(MON531)

Indonesia Canada,
European
Union
(MON531),
Japan, New
Zealand,
Philippines
(MON531),
South Korea
(MON531)

Roundup
Ready® Flex

a
in At

United
States,
South
Africa

Australia

Australia

cited No: MON1076
c

MON757

Yes

Trait: HT

Page 81

Canada,
Australia,
Japan,
Canada,
Philippines
Japan,
Mexico, New
Zealand,
Philippines,
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South Korea

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Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution
Syngenta
Seeds

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named
COT102

All uses

Environment

Plantinge Food

c

United
States,
Australia,
New
Zealand

Trait: IR

Feed
United
States

Flax, Linseed
University of
Saskatchewan

FP967

c

CDC Triffid

Last sold in 2000

StarLink

Trait: HT

United
States,
Canada

Maize (corn)
AgrEvo

CBH-351

United States

Trait: HT+IR
Plant Genetic
Systems

MS3

AgrEvo

MS6

AgrEvo

T14
T25

United
States

4, 2
ber 1

m
United
Nove
d on
States, hive
arc
466
6Canada

c

Trait: HT+F

Trait: HT+F

United
States
016

c

unty
. Co
ay v
in At

15-1
No.
United
aui,
of M

Yes: T25
cited

States

Liberty
Link™

United
States,
Argentina,
Canada,
European
Union
(T25),
Japan
(T25)

Trait: HT

T14: Last sold in
1999

Dekalb
Genetics
Corporation

B16 (DLL25)

Last sold in 1999

d

United
States,
Canada,
Japan

Dekalb
Genetics
Corporation

DBT418

Last sold in 1999

Bt Xtra™

United
States,
Canada

Trait: HT

Trait: HT+IR

Page 82

Argentina,
Japan

Australia
(T25), China
(T25), Japan
(T14),
Mexico, New
Zealand
(T25),
Philippines
(T25),
Russia
(T25), South
Korea (T25),
Taiwan
(T25)

Australia
(T25), China
(T25), Japan
(T14),
Mexico,
Philippines
(T25),
Taiwan
(T25)

Philippines,
South
Korea,
Taiwan

Philippines,
Taiwan

Australia,
Japan, New
Zealand,
Philippines,
South
Korea,
Taiwan

Japan (T14),
South Korea
(T25)

Japan,
Philippines,
Taiwan

GAO-09-60 Genetically Engineered Crops

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Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution
Dow
AgroSciences
LLC

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named
DAS-06275-8

No

All uses

Environment

Plantinge Food

(TC6275)

Feed

Japan

United
States,
Canada

Trait: IR
59122 (DAS59122-7, Event
22)

Monsanto

GA21

Yes

Herculex®
RW

Yes

Dow
AgroSciences
LLC/Pioneer
Hi-Bred
International
Inc.

Roundup
Ready®

Trait: HT+IR

Monsanto

LY038

MON80100

c

United
States,
Canada

c

MON802

MON810

Japan

Japan

c

Yieldgard®

United
States,
Canada

Yes

Yieldgard®

Colombia,
United
South Korea
States,
Argentina,
Canada,
European
Union,
Honduras,
Japan,
Philippines,
South
Africa,
Uruguay

Trait: HT+IR
Monsanto

Australia,
European
Union,
Mexico, New
Zealand,
Philippines,
South
Korea,
Taiwan

European
Union,
Mexico,
Philippines,
Taiwan

Australia,
China,
European
Union,
Mexico, New
Zealand,
Philippines,
Russia,
South Africa,
South
Korea,
Taiwan

China,
European
Union,
Philippines,
Russia,
South Africa,
Taiwan

Australia,
Japan,
Mexico,
Philippines

Australia,
Philippines

Australia,
China,
Colombia,
Mexico, New
Zealand,
Russia,
South
Korea,
Switzerland,
Taiwan

China,
Colombia,
Russia,
Switzerland,
Taiwan

United
States

Trait: IR
Monsanto

016

i
Mau
y of
ount
v. C

Trait: LYS

Monsanto

European
Union

United
South Korea er 14, 2
mb
States,
Nove
d on
Argentina, e
rchiv
Canada,
66 a
-164
. 15 Japan
, No

Trait: HT

ay
in At
cited

United
States,
Canada,
Japan

Trait: IR

Page 83

Japan

GAO-09-60 Genetically Engineered Crops

Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 108 of 150
Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution
Monsanto

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named

Environment

Yes

United
States,
Canada,
Japan

d

United
States,
Canada

Japan

Trait: IR

Monsanto

MON88017
Trait: HT+IR

Monsanto

MON89034

cited

unty
. Co
ay v
c
in At

ed
rchiv
66 a
64
15-1
No.
aui,
of M
United
States

Trait: HT+IR
Monsanto

NK603

Australia,
China,
European
Union,
Mexico, New
Zealand,
Philippines,
Russia,
Singapore,
South
Korea,
Taiwan
Japan

2016
r 14,
mbe
ove
on N

Canada, Japan

Feed
China,
European
Union,
Philippines,
Russia,
Singapore,
Taiwan

Australia,
Mexico,
Japan,
Philippines,
Mexico, New Taiwan
Zealand,
Philippines,
South
Korea,
Taiwan
Japan

Canada,
Japan

Yes

Roundup
Ready®

United
South Korea,
States,
Uruguay
Argentina,
Canada,
Japan,
Philippines,
South
Africa

Uruguay

Australia,
China,
Colombia,
European
Union,
Mexico, New
Zealand,
Russia,
Singapore,
South
Korea,
Taiwan,
Thailand

China,
Colombia,
European
Union,
Russia,
Singapore,
Taiwan,
Thailand

Yes

Herculex® I

United
States,
Argentina,
Canada,
Japan

Uruguay

Australia,
China,
Colombia,
European
Union,
Mexico, New
Zealand,
South
Korea,
Philippines,
South Africa,
Taiwan

China,
Colombia,
European
Union,
Philippines,
South Africa,
Taiwan

Trait: HT

Mycogen (Dow 1507
AgroSciences); (TC1507)
Pioneer
Trait: HT+IR
(Dupont)

Plantinge Food

South Korea

Yes

MON863

All uses

d

Page 84

Colombia,
Uruguay

GAO-09-60 Genetically Engineered Crops

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Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution
Pioneer HiBred
International
Inc.

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named
676

All uses

No

United
States,
Canada

Plantinge Food

Feed

United
States

No

Environment

678
680
Trait: HT+F

Monsanto

MON809
Trait: HT+IR

Northrup King

Bt11

d

Yes

Trait: HT+IR

Syngenta
Seeds

MIR604

Ciba Seeds

176

unty
. Co
ay v
in At

Japan

Japan

United
Japan
States,
Argentina,
Canada,
Philippines,
2016
r 14,
South
mbe
Nove
Africa,
d on
hive
Uruguay
arc

6466
15-1
No.
aui,
of M

cited Yes

Trait: IR

United States,
Japan,
Philippines

Agrisure RW
RootwormProtected
Corn

Yes

NaturGard™
KnockOut™

United
States,
Argentina,
Australia,
Canada,
European
Union

Yes

SunUp,
Rainbow

United
States

(Bt 176)
Trait: HT+IR

Japan

Japan

Australia,
China,
European
Union,
Japan,
Mexico, New
Zealand,
Russia,
South
Korea,
Switzerland,
Taiwan

Australia,
China,
European
Union,
Japan,
Mexico,
Switzerland,
Taiwan

United
Mexico,
States,
Philippines
Australia,
Japan,
Mexico, New
Zealand,
Philippines,
South Korea
China,
Japan, New
Zealand,
Philippines,
South Africa,
South
Korea,
Switzerland,
Taiwan

China,
Japan,
Philippines,
South Africa,
Switzerland,
Taiwan

Papaya
Cornell
University

55-1/63-1
Trait: VR

Page 85

Canada

GAO-09-60 Genetically Engineered Crops

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Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named

All uses

Environment

Plantinge Food

Feed

Plum
USDAAgricultural
Research
Service

ARS-PLMC56(C5)

c

United States

Trait: VR

Potato
Monsanto

BT6
BT10
BT12
BT16
BT17
BT18
BT23

BT6: Last sold in
2001
No: BT10, BT12,
BT16, BT17,
BT18, and BT23

Russet
Burbank
NewLeaf®

Trait: IR
Monsanto

ATBT04-6
ATBT04-27
ATBT04-30
ATBT04-31
ATBT04-36
SPBT02-5
SPBT02-7
Trait: IR

Japan,
Mexico,
Philippines
(BT16)

United
States,
Canada

ed

ATBT04-6: Last
United chiv
Atlantic and
ar
466
sold in 2000
Superior 15-16States,
.
i, No
ATBT04-31: Last
Canada
NewLeaf®
Mau
sold in 2000ounty of
.C
ATBT04-36: Last
ay v
in At
ed sold in 2000
cit
SPBT02-5: Last
sold in 2001
c
SPBT02-7

Mexico,
Philippines
(BT16)

2016
r 14,
mbe
ove
on N

Russia
(SPBT02-5)

Australia,
Australia,
Japan, New Philippines
Zealand,
(SPBT02-5)
Philippines
(SPBT02-5),
Russia
(SPBT02-5),
South Korea
(SPBT02-5)

No: ATBT04-27,
ATBT04-30
Monsanto

RBMT22-082

United
States,
Canada

Australia,
Australia
Japan,
Mexico, New
Zealand

Russet
Burbank
NewLeaf®
Plus

United
States,
Canada

Australia,
Australia,
Philippines
Japan,
Mexico, New
Zealand,
Philippines,
South Korea

NewLeaf® Y

United
States,
Canada

Australia,
Australia,
Mexico,
Japan,
Mexico, New Philippines
Zealand,
Philippines,
South Korea

Last sold in 2000

Trait: IR+VR

Monsanto

RBMT21-350:
Last sold in 2000

Trait: IR+VR

Monsanto

RBMT21-129
RBMT21-350

RBMT21-129:
Last sold in 2000

RBMT15-101
SEMT15-02
SEMT15-15

RBMT15-101:
Last sold in 2001

Trait: IR+VR

SEMT15-15

c

SEMT15-02

c

Page 86

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Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named

All uses

LLRICE06
LLRICE62

United
States

Environment

Plantinge Food

Feed

Rice
AgrEvo

No

Liberty Link®

Canada,
Mexico,
Russia
(LLRICE62)

Canada,
Mexico

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)

Canada
(A2704-12),
European
Union
(A2704-12),
Japan
(A2704-12),
Mexico
(A2704-12,
A2704-21,
A5547-35),
South Africa
(A2704-12)

Japan

Japan,
Mexico,
Russia

Japan,
Mexico

Japan

Australia,
Japan, New
Zealand

Japan

Trait: HT
Bayer
CropScience

LLRICE601

No

United States

Trait: HT

United
States

Soybean
AgrEvo

No

A2704-12
A2704-21
A5547-35

Liberty Link®

United
States
(all 5)

W62
W98
Trait: HT

cited

AgrEvo

A5547-127

unty
. Co
ay v
in At

ed
rchiv
66 a
64
15-1
No.
aui,
of M

No

Liberty Link®

Trait: HT
AgrEvo

GU262
G94-1
G94-19
G168

United
States

No
c

United
States,
Canada

2016
r 14,
mbe
ove
on N

United
States

Trait: HT
DuPont
Canada
Agricultural
Products

Canada
(A2704-12),
Japan
(A2704-12)

Trait: OC

Page 87

GAO-09-60 Genetically Engineered Crops

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Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution
Monsanto

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named
GTS40-3-2

d

Yes

Trait: HT

Monsanto

MON89788

Asgrow (United CZW-3
States);
Trait: VR
Seminis
Vegetable Inc.
(Canada)
Upjohn
(Seminis
Vegetable
Seeds)

ZW20

Environment

United
States,
Argentina,
Brazil,
Canada,
Japan,
Mexico,
Paraguay,
Romania,
Uruguay

2016
r 14,
mbe
ove
on N

d
hive Japan,

o
unty
. Co
ay v
in At
d

cited Yes

Plantinge Food

South Korea

ar
United c
Roundup
6466
Ready 2 o. 15-1 States,
i, N
Canada
Mau
fYield®

No

Trait: HT
Squash

All uses

Philippines,
Taiwan

Feed

Australia,
China,
Czech
Republic,
European
Union,
Malaysia,
New
Zealand,
Philippines,
Russia,
South
Korea,
Switzerland,
Taiwan,
Thailand

China,
Colombia,
Czech
Republic,
European
Union,
Malaysia,
Philippines,
Russia,
Switzerland,
Taiwan,
Thailand

Japan,
Philippines,
Taiwan

Japan,
Philippines,
Taiwan

Trait: VR

Canada

United
States

Canada

United
States,
Canada

d

Yes

United
States

Japan

Japan

United
States,
Canada

Australia,
European
Union,
Mexico, New
Zealand,
Philippines,
Russia,
Singapore,
South Korea

European
Union,
Philippines,
Singapore

Sugarbeet
AgrEvo

T120-7

No

Trait: HT
Monsanto

H7-1

d

Yes

Trait: HT

Page 88

GAO-09-60 Genetically Engineered Crops

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Appendix VI: Information on the
Commercialization of GE Crops

Approved for:

GE crop/
Institution
Novartis
Seeds;
Monsanto

Genetic
transformation, Commercialized
or “event,”a
in the United
Commercial
and traitb
Statesc
named
GTSB77

No

InVigor™

Trait: HT

All uses

Environment

Plantinge Food

United
States

Feed

Australia,
Japan, New
Zealand,
Philippines,
Russia

Australia,
Philippines

Canada,
Japan,
Mexico

Japan,
Mexico

Tobacco
Vector

c

Vector21-41

United States

Trait: NIC

United
States

Tomato
Agritope Inc.

c

351N

United
States

Trait: DR
Calgene

FLAVR SAVR

f

Trait: DR
Calgene

N73 1436-111
Trait: DR

DNA Plant
Technology
Corporation
Monsanto

1345-4
Trait: DR
5345

cited

c

FLAVR
SAVR™

States
No

United
States

8338

No

B, Da, F

c

United
States

Canada,
Mexico

United
States

Trait: DR
Zeneca +
Petoseed

6
, 201

r
Japan, Mexico 14
mbe

Nove
d on
hive
6 arc
1646
. 15- United
Last sold in 1997 FLAVRNo
i,
Mau
States
y ofSAVR™
ount
.C
c
ay v
United
in At

Trait: IR
Monsanto

United
States

Trait: DR

Canada

Canada,
Mexico

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.

r

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

Page 89

GAO-09-60 Genetically Engineered Crops

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

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.

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 6
that, other than its new
01
4, 2same as other
pesticidal protein, StarLink was essentially the
ber 1
v m
commercially available corn varieties.eHowever, EPA granted only a “splitn No
ed o
rchiv
registration” to the pesticidal protein in StarLink corn, thereby allowing
66 a
64
residue of the o. 15-1 in animal feed but not allowing it in the human food
Nprotein
aui,
supply fbecause of concerns that it may be an allergen.1 In 2000, trace
o M
unty
. Co
ay v amounts of StarLink corn were found in commercially available taco
in At
cited
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.

StarLink Corn – 2000

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.

1

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.”

Page 90

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

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 2000/2001.2 (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 shortterm 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
2016
USDA to make additional income supportepayments to producers. In a
r 14,
mb
separate study that compared the change in the price of corn with the
Nove
d on
hive
change in the price of 66substitute good, sorghum, researchers estimated
a arc
64
that the presence5-1 StarLink in the food supply caused a 6.8 percent drop
. 1 of
o
ui, N
in the of Ma of corn, lasting for 1 year.3 However, according to USDA,
ty price
n
Cou
y v. declining corn prices may have been caused by other factors as well, such
n Ata
i
cited
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,

2

T. Schmitz, A. Schmitz, and C. Moss, “The Economic Impact of Starlink Corn,”
Agribusiness, vol. 21, no. 3 (2005).

3

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).

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

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
16
neither the company nor any of its successors 20
r 14, would apply for a GE
mbe
e
notification or permit in the futureNovconduct further field trials.
on to

Bt10 Corn – 2004
cited

ay
in At

ed
rchiv
66 a
64
15-1
No.
aui,
In 2004, M
of Syngenta, a biotechnology developer, notified EPA that
unty
. Co
v company inadvertently had distributed corn seed containing an

the

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.4 FDA also concluded
that the presence of Bt10 corn in the food and feed supply posed no food

4

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.

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

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.
6
ed

201
r 14,
mbe
ove
on N

rchiv
developer, Bayer CropScience
66 a
Liberty Link Rice 601 In July 2006, another 4biotechnology detected regulated genetic material in
-16
(Bayer), informed USDA that it had
. 15
i, No
Mau
and 604 – 2006
a variety of conventional long-grain rice known as Cheniere. USDA
ty of
n
Cou
y v. launched an investigation in August that identified the regulated material
n Ata
i
cited
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.

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

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
2016
United States and the European Union, which, had accounted for as much
r 14
mbe
as 10 percent of U.S. long-grain rice ove
on N exports in recent years.

ay
in At
cited

Event 32 Corn – 2006

ed
rchiv
66 a
-164
Furthermore,Nciting market disruptions caused by the LLRICE incidents,
o. 15
aui,
rice tproducers from five states filed a class action lawsuit against Bayer.
of M
un y
. Co of August 2008, the plaintiffs had not yet presented estimates of rice
v As

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.5

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

5

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).

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

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 there6were also no
2 1
environmental risks. Nonetheless, USDAbissued0an “emergency action
r 14,
m e
notification” for Event 32 seed, and ove issued a stop-sale order. As of
on NEPA
ved
August 2008, these agencies iwere conducting investigations to determine
arch
6466
whether any, No. 15-1 had occurred. According to Dow, it voluntarily
violations
ui
recalledMa
y of unplanted seed containing Event 32. Dow also provided USDA
ount
v. C
Atay with the testing method it used to detect Event 32. However, USDA said
ed in
cit
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.

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

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
16
the DEIS alternatives most closely match er 14,proposed rule. We have
the 20
mb
included that information in table 6.ove
on N

ed
rchiv
66 a
64
15-1
N .
Table 6: GE Regulatory Issues and Alternatives Discussedoin USDA’s DEIS and Proposed Rule
aui,
of M
unty
. Co
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in At
cited
Issue

Alternatives considered (USDA’s preliminary preference is
shown in bold type)

1. No action—continue to regulate GE organisms as potential
1 – Broadening Regulatory Scope to
Include GE Crops Posing Noxious Weed plant pests, and use genetic transformation as the trigger for
regulation (event by event).
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?

Alternative(s) in
DEIS that
correspond to
proposed change(s)
to regulations
2 or 3a

2. 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.

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

Issue

Alternatives considered (USDA’s preliminary preference is
shown in bold type)

2 – Use of Risk-Based Categories for
New Products

1. No action—continue to use a two-tiered system (notifications
and permits).

USDA is considering revisions to the
regulations to increase transparency and to
address advances in technology that may
create new products and concerns.

2. Abolish categories and treat all future proposals for the
introduction of GE organisms on a case-by-case basis.

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?

Alternative(s) in
DEIS that
correspond to
proposed change(s)
to regulations

4. 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.

4

3. Establish a tiered permitting system for all organisms based on
newly devised criteria.

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 , 2016
familiarity.
r 14
mbe full
1. No action—continue with current systemogranting
3 – Regulatory Flexibility to Allow
N ve
d on
nonregulated status to crops that iremoves them from all
Commercialization Despite Minor
h ve
c
regulatory obligations. 6466 ar
Unresolved Risks
1
. 15- the option of granting full
2. Continueui, No
to allow for
USDA is considering ways to provide
Ma
regulatory flexibility for future decisions by nonregulated status and develop appropriate criteria and
ty of
un
procedures through which crops can be removed from
accommodating commercialization of ay v. Co
n At in permitting, but some degree of agency oversight, as
i
certain GE organisms while continuing,
cited
some cases, to regulate the organisms on necessary, to mitigate any minor risks is retained.
the basis of minor unresolved risks. Other USDA’s explanation: Under the second alternative, the added
regulated articles could be treated as they flexibility of being able to retain some oversight may be useful for
have been under the current system, in
some types of GE organisms that might be developed in the
which all regulatory restrictions are
future.
removed.

2

What environmental factors should be
considered in distinguishing between these
kinds of decisions?

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

Issue

Alternatives considered (USDA’s preliminary preference is
shown in bold type)

4 – Regulation of Crops Producing
Pharmaceutical and Industrial
Compounds

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.

Are there changes that should be
considered relative to environmental
review of, and permit conditions for, GE
crops that produce pharmaceutical and
industrial compounds?

Alternative(s) in
DEIS that
correspond to
proposed change(s)
to regulations

2. 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.

2

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.
16
5. Allow field testing of food/feed crops producing substances not
4, 20
intended for food uses only if food safety has emberaddressed.
been 1
Nov
USDA’s explanation: Under the second n
d o alternative, the use of
hive
arc
highly stringent confinement measures can be used to protect the
6466
environment from . 15-1
significant impact and the consideration of food
i, No
safety will further enhance human safety.
Mau
ty of
un
1.
5 – Regulation of Nonviable Plant ay v. Co No action—do not regulate nonviable GE material.
n At
i
Material
2. Regulate nonviable GE plant material in certain
cited
circumstances, on the basis of the risks posed.
The definition of noxious weeds in the
Plant Protection Act includes not only
3. Regulate all nonviable GE plant material.
plants, but also plant products. On the
USDA’s explanation: The second alternative is preferred
basis of that authority, USDA is
because, in most cases, nonviable plant material will not pose a
considering the regulation of nonviable
plant material (i.e., plant materials, such as risk. However, in some cases, oversight might be required to
ensure the safe handling and disposal of this material.
stems and leaves, that do not propagate
new plants).

2

Is the regulation of nonviable material
appropriate and, if so, in which cases
should we regulate?

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

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.

Alternatives considered (USDA’s preliminary preference is
shown in bold type)
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.

1b

2. 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.

2016
r 14,
mbe
ove
on N

What should be the characteristics of this
mechanism?

ed
rchiv
66 a
4
5-16
1. No action—allow1field testing to continue using current
7 – Allowance for Low-Level Presence
No.
aui,
confinement strategies to reduce the likelihood of regulated
of Regulated GE Material in Crops,
of M
unty
articles occurring in commercial commodities or seeds.
Food, Feed, or Seed
. Co
v
Atay
The current regulations have citeprovision 2. Establish criteria under which occurrence of regulated articles
no d in
would be allowable, that is, considered not-actionable by USDA.
for the low-level presence of regulated
articles in commercial crops, food, feed, or Do not allow field testing of crops that do not meet all of these
criteria, including addressing food safety issues if applicable (i.e.,
seed of GE plant material that has not
if the GE plant is a food crop).
completed the required regulatory
processes.
3. Establish criteria under which occurrence of regulated
Should low-level occurrences of a
regulated article be exempted from
regulation?

Alternative(s) in
DEIS that
correspond to
proposed change(s)
to regulations

3

articles would be allowable, that is, considered notactionable 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.

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

Issue

Alternatives considered (USDA’s preliminary preference is
shown in bold type)

8 – Risk Assessment for Imported GE
Commodities

1. No action—continue to evaluate commodity importation
requests on a case-by-case basis.

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?

Alternative(s) in
DEIS that
correspond to
proposed change(s)
to regulations

2. 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.

c

1

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
2016
r 14,
has evaluated the safety of the product and approved it for
mbe
Nove
unconfined environmental release using a review process
d on
hive
equivalent to USDA’s.
6 arc
1646
USDA’s explanation:5Under the second alternative, the proposed
.1 No
aui,
exemption criteria should ensure that exempted GE commodities
of M
ty not result in significant environmental impacts, even if an
n
would
Cou
y v. environmental release should accidentally occur.
n Ata
i

cited
9 – Interstate Movement of WellStudied, Low-Risk GE Material

1. No action—require interstate movement authorizations for all
organisms on the list in current regulations.

Currently, GE Arabidopsis (a mustard plant
commonly used in genetics research) is
exempt from interstate movement
restrictions because they are wellunderstood and extensively used in
research.

2. Exempt a class of GE crops or organisms that are wellstudied and present little or no environmental risk from
permit requirements for interstate movement as is currently
done for Arabidopsis.

Should the movement of GE Arabidopsis
or other GE organisms be exempted from
movement restriction?

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.

10 – Container Requirements for
Shipping GE Material

1. No action—retain current list of approved containers and issue
variances when necessary.

What environmental considerations should
be evaluated if USDA were to move from
prescriptive container requirements for
shipment of GE organisms to performancebased container requirements,
supplemented with guidance on ways to
meet the performance standards?

d

3

2. Switch to performance-based standards for all transport
containers.

3. Create a process to apply for an interstate movement
exemption for a particular species.

2

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.
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)

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

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.

cited

unty
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Appendix IX: GAO Contact and Staff
Acknowledgments

Appendix IX: GAO Contact and Staff
Acknowledgments
GAO Contact

Lisa Shames [phone] or [e-mail]

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.

cited

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Related GAO Products

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Genetically Modified Foods: Experts View Regimen of Safety Tests as
Adequate, but FDA’s Evaluation Process Could Be Enhanced.
GAO-02-566. Washington, D.C.: May 23, 2002.
International Trade: Concerns Over Biotechnology Challenge U.S.
Agricultural Exports. GAO-01-727. Washington, D.C.: June 15, 2001.
Intellectual Property: Deposits of Biological Materials in Support of
Certain Patent Applications. 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.
16

Biotechnology: Information on Prices of er 14, 20
Genetically Modified Seeds in
b
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the United States and Argentina. RCED/NSIAD-00-55. Washington, D.C.:
n No
ed o
rchiv
January 21, 2000.
66 a

cited

(360871)

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Home » Invasive Species » Invasive Species Profiles » Mongoose

LEARN MORE

MONGOOSE

Click below to learn more about

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some2of 6
01 Hawaii's invasive
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What are Invasive
Species?
Invasive Species Profiles
Agencies & Policies
Report an Invasive
Species!
Response updates: LFA
on Oahu

MONGOOSE (HERPESTES JAVANICUS)

Regulatory Status: Hawaii Injurious Wildlife (HAR 124). It is against
Hawaii State law for any person to introduce, keep or breed any
mongoose within the State except by permit from HDOA; permits are
not issued for Kauai County or the island of Lanai. Fines for violations
are between $250 and $1,000 for each mongoose introduced, kept or
bred. HDOA Animal Industry Division Quarantine Rules HAR 142-92.

Response updates:
Coconut Rhinoceros
Beetle

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Prevention and Control Category: KISC Target Species. Please
report all suspected mongoose sightings on Kaua i and Lana i!

Description

16

20
Mongoose are a weasel-like animal totaling about 26 in length with a
r 14,
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long, brownish body, short legs and a tail as long as its body. They haven No
do
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small rounded ears and a pointed nose. The mongoose 5-1active during
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the day and generally sleeps in dens at night.f Maui, N
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Impacts

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Mongoose are opportunistic feeders that will eat birds, small mammals,
reptiles, insects, fruits, and plants. They prey on the eggs and
hatchlings of native ground nesting birds and endangered sea turtles.
The small Indian mongoose has been blamed with the extinction of
ground-nesting birds in Jamaica and Fiji and commonly kill birds,
including 8 federally listed endangered Hawaiian birds, such as the
Hawaiian crow (‘alal ), petrels ( u au) and Hawaiian goose (n n ). It
was estimated in 1999 that mongoose cause $50 million in damages to
Hawai`i and Puerto Rico annually.

Distribution
The mongooses found in Hawai’i are native to India and were originally
introduced to Hawai’i Island in 1883 by the sugar industry to control rats
in sugarcane fields on Maui, Moloka’i and O’ahu. This attempt was
misguided, because while rodents make up a large portion of the
mongooses’ diet, the their substantial negative impact on other
desirable birds, insects, and animals outweighs their minor impact on
rat. Mongoose are now widespread on all of the main Hawaiian islands
except for Lana i and Kaua i, where there are no known populations.

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Mongooses can live in both wet and dry conditions including gardens,
grasslands, and forests.

What you can do
If you see this species on Kaua i or Lana i call 643-PEST

Look-alike Species
Cats, rats, and occasionally fleeing pheasants have been mistaken for
mongooses. Cats have a rounder head, pointed ears, longer legs, a flat
nose, and usually have a jumping pounce. Large rats run low to the
ground, like mongooses, but are usually spotted at night (unlike
mongooses). Pheasants also run with a low profile and since sighting
them lasts only seconds, they can easily be mistaken.

For more information, see:
Herpestes javanicus information from HEAR
Herpestes javanicus information from ISSG
The Hawai‘i Invasive Species Council,
http://dlnr.hawaii.gov/hisc/info/species/mongoose/
Kaua i Invasive Species Committee:
http://www.kauaiisc.org/mongoose/

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NY Times, An Invader Advancesoin tHawaii. 2012:
un y
.C
ay v
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http://green.blogs.nytimes.com/2012/06/11/an-invader-advancesited
c

in-hawaii/?_r=0
The Threat: Rodents & Mongoose:
http://removeratsrestorehawaii.org/the-threat-rodents/
Mongooses in Hawaii Newspapers,Hawai’i Digital Newspaper
Project : https://sites.google.com/a/hawaii.edu/ndnphawaii/Home/historical-feature-articles/mongooses
Biology and Impacts of Pacific Island Invasive Species. A
Worldwide Review of Effects of the Small Indian Mongoose,
Herpestes javanicus (Carnivora: Herpestidae). 2007. Hays and
Conant.
http://scholarspace.manoa.hawaii.edu/bitstream/handle/10125/22595/v
3-16.pdf?sequence=1

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ontact the
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Supervisor

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est
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otline: 808
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43-PEST

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eport a Pest
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Online

Copyright © 2016, State of Hawaii. All rights reserved.

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Jan. 24, 1999

Environmental and Economic Costs Associated with Non-Indigenous
Species in the United States
ENVIRONMENTAL AND ECONOMIC COSTS ASSOCIATED WITH NON-INDIGENOUS SPECIES IN THE UNITED STATES
David Pimentel, Lori Lach, Rodolfo Zuniga, and Doug Morrison
College of Agriculture and Life Sciences
Cornell University
Ithaca, NY 14850-0901
June 12, 1999

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ABSTRACT

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RELATED INFORMATION
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Invading non-indigenous species in the United States cause major environmental damages andhived adding up to
rc losses

66 a
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42% of the species on the Threatened or Endangered species lists f Maurisk primarily because of non-indigenous
are at
ty o
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Cou
species.
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n Ata
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cited

4
more than $138 billion per year. There are approximately 50,000 foreign species5-16the number is increasing. About
1 and

In the history of the United States, approximately 50,000 non-indigenous (non-native) species are estimated to have

Alien animals, plants and microbes cost
U.S. $123 billion a year, Cornell
ecologists report
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been introduced into the United States. Introduced species, such as corn, wheat, rice, and other food crops, and cattle,
poultry, and other livestock, now provide more than 98% of the U.S. food system at a value of approximately $800

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billion per year (USBC 1998). Other exotic species have been introduced for landscape restoration, biological pest

LinkedIn

control, sport, pets, and food processing. Some non-indigenous species, however, have caused major economic losses

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in agriculture, forestry, and several other segments of the U.S. economy, in addition to harming the environment. One
recent study reported approximately $97 billion in damages from 79 exotic species during the period from 1906 to
1991 (OTA 1993).

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0

Estimating the full extent of the environmental damages caused by exotic species and the number of species extinctions
they have caused is difficult because little is known about the estimated 750,000 species in the United States, half of
which have not even been described (Raven and Johnson 1992). Nonetheless, about 400 of the 958 species that are
listed as threatened or endangered under the Endangered Species Act are considered to be at risk primarily because of
competition with and predation by non-indigenous species (Nature Conservancy 1996; Wilcove et al. 1998). In other

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STORY CONTACTS

regions of the world, as many as 80% of the endangered species are threatened due to the pressures of non-native
species (Armstrong 1995). Many other species worldwide that are not listed are also negatively affected by alien

Media Contact

species and/or ecosystem changes caused by alien species. Estimating the economic impacts associated with non-

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607-255-6074
[e-mail]

indigenous species in the United States is also difficult; nevertheless, enough data are available to quantify some of the
impacts on agriculture, forestry, and public health. In this article, we assess as much as possible the magnitude of the
environmental impacts and economic costs associated with the diverse non-indigenous species that have become
established within the United States. Although species translocated within the United States can also have significant
impacts, this assessment is limited to non-indigenous species that did not originate within the United States or its
territories.

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ENVIRONMENTAL DAMAGES AND ASSOCIATED CONTROL COSTS

Most plant and vertebrate animal introductions have been intentional, whereas most invertebrate animal and microbe
introductions have been accidental. In the past 40 years, the rate of and risks associated with biotic invaders have
increased enormously because of human population growth, rapid movement of people, and alteration of the
environment. In addition, more goods and materials are being traded among nations than ever before, thereby creating
opportunities for unintentional introductions (Bryan 1996; USBC 1998).
Some of the approximately 50,000 species of plants and animals that have invaded the United States cause many
different types of damage to managed and natural ecosystems (Table 1). Some of these damages and control costs are
assessed below.
Plants. Most alien plants now established in the United States were introduced for food, fiber, or ornamental purposes.
An estimated 5000 introduced plant species have escaped and now exist in U.S. natural ecosystems (Morse et al.
1995), compared with a total of about 17,000 species of native U.S. plants (Morin 1995). In Florida, of the
approximately 25,000 alien plant species imported mainly as ornamentals for cultivation, more than 900 have escaped
and become established in surrounding natural ecosystems (Frank and McCoy 1995a; Frank et al. 1997; Simberloff et
al. 1997). More than 3000 plant species have been introduced into California, and many of these have escaped into the
natural ecosystem (Dowell and Krass 1992).
Some of the 5000 non-indigenous plants established in U.S. natural ecosystems have displaced several native plant
species (Morse et al. 1995). Non-indigenous weeds are spreading and invading approximately 700,000 ha/yr of the
U.S. wildlife habitat (Babbitt 1998). One of these pest weeds is the European purple loosestrife (Lythrum salicaria),
which was introduced in the early 19th century as an ornamental plant (Malecki et al. 1993). It has been spreading at a
rate of 115,000 ha/yr and is changing the basic structure of most of the wetlands it has invaded (Thompson et al. 1987).
Competitive stands of purple loosestrife have reduced the biomass of 44 native plants and endangered wildlife,

6
, 201

r
including the bog turtle (Clemmys muhlenbengil) and several duck species, that depend on these native plants (Gaudet14
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(ATTRA 1997).
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Many introduced plant species established in the wild are havingoan effect on U.S. parks (Hiebert and Stubbendieck
ty f
n
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y v.
1993). In Great Smoky Mountains National Park,a400 of approximately 1,500 vascular plant species are exotic, and 10
n At
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n
and Keddy 1988). Loosestrife now occurs in 48 states and costs $45 million per year in control costs and N
ed o forage losses

of these are currently displacing and threatening other species in the park (Hiebert and Stubbendieck 1993).

The problem of introduced plants is especially significant in Hawaii. Hawaii has a total of 2690 plant species, 946 of
which are non-indigenous species (Eldredge and Miller 1997). About 800 native species are currently endangered
(Vitousek 1988).
Sometimes one non-indigenous plant species competitively overruns an entire ecosystem. For example, in California,
yellow star thistle (Centaurea solstitalis) now dominates more that 4 million ha of northern California grassland,
resulting in the total loss of this once productive grassland (Campbell 1994).
Similarly, European cheatgrass (Bromus tectorum) is dramatically changing the vegetation and fauna of many natural
ecosystems. This annual grass has invaded and spread throughout the shrub-steppe habitat of the Great Basin in Idaho
and Utah, predisposing the invaded habitat to fires (Kurdila 1995; Vitousek et al. 1996; Vitousek et al. 1997). Before
the invasion of cheatgrass, fire burned once every 60 - 110 years, and shrubs had a chance to become well established.
Now, fires occur about every 3 - 5 years; shrubs and other vegetation are diminished, and competitive monocultures of
cheatgrass now exist on 5 million ha in Idaho and Utah (Whisenant 1990). The animals dependent on the shrubs and
other original vegetation have been reduced or eliminated.
An estimated 138 non-indigenous tree and shrub species have invaded native U.S. forest and shrub ecosystems
(Campbell 1998). Introduced trees include salt cedar (Tamarix pendantra), eucalyptus (Eucalyptus spp.), Brazilian
pepper (Schinus terebinthifolius), and Australian melaleuca (Melaleuca quenquenervia) (OTA 1993; Miller 1995;
Randall 1996). Some of these trees have displaced native trees, shrubs, and other vegetation types, and populations of
some associated native animal species have been reduced in turn (OTA 1993). For example, the melaleuca tree is
competitively spreading at a rate of 11,000 ha/yr throughout the vast forest and grassland ecosystems of the Florida

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Everglades (Campbell 1994), where it damages the natural vegetation and wildlife (OTA 1993).
Exotic aquatic weeds are also a significant problem in the United States. For example, in the Hudson River basin of
New York, there are 53 exotic aquatic weed species (Mills et al. 1997). In Florida, exotic aquatic plants, such as
hydrilla (Hydrilla verticillata), water hyacinth (Eichhornia crassipes), and water lettuce (Pistia straiotes), are altering
fish and other aquatic animal species, choking waterways, altering nutrient cycles, and reducing recreational use of
rivers and lakes. Active control measures of the aquatic weeds have become necessary (OTA 1993). For instance,
Florida spends about $14.5 million each year on hydrilla control (Center et al. 1997). Nevertheless, hydrilla
infestations in just 2 Florida lakes have caused an estimated $10 million in recreational losses in the lakes annually
(Center et al. 1997). In the United States as a whole, a total of $100 million is invested annually in non-indigenous
species aquatic weed control (OTA 1993).
Mammals. About 20 species of mammals have been introduced into the United States; these include dogs, cats, horses,
burros, cattle, sheep, pigs, goats, and deer (Layne 1997). Several of these species have escaped or were released into
the wild; many have become pests by preying on native animals, grazing on vegetation, or intensifying soil erosion.
For example, goats (Capra hirus) introduced on San Clemente Island, California, are responsible for the extinction of 8
endemic plant species as well as the endangerment of 8 other native plant species (Kurdila 1995).
Many small mammals have also been introduced into the United States. These species include a number of rodents,
(the European [black or tree] rat [Rattus rattus)], Asiatic [Norway or brown] rat [Rattus norvegicus], house mouse
[Mus musculus], and European rabbit [Oryctolagus cuniculus] (Layne 1997).
Some introduced rodents have become serious pests on farms, in industries, and in homes (Layne 1997). Rats and mice
are particularly abundant and destructive on farms. On poultry farms, there is approximately 1 rat per 5 chickens (D.
Pimentel, unpublished, 1951; Smith 1984). Using this ratio, the total rat population on U. S. poultry farms may easily

2016
r 14,
mbe
improved rat control since these observations were made, we estimate that the number of rats on poultry andve
No other
d on
hive areas (Wachtel and
farms is approximately 1 billion. With an estimated additional 1 rat per person in homes andrrelated
ac
6466
McNeely 1985), there are an estimated 250 million rats in the United States o. 15-11998).
(USBC
i, N
Mau
ty of
If we assume, conservatively, that each adult rat consumesun
. Co and/or destroys stored grains (Chopra 1992; Ahmed et al.
ay v
n Atthe total cost of destruction by introduced rats in the United States is
i
1995) and other materials valued at $15/yr, then
cited
number more than 1.4 billion (USDA 1998). Assuming that the number of rats per chicken has declined because of

more than $19 billion per year. In addition, rats cause fires by gnawing electric wires, pollute foodstuffs, and act as
vectors of several diseases, including salmonellosis and leptospirosis, and, to a lesser degree, plague and murine typhus
(Richards 1989). They also prey on some native invertebrate and vertebrate species like birds and bird eggs
(Amarasekare 1993).
One of the first cases of the failure of biological control is the use of the Indian mongoose (Herpestes auropunctatus).
It was first introduced into Jamaica in 1872 for biological control of rats in sugarcane (Pimentel 1955). It was
subsequently introduced to the territory of Puerto Rico, other West Indian Islands, and Hawaii for the same purpose.
The mongoose controlled the Asiatic rat but not the European rat, and it preyed heavily on native ground nesting birds
(Pimentel 1955; Vilella and Zwank 1993). It also preyed on beneficial native amphibians and reptiles, causing at least
7 amphibian and reptile extinctions in Puerto Rico and other islands of the West Indies (Henderson 1992). In addition,
the mongoose emerged as the major vector and reservoir of rabies and leptospirosis in Puerto Rico and other islands
(Everard and Everard 1992). Based on public health damages, killing of poultry in Puerto Rico and Hawaii, extinctions
of amphibians and reptiles, and destruction of native birds, we estimate that the mongoose is causing approximately
$50 million in damages each year in Puerto Rico and the Hawaiian Islands.
Introduced cats have also become a serious threat to some native birds and other animals. There are an estimated 63
million pet cats in the United States (Nassar and Mosier 1991), plus as many as 30 million feral cats (Luoma 1997).
Cats prey on native birds (Fitzgerald 1990), plus small native mammals, amphibians, and reptiles (Dunn and Tessaglia
1994). Estimates are that feral cats in Wisconsin and Virginia kill more than 3 million birds in each state per year
(Luoma 1997). Based on the Wisconsin and Virginia data, we assume that 5 birds are killed per feral cat/year; McKay
(1996) reports that pet cats kill a similar number of birds as feral cats. Thus, about 465 million birds are killed by cats
per year in the nation. Each adult bird can be valued at $30. This cost per bird is based on the literature that reports that

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a bird watcher spends $0.40 per bird observed, a hunter spends $216 per bird shot, and specialists spend $800 per bird
reared for release; in addition, note that EPA fines polluters $10 per fish killed, including small, immature fish
(Pimentel and Greiner 1997). Therefore, the total damage to U.S. bird population is approximately $14 billion/yr. This
figure does not include small mammals, amphibians, and reptiles that are killed by feral and pet cats (Dunn and
Tessaglia 1994).
Like cats, most dogs introduced into the United States were introduced for domestic purposes, but some have escaped
into the wild. Many of these wild dogs run in packs and kill deer, rabbits, and domestic cattle, sheep, and goats. Carter
(1990) reported that feral dog packs in Texas cause more than $5 million in livestock losses each year. Dog packs have
also become a serious problem in Florida (Layne 1997). In addition to the damages caused by dogs in Texas, and
conservatively assuming $5 million for all damages for the other 49 states combined, total losses in livestock kills by
dogs per year would be approximately $10 million per year.
Moreover, an estimated 4.7 million people are bitten by feral and pet dogs annually, with 800,000 cases requiring
medical treatment (Sacks et al. 1996). Centers for Disease Control estimates medical treatment for dog bites costs $165
million/yr, and the indirect costs, such as lost work, increase the total costs of dog bites to $250 million/yr (Colburn
1999; Quinlan and Sacks, 1999). In addition, dog attacks cause between 11 and 14 deaths per year, and 80% of the
victims are small children (CDC 1997).
Birds. Approximately 97 of the 1,000 bird species in the United States are exotic (Temple 1992). Of the approximately
97 introduced bird species, only 5%, including chickens, are considered beneficial. Most (56%), though, are considered
pests (Temple 1992). Pest species include the pigeon, which was introduced into the United States for agricultural
purposes.
Introduced bird species are an expecially severe problem in Hawaii. A total of 35 of the 69 non-indigenous bird species

2016
r 14,
mbe
One such species, the common myna (Acridotheres tristis), was introduced to help control pest cutwormsNove
and
d on
hive
armyworms in sugarcane (Kurdila 1995). However, it became the major disperser of seeds arc introduced serious
of an
6466
weed, Lantana camara. In the continental United States, the English or house.sparrow (Passer domesticus) was
15-1
i, No
M u
introduced in 1853 to control the canker worm (Laycock 1966; Rootsa
ty of 1976). By 1900, the had become pests because
oun
they damage plants around homes and public buildings C consume wheat, corn, and the buds of fruit trees (Laycock
y v. and
n Ata
i
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1966). Furthermore, English sparrowscharass native birds, including robins, Baltimore orioles, yellow-billed cuckoos,
introduced between 1850 and 1984 in Hawaii are still extant on the islands (Moulton and Pimm 1983; Pimm 1991).

and black-billed cuckoos, and displace native bluebirds, wrens, purple martins, and cliff swallows from their nesting
sites (Laycock 1966; Roots 1976; Long 1981). They are also associated with the spread of about 29 human and
livestock diseases (Weber 1979).
The single-most serious pest bird in the United States is the exotic common pigeon (Columba livia) that exists in most
cities of the world, including those in the United States (Robbins 1995). Pigeons are considered a nuisance because
they foul buildings, statues, cars, and sometimes people, and feed on grain (Long 1981; Smith, 1992). The control costs
of pigeons are at least $9 per pigeon per year (Haag-Wackernagel 1995). Assuming 1 pigeon per ha in urban areas
(Johnston and Janiga 1995) or approximately 0.5 pigeons per person, and using potential control costs as a surrogate
for losses, pigeons cause an estimated $1.1 billion/yr in damages. These control costs do not include the environmental
damages associated with pigeons, which serve as reservoirs and vectors for over 50 human and livestock diseases,
including parrot fever, ornithosis, histoplasmosis, and encephalitis (Weber 1979; Long 1981).
Amphibians and Reptiles. Amphibians and reptiles introduced into the United States number about 53 species. All
these non-indigenous species occur in relatively warm states -- Florida is now host to 30 species and Hawaii to 12
(McCoid and Kleberg 1995; Lafferty and Page 1997). The negative ecological impacts of several of these exotic
species have been enormous .
The brown tree snake (Boiga irregularis) was accidentally introduced to the snake-free U.S. territory of Guam
immediately after World War II, when military equipment was moved onto Guam (Fritts and Rodda 1995). Soon the
snake population reached densities of 100 per ha, and dramatically reduced native bird, mammal, and lizard
populations. Of the 13 species of native forest birds originally found on Guam, only 3 still exist (Rodda et al. 1997); of
the 12 native species of lizards, only 3 have survived (Rodda et al.1997). The snake eats chickens, eggs, and caged

Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 137 of 150
birds, causing major problems to small farmers and pet owners. It also crawls up trees and utility poles and has caused
power outages on the island. One island-wide power outage caused by the snake cost the power utility more than
$250,000 (Teodosio 1987). Local outages that affect businesses are estimated to cost from $2,000 to $10,000 per
commercial customer (Coulehan 1987). With about 86 outages per year (BTSCP 1996), our estimate of the cost of
snake-related power outages is conservatively $1 million/yr.
In addition, the brown tree snake is slightly venomous, and has caused public health problems, especially when it has
bitten children. At one hospital emergency room, about 26 people per year are treated for snake bites (OTA 1993).
Some bitten infants require hospitalization and intensive care, at an estimated total cost of $25,000 per year.
The total costs of endangered species recovery efforts, environmental planning related to snake containment on Guam
and other programs directly stemming from the snake's invasion of Guam reach more than $1 million per year; in
addition, up to $2 million per year is invested in research to control this serious pest. The brown tree snake has also
invaded Hawaii but thus far has been exterminated. Hawaii's concern about the snake, though, has prompted the federal
government to invest $1.6 million per year in brown tree snake control (Holt 1997-1998). The total cost associated
with the snake is therefore more than $5.6 million/yr.
Fish. A total of 138 non-indigenous fish species has been introduced into the United States (Courtenay et al. 1991;
Courtenay 1993, 1997). Most of these introduced fish have been established in states with mild climates, such as
Florida (50 species) (Courtenay 1997) and California (56 species) (Dill and Cordone 1997). In Hawaii, 33 nonindigenous freshwater fish species have become established (Maciolek 1984). Forty-four native species of fish are
threatened or endangered in the United States by non-indigenous fish species (Wilcove and Bean 1994). An additional
27 native fish species are also negatively affected by introductions (Wilcove and Bean 1994).
Introduced fish species frequently alter the ecology of aquatic ecosystems. For instance, the grass carp
(Ctenopharyngodon idella) reduces natural aquatic vegetation, while the common carp (Cyprinus carpio) reduces water4, 2016

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1984).
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Although some native fish species are reduced in numbers, are drivenauiextinction, or hybridized by non-indigenous
to , N
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fish species, alien fish do provide some economic benefits unthe improvement of sport fishing. Sport fishing
. Co in
v
Atay
contributes $69 billion to the economy iof d inUnited States (Bjergo et al. 1995; USBC 1998). However, even taking
c te the
quality by increasing turbidity. These changes have caused the extinctions of some native fish species (Tayloremal.
Nov et

into account these economic benefits, based on the more than 40 non-indigenous species that have negatively affected
native fishes and other aquatic biota, a conservative estimate puts the economic losses due to exotic fish at more than
$1 billion annually.
Arthropods and Annelids. Approximately 4,500 arthropod species (2,582 species in Hawaii and more than 2,000 in
the continental United States) have been introduced to the United States. Also, 11 earthworm species (Hendrix 1995),
and nearly 100 aquatic invertebrate species have been introduced (OTA 1993). About 95% of these introductions were
accidental, with many species gaining entrance via plants or through soil and water ballast from ships.
For example, the accidentally-introduced balsam woolly adelgid (Adelges piceae) inflicts severe damage in balsam-fir
natural forest ecosystems (Jenkins 1998). According to Alsop and Laughlin (1991), this aphid is destroying the oldgrowth spruce-fir forest in many regions. Over the last two decades, it has spread throughout the southern
Appalachians, where it has destroyed up to 95% of the fraser firs. Alsop and Laughlin (1991) report the loss of 2 native
bird species and the invasion by 3 other bird species as a result of adelgid-mediated forest death.
Other introduced insect species have become pests of livestock and wildlife. For example, the red imported fire ant
(Solenopsis invicta) kills poultry chicks, lizards, snakes, and ground nesting birds (Vinson 1994). A 34% decrease in
swallow nesting success as well as a decline in the northern bobwhite quail populations was reported due to these ants
(Allen et al. 1995). The estimated damage to livestock, wildlife, and public health caused by fire ants in Texas is
estimated to be $300 million/yr. An additional $200 million is invested in control per year (Vinson 1992; TAES 1998).
Assuming similar damages in other infested southern states -- such as Florida, Georgia, and Louisiana -- the fire ant
damages total more than $1 billion/yr. Southern states are also affected by another insect, the Formosan termite
(Coptotermes formosanus), which is reported to cause structural damages totalling approximately $1 billion/yr in

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Southern United States, especially in the New Orleans region (Corn et al. 1999).
The European green crab (Carcinus maenas) has been associated with the demise of the soft shell clam industry in
New England and maritime provinces of Canada (Lafferty and Kuris 1996). It also destroys commercial shellfish beds
and preys on large numbers of native oysters and crabs (Lafferty and Kuris 1996), with an annual estimated economic
impact of $44 million/yr (Lafferty and Kuris 1996).
Mollusks. Eighty-eight species of mollusks have been both intentionally and accidentally introduced and established in
U. S. aquatic ecosystems (OTA 1993). Two have become serious pests: the zebra mussel (Dreissena polymorpha) and
the Asian clam (Corbicula fluminea).
The zebra mussel was first found in Lake St. Clair after gaining entrance via ballast water released in the Great Lakes
from ships that had traveled from Europe (Benson and Boydstun 1995). It has spread into most of the aquatic
ecosystems in the eastern United States and is expected to invade most freshwater habitats throughout the nation in
approximately 20 years (Benson and Boydstun 1995). Large mussel populations reduce food and oxygen for native
fauna. In addition, zebra mussels have been observed completely covering native mussels, clams, and snails, thereby
further threatening their survival (Benson and Boydstun 1995; Keniry and Marsden 1995). Mussel densities have
reached 700,000/m2 in some locations (Griffiths et al. 1991). Zebra mussels also invade and clog water intake pipes
and water filtration and electric generating plants; it is estimated that they will cause $5 billion/yr in damages to these
facilities and associated control costs by the year 2000 (Khalanski 1997).
Although the Asian clam grows and disperses less rapidly than the zebra mussel, it too is causing significant fouling
problems and is threatening native species. Costs associated with its fouling damage are about $1 billion/yr (Isom
1986; OTA 1993).
Another pest mollusk is the introduced shipworm (Teredo navalis), which was first introduced into the San Francisco
Bay. It has caused serious damage since the early 1990s. Currently, damages are estimated to be approximatelymber
ve $200

016
14, 2

No
d on
hive
arc
6466
15-1
. CONTROL COSTS
CROP, PASTURE, AND FOREST LOSSES AND ASSOCIATED
o
ui, N
Many weeds, pest insects, and plant pathogens are biological ty of Ma These non-indigenous species cause several
invaders.
oun
billion dollars worth of losses to crops, pastures,tandv. C annually in the United States. In addition, several billion
y forests
nAa
i
cited
dollars are spent on pest control.
million/yr (Cohen and Carlton 1995).

Weeds. In crop systems, including forage crops, an estimated 500 introduced plant species have become weed pests;
some of these, such as Johnson grass (Sorghum halepense) and Kudzu (Pueraria lobata), were actually introduced as
crops and then became pests (Pimentel et al. 1989). Most of these weeds were accidentally introduced with crop seeds,
from ship-ballast soil, or from various imported plant materials, among which were yellow rocket (Barbarea vulgaris)
and Canada thistle (Cirsium arvense).
In U.S. agriculture, weeds cause an overall reduction of 12% in crop yields. In economic terms, this reduction
represents about $33 billion in lost crop production annually, based on the crop potential value of all U.S. crops of
more than $267 billion/yr (USBC 1998). Based on the survey that about 73% of the weed species are non-indigenous
(Pimentel 1993), it follows that about $24 billion/yr of these crop losses are due to introduced weeds. However, nonindigenous weeds are often more serious pests than native weeds; this estimate of $24 billion/yr is conservative. In
addition to direct losses, approximately $4 billion/yr in herbicides are applied to U.S. crops (Pimentel 1997), of which
about $3 billion/yr is used for control of non-indigenous weeds. Therefore, the total costs of introduced weeds to the
U.S. economy is about $27 billion annually.
In pastures, 45% of weeds are non-indigenous species (Pimentel 1993). U.S. pastures provide about $10 billion in
forage crops annually (USDA 1998), and the estimated losses due to weeds are approximately $2 billion (Pimentel
1991). Forage losses due to non-indigenous weeds are nearly $1 billion/yr.
Some introduced weeds are toxic to cattle and wild ungulates, such as leafy spurge (Euphoria esula) (Trammel and
Butler 1995). In addition, several non-indigenous thistles have reduced native forage plant species in pastures,
rangelands, and forests, thus reducing cattle grazing (Dewey 1991). According to Interior Secretary Bruce Babbitt

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(1998), ranchers spend about $5 billion each year to control invasive non-indigenous weeds in pastures and rangelands.
Nevertheless, these weeds continue to spread.
Control of weed species in lawns, gardens, and golf courses is a significant proportion of the total management costs of
about $36 billion/yr (USBC 1998). In fact, Templeton et al. (1998) estimated that each year about $1.3 billion of the
$36 billion is spent just on residential weed, insect, and disease pest control each year. Because a large proportion of
these weeds, such as dandelions (Taraxacum officinale) are exotics, we estimate that $500 million is spent on
residential exotic weed control and an additional $1 billion is invested in non-indigenous weed control on golf courses.
Weed trees also have an economic impact, and from $3 to $6 million per year is being spent in efforts to control only
the melaleuca tree in Florida.
Vertebrate Pests. Horses (Equus caballus) and burros (Equus asinus), deliberately released in the western United
States, have attained wild populations of approximately 50,000 animals (Pogacnik 1995). These animals graze heavily
on native vegetation, allowing non-indigenous annuals to displace native perennials (Rosentreter 1994). Burros
inhabiting the northwestern United States also diminish the primary food sources of native bighorn sheep and seedeating birds, thereby reducing the abundance of these native animals (Kurdila 1995). In general, the large populations
of introduced wild horses and burros cost the nation an estimated $5 million/yr in forage losses (Pimentel et al. 1999).
Feral pigs (Sus scrofa), native to Eurasia and North Africa, have been introduced into some U.S. parks for hunting,
including parks in the California coastal prairie and Hawaiian islands, where they have substantially changed the
vegetation in these parks (Kotanen 1995). In Hawaii, more than 80% of the soil is bare in regions inhabited by pigs
(Kurdila 1995). This disturbance allows annual plants to invade the overturned soil and intensifies soil erosion. Pig
control per park in Hawaii (~1500 pigs/park) (Stone et al. 1992) costs about $150,000/yr . Assuming that the 3 parks in
Hawaii have similar pig control problems, the total is $450,000/yr (P. C., R. Zuniga, Cornell University, 1999).
Feral pigs have also become a serious problem in Florida, where their population has risen to more than 500,000 ber
em

016
14, 2

Nov
h
6 arc
damage grain, peanut, soybean, cotton, hay, and various vegetable crops, and the5environment (Rollins 1998). Pigs also
1646
.1 i, No
transmit and are reservoirs for serious human and livestock diseases, including brucellosis, pseudobrucellosis, and
Mau
ty of
n
trichinosis (Davis 1998).
Cou
y v.
n Ata
i
cited
(Layne 1997); similarly, in Texas their number ranges from 1 to 1.5 million. In Florida, Texas, and d on
ive elsewhere, pigs

Nationwide, there are an estimated 4 million feral pigs. Based on environmental and crop damages of about $200 per

pig annually (one pig can cause up to $1000 of damages to crops in one night), and assuming that 4 million feral pigs
inhabit the United States, the yearly damage amounts to about $800 million/yr. This estimate is conservative because
pigs cause significant environmental damages and diseases that cannot be easily translated into dollar values.
Other animals that threaten crop production include birds. European starlings (Sturnus vulgaris) are serious pests and
are estimated to occur at densities of more than 1 per ha in agricultural regions (Moore 1980). Starlings are capable of
destroying as much as $2,000 worth of cherries per hectare (Feare 1980). In grain fields, starlings consume about $6/ha
of grain (Feare 1980). Conservatively assuming $5/ha for all damages to many crops in the United States, the total loss
due to starlings would be approximately $800 million/yr. In addition, these aggressive birds have displaced numerous
native birds (Laycock 1966). Starlings have also been implicated in the transmission of 25 diseases, including parrot
fever and other diseases of humans (Laycock 1966; Weber 1979).
Insect and Mite Pests. Approximately 500 non-indigenous insect and mite species are pests in crops in the United
States. Hawaii has 5,246 identified native insect species, and an additional 2,582 introduced insect species (Howarth
1990; Frank and McCoy 1995a; Eldredge and Miller 1997). Introduced insects account for 98% of the crop pest insects
in the state (Beardsley 1991). In addition to Florida's 11,500 native insect species, 949 introduced species have, mostly
accidentally, invaded the state (42 species were intentionally introduced for biological control; Frank and McCoy
1995b). In California, the 600 introduced species are responsible for 67% of all crop losses (Dowell and Krass 1992).
Each year, pest insects destroy about 13% of potential crop production representing a value of about $33 billion in U.S.
crops (USBC 1998). Considering that about 40% of the pests were introduced (Pimentel 1993), we estimate that
introduced pests cause about $13 billion in crop losses each year. In addition, about $1.2 billion in pesticides are
applied for all insect control each year (Pimentel 1997). The portion applied against introduced pest insects is

Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 140 of 150
approximately $500 million/yr. Therefore, the total cost for introduced non-indigenous insect pests is approximately
$13.5 billion/yr. In addition, based on the analysis of management costs of lawns, gardens, and golf courses, we
estimate the control costs of pest insects and mites in lawns, gardens, and golf courses to be at least $1.5 billion/yr.
In addition to crops, about 360 non-indigenous insect species have become established in American forests (Liebold et
al. 1995), of which approximately 30% of these are now serious pests. Insects cause the loss of approximately 9% of
forest products, amounting to a cost of $7 billion per year (Hall and Moody 1994; USBC 1998). Because 30% of the
pests are non-indigenous, annual losses attributed to non-indigenous species is about $2.1 billion per year.
The gypsy moth (Lymantria dispar), intentionally introduced into Massachusetts in the 1800s for possible silk
production, has developed into a major pest of U.S. forest and ornamental trees, especially oaks (Campbell and
Schlarbaum 1994). The U.S. Forest Service currently spends about $11 million annually on gypsy moth control
(Campbell and Schlarbaum 1994).
Plant Pathogens. There are an estimated 50,000 parasitic and non-parasite diseases of plants in the United States, most
of which are caused by fungae species (USDA 1960). In addition more than 1300 species of viruses are plant pests in
the United States (USDA 1960). Many of these microbes are non-native and were introduced inadvertently with seeds
and other parts of host plants and have become major crop pests in the United States (Pimentel 1993). Including the
introduced plant pathogens plus other soil microbes, we estimate conservatively that more than 20,000 species of
microbes have invaded the United States.
U.S. crop losses to all plant pathogens total approximately $33 billion per year (Pimentel 1997; USBC 1998).
Approximately 65% (Pimentel 1993), or an estimated $21 billion per year of losses are attributable to non-indigenous
plant pathogens. In addition, $0.72 billion is spent in total annually for fungicides (Pimentel 1997), with approximately
$0.5 billion/yr for only the control of non-indigenous plant pathogen. This brings the costs of damage and control of

6

non-indigenous plant pathogens to about $21.5 billion/yr. In addition, based on the earlier discussion of pests in lawns, 4, 201
1

ber
vem
gardens, and golf courses, we estimate the control costs of plant pathogens in lawns, gardens, and golf courses to be at
n No
ed o
least $2 billion/yr.
rchiv
66 a
64
15-1
No.
aui, woody plants (Liebold et al. 1995). Two of
In forests, more than 20 non-indigenous species of plant pathogens M
f attack
nty o
the most serious plant pathogens are the chestnut blightCou (Cryphonectria parasitica) and Dutch elm disease
. fungus
v
Atay
(Ophiostoma ulmi). Before the accidental d in
cite introduction of chestnut blight, approximately 25% of eastern U.S. deciduous
forest consisted of American chestnut trees (Campbell 1994). Now chestnut trees have all but disappeared. Removal of
elm trees devastated by O. ulmi costs about $100 million/yr (Campbell and Schlarbaum 1994).
In addition, plant pathogens of forest plants cause the loss of approximately 9%, or $7 billion, of forest products each
year (Hall and Moody 1994; USBC 1998). The proportion of introduced plant pathogens in forests is similar to that of
introduced insects (about 30%), thus, approximately $2.1 billion in forest products are lost each year to non-indigenous
plant pathogens in the United States.
LIVESTOCK PESTS

Similar to crops, exotic microbes (e.g., calf diarrhea rotavirus) and parasites (e.g., face flies, Musca autumnalis) were
introduced along with livestock brought into the United States (Drummond et al., 1981; Morgan, 1981). In addition to
the hundreds of pest microbes and parasites that have already been introduced, more than 60 microbes and parasites
could invade and become serious pests to U.S. livestock (USAHA 1984). A conservative estimate of the losses to U.S.
livestock from exotic microbes and parasites was reported to be approximately $3 billion/yr in 1980 (Drummond et al.
1981; Morgan 1981). Current livestock losses to pests are estimated to be approximately $9 billion/year.
HUMAN DISEASES

The non-indigenous diseases now having the greatest impact on humans are Acquired Immune Deficiency Syndrome
(AIDS), syphilis, and influenza (Newton-John 1985; Pimentel et al. 1999). In 1993, there were 103,533 cases of AIDS
with 37,267 deaths (CDC 1996). The total U.S. health care cost for the treatment of AIDS averages about $6 billion per
year (USPHS 1994).
New influenza strains originating in the Far East spread quickly to the United States. Influenza causes 540 deaths in the
United States each year (USBC 1998). Costs of hospitalizations for a single outbreak of influenza, like type A, can

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exceed $300 million/yr (Chapman et al., 1992).
In addition, each year there are approximately 53,000 cases of syphilis in the United States; to treat only newborn
children infected with syphilis costs $18.4 million/yr (Bateman et al. 1997).
In total, AIDS and influenza take the lives of more than 40,000 people each year in the United States, and treatment
costs for these diseases total approximately $6.5 billion/yr. The costs of treating other exotic diseases pushes this total
much higher. An increasing threat of exotic diseases exists because of rapid transportation, encroachment of
civilization into new ecosystems, and growing environmental degradation.
THE NON-INDIGENOUS SPECIES THREAT

With more than 50,000 non-indigenous species in the United States, the fraction that is harmful does not have to be
large to inflict significant damage to natural and managed ecosystems and cause public health problems. A suite of
ecological factors may cause non-indigenous species to become abundant and persistent. These include the lack of
controlling natural enemies (e.g., purple loosestrife and imported fire ant); the development of new associations
between alien parasite and host (e.g., AIDS virus in humans and gypsy moth in U.S. oaks); effective predators in a new
ecosystem (e.g., brown tree snake and feral cats); artificial and/or disturbed habitats that provide favorable invasive
ecosystems for the aliens (e.g., weeds in crop and lawn habitats); and invasion by some highly adaptable and successful
species (e.g., water hyacinth and zebra mussel).
Our study reveals that economic damages associated with non-indigenous species effects and their control amount to
approximately $138 billion/yr. The Office of Technology Assessment (OTA 1993) reported average costs of $1.1
billion/yr ($97 billion over 85 years) for 79 species. The reason for our higher estimate is that we included more than
10 times the number of species in our assessment and found higher costs reported in the literature than OTA (1993) for
some of the same species. For example, for the zebra mussel, OTA reported damages and control costs of slightly more
that $300, 000 per year; we used an estimate of $5 billion/yr (Khalanski 1997).

2016
r 14,
mbe
e
Although we reported total economic damages and associated control costs to be $138 billion/yr, precise Nov
economic
d on
hive brown tree snake,
costs associated with some of the most ecologically damaging exotic species are not available. The
6 arc
1646
. 15for example, has been responsible for the extinction of dozens of bird and lizard species on Guam. Yet for this snake,
i, No
Mau
only minimal cost data are known. In other cases, such as the tzebra mussel and feral pigs, only combined damage and
y of
n
Cou
y v.
control cost data are available. The damage iand control costs are considered low when compared with the extensive
n Ata
cited
environmental damages these species cause. If we had been able to assign monetary values to species extinctions and
losses in biodiversity, ecosystem services, and aesthetics, the costs of destructive non-indigenous species would
undoubtedly be several times higher than $138 billion/yr. Yet even this understated economic loss indicates that nonindigenous species are exacting a significant toll.
We recognize that nearly all of our crop and livestock species are non-indigenous and have proven essential to the
viability the U.S. agriculture and economy. However, the fact that certain non-indigenous crops (e.g., corn and wheat)
are vital to agriculture and the U.S. food system does not diminish the enormous negative impacts of other nonindigenous species (e.g, zebra mussel and exotic weeds).
The true challenge lies not in determining the precise costs of the impacts of exotic species, but in preventing further
damage to natural and managed ecosystems caused by non-indigenous species. Formulation of sound prevention
policies needs to take into account the means through which non-indigenous species gain access to and become
established in the United States. Since the modes of invasion vary widely, a variety of preventative strategies will be
needed. For example, public education, sanitation, and effective screening and searches at airports, seaports, and other
ports of entry will help reduce the chances for biological invaders becoming established in the United States.
Fortunately, the problem is gaining the attention of policy makers. On February 2, 1999, President Clinton issued an
Executive Order allocating $28 million to combat alien species invasions and creating an Interagency Invasive Species
Council to produce a plan within 18 months to mobilize the federal government to defend again non-indigenous
species invasions. In addition, a Federal Interagency Weed Committee has been formed to help combat non-indigenous
plant species invasions (FIWC 1999). The objective of this interagency committee is education, formation of
partnerships among concerned groups, and stimulation of research on the biological invader problem. Secretary Bruce
Babbitt (1999) has also established an Invasive Weed Awareness Coalition to combat the invasion and spread of non-

Case: 15-16466, 11/18/2016, ID: 10202129, DktEntry: 92-3, Page 142 of 150
native plants, such as knapweed (Centaurea spp.) and St. Johnswort (Hypericum perforatum).
While these policies and practices may help prevent accidental and intentional introduction of potentially harmful
exotic species, we have a long way to go before the resources devoted to the problem are in proportion to the risks. We
hope that this environmental and economic assessment will advance the argument that investments made now to
prevent future introductions will be returned many times over in the preservation of natural ecosystems, diminished
losses to agriculture and forestry, and lessened threats to public health.
Table 1. Estimated annual costs associated with some non-indigenous species introduction in the United States (see text for
details and sources) (x millions of dollars).

Category

Non-Indigenous Losses and
Species
Damages

PLANTS

25,000

MAMMALS

NA

5

0.5
NA
NA
NA
NA

800.5
50
19,000
14,000
250

1,100
800

NA
NA

1,100
800

97

53

1
138

ARTHROPODS

4,500

Imported fire ant
Formosan termite
Green crab
Gypsy moth
Crop pests
Pests in lawns,
gardens, golf courses
Forest pests

1,000

cited

ed
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66 a
64
15-1
No.
aui,
of M

4.6
nty5.6
Cou 1,000
NA .
ay v
in At

600
1,000
44
NA
13,000

400
NA
NA
11
500

1,000
1,000
44
11
13,500

NA

1,500

1,500

2,100

NA

2,100

--1,000
205

--NA
NA

5,000
1,000
205

21,000

500

21,500

NA

2,000

2,000

2,100

NA

2,100

NA

100

100

88

Zebra mussel
Asian clam
Shipworm
Crop plant pathogens
Plant pathogens in
lawns, gardens, golf
courses
Forest plant
pathogens
Dutch elm disease

1,500

800
50
19,000
14,000
250

FISH

MICROBES

1,500

5

Brown tree snake

MOLLUSKS

$45
110
3
27,000
6,000

20

Pigeons
Starlings
REPTILES &
AMPHIBIANS

--$100
3-6
3,000
5,000

NA

Wild horses and
burros
Feral Pigs
Mongooses
Rats
Cats
Dogs
BIRDS

Total

--$10
NA
24,000
1,000

Purple loosestrife
Aquatic weeds
Mealeuca tree
Crop weeds
Weeds in pastures
Weeds in lawns,
gardens, golf courses

Control Costs

20,000

LIVESTOCK
DISEASES

9,000

NA

9,000

HUMAN DISEASES

NA

6,500

6,500

TOTAL

$138,229.1

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ACKNOWLEDGMENTS

We thank the following people for reading an earlier draft of this article and for their many helpful suggestions: D.
Bear, Council on Environmental Quality, Executive Office of the President, Washington , DC; J.W. Beardsley,
University of Hawaii; A.J. Benson, U.S. Geological Survey, Gainesville, FL; B. Blossey, Cornell University; C.R.
Bomar, University of Wisconsin, Stout; F.T. Campbell, Western Ancient Forest Campaign, Springield, VA; R. Chasen,
Editor, BioScience; P. Cloues, Geologic Resources Division, Natural Resource Program Center, Lakewood, Colorado;
W.R. Courtenay, Florida Atlantic University; R.H. Cowie, Bishop Museum, Honolulu, HI; D. Decker, Cornell
University; R.V. Dowell, California Department of Food and Agriculture; T. Dudley, University of Califonia,
Berkeley; H. Fraleigh, Colorado State University; H. Frank, University of Florida; T. Fritts, U.S. Geological Survey,
Washington, DC; E. Groshoz, University of New Hampshire; J. Jenkins, Forest Service, USDA, Radnor, PA; J.N.
Layne, Archbold Biological Station, Lake Placid, FL; J. Lockwood, University of Tennessee; J.D. Madsen, U.S. Army
Crops of Engineers, Vicksburg, MS; R.A. Malecki, N.Y. Cooperative Fish & Wildlife Research Unit, Ithaca, NY; E.L.
Mills, Cornell University; S.F. Nates, University of Southwestern Louisiana; H.S. Neufeld, Appalachian State
University; P.J. O'Connor, Colorado State University; B.E. Olson, Montana State University; E.F. Pauley, Coastal
Carolina University; M. Pimentel, Cornell University; S. Pimm, University of Tennessee; W.J. Poly, Southern Illinois
University; G. Roberts, University of Hawaii; G.S. Rodrigues, Empresa Brasilerira de Pesquisa Agropecuaria, Brazil;
M. Sagoff, Institute for Philosophy and Public Policy, University of Maryland, College Park; B. Salter, Maryland
Department of Natural Resources; D.L. Scarnecchia, University of Idaho; D. Simberloff, University of Tennessee; J.N.
Stuart, University of New Mexico;S.B. Vinson, Texas A & M University; L.A. Wainger, University of Maryland; J.K.
Wetterer, Collumbia University; and C.E. Williams, Clarion University of Pennsylvannia.
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