Regulating Transgenic Crops Pursuant to the Plant Protection Act
| Author | George A. Kimbrell |
| Pages | 281-299 |
Page 281
Chapter 16
Regulating Transgenic Crops Pursuant
to the Plant Protection Act
George A. Kimbrell
The U.S. government’s oversight of genetically engineered (GE) crops can be charitably described as
limited. Over the past 15 years, commercial approval has opened the door to the planting of mil-
lions of transgenic acres, yet the environmental and health impacts of this widespread change in our
agricultural la ndscape are not being adequately studied or regu lated. e U.S. Department of Agriculture
(USDA), entrusted with the chief responsibility for regulation of these transgenic crops, has not contained
them, and as a result they have caused signicant economic harm and transgenic pollution of both con-
ventional and wild plant species. Government investigations, courts, and even the U.S. Congress have a ll
found USDA’s practices inadequate.
Similarly, agricultural biotechnology itself ha s not increased yields, reduced world hunger, or mitigated
global wa rming. Instead, there is growing evidence that these crops carry with them signicant adverse
environmental and intertwined socioeconomic impacts: transgenic contamination (gene ow from GE
crops to related conventional or organic cultivars or wild species); signicant increases in herbicides used in
engineered herbicide-resistant (HR) cropping systems; and the creation of weeds resistant to these herbi-
cides. e vast majority of transgenic crops are genetically engineered to be resistant to the direct applica-
tion of herbicides, mainly Monsanto’s now-ubiquitous Roundup, leading to increased and indiscriminate
usage. rough the widespread adoption of GE “Roundup Ready” cropping systems, Roundup ha s now
become the most heavily used herbicide in the history of agriculture. In addition, USDA has declined to
act as crops under its watch continue to exacerbate one of the greatest threats to agriculture in a generation:
an epidemic of HR “superweeds” requiring ever more numerous applications of increasingly toxic herbicide
cocktails. Instead, USDA has thus far self-limited its own review, providing no post-market monitoring or
restrictions on planting.
Revising the 1986 Coordinated Framework for t he Regulation of Biotechnology,1 which laid out a
mosaic of federa l a gencies to oversee the development of genetically engineered organisms, remains an
important focus of the U.S. biotech policy dialogue. While expert analysts have pointed out the Frame-
work’s shortcomings, numerous congressional bills intended to remedy them have failed to pass.2
1. Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23302 (June 26, 1986).
2. See, e.g., Genetically Engineered Foods Act, S. 2546, 108th Cong. (2004); S. 3095, 107th Cong. (2002); S. 3184, 106th Cong. (2000); H.R.
713, 107th Cong. (2002); Genetically Engineered Food Safety Act, S. 2315, 112th Cong. (2011); H.R. 3883, 112th Cong. (2011); H.R.
5268, 109th Cong. (2006); H.R. 2917, 108th Cong. (2003); H.R. 4813, 107th Cong. (2002); Genetically Engineered Food Right to Know
Act, H.R. 5577, 111th Cong. (2010); H.R. 6636, 110th Cong. (2008); H.R. 5269, 109th Cong. (2006); H.R. 5269, 109th Cong. (2006);
H.R. 2916, 108th Cong. (2003); H.R. 4814, 107th Cong. (2002); Genetically Engineered Pharmaceutical and Industrial Crop Safety Act of
2003, H.R. 2921, 108th Cong. (2003); Real Solutions to World Hunger Act of 2003, H.R. 2920, 108th Cong. (2003); e Genetically Engi-
neered Crop and Animal Farmer Protection Act, H.R. 5266, 109th Cong. (2006); e Genetically Engineered Pharmaceutical and Industrial
Crop Safety Act of 2005, H.R. 5267, 109th Cong. (2006); Real Solutions to World Hunger Act of 2005, H.R. 5270, 109th Cong. (2006);
e Genetically Engineered Organism Liability Act, H.R. 5271, 109th Cong. (2006); Genetically Engineered Technology Farmer Protection
Act, H.R. 6637, 110th Cong. (2008); Genetically Engineered Safety Act, H.R. 5578, 111th Cong. (2010); H.R. 6635, 110th Cong. (2008);
Genetically Engineered Technology Farmer Protection Act, H.R.5579, 111th Cong. (2010); A Bill to Amend the Federal Food, Drug, and
Cosmetic Act to Prevent the Approval of Genetically Engineered Fish, S.230, 112th Cong. (2011); H.R. 521, 112th Cong. (2011); A Bill to
Amend the Federal Food, Drug, and Cosmetic Act to Require Labeling of Genetically Engineered Fish, S. 229, 112th Cong. (2011); H.R.520,
112th Cong. (2011).
Page 282 Food, Agriculture, and Environmental Law
An analysis of the Framework, on which there is already a rich academic literature,3 is beyond the scope
of this chapter, which focuses only on USDA’s oversight. at sa id, imagine that an obscure law already
exists that could better address many of the above issues, should it only be fully implemented. Imagine
further t hat this law provides USDA broad authority to protect the environment, agricu lture, and health
from direct and indirect harms. is law exists and is known as the Plant Protection Act of 200 0 (PPA).4
Yet thus far, USDA has continued to regulate GE crops under regulations promulgated under earlier, nar-
rower laws, and has not applied the full mandate delegated to it in the PPA.
is chapter argues t hat USDA should revise its regulation of transgenic crops to apply its full PPA
authority. It rst provides an overview of agricultural biotechnology’s development and current agronomic
reality, then focuses on some of the main impacts of transgenic crops. e chapter outlines USDA’s current
oversight struct ure and provides a blueprint for needed regulatory improvement. e chapter concludes
that USDA’s oversight could be greatly improved, and as a consequence the impacts of transgenic crops
better analy zed, regulated, a nd prevented, under a robust application of the PPA that takes into consider-
ation the direct and indirect harms of transgenic crops in order to protect all interests of agriculture, public
health, and the environment.
A. Agricultural Biotechnology
As discussed in Chapter 6, agricultural biotechnology generally refers to the use of recombinant DNA
techniques and related tools of biotechnology to genetically engineer crops used in the production of food,
feed, and ber. e resulting products are interchangeably referred to as “transgenic” or “genetical ly engi-
neered” (GE). Genetic engineering is not the same as traditional plant breeding. e latter process involves
identifying similar, related plants with useful traits and crossing these plants to produce ospring with the
desired characteristics of both parents. Genetic engineering is a powerful technology that allows scientists
to combine genetic material from widely dissimilar and unrelated organisms—for example, bacterial genes
with alfalfa genes or chicken genes with maize genes. In other words, scientists can produce combinations
of genetic material that have never before occurred in natu re.5
In the 1980 landmark case Diamond v. Chakrabarty, the U.S. Supreme Court r uled by a 5-4 margin
that living organisms could be patented.6 Because the patentee had introduced new genetic material within
the bacterium cell, the Court held that he had produced something that was not a product of nature and
was thus patentable subject matter.7 at decision paved the way for the U.S. Patent and Trademark Oce
to decide in the 1985 case Ex parte Hibberd that sexually reproducing plants are patentable under the Pat-
ent Act, providing stronger protection and greater prot potential for seed companies.8 Previously, such
plants were only protected under the 1970 Plant Variety Protection Act (PVPA), which provided tempo-
rary exclusivity, but exempted farmers, who could then save seed a nd replant, and plant researchers, who
could use protected varieties to breed improved plants.9 In 2001, another 5-4 Supreme Cour t decision in
J.E.M Ag Supply v. Pioneer Hi-Bred International upheld the granting of utility patents, which do not have
these exemptions, for plants.10 ese decisions opened the door to expansive intellectual property rights in
genetically engineered organisms and crops.
As a consequence, rms raced to patent genetic resources and plant breeding technologies a nd to pur-
chase existing seed companies; the agricultural biotechnology industry emerged through the rapid acquisi-
3. See, e.g., Mary Jane Angelo, Regulating Evolution for Sale: An Evolutionary Biology Model for Regulating the Unnatural Selection of Genetically
Modied Organisms, 42 W F L. R. 93, 112 (2007); Douglas A. Kysar, Preferences for Processes: e Process/Product Distinction and
the Regulation of Consumer Choice, 118 H. L. R. 525 (2004); Gregory N. Mandel, Gaps, Inexperience, Inconsistencies, and Overlaps: Crisis
in the Regulation of Genetically Modied Plants and Animals, 45 W. M L. R. 2216 (2004); John Charles Kunich, Mother Frankenstein,
Doctor Nature, and the Environmental Law of Genetic Engineering, 74 S. C. L. R. 807 (2001); Rebecca Bratspies, Some oughts on the
American Approach to Regulating Genetically Modied Organisms, 16 K. J.L. P. P’ 393 (2007).
4. 7 U.S.C. §§7701 et seq. (2011).
5. See, e.g., Stanley Cohen et al., Construction of Biologically Functional Bacterial Plasmids in Vitro, 70 P. N’ A. S. 3240-44 (1973).
6. 447 U.S. 303 (1980).
7. Id. at 309-10.
8. 227 U.S.P.Q. 443 (Bd. Pat. App. & Interferences 1985).
9. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Intern., Inc., 534 U.S. 124, 140, 122 S.Ct. 593, 603(2001); see also Asgrow Seed Co. v. Winterboer,
10. See J.E.M. Ag Supply, 534 U.S. at 127.
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