Principles of Plant Genetics and Breeding

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Service (USDA-APHIS) uses the authority of the Plant Protection Act to regulate GE organisms. This law gives USDA the authority
to restrict introduction into the environment of plant pests, which are defined as living organisms that cause disease in or damage
to plants not including humans and non-parasitic plants (US Congress 2000). The current USDA-APHIS regulations use this “plant
pest authority” to regulate GE organisms based on the potential plant pest risk caused by the use of plant pest (e.g., viral)
sequences or vectors (e.g., Agrobacterium) in the creation of many GE plants (USDA-APHIS 1997). For plants created through
biolistic transformation that do not have plant pest sequences, the regulations can be imposed on articles that USDA has “reason
to believe” pose a plant pest risk (USDA-APHIS 1997). Technically, it may be possible that the use of plant pest components in the
creation of a GE plant could create a new plant pest or increase the GE plant’s susceptibility to a disease. However, the rarity of
these effects in GE plants and the dependence on the reason to believe clause, causes some to be concerned that the current
regulations are tenuous (National Research Council 2002). In order for a GE plant to be released into the environment in an
unconfined manner and thus sold commercially, USDA-APHIS will evaluate a petition for non-regulated status to determine if the
GE product does not pose a plant pest risk or cause other environmental harm, as evaluated under the National Environmental
Policy Act. Because granting non-regulated status takes the product out from all USDA-APHIS oversight, this feature has drawn
criticism as it may limit USDA-APHIS actions in terms of monitoring and other risk management activities. Also, while much
information in petitions is available to the public, applicants may claim portions are confidential business information under the
Freedom of Information Act, reducing the transparency of the USDA-APHIS system.
In part to address some of the issues discussed above, USDA-APHIS initiated a process in 2004 to revise its regulations based
on the so-called “noxious weed authority” in the Plant Protection Act (USDA-APHIS 2004). This authority gives USDA-APHIS the
ability to restrict introduction into the environment of noxious weeds, which are defined quite broadly as “any plant or plant product
that can directly or indirectly injure or cause damage to crops, . . . other interests of agriculture, . . . natural resources of the
United States, public health, or the environment” (US Congress 2000). The revised regulations would regulate based on potential
noxious weed risk of GE plants, greatly expanding the reasons for USDA-APHIS to assert its authority.
In contrast to the somewhat limited abilities of USDA-APHIS under its current regulations, the EPA broadly uses its authority
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to regulate GE plants that contain pesticidal elements. To
use this law to regulate GE plants, the EPA defined a new pesticide type, the plant-incorporated protectant (PIP), as “a pesticidal
substance produced by the plants and the genetic material necessary for them to produce the substance” (EPA 2001). This allows
the EPA to retain authority over approved products and it often requests additional data from applicants as a condition of continued
registration, thereby reducing the data gaps present during risk assessment. FIFRA provides special protections for information
regarding the health effects of products that might be claimed as confidential under other statutes, and requires that the EPA
submit major decisions to a panel of external experts, called a scientific advisory panel. Thus, relative to other agencies, the EPA
has a more transparent and understandable regulatory process. However, some have criticized the EPA for too restrictively regulating
PIPs by establishing requirements that are not commensurate with the risks posed by GE plants and are unnecessarily burdensome
for applicants, especially since conventionally bred PIPs are exempted from regulation. Nonetheless, the EPA’s efforts
may improve acceptability of the technology, and, in the case of Bt crops, extend the lifetime of their benefits to agriculture by
requiring insect-resistance management.
The FDA regulates foods derived from GE products under the Federal Food Drug and Cosmetic Act (FFDCA). As published in
1992, FDA policy is that it will regulate foods derived from GE products in the same way as those derived from conventionally
developed products (FDA 1992). The FDA’s regulation is based on whether the product has altered nutritional properties or contains
a food additive, which is defined as a substance introduced into food that is not a pesticide and is not “generally recognized
as safe” (GRAS) (FDA 1992). As for conventionally developed foods, FFDCA makes it the responsibility of the developer to determine
that GE-derived foods are safe and any substances new to the variety are GRAS, but the FDA provides a voluntary consultation
process to help developers determine this. The consultation process, through which developers submit data to FDA scientists
until the FDA has no more questions regarding safety, is available for both conventional and GE products. The voluntary nature of
the consultations makes some observers very uncomfortable with the FDA’s regulation of GE foods. On the other hand, FDA
records show that all GE products currently approved in the United States have completed such a consultation, but, because it is
voluntary, none of the information submitted to the FDA is available for public scrutiny. Therefore, while the FDA’s regulation is
most genuinely product-based, the transparency of the system is the lowest among the three agencies.
GE risk assessment concerns and typical data and information evaluation
Given the peculiarities of the US regulatory system for GE crops, how does it actually work? Here, we discuss the risk assessment
concerns and information that the regulatory agencies regularly examine before approving a GE variety for widespread use.
To evaluate the safety of GE crops before approval for food, feed, or planting in the United States, the USDA, EPA, and FDA
consider the potential impact of a large number of environmental- and health-related effects of the GE crops. Notably, the list of
concerns that the agencies evaluate includes all of the potential environmental hazards a recent National Research Council
(2002) panel identified that GE plants could cause:
1 The GE trait could be passed to a wild or weedy relative and increase its weediness or invasiveness, or the GE plant itself
could become weedy or invasive.