Introduction
The benefits of genetically engineered livestock sound limitless: animals grow quicker and are disease-resistant, have healthier meat and flesh, and help medical researchers find cures for diseases. Genetically-modified insects can also address agricultural pest problems by weakening their ability to reproduce or making them less harmful. But if these species are released into the wild or end up in the food chain, they could pose serious problems.
Agencies under the U.S. Department of Agriculture are helping to finance this type of research, but its efforts to ensure new, modified species are adequately contained have been absent.
USDA agencies are responsible for creating security and biosafety programs at its laboratories to prevent impacts on employees, the public and the environment. But many of these agencies efforts to prevent unintended releases of genetically engineered species, ensure laboratories are following safety regulations, or create regulations have fallen short.
National Institute of Food and Agriculture has yet to create a formal process for documenting and monitoring research incidents, like the unauthorized release of GE animals. NIFA relies on reports from universities and other agencies to ensure researchers are complying with regulatory guidelines. As a result, it has struggled to respond to accidents.
In 2001, the University of Illinois sold 386 pigs, which were the offspring of GE animals, to a livestock dealer, who may have sold them for consumption. The researchers claimed that these pigs did not inherit the inserted genetic material, but FDA could not confirm this. The FDA investigator said that under the terms of the study protocols, the animals involved in this study were supposed to be destroyed to prevent introduction into the human food supply. The research program had received $300,000 in NIFA grants.
USDA has authority over GE animals and insects that are considered pests, but the FDA has responsibility over GE animal approvals of new animal drugs that could enter the food supply. Within USDA, regulatory authority over GE animal and insect research is triggered when GE animals, animal pests and plant pests are imported, moved across states, exported or field-tested.
“The agency needs a process for handling incidents of this nature, as well as receiving reports of any serious illnesses, accidents, releases, or safety problems,” the inspector general of USDA said.
The National Research Council has labeled environmental issues a significant concern to GE research. The release or escape of GE animals could result in a genetically modified animal reproducing with wild species, which could lead to a GE organism replacing its relative or becoming established in the community.
Center for Plant Health Science and Technology spent about $550,000 between 2007 and 2008 on GE projects to eradicate plant pests that pose a risk to agriculture and the environment, like the pink bollworm, the Mediterranean fruit fly, and the Mexican fruit fly. The program funds short-term research that is supposed to produce immediate agricultural benefits within three months, and long-term research projects. But CPHST lacks a formal process for selecting projects, evaluating results and its review process was not transparent and lacked controls for tracking reviews. Additionally, its laboratories lacked a comprehensive security plan despite Department regulations requiring them.
Agricultural Research Service does not track its labs’ response to safety recommendations. Officials rely on inspectors and letters from its laboratories to ensure corrections are made, but this approach has resulted in no action being taken at all. The Kerrville Research Facility laboratory, which
manipulates human cells that could pose a public safety concern if inadvertently released, took more than three years to create a biological safety program, despite multiple recommendations by inspectors. Between 2005 and 2007, ARS conducted five GE animal and insect research projects at a cost of $16 million.
The Animal and Plant Health Inspection Service has been slow to develop regulations regarding GE animals and insects comparable to regulations for GE plants. While jurisdiction over GE animals and insects belongs to FDA, APHIS has authority over the importation, interstate movement, and field release of GE animals and insects. APHIS lacks regulations for the introduction, import, field release of GE animals.
In 2008, the Advisory Committee on Biotechnology and 21st Century Agriculture, which provides advice to the Secretary of Agriculture on agricultural biotechnology, expressed concerns that GE animals were being imported from Asian countries without being identified as GE, and that there were no controls for such imports.
“Without such a framework, consumer confidence decreases, even as the risk increases that GE products might be inadvertently released,” the inspector general said.
FAST FACT: Between 2002 and 2008, the National Institute of Food and Agriculture funded 51 GE animal and insect research grant projects and four workshop conferences totaling over $5.4 million.
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