US Academy scientists’ public attack on EPA proposal on regulation of GMOs misdirected, misleading, and irrelevant; deregulation is likely to destroy the export market for US crops altogether. Prof. Joe Cummins
Recently, 60 members of the United States National Academy of Sciences (NAS), led by Nina Federoff have written to EPA to protest what they describe as a proposal  “to further expand [EPA's] regulatory coverage over transgenic crops in a way that cannot be justified on the basis of either scientific evidence or evidence gained over the past several decades...” and, “Based on initial reviews of that draft proposal and recent EPA actions associated with biotechnology-derived crops, it is clear that the agency is departing from a science-based regulatory process, walking down a path towards one based on the controversial European ‘precautionary principle’ that goes beyond codifying data requirements for substances regulated as PIPs [(plant incorporated protectants)] for the past 15 years.”
In the United States, genetically modified (GM) crops are regulated by different government departments. The Environmental Protection Agency (EPA) is responsible for dealing with Plant Incorporated Protectants (PIPs). PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. For example, scientists can take the gene for a specific Bacillus thuringiensis (Bt) pesticidal protein, and introduce the gene into the plant's genetic material, and the plant makes the pesticidal protein that kills the pest when it feeds on the plant. Both the protein and its genetic material are regulated by EPA; but not the plant itself. Another agency, The United States Department of Agriculture Animal and Plant Health Inspection Service (USDA/APHIS) is a multi-faceted Agency with a broad mission that includes protecting and promoting US agricultural health, and regulating GMOs (genetically modified organisms). APHIS uses the term biotechnology to mean the use of recombinant DNA technology, or genetic engineering to make GMOs. APHIS regulates GMOs that may pose a risk to plant or animal health. In addition, APHIS participates in programs that use biotechnology to identify and control plant and animal pests. APHIS’ Biotechnology Regulatory Services regulates the introduction (importation, interstate movement, and release into the environment) of GMOs that may pose a risk to plant health. Crops bearing PIPS face approval by both EPA and by APHIS.
The regulations on GM crops in the United States are put together by EPA and APHIS. EPA is required to seek the advice of independent experts. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) is composed of biologists, statisticians, toxicologists and other experts who provide independent scientific advice to the EPA on a wide-range of health and safety issues related to pesticides. Once the regulations are formulated the documentation behind such regulations are provided for public scrutiny in dockets that can be accessed by the public online and in government reading rooms. After the SAP and the public have commented, the information gathered is evaluated and used to formulate the final regulation.
The regulatory procedures however, appear to have changed. Earlier this year, the Administrator of EPA forwarded to the Secretaries of Agriculture and Health and Human Services a draft proposed rule under sections 21 and 25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) . The draft rule proposed codifying data requirements that specifically address the registration data needs of PIPs. These requirements are intended to provide EPA with data and other information necessary for the registration of a PIP or the issuance of an experimental use permit for a PIP.
Included in the draft rule, EPA proposed that any plant dubbed ‘cisgenic’, meaning that it contains only genetic material from other sexually compatible species, be exempt from registration and regulatory scrutiny. Such a ‘cisgenic’ gene includes its introns and flanking native promoter and terminator in the normal orientation. Cisgenic plants can harbour one or more cisgenes, but do not contain any ‘transgenes’. Transgenesis is defined as the genetic modification of a recipient plant with one or more genes from any non-plant organism, or from a donor plant that is sexually incompatible with the recipient plant. This includes gene sequences of any origin in the anti-sense orientation, any artificial combination of a coding sequence and a regulatory sequence, such as a promoter from another gene, or a synthetic gene. This exemption of cisgenic PIPs from registration is to “encourage research and development of useful biotechnology and reduce the number of PIPs seeking registration”.
There were certainly no requirements comparable to the precautionary principle adopted by most countries other than the United States and Canada. In fact, EPA is in a way moving in the direction that USDA has already taken with respect to its recent deregulation of GM bluegrass, towards the dismantling of GM regulation altogether (see  USDA Creeping towards Regulatory Shutdown, SiS 52).
The issues addressed in the EPA proposal included the following: Product Characterization, Gene Nomenclature, Bioinformatics – allergenicity, Synergism of Pesticidal Substances, Microbial Community Testing and Environmental Impacts of Gene Flow. Data requirement tables include: Human health, Non-target organisms (biodiversity), Environmental fate and effects of gene flow and Resistance management [4-6]. Comments were received on or before April 15, 2011. There were only five public comments submitted, mostly in support of the proposal to stop regulating cisgenic PIPS, and did not include any from Fedoroff.
Fedoroff, a member of the NAS and advisor to diplomats and politicians, has long advocated that regulation of GM crops should cease. She addressed an American Association for the Advancement of Science (AAAS) symposium on 18 February 2011 where she mistakenly claimed : “One especially problematic result of this approach is that EPA treats GE crops as if they were toxic chemicals.”
Fedoroff and her academy henchmen would better have contributed their comments to the regulatory docket at the time the EPA review was in progress. Furthermore, the Academy group appears to have failed to read the actual EPA proposal. It appears that Fedoroff prefers public relations at the expense of full and truthful scientific reporting.
Fedoroff reiterated her demand that GM crops should no longer be regulated by government agencies in a New York Times Op-ed piece “Engineering Food for All” : “And above all, the government needs to stop regulating genetic modifications for which there is no scientifically credible evidence of harm.” She seems to have forgotten that the USDA/APHIS approach has been to deregulate GM crops based on evidence provided by corporations and government agencies that there is no harm from the GM crops. Untested genetic modification using genes such as those from scorpions, virus and pathogenic bacteria such as Agrobacterium tumefacians, or even the extremely powerful bean toxin ricin have been patented and frequently put forward in controlled field trials. The regulatory agencies have not presumed that such are safe before they are tested, even though they have taken what many would regard as a permissive attitude to regulation. Presumption of safety prior to fuller testing, as demanded by Federoff, is particularly serious because GM crops are already unjustifiably presumed to be safe, and on that basis unlabelled in the market.
Perhaps, bending to pressure, EPA recently proposed that certain crops bearing virus coat protein genes should no longer be regulated . EPA is developing a proposal for a specific exemption from regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for two squash lines (CZW-3 and ZW-20) and for the Hawaiian papaya line 55-1. EPA argues that there is a long history of humans using foods containing plant-incorporated protectants. Virus infected plants have always been a part of the natural environment, and organisms that interact with plants have likely been exposed to plant virus coat proteins over long periods of time. EPA is developing this proposed exemption because the Agency, which has completed a review of the data, believes that the PVCP-PIPs covered by this exemption (Squash line CZW-3, Squash line ZW-20 and Hawaiian papaya line 55-1) meet the criteria in the Code of Federal Regulations 40 CFR 174.21 and can be exempt from the requirements of FIFRA. In all of the crops listed above the GM constructions included antibiotic resistance genes as markers and promoters and transcription terminators of a variety of transgenic origin. It seems deceptive to go forward with misleading information. Furthermore, the argument that virus infected crops have been consumed by people for a long time is silly. Virus-infected foods apparently promoted by EPA are not palatable and rejected by humans and other mammals.
There is growing pressure to stop regulating GM crops in the United States and to continue to fight truthful labelling of GM produce. Such efforts are more likely to destroy the export market for US crops than it is to help the US biotech industry, which claims to be struggling.
Article first published 31/08/11
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Todd Millions Comment left 2nd September 2011 10:10:06
'Naturally'-Ms. Fedoroff won't mind in the least signing open ended bonds for damages,of all assets and chattels-current and future,and banked where ever.Visech and the 'changling 'could add their signatures too such undertakings.
Rory Short Comment left 1st September 2011 11:11:33
I have zero sympathy for the struggling bio-tech industry in the USA. It jumped the gun in commercialising GMO's before it was independently established that they were not harmful to humans or other life forms and were also actually useful. This was done by the industry in a reckless search for monetary profits with zero regard for anything else at all.