Tuesday, August 30, 2011

USDA/APHIS assessment

USDA/APHIS Creeping towards Regulatory Shutdown
By Prof. Joe Cummins
ISIS Report
August 30, 2011

Regulating GM crops

Genetically modified (GM) grass tolerant to the herbicide glyphosate, intended for use in golf courses, parks and athletic fields, has become a focal point for the biotech industry and academe bent on killing the regulation of GM crops.

Before going into the bluegrass saga, the basics of GM crop regulation in the United States should be outlined. First, The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) is entrusted to ensure the safe development of agricultural biotechnology by regulating field-testing, interstate movement, and importation of GM organisms (GMOs). APHIS determines whether a GMO is as safe for the environment as its traditional counterpart and hence can be freely used in agriculture. APHIS uses the term ‘biotechnology’ to mean recombinant DNA technology, or genetic engineering (modification) of living organisms [1]. In addition, the United States Environmental Protection Agency (EPA) regulates several biotechnology products, including pesticides produced by plants or microorganisms and non-pesticidal substances such as industrial enzymes, biosensors, and bioremediation agents produced using microorganisms [2]. The Food and Drug Administration (FDA), which determined that bioengineered foods should be regulated like their conventional counterparts in 1992, has not to-date established any regulations specific to bioengineered food [3]. APHIS has undertaken regulation of the testing and release to the environment of GM crops on the basis that the GM crops must not pose a threat to unmodified crops while any threat to humans and farm animals is not considered by APHIS, or by any other agency.

Behind the Grass

A lawn grass company Scotts Miracle-Gro has been at the forefront of development of GM lawn grass. In 2003, Monsanto Company and the Scotts Company submitted a proposal to deregulate creeping bent grass (Agrostis stolonifera) tolerant to the herbicide glyphosate. The primary purpose of the GM creeping bent grass was to control the spread of annual bluegrass (Poa annua). Scotts was fined $500 000 in 2007 after the bent grass escaped from field test sites in central Oregon and established itself in the wild. More recently the grass, presumably from a field test in Idaho, was found growing in nearby southern Oregon. Scotts Miracle-Gro next produced GM Kentucky bluegrass (Poa pratensis), tolerant to glyphosate to combat annual bluegrass. Scotts Miracle-Gro claimed to have drastically altered the method of genetic engineering in creating GM Kentucky bluegrass by eliminating the use of genetic components from bacteria and viruses known to cause disease in crop plants. In that way Scotts Miracle-Gro was able to side step the regulation by USDA/APHIS. USDA administrators agreed that the regulations had been side-stepped and allowed Scotts Miracle Grow to market the GM Kentucky bluegrass without restriction [4].

All it takes is a letter to Vilsack

In a letter addressed to the US secretary of Agriculture, Scotts Miracle-Gro included the details of the genes and methods used to transform Kentucky bluegrass. They used a biolistic method, also known as a gene gun, rather than the bacterium Agrobacterium tumefaceans, a plant pathogen, as a vehicle for introducing the glyphosate tolerance gene. This means that the DNA transfer does not involve Agrobacterium or any other plant pest regulated under the Plant Protection Act.

The genetically ‘enhanced’ bluegrass expresses a more glyphosate tolerant form of 5-enolpyruvylshikimate-3-phosphate synthase from Arabidopsis thaliana. Other donor genetic elements include: ubiquitin promoter from Oryza sativa - actin intron from Oryza sativa - alcohol dehydrogenase 3’ UTR from Zea mays. Kentucky bluegrass is not a federal noxious weed. It is listed as an agricultural seed, and is commonly grown on both home and government lawns [5].

How APHIS defines a “regulated article”

APHIS defines a “regulated article” as [5]: “Any organism which 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 Sec. 340.2 (Code of Federal Regulations TITLE 7–AGRICULTURE CHAPTER III–ANIMAL AND PLANT HEALTH INSPECTION SERVICE), and meets the definition of plant pest, or is an unclassified organism and/or an organism whose classification is unknown, or any product which contains such an organism, or any other organism or product altered or produced through genetic engineering which the Administrator, determines is a plant pest or has reason to believe is a plant pest. Excluded are recipient microorganisms which are not plant pests and which have resulted from the addition of genetic material from a donor organism where the material is well characterized and contains only non-coding regulatory regions. Any living stage (including active and dormant forms) of insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof; viruses; or any organisms similar to or allied with any of the foregoing; or any infectious agents or substances, which can directly or indirectly injure or cause disease or damage in or to any plants or parts thereof, or any processed, manufactured, or other products of plants.”

The regulatory status of crop produced biopharmaceuticals is ill-defined suggesting that such products engineered to exclude plant viruses and bacteria, as well as the wild and weedy relatives of GM crops inadvertently pollinated by the GM crops, are consigned to the APHIS limbo and ignored by that agency.

GM bluegrass volunteer menace

It seems inevitable that unregulated GM Kentucky bluegrass producing vast quantities of small windborne pollen will become a serious volunteer (weed). The annual bluegrass will soon be replaced with a Kentucky bluegrass that cannot be controlled with glyphosate alone. The control of volunteers is already a major problem following planting of GM crops including maize, oilseed rape, soybean and cotton, as they reduce yields unless controlled, which is expensive. Glyphosate-tolerant crops have greater potential to become problem-volunteers than conventional crops [6] and are indeed fast becoming volunteer weeds [7]. Volunteer weed populations of GM oilseed rape have been established along transport routes in Japan [8] and in western Canada [9]. Oilseed rape seeds remain dormant but viable in the soil seed bank for up to 10 years (10).

To conclude

There is growing pressure to shut down regulation of GM crops in the United States. USDA’s dependence on laws that predate genetic engineering and the placement of accountants rather than scientists as key regulators of GM crops is paving the way for the final shut down.

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