Sunday, September 11, 2011

Pharm Crops

Pharm Crops Ignoring Health & Environment
By Prof. Joe Cummins
ISIS Report
September 11, 2011

Pharmaceutical drug production has undergone major changes following the development and approval of drugs called ‘biologicals’ that are for the most part proteins produced by genetic engineering. Biologicals make up at least a quarter of new drug approved, though they are about twice as likely as chemical drugs to experience regulatory action following approval (see ‘Biologicals’, Wonder Drugs with Problems, SiS 42). The recombinant protein drugs are produced using viruses, bacteria, yeast, and cell cultures from insects, rodents, primates or humans. The use of genetically modified (GM) crop plants to produce biologics has been an attractive prospect because the crops are capable of producing vast quantities of recombinant proteins at low cost. There have been a large number of such transgenic ‘pharm crops’ created in the laboratory and field trialled, though none have been approved for commercial drug production. However, some have now progressed to clinical trials.

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Friday, September 9, 2011

Murkowski ‘frankenfish’ ban

Murkowski to push ban on ‘frankenfish’
Associated Press
September 08, 2011

JUNEAU, Alaska - U.S. Sen. Lisa Murkowski plans to offer an amendment that would ban genetically modified fish.

Murkowski’s office says the issue of so-called “frankenfish” came up during a Senate Appropriations Committee hearing Wednesday. Murkowski urged the committee to impose a ban on genetically modified fish when the U.S. Food and Drug Administration’s budget came up. But her office says she agreed, after discussions with Democrats on the committee, to wait to push a ban until an agriculture-related appropriations bill went to the Senate floor.

Her spokesman says Murkowski plans to do that in the form of an amendment.

Alaska’s congressional delegation has been pushing for a ban, seeing genetically modified fish as a potential harm to wild fish - and particularly salmon - populations.

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.

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Thursday, July 21, 2011

Animal-human experiments

New rules urged on hybrid animal-human experiments
By Ben Hirschler
July 21, 2011

LONDON - Scientific experiments that insert human genes or cells into animals need new rules to ensure they are ethically acceptable and do not lead to the creation of “monsters,” a group of leading British researchers said on Friday.

While humanizing animals in the name of medical research offers valuable insights into the way human bodies work and diseases develop, clear regulations are needed to make sure humanization of animals is carefully controlled.

Extreme scenarios, such as putting brain cells into primates to create talking apes, may remain science fiction, but researchers around the world are constantly pushing boundaries.

Chinese scientists have already introduced human stem cells into goat fetuses and U.S. researchers have studied the idea of creating a mouse with human brain cells — though they have not actually done so.

Such controversial research needs special oversight, according to a report from Britain’s Academy of Medical Sciences on the use of animals containing human material.

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Grass skirts regulators

Transgenic grass skirts regulators
By Heidi Hedford
Nature News
July 21, 2011

Technological advances remove basis for government oversight of genetically modified crops.

When the US Department of Agriculture (USDA) announced this month that it did not have the authority to oversee a new variety of genetically modified (GM) Kentucky bluegrass, it exposed a serious weakness in the regulations governing GM crops. These are based not on a plant’s GM nature but on the techniques used for its genetic modification. With changing technologies, the department says that it lacks the authority to regulate newly created transgenic crops.

The grass, a GM variety of Poa pratensis, is still in the early stages of development by Scotts Miracle-Gro, a lawn-care company based in Marysville, Ohio. The grass has been genetically altered to tolerate the herbicide glyphosate, which would make it easier to keep a lawn weed-free. On 1 July, secretary of agriculture Tom Vilsack wrote to the company to say that the variety ‘is not subject’ to the same regulations that govern other GM crops. The decision allows Scotts to bypass the years of environmental testing and consultation typically required by the regulators for GM plants, although the company says there are no plans to market this particular variety.

The grass can evade control because the regulations for GM plants derive from the Federal Plant Pest Act, a decades-old law intended to safeguard against plant pathogens from overseas. Previous types of GM plants are covered because they they were made using plant pathogens. The bacterium Agrobacterium tumefaciens - which can cause tumours on plants - shuttled foreign genes into plant genomes. Developers then used genetic control elements derived from pathogenic plant viruses such as the cauliflower mosaic virus to switch on the genes.

By revealing similar elements in plants’ DNA, genome sequencing has liberated developers from having to borrow the viral sequences. And Agrobacterium is not essential either; foreign genes can be fired into plant cells on metal particles shot from a ‘gene gun’. Scotts took advantage of both techniques to construct the herbicide-resistant Kentucky bluegrass that put the USDA’s regulatory powers to the test.

“The Plant Pest Act was completely inappropriate for regulating biotech crops, but the USDA jury-rigged it,” says Bill Freese, science-policy analyst at the Center for Food Safety in Washington DC. “Now we can foresee this loophole getting wider and wider as companies turn more to plants and away from bacteria and other plant-pest organisms.” The USDA has not made public any plans to close the loophole and has also indicated that it will not broaden its definition of noxious weeds, a class of plants that falls under its regulatory purview, to facilitate the regulation of GM crops.

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