Fwd: Great news from UK + Report questions adequacy of US biotech regulations

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" News Update from The Campaign "

Great news from UK + Report questions adequacy of US biotech

regulations

Thu, 1 Apr 2004 07:11:31 -0600

 

News Update From The Campaign to Label Genetically Engineered Foods

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Dear News Update Subscribers,

 

We have great news to report from the United Kingdom (UK)! There will be no

genetically engineered crops grown in the UK for the foreseeable future!

 

BACKGROUND INFORMATION ON UK DEVELOPMENT

 

The UK Royal Society spent three years studying the environmental effects of

genetically engineered crops. They released their report last October on

genetically engineered rapeseed (also known as canola), sugar beets and corn

(also know as maize). The Royal Society found the rapeseed and sugar beets

to be more harmful to the environment than the regular varieties, but the

genetically engineered corn was reported to be less harmful. However, there

was a great deal of controversy over the determination that the corn was

safe because the neighboring fields were sprayed with a highly toxic

chemical named Atrazine that is banned in many European countries.

 

In spite of the controversy over the safety of the corn, on March 9, 2004,

the UK government gave approval to Bayer CropScience to grow their GM maize

called Chardon LL.

 

However, Bayer CropScience apparently did not like the amount of regulations

that were associated with the approval. As a result, Bayer just announced

their decision to back away from growing the biotech corn.

 

It is now unlikely that any genetically engineered crops will be grown in

the United Kingdom until at least 2008!

 

Posted below are two articles that will provide further details. The first

is a short article from UPI titled " Bayer halts genetically modified maize. "

The second article from the BBC is much longer and titled " Bayer deals blow

to UK GM crops. "

 

NEW PEW REPORT QUESTIONS U.S. BIOTECH REGULATIONS

 

The Pew Initiative on Food and Biotechnology has released a new in-depth

report titled " Issues in the Regulation of Genetically Engineered Plants and

Animals. "

 

Pew does not like to take " sides " in the controversy over genetic

engineering. However, anyone reviewing this report can notice many

shortcomings to the current regulatory scheme. It suggests the current

regulations may not be adequate in light of all the new biotech products

that are being rushed to market.

 

The third article posted below from the Washington Post is titled " Biotech

Regulation Falls Short, Report Says. "

 

The actual report is 174 pages and the Executive Summary is 15 pages. You

can read both online or order a hard copy at the following web page:

http://pewagbiotech.org/research/regulation/

 

Craig Winters

Executive Director

The Campaign to Label Genetically Engineered Foods

 

The Campaign

PO Box 55699

Seattle, WA 98155

Tel: 425-771-4049

Fax: 603-825-5841

E-mail: label

Web Site: http://www.thecampaign.org

 

Mission Statement: " To create a national grassroots consumer campaign for

the purpose of lobbying Congress and the President to pass legislation that

will require the labeling of genetically engineered foods in the United

States. "

 

***************************************************************

 

Bayer halts genetically modified maize

 

LONDON, March 31 (UPI) -- The only company eligible to grow genetically

modified crops in Britain is walking away from the opportunity, frustrated

by what it sees as over-regulation.

 

Germany's Bayer CropScience blamed the Labor government's conditions for

making its herbicide-resistant maize " economically non-viable. "

 

It said British authorities would stall production of the maize for too

long, the BBC reported Wednesday.

 

The government's decision giving a tentative go-ahead to GM

commercialization actually put several new regulatory hurdles in the way of

commercialization, said Bayer's Julian Little.

 

" These were ill-defined in the sense that we didn't know what they entailed.

The timeline was open-ended to the point that it was clear we were unlikely

to get commercialization of this product before 2006-07, " Little said.

 

" That makes an already aging variety old and essentially economically

unviable. "

 

The move is likely to put an end to commercialization of GM crops in Britain

until at least 2008, a move that delights environmentalists.

 

" This is fantastic news, " said a spokesman for Friends of the Earth.

 

***************************************************************

 

Bayer deals blow to UK GM crops

 

BBC NEWS

Wednesday, 31 March, 2004

 

GM crop growing has been shelved for the " foreseeable future " , according to

the UK government.

 

German company Bayer CropScience was the only firm eligible to grow

herbicide-tolerant maize in the UK.

 

But it has blamed government conditions for making the crop " economically

non-viable " because they would stall production of the maize for too long.

 

The move is likely to put an end to commercialisation of GM crops in Britain

until at least 2008.

 

Bayer CropScience spokesman Dr Julian Little told BBC News Online that the

government's decision giving a tentative go-ahead to GM commercialisation

was " symbolic " and made " in the face of a lot of hostility " .

 

But he added the decision had put several new regulatory hurdles in the way

of commercialisation.

 

" These were ill-defined in the sense that we didn't know what they entailed.

The timeline was open-ended to the point that it was clear we were unlikely

to get commercialisation of this product before 2006-2007, " Dr Little

explained.

 

" That makes an already ageing variety old and essentially economically

unviable. "

 

Tough stance

 

He said that the decision had been influenced by calls for new legislation

on guidelines for farmers, a legal framework for liability, further

biodiversity trials and rewrites on present and future European Union

licences for the technology.

 

The company had only been expecting a short delay caused by national listing

of the seed, registration of the pesticide and final approval by the

Advisory Committee on Pesticides, Dr Little said.

 

But environment minister Elliot Morley defended the government's stance on

GM maize.

 

He said: " We do not apologise for the fact there is a tough EU-wide

regulatory regime on GMs. It applies to the whole of the EU not just the UK.

 

" We always said it would be for the market to decide the viability of

growing and selling GM once the government assessed safety and risk.

 

" Number 10's Strategy Unit report on the costs and benefits of GM last year

did say there would be limited short-term commercial benefits in the UK for

growing GM. "

 

Bayer's GM maize, called Chardon LL, was given EU permission for cultivation

in 1999 but it failed to get the green light in the UK until earlier this

month.

 

Deep concern

 

Pete Riley, GM campaigner for Friends of the Earth, commented: " This is

fantastic news... this episode will be acutely embarrassing to ministers,

and of deep concern to Bayer's shareholders.

 

" The government must now abandon this dangerous and unpopular technology. "

 

The Agricultural Biotechnology Council (ABC) expressed its disappointment

that Bayer was unable to continue with commercialisation of Chardon LL.

 

But it said it recognised that this was a commercial decision reached " due

to the unforeseen length of time the GM crop has taken to gain full

regulatory approval " .

 

The next window for the GM crop companies is 2008, when Bayer CropScience

will propose commercialisation of oilseed rape and Monsanto and Syngenta

will be vying to get GM sugar beet approved.

 

'Precautionary approach'

 

Environment Secretary Margaret Beckett approved cultivation of the

herbicide-tolerant maize on 9 March.

 

But she rejected commercial cultivation of GM beet and oilseed rape - the

two other GM crops involved in recent tests, known as the farm-scale

evaluations.

 

Her statement followed five years of consultation, farm-scale trials and a

major survey which showed 90% of the public were against GM crops.

 

She said the GM maize licences would expire in October 2006, and any consent

holders wishing to renew them would have to carry out scientific analysis

during cultivation.

 

Her approach was " precautionary " and " evidence-based " , she said. There was

" no scientific case for a blanket approval for all uses of GM... and no

scientific case for a blanket ban on the use of GM " .

 

***************************************************************

 

Biotech Regulation Falls Short, Report Says

Pew Study Calls for Better Oversight

 

By Justin Gillis

Washington Post Staff Writer

Thursday, April 1, 2004; Page E03

 

Federal regulation of the increasingly exotic products of the biotechnology

industry may soon be inadequate to assure the public the products are safe,

according to a new report.

 

Opinion in Washington is sharply divided on whether the 18-year-old biotech

regulatory system can be fixed with administrative tweaking or whether

Congress needs to pass new laws, said the report by the Pew Initiative on

Food and Biotechnology, a think tank. But either way, the report cites

numerous examples to make the case that action by the federal government is

needed to ensure credible oversight of an industry that is tinkering with

the very foundations of life.

 

" The regulatory system isn't broken, but it is showing signs of wear and

tear, " said Michael Rodemeyer, executive director of the Pew Initiative,

which has taken a centrist position in weighing the risks and benefits of

agricultural biotechnology.

 

The need for fixes is likely to grow pressing as the industry develops

gene-altered fish and insects, farm animals that produce human drugs in

their milk, and plants that make drugs or industrial compounds in their

leaves and seeds, he added. A handful of these products are already in the

late stages of development, but for many of them, federal agencies have

produced no final guidance on how -- or even whether -- they will be

regulated.

 

The Pew report, to be formally released today, is the most detailed analysis

in years of a plan devised during the Reagan administration to oversee the

new crops scientists were designing in their laboratories. The heart of that

plan was to reinterpret existing laws, some of them passed decades earlier,

to apply to the new technology. The result was a patchwork regulatory system

that split jurisdiction among three agencies, all using different laws and

standards.

 

The crops commercialized under that system have included corn, soybeans,

cotton and other plants into which new genes have been inserted to confer

better resistance to weeds and insects. Americans have been eating such

foods for nearly a decade, but polls show most don't know it. Europeans have

been more aware -- and more skeptical -- of the crops, with European

politicians repeatedly citing the perception that the U.S. regulatory system

is weak to oppose the technology in their own countries.

 

While maintaining that the current crops are safe to eat, biotechnology and

food companies have feared a repeat of the controversy as new biotech

animals near commercialization. That is one reason the industry is among

those pressing for clearer regulations.

 

One proposal for tighter regulation of biotech crops was endorsed several

years ago by virtually every group with a stake in the issue: the biotech

industry, the food industry, environmentalists and consumer groups. The

proposal was nearing approval as the Clinton administration left office, but

the Bush administration has not acted on it.

 

Thomas Hoban, a sociologist and food scientist at North Carolina State

University who has followed public opinion on biotech issues for years, said

he visited the Food and Drug Administration last week to brief lower-level

staff members. He described polls showing rising public unease with

agricultural biotechnology. The staffers, mostly scientists, " were livid "

that the Clinton-era proposal had languished, he said. " The scientists are

saying, 'We need it,' " Hoban said.

 

Forthcoming products, ranging from a salmon designed to grow twice as

quickly as normal to plants designed to act as medicines, are likely to pose

tricky new issues of safety and public confidence, but the FDA has been slow

to clarify how it will regulate some of these products, he said. " I want a

much, much stronger FDA on this, as do most consumers, " Hoban said.

 

Several people in Washington trade groups, speaking on condition that they

not be identified because they need to maintain good relations with the FDA,

said the process of creating new rules had been bogged down by disagreement

between some of the scientists in the agency and the FDA's general counsel,

Daniel E. Troy. Troy is said to be more cautious about expanding the FDA's

authority to regulate various products.

 

Before joining the Bush administration, Troy was a lawyer who sometimes

represented tobacco and pharmaceutical companies in disputes with the FDA.

He declined requests for an interview through an agency spokesman. The

spokesman, Brad Stone, issued a statement saying " the agency and the

administration are carefully weighing the public health, scientific and

legal ramifications of this technology. " The statement said this review

would necessarily take time, but it added that " the agency is prepared to

take any appropriate measures necessary to protect the public health. "

 

Indeed, it is clear that the Bush administration is well aware of many of

the looming issues, and the White House science office is leading

discussions aimed at clarifying government regulations.

 

Perhaps the biggest dispute now is how to regulate genetically engineered

animals, such as fish meant for human consumption and farm animals

genetically altered to produce human drugs in their milk.

 

Two plans have been widely discussed in Washington. One would create a

system of voluntary consultations between the FDA and the biotech industry.

That plan, similar to the approach the FDA takes now for biotech crops,

enjoys little support among industry, consumer or environmental groups, but

it is something the FDA clearly has legal authority to do. A stricter plan,

favored by virtually all groups, would regulate the animals under a statute

originally designed for new animal drugs, and would involve detailed,

mandatory reviews of food safety. But it would also require a creative

interpretation of the laws governing the FDA.

 

The Pew report said it's not clear that even the stricter approach would

provide for an adequate review of environmental questions involving

gene-altered animals, one reason some groups want Congress to pass a new

biotech law.

 

 

 

 

 

 

 

 

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