GENET archive


6-Regulation: 'Single window clearance for GM crops unsuitable forIndia'

                                  PART I
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TITLE:  'Single Window Clearance For GM Crops Unsuitable For India'
SOURCE: The Financial Times, India , by Ashok B. Sharma
DATE:   16 Sep 2004

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'Single Window Clearance For GM Crops Unsuitable For India'

Indian biotech industry may be clamouring for an autonomous single window
system of clearance for transgenic crops and products, but United States
Department of Agricluture (USDA) vegetable laboratory research leader Dr
Autar K Mattoo is of the view that multi-agency system of clearance is
best suited for the US, the country of its origin.

Dr Mattoo's views are at variance with the MS Swaminathan panel report on
agricultural biotechnology and the draft report RA Mashelkar Committee on
recombinant pharma, which have recommended an autonomous single window
system of clearance.

Speaking to FE, the India-born scientist, Dr Mattoo said that the US has
put in place a perfect infrastructure for regulation and release of
genetically modified (GM) crops and products. Each of the three
government institutions - United States Department of Agriculture (USDA),
Food and Drugs Adminstration (FDA) and Environment Protection Agency
(EPA) have well defined roles to play. "In US the system is transparent
and science-based. India should replicate the US system of regulation and
clearance of GM crops and products," he said.

Dr Mattoo who now works as a research leader in the USDA vegetable
laboratory, Beltsville Agricultural Research Centre said: "I am not in
favour of a single window system of clearance. Approval and regulations
should be done by expert bodies relating to different fields." He said
that in the US, the USDA is concerned with the regulation of transgenic
crops, while FDA is concerned with the regulation of GM food and
recombinant pharma products. The EPA is needed for clearance when
environmental issues are involved.

He said that with a view to instill public confidence in transgenic
technology, it is necessary that "responsibility and accountability are
in-built in the structure." "These should be the core principles, he said.

Dr Mattoo cited examples by saying that in the US, company scientists
provide protocols to the regulator agencies and if there is a breach of
trust or any irregularity committed, heavy penalties are imposed on companies.

                                  PART II
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TITLE:  'GM foods must be brought under PFA Act'
SOURCE: Business Standard, India
DATE:   15 Sep 2004

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'GM foods must be brought under PFA Act'

Ahmedabad - The Government must bring the genetically modified (GM) foods
under the purview of the Prevention of Food Adulteration Act (PFA Act),
felt speakers at a two-day national symposium on biotechnology, which
concluded in Ahmedabad on Saturday.

Speaking on the issue of 'Safety Evaluation on Genetically Modified
Foods: Indian Regulatory Review', P K Ghosh, senior vice-president,
BioCare SBU, Cadila Pharmaceuticals Ltd, said that while no genetically
modified foods are being produced in India as of now, the situation will
not remain so for too long.

"With genetically modified foods likely to be produced in the country
soon, there is a need to bring these under the purview of the PFA Act, as
these can be toxic, allergic and have nutritional effects," said Ghosh.

The biggest advantage of the GM food is that these are tolerant to
insects, diseases, herbicides and the like, but are known to be toxic and
allergic. "Some of the factors that need to be considered for safety of
GM foods are that the description, including source and sequence of
transgenes and effects of GM foods on mammalian cells, must be documented
on the products," he said.

Ghosh, however, added that one of the biggest compromise that will have
to be made regarding GM foods is that no safety studies are conducted on
humans before GM foods are introduced in the market.

At present, the Indian regulatory guidelines are those under the
Environment Protection Act 1986 and Rules 1989. Companies wishing to
introduce GM foods have to obtain a certification from the Genetic
Engineering Approval Committee (GEAP) before they can be introduced.

To cite an instance, Bt cotton is a genetically modified seed that has
been granted permission in India and is gaining popularity among cotton
farmers because of its resistance against bollworm.

Making a few suggestions about GM foods, Ghosh stated that foremost, it
is the responsibility of the government to ensure safety of GM foods.

"Companies also must give complete information on processes through which
a GM food has been developed, he said.

Ghosh added that the government must publish a list of 'safe genes',
which means that once a gene is notified as safe, companies will not be
required to seek approval from the authorities every time they want to
introduce it into the market. "There is also a need to put in place a
mechanism to monitor GM foods for implicated long term risks," felt Ghosh.

Preventive measures

- With genetically modified foods likely to be produced in the country
soon, there is a need to bring these under the purview of the PFA Act, as
these can be toxic, allergic
- GM foods are those that are made from genetically modified organisms
such as plants, animals and micro organisms
- It is the responsibility of the government to ensure safety of GM
foods, Ghosh said

                                  PART III
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TITLE:  India to Promote GMO Crops
SOURCE: Reuters, Atul Prakash
DATE:   3 Sept 2004

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INTERVIEW: India to Promote GMO Crops

NEW DELHI - India plans a new policy promoting speedy approval of GMO
crops to boost yields and feed its growing population, a government
minister said.

The policy, which should be in place within eight to nine months, would
also promote foreign and private sector investment in the biotechnology

"We intend to have a biotech policy as quickly as possible to supply to
the farmers pest-resistant and drought-resistant seeds with high
nutritional values," Kapil Sibal, federal science and technology
minister, told Reuters in an interview.

The debate on biotech grains has intensified worldwide, with advocates
saying they could lead to a more secure future for food, while opponents
say they could produce new toxins and allergens, affecting the health of

India opened the door to genetically modified organism (GMO) technology
in 2002 after years of trials and allowed Maharashtra Hybrid Seeds Co.
(MAHYCO), in which U.S. biotech giant Monsanto Co. owns a 26 percent
stake, to sell transgenic cotton.

It may take many years for the approval of a second GMO crop. Sibal said
at least seven GMO crops, including rice, potatoes and mustard, were
being field-tested in India.

"But these products are six to seven years down the line," he said,
adding that the government would seek to speed up the approval process
for biotech products. The new policy would emphasize the use of
biotechnology to increase food grain production to take care of India's
growing food needs, the minister said.


"By 2025, we will have to produce 420 million tonnes of food grains to
feed our population. That means we have to increase our (crop)
productivity twice just to meet the demand of our people," Sibal said,
adding that any surplus could be exported.

India, with more than 1 billion people, produces about 200 million tonnes
of food grains every year.

Sibal said the government would like to collaborate with foreign entities
in setting up joint ventures for research and development of
biotechnology in the country.

Crop yields have been falling in India since the 'green revolution' of
the 1960s, he said, adding that hybrids were no longer an option to boost
farm output as excessive use of fertilizers had changed soil composition.

The green revolution helped the country lift grains production by using
hybrid seeds, fertilizers and pesticides in fields that were largely
irrigated. Nearly two-thirds of India's cultivable land depends on
monsoons for irrigation.

"If we apply best agricultural practices, we can in fact double our food
production, but that also will not be enough."

Sibal said the government planned to restructure the Genetic Engineering
Approval Committee, which has representatives from the ministries of
science and technology, environment and health.

The government was equally keen to have bio-safety standards in place,
and would only welcome private companies if such standards were complied
with, the minister said.

"Biotechnology and bio-safety must go hand in hand," he said.


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