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6-Regulations: U.S. advisor in India: "We don't believe in process labelling"



                                 PART I
------------------------------- GENET-news -------------------------------

TITLE:  "We don't believe in process labelling"
SOURCE: The Hindu, India, by R. Prasad
        http://www.hindu.com/seta/2006/02/02/stories/2006020200411600.htm
DATE:   02 Feb 2006

------------------ archive:  http://www.genet-info.org/ ------------------


"We don't believe in process labelling"

This is the first time that Madelyn E. Spirnak, Senior Advisor for
Agricultural Biotechnology, U.S. Department of State, is visiting India.
In an interview during her recent visit to Chennai, she spoke about
various issues concerning genetically modified crops. Excerpts:

FOCUS AREAS: "It is important for this [Indian] Government to work on
crops with salinity and drought resistance, and enhanced nutrition,"
says Madelyn Spirnak.


What brings you to India?

I primarily travel to different countries to discuss agriculture
technology products as a developmental tool to increase production in
developing countries and to also talk about regulatory policies. India
is an important country in so many ways.


There has been so much resistance to genetically modified (GM) crops in
European countries and a few other countries. How do you intend to
overcome it?

I think we hear a lot about resistance. We don't hear a lot about
acceptance and how widely it is being used. In Europe, just over three
years, three more countries are growing GM crops.

Critics of the technology may criticise it because the technology is new
and it is unknown and there is a fear of the unknown, which is a normal
human fear. But the science has been tested for over ten years. We [the
U.S.] first commercialised Bt [Bacillus thuringiensis] cotton in 1996.


The Bt cotton crop failed in Andhra Pradesh and some other states.
Commercial cultivation of three varieties in Andhra Pradesh has not been
allowed. Your comments.

I don't know about it specifically and I don't have details of the case.
So I don't want to talk about something I don't know. But my information
is farmers, on the whole, are supportive of Bt cotton.

The yields have increased significantly and the acreage was 500,000
hectares in 2004 throughout India. In 2005 that increased to 1.3 million
hectares. It is a significant increase for a one-year period. So that
must indicate that farmers are interested in using the technology.

I am not an India expert, but I have heard and I understand that there
were other conditions that led to problems with cotton crops that were
not connected with the gene technology. Climatic conditions like drought
or rain, where many crops failed not just the Bt cotton.


Many studies that show positive results in India are either done by seed
companies or are funded by them. How much of objectivity can we expect
from such studies?

Any regulatory process has to look at the studies and make some
determination. As I understand, States determine which varieties have to
be licensed. That is the [State's] responsibility to determine that an
appropriate variety is being used. I don't want to get into the ethical
issues. That is not the issue here.


There is a need to have refuge when growing GM crops. But with the
average land holding in India being small, how relevant is GM technology here?

I think the technology has to be used properly. If the farmer thinks he
would profit he would buy it. Maybe the technology is not appropriate
for all farmers. But then they should have a choice if the Government
has conducted the tests and determined that the technology is safe.

If you have a science based regulatory system, you have adequate
transparent risk perception process that can establish some confidence
about the product. And if the process has deemed that the technology can
be used, then it should be a choice for the farmer whether or not to use
it. But you need to have a regulatory process in place.


There is widespread apprehension that pests would develop resistance
faster to GM crops and weeds would become superweeds. Your comments.

Many fear about resistance. On resistance, let me mention I am not a
scientist; I am a diplomat and not a farmer either. So I will tell you
what I know. Resistance is an issue for any herbicide or pesticide.

So you have to follow certain methods to reduce the chances of
resistance. So you need to have refuge, you need to follow integrated
pest management to reduce the chances of losing the efficacy of the
herbicide or pesticide.

So I don't think anyone can say that any one method of herbicide is
going to last forever. So you need to think about the next generation.
That is one answer.

I have read about some instances where there may be some weeds
developing resistance but don't think it is a situation that is
widespread. So you need to be always thinking ahead.

But we focused much on Bt and Roundup Ready. There is the next
generation of biotechnology that is being developed to increase
nutrition. There is a project in existence for a while for golden rice
to increase betacarotene.

There are projects going on in the U.S. to increase starch and reduce
sugar in crops. So there is great promise in the technology beyond the
issues of herbicide and pesticide. And it is important for this [Indian]
Government to work on crops with salinity and drought resistance, and
enhanced nutrition.


There have been instances where the yield from GM crops has been less
compared with conventional crops. Your comments.

Whether it was a gene or hybrid variety that was not an appropriate
variety, I don't know. I don't believe from what I have heard that the
cause for failure has to do with the transgenic nature of the crop.


Monsanto was fined $1.5 million under the (U.S.) Foreign Corruption Act
last January for bribing Indonesian officials. So is the apprehension
about its track record unjustified?

I don't want to talk about any specific company or case. We have strong
anti-corruption Act [in the U.S.]. So all companies know that they need
to comply, else they will be fined.

Public attitude towards the company has been influenced by negative
stories and certain incidents and by the way the media has projected
them. The media wants to find a story. It is interested in cases that
interest the public. We don't hear of successes of different countries
growing Bt cotton; those are ones that don't come up all the time but
negative stories do.


Why is the U.S. very much against labelling GM food?

In the U.S., we have a policy. If you have a final product that is a
substantial equivalent to a conventional product, you need not have to
label that it contains GMOs [genetically modified organisms] just
because it is a product of GMO; it is a process involved. At the end of
the day, it is considered equivalent to the conventional product and so
we don't believe in labelling.

On the other hand, if you have nutrient enhanced product or a product
that contains allergens or toxin, then labelling is required. So we
don't believe in process labelling and that is the difference between
the U.S. and other countries.

Products can be labelled as a marketing issue, or companies or retailers
can choose to label, but it is not a requirement.


But why is the U.S. against labelling even for exports?

Because it would increase costs to producers as well as consumers. As I
told you, nearly 90 per cent of soybean, 80 per cent of cotton and 50
per cent of maize are GM [in the U.S.]. We don't segregate [GM and non-
GM food].

So if you are requesting a shipment which has no GM or you just have a
threshold for GM ingredient, then you are requesting special handling.
That will increase costs.

Some people might say, why don't you want the consumers to know and the
question is what will it help to know if it has been produced by a
certain process. It doesn't change the product. Because we believe there
is no substantial difference between GM and conventional product.


What will be your stance in the continued opposition to GM food in
Europe due to the labelling issue?

The EU will import soybean, will grow corn and will import processed
food with some ingredients produced through GM technology.

But it will be a costly and difficult process to sell this product to
the EU now as it has to be labelled to meet EU requirements.



                                 PART II
------------------------------- GENET-news -------------------------------

TITLE:  National Regulations Should Reflect Risks of GE Crops
SOURCE: Biopspectrum, India, by Arpad Pusztai
        http://www.biospectrumindia.com/content/columns/10601061.asp
DATE:   06 Jan 2006

------------------ archive:  http://www.genet-info.org/ ------------------


National Regulations Should Reflect Risks of GE Crops

Arpad Pusztai
Scientific Consultant to GenOk, Tromso, Norway

National Regulations Should Reflect Risks of GE Crops

Engineered artificial gene constructs may undergo mutation and evolution
to an end, therefore making the safety assessment of GE crops an
exercise without a firm predictive scientific basis.

Acceptance of products and associated agricultural practices of the
biotechnology industry is running into problems, probably due to the
perception held by many scientists that the technical ability of
biotechnology industry to produce safe genetically engineered (GE) crops
has developed faster than the understanding of the underlying scientific
principles of gene splicing. Consumers and scientists alike feel that
the possible consequences for health and environment of the spread of GE
crops are not properly understood and that without sufficient research
funding and having generally agreed methodologies for assessing the
unique risks of GE crops, we shall never be able to properly address
them. It should not be surprising that societal concerns about genetic
engineering of something as basic as our food and how they are produced
are high and no matter of patronizing platitudes by the scientific,
political and industrial establishments will make these concerns to go away.


Bizzare approach

The approach of the biotechnology industry to the safety of its products
or the understanding how society perceives risk is bizarre. The harsh
treatment of sceptics and dissident scientists does not demonstrate the
establishment's great willingness to listen to views not in tune with
their pre-set ideas. Openness is not much helped either that due to the
high cost of biological testing, biotechnology companies only do minimal
and superficial environmental and health risk assessments. Cost will
also be a major factor in their reluctance to finance research to
develop scientifically sound methodologies but rather they prefer to
declare the present agricultural practices to grow GE crops as safe and
that foods prepared from them present no risks for the consumer. The
fact that in the decade since the introduction of GE crops only one
human feeding study has been conducted and basic academic animal
nutritional/toxicology studies published in peer-reviewed journals are
also few and far between gives plenty of ammunition to those who oppose
GE crops.

Presently there is an intensive scientific and legislative debate in
many countries, including India, about the possibility of the large-
scale growing of GE crops without jeopardizing the GE-free status of
organically or conventionally grown crops. Pro-industry scientists
advocate that even with cross-pollinating crop species only a few metres
of separation distance between GE and non-GE crops will be adequate to
prevent genetic pollution. However, in the laboratory to prevent the
escape and proliferation of untested experimental GE organisms, all
developmental work is strictly contained. Moreover, to guarantee the
purity of certified seeds even the industry specifies considerably
larger separation distances. Thus, for contract growers of certified
hybrid seeds, such as hybrid corn, distances of 400 m or more are
demanded. In contrast, the biotechnology industry proposes to release GE
crops into the environment without adequate biological controls to
prevent their dispersal or the artificial transgenes they express.
According to their proposals, the strict safety guidelines that apply to
GE organisms in the laboratory are not deemed to be necessary when these
are grown in open fields, but without scientifically justifying this
double standard in safety conduct. One might consider that even more
stringent safety controls should be enforced in the natural environment
than in the laboratory, particularly as we do not have a backup with
products of this irreversible technology. Moreover, there is already
sufficient evidence to show that engineered artificial gene constructs
may undergo mutation and evolution to an end that we are not aware of,
and therefore making the safety assessment of GE crops an exercise
without a firm predictive scientific basis. Indeed, one cannot safety
assess something that has not yet evolved.


Genetic contamination

In the absence of adequate methods to remove inserted transgenes, once
the seeds are genetically contaminated, it will be nearly impossible to
recover the original uncontaminated seed stock. Under the regulatory
systems of most countries, testing of seeds for genetic contamination is
done after the event and not before. In the USA and Canada the whole
seed system has become contaminated after ten years of large-scale
commercialisation of GE crops. Thus, even though only about one percent
of the corn seeds sown in Iowa (USA) was StarLink, in the absence of
adequate separation between the GE and non-GE cornfields and segregation
of the seeds after harvest, about 50 percent of the corn produced
contained the StarLink transgene, demonstrating that coexistence of GE
and non-GE crops is impossible. The proposal by the MS Swaminathan Task
Force that regions in India representing either primary or secondary
centres of genetic diversity for major crops such as rice should be
conserved for posterity as "agro-biodiversity sanctuaries" and "organic
farming zones", is manifestly impractical and will not stop the genetic
contamination of rice crops in other areas. In a democracy once the
floodgates are opened it is impossible to control who grows what. It
also means that other parts of the country will be opened up for GE
crops. This therefore is nothing but a back door entry to introduce them
by a slight of hand which, on the face of it, appears to give false
assurances to people that there is no threat at all that genetic
contamination will spread in the country.


Risks of GEOs

In order to satisfy the legitimate demands of the scientific community
and society any large-scale growing of GE crops and their coexistence
with crops grown using traditional and organic agricultural practices
must be based on or at least take into account the scientific guidelines
as laid out very recently in the authoritative ESA (Ecological Society
of America) Report on the possible risks of GEOs (genetically engineered
organisms) because these may create new, and more vigorous pests and
pathogens; exacerbate the effects of existing pests through
hybridisation with related transgenic organisms; harm non-target species
of organisms; disrupt biotic communities, including agro- ecosystems;
cause irreparable loss or changes in species diversity or genetic
diversity. Therefore GEOs require greater scrutiny than crops produced
by traditional breeding

We shall also have to consider that GEOs may pose risks to the
environment because we have little or no prior experience with the trait
and host combination; GEOs may proliferate and persist without human
intervention; genetic exchange is possible between a transformed
organism and non-domesticated organisms; trait confers an advantage to
the GEO over native species in a given environment.

If these principles are not taken into account in proposed legislations,
the large-scale growing of GE crops can irreversibly harm our
environment by genetic contamination of our traditional crops and weeds
by cross-fertilization and by horizontal gene transfer respectively.
Moreover, in the absence of science-based regulation of the cultivation
of pesticide-producing (i.e. Bt-toxin) GE crops, the development of
resistance in pests to biopesticides which are also used in organic or
traditional agriculture will be speeded up. The uncontrolled large-scale
cultivation of herbicide-resistant GE crops will not only contaminate
our environment but also lead to the creation of herbicide-resistent
superweeds and thus increase rather than reduce the chemical-load of the
land and endanger our clean water supply.


Transparency

It is therefore not unreasonable to suggest that the environmental and
health risks or safety assessments of GE crops/foods should not be
carried out only by biotechnology companies but it must also be verified
by independent scientists through a transparent funding system. Any
controlling legislation must also be based on these assessments and
debated by all stakeholders in the society. The basic rule must be that,
since we all want to live in a healthy and natural environment and eat
foods which will not endanger our health, we are all entitled to
scrutinise the evidence relating to the safety of GE crops. Secrecy is
therefore against the public interest and unjustified. GE technology is
irreversible and therefore we have to seriously weigh up the pros and
cons of its introduction. In democracies it is the people's inalienable
right that they should be able to decide whether society can afford to
take on the very real risks and the possibly dangerous consequences of
genetic engineering for the possibly vain hope of some future benefits
for society.


                                 PART II
------------------------------- GENET-news -------------------------------

TITLE:  GM Food Labels Should Not Be Misleading
SOURCE: Biospectrum, India, by Kirit S Javali
        http://www.biospectrumindia.com/content/columns/10601061.asp
DATE:   06 Jan 2006

------------------ archive:  http://www.genet-info.org/ ------------------


GM Food Labels Should Not Be Misleading

Law Offices of Jafa & Javali is a full fledged Corporate law firm with
niche expertise in IPR & Biotech law, with offices in New Delhi,
Bangalore and Mumbai.
advocates@jafajavali.com

The debate over foods derived from GM crops often touches on the subject
of labeling. Ideally a label should not prejudice the consumer for or
against the product.

Labeling of genetically modified food and processed food using GMOs is
an equally important issue with respect to food safety. With food laws
being re-written by the Government of India, the proposal to enact a
Food Safety and Standards Bill, 2005 (draft Bill is under circulation
for comments) which will repeal a number of the existing food laws and
take out food safety from another eight Central and state laws, assumes
significance. The Ministry of Food Processing must be complimented for
bringing out a comprehensive legislation that brings food manufacturing,
its sale, and safety under a single umbrella. The proposed Bill also
provides for setting up of a National Food Safety and Standards
Authority, as well as provisions for setting up a Food Appellate
Tribunals at the Central and state levels, and a number of scientific
panels and committees.

The Bill is however, silent on the issue of labeling of food products
whether these are genetically modified or not. The Bill defines
genetically engineered or modified food to mean food and food
ingredients composed of or containing genetically modified or engineered
organisms obtained through modern biotechnology.

The debate over foods derived from genetically modified (GM) crops often
touches on the subject of labeling. Under the said Bill there is no
specific reference to labeling of genetically modified food. It provides
for a general definition whereby all food items should contain a label.
Many consumers argue and insist on their right to choose. As a result,
many governments across countries have begun to heed these suggestions
and have either implemented labeling regulations or are working on them.

Unfortunately, while the question seem simple, the issue is not,
especially if the starting point of labeling includes the process rather
than the final product. Issues such as safety, cost, truth in
advertising, choice, fairness, science, trade-barriers, regulatory
responsibility, accountability, legal liability, among others are involved.


Labeling policies

Before any labeling rules can be implemented, governments would have to
set up standards and services to conduct testing of the presence of GM
ingredients; certification; and ensure that the quality standards are
clear and achievable.

While it is easy to detect GM ingredients in products where the GM
ingredient is the main ingredient (like tofu or popcorn), it would not
be so easy to detect them in processed products like oils, sugars and
starches, which no longer contain any novel DNA or proteins.

On another note, much of the food that is bought and consumed in
developing countries is not packaged and consequently not labeled.
Examples are soybean milk from a street vendor or fresh fruits and
vegetables from the market.

Another issue that regulators have to grapple with is the wording:
ideally a label should not prejudice the consumer for or against the product.

There is also the issue of whether the label would be useful or
educational. To a homemaker who has heard little about the debate on GM
food, a label that reads, "Made from genetically modified soybean" or
"Grown from seed obtained through modern plant biotechnology" may create
more confusion.


International Approaches to Labeling

Codex: The Codex Alimentarius Commission implements the joint FAO-WHO
food standards program, the purpose of which is to protect the health of
consumers and to ensure fair practices in the food trade. In view of
this, it is pertinent to follow its rules and regulations in matters of
food safety and labeling. The decisions made by Codex have profound
effects on economics and health and well-being of citizens around the
world. The fact that 165 nations are members of Codex and this
membership represents 98 percent of the world's population, further
illustrates the great influence Codex has.

USA: The US has based their position on the doctrine of 'substantial
equivalence', where labeling would be necessary only if the food was not
substantially equivalent to a conventional food based on composition,
nutritional differences, toxicity and new factors like allergens and
intended use.

European Union/ UK: The EU, (The UK, France, Austria, Denmark, Holland,
Germany, Belgium, Finland, and Spain) position suggests a middle path,
opposed to the US doctrine of substantial equivalence. It favored safety
evaluation prior to market entry and mandatory labeling where the food
can have an impact on health like the presence of allergens and
substances not present in conventional foods.


Labeling Regulations in India

In some respects the existing Prevention of Food Adulteration Laws are
more stringent as compared to Codex standards e.g., vegetables oils,
butter and fats, permitted additives and food with special dietary uses.

Some of the laws for different types of products also come under
prevention of Food Adulteration Act, 1954 & Rules 1955. However, some
are voluntary and prepared by the Bureau of Indian Standards. Some of
them are as follows:


Agmark (Agricultural Marketing)

- Agmark products are free from adulteration and conform to the
scientifically laid down principles of purity. It ensures consumer protection.
- Each batch of Agmark products is pre-tested for quality in well-
equipped lab by quality control and specially trained chemist.


Fruit Products Order, 1955

- It includes sanitary requirements of a factory manufacturing fruit
products, specifications for the processing of various types of fruits,
sauces, vinegar, pickles, sun-dried and dehydrated vegetables, onions
etc. Rules have also been laid down on limits of poisonous metals in
fruit products, permissible harmless food colors. Preservatives and food
additives.


ISI Mark by BIS

- This is also voluntary. Any manufacturer can adopt it to ensure safety
of the product.


Labeling Provisions

In the larger interest of our country, with the burden of feeding an
ever-growing population, it is quite possible that genetically modified
crops and food with their potential benefits will enter the market in a
big way.

A reliable system of labeling demands an equally reliable system of
monitoring ingredients through the production chain. Labels should tell
consumers how and why these foods have been modified. The choice should
be left to consumers who should make a choice on the basis of his/ her
perception.


Verifiable Labeling

The proposed Food Bill should consider the aspect of labeling in terms
of the future when GM food may actually be permitted by the government.

The only way to develop and maintain a labeling system that is truthful,
not misleading, and verifiable is to ensure it is based on objective
criteria, such as the actual composition of the food, and not on the
method of manufacture.

--


GENET
European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
In den Steinäckern 13
D - 38116 Braunschweig
Germany

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