FDA Approved Genetically Engineered Soy and Corn in Baby Food and Nutritional S

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http://greenpeaceusa.org/media/publications/babyfood.htm

 

FDA Approved: Genetically Engineered Soy and Corn in Baby Food and Nutritional

Supplements

 

Laboratory analyses commissioned by Greenpeace have revealed the presence of

transgenic DNA from genetically engineered (GE) foods in a popular brand of baby

foods and in nutritional supplements used for tube feeding in hospitals and

nursing homes. Gerber Mixed Cereal for Baby, a dry three-grain cereal mix for

infants, tested positive for DNA from transgenic insect resistant " Bt " corn and

herbicide tolerant " Roundup Ready " (RR) soybeans. The two supplements, Novartis'

IsoSource and Ross Products' Osmolite both contained transgenic DNA from RR soy.

 

In addition to commissioning the analyses, Greenpeace sent a questionnaire to

these and other makers of baby foods and supplements, requesting information

about their policies regarding genetically engineered ingredients. The survey

questions and responses are detailed in Appendix IV.

 

The British Medical Association (BMA), which represents over 115,000 doctors,

released a report last month calling for a moratorium on the introduction of GE

crops into the environment and food chain. Among other concerns, the BMA noted

the potential for altered plants to add to the spread of antibiotic resistance,

to lead to new and untraceable allergies, and to contain toxic by-products. The

report suggests that precautionary action should be taken " for the foreseeable

future...until the health and environmental impact of genetically modified

organisms are fully assessed.... " 1

 

The altered corn found in the Gerber cereal includes genes that produce a

bacterial toxin, Bacillus thuringiensis (Bt). When genetically altered Bt plants

grow, they produce the toxin, which is an insecticide farmers use to ward off

certain pests. In 1991, Dr. Rebecca Goldberg outlined the kind of assessment

that should be required of Bt plants and stated, " …There is insufficient

evidence to conclude that Bt plants should be accepted for human consumption. " 2

Yet the Food and Drug Administration (FDA) has never required the kind of

comprehensive testing Dr. Goldberg suggested.

 

Instead, the FDA relies on the industry to voluntarily assess the safety of its

products, despite the fact that the industry has not conducted long-term tests

for effects on human health. The industry relies on chemical analyses or

short-term animal feeding studies that typically last no more than ten weeks. No

independent testing or review of industry data is required, and often studies

are unpublished, making critical scientific analysis impossible.

 

Dr. Michael Hansen of the Consumers Policy Institute, a division of Consumers

Union, has criticized the FDA policy for requiring industry " to make judgment

calls that should be done by an agency with no commercial interest in the

outcome and which is accountable to the public. " He also noted that during the

comment period prior to the agency's adopting this policy, the FDA received

opposition to the proposal from the American Association of Retired Persons and

the attorneys general of eight states, as well as over 4,000 public comments,

most of which called for GE foods to be labeled.3

 

Problems with company testing have already been exposed. The RR soybeans, found

in the Novartis IsoSource and the Ross Products Osmolite, as well as the Gerber

baby food, are grown with direct application of Monsanto's flagship product, a

toxic weed killer called Roundup. Yet the FDA approved the engineered soy based

on Monsanto's tests of RR soybeans grown without any application of the

chemical. This lack of proper testing prompted two Australian scientists to

write to the FDA, saying, " Without [such] basic studies, the FDA is in no

position to vouch for the safety of this controversial product now pervading the

diet of millions of unwitting consumers. " 4

 

The FDA has also been criticized at home for its lax approach to the issue of

allergens and GE foods. The FDA does not require genetically engineered foods to

be labeled unless an inserted gene comes from a source that is known to be

allergenic, or if the food is nutritionally changed. Writing in the New England

Journal of Medicine, Dr. Marion Nestle states, " Because FDA requirements do not

apply to foods that are rarely allergenic or to donor organisms of unknown

allergenicity, the policy would appear to favor industry over consumer

protection. " 5

 

More recently, the FDA proposed a policy for industry regarding the use of

antibiotic genes in transgenic plants. In the engineering process used for many

altered plants, scientists need a way to determine whether the gene insertion

procedure is successful. Antibiotic resistance genes are used as a " marker " to

help determine the success of the gene insertion.

 

In its guidance to the industry, the FDA begins with the premise that " …the

likelihood of transfer of an antibiotic resistance marker from plants to

microorganisms in the gut or in the environment is remote and…would not add to

existing levels of resistance in bacterial populations in any meaningful way. " 6

 

Yet in an article in La Recherché several months before the FDA's proposal was

announced, the chief expert on antibiotics from the French Pasteur Institute

noted the likelihood for antibiotic resistance to transfer from altered plants

in the environment, and the potential for such transfer in the digestive tract.

In " Transgenic Plants and Antibiotics, " Dr. Patrice Courvalin states, " We must

remember that the opportunities for genetic exchange between living organisms in

nature are immense….The intensive cultivation of plants carrying a resistance

gene does result in the presence, in higher numbers, of this gene in nature,

thereby creating the conditions for its evolution and dissemination. " 7

 

In one alarming statement in its guidance to industry, the FDA suggests that in

the case of the potential for inactivation of an antibiotic through ingestion of

an engineered food, " …advice could be provided that the antibiotic…should not be

taken together with food. " 8 It is striking that the FDA would propose labeling

drugs to protect consumers against the effects of GE foods, when the agency is

unwilling to protect consumers by requiring labeling of the foods.

 

In his paper, Dr. Courvalin also noted that certain common soil bacteria that

may take up antibiotic resistance genes from plants, such as Acinetobacter, are

among the bacterial species responsible for infecting individuals with depressed

immune systems. A 1998 laboratory experiment demonstrated that gene transfer of

antibiotic resistance genes could occur from genetically engineered sugarbeet to

Acenitobacter, making the bacteria resistant to this antibiotic.9 Dr. Courvalin

warned that the elderly, patients with AIDS or leukemia, and those undergoing

chemotherapy or other intensive care might be most at risk if such resistance

spreads.10

 

Finally, there are serious concerns regarding toxins that may result from

genetic engineering. Dr. Goldberg noted that the Bt toxin in plants differs from

the already challenging problem of pesticide residues in food in that " they

[are] integral components of plants, pesticides wary consumers cannot wash

off. " 11 Other scientists have raised the concern that RR soybeans may have

altered levels of phytoestrogens, a change that could be particularly harmful to

children.12

 

The potential for unintended toxicity resulting from genetic transfers is the

focus of a fierce debate over the results of a study done by Dr. Arpad Pusztai

last year. Pusztai found that rats fed with genetically engineered potatoes

suffered damaged immune systems and stunted growth of vital organs. The cause of

these deficiencies remains undetermined, though, and scientific reviews have

both challenged and supported Pusztai's data.

 

One reviewer, who joined 21 other scientists in a memorandum in support of

Pusztai earlier this year, is Dr. Vyvyan Howard, a fetal and infant

toxopathologist from the University of Liverpool. Dr. Howard was recently quoted

in Scientific American as saying that Pusztai's results show that GE foods could

result in " …long-term, low-dose toxicity from subtle changes to the nature of

the food chain…. It is precisely this type of finding which means that animal

testing for developmental toxicological effects is essential. " 13

 

Conclusions

 

 

 

Gerber is the largest selling brand of baby foods in the country. As such, the

company has a responsibility to take the lead in assuring parents that the food

they purchase for their children is safe. Other baby food companies and much of

the food industry in general would likely follow the lead of this iconic

American company, were Gerber to commit to providing GE-free food. Ross

Products, Novartis, and other companies that produce medical foods must also

take special care to ensure that those who are particularly at risk are not

exposed to potentially hazardous foods.

 

Novartis, as a leading producer of engineered crops as well as a leading baby

food company, must be especially sensitive to the impression it gives when it

fails to provide information about the foods it produces for American children.

Even the appearance that its experimental crops are being dumped in our

children's food, because the rest of the world will not accept the risks, is

unacceptable. Last August, the Swiss baby food company Wander, which is also

owned by Novartis, immediately withdrew an organic baby food from the market

when it was found to contain transgenic DNA from soy.14 Swiss-based Novartis is

also the world's leading pharmaceutical company, making its use of antibiotic

resistance genes in its engineered plants all the more disturbing.

 

All food producers should follow the lead of dozens of supermarket chains,

restaurants and global food manufacturers, which are declaring their intention

to avoid genetically engineered food in their products (see Appendix II for a

summary). These foods offer no benefits to consumers, yet it is consumers and

their children and families who bear the risks.

 

Governments around the world are also taking action to protect the public and

the environment from the irreversible consequences of GE (see Appendix III). In

Italy, a presidential decree from March 31, 1999 stated that food products for

infants or children " must not contain pesticide residuals greater than 0.01

mg/kg or genetically modified ingredients. " In the United Kingdom, local

authorities from Kent, Surrey, Oxfordshire, North Tyneside, Southampton and

Lodon's Lambeth have banned GE foods from their schools.

 

It is well past time for our government to ensure the safety of our food supply

by requiring independent, long-term environmental and health testing for all

genetically engineered foods. Our ailing loved ones, our elderly, and our

children must not be guinea pigs in this experiment on our food.

 

A Note on the Testing Procedure

 

 

 

Baby foods were purchased at major grocery stores (Food Emporium, Gristedes,

Pathmark) and independent markets in the New York metro area. Tube feeding

formulas were purchased at a pharmacy (Ricky's Drug Store, NYC) and through a

nursing home supply company.

 

Eight samples were sent in their original packaging to RHM Technologies for

qualitative analysis. Earlier this year, this company announced its development

of a highly sensitive and accurate method for detecting genetically modified DNA

in processed foods. RHM uses PCR testing combined with techniques that " clean

up " food samples of substances (salt, carbohydrates, and other common food

components) that can inhibit the accuracy of PCR testing. Its process has also

been amplified, enabling detection of DNA in complex foods. See Appendix I,

" Detection of Genetically Modified Ingredients in Food, " for further information

from RHM about its testing procedures.

 

 

1British Medical Association, The Impact of Genetic Modification on Agriculture,

Food and Health, May 1999.

 

2Rebecca Goldberg & Gabrielle Tjaden, Are Btk Plants Safe to Eat? (Global

Pesticide Campaigner, January 1991).

 

3Michael Hansen, A Regulatory Patchwork - With Big Holes (The Environmental

Forum, March/April 1999), pp. 50-51.

 

4Ute Baumann and Stanley Robert, Letter to FDA, cited in The Guardian (UK), May

24, 1999.

 

5Marion Nestle, " Allergies to Transgenic Foods - Questions of Policy, " The New

England Journal of Medicine, vol. 334, #11, March 14, 1996.

 

6FDA, " Guidance for Industry: Use of Antibiotic Resistance Marker Genes in

Transgenic Plants, " 1998, www.fda.gov (docket #98D-0340).

 

7Dr. Patrice Courvalin, " Transgenic Plants and Antibiotics, " La Recherche 309,

May 1998 (translated by Elisabeth Abergel for the Edmonds Institute).

 

8FDA, " Guidance for Industry, " 1998.

 

9Gebhard F. and Smalla K. (1998), Transformation of Acinetobacter sp. strain

BD413 by transgenic sugar beet DNA, Appl. Environ. Microbiol. 64, pp. 1550-1559.

 

10Courvalin, 1998.

 

11Goldberg, 1991.

 

12Marc A. Lappé, Ph.D., Britt Bailey, M.A., Chandra Childress, M.S., & Kenneth

D.R. Setchell, Ph.D., " Alterations in Clinically Important Phytoestrogens in

Genetically Modified, Herbicide-Tolerant Soybeans " (Pre-publication abstract),

Journal of Medicinal Food (Vol 1., no. 4), Maryanne Liebert Publishers); see

also Lappé and Bailey, Genetically Engineered Soya: Contaminating the Great

Treasure (Center for Ethics and Toxics, 1997).

 

13Peta Firth, " Leaving a Bad Taste, " Scientific American, May 1999, p.34.

 

14Wander AG press release, August 25, 1998: " Wander AG Replaces Mamina Brand Soy

Products. "

 

APPENDIX I: DETECTION OF GENETICALLY MODIFIED INGREDIENTS IN FOOD

 

RHM Technology Ltd.

The Lord Rank Centre

Lincoln Road, High Wycombe

Buckinghamshire HP12 3QR

ENGLAND

Contact: Anne Kaye, Marketing Coordinator

Dr. Gordon Wiseman, Biochemist

Telephone : +44 (0)1494 526191

Faxcimile : +44 (0)1494 428080

www.rhmtech.demon.co.uk

 

The Background

 

 

 

RHM Technology has developed a highly sensitive quantification test for

genetically modified (GM) materials in ingredients and finished products.

 

Genetic modification of food is one of the most controversial issues currently

confronting the food industry. Current legislation (EC No 1139/98), which came

into effect on the 1st September 1998, requires products containing any

genetically modified material, irrespective of the level present, to be labelled

with, for example, 'produced from genetically modified soya.' The European Union

(EU) is currently producing a proposal for threshold levels for labelling, to

take into account the presence of GM material by adventitious contamination. It

is likely that the threshold level will be in the region of 1-2%.

 

RHM Technology has made a significant investment in state of the art

instrumentation and methodology that not only enable the detection of GM

materials to extremely low levels, typically 10ppm in ingredients and 100ppm in

processed materials, but also accurately quantifies the GM material present.

 

Why RHM Technology?

 

 

 

RHM Technology is well positioned to offer this service, having many years'

experience in the application of molecular biological techniques on behalf of

major organisations. RHM Technology provides an engineering, food technology,

information and scientific service to the food industry. With over 130 staff,

RHM Technology is today one of the largest food industry technology centres in

the United Kingdom.

 

The Techniques

 

 

 

Using highly sensitive techniques, such as the polymerase chain reaction (PCR),

extremely low levels of DNA can be detected, typically less than 1ng of DNA in

1g (1ppb) of material.

 

However, such highly sensitive techniques are not without their potential

problems. The PCR test is very susceptible to inhibitory factors such as salt,

calcium, carbohydrates and polyphenolics commonly found in foods. At RHM

Technology we employ stringent techniques to exhaustively " clean " up analytes,

and sequential dilutions are used to overcome inhibitors. Failure to remove

these inhibitors will lead to false negative results with potential

embarrassment if products are subsequently found to contain GM materials.

 

Unlike analyses available elsewhere, our DNA primer sets have been extended to

amplify smaller DNA fragments than other laboratories, enabling detection of

heat degraded GM sequences in processed food. This enables us to offer a highly

sensitive service that goes beyond the straightforward analysis of ingredients

to include the analysis of GMOs in difficult and complex food matrices such as

oils and finished products. By further incorporating a normalising control we

are able to extend the highly sensitive PCR detection method to provide an

accurate quantification of GM material present.

 

All our procedures include stringent positive and negative controls to support

the validity of our results.

 

APPENDIX II: SUMMARY OF FOOD INDUSTRY ACTION TO AVOID GE FOOD

 

Austria

Unilever Austria announced that it would not use GE ingredients for the

foreseeable future. Three other major manufacturers and four large supermarket

chains announced their commitment to avoiding GE ingredients.

 

Belgium

A leading supermarket, Delhaize Le Lion*, has committed to eliminating GE foods

from its store brands.

 

France

Three major supermarkets, including leaders Carrefour* and Auchon, committed to

keeping GE ingredients out of their store brand products. Four food companies,

including baby food maker Vitagermine, committed to making their products

GE-free.

 

International

Kraft Jacobs Suchard and Danone, two of Europe's largest food companies, stated

that they would not use GE ingredients in their products sold in Europe.

 

Ireland

The largest supermarket chain, Superquinn*, committed to eliminating GE

ingredients from its store brand products.

 

Italy

Two major supermarket chains, including Esselunga*, committed to eliminating GE

ingredients in store brands. The food company Barilla also declared it would not

use GE ingredients.

 

Spain

Nestle Spain announced its company policy is neither to sell nor produce food

with GE ingredients. The country's largest supermarket chain, Pryca, committed

to eliminating GE ingredients from its store brands.

 

Switzerland

Two major supermarket chains, including Migros*, committed to eliminating GE

ingredients in their store brands. Two major food companies and two food

industry associations declared measures to avoid GE food.

 

United Kingdom

Nestle UK, Unilever UK and Cadbury committed to eliminating GE ingredients from

the food products they sell in the UK. Top grocery chains, including Tesco (the

largest chain), Sainsbury*, Safeway, Marks & Spencer*, Iceland and Asda

committed to eliminating GE ingredients from their store brands.

 

United States

Several natural food companies have taken steps to avoid GE food. Hain Foods

reformulated its corn chip recipe to avoid GE soy. Eden Natural Foods has stated

in advertising that their products will not contain GE ingredients.

 

Chefs Collaborative 2000, representing 1,500 chefs nationwide, joined Greenpeace

last fall in calling for GE foods to be labeled and subject to safety testing.

 

*Denotes that the company is a member of a consortium of European supermarkets

organized by Sainsbury (UK), which joined together in March 1999 to assure

sources for non-GE ingredients for their products.

 

APPENDIX III - SUMMARY OF GOVERNMENT ACTIONS ON ENGINEERED PLANTS

 

Australia/New Zealand

In December 1998, the Australia-New Zealand Food Standards Council called for

mandatory labeling of GE food.

 

Austria

Austria banned the import of Novartis' Bt corn in 1997. No commercial GE crops

are being grown. Austria also banned Monsanto Bt corn in May, after a Cornell

University study showed the crop could adversely affect monarch butterflies.

 

Brazil

In March, Brazil's second-largest soybean growing state, Rio Grande do Sul,

announced its intention to ban the planting of GE crops. The Brazilian

Environment Ministry joined a Greenpeace lawsuit to stop the planting of biotech

crops in Brazil until full impact assessments are done.

 

European Union

The EU enacted legislation requiring the labeling of GE foods last September.

Though well ahead of U.S. regulations, the law contains loopholes that allow

many products produced with GE ingredients to remain unlabeled. In February of

this year, the European Parliament called for stronger requirements and for

manufacturers to be legally liable for damage to health or the environment from

GE crops.

 

France

A de facto ban on cultivation of GE crops is in effect, since the High Court

ruled last December that a case brought by Greenpeace raised issues that should

be resolved at the EU level.

 

Greece

In April, the Greek Environmental Ministry blocked the approval of seven GE

crops, including Monsanto cotton and corn varieties. The Greek government also

called for an EU-wide moratorium on GE crops.

 

Luxembourg

Luxembourg banned the import of Novartis' Bt corn in 1997.

 

Switzerland

In April, the Swiss Federal Environmental Agency rejected applications for field

trials of GE corn and potatoes, stating that the safety of the GE corn for human

health and the environment cannot be demonstrated with the current scientific

evidence and experience.

 

United Kingdom

Last October, the UK government reached a voluntary agreement with industry on a

three year moratorium on commercial planting of GE crops.

 

APPENDIX IV - FOOD COMPANIES SURVEYED BY GREENPEACE

 

 

 

The companies listed below were asked the following questions regarding their

products:

 

Do you use genetically engineered (GE) ingredients or products derived from GE

organisms in your products?

If yes, which products contain GE ingredients?

If no, what steps have you taken (if any) to ensure that you are not using GE

ingredients?

 

Do you currently inform your customers whether you use GE ingredients or

products derived from GE organisms in your products?

If no, do you plan to do so in the future?

 

Are you interested in finding sources for ingredients that are NOT produced with

genetic engineering?

 

Would you like more information from Greenpeace on sources for non-GE

ingredients, labeling, or other issues related to biotechnology?

 

 

 

As of the writing of this report (6/10/99), only Healthy Times Natural Foods had

responded in writing. The company faxed its answers and followed up with phone

conversations. Healthy Times states that it does not use GE ingredients, and

that it will inform its customers with a note on thei packaging. Organic Baby

spokesperson Rick Keller told us in a phone conversation that his company relied

on Oregon Tilth certification standards, which exclude the use of GE foods, to

assure that the company's products are GE free.

 

Nestle, USA Inc.

Chair and CEO Joe Weller

800 N. Brand Blvd.

Glendale, CA 91203

Tel: 818-549-6000

Fax: 818-549-6952

 

Novartis Nutrition Corporation

CEO Michael Valentino

5100 Gamble Drive

Minneapolis, MN 55416

Tel: 612-925-2100

Fax: 612-593-2087

 

Ross Products

President Joy Amundson

6480 Bush Blvd.

Columbus, OH 43215

Tel: 614-624-7677

Fax: 614-624-0030

 

Mead Johnson

President Christopher White

Evansville, IN

Tel: 812-429-5000

Fax: 812-429-7538

 

Beech Nut Nutrition Corporation

Milnot Company

CEO Scott Meader

100 S. 4th Street

St. Louis, MO 63102

Tel: 314-436-7667

Fax: 314-436-7679

 

Gerber Products

Jan Relford, VP Public Affairs

445 State St.

Fremont, MI 49412

Tel: 616-928-2000

Fax: 616-924-6724

 

Earth's Best - A Division of HG Heinz

PO Box 28

Pittsburgh, PA 15230

Tel: 800-442-4221

Fax: 412-237-4230

 

Organic Baby - Glacier Foods

1117 K Street

Sanger, CA 93657

Tel: 559-875-3354

Fax: 559-875-3179

 

Healthy Times Natural Foods

13200 Kirkham Way

Building 104

Poway, CA 92064

Tel: 619-513-1550

Fax: 619-513-1533

 

 

 

 

 

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