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FDA documents showing GMO hazards

_http://biointegrity.org/list.html_ (http://biointegrity.org/list.html)

 

 

 

INDEX:

KEY FDA DOCUMENTS REVEALING

(1) HAZARDS OF GENETICALLY ENGINEERED FOODS--AND

(2) FLAWS WITH HOW THE AGENCY MADE ITS POLICY

Alliance for Bio-Integrity HOME

 

 

About the Documents

 

 

You will see scanned reproductions (exact copies) of some of the Food &

Drug Administration' Drug Administration'<WBR>s (FDA) internal memoranda about

the hazards of genetically engineered foods. These documents became

available through the A Drug Administration'<WBR>s (FDA) internal memoranda

about

the hazards of genetically engineered foods. These documents became

available through the Alliance for Bio-Integrity'<WBR>s lawsuit (Alliance for

Bio-Integrity et al., vs. Shalala, et al.) to ga

 

 

How to View and Print

In order to make these documents easily accessible, we've saved each page

in two different formats: one intended for viewing on your monitor using

your internet browser (click on " View Document " ), and one formatted in PDF

suitable for printing onto a 8 1/2 " X 11 " sheet of paper (click on " Print

Document " ).

 

 

To print the PDF files you will need free software called Adobe Acrobat

Reader. If you don't already have Adobe Acrobat Reader, you can download it

.._here_ (http://www.adobe.com/products/acrobat/readstep.html) . Depending on

your computer and internet connection, downloading Adobe Acrobat Reader may

take up to fifteen minutes. You may find that the best way to view and

read the documents on your monitor is to select the PDF files; they are larger

files and therefore may take slightly longer to download, but the Acrobat

Reader enables you to enlarge or reduce the image size to fit your monitor.

 

 

 

A. FDA Scientists Discuss Various Safety Concerns

 

1.. Comments from Dr. Linda Kahl, FDA compliance officer, to Dr. James

Maryanski, FDA Biotechnology Coordinator, about the Federal Register document

" Statement of Policy: Foods from Genetically Modified Plants. " Dated

January 8, 1992. (3 pages) View Our

_View Our Summary_ (http://biointegrity.org/FDAdocs/01/index.html) - _View

Document _ (http://biointegrity.org/FDAdocs/01/view1.html) - _Print

Document_ (http://biointegrity.org/FDAdocs/01/01.pdf)

 

 

2.. Memorandum from Dr. Edwin J. Mathews to the Toxicology Section of the

Biotechnology Working Group. " Analysis of the Major Plant

Toxicants. " Dated October 28, 1991. (2 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/02/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/02/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/02/02.pdf)

 

 

3.. Memorandum from Dr. Samuel I. Shibko to Dr. James Maryanski, FDA

Biotechnology Coordinator. " Revision of Toxicology Section of the

Statement of Policy: Foods Derived from Genetically Modified Plants. " Dated

January 31, 1992. (3 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/03/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/03/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/03/03.pdf)

 

 

4.. Comments from Dr. Louis J. Pribyl re: the " Biotechnology Draft

Document, 2/27/92. " Dated March 6, 1992. (5 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/04/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/04/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/04/04.pdf)

 

 

5.. Comments from Dr. Louis J. Pribyl re: " ... the March 18, 1992 Version

of the Biotechnology Document. " Dated March 18, 1992. (1 page) _View Our

Summary_ (http://biointegrity.org/FDAdocs/12/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/12/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/12/ljpp.pdf)

 

 

6.. Comments from Division of Food Chemistry and Technology and Division

of Contaminants Chemistry. " Points to Consider for Safety

Evaluation of Genetically Modified Foods. Supplemental Information.6.. Comments

from

Division of Food C_View Our Summary_

(http://biointegrity.org/FDAdocs/10/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/10/view1.html)

- _Print Document_ (http://biointegrity.org/FDAdocs/10/10.pdf)

 

 

7.. Memorandum from Dr. Mitchell Smith, Head, Biological and Organic

Chemistry Section, to Dr. James Maryanski, Biotechnology Coordinator. Subject:

" Comments on Draft Federal Register Notice on Food Biotechnology, Dec. 12,

1991 draft. " Dated January 8, 1992. (2 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/07/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/07/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/07/07.pdf)

 

 

8.. Letter from Dr. James Maryanski, Biotechnology Coordinator, to Dr.

Bill Murray, Chairman of the Food Directorate, Canada. the safety

assessment of foods and food ingredients developed through new biotechnology.

Dated October 23, 1991. (2 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/06/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/06/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/06/06.pdf)

 

 

9.. Comments from Dr. Carl B. Johnson on the " draft statement of policy

12/12/91. " Dated January 8, 1992. (2 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/05/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/05/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/05/05.pdf)

 

 

10.. Memorandum from Dr. Gerald B. Guest, Director of the Center for

Veterinary Medicine, to Dr. James Maryanski, Biotechnology Coordinator. Subject:

" Regulation of Transgenic Plants--FDA Draft Federal Register Notice on Food

Biotechnology.10.. Memorandum from Dr. Gerald B. G_View Our Summary_

(http://biointegrity.org/FDAdocs/08/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/08/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/08/08.pdf)

 

 

 

 

B. Specific Objections to Use of Antibiotic-ResistanB. Specific Ob

 

 

11.. Memorandum from Dr. James Maryanski, Biotechnology Coordinator, to

Dr. Murray Lumpkin. " Use of Kanamycin Resistance Marker Gene in

Tomatoes. " (1 page)

_View Our Summary_ (http://biointegrity.org/FDAdocs/14/index.html) - _View

Document_ (http://biointegrity.org/FDAdocs/14/view1.html) - _Print

Document_ (http://biointegrity.org/FDAdocs/14/cfsanml1p.pdf)

 

 

12.. Memorandum from Dr. Murray Lumpkin to Dr. Bruce Burlington. Subject:

" The tomatoes that will eat Akron. " Dated December 17, 1992. (7 pages) View

Our Summary - _View Document_

(http://biointegrity.org/FDAdocs/15/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/15/mlbbp.pdf)

 

 

13.. Memorandum from Dr. Albert Sheldon to Dr. James Maryanski,

Biotechnology Coordinator. " Use of Kanamycin Resistance Markers in

Tomatoes. " Dated March 30, 1993. (3 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/16/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/16/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/16/ocderp.pdf)

 

 

 

 

C. Safety Questions Raised by Tests on the Flavr Savr Tomato--the Most

Thoroughly Tested Bioengineered Food

 

 

14.. Memorandum from Dr. Fred Hines to Dr. Linda Kahl. " FLAVR

SAVR Tomato: " ... " Pathology Branch's Evaluation of Rats with Stomach Lesions

From Three Four-Week Oral (Gavage) Toxicity Studies " ... " and an Expert

Panel's Report. " Dated June 16, 1993. (3 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/17/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/17/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/17/fhlkp.pdf)

 

 

15.. Memorandum from Robert J. Scheuplein, Ph.D. to the FDA Biotechnology

Coordinator and others. " Response to Calgene Amended Petition. "

Dated October 27, 1993. (3 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/11/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/11/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/11/schp.pdf)

 

 

16.. Memorandum from Dr. Carl B. Johnson to Dr. Linda Kahl & Others.

" Flavr Savr tomato; significance of pending DHEE question. " Dated

Dec 7, 1993. (1 page)

_View Our Summary_ (http://biointegrity.org/FDAdocs/20/index.html) - _View

Document_ (http://biointegrity.org/FDAdocs/20/view1.html) - _Print

Document_ (http://biointegrity.org/FDAdocs/20/flavrsavrp.pdf)

 

 

17.. Memorandum from Dr. Fred Hines to Dr. Linda Kahl. " FLAVR

SAVR Tomato " ... " Pathology Branch's Remarks to Calgene Inc.'s Response to FDA

Letter of June 29, 1993. " Dated December 10, 1993. (3 pages) _View Our

Summary_ (http://biointegrity.org/FDAdocs/18/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/18/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/18/fhlkdecp.pdf)

 

 

 

D. Additional Evidence of Improprieties In The Formation Of FDA Policy On

Bioengineered Foods

 

 

18.. Note from Dr. James Maryanski, Biotechnology Coordinator, to Mr.

Michael Taylor. " Food Biotechnology Policy Development.18.. Note from

Dr. James Maryanski_View Our Summary_

(http://biointegrity.org/FDAdocs/19/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/19/view1.html)

- _Print Document_ (http://biointegrity.org/FDAdocs/19/JMMTp.pdf)

 

 

19.. Document titled " FDA REGULATION OF FOOD PRODUCTS DERIVED FROM

GENETICALLY ALTERED PLANTS: POINTS TO CONSIDER " Not dated. (3 pages) _View Our

Summary_ (http://biointegrity.org/FDAdocs/21/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/21/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/21/fdaptcp.pdf)

 

 

20.. Memorandum from Dr. James Maryanksi, Biotechnology Coordinator, to

the Director of the Center for Applied Nutrition. " FDA Task Group on

Food Biotechnology: Progress Report 2. " Dated August 15, 1991. (1 page)

_View Our Summary_ (http://biointegrity.org/FDAdocs/22/index.html) - _View

Document_ (http://biointegrity.org/FDAdocs/22/view1.html) - _Print

Document_ (http://biointegrity.org/FDAdocs/22/JMtoCFSp.pdf)

 

 

21.. Memorandum from David Kessler, Commissioner of Food & Drugs. Subject:

" FDA Proposed Statement of Policy Clarifying the Regulation of Food

Derived from Genetically Modified Plants--DECISION. Drugs. " FDA

Proposed

State_View Our Summary_ (http://biointegrity.org/FDAdocs/23/index.html) -

_View Document_ (http://biointegrity.org/FDAdocs/23/view1.html) - _Print

Document_ (http://biointegrity.org/FDAdocs/23/kesslerp.pdf)

 

 

22.. Letter from Terry Medley, J.D. (of USDA's Animal and Plant Health

Inspection Service), to Dr. James Maryanski, Biotechnology Coordinator.

" Comments on FDA Draft Statement of Policy on foods derived from new

plant varieties, including plants derived by recombinant DNA techniques. Dated

April 2, 1992. (5 pages) _View Our Summary_

(http://biointegrity.org/FDAdocs/24/index.html) - _View Document_

(http://biointegrity.org/FDAdocs/24/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/24/tmjmp.pdf)

 

 

23.. Note from Eric Katz (Dept. of Health & Human Services) to John

Gallivan. " Food Biotechnology Policy Statement. " Dated March 27, 1992.

(2 pages) _View Our Summary_ (http://biointegrity.org/FDAdocs/25/index.html)

- _View Document_ (http://biointegrity.org/FDAdocs/25/view1.html) -

_Print Document_ (http://biointegrity.org/FDAdocs/25/ekjgp.pdf)

 

 

24.. Memorandum from James B. MacRae, Jr. (of the Office of Management and

Budget), for C. Boyden Gray (President Bush's White House counsel).

" FDA Food Biotechnology Policy. " Dated March 21, 1992. (2 pages) _View

Our Summary_ (http://biointegrity.org/FDAdocs/09/index.html) - _View

Document_ (http://biointegrity.org/FDAdocs/09/view1.html) - _Print Document_

(http://biointegrity.org/FDAdocs/09/09.pdf)

 

 

 

 

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