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30 November 2000

Table of Contents

Monsanto Poisons Columbia: US 'War On Drugs'
Yield problems with RR soybeans under dry conditions
Sierra Club FINAL comments to EPA on StarLink (excellent summary)
Sierra Club TECHNICAL comments to EPA on StarLink (excellent summary)
Sierra Club Questions on the Assessment of Scientific Information (excellent summary)
Sierra Club REFERENCES to comments to EPA on StarLink (excellent summary)
The strategy of Flooding with useless Research
Alliance for Bio-Integrity statement re: Starlink corn

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Date: 25 Nov 2000 04:24:35 U
From: geno@zap.a2000.nl

Monsanto Poisons Columbia: US 'War On Drugs'

On 25 Nov 2000, at 5:53, msdarkstar@angelfire.com wrote:

[Am-First] Monsanto, US 'War On Drugs' Poisoning Columbia's Environment http://www.egroups.com/message/MainLineNews/8784


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Date: 25 Nov 2000 04:41:22 U
From: geno@zap.a2000.nl

On 24 Nov 2000, at 15:10, GENETNL wrote:

GENET
European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
Kleine Wiese 6 , D – 38116 Braunschweig , Germany

phone: +49-531-5168746     fax: +49-531-5168747
email: genetnl@xs4all.be

archive: http://www.gene.ch/genet.html

Yield problems with RR soybeans under dry conditions

by Alan Blaine, Agronomy Notes, Mississippi State University , November 8, 2000
http://ext.msstate.edu/newsletters/agronotes/agronomynotesnovember.ht....

Soybeans Extension Service

Sections:
Soybeans
Variety selection.
Early maturing varieties.
Planting dates.

Soybeans

This year turned out to be the worst year ever for many soybean growers, as drought conditions caused problems statewide. Since much of the soybean crop is grown in a dryland setting, growers must continue to carefully consider variety selection, the use of early maturing varieties, and planting dates.

Variety selection.

This year has proven how unpredictable a growing season can be. Varietal differences are observed every year, but quite a few varieties showed their ability to withstand adverse conditions this year. Many varieties that looked good last year proved failures this season. This emphasizes the need for a yield history, preferably at least two years of yield data, before planting a large acreage in new varieties.

Early maturing varieties.

Due to the earliness of the past couple of growing seasons, we will see an increase in early maturing varieties. Some interest is being expressed in Group III's, but the bulk of the plantings to early maturing varieties should be in IV's. From a dryland standpoint, Group IV's offer a greater potential to increase yields than any of the later maturity groups.

If we could predict the weather, we would know exactly what and when to plant. Since this cannot be accomplished, Group IV's allow us the opportunity to increase yields by setting pods during a time frame more conducive for fruit set. For the 2000 soybean crop, pod set was as good as farmers have experienced. However, there was not enough moisture to fill them out after pod set.

Another consideration is the use of Roundup Ready varieties. As a whole, when growing conditions become extreme, the Roundup Ready varieties seem to be more greatly affected. While the Roundup Ready option is an excellent technology, especially dryland, growers need to do their homework regarding varietal performance prior to planting.

Many producers would be better off planting a proven variety like Hutcheson rather than take chances with a new variety. If you do plant new varieties, do not plant more than 5 to 10 percent of your acreage in any variety with less than two years of state yield data. This may seem slightly extreme, but your entire crop depends on the variety you plant. This is a decision you will live with all year and one that should not be made lightly. Roundup Ready varieties are getting better, but few of them have the yield history needed to put all your acreage in them.

With more than 250 varieties available for sale, variety selection is a monumental task. The 2000 growing season was quite extreme, but several varieties consistently performed in the top 10 to15 percent. These are the varieties growers should plant on the bulk of their soybean acreage.

Planting dates.

One input over which growers have less control is planting dates. Early planting should be a goal of every soybean producer in this state. Although farmers grow other crops, in order to make soybeans profitable, they must plant soybeans as early as possible. Unless you are double cropping or planting behind flood waters, soybeans growers should have a goal of planting soybeans before you start planting cotton. While growers need to spread their risks with maturity groups, not enough growers are taking advantage of the option of early planting.

After this past season, we can look for three things to take place: Roundup Ready acreage, Group IV plantings, and the percentage of acreage planted early will all increase. All of these options are good, but we will still need to do some advance planning regarding how to make these things work. Preliminary yield information (Group IV's and V's) are currently available. If you would like a copy, please contact your county extension office.


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Date: 28 Nov 2000 14:02:05 U
From: Ericka doodles@netins.net
From: Laurel Hopwood jhopwood@wviz.org

Yesterday I mistakenly posted our comments to the EPA. Some things were changed since then. Please delete that posting, if you've kept it in your records. Here's the final, that was submitted to US EPA.
Laurel

Sierra Club FINAL comments to EPA on StarLink (excellent summary)

Sections:
Sierra Club opposes Aventis' petition
StarLink Cry9C genes and Cry9C protein to appear conventional corn crop
EPA's biotechnology peer review process needs improvement
EPA's current StarLink reassessment may produce a premature judgment
EPA announces "rigorous scientific and public review of new information"
Sierra Club objects to EPA's limited StarLink corn inquiry to Cry9C allergenicity questions
EPA directed the Science Advisory Panel (SAP) to conduct a limited inquiry

NOVEMBER 27, 2000

Ms. Carol Browner, Administrator
EPA DOCKET via email: opp-docket@epa.gov
Public Information and Records Integrity Branch (PIRIB)
Information Resources and Services Division (7502C)
Office of Pesticide Programs (OPP), U.S. Environmental Protection Agency
1200 Pennsylvania Ave., N.W., Washington, DC 20460

RE: Docket # PF-867B – Aventis' StarLink Cry9C Bt Corn Plant-Pesticide Reassessment

Dear Administrator Browner:

Comments are being submitted to the Environmental Protection Agency's (EPA) Docket #PF-867B on behalf of the Sierra Club concerning the agency's StarLink Cry9C Bt Corn Plant-Pesticide reassessment and Aventis' 4-year time line limited tolerance exemption petition to EPA for approving the Cry9C protein in food products for human consumption. Aventis is seeking an exemption from the requirement of a tolerance under the Federal Food, Drug, and Cosmetic Act for the Cry9C protein and the genetic material (DNA) necessary to produce it, that are present in processed foods made from StarLink corn grain.

According to the October 31, 2000 Federal Register notice: "On April 7, 1999, EPA announced the receipt of a pesticide petition (PP 9F5050) (64 FR 16965) (FRL-6069-8) from AgrEvo USA Company; (Aventis has since succeeded to the interests of AgrEvo USA Company; also, this petition superceded a petition for an exemption that was submitted in 1997 by AgrEvo at the time AgrEvo initially applied for registration.) The petition, 9F5050, proposed an amendment to 40 CFR 180.1192 to expand the exemption from the requirement of a tolerance for Bacillus thuringiensis subspecies tolworthi Cry9C protein and the genetic material necessary for its production in corn. At that time and currently, the existing exemption covered these substances in corn, only when the corn was used for animal feed, and in meat, poultry, milk, or eggs resulting from animals fed such feed. The petition sought to extend the exemption for these substances to all food commodities." EPA invited public comment on the submission as it relates to the Aventis petition.

Sierra Club opposes Aventis' petition for StarLink tolerance exemption of genetically engineered Cry9C protein and DNA in food commodities

The Sierra Club is vigorously opposed to the EPA granting any type of approval for Aventis' pending petition to establish an exemption from the requirement of a tolerance for the genetically engineered "plant-pesticide" materials occurring in StarLink corn. Aventis' genetically engineered "plant-pesticide" materials are the Bacillus thuringiensis subspecies tolworthi Cry9C protein and the genetic material (DNA) necessary for the production of this protein.

The requested exemption would cover both the Cry9C DNA and Cry9C protein in all food commodities. The reasoning behind the Sierra Club's opposition to approval is that EPA, at this time, does not possess sufficient peer-reviewed scientific evidence to be able to support or confirm the claims made by Aventis in its pending petition for an exemption. In fact the weight of mounting scientific evidence of Cry9C protein's allergenicity, which was entirely ignored by Aventis in its petition, also points out technical reasons why EPA must deny Aventis' petition.

Another significant public health and environmental concern that is not required to be addressed by Aventis' petition or EPA is the safety and efficacy of allowing transgenics such as StarLink corn to be used for animal consumption that will eventually end up being used for human consumption. Transgenic corn fed to animals has not been adequately proven to be a safe practice and EPA, FDA and USDA need to seriously review all the scientific evidence rather than continuing to ignore it. See later comments and list of references at the end relating to gene transfer.

The Sierra Club also raises a legal applicability question of whether EPA has authority to approve Aventis' specific petition for StarLink tolerance exemption with regard to the contaminated conventional corn resulting from cross pollination with StarLink corn. If the conventional corn is cross pollinated by StarLink pollen and becomes contaminated with Cry9C DNA and protein, will EPA treat the Cry9C contaminated conventional corn as "StarLink" since it was grown from non-StarLink seeds and is not legally under Aventis' control? If EPA considers the Cry9C contaminated conventional corn as legally being "StarLink" corn, Sierra Club likewise vigorously opposes any approval by the EPA to Aventis' pending petition for a tolerance exemption of the tainted conventional non-StarLink corn.

Potential for StarLink Cry9C genes and Cry9C protein to appear in next years conventional corn crop contaminated with StarLink pollen

While Aventis has withdrawn its StarLink registration and will not sell any more StarLink seeds in the US for spring planting, this does not rule out or address the possibility of thousands of acres of non-StarLink seeds that may contain Cry9C DNA and may be grown in 2001 and 2002 growing seasons in the US. A technical and legal question surrounds the contaminated conventional corn seeds that may be grown in 2001-2002 seasons. The Garst Seed Company has already identified Cry9C protein in significant portions of conventional corn crop but neither Garst nor Aventis officials have identified whether the Cry9C protein contamination was due to StarLink cross pollination or commingling in the grain elevators.

EPA's biotechnology peer review process needs improvement

Special comments need to be emphasized on EPA's scientific review process of the Aventis StarLink genetically engineered corn, because the agency's biotechnology peer review process highlights a series of lingering problems, subjective EPA administrative opinions and flawed science policy decisions occurring since the early 1990s involving the federal government's reviews of transgenic crops and their potential public health and environmental impacts.

Moreover, the EPA's peer review process-extending to all genetically engineered crop registration requests, primarily those already approved by the agency-has revealed a badly flawed federal system (reinforced by recent StarLink contamination revelations and which is simply one example of the flaws) that circumvents good science, does not develop good science policy to properly review transgenics, an unacceptable failure to seek environmental impact consultations with other federal agencies under endangered species laws, inappropriate and ineffective regulations, failing to enforce existing federal laws, and failure to promote the public's trust regarding the EPA's ability to carry out its mission in protecting the public from potential hazards inherent in inadequately tested and poorly regulated genetically engineered crops.

Clearly the EPA must do better! EPA must do good science and public policy which it has consistently neglected to do so far in the regulation of transgenics. The public's expectations are riding high in the StarLink corn violations as the widespread scandal continues to grow in allowing this illegal corn to enter the human food system inadequately tested, completely unlabeled, and virtually untraceable, but hopefully now the EPA will set a new trend of performing good peer review and establishing good science policy where there has been a serious lack of with respect to transgenics crop review and approval in recent years.

EPA's current StarLink reassessment may produce a premature judgment

Nonetheless after reviewing EPA's recent Federal Register Notice (see "Assessment of Scientific Information Concerning StarLink Corn Cry9C Bt Corn Plant-Pesticide," October 31, 2000, Pages 65245-65251, Volume 65, Number 211), the question is obviously why the EPA has deliberately chosen to limit the scientific inquiry and peer review process to such a narrow focus? Evidently the public needs to continue to raise new EPA science policy issues and staff peer review questions over the framework of EPA's current StarLink reassessment, which now appears to be a rush to judgment without properly considering, for example, the following areas:

These public health and environmental concerns are significant considering the EPA's recent announcement and suggests that EPA is moving along the same path of the past that resulted in the StarLink controversy.

EPA announces "rigorous scientific and public review of new information"

In late October 2000, EPA announced steps it will take to ensure a "rigorous scientific and public review of new information" submitted by Aventis and the biotechnology-based food industry on illegal StarLink corn contamination occurring widely in U.S. food products. In addition, EPA made available the new Aventis information and promoted a 30-day public comment period ending November 27, 2000. After that, a formal scientific peer review begins with the EPA's FIFRA Science Advisory Panel (SAP) meeting to discuss the agency's review and possible action on new information submitted in Aventis' tolerance exemption petition for the Cry9C protein in food products.

According to Stephen Johnson, EPA Deputy Assistant Administrator, "The Agency will conduct a thorough scientific analysis of this new [Aventis] information, and will follow a rigorous process of scientific and public review to evaluate the allergenic potential of StarLink corn."

At first, EPA's statement sounds laudable on the surface and yet a basic question is why the EPA failed to be aware of the predictable real world problems a few years ago during its earlier limited StarLink approval of the Cry9C Bt corn such as cross pollination with conventional corn varieties, failure to effectively segregate StarLink corn from conventional corn, failure to test for StarLink contamination, and other poorly addressed questions where EPA needed to take a proactive role in but instead failed to fulfill its duties. While Aventis' is the chief regulated entity to blame for failure to comply with the StarLink limited registration allowing only for animal consumption, what is equally surprising is EPA was unable to foresee the StarLink problems before they arose in order to prevent them in the first place with its regulatory and discretionary powers.

But more than EPA's past failures with regards to transgenics approvals to sell these novel seeds to farmers is a major new scientific concern and public trust issue that EPA's current scientific review of StarLink corn will be substantially less than the "rigorous scientific" approach publicly announced by the agency October 25, 2000, because EPA officials have made a highly questionable science policy decision to submit to public review and solicit public comments on such a narrow scientific investigation of Aventis StarLink corn's Cry9C protein allergenicity and a few limited related issues.

Apparently the formal comprehensive scientific peer review (and public review) sought by EPA will not occur based on the excessively limited scope of the agency's StarLink corn inquiry unless EPA reconsiders and encourages a more comprehensive scientific and public health inquiry. The public interest will be harmed by EPA's highly subjective and potentially illegal decision to limit the scientific inquiry surrounding StarLink corn.

Sierra Club objects to EPA's limited StarLink corn inquiry to Cry9C allergenicity questions

Consequently, the Sierra Club vigorously objects to the EPA's judgment in announcing such a restrictive inquiry on StarLink corn contamination and that it be limited to only questions of Cry9C protein allergenicity; a conclusion is that EPA is intentionally excluding relevant issues, for example, including but not limited to the following areas of concern:

  1. potential for Cry9C DNA toxicity,

  2. potential for Cry9C DNA horizontal gene transfer,

  3. potential for Cry9C protein toxicity besides allergenicity,

  4. potential for unknown novel StarLink toxins besides Cry9C protein,

  5. probability of cross pollination of StarLink corn with non-StarLink corn resulting in StarLink gene flow into non-StarLink corn,

  6. worker health hazards from exposure to StarLink corn seeds, pollen and other plant components (containing Cry9C DNA and/or Cry9C protein),

  7. soil ecology impacts from Cry9C DNA and Cry9C protein,

  8. other Cry9C protein and Cry9C DNA environmental impacts such as adverse effects on non-target species including beneficial insects,

  9. StarLink's inadequately proven "substantial equivalence" to conventional corn,

  10. potential human health hazards in animal consumption of StarLink corn,

  11. potential evidence that antibiotic resistance genes cause harm to humans, and

  12. instability of StarLink gene construct, will not be addressed or reviewed by the agency's scientists and policy makers.

Another potential public concern is whether Aventis' has submitted all relevant regulatory data to EPA that the firm possesses on StarLink since pressing corporate liability and market value issues may drive the company to want to with hold critical scientific information from the EPA; this transpired with pesticides.

EPA directed the FIFRA Science Advisory Panel to conduct a limited inquiry

The EPA's limited scientific investigation extends even to the agency's FIFRA Scientific Advisory Panel (SAP) of independent, external scientific experts, which top EPA officials appear to be attempting to hamstring. The EPA's SAP is being seriously restricted in its own scientific inquiry of the StarLink corn questions since top EPA officials have directed the SAP members to focus on such a narrow line of inquiry at the SAP's formal November 28-December 1 meeting (see EPA's list of Questions #1-9 for the SAP to address November 28, 2000: "Assessment of Scientific Information Concerning StarLink Corn Cry9C, Bt-Plant Pesticide"). The serious public health and environmental concerns that arise from such a restrictive scientific and public process by EPA and the SAP is that this does not represent a credible and acceptable scientific peer review process because it appears to be an attempt by EPA to predetermine the outcome in favor of Aventis' tolerance petition.

The Sierra Club's comments are being submitted by email and regular mail to Docket # PF-867B.

Respectfully yours,

Neil J. Carman, Ph.D.
Genetic Engineering Committee
Sierra Club
54 Chicon Street, Austin, Texas 78702-5431
512-472-1767 phone     512-477-8526 fax     Email: Neil_Carman@greenbuilder.com


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Date: 28 Nov 2000 14:02:05 U
From: Ericka doodles@netins.net
From: Laurel Hopwood jhopwood@wviz.org

Sierra Club TECHNICAL comments to EPA on StarLink (excellent summary)

Sierra Club's Technical Comments On Aventis' Starlink Cry9C Bt Corn Plant-pesticide 4-year Time Line Limited Tolerance Petition And Reassessment: Docket # PF-867B

Sections:
1. Starlink Dilution Estimates.
2. Highest Exposed Subpopulations To Cry9C Protein.
3. Cross Pollination Estimates.
4. Aventis' Claim of Safety of Cry9C DNA.
5. Aventis Submitted Inadequate Information.
6. Detection of Cry9C Protein Vs. Cry9C DNA In Foods.
7. Bt/Cry9C Protein Allergy And Safety Issues.
8. Cry9C Protein's Homology Compared To Peanut Protein.
9. Cumulative Effects.

1. Starlink Dilution Estimates.

Aventis provides questionable to weak estimates of dilution of StarLink corn from harvesting through food processing stages based upon multiple assumptions. AVENTIS relies too extensively on theoretical estimates rather than field data. For example, Aventis states on p 13 of Section C – Context for the Assessment: "Assuming conservatively that there are only seven handling and processing operations, each of which is assumed to dilute the [StarLink] grain by a factor of three, suggests that one truckload of pure StarLinkTM corn would be diluted by several orders of magnitude, prior to reaching the food processor or consumer."

Estimates derive from assumptions on corn harvesting, grain delivery to grain elevators, grain elevator handling including blending and commingling inside the grain elevators, grain processing at dry mills, and wet milling. The dilution may be greater at the larger grain elevators versus the smaller grain elevators, but Aventis provides no more detailed information or data besides some general range of country elevators of "... from 10,000 bushels to 1,000,000 bushels with an average of 70,000 to 80,000 bushels."

There is no data supplied by Aventis on how many grain elevators are sized on the low end of the range where there may be less commingling of StarLink and conventional corn and less dilution.

There is no data from Aventis on how many farmers were growing and harvesting StarLink corn crops in the same area (within the same county and adjacent farms) and may have also used the same grain elevators at the same time assuming they planted and harvested in the same period. Aventis submitted no data on the largest StarLink corn crops where commingling may be less when a farmer with a large StarLink acreage takes his crop to a local grain elevator.

Aventis has failed to provide adequate supporting data on the grain elevator commingling of StarLink with conventional corn to make the case that there will always be a dilution effect "... on the order of 3 to 5 times is a conservative expectation ...". Why did Aventis avoid submitting StarLink data on the detectable Cry9C protein and DNA percentages in grain elevators to backup its claim of dilution?

At how many grain elevators was there zero commingling of StarLink and conventional corn? Aventis has provided no data on how frequently zero commingling may have occurred or the frequency of its theoretical dilution factor of three.

At how many milling operations and food processors was there zero dilution of StarLink and conventional corn? Aventis has provided no data on how frequently that zero dilution may have occurred.

Zero commingling and dilution are critical questions that are unanswered since it means a significantly higher concentration of Cry9C protein in food products than what Aventis claims it can estimate.

If Aventis' dilution and commingling claim is assumed to be reasonably conservative, it suggests such a low probability would exist for detecting either the Cry9C protein or Cry9C DNA in all food products that they would never be detectable in such low concentrations; but this low probability and Aventis' reasonably conservative approach is challenged by a small number of random samples in food stores collected by Friends of Earth and later demonstrated to contain Cry9C DNA at detectable concentrations. If the Cry9C DNA is present, EPA needs to assume that the Cry9C protein may likewise be present.

2. Highest Exposed Subpopulations To Cry9C Protein.

Certain subpopulations have been evaluated by Aventis for exposure to StarLink's Cry9C protein, but only through consumption of processed food products. However, Aventis completely failed to consider that some farmers may have kept for their own use or locally sold some of their StarLink corn for direct consumption by local consumers. Such local consumption patterns may be expected to be relatively small compared to the total percentage of the StarLink crop planted in 1999 and 2000, but it needs to be evaluated by EPA and Aventis since it's not too far fetched that some farmers might eat a small portion of their own corn.

Has Aventis interviewed farmers growing StarLink as to how much may have been consumed directly by local consumers? Exposure to the Cry9C protein would be significantly higher in such individuals, but this exposure pathway was evidently ignored by Aventis and EPA for the 1999 and 2000 crop seasons. Such eating of StarLink corn by local consumers and farmers may increase significantly the potential for sensitization to the Cry9C protein.

Farm workers, grain elevator operators and mill workers may also possess among the highest potential exposures to Cry9C protein in several ways. A farm worker, for instance, might face multiple exposures: 1) StarLink corn harvesting; 2) windblown StarLink pollen drift; 3) StarLink corn direct consumption; and 4) StarLink in food products. Certainly some farmers, farm families, local rural residents and local rural consumers might as well fit within such multiple pathway scenarios. Aventis totally excludes the potential of farm worker exposure and one who is also highly allergic. Aventis has failed to fully identify the most vulnerable subpopulations at risk from Cry9C protein and DNA.

What about a pregnant farm worker (in the first trimester) who exposes her unborn fetus to the Cry9C protein through multiple pathways: 1) StarLink corn harvesting; 2) windblown StarLink pollen drift; 3) StarLink corn direct consumption; and 4) StarLink in food products, or combinations of the above pathways. Aventis completely ignores the potential of fetal exposure of a pregnant female farm worker. Allergic reactions and anaphylactic shock in a pregnant farm worker might seriously threaten or impair the life of the unborn fetus.

Aventis and EPA have not seriously considered multiple exposure pathways for certain sensitive subpopulations.

3. Cross Pollination Estimates.

Aventis' claims that "buffer zones of 660 ft. were required for StarLinkTM plantings," but Aventis is currently having to interview farmers (Aventis does not state how many farmers it has interviewed) to identify potential acreage for cross pollination, which its preliminary estimates being at least 168,000 buffer acres planted in corn for the 2000 crop season. Aventis fails to say how many farmers actually complied with the 660 ft. buffer zone requirement, and some farmers have reported in media articles that they were not informed by Aventis of the requirement for 660 ft. buffer zones around their StarLink fields.

Aventis needs to submit data on samples of buffer-crop corn indicating what level of StarLink cross pollination may have occurred. Aventis cites a single unpublished study being an abstract by Jemison and Vayday as indicating that cross pollination of corn at 100 ft. downwind was only 1% and declined exponentially to 0.1% at 130 ft. Aventis suggests that since EPA required a 660 ft. buffer zone, that should be sufficient but Aventis fails to divulge the percentage of compliance by farmers planting StarLink corn.

Aventis completely fails to consider that some farmers may have kept or locally sold some of their contaminated conventional corn (cross pollinated by StarLink) for direct consumption by local consumers. Such local consumption patterns may be expected to be relatively small compared to the total percentage of the StarLink crop planted in 1999 and 2000, but it needs to be evaluated by EPA and Aventis since it's not too far fetched that some farmers might eat a small portion of their own corn.

Has Aventis interviewed farmers growing StarLink as to how much may have been consumed directly by local consumers? Such consumption of StarLink corn by local consumers and farmers may increase significantly the potential for sensitization to the Cry9C protein.

4. Aventis' Claim of Safety of Cry9C DNA.

Aventis failed to submit information to EPA on the detectability and presence of Cry9C DNA in food. Aventis makes the assumption that its transgenic Cry9C DNA possesses the same flawed safety assumptions as naturally occurring DNA, but Aventis provides no data to support its assumption of transgenic DNA being essentially the same as naturally produced DNA. Aventis chose instead to cite a flawed EPA opinion about the safety of DNA in general. The concern is that the EPA may have erred in assuming that toxicity may not be expected from consumption of DNA and other genetic material in genetically modified crops including StarLink.

Aventis cites an EPA statement in Section D. Safety of Cry9C DNA and DNA generally: "With respect to the safety of Cry9C DNA and DNA in general, EPA has concluded that: 'DNA is common to all forms of plant and animal life and the Agency knows of no instance where these nucleic acids have been associated with toxic effects related to their consumption as a component of food. These ubiquitous nucleic acids as they appear in the subject plant-pesticide have been adequately characterized by the applicant and supports EPA's conclusion that no mammalian toxicity is anticipated from dietary exposure to the genetic material necessary for the production of the Cry9C protein (63 Fed. Reg. 28259; 5/22/98).'"

But EPA itself appears to have ignored a wealth of new scientific findings on the effect of bacterial DNA on the immune system and the transforming ability of dietary, inhaled and dermal applications of DNA. The EPA has failed (and Aventis as well) to consider the data showing that the DNA and other genetic material in GM crops may significantly effect those consuming the crop which has so far been completely ignored or disregarded in the EPA StarLink review and Aventis' StarLink assessment. As a result, the EPA may have erred in assuming that toxicity may not be expected from consumption of genetic material in genetically modified crops (Cummins 2000).

It needs to be emphasized that the EPA's 1998 Federal Register statement failed to acknowledge that in 1997 fragments of ingested DNA from the M13 bacteria phage has been found incorporated into the DNA of the chromosomes in somatic tissues of the mouse (Schubbert et al 1997) and, more recently, new evidence that DNA of corn was found incorporated into the cells in meat of hogs fed corn (Jahreis and Kraft 2000). However, the significance of such gene incorporations has not yet been established. It may or many not be associated with detrimental consequences. Nevertheless, it is not prudent to ignore such important observations. Indeed, a moratorium on planting of genetically engineered crops is warranted and should be put in place until the impact of the new findings is evaluated.

Even more recently, naked and free nucleic acid has been has been identified as significant unregulated hazards (Ho et al 1999). DNA vaccines have generated a huge literature and clinical applications showing the activity and cellular incorporation of DNA administered by oral, inhalation, injection,vaginal or dermal application (Molling 1997, Donnoley et al 1997 and Gurunathan et al 2000). Ingestion of bacteria does not appear to be an effective means of delivering DNA because the bacterial cell walls effectively contain the nucleic acid (for example, in yogurt the milk products are digested but the bacteria of the culture are passed intact). Lysis genes have been found necessary and effective in triggering release of DNA for mucosal vaccine delivery (Jani and Mekalanos 2000). In contrast, the crops eaten by animals release oligonucleotides and DNA peptide complexes during digestion and such molecules circulate to a significant degree.

The bacterial genes used in constructing genetically engineered crops have a property that impacts on the immune system over and above the ability to produce antibodies. Eukaryote DNA has relatively low frequencies of the dinuleotide motif CpG and that motif is methylated and plays a role in gene regulation while bacteria and their viruses have a high frequency of the CpG motif that is usually unmethylated. Apparently the CpG motif in DNA molecules and oligonucleotides provides a signal that the immune system recognizes and initiates a primary sequence of reactions leading to activation of the immune system leading to inflammation (Manders and Thomas, 2000 and Gurunathan et al 2000). Oligonucleotides rich in the CpG motif are used to enhance immunization. Inflammation is an essential part of the immune response but it adversely effects existing conditions such as autoimmune disease. Furthermore, it has been found that CpG oligonucleotides rescue B cell lymphoma cells from anti-IgM mediated growth inhibition (Han et al 1999). The oligonucleotide acts as a promoter of lymphoma.

In addition, Gorecki and Simons (1999) pointed out a danger to the fetus in DNA vaccination of the mother. That danger was the creation of tolerance in the fetus leading to individuals more susceptible to infection and/or they may become carriers. The introduction of genes with bacterial CpG motif to the fetus is likely to have untoward consequences. The bacterial genes used in genetically modified crops have been found to have significant impacts on the individuals ingesting gene-altered crops. The impacts include inflammation and lymphoma promotion. The consequence of gene-altered food genes being incorporated into the chromosomes of somatic cells of those consuming genetically engineered food and their unborn has been ignored by those charged with evaluating the hazards of gene-altered crops. The EPA has clearly erred in ignoring such important findings in evaluating StarLink corn.

5. Aventis Submitted Inadequate Information.

Aventis' original and revised submissions of October 25, 2000 and November 3, 2000 do not provide the information necessary to technically support the company's request for a tolerance petition. Another reason is because Aventis' documents have not been submitted to any kind of credible independent peer-review scientific process beyond Aventis scientists, Aventis contractors, the EPA and its SAP, which raises credibility about the information compiled by Aventis. Scientists and officials either working directly for Aventis or hired by Aventis have a conflicting financial interest in EPA's acceptance and approval of the tolerance petition.

Among the 53 references listed by Aventis, more than 50% of the citations were not published in peer-reviewed scientific journals making it difficult to assess their credibility. Aventis cited 15 of its own internal studies but none appeared to have been published in peer-reviewed journals where Aventis data and analysis would have been reviewed by independent scientists who are experts in the field. Aventis further includes a statement by Dr. Steve Taylor in its petition who has been quoted in the media making baseless comments on the safety of StarLink corn without having conducted studies and submitting them to peer-reviewed journals for publication.

Dr. Taylor simply states his opinion on StarLink: "...I do not believe there has been any risk to the public." Even without having conducted allergenicity studies on Cry9C protein, Dr. Taylor has an opinion and without considering differences between the Cry9C protein and other allergens. He chose to selectively ignore the information provided by Dr. Michael Hansen at the October 20, 2000 EPA SAP meeting where evidence from Bt allergenicity studies were presented.

6. Detection of Cry9C Protein Vs. Cry9C DNA In Foods.

Aventis' petition emphasizes the high probability of low concentrations of Cry9C protein in most food products. Aventis' information on the non-detection of Cry9C protein in processed foods appears to conflict with the FOE and media reports of the detection of Cry9C DNA, since Aventis' data and assumptions suggest that the levels of the protein (and DNA) are too low to be detectable. According to Aventis, the levels of Cry9C protein is most likely too low in concentration to present an allergy problem overall but this seems inconsistent with the detection of the Cry9C DNA and the potential for the Cry9C protein to be present as well.

If Cry9C protein is present in low concentrations in most food products, the Cry9C DNA will also be in low concentrations though not necessarily at the same levels.

To confirm Aventis' claims of low concentrations of Cry9C protein in food products, the best way is to test a range of contaminated food products confirmed to possess the Cry9C DNA and analyze them for the Cry9C protein. Aventis nor EPA have provided such information which is vital to the claims of low probability of potential health effects from consumption of StarLink-containing foods.

7. Bt/Cry9C Protein Allergy And Safety Issues.

Aventis claims that Bt corn plants containing the Bt protein like Cry9B (homologous with Cry9C protein) have been widely and safely used for several years, but obviously Aventis is not going to cite information or references suggesting otherwise –that safety hazards may exist for farmers, farm workers and mill workers who are exposed to Bt corn pollen and Bt corn plant tissues containing the Bt delta-endotoxin. Aventis attempts to discredit new allergic evidence of the Bt toxin.

New evidence was cited at the October 20, 2000 EPA Science Advisory Panel meeting by Dr. Michael Hansen (see "Comments on the human health and product characterization sections of EPA's Bt Plant-Pesticides Biopesticides Registration Action Document"). Dr. Hansen states: "We do not think that the human health data that EPA currently has are adequate. In particular, EPA seems to have ignored a crucial study that suggests that the Bt delta endotoxin is an inhalant allergen, which could present risks, in an occupational sense, to farm workers and mill workers that are exposed to dust from the processing of Bt crops."

Aventis claims of Bt safety are quite clearly false and contradicted by the Bernstein study and that the EPA has no health proved basis of safety for the Bt delta endotoxin.

Aventis states incorrectly on page 19 which is contradicted by published studies such as by Bernstein: "Since allergy to Cry9C protein does not already exist, the extremely low level of Cry9C protein estimated to be consumed using a reasonable, worst case exposure assessment leads to the conclusion that the Cry9C protein present in StarLinkTM corn is very unlikely to become an allergen." The likely reason that Aventis prefers to ignore these studies is they do not support the company's case for a tolerance exemption if there is significant allergy potential. Aventis may also be able to reduce its legal liability and market losses if it can deflect regulatory actions against it from the US EPA, US FDA and USDA if the petition for limited tolerance exemption is approved for 4-years.

Aventis has also completely ignored the sensitization of Cry9C protein to farmers, farm families and local consumers who may have consumed 100% pure, undiluted StarLink corn due to Aventis' possible failure to properly inform and educate farmers about not using StarLink for human consumption.

Aventis has likewise chosen to entirely ignore the potential sensitization of Cry9C protein through exposure to wind blown StarLink pollen by farmers, farm families, farm workers and locals living and working in proximity to the StarLink corn fields. These subpopulations are among the highest potentially exposed to Cry9C protein. EPA has itself so far neglected to seriously consider the probability of such StarLink pollen exposure as among the highest groups exposed.

Aventis has not required warning signs to be posted around StarLink fields.

8. Cry9C Protein's Homology Compared To Peanut Protein.

Aventis makes questionable and poorly substantiated claims regarding the homology comparisons between Cry9C protein and known peanut allergens. The homology issue is critical in understanding the potential for Cry9C allergenicity by examining the amino acid sequence and the tertiary protein structure (three dimensional folding of the whole molecule). Tertiary protein structure is important to consider since it contributes to protein function and allergenicity. Aventis seems to basically ignore the tertiary structure of Cry9C and over emphasizes the amino acid sequence for homology between Cry9C and peanut allergens. But SAP advisors criticized using only the amino acid homology comparisons alone since the approach fails to consider the tertiary structure of the Cry9C protein in evaluating its allergenicity potential.

The question critical in amino acid homology comparisons is to determine whether the Cry9C protein is similar in its functional structure to any known allergens, but Aventis' scientists also need to carefully evaluate the three-dimensional nature of the allergy-causing parts of allergenic proteins. In addition, a present barrier in such evaluations is that there are still many allergens and epitopes whose sequences are unknown making homology comparisons difficult at best.

In fact StarLink's Cry9C protein has powerful allergenicity potential based on its physiochemical properties. According to the Science Advisory Panel members, Cry9C protein possesses the two properties accepted as "the best available criteria presently known [for functioning as food allergens]: 1) heat stability and 2) resistance to digestion." Even Aventis recognized these two properties in its petition (Aventis III. Hazard Assessment and Appendix 2 – letter from Dr. Susan Hefle).

The SAP further states "these properties can be used as screening toolsa" Dr. Hefle states that Cry9C's molecular weight of 68.7 kDa likewise falls into the upper end of the weight range of known allergens (10-70 kDa) although most allergens tend to fall within 10-40 kDa according to some experts in the allergy field. Furthermore Dr. Hefle reports that Cry9C protein possesses a 55 kDa band after digestion or degradation, which implies that it's molecular weight after some denaturing to a small weight still falls within the weight range of known allergens.

EPA recently released a revised assessment of Cry9C protein as having an "extremely low" risk for harm to public health, but this does not indicate how many consumers might be harmed by Cry9C exposure or what that harm constitutes in medical symptoms. Proving an "extremely low" risk is easier to claim than to prove for millions of consumers. Consumption of millions of bushels of StarLink corn is basically a giant clinical trail on millions of Americans and proving safety on such a scale is an impossible claim.

However, the lab studies sent to EPA by AgrEvo, Aventis' predecessor, claiming to support that Cry9C is not allergenic are significantly flawed for several reasons. EPA correctly criticized AgrEvo's rat study by stating: "The brown Norway rat model is not a validated test for food allergy at this point and the study submitted is significantly flaweda" Significant flaws include AgrEvo's failure to submit crucial data, including the concentration of Cry9C in the extracts injected into the rats, the number of rats tested, and the time that elapsed between injections of serum and challenge antigens. This is probably the reason why Aventis' lab studies have not been subjected to independent peer-review and have not been accepted for publication in a scientific journal. The concern is that Aventis is less interested in submitting good scientific data to EPA and more interested in protecting its bottom line.

9. Cumulative Effects.

Aventis totally ignores and thus excludes the possibility of cumulative health effect from StarLink exposure combined with other allergens and harmful substances. Consumption of foods containing allergens such as mixing StarLink-containing corn taco shells with peanuts or other allergy inducing foods. Since there is no warning on any of the 300 recalled StarLink-containing foods, consumers might combine such StarLink-containing foods with others containing different allergens. Aventis and EPA need to consider such likely possibilities.

Farm workers, farmers, farm families, grain elevator operators, mill workers, local rural residents, and local rural consumers may also possess among the highest combined or cumulative exposures to Cry9C protein, Cry9C DNA and other hazards that have not been addressed by Aventis or EPA.


Top PreviousNextFront Page

Date: 28 Nov 2000 14:02:05 U
From: Ericka doodles@netins.net
From: Laurel Hopwood jhopwood@wviz.org

Sierra Club Questions on the Assessment of Scientific Information (excellent summary)

Questions for the FIFRA Scientific Advisory Panel Assessment Of Scientific Information Concerning Starlink Corn Cry9C, Bt Plant-pesticide,

November 28, 2000

Sections:
ALLERGENICITY
SENSITIZATION
What is a "Reasonably Conservative Approach"
What is the Probability of an Allergic Reaction
Has EPA defined the most Sensitive Population with respect to Allergenicity?
What kinds of Additional Data is Needed to Improve the Scientific Basis
EXPOSURE ESTIMATES
Please comment on EPA's methodology for estimating dietary exposure to the Cry9C protein
Please comment on the Comparison of the Levels of Potential Human Exposure
OVERALL
How would you Assess the overall probability?
Please indicate the Priority of Additional Information
A. What is "Acceptable Risk"?
B. Has the EPA Outlined a Definition of "Acceptable Risk"?
When Registering Chemical Pesticides does the EPA Consider Alternative Methods to the Pesticide?
Questions on "Acceptable Risk"
How is "adversity" defined?
No Data of Starlink Getting into the Food Chain
REFERENCES


ALLERGENICITY

1. What is the likelihood (high, medium or low) that StarLink's Cry9C protein is a food allergen?

Qualitative statements of risk (allergic potential in this case although StarLink may possess other unknown or unreported risks) cannot be made without some systematic boundaries or criteria which EPA has not provided. What is EPA's definition of a "high", "medium" or "low" probability? EPA has not outlined definitions of a "high", "medium" or "low" probability. Clearly, EPA does not expect its expert SAP advisors to be able to assess the risks of allergenicity in any quantitative manner. Given this deficient state of risk assessment, EPA must first ask the SAP experts if it is possible to predict the allergenicity of novel proteins in genetically engineered foods at all, and if so, what predictions the state of the science allows. EPA must also ask the SAP panelists to explain the basis for their answers to this very subjective question.

EPA needs to consider several independent peer-reviewed studies of Cry9C allergenic characteristics to make a proper determination of StarLink's Cry9C protein potential allergenicity and not rely too heavily on information supplied by Aventis. The independent peer-reviewed studies need to provide a consistent quantitative basis for allowing EPA to make a good science decision on StarLink's Cry9C protein potential allergenicity. But it appears that no adequate independent peer-reviewed studies of Cry9C allergenic characteristics exist.

SENSITIZATION

2. What is the likelihood (high, medium or low) that the use of StarLink corn in making processed food has resulted in the sensitization of some individuals to the Cry9C protein?

EPA must define "high", "medium" and "low", and require each panel member to explain the basis for their opinion.

Why is EPA limiting the SAP's consideration to past events? Even according to Aventis, StarLink will be in the food supply for at least another 4 years. Why is EPA limiting the SAP's consideration to "some individuals" "making processed foods"? EPA must ask if any individuals, including highly exposed individuals such as farmers, farm families, farm workers, pregnant farm workers (in first trimester), grain elevator operators or mill workers might have become, or might in the future become sensitized.

3. EPA asks: Is it a "reasonably conservative approach" to accept Aventis' contention that StarLink be compared to peanuts in assessing allergenicity?

EPA must define "reasonably conservative approach". Does it mean acceptable to most scientists with expertise in allergenicity and immunology? But EPA has failed to define what it means by a "reasonably conservative approach" as to whether it is scientifically appropriate to evaluate Aventis' contention that StarLink be compared to peanuts in assessing the StarLink protein's allergenicity. So it's scientifically uncertain if Aventis' approach is actually a "reasonably conservative approach" and EPA can not assume that Aventis' approach is a "reasonably conservative approach" until EPA can provide a definition. Since the EPA has failed to provide a basis for determining what is a "reasonably conservative approach" in making such an evaluation, it is inappropriate to make such a claim.

Aventis' contention that it is reasonable to compare the allergenic characteristics of StarLink corn to peanuts is further compounded by another area of uncertainty. Comparing StarLink corn species to peanut species raises a significant question about whether it's appropriate to make comparisons between a transgenically created plant species to a non-transgenics species. Can transgenic and non-transgenic species be compared? Even EPA has recognized that StarLink is a transgenic corn variety that requires a pesticide registration and approval process under federal law which is not required of non-transgenic corn species or varieties. These biological differences are far more than legal technicalities.

In the case of StarLink as a transgenic corn species, Aventis makes the assumption that it is perfectly appropriate to compare a transgenic species to a non-transgenic species. By introducing transgenic material from a diverse array of organisms into corn to create StarLink (i.e., vectors, etc.), Aventis has created a new form of corn unlike any known species, subspecies or varieties produced by nature or traditional breeding since the latter have not introduced such a similar transgenic package into corn. Clearly it is clearly unreasonable to assume that it is appropriate to make a comparison between a transgenic and a non-transgenic species. In order to compare StarLink to another plant species, it may be more biologically reasonable to compare a transgenic species to another transgenic species.

Aventis has failed to recognize or chose to overlook for convenience sake that significant biological differences between peanut and corn species which make such comparisons tenuous at best. Setting aside such transgenic characteristics for the moment, StarLink corn and peanuts are very different according to plant classification texts and accepted taxonomic literature. For example, StarLink corn is a higher plant species classified in the grass family under the monocot grouping of higher flowering plant families, but peanuts on the other hand are classified as a flowering plant group of species within the legume family, which is one of many dicotyledonous families. Grasses and legumes are significantly different groups of flowering plants. The conclusion is that grass and legume families are very divergent higher plant groups and taxonomically distinct based on gross morphological characteristics, reproductive biology, genetics, secondary biochemistry, and other features of their biology. Grasses and legumes are reproductively incompatible since they do not hybridize in nature or in greenhouses due to inherent genetic incompatibilities.

Based on limited biological similarities between grasses and legumes, Aventis makes an assumption that it is a "reasonably conservative approach" that StarLink be compared to peanuts in assessing allergenicity. This assumption by Aventis is clearly inappropriate, improper and inconsistent based on what is known about the significant differences in the biology of StarLink corn and peanuts. Peanuts and corn are biochemically and reproductively quite distinct such that none of the plants in the two families are able to undergo hybridization in nature or in greenhouses.

4. What is the overall probability (high, medium or low) that the likely levels in the U.S. diet of StarLink protein is enough to cause a "significant" allergic reaction in the population?

What estimation is EPA referring to when it asks the SAP panel to consider "likely levels in the U.S. diet"? EPA does not refer to the Aventis' petition. Will the SAP panel use estimates of high end exposure or simply average estimates? Will the SAP panel consider the likely possibility of cumulative exposure?

What does "significant allergic reaction in the population" mean with respect to population parameters since EPA is unclear? One reaction out of a million exposed persons? One reaction out of a thousand children? One reaction out of a hundred people with gastrointestinal disease?

Has the EPA defined the most sensitive population with respect to allergenicity?

What does "significant allergic reaction in the population" mean with respect to severity of end point? Reactions which prevent attendance at work or school but would not be reported to health professionals? Those requiring hospitalization? Deaths? Would EPA consider an extra case of diarrhea in one out of a thousand individuals (perhaps a hundred thousand persons in the US alone) "significant"? Would only one death be "significant"?

EPA has failed to design and conduct a peer-reviewed study to determine the overall probability (high, medium or low) that the likely levels in the U.S. diet of StarLink protein is enough "significant" allergic reaction in the population. Without performing such a peer-reviewed study, it's not possible to assess whether the overall probability is high, medium or low.

EPA has further failed to establish scientific guidelines on how to conduct such a peer-reviewed study to determine the overall probability. The first step is establishing scientific guidelines subject to peer-review among scientific experts and then carrying out such a study once it's been approved.

EPA is putting the cart before the horse and is trying to essentially guess what the overall probability (high, medium or low) is and if the likely levels in the U.S. diet of StarLink protein is enough to cause a "significant" allergic reaction in the population. This is not how science and science-based policy are performed.

5. What kinds of additional data is needed to improve the scientific basis for assessing the allergen risk of StarLink (i.e. Data on food processing methods; Levels of Cry9C found in processed food; Mixing of StarLink with other corn; Levels of antibodies in people who had significant exposure to StarLink; Medical reports for people who experienced adverse effects from eating or working with StarLink).

By asking what will "improve" risk assessment, frames the discussion around the assumption that risk assessment is basically competent. Even if the EPA does everything suggested by a SAP panel answering this question, it may still be unable to assess risk. The Agency avoids asking questions which will allow the panel to describe their view of the fundamental state of risk assessment capabilities. EPA must ask whether the state of risk assessment is sufficiently advanced that it predict the allergenicity of genetically engineered foods with any certainty.

StarLink allergenicity potential needs to be considered along with other foods in a cumulative allergenicity potential since people could be exposed from StarLink from multiple food sources as StarLink is used in thousands of processed foods.

StarLink's allergenic potential needs to be addressed in all segments of the population from the elderly to infants and pregnant women.

EXPOSURE ESTIMATES

6. Please comment on EPA's methodology for estimating dietary exposure to the Cry9C protein, especially on whether the upper bound estimates are meaningful given corn processing pathways, processing food distribution pathways, and individual consumption patterns.

EPA has not considered or evaluated other exposure pathways for certain subpopulations as previously discussed including but not limited to farm workers, farmers, farm families, grain elevator operators, mill workers, local rural residents, and local rural consumers. Clearly thousands of such individuals may experience multiple exposures from StarLink corn seed handling, harvesting, pollen, grain transfer, milling, food processing, and consumption. Aventis conveniently assumed that such multiple exposure pathways is too low to attempt to calculate a risk for and EPA must not accept Aventis' calculations as relevant to all exposed subpopulations. Aventis' low risk calculations may bear more on the larger population of consumers, but the calculations have not addressed other exposure possibilities.

Please comment on the Comparison of the Levels of Potential Human Exposure

7. The submission from Aventis CropSciences contends that "[i] the most conservative approach to safety assessment of the Cry9C protein, the reasonable worst case dietary exposure to the Cry9C protein per day is compared to the amount of peanut allergen required to elicit a clinical response in peanut sensitized individual." Please comment on whether the comparison of the levels of potential human exposure to Cry9C protein with the levels of peanut allergen causing allergic symptoms in peanut-sensitive individuals is a reasonably conservative approach to assessing potential risks of Cry9C protein.

After the October 20, 2000 SAP meeting, the EPA obviously possesses sufficient information and data on Cry9C protein to make a determination that it possesses allergenicity specifically as an inhalant allergen. But EPA has so far chosen to selectively ignore the significance of Cry9C protein's inhalant allergenicity. Therefore Aventis claim of using "the most conservative approach" is not credible and must not be accepted by EPA as evidence of no harm.

But EPA does not yet appear to have adequate information as to its potential dietary allergenicity of Cry9C, although anecdotal reports have appeared in the media of adverse symptoms reported by consumers who may have eaten taco shells and other foods containing StarLink. EPA needs to consult with the FDA and medical doctors on these anecdotal reports of health problems. It is not feasible at this point to confirm whether Aventis' method is "the most conservative approach" for calculating Cry9C protein's dietary allergenic potential.

OVERALL

8. Based on your review of the currently available data, how would you assess the overall probability (high. medium, low) that the likely levels in the US diet of Cry9C protein are sufficient to cause significant allergic-reactions in the exposed population? Please explain the basis for that conclusion.

Assessing the overall probability of "significant allergic reactions" to Cry9C protein is difficult to determine with a degree of certainty given the limited information in the EPA Docket provided by Aventis and EPA, because there are several concerns and limitations of the Aventis data especially. Calculating the overall probability (high. medium, low) can not be credibly done until significantly more data is available to allow estimates with more certainty.

Please indicate the priority of additional information

9. Please indicate the priority that should be given to obtaining the following types of additional information for the purpose of improving the scientific basis of assessing the potential allergenic risk of the Cry9C protein:

  1. priority: Monitoring of reports from the medical community for individuals who claim to have experienced adverse effects either after consuming food that might have been made from StarLink corn or from occupational exposure to StarLink corn.

  2. priority: Data on the presence of specific antibodies in individuals either who claim to have experienced adverse effects after consuming food that might have been made from StarLink corn or who have significant occupational exposure to StarLink corn or corn products.

  3. priority: Data on the levels of Cry9C protein found in processed food.

  4. priority: Data on the impacts of different processing methods on the level of Cry9C protein in processed food.

  5. priority: Data on the extent of mixing of StarLink corn grain with StarLink-free corn grain.

ADDITIONAL QUESTIONS THAT EPA NEEDS TO ADDRESS AND MAY NEED TO DIRECT TO THE SCIENCE ADVISORY PANEL'S SCIENTISTS TO DISCUSS.

A. What is "acceptable risk",

with respect to allergenicity from plant pesticides generally, and how did EPA arrive at this determination of acceptable risk? Did EPA consult fully with the public since this is such a limited petition and scientific review? Has EPA polled a representative sample of people to determine what risks they are willing to bear and in what degree they are willing to bear them for the nonexistent "benefits" of Cry9C protein in corn?

B. Has EPA outlined for the SAP scientists a definition of "Acceptable Risk"?

If not, how can they expect an comprehensible answer? Note that for chemical pesticides, a cancer risk of 10-6 (one in a million) is considered "de minimus". What is de minimus with respect to allergenicity in terms of adversity of end point (on a continuum of mere stomach upset to death) and in terms of numbers of cases (or deaths)?

C. When considering whether to register chemical pesticides, EPA's cost-benefit analysis takes into account whether alternative methods to the pesticide are available.

Clearly, there are alternatives to StarLink corn such as non-StarLink corn. Therefore, it becomes important to ask: "Why is any risk of allergenicity acceptable when considering the registration of StarLink? D. Questions of "acceptable risk" are only tangentially scientific in nature, as for example, when considering what end points constitute "adversity."

This is a question which must be answered by an informed public. Why is EPA putting a question of acceptable risk before the SAP, when it has never asked this question of the public, who will be the ones bearing the risks, and not likely, any of the benefits of StarLink? Why makes these scientific observers' opinions about acceptable risk any more valid than those of ordinary citizens?

E. According to the EPA documents and Aventis' petition, it appears that EPA has no data to support or prove that StarLink genetic sequences do not get into meat, milk and eggs from animals fed StarLink corn

This may be an area of great vulnerability in terms of public health and yet EPA seems to lack such conclusive scientific evidence of no harm. The EPA needs to know that there is a European study which shows that mice fed a form of Bt corn took up genetic sequences from it and that those sequences were found in mouse tissues including fetal tissues. The significance of this observation is unknown.

It needs to be pointed out that evidently the EPA does not know if foreign DNA sequences from StarLink are not present in our meat, milk and eggs. And complicating this public health issue, since humans have eaten StarLink corn too, is that EPA cannot assure anyone that these gene sequences are not in our own tissues, including those of human fetuses.

Does EPA possess an explanation of the consequences of these foreign genetic sequences like StarLink Cry9C DNA being taken up as a result of eating the GE crops? What data does EPA have to show that there is no harm from this?


Top PreviousNextFront Page

Date: 28 Nov 2000 14:02:05 U
From: Ericka doodles@netins.net
From: Laurel Hopwood jhopwood@wviz.org

Sierra Club REFERENCES to comments to EPA on StarLink (excellent summary)

REFERENCES

  1. Aventis' Updated Safety Assessment of StarLink TM Corn Containing Cry 9C Protein" October 24,2000 Aventis Crop Science 74 pp

  2. Barnett, A. (2000). GM genes 'jump species barrier' The Observer May 28, 2000. A leading zoologist has found evidence that genes used to modify crops can jump the species barrier and cause bacteria to mutate, prompting fears that GM technology could pose serious health risks. A four-year study by Professor Hans-Hinrich Kaatz, a respected German zoologist, found that the alien gene used to modify oilseed rape had transferred to bacteria living inside the guts of honey bees. The research is highly significant because it suggests that all types of bacteria could become contaminated by genes used in genetically modified technology, including those that live inside the human digestive system. This kind of horizontal gene transfer involves the direct uptake of foreign genetic material. It has been found to happen also in the field. After GM sugar beet was harvested, the GM genetic material persisted in the soil for at least two years and was taken up by soil bacteria.

  3. Bergelson, J. et al "Promiscuity in transgenic plants. Sept 3, 1998 " Nature 395, 25. This University of Chicago study suggests that herbicide resistant crops such as canola, can transfer those properties to weedy relatives. This traditional weed then becomes a stronger superweed. The superweed can then have the ability to out compete native species in the environment and destroy natural biological systems. The scientists also learned that the transgenic plants were 20 times more likely to outcross.

  4. Bernstein et al, "Immune responses in farm workers after exposure to Bacillus thuringiensis pesticides." 1999 Environmental Health Perspectives, 570.

  5. Birch, A.N.E. et. al., "Interactions between plant resistance genes, pest aphid populations and beneficial aphid predators." Scottish Crop Research Institute Annual Report, 1996-97, pp. 68-72 Transgenic lectin-producing potatoes (lectin is a toxin of the same group as the Bt-toxin) harmed ladybugs by eating aphids reared on transgenic lectin-potatoes, which reduced the lifespans and egg production of ladybirds.

  6. Bucchini, Luca and Goldburg, Rebecca. Comments from Environmental Defense on EPA's "Cry9C Food Allergenicity Background Document" School of Public Health, Johns Hopkins University,Baltimore, MD and Environmental Defense, New York, NY. Presented to the EPA Science Advisory Panel, Arlington, VA. February 29, 2000.

  7. Crecchio, C. and Stotzky, G. 1998. "Insecticidal activity and biodegradation of the toxin from Bacillus thuringiensis subsp. kurstaki bound to humic acids from soil." Soil Biology and Biochemistry 30,463-70.

  8. Cummins, J. "The United States Environmental Protection Agency may have erred in assuming that toxicity may not be expected from consumption of genetic material in genetically modified crops." November 2000. Personal communication.

  9. Donnelly,J, Ulmer,U, Shiver,J and Lui,M. "DNA Vaccines" 1997 Annu Rev Immunol 15, 617-48

  10. Gebhard, F. and Smalla, K. (1999). Monitoring field releases of genetically modified sugar beets for persistence of transgenic plant DNA and horizontal gene transfer. FEMS Microbiology Ecology 28, 261-272.

  11. Gorecki,D and Simons,J "The dangers of DNA vaccination" 1999 Nature Medicine 5, 126

  12. Guunathan,S, Klinman,D and Seder,R. "DNA Vaccines" 2000 Annu Rev. Immunol 18, 927-74

  13. Hansen, Michael. "Comments on the human health and product characterization sections of EPA's Bt Plant-Pesticides Biopesticides Registration Action Document," Consumer Policy Institute- Consumers Union, Presented to the EPA Science Advisory Panel. Arlington, VA. October 20, 2000.

  14. Haskin, Colin, "Weeds on the warpath" The Globe and Mail, April 26, 2000 In the first officially confirmed case of its kind, weeds in Canada have become resistant to three kinds of herbicide, reports New Scientist magazine. The plants picked up genes from three different, genetically modified varieties of the rapeseed crop canola.

  15. Hilbeck, Angelika, et al, Journal of Environmental Entomology At the Swiss Federal Research Station for Agroecology and Agriculture in Switzerland, two studies were conducted that looked at the effects of Bt toxin on green insects. In nature, these insects feed on the major pest targeted by Bt corn,the European corn borer. Lacewings, which are known for their appetite for aphids and other insects, play an important role in maintaining the equilibrium of insect populations. They are also important for pest control strategies. Researchers found that the mortality rate of lacewing larvae increased significantly after eating Bt toxin similar to that found in GE corn.

  16. Holmes, M. T. et al., "Effects of Klebsiella planticola on soil biota and wheat growth in sandy soil." Applied Soil Ecology 326: 1-12, 1998. Applied Soil Ecology Vol. 11 (1) pp. 67-78 This Oregon State University study suggests that a genetically engineered strain of the common soil bacteria Klebsiella had the unexpected effect of killing wheat. The addition of a genetically engineered bacterium, Klebsiella planticola to a small microcosm consisting of wheat plants and sandy soils kills the plants, while the addition of the non-engineered parent, Klebsiella planticola does not. Klebsiella (SDF 20) is a lactose-fermenting bacterium engineered to produce increased ethanol concentrations in fermentors that convert agricultural wastes to ethanol. The system (developed in Germany) envisioned the disposal of fermentation residues, including the engineered bacteria, as an organic soil amendment. The report that the engineered bacteria cause plant death raised the possibility that soil amendments would kill or impair crops in the fields where they were used and, further, that, once released and established, the Klebsiella could not be eliminated.

  17. Ho,M, Ryan,A, Cummins,J and Traavik,T 'Unregulated hazards "naked" and "free" nucleic acids" 1999 ISIS Report Prepared for the Third world Network http://www.i-sis.org

  18. Hsu,S, Chung,S, Robertson,D, Ralph,L, Chelvarajan,R and Bondada,S 1999 "CpG oligodeoxynucleotides rescue BKS-2 immature B cell lymphoma from anti-Ig-M-mediated growth inhibition by up-regulating of egr-1" International Immunology 6, 871-9

  19. Huang, F., L.L. Buschman, R.A. Higgins, and W.H. McGaughey. 1999. "Inheritance of resistance to Bacillus thuringiensis toxin (Dipel ES) in the European corn borer." Science 284:965-967. Resistance of European corn borer to Bt toxin is not recessive as previously thought, but appears to display the inheritance pattern of an incompletely dominant autosomal gene. Consequently, the high-dose/refuge strategy may be insufficient to limit the development of resistance to Bt by the corn borer. These studies suggest that existing refuge strategies designed to limit the development of insect resistance to Bt may not be effective.

  20. Jahreis,G and Kraft,J "Fate of forage DNA in farm animals" 2000 European Food Research and Technology 212

  21. Jain,V and Mekalanos,J "Use of lambda phage S and R gene products in an inducible lysis system from Vibrio cholerae and Salmonella enterica servovar Typhimurium-Based vaccine delivery systems" 2000 Infection and Immunity 68, 986-9

  22. Jorgensen, Rikke and Bente Andersen, "Spontaneous hybridization between oilseed rape (Brassica napus) and weedy B. campestris (Brassicaceae): A risk of growing genetically modified oilseed rape." American Journal of Botany, Vol. 81, pp. 7973 ff., 1994.

  23. Liu, Y-B, B.E. Tabashnik, T.J. Dennehy, A.L. Patin, and A.C. Bartlett. 1999. "Development time and resistance to Bt crops." Nature 400:519.

  24. Losey, J., Rayor, L., and M. Carter. "Transgenic pollen harms monarch larvae." Nature 20 May 1999 vol 399 pg 214 Cornell University study showed that the pollen from transgenic Bt corn kills monarch butterflies in laboratory tests. Nearly half of the monarch butterfly caterpillars fed on milkweed leaves dusted with Bt pollen died after four days compared to none of those consuming pollen from normal corn. Also, those that survived exposure to Bt pollen grew more slowly than those fed non-Bt pollen. Monarchs feed exclusively on milkweed, which grows in abandoned lots, along roadside, and near agricultural fields. http://www.biotech-info.net/transpollen.html

  25. Manders,P and Thomas,R "Immunology of DNA vaccines: CpG motifs and antigen presentation" Inflamm Res 49, 199-205

  26. Mikkelsen, T., Andersen, B., Jorgensen, R. "The risk of crop transgene spread." Nature 1996; Vol 380:p 31. Field trails in Denmark and Scotland have shown that GM oilseed rape transferred its inserted transgene by cross-pollination of wild relatives.

  27. Molling,K "Naked DNA for vaccine or therapy" 1997 J Mol Med 75,242-6

  28. New Scientist "Pollen from GE canola spreads." 4/99. New research by British botanists shows that pollen blown from large fields of genetically modified oilseed rape remains fertile over greater distances than expected. Even at sites 400 metres away from transgenic plots, as many as 7% of the seeds from non-GM oilseed rape plants were herbicide resistant. The research suggests that bees may be important pollen vectors over a range of distances and farm-to-farm spread of oilseed rape transgenes will be widespread.

  29. Obrycki, John, field study done at Iowa State University: Confirmed the toxicity of Bt-corn pollen to monarch caterpillars. Nearly 20% of the caterpillars fed milkweed leaves taken from Bt-corn fields and adjacent areas died, compared to no deaths among caterpillars exposed to normal corn pollen.

  30. Open Letter to All Governments Statement from World Scientists http://www.i-sis.org

  31. Open Letter To The Government from Physicians and Scientists for Responsible Application of Science and Technology http://www.psrast.org/ctenvir.htm

  32. Report from Germany that GM genes in GM pollen have transferred to the bacteria and yeasts in the gut of baby bees. http://www.guardianunlimited.co.uk/gmdebate/Story/0,2763,319432,00.ht....

  33. Roundup Kills More Than Weeds, 4/00. Summary: Monsanto's advertising campaigns have convinced many people that Roundup is safe, but the facts simply do not support that conclusion. Independent scientific studies have shown that Roundup is toxic to earthworms, beneficial insects, birds and mammals. Plus it destroys the vegetation on which they depend for food and shelter. And although Monsanto claims that Roundup breaks down into harmless substances, it has been found to be extremely persistent, with residue absorbed by subsequent crops over a year after application. http://www.organicgardening.com/watchdog/roundup.html

  34. Saxena, D., Flores, S. and G. Stotzky. "Insecticidal toxin in root exudates from Bt corn." Nature 1999; 402:480. New York University researchers reported preliminary findings from a study indicating that root exudates from Bt corn contain biologically active Bt toxin that the toxin retains its activity long after its release. Bt-corn can also exert toxicity among non-target pests or friendly insects. Bt toxin, which was introduced in the plant can persist, accumulate and remain as insecticide in soil. As the toxin binds with humic acids or it is absorbed in clay particles, it is rendered inactive and unavailable for degradation by the microbes. As the toxin is concentrated by more Bt toxin crop residues, it can constitute hazard to non-target organisms and enhance the selection of toxin resistant target species. With beneficial insects now placed in the death row amid emerging resistant pests, genetic engineering in corn could cause huge crop losses. http://www.biotech-info.net/exudates.pdf

  35. Schubbert,R, Renz,D, Schmitz,B and Doerfler,W "Foreign (M13) DNA ingested by mice reaches peripheral leucocytes, spleen,and liver via the intestinal wall mucosa and can be covalently linked to mouse DNA" 1997 Proc. Natnl Acad Sci USA 94, 961-6

  36. Snow, Allison A. and Pedro Moran Palma, "Commercialization of Transgenic Plants: Potential Ecological Risks," BioScience Vol. 47, pp. 86-96 Summary: Crop-to-wild gene flow is known to occur. Soon many plants will possess transgenic resistance to several types of herbicides, insects, and diseases.

  37. United States Environmental Protection Agency "Bacillus Thuringiensis Subspecies tolworthi Cry9C Protein and the Genetic Material Necessary for its Production in Corn; Exemption from the Requirement of a Tolerance"Federal Register May 22, 1998 (volume 63,number 99) Rules and Regulations

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Date: 28 Nov 2000 22:31:26 U
From: Mark Gold mgold@tiac.net

Mark Gold
Aspartame Toxicity Information Center
12 East Side Dr., #2-18, Concord, NH 03301

603-225-2110    mgold@tiac.net
http://www.HolisticMed.com/aspartame

Please Help Support the
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The strategy of Flooding with useless Research

Hi! Here a quote from the Nov. 27, 2000 Dairy Profit Weekly:

An important note:

I believe the idea of flooding the scientific community with poorly-designed studies started with the tobacco industry. Many of those industry studies were buried, fraudulent, or had useless designs.

In the 1970's and 1980's, the MSG (monosodium glutmate) industry followed the practice with a huge number of studies, reviews conferences, and a PR book in a fairly successful attempt to convince physicians and organizations that MSG was safe (despite voluntarily removing MSG from baby food because of risks of irreversible brain damage). It is now known that the industry's studies vary from badly flawed to scientific fraud – secretly giving aspartame to control subjects, secretly giving brain-protecting drugs to animals, and a myriad of other tricks. Some of the industry tricks are outlined in a fantastic article from Accountability in Research (1999) Vol 6, pp. 259-310 reprinted at: http://www.truthinlabeling.org/l-manuscript.htm

Monsanto copied many of the tricks of the MSG industry by flooding the research community with horrendously-designed studies of aspartame. Active "placebos", decades of mistakes in simple chemical measurements (off by 400% to 1000%), ignoring certain types of toxicity reactions, etc., etc. A PR book was written, huge numbers of badly flawed studies were published, careful reviews were written throwing praise on the badly flawed studies.

The same thing will probably happen with GM studies. It does not matter that many of the biotech studies are anywhere from badly flawed to useless. The reason it does not matter to the industry is that they're using the same techniques used successfully (for a while at least) when promoting MSG and aspartame. Namely:

  1. Flood the scientific community with studies (even useless studies)

  2. Have friends write reviews in general medical and medical specialty journals about the safety of GM foods. They cite the useless studies, but probably 0.01% of physicians would even take the time to follow any of these citations. And many that do can easily be fooled by the way Monsanto and others manipulate the design of the experiment and manipulate the data to get the result they are looking for.

  3. Have reviews of GM foods written by friends in many of the organizations they fund and many of the magazines they advertise in.

  4. If one study is published showing GM dangers, have 3+ studies published showing the opposite result.

    etc.

This type of flood of "research" is to be expected since similar techniques were able to trick scientists and physicians for many years on the tobacco, MSG, and aspartame issues.

I think it is very important to repeatedly give consumers details of the tricks that these companies are using to find "no problems" with GM foods.

Best Wishes,

Mark Gold

Nov. 27, 2000 Dairy Profit Weekly:

"Meet, milk and eggs from livestock and poultry fed genetically modified or biotech feeds are safe to eat, said the Federation of Animal Science Societies, a group of more than 10,000 animal scientists. The federation's statement was issued earlier this month after McDonald's European restaurants asked suppliers to provide food produced without biotech feeds.

"The animal scientists reiterated what the scientists have said before: that all of the data available worldwide from more than 20 research studies published in peer-reviewed journals show conclusively there is no effect of feeding biotech crops to livestock and poultry on the nutritional value or safety of their products. An additional 20-some studies are now undergoing peer review, said the group's executive director Barbara Glenn, with no evidence the genetic material in feed remains in animal food products."

[Dairy Profit Weekly, 6437 Collance Rd., East Syracuse, NY 13057]


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Date: 29 Nov 2000 12:01:38 U
From: Jason Boehk jasonab@fiam.net

Below is the text of Steven Druker's statement to the scientific panel assembled by EPA to determine whether Starlink corn should be granted a temporary approval for human consumption. (This statement was read by a representative of the Alliance for Bio-Integrity.)

Druker is Executive Director of the Alliance for Bio-Integrity, the organization which organized a major lawsuit against the FDA over its non-regulation of genetically engineered foods. Please note that on November 17th, the Alliance for Bio-Integrity filed its notice of intent to appeal the lawsuit's dismissal by the US District Court in Washington, DC.

This text is found at: http://www.biointegrity.org/11-28-2000-Statement-to-EPA.html

Excerpt: "It is time to end the fraud that is being perpetrated on the American people. It is time for responsible scientists to forthrightly acknowledge that all bioengineered foods entail unique hazards and that none can be considered safe unless it has been confirmed to be so through the kinds of rigorous feeding tests that have yet to be applied."


Note: FIFRA stands for Federal Insecticide Fungicide and Rodenticide Act. The EPA administers implementation of this Act, and has a panel of experts to give them advice.

Alliance for Bio-Integrity statement re: Starlink corn

STATEMENT FOR THE FIFRA SCIENTIFIC ADVISORY PANEL OPEN MEETING ON STARLINK CORN

By Steven M. Druker
Executive Director, Alliance for Bio-Integrity
November 28, 2000

StarLink corn should not be approved for human consumption, even if this panel determines that the pesticidal substance it exudes is no more hazardous than the pesticidal substances generated in other brands of genetically engineered organisms. That is because it is unrealistic –and unscientific –to focus solely upon the intended expression product of the transgene while disregarding the potential for the genetic engineering process to cause disruptions that can lead to the generation of unintended and essentially unpredictable new toxins, carcinogens, and allergens.

This hazard has been acknowledged by hundreds of experts, and it was also clearly recognized by the FDA's own staff scientists who reviewed the safety issues of bioengineered foods. This fact came to light when the FDA was compelled to divulge its files in the course of a lawsuit my organization has led against it.  FDA records reveal its experts repeatedly cautioned about the potential of bioengineering to induce unintended harmful substances and advised that toxicological feeding studies would be necessary to adequately screen for them. The fact that the awareness of the distinct risks pervaded the agency's expert staff is attested in a memo by an FDA official to the Biotechnology Coordinator stating: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." Photocopies of this and many other key documents from FDA files are available at our website www.biointegrity.org

However, as the FDA admits, it was then (and still is) operating under a White House directive "to foster" the biotechnology industry. This may explain why FDA administrators systematically disregarded the extensive warnings from their scientists, covered them up, and even went on to claim they were "not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way..." (FDA Policy Statement, May 29, 1992, Federal Register vol. 57, No. 104 at 22991.)

It is because the FDA refuses to recognize the risks of unintended and essentially unpredictable harmful substances that it has relinquished all regulatory decisions about pesticide-producing crops to the EPA. By pretending that the food safety question centers on the known pesticidal substance, it claims that the sole regulatory issue falls under FIFRA and that there is no remaining issue under the Food, Drug and Cosmetic Act for it to consider. In fact, the potential for harmful substances other than the intended pesticide makes it imperative that the precautions of the Food, Drug and Cosmetic Act be applied.

Just because the FDA has adopted an irresponsible and immoral course of behavior does not justify the EPA and this panel from likewise abdicating sound science and responsible action. I call upon this panel to acknowledge that whatever it specifically decides about the safety of the particular pesticidal substance in StarLink corn, there are other outstanding safety issues that have not been adequately resolved through scientific evidence as required by the Food, Drug and Cosmetic Act.

Please bear in mind that bioengineered foods have only come to market based on the FDA's claim that they are recognized as safe by an overwhelming consensus among experts. But it is clear such a consensus has never existed. FDA files demonstrate it did not exist when the agency gave bioengineered foods blanket approval in 1992, and there is abundant evidence no consensus exists today.  It is also clear that the FDA knows about the continued lack of consensus.

It is time to end the fraud that is being perpetrated on the American people. It is time for responsible scientists to forthrightly acknowledge that all bioengineered foods entail unique hazards and that none can be considered safe unless it has been confirmed to be so through the kinds of rigorous feeding tests that have yet to be applied. If the FDA refuses to act with integrity, it is time for the EPA to fill the void and remedy the situation. Will you, the members of this panel, continue the pretense that the only safety issue is a neatly circumscribed one, or will you act as genuine representatives of scientific knowledge? History will judge your performance.