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August 4, 2001
 

Barry Cortez, Branch Chief
California Department of Pesticide Regulation
1001 I Street
Sacramento, CA 95814-2828

Re: challenge to the safety of AuxiGro WP (EPA Number 70810-1) when used as a fungicide for the prevention of powdery mildew on grapes

Re: challenge to the safety of AuxiGro WP  (EPA Number 70810-1) when used as a plant growth regulator (PGR) to increase total yield on almonds, grapes, onions and tomatoes

Dear Mr. Cortez:

On February 22, 2001, I requested that the California Department of Pesticide Regulation (CDPR) allow me to read and review all material submitted to the CDPR in support of the Auxein Corporation (now Emerald BioAgriculture) application for approval of its product, AuxiGro WP (AuxiGro) for use as a plant growth regulator (PGR) to increase total yield on almonds, grapes, onions and tomatoes, including, but not limited to, material relevant to health and safety issues and the chemical composition of the product as well as any other material that the CDPR deems appropriate.

I further requested that the CDPR have the product analyzed by a laboratory without ties to the food and/or drug industries to demonstrate that the processed free glutamic acid used in AuxiGro, just like any other processed free glutamic acid, contains contaminants including, but not limited to, D-glutamic acid and pyroglutamic acid, in addition to L-glutamic acid.

On June 22, 2001, I  requested that the CDPR allow me to read and review all material submitted to the CDPR in support of the Auxein Corporation application for approval of AuxiGro when used as a fungicide for the prevention of powdery mildew on grapes, including, but not limited to, material relevant to health and safety issues and the chemical composition of the product as well as any other material that the CDPR deems appropriate.

As of this date I have received

A cover letter.

Two reports of acute toxicity wherein the studies on rabbits did not simulate the conditions that would be encountered by a rabbit living in, or visiting, a field that was treated with AuxiGro.

A file referred to as #830.6302 - 830.7550 which consisted of 14 pages (pages 21 - 34) made up of an index to Physical and Chemical Properties of Aux01F03 and procedures      and tests used to determine pH and bulk density.

Twenty (20) pages of copies of propaganda from the Web page of The Glutamate Association (the United States public relations arm of Ajinomoto's International Glutamate Technical Committee (IGTC)).

A copy of a study by Anantharaman entitled "In Utero and Dietary Administration of Monosodium L-glutamate to Mice: Reproductive Performance and Development in a Multigeneration Study," published in Glutamic Acid: Advances in Biochemistry and Physiology, a book of the proceedings of a conference held by Ajinomoto and the IGTC in Milan, Italy in 1978 or 1979.

Four (4) pages from an essay by Patricia Talliaferro.

A copy of the executive summary from the report: "Analysis of Adverse Reactions to Monosodium Glutamate (MSG)" done for the FDA by the Federation of American Societies for Experimental Biology, dated July, 1995 -- but not a copy of the entire report that contains a great deal of pertinent data.

Copies of seven studies of biochemistry or metabolism of protein from which glutamic acid and/or GABA are released after the protein is ingested -- studies that are irrelevant to understanding glutamic acid that is released from protein prior to ingestion.

As of this date, the CDPR has refused to provide me with information that I specifically requested.  Once I received a formal denial.  More often, the CDPR has simply ignored my requests.  The excuse for withholding information from me was that the requested information constituted a trade secret.

At this time, I again respectfully request the answers to my questions as follows.  None could possibly be construed to be trade secrets:

Processed free glutamic acid (MSG)

What is the amount of processed free glutamic acid (MSG) in AuxiGro?

What is the amount of processed free glutamic acid (MSG) contributed by inert ingredients?

What is the amount of processed free glutamic acid (MSG) contributed by active ingredients other than the "L-glutamic acid?"

What is the amount of processed free glutamic acid (MSG) that will remain as residue on fruit, grain, nuts, seeds and vegetables when brought to market?

What is the amount of processed free glutamic acid (MSG) that will be taken up by vegetation and remain as residue in fruit, grain, nuts, seeds and vegetables when brought to market?

What impurities, of any kind, are there in AuxiGro?  (According to EPA documents, no unknown impurities are expected to be found in the formulation.)

Carcinogenic material
What are the names and amounts of carcinogenic material that will remain as residue on fruit, grain, nuts, seeds and vegetables when brought to market?  It is the names and amounts of the carcinogenic material, not the names and amounts of ingredients, that is being asked for.

What are the names and amounts of carcinogenic material that will be taken up by vegetation and remain as residue in fruit, grain, nuts, seeds and vegetables when brought to market?

What amount of carcinogenic material comes from the active ingredient called "L-glutamic acid?"

What amount of carcinogenic material comes from the inert ingredients?

Are any ingredients made using acid hydrolysis of protein?  Acid hydrolysis of protein produces mono and dichloro propanols (which are carcinogenic).

According to EPA documents, one of the inert ingredients has been labeled a probable human carcinogen by OSHA.  What human carcinogen is that?

Genetically engineered material
Ajinomoto Co., Inc. has used genetically engineered enzymes and/or bacteria in producing processed free glutamic acid (MSG).  Does Ajinomoto Co., Inc. manufacture the processed free glutamic acid used in AuxiGro?  (They call it L-glutamic acid.)  If they do, do they use genetically engineered enzymes and/or bacteria in producing processed free glutamic acid (MSG)?  Please note that the question is who manufactures the processed free glutamic acid, not who supplies it.

If not manufactured by Ajinomoto Co., Inc., who manufactures the processed free glutamic acid?  Is the method of manufacture referred to as bacterial fermentation?  Are enzymes or bacteria used in producing the "L-glutamic acid" genetically modified?

Allergenic ingredients known to have caused death in highly sensitive people
Hydrolyzed casein protein is a milk product. Government documents suggest that one of the inert ingredients in AuxiGro is hydrolyzed casein protein. Milk is know to cause severe allergic reactions in some milk-sensitive people and has been know to lead to death.

What amount of hydrolyzed casein (milk) protein is used in AuxiGro?

What amount of hydrolyzed casein (milk) protein will remain as residue on fruit, grain, nuts, seeds and vegetables when brought to market?.

What amount of hydrolyzed casein (milk) protein will be taken up by vegetation and remain as residue in fruit, grain, nuts, seeds and vegetables when brought to market?

Pork enzymes and/or other pork products present in the processed free glutamic acid (MSG) used in AuxiGro
Ajinomoto Co., Inc. has used pig enzymes in the manufacturer of its flavor enhancer monosodium glutamate. That information was made public in January of 2001.  Because monosodium glutamate is nothing more than processed free glutamic acid and salt, it is conceivable that pig enzymes are also used in producing the processed free glutamic acid used in AuxiGro.

Does Ajinomoto Co., Inc. manufacture the processed free glutamic acid used in AuxiGro?  (Auxein Corporation calls the processed free glutamic acid "L-glutamic acid.")  If Ajinomoto Co., Inc. does, do they use pork enzymes and/or other pork products in making the processed free glutamic acid (MSG) used in AuxiGro?  Again, please note that the question is who manufactures the processed free glutamic acid, not who supplies it.

If not manufactured by Ajinomoto Co., Inc., who manufactures the processed free glutamic acid used in AuxiGro?  Does the method of manufacture use pork enzymes and/or other pork products in producing the processed free glutamic acid (MSG) used in AuxiGro?

Beef enzymes and/or other beef products present in the processed free glutamic acid (MSG) used in AuxiGro
When Ajinomoto Co., Inc. was forced to withdraw its flavor enhancer monosodium glutamate (MSG) from the market in Indonesia in January, 2001 because pig enzymes were used in its manufacturer, Ajinomoto offered to use beef enzymes instead.

Does Ajinomoto Co., Inc. manufacture the processed free glutamic acid used in AuxiGro?  (Auxein Corporation calls it L-glutamic acid.)  If they do, do they use beef enzymes and/or other beef products in making the processed free glutamic acid (MSG) used in AuxiGro?  Again, please note that the question is who manufactures the processed free glutamic acid, not who supplies it.

If not manufactured by Ajinomoto Co., Inc., who manufactures the processed free glutamic acid?  Does the method of manufacture use beef enzymes and/or other beef products in producing the processed free glutamic acid (MSG) used in AuxiGro?

Amounts of processed free glutamic acid (MSG) needed to cause brain lesions, endocrine disorders, and adverse reactions.
What is the least amount of processed free glutamic acid (MSG) needed to cause brain lesions?

What is the least amount of processed free glutamic acid (MSG) needed to disrupt an endocrine system?

What is the least amount of processed free glutamic acid (MSG) needed to cause an adverse reaction in an MSG-sensitive person?

The amount of processed free glutamic acid found in unadulterated produce.
One of the items submitted to the CDPR by Auxein Corporation was a table taken from the Web site of The Glutamate Association titled "Glutamate Content of Foods." It is not clear from the table whether some of the foods mentioned were raw and unprocessed, or whether some (or all) had been processed or treated with AuxiGro. Moreover, there was no indication of when (the date) the estimates or analyses were done.  Neither was there any indication if all of the estimates or analyses were done at the same time -- or if The Glutamate Association selected numbers that suited them from various sources.
What is clear, however, is that these were old data, and using old data serves a very important purpose if one wants to fool people into thinking that there is a great deal of free glutamic acid in unprocessed food.  Analyses of the glutamate content of foods done years ago are generally overestimates of the amount of free glutamic acid present in produce and food products, and may, in addition, be unreliable. With less sophisticated analytical procedures than we have today (procedures which, even today, are less than perfect), bound glutamic acid could have been inadvertently freed from protein during analysis and counted as free glutamic acid.  I would guess that newer analyses have not been done because, if done properly, newer analyses would reflect the small (if any) amounts of free glutamic acid actually found in unadulterated produce and would thus expose one of Ajinomoto's principal arguments for the safety of monosodium glutamate as being fraudulent.  And if done and distorted, Ajinomoto, Co., Inc. would risk the chance of being exposed for falsifying data.

Will the CDPR be using the information in that table in making its decision about licensing AuxiGro?

Mislabeling of AuxiGro
The AuxiGro label states that AuxiGro contains 29.2% of a chemical referred to as "L-glutamic acid" as an active ingredient.  But both EPA documents and CDPR documents indicate that there is additional "L-glutamic acid" in AuxiGro. The labeling is certainly deceptive and misleading.  Doesn't this constitute mislabeling?
The Public Report Regarding the Registration of AuxiGro WP Containing the Active Ingredient L-Glutamic Acid
The Public Report Regarding the Registration of AuxiGro WP Containing the Active Ingredient L-Glutamic Acid, that was issued prior to 2001, says that CDPR's medical and toxicology staff determined that the small amounts of L-glutamic acid being applied would not have an adverse effect on people consuming treated grapes." Given that:
1) the CDPR had no data on the amount of "L-glutamic acid" that would be left as residue in and on crops,

2) the CDPR had no data on the least amount of "L-glutamic acid" that would be needed to cause an adverse reaction in a highly sensitive person, and

3) it is common knowledge that some people with allergies and sensitivities react to minute amounts of the material to which they are allergic or sensitive,

how did the CDPR make that determination?

The Public Report says that the form of "L-glutamic acid" used in AuxiGro "is identical to the naturally occurring glutamic acid found in the human body and in a wide range of foods, including grapes."  That's a lie. Naturally occurring glutamic acid found in the human body and in a wide range of foods, including grapes does not contain contaminants.  Why was this lie recited in the Public Report?

The fact that "the amount of glutamic acid naturally present in grapes far exceeds the allowable use rate on the [AuxiGro] product label" is irrelevant to the toxicity of the processed free glutamic acid (MSG) used in AuxiGro. The glutamic acid naturally present in grapes is primarily, if not entirely, bound in protein, and does not cause brain lesions, endocrine disorders, or adverse reactions. The glutamic acid used in AuxiGro can cause brain lesions, endocrine disorders, and adverse reactions.  Why has the CDPR used this bogus argument in making its case for licensing AuxiGro?

The Public Report says that "there is little likelihood of residues remaining on the grapes at time of harvest."  I find it extremely interesting that I, a consumer, in making my case for the toxicity of AuxiGro, am required to give the CDPR "scientific data," while Auxein Corporation simply has to say that there is "little likelihood..." and the product is approved for use in California.  Why does the CDPR use this double standard?  Is it, or is it not, the responsibility of the CDPR to protect consumers from potentially harmful products falling within its jurisdiction?

The Public Report says that the EPA "also extensively reviewed AuxiGro WP and its active ingredient, with consideration towards sensitive populations." That's a lie. EPA's approval violates its own rules which require that for an exemption from the requirement of a tolerance to be granted, data submitted in support of the exemption must be complete, valid, and reliable.  The data reviewed by the EPA were confined to the conjectures and data submitted by Auxein Corporation, with no regard for data omitted, and no mention of consideration of milk-sensitive populations.  Maybe the CDPR didn't know those things at the time the "Public Report Regarding the Registration of AuxiGro WP Containing the Active Ingredient L-Glutamic Acid," was issued prior to 2001.  An Objection, demonstrating the lie, is in the process of being filed with the EPA.  Is the CDPR going to continue to claim that the EPA "extensively reviewed AuxiGro WP and its active ingredient, with consideration towards sensitive populations?"

In addition to answering my questions, please send me a copy of the CDPR's review of the fungicide application that was recommended for approval a year or so ago. Given that Auxein Corporation provided no data on the amount of AuxiGro that would remain as residue in and on crops, and provided no data on the least amount of processed free glutamic acid needed to cause brain damage, endocrine disorders, or adverse reactions, what calculation did CDPR scientists do to determine that "the small amount" of processed free glutamic acid would not cause brain damage, endocrine disorders, or adverse reactions?  From what I have seen so far, I cannot imagine what CDPR scientists might have seen at that time that caused them to say that AuxiGro should be licensed for use in California.  I would like to be sure to address all of those issues.

Enclosed is the signed CDPR Affirmation of Status sent to me for completion by Rudy Lapurga.to be submitted with this request.  I have also sent Mr. Lapurga an original of the Affirmation of Status.

Sincerely yours,
 
 

Adrienne Samuels, Ph.D.
1547 Santa Sabina Court
Solana Beach, CA 92075

858-481-9333

cc: Rudy Lapurga
 

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