On June 8, 1999, we first formally presented our concerns to the CDPR

June 8, 1999
 

Barry Cortez
Branch Chief
California Department of Pesticide Registrations
830 K Street
Sacramento, CA  95814-3510

Dear Mr. Cortez:

It has come to my attention that Auxein Corporation has applied to the California Department of Pesticide Registration for registration of its plant "growth enhancer," AuxiGro Wettable Powder Plant Metabolic Primer (AuxiGro) for use as a fungicide/plant growth regulator- for the control of powdery mildew and bunch rot on grapes (Tracking Number 174906; EPA Registration Number 70810-1).

AuxiGro is a manufactured product made of 29.2% free glutamic acid, 29.2% gamma aminobutyric acid (GABA) and 41.6% unspecified. I am writing to ask that registration of AuxiGro for use on grapes be denied and that no spray containing glutamic acid be approved for use in the state of California. I offer evidence of the inappropriateness of the Environmental Protections Agency's (EPA) glutamic acid exemption from tolerance as well as evidence of the potential toxicity of AuxiGro as follows:

On the subject of the free glutamic acid component of AuxiGro

The glutamic acid in AuxiGro is a manufactured product. The EPA now refers to it as L-glutamic acid -- which it is not. The glutamic acid in AuxiGro is a chemical compound undoubtedly made by microbial fermentation by the Ajinomoto Company. "In this method, bacteria ... are grown aerobically in a liquid nutrient medium containing a carbon source ..., a nitrogen source such as ammonium ions or urea, and mineral ions and growth factors. The bacteria selected for this process have the ability to excrete glutamic acid they synthesize outside of their cell membrane into the medium and accumulate there. The glutamic acid is separated from the fermentation broth by filtration, concentration, acidification, and crystallization, followed by conversion to its monosodium salt, MSG" ( See Leung, A. and Foster, S. Encyclopedia of Common Natural Ingredients Used in Food, Drugs, and Cosmetics New York: Wiley, 1996. Pp 373-375).

Manufactured free glutamic acid contains L-glutamic acid, D-glutamic acid, pyroglutamic acid, and, a variety of other components or contaminants. (See commentary and references in http://www.truthinlabeling.org/manufac.htm - On the Subject of Manufactured vs. Natural Glutamic Acid) (See Deki, M., Echizen, A., and Temma, T. Minor Components in Monosodium Glutamate. Bulletin of the Central Customs Laboratory, 1977;17:)

On the other hand, the glutamic acid that occurs in protein is L-glutamic acid, only. (See commentary and references in http://www.truthinlabeling.org/manufac.htm - On the Subject of Manufactured vs. Natural Glutamic Acid)

The glutamic acid in AuxiGro is essentially identical to the glutamic acid used in the flavor enhancer "monosodium glutamate" and other flavor enhancers. Both are manufactured. Both contain L-glutamic acid, D-glutamic acid, pyroglutamic acid and a variety of contaminants which differ depending on the base material used and the method of processing. Both are deemed "naturally occurring" by the Food and Drug Administration (FDA) because they both start with material found in nature.

On the relationship of processed free glutamic acid to both glutamic acid found in protein and any free glutamic acid that might be associated with protein

 

Intact protein (which invariably contains L-glutamic acid bound in long chains with other amino acids) does not cause adverse reactions in MSG-sensitive people. If there is free glutamic acid found in unadulterated, unfermented, or otherwise unprocessed food, that free glutamic acid does not cause adverse reactions. Only glutamic acid that has been freed from protein or produced by fermentation prior to ingestion, inhalation, or skin contact causes MSG-reactions. There are, for example, hundreds of reports of adverse reactions following ingestion of processed free glutamic acid (MSG) on file at the FDA Adverse Reactions Monitoring System, but prior to the introduction of AuxiGro, there were no reports of MSG reactions following ingestion of whole protein. (See http://www.truthinlabeling.org/msgfacts.htm - Basic Facts about Processed Free Glutamic Acid [MSG])

 

On the subject of research relevant to the safety/toxicity of processed free glutamic acid (MSG)

1. Processed free glutamic acid, essentially identical to the processed free glutamic acid used in AuxiGro, causes brain lesions and neuroendocrine disturbances in experimental animals and adverse reactions in humans. (See http://www.truthinlabeling.org/humansatrisk.htm - What Scientists Tell Us about MSG and http://www.truthinlabeling.org/additional.htm - processed Free Glutamic Acid (MSG): Selected References Sufficient to Demonstrate that MSG Places Humans at Risk).

2. The few studies that have concluded otherwise are limited to studies underwritten by the glutamate industry. (See Sponsorship of Selected Scientists Who Have Conducted Research and/or Spoken Publicly about the Safety of MSG.)

3. Industry-sponsored studies that conclude that processed free glutamic acid is "safe" are flawed to the point of being fraudulent. Those presented to the EPA by Auxein Corporation as evidence that processed free glutamic acid is "safe" were done in the 1960s and 1970s and have long since been refuted. In more recent double-blind studies, not submitted by Auxein Corporation to the EPA, wherein the ingredient monosodium glutamate was used in test material as the source of processed free glutamic acid (MSG), placebos contained processed free glutamic acid (MSG) coming from other sources, and/or placebos contained aspartic acid (a similar neurotoxic amino acid found in the artificial sweetener aspartame). As would be expected, subjects reacted to placebos as well as test material.

Another example. Many researchers claim to use well subjects only: subjects were only allowed to participate in their research (and be paid handsomely for their participation) if they were not, and had never been, sick. It is only upon careful scrutiny that the reader will realize that to be included in the studies, subjects had to claim never to have had any of the reactions that are associated with MSG-toxicity. (See Samuels, A. Monosodium L-glutamate: a double-blind study and review. Letter to the editor. Food and Chemical Toxicology. 33: 69-78, 1995.)

4) Processed free glutamic acid (MSG) is implicated in addiction, stroke, epilepsy, degenerative disorders (Alzheimer's disease, Parkinson's disease, and ALS, for example), brain trauma, neuropathic pain, schizophrenia, anxiety, and depression -- all seemingly diverse disease processes of the central nervous system that appear to be associated with the "glutamate cascade."

On the subject of Auxein's submission to the EPA to grant the glutamic acid used in their product an exemption from tolerance

 

Auxein Corporation's application to the EPA was without merit.

In their application to the EPA for an exemption from tolerance for glutamic acid and for GABA, and their application for registration of AuxiGro, Auxein Corporation spoke of the glutamic acid in their product as though it were identical to glutamic acid found in protein which it is not and drew conclusions about the appropriateness of using those products from that distortion of the truth and their personal opinion, not from fact gleaned from science. Glutamic acid found in the human body is not "a white, practically odorless, free flowing crystalline powder," as stipulated by Auxein Corporation. The blood-brain barrier does not protect the brain from large infusions of glutamate. And the placental barrier does not, in all cases, protect the developing fetus against processed free glutamic acid ingested by the mother. Those are distortions of the truth. They are lies. Moreover, Auxein Corporation failed to show the EPA the copious data, easily accessed from the scientific literature, that clearly demonstrate that use of free glutamic acid places humans at risk. Identifying all data that address the issue of potential toxicity is required by law in making application to the EPA.

Glutamic acid is a toxic substance known to kill brain cells in experimental animals. Auxein Corporation did not share that information with the EPA. The literature would suggest that the greatest damage would be done to infants and young animals, with the elderly being next most at risk. Auxein Corporation did not share that information with the EPA. Rather, Auxein Corporation showed the EPA a number of industry-sponsored studies done in the 1960s and 1970s that concluded that processed free glutamic acid (MSG) is "safe." Those studies have since been repudiated. Glutamic acid is know to cause neuroendocrine disorders later in life when fed to infant laboratory animals. In other words, glutamic acid is an endocrine disruptor. No mention of that fact was made by Auxein Corporation in its application to the EPA; and no toxicological studies exploring brain damage in infant animals were done. Indeed, in the Final Rule under the heading "Endocrine Disruptors" you will find the words "The [EPA] has no information to suggest that glutamic acid will adversely affect the immune or endocrine systems." (Since such data are abundant in the scientific literature, it would appear that the EPA made no effort to look at data outside of those supplied to it by Auxein Corporation.) "The [EPA] is not requiring information on the endocrine effects of this biochemical pesticide at this time."

Auxein Corporation has made the assertion that "Glutamic acid in the environment is readily utilized by microorganisms." That statement is made without substantiation. Neither is it clear whether Auxein Corporation is referring to L-glutamic acid only or including D-glutamic acid, pyroglutamic acid, the other contaminants found in processed free glutamic acid such as that used in AuxiGro, and the 41.6% undisclosed ingredients in AuxiGro.

In a statement taken from the EPA Office of Pesticide Programs Biopesticide Fact Sheet: Gamma aminobutyric acid (GABA) and L-glutamic acid, the EPA alleges that "There is no expected increased human exposure to GABA and L-glutamic acid in drinking water from the pesticidal use. When the end-use product is applied to plants, most of it is absorbed." But the EPA has no basis in fact for making such statements. It can only be that there is no expected increase in human exposure because Auxein Corporation told them there was none. There is no science that demonstrates that the chemicals in AuxiGro will be absorbed. And not even Auxein Corporation is telling us how much of the spray goes directly onto and into the ground and what happens to it there.

The EPA goes on to say, "But the potential exists for a minimal amount of it to enter ground water or other drinking water sources if, after application, weather patterns are such that significant rainfall and surface water runoff occur." Yet neither Auxein Corporation nor the EPA has evaluated the extent of the potential for AuxiGro entering ground water or other drinking water sources. Why would there not also be potential for large amounts of AuxiGro to enter ground water or other drinking water sources? Why would not irrigation facilitate runoff of AuxiGro? Why wouldn't the AuxiGro spray find its way into nearby open irrigation ditches such as those found in California's central valley?

The EPA states that "the health risk to humans is considered negligible based on the summary of available toxicity studies, the low application rate of the active ingredient, and the prevalence of the active ingredients already in nature." Again I would point out that Auxein Corporation's summary of available toxicity studies consisted of a summary of industry-sponsored studies, with none of the voluminous literature that points to the toxic potential of processed free glutamic acid mentioned. I would also point out that the active ingredient in AuxiGro is processed free glutamic acid which is not an ingredient otherwise found in nature.

The AuxiGro label approved for use in 1999 recommends that "Optimal results are attained when a silicone-based surfactant is used with AuxiGro." The use of silicone based adjuvants and surfactants with processed free glutamic acid was not discussed when the EPA granted a glutamic acid exemption from tolerance of a residual. I think it fair to assume that the use of a silicone adjuvant would optimize the adherence of the processed free glutamic acid to the plant(s) being sprayed, would prevent the processed free glutamic acid from washing off the plant, and would limit the vulnerability of the glutamic acid to microorganisms. But assuming is worthless. There are no data.

Data supplied by Auxein Corporation do not address the issue of how AuxiGro is taken up into the plant.

Data supplied by Auxein Corporation do not address the issue of what heating (cooking) produce sprayed with AuxiGro will do.

Auxein Corporation submitted material on digestion of protein to the EPA as evidence that their product is "safe." But digestion of protein, wherein a number of amino acids are freed over an extended period of time, in a balance established by nature, competing with each other for transport into the blood stream and onward from there, is a very different process than digestion of a bolus of processed free glutamic acid wherein L-glutamic acid, D-glutamic acid, pyroglutamic acid, and contaminants have been freed from protein prior to digestion and are immediately ready for uptake into the blood stream. Moreover, glutamic acid can be absorbed into the human body in the mouth and small intestines, long before it would even reach the stomach if it were ingested in protein. (See http://www.truthinlabeling.org/msgsprayed.htm - MSG is Back in Baby Food - Sprayed Right on Crops as They Grow)

Auxein Corporation has presented no data on the fate of processed free glutamic acid sprayed onto crops, onto the ground, and into the air.

The concept of a "slow neurotoxin" has been postulated by Peter Spencer. Spencer found that during World War Two, natives in Guam who ate seeds from the cycad tree while hiding in the jungle for protracted periods of time suffered an ALS type dementia later in life. The neurotoxin identified by Spencer is an analog of glutamic acid. (References: Spencer, P.S. Guam ALS/Parkinsonism- dementia: a long-latency neurotoxic disorder caused by "slow toxin(s) in food? Can J Neurol Sci. 14: 347-357, 1987. Spencer, P.S. Environmental excitotoxins and human neurodegeneration. Conference on excitotoxic amino acids, London, November, 1991. --- Peter S. Spencer, Center for research on occupational and environmental toxicology, Oregon Health Sciences University, Portland, Oregon 97201 USA Spencer, P.S. Western pacific ALS-parkinsonism-dementia: A model of neuronal aging triggered by environmental toxins. In Parkinsonism and Aging, ed D.B. Calne et al., pp 133-144. New York: Raven Press, 1989. --- Spencer, P.S., Ross, S.M., Kisby, G., and Roy, D.N. Western pacific ALS: putative role of cycad toxins. In: Amyotrophic Lateral Sclerosis: Current Clinical and Pathophysiological Evidence for Differences in Etiology, ed J.A. Hudson. Toronto: University of Toronto Press, 1990. --- Spencer, P.S. Linking cycad to the etiology of western pacific amyotrophic lateral sclerosis. In: ALS. New Advances in Toxicology and Epidemiology, ed F.C. Rose and F.H. Norris. Smith-Gordon, 1990. Spencer, P.S. Amyotrophic lateral sclerosis and other motor neuron diseases. In: Advances in Neurology, Vol 56, ed L.P. Rowland. New York: Raven Press, 1991.)

There is a copious literature on addiction, stroke, epilepsy, degenerative disorders (Alzheimer's disease, Parkinson's disease, and ALS, for example), brain trauma, neuropathic pain, schizophrenia, anxiety, and depression, seemingly diverse disease processes of the central nervous system that appear to be associated with the "glutamate cascade." In May, 1998 a conference was hosted by the National Institutes of Health as a vehicle through which researchers might share what they knew about the relevance of glutamic acid to these various disease processes. Auxein Corporation made no reference to these various disease conditions, to the "glutamate cascade" or to the NIH conference.

Human reactions to processed free glutamic acid (MSG) such as that granted an exemption from tolerance by the EPA are toxic reactions, often referred to as sensitivity reactions. They are not allergic reactions.

On the subject of the defenders of the safety of processed free glutamic acid (MSG)

 

Some individuals and some organizations with alleged interest in food safety have reviewed the safety of MSG favorably (American College of Allergy and Immunology, 1991; Institute of Food Technologists, 1980; McNutt, 1991; Schmitz, 1990; Taliferro, 1995; Tufts University Diet and Nutrition Letter, 1992; University of California at Berkeley Wellness Letter, 1989; University of California at Berkeley Wellness Letter, 1996; Wood, 1991).

Others have prepared brochures either stating that there is no evidence that ingestion of monosodium glutamate or other MSG-containing food additives should cause consumers concern; or listing food additives that might cause consumers concern while omitting mention of MSG-containing ingredients (American Academy of Allergy and Immunology, 1993; FDA in cooperation with IFIC, 1992; Scripps Clinic and Research Foundation, 1995). The American Academy of Family Physicians Foundation allowed IFIC to claim "Favorable Review by the American Academy of Family Physicians Foundation" on a 1991 brochure (International Food Information Council [IFIC], 1991). The American Medical Association refused to implement a Resolution passed by its membership at its 1991 annual meeting calling for the AMA to "...encourage all appropriate regulatory agencies, including the Food and Drug Administration, to mandate labeling of all foods containing even small amounts of additive L-glutamic acid so that individuals wanting to avoid this substance may do so" (American Medical Association , 1991).

Whether literally agents of the glutamate industry, or simply influenced by them, they publish material that is read by others who respect their opinions; material that is uncritical of anything said or done by the glutamate industry. Characteristic of those referred to here is their unwillingness to print any addition, correction, or retraction after errors or omissions in published material are pointed out to them.

Influence of the International Glutamate Technical Committee (IGTC) can be felt at every level. IGTC chairman Ebert has served on the FDA Food Advisory Committee; the Grocery Manufacturers of America (Technical Committee on Food Protection, the Codex Subcommittee on Food Additives and the GRAS-FASEB Monograph Committee); the National Food Processors Association; the Institute of Food Technology (Technology Toxicology and Safety Evaluation Division, and Scientific Lecturer); the National Research Council of the National Academy of Sciences Assembly of Life Sciences (Food and Nutrition Board: the Committee on Food Protection, and the GRAS List Survey); the American Medical Association (Industry Liaison Panel); the FAO/WHO Codex Alimentarius Food Standards Program as an Industry Observer; and the International Food Additives Council as Executive Director.

Ebert, a food-industry pharmacologist and toxicologist, has provided scientific and technical expertise for programs of many associations managed by The Kellen Company. His nomination to the FDA Food Advisory Committee did not refer to his affiliation with the IGTC, but listed him only as Senior Vice President of The Kellen Company. With him on the FDA Food Advisory Committee, was Kristin McNutt, a paid spokeswoman for the glutamate industry.

Ebert is also an active member of the Institute of Food Technologists (IFT).

Glutamate industry representatives and friends sit on boards of "independent" organizations. Glutamate industry researcher and spokesman Ronald Simon, M.D. has been a member of the Scientific Advisory Board of the Center for Science in the Public Interest (CSPI). Monsanto's Robert Shapiro sits on the board of the Tufts University School of Nutrition. Allergy support groups often include industry-friendly allergists on their medical advisory boards. Steve Taylor, Ph.D., a long time representative of the glutamate industry, has served on the Medical Advisory Board of The Food Allergy Network. "Independent organizations" whose medical advisory board members have ties to the glutamate industry have not provided information to their members about MSG-containing ingredients.

The outstanding characteristic of the defenders of the safety of processed free glutamic acid is that they parrot the words of the glutamate industry, making such deceptive, misleading, and/or false statements as "The glutamic acid in AuxiGro is identical to the glutamic acid found in nature," "MSG" (which was invented in 1908) "has been used in Chinese cooking for 2,000 years," "The glutamic acid in AuxiGro is naturally occurring," "Tomatoes, mushrooms, and Parmesan cheese all contain MSG," or "There is a blood-brain barrier that keeps glutamic acid that you eat from entering the brain." They offer the words laid out for them by the glutamate industry designed to proclaim the "safety" of processed free glutamic acid (MSG), but they offer no science to prove them.

On the subject of conflicts of interest

 

The FDA works closely with Ajinomoto and other members of the glutamate industry. So closely, in fact, that for years Andrew G. Ebert, Ph.D., Chairman of Ajinomoto's International Glutamate Technical Committee (IGTC) met at will with high ranking officials at the FDA to discuss, and have approved, their badly flawed protocols for double-blind studies to be used by the IGTC to conclude that processed free glutamic acid is "safe." So closely, in fact, that Ebert and at least one other agent of the glutamate industry were, several years ago, invited to serve on the FDA Food Advisory Committee. It should come as no surprise to find that the FDA makes no attempt to evaluate conflicts of interest among those who pretend to demonstrate the safety of processed free glutamic acid (MSG).

On the subject of possible conflicts of interest in academicians and others who might suggest to the California Department of Pesticide Registrations that spraying glutamic acid on food crops, on the ground, and into the air, poses no risk to humans

The glutamate industry, led by Ajinomoto is rich and powerful. They employ neutral sounding corporations such as the International Food Information Council and the International Life Sciences Institute to promote their interests, fund universities, medical schools, and individual M.D.'s and Ph.D.'s and to promote their products without making it obvious that they represent the glutamate industry.

In the 1970s, W. Ann Reynolds worked with Lewis Stegink and Lloyd Filer who were at the University of Iowa Medical School, a center for industry-sponsored research. Subsequently, Reynolds took a job in administration with the University of California. She is gone from California now, but it might be that while Reynolds was with the University, she helped the glutamate industry get its food in the door. Reynolds still speaks out about the safety of processed free glutamic acid (MSG) from her post with the state of New York.

The Berkeley Wellness Letter is a monthly publication that calls itself a health newsletter. The Berkeley Wellness Letter from time to time carries brief mention of the safety of processed free glutamic acid (MSG).

For many years, UCLA has been mentioned as a center for studies on the safety of processed free glutamic acid (MSG). Several names were offered to the FDA by the International Glutamate Technical Committee, but research at UCLA was finally done by Dr. Andrew Saxon. Saxon participated in both research that claimed to demonstrate the processed free glutamic acid (MSG) was "safe," and that aspartame, a sugar substitute made, in part, from aspartic acid, is also "safe."

UC Davis is the home of a number of researchers funded by Ajinomoto or others in the glutamate industry. Some years ago I spoke to Dr. O'Mahony who suggested that it would not be an efficient use of my time to drive up to Davis to visit him because all of his research was funded by Ajinomoto. O'Mahony does (or did) research designed to "prove" that there is a fifth taste sensation produced by processed free glutamic acid (MSG). It has been given the name Umami, and is one of Ajinomoto's attempts to legitimize the use of processed free glutamic acid (MSG).

Others at UC Davis are food technologists, some being members of the Institute of Food Technologists (IFT) toxicology division. They would not be expected to question the assertions of Andrew G. Ebert, a fellow IFT member and toxicologist who has represented the interests of Ajinomoto for many years. Indeed, since no professional can research every area brought to his attention, it only makes sense to rely on friends.

Physicians Ronald Simon and Donald Stevenson, associated with Scripps Clinic in LaJolla, have done research sponsored by the IGTC. Simon and Stevenson were privy to FDA confidential reports before those reports were released to the public.

On the subject of "safe levels" of free glutamic acid

In the late 1980s or early 1990s Peter Spencer introduced the concept of a slow neurotoxin, a neurotoxin that only manifests itself years after the neurotoxin was ingested.

In a 1992 report of the FDA, the Federation of American Societies for Experimental Biology (FASEB) concluded, in part,

"...The continuing controversy over the potential effects of glutamate on growth and development of neonatal animal models suggests that it is prudent to avoid the use of dietary supplements of L-glutamic acid by pregnant women, infants, and children. The existence of evidence of potential endocrine responses, i.e., elevated cortisol and prolactin, and differential responses between males and females, would also suggest a neuroendocrine link and that supplemental L-glutamic acid should be avoided by women of childbearing age and individuals with affective disorders."

In 1993, Martinez et al. published results of a study that found elevated levels of glutamic acid in cerebrospinal fluid during migraine headache (Martinez F., Castillo, J. Rodriguez, J.R., Leira, R., and Noya, M. Neuroexcitatory amino acid levels in plasma and cerebrospinal fluid during migraine attacks. Cephalalgia 13(2): 89-93, 1993).

We have seen an announcement from Wyeth-Ayerst Laboratories Division of American Home products Corporation that warns that its RotaShield vaccine, the first vaccine for use in preventing rotavirus, "should not be given to infants who are hypersensitive to latex or to any component of the vaccine, including...monosodium glutamate."

We have seen a letter from the Dole Consumer Center that reads "We are in receipt of your inquiry about AuxiGro. We assure you we do not use this neurotoxin on our produce."

We have read reports of studies wherein subjects we given as little as .5 grams of processed free glutamic acid (MSG) as test material, and subjects responded to that dose of MSG with adverse reactions.

We know from an exhaustive search of the literature, that no study designed to determine the least amount of processed free glutamic acid that could cause an adverse reaction has ever been done.

We know that since Auxein Corporation began testing AuxiGro, the Truth in Labeling Campaign has been receiving reports of MSG reactions following ingestion of head lettuce, russet potatoes, broccoli, and strawberries.

We know there is no known safe dose of processed free glutamic acid (MSG), whether that MSG comes from AuxiGro or other sources.

On the subject of public safety

 

I cannot "prove" to the California Department of Pesticide Registrations (CDPR) that the processed free glutamic acid given an exemption from tolerance by the EPA is toxic. However, I can, and have, demonstrated that the exemption from tolerance granted by the EPA is without merit. I have demonstrated that there is a vast body of material in the scientific literature that suggests that processed free glutamic acid has toxic potential, and that there is clear evidence that industry-sponsored research that would claim otherwise, is flawed to the point of being fraudulent. It is on this basis that I respectfully request that the CDPR independently evaluate the potential toxicity of the processed free glutamic acid proposed for use in California, hoping that unless and until the substance is actually proved to be safe, California not approve AuxiGro for use on grapes, and not allow processed free glutamic acid to be sprayed on crops, onto the ground, or into the air.

I would be pleased to provide the CDPR with additional information, and would also be pleased to argue the toxicity of processed free glutamic acid before the CDPR.

Thank you for your consideration.

Respectfully submitted,

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

858/481-9333
adieonly@aol.com

cc: Regina Sarracino
.....Ann Prichard