The U.S. Environmental Protection Agency (EPA)

In July of 1998, with time on my hands, I determined to teach myself how to do a keyword search of the Federal Register. The details of my labors are irrelevant, except to say that when I plugged in the key word "glutamate," I discovered that on January 7, 1998, the EPA had approve spraying processed free glutamic acid, used in plant "growth enhancers," on all agricultural products (Federal Register, 1998).

Application to register AuxiGro, the first MSG-containing product to seek registration, had been published in the August 8, 1997 Federal Register (Federal Register, 1997a). Knowing that the product was being offered for sale, I called the EPA pesticide registration department to ask if and when that registration had been granted; and was informed that there was no such product on their computer. Having in hand the EPA registration number being used by the manufacturer, I insisted that the product had been registered. It was finally determined that AuxiGro had been registered on January 14, 1998. But people still call to inform me that they have called the EPA and been told that no such thing as AuxiGro has been registered; and I have not yet seen notice of the registration published in the Federal Register.

On July 14, 1998, J. Samuels wrote to the EPA Freedom of Information office (FOI) to request background material on the approval of glutamic acid spray on agricultural products. The FOI responded in a timely fashion that they could provide no information at this time, because the product had not yet been registered. When I supplied FOI with the product registration number, I was told that as soon as the file had been purged for proprietary information, it would be sent to J. Samuels. But first it had to be retrieved from the office of Edward Allen, who had borrowed it. I was told there was no other copy than that which had been taken by Mr. Allen. On August 26, 1998 I called FOI to determine the status of J. Samuels' FOI request. On August 28, 1998, I called and left a message for Frances Mann and later called, again; at which time Ms. Mann of the FOI office told me she was putting the Request for Registration into the mail. When I pointed out that I had requested the Administrative File, not the Request for Registration, she said she would look into it and get back to me.

On July 13, 1998, J. Samuels wrote to the EPA, alerting the EPA to the fact that a grievous error had been made in approving the use of a neurotoxic amino acid in a spray for use on food. Initial correspondence with the EPA was directed to Lynn Goldman, M.D., Assistant Administrator for Prevention, Pesticides, and Toxic Substances, with a follow-up conversation with her assistant, Douglas Parsons.

Subsequently, a phone call was received from Edward Allen (Regulatory Action Leader, Biopesticides and Pollution Prevention Division (BPPD), Office of Pesticide Programs, EPA; Roy Sjoblad, Ph.D., Branch Chief, Biochemical Branch; and Freshteh Tothrol, Ph.D., (the scientist who reviewed the Auxein applications); who called to assure J. Samuels that the research relating to Auxein's submission had been thoroughly reviewed, and that the product posed no risk to humans. In response to J. Samuels' protestations that the literature clearly indicated that ingestion or other use of free glutamic acid placed both humans and wildlife at risk, Dr. Sjoblad, told J. Samuels that

"We're simply asking you to support the claims you made that. You can do that. You have these claims. We're not aware of it. It's your responsibility..."

Subsequently, J. Samuels received an e-mail from Janet Andersen, Ph.D., Division Director, BPPD, addressed, evidently, to all those who had written to the EPA by that time (J. Andersen, personal communication, July 27, 1998). The short letter contained basic misinformation and misquoted J. Samuels. That letter read, in part,

"The glutamic acid EPA has approved is 99.3% pure (pharmaceutical grade) L-glutamic acid and is NOT MSG (monosodium glutamate). The Auxein Corporation product contains L-glutamic acid and gamma aminobutyric acid. The product does not contain MSG; EPA is aware of the potential for allergic reactions to MSG."

I also know, and the EPA has received material, including citations and abstracts of studies that contain the information that: 1) pharmaceutical grade L-glutamic acid was used to destroy retinas, kill brain cells, and cause neuroendocrine disorders before neuroscientists realized that they could accomplish the same effect using an inexpensive food additive called monosodium glutamate; 2) food additive monosodium glutamate, by FDA definition, must contain 78 percent free L-glutamic acid and 21 per cent sodium; and 3) it is the free glutamic acid that occurs as a consequence of manufacture that causes adverse reactions, regardless of the name of the ingredient or product that contains it.

But I do not know why the EPA has ignored the fact that Auxein Corporation violated the FFDCA, has ignored the hard science that says that the free glutamic acid in the Auxein Corporation product has toxic potential, and has said that J. Samuels said "In an email message to EPA on July 23rd, Mr. Samuels has indicated he is not concerned about L-glutamic acid," when J. Samuels never did, and never would, make such a statement. Neither do I know why Andersen responded to a letter from J. Samuels with the answer to one of his many question while ignoring all of the others.

In a letter to J. Samuels dated August 21, 1998, Andersen made the following statements:

1) "There is no scientific evidence that oral consumption of L-glutamic acid normally found in plants and animal proteins causes adverse effects."

The statement is true. It is not the L-glutamic acid normally found in plants and animal proteins that causes brain lesions, neuroendocrine disorders, learning disabilities, and adverse reactions; it is processed free glutamic acid (which consumers refer to as MSG)–the type of glutamic acid found in AuxiGro–that causes those disease conditions.

2) "We have reviewed the scientific studies you sent us showing adverse effects of L-glutamic acid resulting from either direct injection or high-volume force feeding to rodents. None of this data is relevant to the effects of oral ingestion by humans."

Andersen did not respond to the fact that J. Samuels also sent the EPA feeding studies that demonstrated that free glutamic acid caused adverse reactions both in laboratory animals and in humans.

3) "Prior to registering ‘AuxiGro,' the Biopesticides and Pollution Prevention Division (BPPD) in OPP performed a risk characterization on L-glutamic acid as mandated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by the Food Quality protection Act (FQPA)."

Both the references provided to me by the EPA and the statements made in publication of the Final Rule, demonstrate that the EPA has violated Sections 408 (b)(2)(D), 408(c)(2)(A)(i), and 408(c)(2)(B) of the Federal Food, Drug and Cosmetic Act, and ignored Executive Order 13045 entitled Protection of Children from Environmental Health Risks and Safety Risks (62FR 19885, April 23, 1997). Andersen did not address that issue.

According to Section 408 (b)(2)(D) of the Federal Food, Drug and Cosmetic Act, it is the responsibility of the EPA to review the scientific data and other relevant information in support of any action to be taken, and consider its validity, completeness, reliability, and relationship to human risk

According to Section 408 (c)(2)(A)(i) of the Federal Food, Drug and Cosmetic Act, the EPA is allowed to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on food) only if there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. This includes exposure through drinking water.

According to Section 408 (c) (2) (B) of the Federal Food, Drug and Cosmetic Act, in considering an exemption from the requirement of a tolerance, EPA is required to give special consideration to exposure of infants and children.

According to Executive Order 13045 entitled Protection of Children from Environmental Health Risks and Safety Risks, "...each Federal agency: (a) shall make it a high priority to identify and assess environmental health risks and safety risks that may disproportionately affect children."

Approval of the use of free glutamic acid in a spray to be used on agricultural products was based, in part, on 14 toxicological studies published in 1979 or before, either found or referenced in one book published in 1979 on behalf of The Glutamate Association, (Filer, 1997) with no reference to the fact that those studies have long since been refuted, and no consideration of the fact that glutamic acid is a neurotransmitter and a neurotoxin known to cause endocrine disorders later in life when ingested by the young. There were no other toxicological studies from the literature considered.

4) "The amount of L-glutamic acid in the pesticide product ‘AuxiGro,' when used according to the label instructions, results in a final application rate of 0.125 to .75 pounds of product or 0.04 to 0.25 pounds (0.64 to 4 oz) per acre. In addition, the L-glutamic acid is applied three to four weeks prior to harvest. Virtually no residues of L-glutamic acid will remain on the crops at the time of harvest."

Andersen uses the word "virtually." I wonder how she knows. The EPA Final Rule establishing a temporary exemption from the requirement of a tolerance for residues of glutamic acid (Federal Register, 1997b), reads, in part, "...because this amino acid is found naturally in plants, the Agency has determined that residue analysis would not yield meaningful results, i.e., the analysis would not discern whether the glutamic acid source was the plant or the product treatment." No claim is made that there will be no residue. The Final Rule goes on to say, "Residues remaining in or on the raw agricultural commodity after this expiration date will not be considered actionable..." Andersen seems to know something that those who wrote the Final Rule didn't know. Those who wrote the Final Rule establishing a temporary exemption from the requirement of a tolerance for residues of glutamic acid spoke of "residues remaining."

>>>Read The toxicity/safety of processed free glutamic acid (MSG): A study in suppression of information in its entirely

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