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Local Davis biotech employee says health affected by work

by repost
The mother of Davis injured Agraquest worker David Bell recently spoke at a forum at UC Davis on the illness of her son and the role of the biotech company Agraqest.
trend__sandi_with_son_s_bills.jpeg
Local Davis biotech employee says health affected by work


The California Aggie // City News // Local biotech employee says health affected by work

Local biotech employee says health affected by work
Officials say no threat to public health

Written by POOJA KUMAR
Published October 30, 2008
A presentation hosted by Davis Students for Nader two weeks ago raised questions about the possibility of harmful microbes in local soil, but public health officials say the claims are unfounded.

The presentation featured the mother of former Sacramento resident David Bell, who claimed he became ill after working with biopesticides for Davis biotech firm AgraQuest in the late1990s.

Jeff Pinnow, supervising hazardous materials specialist for Yolo County Environmental Health, said that the complaint did not come into Yolo County until 2007, even though Bell began experiencing symptoms a few months after he started at the company in 1998. Bell's mother, Sandi Trend, took it to the Yolo County District Attorney's Office and was mainly approaching it from the standpoint of worker's compensation issues, said Pinnow.

When Pinnow looked at the complaint he said that most of it dealt with worker's health and safety as well as soil importation into the country.

"If we thought it was a threat we would have initiated some type of investigation or we would have found some other agency to do it," Pinnow said. "[Any loose microbes] have been out getting rained on and open to elements for 10 years and I have one repeated case of illness.The likelihood of that being a public health threat - it doesn't even rise to that level."

Pinnow said that if the information had been reported in 1998 or 1999, there would have been more urgency.

At a presentation hosted by Davis Students for Nader, Trend spoke about her son's experience working at AgraQuest. Months after he had been working at the company's original location as an assistant researcher at Kennedy Place in Davis, Bell's health began to deteriorate. The company moved to a new facility on Drew Avenue in 1999.

After several clinic visits and a total of four sinus surgeries since then, a series of exams at the Mayo Clinic showed Bell had histoplasma, a mold found in soil, in his body and he was diagnosed with histoplasmosis. Bell has had a series of immunoglobulin infusions, each lasting for seven hours, for three years. Each costs $7,000 to $15,000, Trend said.

A written statement from AgraQuest said that the Bacillus subtilis strain is the only active ingredient in AgraQuest's product Serenade, a project Bell was working on. "It has been tested in accordance with EPA and EU guidelines for microbial pesticides and poses no significant risk to handlers or the environment used according to label instructions," the report says.

The statement also says that the EPA, which regulates all products sold for pest management purposes, investigated the report. In March, the EPA issued a document that said,"Histoplasmosis is an infection due to Histoplasma, a fungal species not related to Bacillus subtilis."

AgraQuest's statement said, "The CDC further reports that Histoplasma is endemic in certain areas of the U.S. and is commonly found 'in poultry house litter, caves, areas harboring bats and in bird roosts.' Positive histoplasmin skin tests occur in as many as 80 percent of people living where Histoplasma is common."

Trend said she traced back several possible infectious agents in AgraQuest's patents to agents that were found in her son during his visit to the Mayo Clinic.

"Although different organisms have been identified in his blood and cultures, they can be traced back to AgraQuest's patents or their products. Some are traced back to AgraQuest scientists who worked there the same time my son did."

Yolo County Environmental Health inspections found two minor violations in 2003 and2006.

"We do regulate the current facility on Drew Avenue for hazardous waste," Pinnow said. "I took a report of previous inspections. They basically had a couple of violations in the hazardous waste program - nothing that I haven't seen at least at a couple other facilities."

The violations included an instance of not labeling hazardous waste containers and failing to submit a waste disposal form (though the form was on file at the office). Other than that,AgraQuest has followed safety standards, Pinnow said.

"Allegations of dumping stuff is of one person. That's the only allegation I have heard," he said.

According to the statement from AgraQuest, a judge found that Bell's claim of injury was unfounded, a decision that was supported by a later appeals board.

Supporters of Bell say they are having a difficult time bringing this issue to the attention of officials.

"Your city, your college, your residents - you have a danger in your neighborhood," said Dina Padilla, Peace and Freedom Party candidate for the Congressional elections. "We don't know how far this danger exists in the water, in the food. We need to contact city council,media and Congress people."

Doug Haney, who says he is an expert on molds, fungi and microbes, has been investigating the case. He said he has been looking at natural crops as opposed to mutated crops.

"It's important that you pay attention to what's going on in Davis," Haney said. "The problem is that soil was being brought across country and county lines without documentation. That's what I'm worried about in Davis. When you have a mutated crop you can have a disease that becomes immediate, midterm or one that takes 20 to 30 years to develop, such as cancer."


POOJA KUMAR can be reached at city [at] californiaaggie.com.
FALSE & MISLEADING INFORMATION IN CAL AGGIE ARTICLE CONCERNING DAVID BELL and AGRAQUEST

by Sandi Trend
Monday Feb 9th, 2009 9:09 PM

In the October 30, 2008 - California Aggie article; "Local biotech employee says health affected by work" - "Officials say no threat to public health".

The first sentence, "A presentation hosted by Davis Students for Nader two weeks ago raised question about the possibility of harmful microbes in local soil, but public health officials say the claims are unfounded."

Included in this article is a statement by Jeff Pinnow (surpervising hazardous material specialist for Yolo County Environmental Health):

"The complaints [regarding Agraquest and work related exposure] did not come into Yolo County until 2007" and "David Bell's mother, Sandi Trend, took it to the Yolo County District Attorneys Office and was mainly approaching it from the standpoint of worker's compensation issues".

The statement from Jeff Pinnow, "did not come into Yolo County until 2007" is completely false and misleading. Yolo County became aware of David Bell’s occupational exposure in 2004 when the National Institue of Occupational Safety and Health sent a letter (on or around 6/30/2004) to Cal/OSHA and well as to The Yolo County Health Department [concerning David Bell’s exposure to Histoplasa at Agraquest].

As is evidenced by the 8/2/2004 response letter from Bette G. Hinton, Officer/Director of the Yolo County Health Department clearly shows Yolo County was 100% aware of David’s work related exposure in 2004 and not 2007 as Jeff Pinnow claimed.

Over a month had passed before Bette G. Hinton addressed the issues brought before her. Ms. Hinton said in an 8/2/2004 response letter that the 2nd AQ location at 1530 Drew Avenue in Davis, Ca had been inspected by Cal/OSHA and stated, "with findings that do not suggest "ongoing exposure" [EMPHASIS ADDED] to Histoplasma organism".

Ms. Hinton was immediately notified that where David had gotten sick was at the 1st AQ location at 1105 Kennedy Place in Davis, Ca. and not the Drew Avenue location where Cal/OSHA inspected. There was never a reply from Ms. Hinton.

To date there has never been an inspection of the 1105 Kennedy Place building nor the grounds surrounding the building [where AQ "dumped" liquid substances down the so-called "drain", that was merely a hollowing out in the concrete that led directly onto the ground] per requests from several of the City of Davis residents.

Additionally, Jeff Pinnow's statement In the Cal Aggie article, "mainly approaching it from the standpoint of worker's compensation issues" is again completely false and misleading.

Ms. Trend presented Detective Stroski of the Yolo County District Attorney's office the facts per Detective Stroski's request.

Detective Stroski was advised and given written documentation of Several mandated Federal and state laws that were violated by AQ concerning; adverse health effects (must be reported with respect to pesticides, insecticides, fungicides etc) per:

California Department of Pesticide Regulations:

•Division 6. Pesticides and Pest Control Operations; Chapter 2. Pesticides; Subchapter 1. Pesticide Registration; Article 6. Adverse Effects Disclosure

•Chapter IX; REGULATORY ACTIONS AFTER THE PRODUCT IS REGISTERED;

•B. RENEWAL OF PRODUCT REGISTRATION
•F. ADVERSE EFFECTS DISCLOSURE
•G. REEVALUATIONS
•H. RISK ASSESSMENTS

Federal Fungicide and Rodenticide Act (FIFRA)

•7 U.S.C. §136 et seq. (1996); Summary of the Federal Insecticide, Fungicide, and Rodenticide Act

On April 3, 1998 there was the, "1998 PESTICIDE REGISTRATION NOTICE 98-3; NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, DISTRIBUTORS AND REGISTRANTS OF PESTICIDE PRODUCTS", which in part says:

"which requires pesticide registrants to report information concerning unreasonable adverse effects of their products to EPA (62 FR 49370). The purpose of the rule is to clarify what information to submit, how and when to submit it, as well as which failures to report information, or delays in reporting, will be regarded by EPA as violations of FIFRA section 6(a)(2), actionable under FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N)."

•III. AGGREGATE REPORTING The regulations establish different requirements for reporting time frames and for content of incident reports depending on the defined severity categories (see Section VIII. Exposure Types and Severity Categories). (numerous others are included in this law)


AGRAQUEST FURTHER VIOLATED (TO NAME A FEW BUT NOT LIMITED TO):

* None reporting of work related injury/illness per Federal and state of California Occupational Safety and Health laws:

* California Code of Regulations: Title 8 Section 342; "Immediate reporting of any serious injury, illness, or death of an employee at the workplace"

* none compliance of Right-To-Know of Hazards in the Workplace

* Insurance Code Section 11760], Labor Code 5401 Reg 101119; "Claim Form provided to employee within one day of knowledge of injury"

* Labor Code 3602; "Liability exists for any injury sustained by an employee “arising out of and in the course of employment”

* Labor Code 4600; "Medical Treatment; employee is entitled to treatment that is “reasonably required to cure or relieve from the effects of the injury”

* Labor Code 4650; "Injury Causes Temporary Disability-Payment to Begin"

Further on Detective Stroski, Detective Stroski, after reviewing the material Ms. Trend had given him concerning Agraquest and the compelling evidence to her son, David’s sudden and ongoing declining health as the result of working for the company, had contacted the California Department of Insurance who then contacted the Sacramento County District Attorneys Office. No action was taken by any of the three agencies in relation to upholding Federal and state laws violated by AQ. In fact, when Detective Stroski was approached months later at the California Department of Insurance, and questioned, "why the Yolo County District Attorneys Office was not prosecuting AQ" he was told, "we don't have the funding"

AQ's 1530 Drew Avenue location was inspected and AQ was cited and fined by Cal/OSHA for "several illegal fume-hoods" (however, under oath Denise Manker of AQ said there was only one fume hood.) This was the only known citation that AQ had received until the October 30, 2008 - California Aggie article in which is stated:

"Yolo County Environmental Health inspections found two minor violations in 2003 and 2006"

We do regulate the current facility on Drew Avenue for hazardous waste," Pinnow said, "I took a report of previous inspections. they basically had a couple of violations in the hazardous waste program - nothing that I haven't seen at least at a couple other facilities."

"The violations included an instance of not labeling hazardous waste containers and failing to submit a waste disposal form (though the form was on file at the office). Other than that Agraquest has followed safety standards, Pinnow said."

"Allegations of dumping stuff is of one person. That's the only allegation I have heard, he said".

It should be noted that hazardous waste/toxic substances had been removed from AQ's 1105 Kennedy Place location & 1530 Drew Ave., as well as from the CEO and founder, Pam Marrone's other start-up company, NovoNordisk - ENTOTECH in Davis, Ca. (Entotech was the exact same type of biotechnology research and development company as AQ). Hazardous waste/toxic substances removed are as follows:

* ALKALINE SOLUTION (PH>= W/O METALS
* ARSENIC
* BIOLOGICAL WASTE (FOOD PROCESSING, ETC.)
* BLANK/UNKNOWN
* CADMIUM
* CORROSIVES
* CYANIDES (SOLUBLE CYANIDE SALTS), NOT
* IGNITABLE
* LABORATORY WASTE
* LABORATORY WASTE CHEMICALS
* LEAD
* LIQUIDS W PH<=2
* LIQUIDS WITH MERCURY>= 20 MG/L
* MERCURY
* NON-HALOGENATED SOLVENTS
* OFF-SPEC, AGED, OR SURPLUS INORGANICS
* OTHER EMPTY CONTAINERS>= 30 GALLONS
* OTHER INORGANIC SOLID WASTE
* PHOTOCHEMICALS/PHOTOPROCESSING WASTE
* SILVER
* SURPLUS INORGANICS
* UNSPECIFIED OIL-CONTAINING WASTE
* UNSPECIFIED SOLVENT MIXTURE

It is quite shocking that officials within Yolo County and the City of Davis have such a lack of concern with regard to health and safety in and from a biological laboratory who "collects microbes from soils and plants all over the world, tests their ability to combat plant diseases and pests, and makes pesticides out of the best candidates." Sacramento Business Journal, TITLE: AgraQuest gets another pact (November 24, 2000)

Additionally contained within the Cal Aggie article were the warnings from both Dina Padilla, 2009 Congressional candidate and Mr. Haney, environmental health researcher - to the residents of Davis.

Padilla:

"Your city, your college, your residents - you have a danger in your neighborhood", "We don't know how far this danger exists in the water, in the food. We need to contact the city council, media and Congress people."

Haney:

"It's important that you pay attention to what's going on in Davis", The problem is that soil was being brought across cuntry and county lines without documentation. That's what I'm worried about in Davis. When you have a mutated crop you can have a disease that becomes immediate, midterm or one that takes 20 to 30 years to develop, such as cancer."


Information concerning Agraquest's workplace involvement with the fungus, Histoplasma being found in David Bell's blood serum in 2003 by the Arizona Mayo Clinic, and Agraquest's products approved by the EPA. was additionally sent to the U.S. federal regulatory agency, the Environmental Protection Agency (EPA) in late 2003 or early 2004 As is documented in e-mails to and from the EPA, (Shanaz Baccus) the end result was "no action" was taken against Agraquest per EPA's responsibilities to protect human health and the environment.

The EPA merely referred the matter over to Daniel Sudakin, Assistant Professor of Oregon State University - Department of Environmental and Molecular Toxicology. Sudakin said, “There is nothing I can do”.

When the EPA was contacted concerning Sudakin’s, “nothing I can do” response the EPA reply was, “Did you try CDC and OSHA? OSHA covers manufacturing regulations”. “As far as I know histoplasmosis is not associated with any active ingredient registered as a microbial pesticide for Agraquest.”

The above statement from the EPA, “As far as I know histoplasmosis is not associated with any active ingredient registered as a microbial pesticide for Agraquest.” in itself could be taken as the responsibility of the EPA lies solely on the active ingredient registered and this would infer that EPA has no further responsibilies to any adverse effects to human health and the environment. However, the is not the EPA’s position. As is evidenced in their own statement, “Before a pesticide can be marketed and used in the United States, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires that EPA evaluate the proposed pesticide to assure that its use will not pose unreasonable risks of harm to human health and the environment. This regulation involves an extensive review of health and safety information.”

With respect to the EPA and the statement in the Cal Aggie article, “ “A written statement from AgraQuest said that the Bacillus subtilis strain is the only active ingredient in AgraQuest's product Serenade, a project Bell was working on. "It has been tested in accordance with EPA and EU guidelines for microbial pesticides and poses no significant risk to handlers or the environment used according to label instructions," the report says.”

The EMPHASIS in the above statement, “the Bacillus subtilis strain is the only active ingredient in AgraQuest's product Serenade, a project Bell was working on “ is quite relevant.

The submissions of April 28, 1999 and June 19, 1999 by Agraquest to the EPA was the Serenade, [QST 713] Technical wettable powder spoke of in the Cal Aggie Article. David had transferred this wettable powder from LARGE drums into 24 pound bags for shipment. David was told "it was safe" and didn't wear a respirator. However, The EPA themselves only allowed a “conditional time-limited registration” instead of a full registration of Agraquest’s submission of QST Technical (QST 713) in 2000,. The reasons listed::

The submitted manufacturing processed did not have sufficient quality control fermentation batches

Data for the 12 month storage stability of the end-use product has not been submitted.

•Additional data described in the December 12, 1999 review and March 8 2000 letter are required to upgrade submitted process, MRID# 44519-04 to acceptable. This includes:

•1) A formal submission that clearly describes new quality control steps taken to assure the consistent CFU/g values and limit microbial impurities in the Technical Powder.

•2) A 5 batch analysis of Technical Powder produced from cell cultures with latest QC.

•3) Raw data for the above mentioned 5 batch analyses.

Ecological Effects Data Required

•A 21 day Freshwater Aquatic Invertebrate Study must be performed. Attenuated and filter sterilized controls should be used in the test. Test lab should attempt to determine cause of death and whether pathogenicity involved.

•[Shrimp] Required due to report of disease in terrestrial amphipod crustacean associated with B. subtilis infection. Protocol must be submitted before initiating study.

•QST Technical was shown to cause mortality to parasitic Hymenoptera. MRID 44619-14 is graded supplemental. Potential pathogenicity was not investigated.

•[HONEY BEE] All test concentrations showed treatment related mortality. MRID 4456519-17 is supplemental due to the short test duration and the lack of a determination as to whether mortality was due to toxicity only or whether pathogenicity contributed.
___________________________________________________________________________________

Because of the California Aggie's Article IT CAN BE PROVEN WHAT AGRAQUEST HAS AND IS HIDING.

FOR THE FIRST TIME, IN THE NEARLY 10 YEAR STRUGGLE OF DAVID BELL, IT CAN BE PROVEN WHAT THE BIOLOGICAL RESEARCH & DEVELOPMENT COMPANY, AGRAQUEST IS AND HAS BEEN CONCEALING

By AQ finally making the “public statement” about David Bell and his workplace exposure in the October 2008 issue of the California Aggie, “Local biotech employee says health affected by work”, it can now be proven what AQ has been withholding and concealing.

The California Aggie’s article refers to AQ’s product. Serenade as well as Histoplasma:

“A written statement from AgraQuest said that the Bacillus subtilis strain is the only active ingredient in AgraQuest's product Serenade, a project Bell was working on. "It has been tested in accordance with EPA and EU guidelines for microbial pesticides and poses no significant risk to handlers or the environment used according to label instructions," the report says.”

Serenade’s active ingredient is the bacterium, Bacillus subtilis strain, QST 713 (formerly QRD 713), which was discovered by AQ scientist, Sherry Heins in a peach orchard in Fresno, California.

•All of the AQ products on the market which contain Bacillus subtilis ARE the strain QST 713.

What was not disclosed in the written statement from AQ is that David was not only exposed to AQ’s product Serenade, Bacillus Subtilis Strain QST 713, but numerous strains of bacteria and fungi., specifically bacillus subtilis strain - AQ 153, which was also being tested at AQ.


•The Bacillus subtilis strain AQ 153 was discovered by George Vandemark (not with AQ) and was deposited with the American Type Culture Collection as ATCC 55614 by Agritope in Oregon.

•Bacillus subtilis AQ 153 is a different strain of bacillus subtilis than the strain of Bacillus Subtilis used by AQ in their Serenade product, (QST 713).

The application that Agraquest founder and CEO, Pam Marrone filed with the United States Patent Office for the registration of United States Patent 6,004,774 on 11/25/1998 (listing the four AQ scientists as inventors) lists Bacillus Subtilis strain AQ153 [ATCC 55614] (ACTIVE INGREDIENT) is the only bacillus subtilis strain listed. This is the same patent which says, "to treat human fungal diseases", "disseminated disease" and "for example, Aspergillus sp, Histoplasma sp, and Tinea sp."

Further, only 4 days after David first sought emergency medical care all four scientists from AQ started signing over their interest rights to U.S. Patent 6,004,774.

Agraquest does not make these well documented facts public.

[Histoplasma was detected in David’s blood serum as well as he tested HIGH POITIVE in test for IgG Anitiodies to Aspergillus (showing levels of exposure and antibiodies his body had built up as a defense against it)]

It should be noted; histoplasma IS NOT endemic to the valley in which David lived or worked and in fact is found in dry and humid climates.

The Fungus and Bacteria of Deregulation and Biotech Worker David Bell
http://www.workersmemorialday.org/documents/fungus.htm

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