Pfizer Biotech Stem Cell Researcher To Report On Health And Safety Dangers

CORRECTION! The biotech industry IS regulated in the USA. There are state and federal agencies that regular worker safety and BL levels allowed in all labs. Each BL level has specific safety requirements. There are also regulations that lab suppliers such ATCC, and chemical companies must adhere to. This includes DEA regulations. Any biotech company wishing to purchase products must comply with these regulations. All biotech company are regularly inspected by the various state and federal agencies. I don't know what safety regulations are in place in New Zeland. Perhaps the New Zeland government need to improve their worker protections. My information comes from 18+ years in the biotech industry working with every type of company from start-up R&D to established diagnostic companies.

With all due respect to you Peace Witch, I DISAGREE with your comment, "CORRECTION" to "Pfizer Biotech Stem Cell Researcher To Report On Health And Safety Dangers April 28, 2009".

The biotech industry IS NOT regulated in the USA although it is purported to be.

The biotech industry POLICE THEMSELVES and have key people within the very Federal and state agencies that are to regulate them. There are considerable conflicts of interest within these Federal and state agencies; monetary as well as others.

This industry is apparently on a self reporting system; meaning that they themselves choose whether or not to report incidents, injury, illness and diseases as a direct result of unsafe work practices.

The reason?
"IF" this industry adhered to mandated Federal and state laws, then the reporting of incidents, injury, illness and diseases; as a result of workplace exposure would result in a red flag being raised to federal and state agencies. This in turn would affect government and state grants, private investment money not to mention company's products and patents already on the market and/or in the works.

In short, there is NO ACCOUNTABILITY within the biotech industry in the United States;

*Federal and state agencies DO NOT inspect biotech facilities.

*Federal and state agencies DO NOT know if the biotech facility has the proper Biological Level category; (example; unknown microorganisms located at a bio-safety level lab 2 in a converted medical office located in a zoned "office park" and "residential neighborhood" without proper containment nor safety precautions.

Perhaps you, Peace Witch are fortunate enough to have worked in compliant Research and Development biotech companies. However, it is not fair for you to assume that ALL biotech companies are in the same category.

Your comment discounts the very real and heartbreaking results that have befallen employees who have injury, illness, disease and even DEATH as a result workplace exposure in the biotech industry.

Dr. Jeannette Adu-Bobie did not spend years in college, with countless hours burning the midnight oil to become a scientist; as have so many others, to have this happen to her. She did not take a position in the biotech industry with the hopes of making a difference in this world to lose her limbs and become disabled. Her case is only a small fraction of what has happened to an alarming amount of people working in the biotechnology field. Other scientists who have worked in this field and have life long ill effects as a result did not say upon acceptance of a position, "Oh good, this is the job that is going to make me sick, disfigure me, and maybe if I'm lucky it will kill me". I am appalled at your lack of compassion.

I invite you to read [letter in it's entirety with scanned documentation can be found
http://www.biotechawareness.com/index~option~com_content~view~article~id~170:february-23-open-letter-to-aphis-regulatory-analysis-and-development~catid~25:letters~Itemid~54.php:

February 23, 2009 OPEN LETTER TO APHIS; REGULATORY ANALYSIS AND DEVELOPMENT
Monday, 09 March 2009 01:28
Sandra (Sandi) Trend
[ADDRESS OMITTED]
February 23, 2009
Docket No. APHIS-2008-0023
Regulatory Analysis and Development, PPD
APHIS, Station 3A-03.8
4700 River Road, Unit 118
Riverdale, MD 20737-1238

RE: ENVIRONMENTAL RELEASE OF CERTAIN GENETICALLY ENGINEERED (GE) ORGANISMS and PROPOSED RULE FOR BIOTECHNOLOGY REGULATIONS

ATTENTION: Cindy Smith, Administrator

Dear Ms. Smith,

I wish to take part and comment on the agency’s role in genetically engineered organisms and natural organisms that are used for bio-control products.

Although what I am understanding in reading the Press Releases, USDA REOPENS PUBLIC COMMENT PERIOD ON PROPOSED RULE FOR BIOTECHNOLOGY REGULATIONS is the wording “certain” genetically engineered organisms is used. I believe this to be rather broad in terminology and does not define which genetically engineered organisms the agency is referring to. I also believe that all “natural” organisms, or natural in origin, should also be addressed. Not all “natural” organisms are safe.

Therefore, my comments are based on all organisms sought, experimented with, developed and manufactured for the purpose of bio-control products for the diseases of plants and for insect control. I am as well commenting on the importation of any and all organisms which are brought into the United States as well as the need for stricter Biotechnology Regulations AND enforcement of these regulations.

I would like to explain my role in the biotechnology arena. I am the Mother of an injured ex-biotechnology worker who worked in this industry for a company who boasts they travel the world over to find novel microorganisms to be screened for candidates for the use in the place of synthetic or chemical pesticides, insecticides, fungicides etc. for plant diseases and insect control. The company’s name is Agraquest in Davis, California.

WHERE ARE THE MICROORGANISMS FOR BIOLOGICAL PRODUCTS FOUND?:
Are you aware where these microorganisms are sought? Agraquest has made very public where they search for these microorganisms (novel); in soil, plants, plant roots, lichen, leaves and/or it’s litter, mulch and other decaying organic matter, fruit, bird feathers, dead insects, lake beds, forests, dunes and ocean caves, animals from terrestrial sources, marine sources (sponges, sea urchins, etc.) insects of all kinds, rain forests, jungles, dry creek beds, orchards, farm fields, and gardens. They have published they have microorganisms from New Zealand, the Amazon, Mexico, Honduras, and Micronesia to name just a few, and this is only what has been published.

MICROORGANISMS ENTER THE UNITED STATES ILLEGALLY - HOMELAND SECURITY ISSUE:
Are you aware Agraquest has smuggled into the United States bags of dirt in suitcases on commercial airlines for the purpose of finding novel microorganisms within this soil? Are you aware that federal and state agencies were contacted about this and the only agency that responded was your agency APHIS, who said Agraquest did not have a permit to bring soil in to the United States at the time?

NONE REPORTING OF WORK RELATED INCIDENTS BY BIOTECHNOLOGY EMPLOYERS:
Do you know that biotech companies, such as the one my son worked for, are well aware of workplace exposures to known and unknown microorganisms and choose NOT to report incidents and illness’s (per the Federal Insecticide, Fungicide, and Rodenticide Act; Adverse Effects Reporting [FIFRA § 6(a)(2)] and the State of California Division 6. Pesticides and Pest Control Operations; Chapter 2. Pesticides: Subchapter 1. Pesticide Registration; Article 6. Adverse Effects Disclosure) for fear of not getting registrations or re-registrations from the EPA or the State of California Department of Pesticide Regulations?

•I can only report on what happened to my son as a result of workplace exposure to known and unknown microorganisms in this biotechnology company:

•Five (5) months and nine (9) days after my son began employment, at Agraquest in Davis, California, as an Assistant esearcher/microbiologist my son sought medical attention from an immediate care medical cliniwith purulent drainage of bloody pus coming from his nose. He had been throwing up for days before this.

•This incident was never reported to any state or federal agency, per:
• FIFRA; Adverse Effects Reporting
•California’s Department of Pesticide Exposure; Adverse Effects Disclosure

•Symptoms that followed were; fever, body aches, chills and the left side of his face was numb, from the lower eyelid to the top lip.
•Within 7 days he was scheduled for major sinus surgery by an ear, nose and throat surgeon, who later said, “I saved your life”. (3 more major sinus surgeries have followed with countless in-office
sinus procedures).
•Months after my son left the company he learned that the same time he got sick there were calls from 11 other employees working in the lab who had gotten sick the same time he did and the receptionist was told to shut and lock the lab door.

•This too was never reported to any state or federal agency, per:
• FIFRA; Adverse Effects Reporting
•California’s Department of Pesticide Exposure; Adverse Effects Disclosure

•My son has been hooked up to an IV pump in the hospital receiving IV Immunoglobulin infusions for 3 years, every 28 days because he stopped producing the required amount of B-Cells for an intact immune system.
•My son continues to have infections and is sick even though his workplace acquired illness was 10 years ago.
•At the end of 2005 his medical bills have exceeded $333,000.00 and have continued to climb.
•The company has ignored several attempts of obtaining federal and state worker right-to-know laws of hazards in the workplace [Hazard Communications].

HUMAN PATHOGENS:
Nineteen (19) microorganisms have tested positive in either my son’s blood serum, sputum and/or nose cultures and/or IgG antibody levels, all relating to workplace exposure at the biotechnology company, Agraquest.

•The human pathogen, Histo-yeast was identified in my son’s blood serum by the Mayo Clinic in Scottsdale, Arizona.

•It was discovered that three (3) months and fifteen (15) days after my son first started employment with the company, the Founder and CEO had filed a patent application [number 09/199,871]with the United States Patent office in which the invention said, "may be used to treat human fungal diseases in which the disseminated disease is a condida, for example, Aspergillus sp, Histoplasma sp. and Tinea sp."
http://www.biotechawareness.com/images/Picture%205.jpg
http://www.biotechawareness.com/images/6004774_showing_histo.jpg

•Agraquest CEO and Founder, Pam Marrone is FIRST NAMED INVENTOR FOR APPLICATION NUMBER 09/199,871 (PATENT # 6,004,774)
http://www.biotechawareness.com/images/marrone_first_named_inventor.jpg

•It was also discovered that on 1/22/1999, four days after my son first sought emergency medical care, all four (4) Agraquest scientists, who are listed as inventors on patent assignment # 09/199,871, started signing away their interest rights on the patent to a company in Beaverton, Oregon.
http://www.biotechawareness.com/images/AQ_SIGNED_AWAY_INTEREST.jpg

I find it most disturbing, given the numerous outbreaks of e-coli and salmonella, that the EPA’s, Biopesticides andPollution Prevention Division preprinted Form; 8570-6 states:
http://www.biotechawareness.com/images/fermnation_batchesecoli_salmonella.jpg

Why should the public be afraid that ANY of the above human pathogens could be a contaminant of a biological control product used on human and animal food crops and/or used for insect control?

PRODUCT CONTAMINATION?
In 2000, the company my son worked for, submitted two (2) fermentation batches to the EPA, Biopesticides and Pollution Prevention Division. Instead of granting full registration to the Agraquest, based on their testing of these submissions, the EPA’s Biopesticides and Pollution Prevention Division only granted the company a Conditional Time-Limited Registration. Clearly, one would assume that what was submitted to the EPA by the company would be perfect. There is no doubt, based on the four (4) page form that was sent to Agraquest, that the EPA did not come to this conclusion that the fermentation submission were without problems.

•My son was exposed to the two (2) 1999 fermentation batches which were submitted to the EPA by Agraquest, as well as the wettable powder form of Bacillus Subtilis Technical (QST 713). He did not wear a respirator and was told by the company, “it was safe”.
http://www.biotechawareness.com/images/conditional_registration_aq_qst_713_2000_copy.pdf

2006 NETHERLANDS, INSTITUTE OF FOOD SAFETY REPORT - NATURAL ORGANISMS, GMO’s, GEO’s - QUESTION OF SAFETY TO HUMAN HEALTH AND THE ENVIRONMENT:

And last, but not least I wish to reference the Netherlands, Institute of Food Safety report that was written in 2006 which clearly indicates that the ENVIRONMENTAL RELEASE OF CERTAIN GENETICALLY ENGINEERED (GE) ORGANISMS and natural organisms (or of natural origin) for the purpose of plant disease and/or insect control is being found to not be as safe as had been expected with regard to human health and the environment.
http://www.biotechawareness.com/images/Netherlands1.jpg
http://www.biotechawareness.com/images/Netherlands2.jpges/Netherlands1.jpg

EPA CONSULTANT, DR. DANIEL SUDAKIN - LACK OF OVERSIGHT:
It is quite interesting that Dr. Daniel Sudakin is referenced in the Netherlands, Institute of Food Safety report (2006), as he was contacted by the EPA [Shanaz Baccus] concerning my son and his workplace acquired illness from Agraquest in late 2003 or early 2004,. Addressed was the histoplasma yeast that was found in my son’s blood serum. [all e-mails available on request]

•On 1/24/2004 Dr. Sudakin had sent an e-mail which said:

•"I am a physician who provides consultation to the the EPA in matters relating to human pesticide exposures. Your inquiry to EPA regarding Histoplasma was forward to to me, and I would be interested in speaking with you to collect more information. Is there a time that would be convenient for you in the next 48 hours? Please let me know."

•Shortly after speaking with my son, Dr. Sudakin’s response was, “There is nothing I can do”.

•On 6/7/2004, after contacting the EPA concerning Dr. Sudakin’s response of, “There is nothing I can do”, the EPA [Shanaz Baccus] merely said:

•"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."

•On 6/9/2004 a reply e-mail was sent to the EPA [Shanaz Baccus]:

•“[My son] didn't get the Histoplasmosis (I don't believe) from any ingredient of their formulas, however, he contracted it from the histoplasma capsulatum that they had on site. As I said before, they smuggled in microbes/fungus from all over the world in suitcases. On a trip to South America one of the scientist was bragging about how he got it through customs. They were bringing feces and soil samples from all over the world."

•"Also, Agraquest has a plant in Mexico... and no doubt they could have brought histoplasma capsulatum in from there. There are caves in Mexico that have warnings that Histoplasma Capsulatum is in the caves from bat droppings."

•"They have also stated that friends and family bring in all sorts of things to be tested to see if there are microbes/fungus that might be helpful for "natural pesticides".

•"The whole point is my son is SICK and it is because of what he picked up in the lab. Someone has to be held accountable for what they did to him." Please. I beg of you... please help us."

•There was never a response from Shanaz Baccus nor anyone else at the EPA to the e-mail above nor any other communications from the agency. Other federal and state agencies were also contacted with no results.

IN SUMMARY:
I am not insinuating that all research and development biotechnology companies, who search for and screen microorganisms of natural origin, are falling between the cracks as far as the EPA’s requirement and regulations. However, with respect to the EPA and their lack of oversight of Agraquest, serious questions should be raised as to why the EPA did not investigate Agraquest’s operations. Given the fact that the EPA themselves had found problems with the 1999 submissions to them, which the EPA would only give a Conditional Time-Limited registration, should have in itself
raised a red flag.

Ms. Smith, I URGE you to carefully take into consideration what I have said in this letter when you draft a revised RULE FOR BIOTECHNOLOGY REGULATIONS. The biotechnology industry is not being honest and forthright with their attempts to cover-up the real truth with regard to this field; their bread and butter so to speak.

There is much corruption and deception in the biotechnology industry and they are not being held accountable for the harm they are causing. There is no real oversight in this industry. Is the cost of lives lost and ruined, not to mention the devastating effects on the environment itself; that future generations will have to try and repair, worth turning a blind eye to what is happening in this field?

I urge you Ms. Smith, once again, to take the necessary steps to ensure the implementation of strict regulations in the biotechnology industry, for not only unnecessary risks to the environment, but also for the safety and health of those working in this industry, including the farm workers who are exposed to biological control products daily.

SUGGESTED STRICTER BIOTECHNOLOGY REGULATIONS

WORKPLACE EXPOSURE:
1) The biotech worker/s should have complete and exclusive rights to the identity and genetic code of all agents ie: any and all microorganisms; whether newly discovered, acquired and/or is “in stock” and any and all hazardous material which is; in, on or around the premises. Additionally, the microorganisms should be properly contatined at all times.

Why should biotechnology companies who have “strain access” agreements with each other have this information when the biotech worker, who has the possibility of exposure, does not? These collaborations also include the location where the microbe is from, ie; state or country.

2) It should be mandated, by both federal and state law, that when there is any illness and/or disease acquired by an employee; in or around a biological environment, the Center for Disease Control should be contacted immediately so a culture can be obtained for identification of the cause.

It should not be at the biotechnology company’s discretion whether to report the injury, illness and/or disease as a result of, or the possibility of a workplace exposure to any microorganism.

3) Biotech workers need staunch whistle blower laws to protect them.

INSPECTIONS - OSHA is not up to date with new technologies and therefore is incapable of proper and complete inspections of the biotechnology industry.

4) There should be Physicians within each state’s Occupational Safety and Health Office to inspect biotechnology companies on a regular basis.

Industrial Hygienists and Compliance Officers are not trained to know what they are looking for, nor do they know about microorganisms and infectious diseases.

5) It should not be acceptable for any state’s OSHA reporting of, “met minimal safety standards” to any biotechnology company where any hazardous material and/or microorganism; whether it be newly discovered, acquired or is “in stock”;
and is in, on or around the premises.

6) The Biotechnology Industry should not be on THE HONOR SYSTEM.

STUDIES ON SAFETY OF BIOLOGICAL PRODUCT:
7.) There should be NO exemption from the requirement of a tolerance for residues of ANY biochemical/biological pesticide, insecticide, fungicide etc. in or on ANY food commodity, unless it has been proven not to harm human health and the environment. Published and/or UNPUBLISHED findings and reports submitted by the biotech company should NOT BE allowed.

Further, published and or UNPUBLISHED finding and reports from other entities should not be accepted unless it can be proven there is NO conflict of interest, financial or otherwise.

HOMELAND SECURITY ISSUE
8) NO bio-control product, that is manufactured outside the United States, should be allowed to be used for plant disease and/or used for insect control within the United States borders.


And last but extremely important:
9) Before any biological agent is released in the environment, the complete identity and genetic code should be filed with the government and assessable to the public.

Thank you for your time Ms. Smith. I hope you will take this letter under consideration when implementing NEW RULES for the biotechnology industry. This industry needs to be transparent. If you should have any questions, or need further documentation, please feel free to contact me.

Sincerely,
Sandi Trend

Where are the regulations? Just about every industry has been deregulated. No one is doing their job to ensure "regulations " or laws! SHOW us the proof! Because if there are regulations, they are not enforced! Those who have been exposed are NOW scientists and cannot find out what they have been exposed because the companies who have control of these labs, consider the exposures as TRADES SECRETS.These companies do not care about their employees just as most other employers do not care about the welfare, health and safety of other workers and or those they come iin contact with like their families. friends, communities!. This whole earth and it's people are in danger with those who decide to try and play God with people's lives, all for profit. "THEY'RE MAD AS HATTERS!" for creating these horrific dangers to all of mankind to which many were eradicated decades ago. THE ones who profit, make the profit and anyone below them-those who work with bio-pathogens are unprotected in their labs-workplace, suffer the consequences, as are the rest of us. So! Ask the question. Are YOU protected in your workplace? AND if you are not, then try and get the employer to follow the "regulations". You"ll be fired in a nanosecond and YOU won't be able to get anyone to do the right thing LIKE enforcing the "laws or regulations" you speak of and or find out what you have been exposed to to get medical treatment because it's a "TRADE SECRET?

I can only ASSUME that my April 27th reply to Peace Witch could not be met with an argument and therefore has been dismissed.

It is my belief that ANYONE who can dismiss the injury, illness, disease and even death caused by unsafe working conditions in the biotechnology field MUST be a biotech company owner, investor or a corrupt politician: ALL with financial gain for a heart.

They will pay the price for what they have done. (I myself would like to be a mouse in the corner when it happens).