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Re: [SANET-MG] FDA regulation, Was:reply from industry on pharm crops



Thanks to Art Petrzelka for the comments from experience. Exposing
people to secret crop  field test releases (and production) of
pharmaceuticals to potentially lethal gene products such as human
aprotinin seems to be a new experience in the area of regulation. The
only thing that has protected  both  proponents and regulators from
public censure has been the very secrecy of the field tests and
production. Certainly Art is correct in describing the care taken in
normal pharmaceutical production but the details of the production  are
held as confidential business information between  proponent and
regulator. Because  public  bystanders of the field test releases (and
production) are exposed and subject to injury from the tests
(production) the details of the field test releases (production) must be
made public. Unfortunately, the news media seem to have  participated in
a conspiracy of silence with proponents and regulators most people are
unaware of the exposures that may have caused their illness or death.
somehow, we must get the word out to the public. sincerely,joe

Art Petrzelka wrote:

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One item that the FDA, USDA, and transgenic proponents have been
tiptoeing around, in the hopes that nobody would point it out, is that
pharmaceutical _production_ is heavily regulated.
I have worked in several regulated industries. FDA pharmaceutical
regulations are slightly more lenient than Section III of the ASME
Boiler Code for nuclear plant construction. I spent 6 years in a
Procter & Gamble pharmaceutical plant, and was the site Validation
Manager for a year, responsible for training people to produce the
validation plans for the computers and controls that were our primary
record. It was a new development effort.

Every unit of raw materials must be accounted for. It must be
documented when, where, how much, by whom, using what documented
procedures, and in what process equipment each measurable unit of that
material was used.

The source of the materials must be documented, back to the source.
The destination of each package of product that leaves the plant must
be documented. Carriers and warehouses and wholesalers get into the
mix, also.

The two basic facts of FDA production are:
A)  There must be a paper trail for each ingredient in the finished
product.
B) Standard Operating Procedures (SOP) and Best Practices must
describe exactly how the finished product is made.

The intent of A) is to facilitate product recalls. If a minor
ingredient has to be recalled, every manufacturer who used that
ingredient must recall their product that contains that ingredient,
and must notify every customer (warehouse, wholesaler, chain store)
who bought it from them.

The intent of B) is that the process must be sufficiently described in
detail so that the process could be rebuilt from the documentation and
produce identical results. Therefore, design documentation becomes
very important, as well as any test procedures used during startup.

There is no way on God's earth that farming can be reduced to such a
process.
There is no way in hell that the GMO "process" can be described by B).
There is a total lack of control once the product is put out there.
Such release of pharmaceutical substances would require notification
of the FDA, as well as local government and law enforcement agencies.
A follow-up plan would be taken out of mothballs and filled in with
the proper cleanup and recovery procedure.

To emphasize the rigor with which pharmaceutical substances are
controlled, not only are the pharmaceuticals controlled, but packaging
materials, and especially labels, must be accounted for accurately. If
a label is ruined, that fact is entered into the plant record, which
is retained at least one year past the expiration date of the product,
or at least three years if there is no expiration date.

Finally, there are different levels of contamination allowed for food
and pharmaceuticals. While the allowable contamination level for food
allows for certain levels of insect parts, hairs and rodent claws,
pharmaceutical ingredients have an allowable contaminstion level of
0.  This makes it quite difficult when making natural laxatives using
bran or psyllium. The reject level is high because the harvesting
process isn't designed to filter out contaminants on a pharmaceutical
level.

Perhaps you will be able to share my sense of amusement now while
listening to government officials speaking about pharmaceutical crops
with a straight face, by knowing that there isn't a single fact within
their heads to contradict what they are saying.

On Thursday 03 June 2004 09:04 am, you wrote:


Hi Jonathan,
Doctor Shantharum  seems to be totally shameless . In particular to
claim that aprotinin is a laboratory reagent not a  pharmaceutical is
staggering. The pharmaceutical is used so very extensively in surgery!
The claim that the product  is identical to the normal drug  fails to
deal with the  difference in plant product in the area of glycosylation
along with changes in the gene to accommodate plant production. Why he
ignores the production and marketing by Prodigene , from my report
"Meanwhile, Prodigene Corporation and Sigma-Aldrich are marketing
aprotinin (AproliZean) from maize and from a transgenic tobacco" is
unclear?
Dr. Shantharum is really playing with fire because  aprotinin is linked
to human death through sensitization and anaphylaxis.  He may have
created liability  by claiming such dangerous drugs to be harmless.The
fact that the crop production may injure bystanders bother him  not at
all However, he makes the key confession , by noting that the plant
products do not  require FDA approval because they are "identical" to
approved drugs!
sincerely,joe

GM WATCH wrote:


hi joe
had this response from Shanthu Shantharam to your report about pharma
crops in the US, which we fwded to the gmwatch list.
best wishes
jonathan www.gmwatch.org


Your report on how GM crops are secretly grown and marketed in America
is rather misleading.  The facts are that the companies involved are
growing transgenic maize producing GUS and aprotinin both of which are
not drugs or pharmaceuticals, but laboratory reagents in their pure
form.  Transgenic crops producing these two compounds are indeed being
grown, but under proper regulatory permits.  USDA, APHIS does not
regulate the products purified from these transgenic crops, neither
does US-FDA as the end product in its pure form is both functionally
and structurally same as the ones already on the market and there is
no scientific reason to suspect it otherwise.  What Aldrich chemical
company is marketing is the chemical compound in its pure form and not
the transgenic crops.  Neither environmental safety nor public safety
has ever been compromised and there would have been no need to raise
alarm if the facts had been checked out.

Shanthu Shantharam, Biologistics International, LLC, Ellicott City, MD
21042.


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Art Petrzelka wrote:

-----BEGIN PGP SIGNED MESSAGE-----
Hash: SHA1

One item that the FDA, USDA, and transgenic proponents have been tiptoeing
around, in the hopes that nobody would point it out, is that pharmaceutical
_production_ is heavily regulated.

I have worked in several regulated industries. FDA pharmaceutical regulations
are slightly more lenient than Section III of the ASME Boiler Code for
nuclear plant construction. I spent 6 years in a Procter & Gamble
pharmaceutical plant, and was the site Validation Manager for a year,
responsible for training people to produce the validation plans for the
computers and controls that were our primary record. It was a new development
effort.

Every unit of raw materials must be accounted for. It must be documented when,
where, how much, by whom, using what documented procedures, and in what
process equipment each measurable unit of that material was used.

The source of the materials must be documented, back to the source. The
destination of each package of product that leaves the plant must be
documented. Carriers and warehouses and wholesalers get into the mix, also.

The two basic facts of FDA production are:
A)  There must be a paper trail for each ingredient in the finished product.
B) Standard Operating Procedures (SOP) and Best Practices must describe
exactly how the finished product is made.

The intent of A) is to facilitate product recalls. If a minor ingredient has
to be recalled, every manufacturer who used that ingredient must recall their
product that contains that ingredient, and must notify every customer
(warehouse, wholesaler, chain store) who bought it from them.

The intent of B) is that the process must be sufficiently described in detail
so that the process could be rebuilt from the documentation and produce
identical results. Therefore, design documentation becomes very important, as
well as any test procedures used during startup.

There is no way on God's earth that farming can be reduced to such a process.
There is no way in hell that the GMO "process" can be described by B).

There is a total lack of control once the product is put out there. Such
release of pharmaceutical substances would require notification of the FDA,
as well as local government and law enforcement agencies. A follow-up plan
would be taken out of mothballs and filled in with the proper cleanup and
recovery procedure.

To emphasize the rigor with which pharmaceutical substances are controlled,
not only are the pharmaceuticals controlled, but packaging materials, and
especially labels, must be accounted for accurately. If a label is ruined,
that fact is entered into the plant record, which is retained at least one
year past the expiration date of the product, or at least three years if
there is no expiration date.

Finally, there are different levels of contamination allowed for food and
pharmaceuticals. While the allowable contamination level for food allows for
certain levels of insect parts, hairs and rodent claws, pharmaceutical
ingredients have an allowable contaminstion level of 0.  This makes it quite
difficult when making natural laxatives using bran or psyllium. The reject
level is high because the harvesting process isn't designed to filter out
contaminants on a pharmaceutical level.

Perhaps you will be able to share my sense of amusement now while listening to
government officials speaking about pharmaceutical crops with a straight
face, by knowing that there isn't a single fact within their heads to
contradict what they are saying.

On Thursday 03 June 2004 09:04 am, you wrote:


Hi Jonathan,
Doctor Shantharum  seems to be totally shameless . In particular to
claim that aprotinin is a laboratory reagent not a  pharmaceutical is
staggering. The pharmaceutical is used so very extensively in surgery!
The claim that the product  is identical to the normal drug  fails to
deal with the  difference in plant product in the area of glycosylation
along with changes in the gene to accommodate plant production. Why he
ignores the production and marketing by Prodigene , from my report
"Meanwhile, Prodigene Corporation and Sigma-Aldrich are marketing
aprotinin (AproliZean) from maize and from a transgenic tobacco" is
unclear?
Dr. Shantharum is really playing with fire because  aprotinin is linked
to human death through sensitization and anaphylaxis.  He may have
created liability  by claiming such dangerous drugs to be harmless.The
fact that the crop production may injure bystanders bother him  not at
all However, he makes the key confession , by noting that the plant
products do not  require FDA approval because they are "identical" to
approved drugs!
sincerely,joe

GM WATCH wrote:


hi joe
had this response from Shanthu Shantharam to your report about pharma
crops in the US, which we fwded to the gmwatch list.
best wishes
jonathan www.gmwatch.org


Your report on how GM crops are secretly grown and marketed in America
is rather misleading.  The facts are that the companies involved are
growing transgenic maize producing GUS and aprotinin both of which are
not drugs or pharmaceuticals, but laboratory reagents in their pure
form.  Transgenic crops producing these two compounds are indeed being
grown, but under proper regulatory permits.  USDA, APHIS does not
regulate the products purified from these transgenic crops, neither
does US-FDA as the end product in its pure form is both functionally
and structurally same as the ones already on the market and there is
no scientific reason to suspect it otherwise.  What Aldrich chemical
company is marketing is the chemical compound in its pure form and not
the transgenic crops.  Neither environmental safety nor public safety
has ever been compromised and there would have been no need to raise
alarm if the facts had been checked out.

Shanthu Shantharam, Biologistics International, LLC, Ellicott City, MD
21042.


********************************************************
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list. Type "unsubscribe sanet-mg" in the body of the message.

Visit the SANET-MG archives at:
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and other resources available through the SARE program, please visit
http://www.sare.org.


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=w7zA
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For more information on grants and other resources available through the SARE program, please visit http://www.sare.org.



********************************************************
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Visit the SANET-MG archives at: http://lists.sare.org/archives/sanet-mg.html
For more information on grants and other resources available through the SARE program, please visit http://www.sare.org.