From: "Torsten Brinch" <iaotb@inetdotuni2.dk>
Newsgroups: alt.agriculture,sci.agriculture
Subject: Re: Is Organic Farming Sustainable?
Date: Wed, 14 Jul 1999 11:41:03 +0200

sarah skrev i meddelelsen <1duw885.1kz6u01izcrf6N@amitiel.demon.co.uk>...
>Torsten Brinch <iaotb@inetdotuni2.dk> wrote:

>> Agreed on all the above counts, Sarah. But  actually the last
>> reason was decisive for me. It occurred because I incidentally
>> stumbled into reading the scientific registration documents for
>> a most common fungicide used in grain production in my country,
>> and I found several of these documents to be flawed and
>> scientifically of a despicably low scientific value. And the
>> registration authorities could not care less. My impression
>> was enforced by similar experiences in other events of
>> applied pesticide safety science. That's when I thought,  this
>> game cannot be mine, and I decided to abandon ship.

>Torsten, I'm glad we agree... I've had this discussion with Oz before,
>and his refusal to see sense disheartens me ;-)

>My concern about pesticides is minor compared with the first two (and
>the fears of people who read scare stories in the popular press). I'd
>welcome your comments on the actual level of threat if you felt willing
>to share them.

I assume that you mean to restrict comments to the actual
level of threat to human health from pesticide residues in food.

Human health risk from pesticide residues in food from current
pesticide use must generally be perceived  to be insignificant.
It is the centerpiece of pesticide registration, Sarah.

Slight perturbations may well be caused when new knowledge
emerges, meaning that for a transitional period, health risk from
specific pesticides in specific use situations may no longer be
perceived as insignificant. But that will invariably lead to the effect
that the registration system adapts (e.g. restricts or bans the culprit
pesticide use), such that health risk from pesticide residues from
current pesticide use can  once more be perceived  to be generally
insignificant.

Therefore it will be generally true to say that any health risk
to humans due to pesticide residues in food from currently used
pesticides is difficult to perceive as anything but remote.

That said, it can not be held that the present system of pesticide
registration excludes the possibility of actual  harmful effects
in humans from pesticide residues in food.

As I told you, I simply lost trust in that system, when I found, on
inspection, that it was not as good as I thought -- and when I found
what was at the core of the system and what it could not do or would
not do. It is not that I've come to fear eating non-organic food
on occasion, nor that I would like to fuel  particular scares -- they
would generally have a weak scientific basis, and with all its frailties,
the pesticide registration system does takes the minimization
of human health  risk from pesticide residues in food particularly
seriously. It's really just that I've  withdrawn my support from
the pesticide registration  system, and consequently, from the
production of non-organic food -- in an orderly fashion -- no panic --
and chosen  to eat -- organic.

Best regards,

Torsten Brinch

From: "Torsten Brinch" <iaotb@inetdotuni2.dk>
Newsgroups: sci.bio.food-science,nz.politics,sci.agriculture
Subject: Re: New spray patents for GM crops (Was: Re: GMO contamination 
	evidence)
Date: Fri, 31 Dec 1999 11:23:55 +0100

Jim Webster skrev i meddelelsen <845soo$dbp$3@newsg1.svr.pol.co.uk>...
>
>Torsten Brinch wrote in message ...
>>Oh, I happily consumed sprayed produce for many years, until
>>I happened to need some analytical residue data from the
>>scientific registration documentation for a widely used fungicide
>>on  cereals. As a good analytical chemist, I thought everything to
>>be well under control. But sadly, and genuinely surprised, I found the
>>documentation to be flawed and to carry sufficient hallmarks
>>to raise  suspicion of fraud; and when I dug deeper, and started
>>to look at material on other pesticides, I found more of the
>>same stench.

>What intrigues me and may also be a problem for Oz is the fact
>that this hasn't been picked up elsewhere. In the UK and the US
>there are a pile of consumer groups and green organisations
>who effectively have a commercial interest in digging up this stuff.

That intrigues me too, Jim. Some of the apparent flaws I found
simply threw themselves into my face. Just a single example
(but I could go on for pages and pages with other and
quite similar examples):

Why was I the first to spot that the two chromatogrammes, see:
http://inet.uni2.dk/~iaotb/fen1.gif (from BASF lab report 1672)
are apparently identical copies of one measurement, although
they allegedly originate from two different samplings and cleanups
8 and 21 days post treatment? Not only are the two independent
detector traces identical, also both traces have landed identically
on the preprinted recorder paper grid! Is this the coincidence of
a century?

Hm, As a good citizen I alerted the relevant authority
(Danish pesticide registration office), within 12 _hours  of my first
reading of that report,  (and of course I did not  run screaming to
some extremist enviro  movement with the matter). I mean, what
is a pesticide authority for, if not to look seriously into pesticide
matters. At least that was what I _then_  thought they were
there for...

But I found that pesticide authority completely disinterested, Jim.
I had to harass them in writing and on telephone for more
than a _year_ before they eventually decided to ask the pesticide
company responsible for the report about the strangely coincidental
chromatogrammes!

And guess what the company  answered: "We find this very strange,
but we are unable to clear up the matter as all raw data for the
report have now been destroyed. Please ignore these
chromatogrammes."

But that was _not_ what the Danish pesticide chose to do! They
wrote me: "We have found these  chromatogrammes to be OK --
we would expect them to be very similar, as they have been
derived  from two samplings close in time". I protested heartily,
Jim, cause these chromatogrammes are not similar, they are
bloody impossibly identical.

As I obviously was not so easily shut up, the Danish Pesticide
Authority now chose to let an independent analytical scientist from
their own ranks look into the matter. And he judged in writing, that it was
extremely improbable that two different samplings could have given
such very similar (sic) chromatogrammes, and that this improbability
was enhanced by the way the traces had been recorded relative
to the preprinted recording paper grid. But, as he added, although
it would be improbable to the extreme, one could not _entirely_
rule out the possibility that it could happen.

So, Jim, now the reaction  from of the Danish Pesticide Authority
to their expert's opinion. Can you imagine: "Just as we said", they
wrote to me, when they copied me in on the expert's report
on this,"these chromatogrammes are  as they would be
expected to be".

I guess I could have gone on harassing said authority (at that stage
they indeed had two files for public requests for data,
-- one file for my requests -- and one for the rest :-). But I didn't.
I suppose I could have given away my files, my findings, to
Greenpeace or similar (if someone there would be interested,
 -- these matters, as you probably can imagine, quickly tend to
become rather too technical as gun powder for public campaigns)

No, Jim, I just left it there -- with my new-found knowledge of
what my pesticide autority is able and willing to do for me,
when the going gets tough. And I chose to eat organic henceforth.

--
Best regards

Torsten Brinch

Email: iaotb@inetdotuni2.dk
(interpret 'dot' in domain name)

From: "Torsten Brinch" <iaotb@inetdotuni2.dk>
Newsgroups: sci.bio.food-science,nz.politics,sci.agriculture
Subject: Re: New spray patents for GM crops (Was: Re: GMO contamination 
	evidence)
Date: Fri, 31 Dec 1999 18:13:23 +0100

Harold Lindaberry skrev i meddelelsen <386CDD89.8BCA796C@epix.net>...
>Torsten Brinch wrote:

>><..>
>> Why was I the first to spot that the two chromatogrammes, see:
>> http://inet.uni2.dk/~iaotb/fen1.gif (from BASF lab report 1672)
>> are apparently identical copies of one measurement, although
>> they allegedly originate from two different samplings and cleanups
>> 8 and 21 days post treatment? <..>

>It certainly appears that the GC charts are identical, I don't know
>what the chemical is

Fenpropimorph, a fungicide.

>or what the level peaks represent

Noone does, it is entirely unclear. As the expert, which was put on
the case to shut me up, remarked. "It is not possible from the
report to find out how the conclusions were analytically
achieved".

>or whether  the the insertion was deliberate or unintentional -
>certainly there is the possibility of secretarial or other error
>in combining and assembling the data for submission.

Sure. Incautious use of scissors, glue and paper can be
deceptive. But look again. If that should be the explanation,
then who added a 'manufactured' extra murky peak on the
base line of one of the chromatogramme detector traces
(the left bottom, C14 detector, during the dead period of
elution)

Anyhow, Old Grey, this study and the reporting of it
was obviously not performed according GLP.

Nonetheless the study was quoted by the pesticide authority
as evidence of a max  5 ppm residue shortly after application,
and a fast dissipation in the crop -- when fenpropimorph
was reregistered a few years later -- using the same
non GLP, and possibly scientically flawed report.


--
Best regards

Torsten Brinch

Email: iaotb@inetdotuni2.dk
(interpret 'dot' in domain name)

From: "Torsten Brinch" <iaotb@inetdotuni2.dk>
Newsgroups: sci.bio.food-science,nz.politics,sci.agriculture
Subject: Re: New spray patents for GM crops (Was: Re: GMO contamination 
	evidence)
Date: Fri, 31 Dec 1999 19:20:58 +0100

Harold Lindaberry skrev i meddelelsen <386CDD89.8BCA796C@epix.net>...

><..>whether the the insertion
>was deliberate or unintentional - certainly there is the possibility of
>secretarial or other error in combining and assembling the data for submission.
>I frankly can see no reason for a company to want to fudge residue data<..>

Apropos: Do take a look at these two mass spectrogrammes, Harold:
http://inet.uni2.dk/~iaotb/fen2.gif

They appeared in two different reports (BASF lab report 1672
and 1684 respectively) on metabolism in wheat  and soil
respectively, and they form part of the documentation for
the metabolism of fenpropimorph.

There is no question that these two mass spectrogrammes are
duplicates of the same measurement, as evidenced by the
same serial no, and same amplification factor. The only difference
is that the particular part of the caption which says 'WEIZ' (which is
German for 'wheat') has somehow gone lost under a strangelooking
'blob' during the duplication on the copy which appears in the
soil report.

Indeed the company explained that a 'secretarial error' had
occurred during the cutting and pasting to produce these
reports. And indeed they promptly were able to supply
the 'correct' MS  from their archives, the one which
allegedly _should_  have been included in the soil report.

Nonetheless, when the time for reregistration came about,
a slightly revamped version of that soil report was submitted,
and once again with the same wrongly mass spectrogram cut
and pasted into it.

--
Best regards

Torsten Brinch

Email: iaotb@inetdotuni2.dk
(interpret 'dot' in domain name)

From: "Torsten Brinch" <iaotb@inetdotuni2.dk>
Newsgroups: sci.bio.food-science,nz.politics,sci.agriculture
Subject: Re: New spray patents for GM crops (Was: Re: GMO contamination 
	evidence)
Date: Sun, 2 Jan 2000 15:53:26 +0100

Dave Lloyd skrev i meddelelsen <386f52d1.175689436@newsource.ihug.co.nz>...
>On Fri, 31 Dec 1999 19:20:58 +0100, "Torsten Brinch" <iaotb@inetdotuni2.dk>
>wrote:
>
>>Apropos: Do take a look at these two mass spectrogrammes, Harold:
>>http://inet.uni2.dk/~iaotb/fen2.gif
>>
>>They appeared in two different reports (BASF lab report 1672
>>and 1684 respectively) on metabolism in wheat  and soil
>>respectively, and they form part of the documentation for
>>the metabolism of fenpropimorph.
>>
>>There is no question that these two mass spectrogrammes are
>>duplicates of the same measurement, as evidenced by the
>>same serial no, and same amplification factor.
>
>Why is it not possible for a different lab to do the tests again,
>if the test results look suspicious?


Why, Dave, physically it is quite possible to do the tests again.
But firstly that would cost money, which noone is willing to supply.

Personally I've only managed an attempt to reproduce the
protolytic constant study for this particular pesticide, a piece
of work which can be done with very little effort and expense.

The company had submitted a study  (BASF Bericht Nr. 2541)
with the result  pkB=7, which indeed looks highly suspect,
considering the fact that this pesticide chemically speaking
is a N-substituted morpholine.  Quite as anyone with a basic
understanding of organic chemistry would expect on purely
theoretical grounds, I found the pkB given by the submission
to be not  reproducible.

However, as judged by the reaction (none) when I sent
the result to the company with a request for clarification
-- and my full report to the pesticide authority -- there
is more than lack of funds which  makes it practically
'impossible' to correct,  through the repeating of experiments,
any suspect findings which might be found in pesticide
documentation.

It is my impression, in my dealings with the Danish Pesticide
registration office, that the problem of sitting with more or less
suspect science within the documentation material is well known
and internally acknowledged, but that the favored reaction is to
operate with a not too well defined 'downscaling' of the
'weight' such results are given to produce a base for registration ---
and there is certainly not any drive or motive to check up on
even the weirdest results. There is simply no 'apparatus' present
to do the latter thing, that's why. The whole pesticide registration
system is build on the assumption, that results which are submitted
from companies, can and _must be_ a priori trustworthy. Any sign
that such trust might at times be misplaced endangers the system
as such, and that is entirely unwanted, for anyone who is seriously
and professionally involved within that system. So, such signs are
of course best dealt  with 'under the table', so to speak.

My 'crime', when I stumbled across such signs was that I did
not sufficiently understand the workings of this system from the
inside -- and consequently I was thinking, and acting, as if such
things might just as well be dealt with openly. And in practical
life, they can't.


--
Best regards

Torsten Brinch

Email: iaotb@inetdotuni2.dk
(interpret 'dot' in domain name)

From: "Torsten Brinch" <iaotb@inetdotuni2.dk>
Newsgroups: sci.bio.food-science,nz.politics,sci.agriculture
Subject: Re: New spray patents for GM crops (Was: Re: GMO contamination 
	evidence)
Date: Sun, 2 Jan 2000 21:09:02 +0100

Harold Lindaberry skrev i meddelelsen <386F819F.4C5BC6B4@epix.net>...
>Torsten Brinch wrote:
>> <..> the problem of sitting with more or less
>> suspect science within the documentation material is well known
>> and internally acknowledged, but that the favored reaction is to
>> operate with a not too well defined 'downscaling' of the
>> 'weight' such results are given to produce a base for registration ---
>> and there is certainly not any drive or motive to check up on
>> even the weirdest results.

>Weirdest of results ? Companies are required to submit all data
>not just the expected data.


I know, Old Grey, that this is legally the case in the US
(but it isn't in Europe, btw).

If we take the BASF Bericht 2541, which determined pkB= 7
for the pesticide I am talking about here,  then -- although
this result is weird as hell -- the company would indeed be
required to submit that study to the EPA -- at least in principle.

But does US law not also directly or impliedly require a company
to identify and if necessary repeat a study which has given
an obviously flawed result? Isn't it sort of implied, that studying
something has not been done properly, until a believably
valid result has been achieved?

Or is it just fine, if only the two parties of the registration
process, the registrant and the registration authority
are brought in a position where they can both tick away
on their submission requirement lists:
-Submission of protolytic constant study.  Registrant: "Done",
-Submission of protolytic constant study. Authority: "Received",
disregarding that  the result of the study is weird, and that it
will predictably prove to be worthless to anyone who might in
fact actually use it for some practical purpose, say,  to
develop or validate an analytical procedure?

--
Best regards

Torsten Brinch

Email: iaotb@inetdotuni2.dk
(interpret 'dot' in domain name)

From: Harold Lindaberry <harlind@epix.net>
Newsgroups: sci.bio.food-science,nz.politics,sci.agriculture
Subject: Re: New spray patents for GM crops (Was: Re: GMO contamination 
	evidence)
Date: Sun, 02 Jan 2000 22:42:08 GMT

Torsten Brinch wrote:

> Harold Lindaberry skrev i meddelelsen <386F819F.4C5BC6B4@epix.net>...
> >Torsten Brinch wrote:
> >> <..> the problem of sitting with more or less
> >> suspect science within the documentation material is well known
> >> and internally acknowledged, but that the favored reaction is to
> >> operate with a not too well defined 'downscaling' of the
> >> 'weight' such results are given to produce a base for registration ---
> >> and there is certainly not any drive or motive to check up on
> >> even the weirdest results.
>
> >Weirdest of results ? Companies are required to submit all data
> >not just the expected data.
>
> I know, Old Grey, that this is legally the case in the US
> (but it isn't in Europe, btw).
>
> If we take the BASF Bericht 2541, which determined pkB= 7
> for the pesticide I am talking about here,  then -- although
> this result is weird as hell -- the company would indeed be
> required to submit that study to the EPA -- at least in principle.
>
> But does US law not also directly or impliedly require a company
> to identify and if necessary repeat a study which has given
> an obviously flawed result?

    It was my experience chemistry would not sign off until they felt all
their questions had been satisfactorily resolved. their job is to assess if
the level of requested in the petition is realistic and is not set too high -
it is the toxicology branch who assesses whether this constitutes a potential
hazard.

> Isn't it sort of implied, that studying
> something has not been done properly, until a believably
> valid result has been achieved?

    See above

>
>
> Or is it just fine, if only the two parties of the registration
> process, the registrant and the registration authority
> are brought in a position where they can both tick away
> on their submission requirement lists:
> -Submission of protolytic constant study.  Registrant: "Done",
> -Submission of protolytic constant study. Authority: "Received",
> disregarding that  the result of the study is weird, and that it
> will predictably prove to be worthless to anyone who might in
> fact actually use it for some practical purpose, say,  to
> develop or validate an analytical procedure?

    I am aware of one instance where while their main lab had the equipment
and had verified the method that the method was not approved until their
field labs also had the equipment to run field samples.

    Harold

>
>
> --
> Best regards
>
> Torsten Brinch
>
> Email: iaotb@inetdotuni2.dk
> (interpret 'dot' in domain name)

From: Oz <Oz@upthorpe.demon.co.uk>
Newsgroups: sci.bio.food-science,nz.politics,sci.agriculture
Subject: Re: New spray patents for GM crops (Was: Re: GMO contamination 
	evidence)
Date: Mon, 3 Jan 2000 13:22:48 +0000

In article <Ib_b4.65$jg4.243@news.get2net.dk>, Torsten Brinch
<iaotb@inetdotuni2.dk> writes
>Harold Lindaberry skrev i meddelelsen <386FD35B.5FAC3A81@epix.net>...
>
>>It was my experience chemistry would not sign off until they felt all
>>their questions had been satisfactorily resolved. their job is to assess if
>>the level of requested in the petition is realistic and is not set too high -
>>it is the toxicology branch who assesses whether this constitutes a potential
>>hazard.
>
>
>Thanks, Harold. Some times your short is too short for me, an outsider
>to the world from which you have inside knowledge. I have trouble
>here understanding fully the bit 'if the level of requested...too high',
>and I would be grateful, if you could give it a just a few more words.

As you know I have a friend involved in registrating products in the UK
(veterinary) and of course he knows (and I have met) those that do the
crop pesticide registration. Clearly I can't speak for Dk but their view
is that the UK is significantly tougher than much of the rest of europe
(particularly germany and france) as exemplified by the fact that it
takes from 1 to 3 years longer for registration to be approved in the
UK. The cause of this is twofold. Firstly they frequently refuse to
accept work that has been accepted elsewhere as adequate and demand
further testing and secondly they require a broader range of tests.

Again I cannot speak for Dk but the very general and strongly held view
of these people involved in registration is that the registrating
authority far prefers to reject a registration on the grounds that they
cannot take any blame for something they refused to register and that
most of the time they are downright unreasonable. The last registration
documentation my friend submitted totalled three tons of documents in
order to meet the requirements of the registrators. A single slip (such
as a document being in the wrong place in that 3 tons) required a re-
registration and re-submission of the 3 tons of documents.

Personally I doubt that more than a few kilos of results of tests had
any significant relevence to deciding on the safety or otherwise of the
product. The result is that his company no longer develops any animal
medicines (human ones are much easier to register and my even pay back
the R&D) and are heading in a similar direction with crop products. I'm
sure you find this good news. I don't.

--
Oz

From: Harold Lindaberry <harlind@epix.net>
Newsgroups: sci.bio.food-science,nz.politics,sci.agriculture
Subject: Re: New spray patents for GM crops (Was: Re: GMO contamination 
	evidence)
Date: Mon, 03 Jan 2000 11:31:10 GMT

Torsten Brinch wrote:

> Harold Lindaberry skrev i meddelelsen <386FD35B.5FAC3A81@epix.net>...
>
> >It was my experience chemistry would not sign off until they felt all
> >their questions had been satisfactorily resolved. their job is to assess if
> >the level of requested in the petition is realistic and is not set too high -
> >it is the toxicology branch who assesses whether this constitutes a potential
> >hazard.
>
> Thanks, Harold. Some times your short is too short for me, an outsider
> to the world from which you have inside knowledge. I have trouble
> here understanding fully the bit 'if the level of requested...too high',
> and I would be grateful, if you could give it a just a few more words.

    " a few more words " ;-) Actually I don't know how things work in Europe and
I shouldn't even be commenting. In the US the company proposes or requests the
tolerance level and and on the label establishes application  rates and pre
harvest application interval. The chemistry branch determines whether the
highest rate and shortest interval will exceed the proposed level. At least that
was the situation when I left the registrations process - Early in the
registration days products could be registered on a NR ( no residue basis )
which was generally at that time 0.1 ppm and later realizing that there was no
such thing as NR but only NR to the sensitivity of the method so a numerical
value was added. Even if the toxicology branch determines
10 ppm is a safe level in the diet the chemistry branch will not sign off if it
is determined 0.1 ppm is what will be adequate that is what will be granted not
10 ppm. Due to the fact that No Effect safety levels are based on life time
whole diet studies divided by 100 ( at least ) I have no personal concern about
pesticide levels in food. IMO if the rest of our personal safety and well being
was a safe as pesticides in food the world would be a lot better off.

Harold.

From: <iaotb@inet.uni2.dk>
Newsgroups: sci.agriculture
Subject: Re: Whoa! (Was: Farming - How much acreage necessary)
Date: Tue, 3 Mar 98 11:23:54 +0100

On Sun, 1 Mar 1998 17:53:19 +0000,
Oz  <Oz@upthorpe.demon.co.uk> wrote:

>In article <67982.iaotb@inet.uni2.dk>, iaotb@inet.uni2.dk writes
>
>[On suspect data in a submission for registration].
>
>I don't doubt your findings. It's a pity you can't get the equivalent
>report from other countries too, they might be more accurate.

They wouldn't be. A report is born somewhere in time and space, then signed
by the author. An agchem company cannot send different reports on the same
thing to different countries, there is a one report -- one study
relationsship.

As these reports are in the Danish EPA archives, they are elsewhere too.

Here's one more riddle. This one is from the Fenpropimorph _wheat_
metabolism study, I posted the reference earlier.  It was the study from
which that wrong MS was plausibly accidentally copied into another study,
the study of soil metabolism, as I described in an earlier post.

In the WHEAT metabolism study, two HPLC diagrams had been chosen
for inclusion to illustrate HPLC measurements of metabolites in wheat.
Sampling 8 and 21 days since application, respectively.

The two diagrams are immediately to the eye apparently exactly identical,
and on close examination indeed superimposable. Not only are the pen
traces from two simultaneously operated  different detectors identical, the
traces of the two diagrams also intersect the preprinted pattern
identically on the recorder roll paper. How can _this_ be explained?

Well. How _was_ it explained, cause this was reported to the relevant
authority too. Indeed it was reported more than once. Eventually
(years) the agchem company was asked to investigate. The result of the
investigation was strikingly different from the result of the flawed MS
investigation of the soil study, though. The raw data for the wheat study
were not available in the agchem archives. All raw data had
apparently and unfortunately been destroyed after the final report had been
produced  via the cutting and pasting processes. Therefore no
replacement diagram could possibly appear from the investigation. The
author did agree, that the similarity between diagrams was striking and
strange, he suggested that the relevant authority should consider the
diagrams not valid for evaluation. Ignore them, was his suggestion.

In all innocence, if this is what this is, well, it is what it is.
What else could he do, if it is, but leave the question open?

For the relevant authority however, the question remained
what to believe. Because if one looked carefully, the diagrams
were not completely identical, a little strangelooking disturbance on one
trace did in fact appear in one diagram , but not in the other. If these
diagrams originated from copies of the same measurement, someone had
_added_ something manually, and this could not have happened accidentally,
and then it would indicate a bad act.  The relevant authority now chose to
ignore the suggestions of the author of the study. Relevant authority
decided that the diagrams were _not_ strangely identical, even better:
these diagrams were jolly fine, valid, and exactly as they would be
expected to be [sic]. After all the two samplings were separated only by 14
days, relevant authority noted.

Under the influence of my heavy protests against this view, which I still
see as an assault against reason, the relevant authority fell back to
asking an expert from another relevant authority. The expert did assess
that it was indeed very unlikely that two different samples could give
results that were identical; and if this had nonetheless happened, it would
indeed be very unlikely that the resulting traces would land identically
on the pattern of the preprinted roll of paper. The expert could not
completely preclude, though, the existence of a remote possibility, that
however extremely rare this would be, such things could happen. The first
relevant authority said: "Thanks, just as we said, there is nothing wrong
with these diagrams."

An interesting byproduct of the expert involvement came because I had
questioned, whether the validity of the conclusions of the report was
undisturbed when some of the supporting data had been withdrawn by the
author. The expert noted that it would be quite unreasonable to change
assessment of the conclusions, as they were based on the implementation of
several different methods and measurements, and then he noted (sic) that it
was not possible to see from the report,  which data and methods the author
had actually used to arrive to his conclusions.

The wheat metabolism study was the only basis for scientific knowledge of
how fenpropimorph is metabolised in wheat --for the first 12 (twelve) years
of registration in Denmark. The study was resubmitted by Novartis in 1994
for re-registration purposes, and its conclusions have indeed been given
weight in the EPA decision to approve fenpropimorph for _another_ 10 years.



Best regards,

Torsten Brinch

From: <iaotb@inet.uni2.dk>
Newsgroups: sci.agriculture
Subject: Re: Whoa! (Was: Farming - How much acreage necessary)
Date: Sun, 1 Mar 98 15:39:29 +0100

On Fri, 27 Feb 1998 13:44:10 +0000,
Oz  <Oz@upthorpe.demon.co.uk> wrote:

>In article <63904.iaotb@inet.uni2.dk>, iaotb@inet.uni2.dk writes
>
>>Oz. The two headers. There are certain similarities and differences there.
>>How can they be explained?
>
>To be honest, Torsten, I really do not have the time to go through these
>documents and mug up on the science involved.

I laid out all the facts for you; walking through documents and science
would be a waste of your time, as it would not change your thoughts about
these headers a bit.

The two headers:

3*103    108406-WEIZ.4B/I.DEX60CM.100-200/10C.70EV.10-7    AMP:00057856

 *103    108406     .4   .DEX60CM.100-200/10C.70EV.10-7    AMP:00057856

I think you cannot fail to notice, that the similarities
between the headers from the wheat study and the soil studies can
only  be explained by assuming that they originate from  copies of the
same MS-measurement. Thus: explaining the similarities is trivial.

What is not trivial is the question how the _differences_ were introduced.
Did it happen through deceit or by accident?

>If you have found a
>problem then I would suggest you contact the relevent authority and/or
>the agchem company involved.

Thanks :-). Don't worry Oz, I am not 'reporting a problem on Internet
foully'.

Of course I contacted the relevant authority (Danish EPA) -- this happened
less than 24 hours after I received the second study. The agchem company
(BASF) was then contacted through the EPA. The agchem company concluded an
investigation into the similarities question, and reported:

1. The two diagrams are copies of the same MS.

2. The MS for the metabolite found in the soil study was located in
   agchem company archives, and a copy of the replacing diagram was
   enclosed in the report.

3. The diagram from the wheat study had apparently accidentally been
   included in the  soil study, during the cutting/pasting process used
   to produce the report.

4. It would not be possible to investigate which circumstances
   led to this unfortunate misrepresentation of data.


>In any case what I think, or don't think,
>is of little importance in this case.


I think the agchem company's explanation is plausible:
Unfortunate the wrong diagram was pasted in, and unfortunately someone
spilled coffee on exactly that part of the header, which would otherwise
readily have identified the mishap. It could have happened.

The allegedly correct replacement MS diagram, which appeared from the
investigation, does have some disturbing features, however, which are
difficult to explain from information otherwise given in the report. A very
significant C14 radioactive marking of the test sustance was used, thus
heavy weight fragments should have been apparent in the MS. They were not
apparent.

Yes, relevant authority was informed, Oz. Relevant authority asked an
expert from another relevant authority,  who pointed out, that one could
plausibly assume that data must have been filtered. This assumption was
then grabbed by the first relevant authority, unresearched, and no further
questions was asked, although the assumption is not  based on any statement
from the data submitter. The case was effectively closed.

A few years later Ciba-Geigy, now Novartis, resubmitted the same report -
slightly otherwise cut-and-pasted, but uncorrected and including the same
flawed MS. No, Oz, this time I did not inform the relevant authority.
Plausibly BASF just forgot to tell Novartis about the whole thing.
Plausibly BASF did not even bother to send a short notice and the correct
MS to other registration offices in other countries who had received the
original report. Plausibly BASF did not bother at all.


Best regards,

Torsten Brinch

From: <iaotb@inet.uni2.dk>
Newsgroups: sci.agriculture
Subject: Re: Whoa! (Was: Farming - How much acreage necessary)
Date: Fri, 27 Feb 98 14:24:47 +0100

On Sun, 22 Feb 98 23:56:36 +0100,
iaotb@inet.uni2.dk  <iaotb@inet.uni2.dk> wrote:

>On Sat, 21 Feb 1998 19:42:20 +0000,
>Oz  <Oz@upthorpe.demon.co.uk> wrote:
>
>>So, Torsten, what is your conclusion?
>
>That I have successfully brought you into a transitional phase of doubt,
>who to trust or believe in this matter. It is up to you to find a way out.


Here's one more riddle. This one also originates in the collection
of documents and data recently submitted by Novartis for the
re-registration of the fungicide fenpropimorph (Tilt, Corbel).

Among others, these two studies were submitted,

------------------------------------------------------------------------
19.0-1 Investigations into the metabolism of fenpropimorph in wheat
       (Report No.1672 BASF Oktober 1979)

"4 metabolites accounted for 38 % of the [..] residues. The probable
structure of these was identified." (Novartis registration summary 1994)
------------------------------------------------------------------------

and

------------------------------------------------------------------------
21.1-3 Stage on the investigations of the metabolism of fenpropimorph
       in soil
       (Report No.1684 BASF November 1979)

"The charactherisation/identification of [..] residues resulted in
the finding of mainly parent and three metabolites with masses 249,
115 and 333." (Novartis registration summary 1994)
------------------------------------------------------------------------

Both reports include photocopies of the results from the
MS (Mass Spectrometry) which was used to identify metabolites,

These are the MS headers from the diagrams for the metabolite mass 115
fractions which were isolated in the wheat and soil studies, respectively:


3*103    108406-WEIZ.4B/I.DEX60CM.100-200/10C.70EV.10-7    AMP:00057856

 *103    108406     .4   .DEX60CM.100-200/10C.70EV.10-7    AMP:00057856


[Notes:
a. Parts of the header in the soil study is missing/unreadable
b. The first section of the header is the run/analytical tag Nos
c. The middle section of the header is a user supplied caption
d. The last section is a variable ampfactor assigned by the instrument
e. German 'WEIZ'  = WHEAT]

Oz. The two headers. There are certain similarities and differences there.
How can they be explained?


Best regards,

Torsten Brinch

From: <iaotb@inet.uni2.dk>
Newsgroups: sci.agriculture
Subject: Re: Whoa! (Was: Farming - How much acreage necessary)
Date: Tue, 10 Feb 98 17:34:24 +0100

On Mon, 9 Feb 1998 14:43:07 +0000,
Oz  <Oz@upthorpe.demon.co.uk> wrote:

>What does it mean??  :-(

Ah. I assume you are asking for enlightenment, what does pKa mean? And
since I am a skilled chemist, and a damned good teacher (and unemployed,
how's that for a sales pitch :-)) ---

 "Well, Oz. Fenpropimorph is basic (as opposed to acidic).
 As a base, fenpropimorph will be un-ionized at high pH values,
 and at low pH values, it is ionized as organic salt.

 Now let us ask the question: when, at which pH values,
 will that molecule be ionized, and when will it not? How can we know?

 The answer, scrapping all theory, because in practise this is quite
 simple: You need the pKa for this, because it indicates the pH  'breaking
 point' for the transition.

 ***1st Rule of thumb: At pH=pKa, you will find ionized and un-ionized in
 equal amounts. Ratio 50:50

 If the pH is shifted away from pKa in either direction, however,
 either the ionized or the un-ionized form will predominate.

 ***2nd Rule of thumb: pH shifted one unit will give you a  ratio 10:90 (or
 90:10), shifted 2 pH units 1:99 (or 99:1). And so forth.

 Good Student Oz, you may still wonder, _why_ you need to know about this.
 To tell you the truth, you will not be able to manipulate chemicals
 and samples for analysis rationally at all, unless you pay heed to the
 very different physical behaviour of unionized and ionized molecules.
 You need to know when you have one, and when you have the other. And
 how to make one of them transition into that other form.
 One is quite watersoluble, remember, the other is not; One is extractable
 in  non-polar media, the other is not; one  evaporates appreciable, the
 other  does not. This subject is very important for anyone wanting to
 produce, to interpret or to evaluate analytical data. You would also need
 this knowledge BTW, if you should decide to fake a few lab reports, which
 I am  sure that you would not even dream of. But even without such
 devious acts, believe me, you can still  make a fine mess out of  things,
 if you do not get a good grasp of those pKa's and pH's"



I hope this suffices, Oz.

Novartis and BASF submitted, for the fungicide fenpropimorph,
the protolysis dissociation constant pKa 7.


Oz. Your assignment. Do you believe this?



Best regards,

Torsten Brinch