Dairy Food Safety Researcher
(Continued from Pago A2l)
However, the history of how the
tests came to be is telling in the
reluctance of the political and reg
ulatory sectors to give up the
recently devised testing system.
In recounting the history, Cullor
hit upon several key facts that
seem to indicate that science, fair
ness and reason was overruled by
political and public relations
ploys.
the key reason the tests were
developed was to provide a tool
that would allow the regulatory
structure within the dairy industry
to screen raw milk for antibiotic
residues, as part of a goal of having
no traces of man-made antibiotics
in milk.
Whether or not that should be
the goal has been and continues to
be debated. Nevertheless, with
tests in hand, the industry began in
January to use new tests to screen
for any trace of antibiotic residues.
According to Cullor, since
mid-1994 there have been antibio
tic residue assays used in practice
that have never been “scientifical
ly field tested” nor received NMC
Inc. Research Committee recom
mended validation protocol.
These same tests, Cullor said,
are “accepted” by the Center of
Veterinary Medicine/Food and
Drug Administration, “perfor
mance tested” by the Association
of Official Analytical Chemists,
and “recommended” by the
National Conference On Interstate
Milk Shipments (NCIMS).
According to Cullor, these tests
are used for tanker milk, for trace
back on bulk tank milk, and rou
tinely used on individual animal
milk samples, although they have
not been field tested on tanker
loads, on bulk tank milk, and never
received the NMC Inc. validation
protocol.
“During late 1990, the Govern
ment Accounting Office (the GAO
is an agency of and answerable to
the U.S. House ofßeprcsentatives)
reported that, in their opinion, the
Food and Drug Administration did
notpossess the appropriate techno
logies to assure consumers that the
nation’s milk supply was free of
antibiotic residues.
“In respondingto this report, the
FDA pulled together a mechanism
to cerfity such assays.”
According to Cullor, the assays
(or tests) which were developed
were done through an “interpretive
memorandum issued by the FDA
(milk branch)” that summarized
the laboratory evaluations of the
proposed beta-lactam antibiotic
residue tests.
According to Cullor, this
method of testing tests is a protocol
that calls “for the evaluation of
manufacturer’s label claims by
using spiked milk samples with the
parent compound of the antibiotic
under study.”
In simpler terms, this means that
the Center For Veterinary
Medicine/FDA accepted tests
devised by test manufacturers and
tested them by seeing if they would
react to milk purposefully spiked
with the parent chemicals in anti
biotics (not the residues).
They repeated this elementary
procedure from 30 to 60 times per
test being evaluated, and at diffe
rent dose levels in the milk.
That’s it
According to Cullor, no field
research was done and no tests
were done to determine the num
ber of false positive reactions to
other substances.
In other words, the tests were
never checked to see what else
would cause a positive reaction.
Cullor said that in his laboratory’s
study using these same tests the
cow’s natural antibodies could
cause a positive reaction for drug
residues.
As a chemical antibiotic breaks
down in the cow’s system, por
tions of the chemical called
residues linger. They are called
“violative” because they inhibit
growth.
The residue tests were never
evaluated as residue tests, accord
ing to Cullor. “They had to do
something in a hurry and this is
what they did. And for me to say,
‘Now you need to start all over,’ is
not popular.”
His suggestion for the industry
and government to either adopt his
recommendation of sharing
responsibility so that milk produc
ers stop being financially hurt and
put out of business on the basis of
un-scientifically proven tests, or
start all over and conduct the tests
Mlanco
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lancaatar Farming, Saturday, September 2, 1995-A23
on these residue tests that good sci
ence dictates.
“What they did was fine. It was a
good start,” he said of the FDA
tests. “But you ought to go into the
field and see how it works in the
real world. That’s what bothers
__ _ >»
me.
He said that,"... from a scientif
ic point of view, (what needs to be
done) is to really put together a
protocol to validate these tests that
includes field trials.”
He said that, as a scientist, he
would “... call time out and go back
and fix (the testing procedures)
according to scientific principles.”
However, because of the politi
cal and business ramifications,
Cullor said he doesn’t think that
abandoning the tests is possible.
That’s why he suggested a system
for using the current tests as
screens only, backed up by precise
third-party validation tests.
Currently, validation of the tests
is to have the same lab repeat the
same residue test on the same milk
sample. That ensures that the
residue test is consistent, not
correct.
“If you really believe the tests
are good, fine, keep it as a screen
ing test and then send it to a third
party. Let the processing plant pay
for it (if the screening test was a
false positive and the milk was
dumped).”
He said that he has heard quoted
prices for conducting a precise
residue test ranging from $2OO to
$4OO per sample.
But that compares to the thou
sands of dollars an individual pro
ducer can lose based on the current
residue tests. To the individual, a
loss of that can mean the end of the
dairy farm.
“Instead of a little freckled-face
guy in California yelling and
screaming,” Cullor said about his
call for changes in residue testing
procedures, if processors were to
find out how expensive it is to pay
for the false positives, then a group
with strong political clout might be
able to form that could get some
thing done to correct the situation.
“If tests perform then fine,” he
said about his suggestion for pro
cessors using backup testing and
reimbursing the producer for
wrongfully dumped milk, etc.
"It spreads risk, responsibility,
helps producers, and the consum
er, it stills keep them protected.
“But we can keep that vital
resource, the dairy producer. They
can maintain their ability to sup
port their families and support the
rest of the country that consumes
their dairy products.
“If you don’t do that, the insur
ance industry is already con
cerned,” he said.
That statement was reinforced
during the meeting in a talk by
Robert Moser, a representative for
Nationwide Insurance Co.
In his presentation, Moser said,
‘Toward the end of January, I
noticed a number of losses coming
through with milk identified as a
problem and the
description of the loss
indicating the cuase of
the (as) antibiotics in the
milk.
“Our past history
shows wc would have
eight to 10 of these types
of claims durmg a year.
In January, we had more
than this number in
about three weeks.”
He said he had all
claims sent to him
instead of going to an
adjuster. Then he started
making direct calls on
the fanners making the
claims. (The insurance
policy covered these
losses) And Moser
started calculating the
insurance company’s
losses because of the
laige number of milk
dumpings.
\ “With most of the
trucks being two com
partment trucks, this
means that we would
have to dump around
20,000 pounds and we
looked at an average
loss of around $2,500.
“With this year’s esti
-1 male of 100 claims, very
j quickly our anticipated
loss appears to be
$230,000 this year.
“This is in contrast to
1 10 claims in 1994 for a
total loss of approxi
mately $25,000.”
He said that while in
the past a farmer might
tell him that he treated a
, cow and her milk acci
dently got in the tank,
“When I started contact
ing farmers this January
and February, the story
changed drastically.
Most of the farmers said
that they had not treated
any of the animals
recently and had no idea
of what the problems
were.
“Some of the farmers
even went so far as buy
ing locks for their barns
(Turn to Pago A2B)