Drug
Four animal drug firms, Elanco
Products, American Cyanamid,
Monsanto and Upjohn, have joined
forces to explain to the Food and
Drug Administration, and
Department of Agriculture, and
Congress that bovine growth
hormone (BGH) can be used in
lactating cows without en
dangering the quality or safety of
milk.
Representatives of the four
firms met with FDA officials to
give their joint presentation
recently, according to a
memorandum of the meeting
prepared by Dr. Woodrow M.
Knight of FDA’s Center for
Veterinary Medicine.
In addition to saying BGH poses
no danger to the environment and
is not biologically active in
humans, the firms’ represen
tatives also stated that it will not
endanger the ability of the small
dairy farmer to compete with the
larger farmers, Knight reported.
Meanwhile, American
Cyanamid has written FDA that
use of bovine growth hormones will
have no impact on the environment
and urged the agency to reject a
coalition’s petitioned denial of a
New Animal Drug Application for
somatotropin bovine growth
hormone (BGH) based on en
vironmental concerns.
American Cyanamid rejected
the petition’s interpretation of the
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Firms Explain Safety Of BGH
“true nature” of BGH and its
status under FDA regulations,
saying that it is “not a new genetic
bacterial material, only another
purified pharmaceutical
preparation.” It continued:
“Cyanamid suggests that,
because of this crucial distinction,
the concerns of the petitioners are
without foundation and that an EIS
(Environmental Impact
Statement) is not needed and there
is no reason based on genetic
concerns for denying any ap
plications for approval of such
products. Indeed other phar
maceuticals similar to bovine
somatotropin, e.g., human insulin,
human interferon and human
somatotropin, have been approved
by FDA, manufactured and sold
without environmental impact. ’ ’
The firm said the petitioners, the
Foundation on Economic Trends
and its president, Jeremy Rifkin,
the Humane Society of the U.S., the
Wisconsin Family Farm Defense
Fund, and the Secretary of State of
Wisconsin, fail to make clear the
status of these products at FDA or
to relate their requests “to past
and present FDA regulations
governing animal drugs (and
human drugs as noted above) and
environmental considerations
which are in place and are
operative.”
Noting the agency’s In
vestigational New Animal Drug
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revocation, it added, “The FDA
thus has ample authority to take
whatever action is needed to
protect both human and animal
health and, indeed, environmental
safety.”
Additionally, American
Cyanamid pointed out that the
agency revised its environmental
regulations in 1985 and stated that
INAD’s “are categorically exempt
from the requirements of the
preparation of environmental
assessment (EA),” continuing:
“Thus, an environmental
assessment is not required for an
INAD if the drug is intended to be
used for clinical studies ‘in which
waste will be controlled or the
amount of waste expected to enter
the environment may reasonably
be expected to be non-toxic.’ Thus,
at this stage, not even an en
vironmental assessment is
routinely required, much less an
Environmental Impact
Statement.”
FDA’s environmental
regulations state that no category
of FDA action “routinely
significantly affects the quality of
the human environment and...
therefore automatically requires
an EIS,” American Cyanamid
said, adding that “no FDA actions.
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including, perforce, JNAUA's and
INAD’s routinely require ElS’s.”
“But the FDA has gone on to rule,”
it continued, “that before the FDA
approved any application to
permit the marketing of these
products, it will require the
preparation of an environmental
assessment.”
Petitioners’ Requests
“Premature”
American Cyanamid said,
“Given this pattern of regulation
the petitioners’ requests are
clearly premature,” adding that
“FDA might not approve bovine
somatotropin on grounds totally
unrelated to environmental con
siderations,” and noting that
certain of the petitioners “have
already been judicially instructed
that their requests for EA’s and
ElS’s indevelopmental research
projects are misplaced.”
FDA exhibited its awareness of
public concern for “the orderly
progress of new technologies in
harmony with environmental
safety,” it said, in requesting
American Cyanamid to submit an
EA covering the investigational
use of the firm’s bovine
somatotropin and it complied with
the request.
Impact on Dairy Fanners
The firm said the adverse
economic impact of bovine
somatotropin on the dairy farmer
forecast by the petitioners is also
“in error,” and that the petitioners
reliance on a Cornell University
study on the economic impact of
BGH as the basis of their economic
allegations is “a severe misuse of
the Cornell scientists’ work and...
without foundation. ’ ’
The Cornell study, American
Cyanamid said, made it “abun
dantly clear” that it is the federal
milk price support system “that
has and will continue to affect the
dairy industry in the most
significant way in the years to
come.” Potential removal of these
price supports to achieve a natural
balance of supply and demand
“will cause the number of dairy
farms to decrease significantly,
again independent of any actions
taken with respect to bovine
somatotropin,” the firm said,
contending that “it is clearly the
potential future changes to the
government surplus system that is
the prime concern to petitioners,
not bovine somatotropin.”
Petitioners’ concerns on in
creased total feed requirements
were also rejected by American
Cyanamid as a misinterpretation
of the Cornell study findings,
saying that the study’s conclusion
that feed requirements of in
dividual cows producing increased
amounts of milk may increase
“does not support the apparently
intended inference that the total
feed requirements for the entire
U.S. dairy herd nationwide will
increase.”
“In fact, total feed requirements
to produce the total U.S. milk
supply will decrease slightly with
bovine somatotropin use as
compared to such requirements
without use of bovine
somatotropin,” American
Cyanamid commented, saying,
“The simple fact is that all the
studies published to date reveal
that when bovine somatotropin is
used, less feed is required per
pound of milk produced.”
The petitioners' citing of the
Cornell study as linking bovine
somatotropin use with an estimate
that “...between 25 percent and 30
percent of all dairy farms in the
U.S. will' be forced out of
business... Within five years
nearly one out of every two... will
be eliminated,” has been refuted
by the senior author of the report
as “totally off the wa11... There is
nothing in our study that says
anything remotely like this,”
American Cyanamid said.
Additionally, the firm questioned
the petition’s allegations on the
adverse effects of BGH on the
health of dairy cows, stating, “No
scientific authority is cited for any
of these allegations.” The com
pany contended that scientific
studies conducted to date
demonstrate “exactly the op
posite.” American Cyanamid cited
a study by Bauman et al. which
concluded that treatment with the
product;
“...obviously ...did not stress the
animals adversely. The animals
were in good health through the
study... We have never observed
any health abnormalities or
evidence of stress... In fact, the
dramatic increases in efficiency
we have observed with BGH
treatment would have never oc
curred if cows were unhealthy or
stressed in any way.”
American Cyanamid noted also
that the Cornell study “demon
strated that under conditions of
market equilibrium there would be
essentially no increase in New
York State milk production
projected with the use of bovine
somatotropin over the level ex
pected without bovine
somatotropin or government price
supports.”
“The sole undeniable fact,”
according to the firm, “is that
bovine somatotropin will allow the
U.S. dairy industry to produce that
volume of milk which is socially,
economically and politically ac
ceptable to the nation as a whole
utilizing less feed and at less cost
to the farmer, large or small.”
(Reprinted by permission of
F ood Chemical News.)