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![handle is hein.animal/fdavt0003 and id is 1 raw text is: 2444V:
January/February 1988
Vol. III, No. I
FDA VETERJNARL4JAM,.
IL
On October 15, 1987, Dr. Gerald B. Guest, director of CVM, and Dr. G.A.
Mitchell, director, Bureau of Veterinary Drugs, Canada, shared a podium at the
Animal Health Institute's 1987 Mid-Year Animal Drug Meeting at Captiva Island,
Florida. These are excerpts of Dr. Guest's and Dr. Mitchell's remarks.
Dr. Guest
P rime Minister Mulroney of Canada
and President Reagan have agreed
in principle and over time to eliminate
all barriers to free trade between the
two countries [Canada and U.S.]. The
treaty for this agreement has now gone
to our Congress for consideration and,
the administration hopes, Congres-
sional approval. At present, key Con-
gressmen are studying the details of
the treaty.
The roles of the Canada Bureau of
Veterinary Drugs and the Center for
Veterinary Medicine of the United
States in this total treaty are somewhat
dwarfed by the anticipated changes
involving tariffs, lumber, wheat,
automobiles, and other very large ticket
items. Nonetheless, what the treaty
implies for the consumer, the Food and
Drt Administration, and our livestock
prod cer constituencies is important.
My interest in international harmoni-
zation dates back to around 1980. It
appeared to me at that time that we
were heading toward some trouble-
some issues in the animal drug regula-
tory arena that could cause serious dis-
ruption in the movement of food animal
products. My conclusion was not due
to super powers of foresight. It
stemmed from early talk concerning
the hormone fears in Europe and dis-
cussion with regulatory colleagues in
those countries. There was no doubt
that there was need for more commu-
nication between regulatory authori-
ties. It became apparent that the world
consumer would be better served if in-
ternational scientific consensus could
guide our future. We began in 1981 to
explore a mechanism for a beginning,
knowing that the goal was a very ambi-
tious one.
The first recognizable step in our har-
monization plans took place in Colum-
bia, Maryland in January 1983, at the
First International Consultation on Vet-
erinary Drug Registration. The United
States, CVM, hosted the meeting.
Fourteen countries and four interna-
tional organizations attended the first
meeting. Agreements reached at the
first consultation set the stage for fur-
ther meetings. The need to communi-
cate and harmonize was expressed
over and over during the Columbia
meeting. A second meeting occurred in
1984 in Oslo, Norway, and a third con-
sultation in Paris in June 1986. More
than 40 countries were represented in
Paris. There is no doubt that this
activity set the stage for the important
beginning of veterinary drug residue
standardization by the Codex Alimen-
tarius Commission (CAC).
Many of the leaders from the regula-
tory officials consultation formed the
nucleus of an historic Expert Consulta-
tion on Residues of Veterinary Drugs in
Foods held in Rome, Italy, in the Fall of
1984. At that time, those of us in the
veterinary drug world began to focus
on food safety issues from a global per-
spective. That meeting set the stage
for the CAC to establish the Codex
Committee on Residues of Veterinary
Drugs in Foods (CCRVDF).
As you know, that Committee has
had an outstanding beginning. Follow-
ing the first meeting in October 1986,
the CCRVDF recommended that the
(Continued, page 4)
The following is a summary of
CVM's major deregulatory accomplish-
ments during the past seven years (as
mandated by the Reagan Adminis-
tration):
Animal Drug Safety Policy
The Food Additive Amendments of
1958 added the Delaney Clause to
the Food, Drug, and Cosmetic Act.
This clause proscribed the approval of
any food additive found to induce
cancer in man or in animals, and the
FDA interpreted the clause as applying
to compounds for use in food-pro-
ducing animals.
Accordingly, the Drug Amendments
of 1962 included an additional provi-
sion (the DES Proviso) that permitted
the approval of the use of a carcino-
genic compound in food-producing ani-
mals if no residue of the compound
would be found in the edible tissue of
treated animals by an analytical
method capable of verifying the ab-
sence of residues. The DES Proviso
proved to be unworkable largely be-
cause the development of more sensi-
tive methods of detecting residues of
a compound resulted in the finding of
residues in tissue at concentrations
much lower than expected.
As a result, the agency attempted to
reconcile the purpose and language of
the DES Proviso with the basic statu-
tory objective of minimizing public
exposure to carcinogenic compounds.
(Continued, next page)
In This Issue:
CVM/FSIS Seek Quality Control 7
Bogus Equine Drugs Discovered 8
Tissue Residue Briefs . 8
Contracts Awarded 10
Regulatory Highlights . 10
U.S. DEPARTMENT OF HEALTH AND HUMAN
PUBLIC HEALTH SERVICE
SERVICES
FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE](ViewImageLocal?handle=hein.animal/fdavt0003&div=1&collection=&method=preview&ext=.png&size=3)