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4 FDA Veterinarian 1 (1989)

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                                                            January/February 1989



lt~                                                                     Vol. IV, No. I
                    FDA VETEMNARJA


ICVM LOOKS AT SAFETY OF NATION'S DAIRY PRODUCTS


By Nancy King


A s a dietary item needed for the
    maintenance of good health, milk
is an extremely important food, espe-
cially for children and as a source of
calcium for all age groups. The respon-
sibility for insuring the safety of milk
and milk products is the concern of
many interested groups in the United
States, including Federal and State
governments, all segments of the dairy
industry, and individual communities.
Taking a look at the U.S. Public Health
Service's efforts to minimize the inci-
dence of harmful residues in dairy
products, the FDA Veterinarian
gathered information on some of these
groups' responsibilities for safe and
wholesome milk products in the mar-
ketplace. For a historical perspective on
milk sanitation programs, it is neces-
sary to look at the model regulation
which was begun to achieve a level of
milk sanitation to fight milkborne dis-
eases.

Pasteudzed Milk Ordinance (PMO)
   The milk sanitation program of the
 U.S. Public Health Service is one of


PHS's oldest activities, dating back to
1924. Because outbreaks of milkborne
diseases had been a major public health
problem, PHS developed a model regu-
lation to assist the States in beginning
and maintaining programs for milk sani-
tation. As a result of this achievement,
today fluid milk and its products are
associated with less than one percent
of all reported disease outbreaks. The
model regulation is called The Grade
A Pasteurized Milk Ordinance (PMO).
  The PMO was developed by the Pub-
lic Health Service/FDA with the
assistance of milk sanitation and
regulatory agencies at every level of
Federal, State, and local government,
including both health and agriculture
departments; all segments of the dairy
industry, including producers, plant
operators, equipment manufacturers,
and associations; many educational
and research institutions; and con-
sumer groups having milk-related in-
terests.
  The PMO is the basic standard used
in the voluntary cooperative State/PHS
program for certification of interstate
milk shippers, a program in which all


50 States participate. It is incorporated
by reference in Federal specifications
for procurement of milk and milk
products; is used as the sanitary regu-
lation of milk and milk products served
on interstate carriers; and is recognized
by the public health agencies, the milk
industry, and many others as a national
standard for milk sanitation.
  Public Health Service/FDA has no
legal jurisdiction in the enforcement of
milk sanitation standards except on
interstate carriers and milk and milk
products shipped in interstate com-
merce. Elsewhere PHS/FDA serves
solely in an advisory and stimulatory
capacity. Federal input is designed
primarily to assist State and local
regulatory agencies to promote the
establishment of effective and well-
balanced milk sanitation programs in
each State, to stimulate the adoption
of adequate and uniform State and
local milk control legislation, and to
encourage the appreciation of uniform
enforcement procedures through
appropriate legal and educational
measures.
  The PMO provides standards for
  milk, cottage cheese, dry curd and low-
fat cottage cheese, but not products
such as ice cream, evaporated milk,
and butter. These products are regu-
lated by FDA, using its good manufac-
turing practices, under the Food, Drug,
and Cosmetic Act. They are also regu-
lated by individual States and some of
these products are purchased under
the Commodity Credit Corporation. The
              (Continued, next page)
   In This Issue:
   FDA's VMAC Activities ...... 5
   AVMA RX Guidelines ........ 7
   Swine ID ...............  11
   Educational Events  ......... 11
   Bulk Drug Indictments  ....... 13


     Special Bulletin-Generic Animal
                   Drug Bill Passed

  On November 16, 1988, the President signed into law the Generic
Animal Drug and Patent Term Restoration Act. Among other things, it
extends eligibility for the submission of Abbreviated New Animal Drug
Applications (ANADAs) to drug products first approved as New Animal
Drug Applications (NADAs) after the 1962 Amendments to the Federal
Food, Drug, and Cosmetic Act.
  The new Act also requires FDA to publish, within 60 days of enact-
ment, a list of the official and proprietary name of each new animal drug
approved prior to the date of enactment. FDA is in the process of com-
piling the list which will be updated every 30 days.
   The next issue of the FDA Vetednadan will explain more of the details
of the bill.


                      U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
                                     PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION                                      CENTER FOR VETERINARY MEDICINE

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