I #'r^ orl pi ') 0 -_"
(Amendment 17 to B. A. I. Order 276) (Effective April 20, 1943)
United States Department of Agriculture
AGRICULTURAL RESEARCH ADMINISTRATION
BUREAU OF ANIMAL INDUSTRY
ORDER AMENDING REGULATIONS GOVERNING THE PREPARATION,
SALE, BARTER, EXCHANGE, SHIPMENT, AND IMPORTATION OF
VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS INTENDED
FOR USE IN THE TREATMENT OF DOMESTIC ANIMALS
Pursuant to the authority conferred upon the Secretary of Agriculture by
section 2 of the act of Congress approved February 2, 1903 (32 Stat. 792: 2'1
U. S. C. 111), and by the act of Congress approved March 4, 1913 (37 Stat. 832-833;
21 U. S. C. 151-158), and in order better to effectuate the purposes of these acts,
Title 9, Chapter I; Subchapter E, Code of Federal Regulations, [B. A. I. Order 276,
August 18, 1922], as amended, is hereby further amended effective April 20, 1943,
(1) Section 114.18 [par. 2, Circ. Letter 1796, B. A. I., Sept. 29, 1933] is amended
to read as follows:
SEC. 114.18. Serum and virus; release for marketing. When the last full day
for concluding a satisfactory test ends before noon the product, after having been
labeled as required by part 112, together with the test animals, may be released
after the regular forenoon observations have been made. When the last full day
of a tentatively satisfactory test does not end before noon, the product, after
having been labeled as required by part 112, may be released after the regular
forenoon observations have been made: Provided, That, if, as the result of a
careful examination of the test animals by a veterinary inspector at the regular
forenoon observation time of the next regular workday, the test is declared
unsatisfactory, the manufacturer shall immediately recall all of the product in
order that it may be placed under Bureau lock.
(2) Section 118.4 [reg. 18, sec. 1, par. 4, B. A. I. Order 276, amdt. 1, Dec. 26,
1922, amdt. 5, Jan. 28,1929] is amended to read as follows:
Ste. 118.4. Virus pigs; inoculation requirements. Pigs for the production of
inoculating virus shall weigh not less than 40 pounds nor more than 125 pounds
each and shall be inoculated only with highly virulent hog-cholera virus. No
hog-cholera virus shall be used for inoculating pigs for the production of inocu-
lating virus, hyperimmunizing virus as prescribed in section 118.15, or simul-
taneous virus as prescribed in section 118.17 and for inoculating pigs in serum
tests as prescribed in section 119.33 unless it has been produced not more than 60
days prior to use and since completion has been held only in containers of the
iboro-silicate type or equal of high resistance and low alkalinity and which are
properly marked for identification and guaranteed by the manufacturer to be
acceptable to the Bureau and to meet the tests developed for determining these
qualities. Other virus may be made suitable for inoculation purposes only by
passing it through pigs of the same weight and in the same manner as prescribed
in section 121.3. Virus derived from these pigs may be used for hyperimmuniza-
tion If the animals react as prescribed in section 118.5.
(3) Section 118.7 [reg. 18, sec. 1, par. 7, B. A. I. order 276, Aug. 18,1922, amdt. 3,
Nov. 29,1924] is amended to read as follows:
SEC. 118&7. Pigs that become visibly sick within three days after they have been
examined for admission to the premises as prescribed by section 117.9 must be
rejected and either shall be destroyed or handled as prescribed by section 117.14.
Whenever the third day for observation of pigs falls on a Sunday or a holiday
such observation shall be made on the fourth day after admission to the premises,
(4) Section 118.37 [reg. 18, sec. 5, par. 3, B. A. I. order 276, amdt. 12, May 24,
1935] is amended to read as follows:
SEo. 118.37. Simultaneous virus; return date. The expiration or return date
placed upon the label of each immediate or true container of simultaneous virus
shall be one of the following: (a) a date within 90 days after the date of manu-
facture: Provided, That the simultaneous virus is stored and marketed In con-
UNIVERSITY OF FLORIDA
hill 111111 III iinm11111 liii111111111111111111111 U
2 3 1262 08859 2786
trainers acceptable to the Bureau; (b) a date within 120 days after the date of
manufacture when the product is marketed in containers described in section
118.4 and ig to be exported to a foreign country and the containers thereof are
(5) Section 119.4 [reg. 19, sec. 2, par. 2] is amended to read as follows:
SEc. 119.4. Hyperimmune hogs; bleeding and times. Anti-hog-cholera serum
shall be derived only from hyperimmune hogs which have been subjected to not
more than four successive bleedings after each hyperimmunization. The first
bleeding shall take place not earlier than 10 days after hyperimmunization, sub-
sequent bleedings shall not take place more frequently than once in 7 days, and
the last bleeding shall be made on a date not later than 38 days after hyperim-
munization: Provided, Final bleeding may be deferred by the Chief of Bureau
on special request. These hogs may be bled as aforesaid on any regular working
hour of the day of bleeding. However, none shall be passed for food earlier than
10 full days after the time of hyperimmunization.
(6) Section 119.33 [reg. 19, sec. 4, par. 11] is amended to read as follows:
SEo. 119.33. Serum tests; virus required. Simultaneous virus or its equivalent
of high virulence as described in section 118.4 and in sufficient quantities to meet
the needs shall be furnished by licensed establishments for use as the inspector.
in charge may deem advisable for inoculating pigs in serum tests.
(7) By amending paragraphs (c) and (d) of section 119.36 [reg. 19, sec. 5, par. 2,
rules C and D] to read as follows:
(c) Conditions under which to be declared "unsatisfactory for potency." A
serum test will be declared "unsatisfactory for potency" when at least two of
the control pigs react as described in paragraph (a) and the following conditions
(1) When one or more of the serum-treated pigs become visibly sick subse-
quent to the third day after the time of inoculation and fail to fully recover
before the test animals are released by a veterinary inspector as provided in
(d) Test; conditions under which to be declared "no test for potency." A
serum test will be declared "no test for potency" when any one of the following
conditions obtains, but such action will not operate to prevent a retest under the
provisions of the regulations in this subchapter:
(1) When one or more of the serum-treated pigs become visibly sick on or
before the third day after the time of inoculation and fail to recover within the
(2) When two or all of the control pigs become visibly sick on or before the
third day after the time of inoculation.
(3) When two or all of the control pigs do not manifest symptoms of hog
cholera as described in paragraph (a).
(4) When two or all of the control pigs do not show lesions of hog cholera
upon post-mortem examination as described in paragraph (a).
(5) When two or all of the control pigs manifest symptoms of hog cholera
within seven days as described in paragraph (a) but do not become sick to the
degree described in said paragraph.
(6) When the serum-treated pigs develop during the test period symptoms
of any infectious, contagious, or communicable disease (other than hog cholera)
which is not caused by the serum used.
(7) When a condition obtains in any of the test pigs which is not otherwise
covered in this section.
Done at Washington, D. C., this 15th day of April 1943. Witness my hand
and the seal of the Department of Agriculture.
xI UNIVn BCLAUDIE RI. WICKARD,
IrA !t V- -- rQm tr AL. 4 Secretary of Agriculture.
U. S. GOVERNMENT PRINTING OFFICE. 1543