Regulations governing the preparation, sale, barter, exchange, shipment, and importation of viruses, serums, toxins, and...

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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
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United States -- Bureau of Animal Industry
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Government Printing Office ( Washington )
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aleph - 029845297
oclc - 85229294
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U.S. DEPOSITORY
(Amendment 5 to B. A. I. Order 276)

United States Department of Agriculture
BUREAU OF ANIMAL INDUSTRY


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
(Effective on and after March 1, 1929)


UNITED STATES DEPARTMENT OF AGRICULTURE,
OFFICE OF THE SECRETARY,
Washington, D. C., Janatary 28, 1929.
Under authority conferred by law upon the Secretary of Agriculture, B. A. I.
Order 276, dated August 18, 1922, as amended, is hereby further amended in
the following particulars:
Subdivisions (b) and (d), section 1, regulation 7, are revoked, and in lieu
thereof the following subdivisions are prescribed:
(b) Suitable rooms and compartments in such places, and receptacles
and containers and the like in such numbers as may be necessary for hold-
ing viruses, serums, toxins, or analogous products as required by these
regulations. Such rooms, compartments, and receptacles shall be equipped
for securing and/or sealing and shall be held under locks and/or seals fur-
nished by the bureau, and the keys of said locks shall not leave the custody
of a bureau employee. Wherever the term bureau lock is used in these
regulations it shall be construed to mean bureau lock and/or seal.
(d) Automatic recording thermometers or gauges equipped for locking
and/or sealing as provided in subdivision (b) of this section and other
thermometers, which will register temperatures accurately and satisfac-
torily for use as required by these regulations.
Paragraph 3, section 1, regulation 9, is revoked and in lieu thereof the fol-
lowing paragraph is prescribed:
PARAGRAPH 3. All steam and dry heat sterilizers used in connection with
the production of anti-hog-cholera serum and hog-cholera virus shall be
equipped with automatic temperature-recording gauges. Charts used on
these gauges shall be available at all times for examination by bureau
employees.
Paragraph 4, section 6, regulation 17, is revoked and in lieu thereof the fol-
lowing paragraph is prescribed:
PARAGRAPH 4. All tags which are used to identify animals shall be fur-
nished and attached by licensed establishments, and when said tags are not
in use they shall be held under bureau lock, provided that, when ordered
by the chief of bureau, tags furnished by the department shall be used.
Paragraph 4, section 1, regulation 18, as amended, is modified so that pigs
from which virus is derived for the inoculation of other pigs shall weigh not
less than 40 pounds nor more than 110 pounds each.
Paragraph 4, section 4, regulation 138, as amended, is revoked and in lieu
thereof the following paragraph is prescribed:
PARAGRAPH 4. Simultaneous virus which has been mixed and phenolized
as provided in this section, together with the virus stock sample, shall be
held under bureau lock as provided under subdivision (b), section 1, regu-
lation 7, hereof, until such time as the tests required by these regulations
have been completed and have shown the virus to be free from contamina-
tion, provided simultaneous virus which is exported to a foreign country
may be released from under bureau lock prior to the conclusion of said
tests.
35033-29









Paragraph 3, section 5, regulation 18, is revoked and in lieu thereof the fol-
lowing paragraph is prescribed:
PARAGRAH 3. The return date placed upon the label of each immediate
or true container of simultaneous virus shall be a date within 60 days
after the date of manufacture, except when the product is exported to a
foreign country a return date within 120 days after the date of manufacture
may be used. When simultaneous virus which is exported as aforesaid
bears a return date in excess of 60 days after the date of manufacture the
containers thereof shall be labeled distinctively.
Paragraphs 12 and 13, section 2, regulation 19, are revoked and in lieu thereof
the following paragraphs are prescribed:
PARAGRAPH 12. Anti-hog-cholera serum which has been heated as provided
in the preceding paragraph should not be handled thereafter in a manner
which witl expose the product to contamination.
PAR. 13. Whenever practicable, in preparing batches of ordinary de-
fib rinated-blood serum, all the blood from a given number of hyperimmune
hogs shall be placed in the same batch. However, in order that the batch
may closely approximate 200,000 cubic centimeters, as many individual
bleedings of any one hog's blood as required for this purpose may be used.
The remainder of such individual hog's blood shall be placed in another
single batch. In selecting the bleedings for this purpose those which will
cause the batch most closely to approximate 200,000 cubic centimeters shall
be used. Single bleedings shall not be divided.
Paragraph 1, section 3, regulation 19, as amended, is revoked, and in lieu
thereof the following paragraph is prescribed:
PARAGRAPH 1. Anti-hog-cholera serum prior to testing shall be mixed in
batches of not more than 200,000 cubic centimeters each, except that concen-
trated clear serum shall be mixed in batches of not more than 300,000 cubic
centimeters each. Final mixtures or batches of serum shall contain rela-
tive proportions of the several bleedings. Each batch of serum shall be
thoroughly mixed in a single container and be constantly agitated during
the bottling process. After having been phenolized and mixed, a repre-
sentative sample consisting of at least 375 cubic centimeters collected in
three containers of not less than 125 cubic centimeters each, to be known as
the serum-test sample," shall be taken and marked with identifying marks
by a bureau employee. The serum, together with the test sample, shall be
held under bureau lock as provided under subdivision (b), section 1, regu-
lation 7, hereof, until such time as the tests required by these regulations
have been completed and have shown that the serum is not worthless,
contaminated, dangerous, or harmful.
Paragraph 3, section 3, regulation 19, is modified to provide that the test
samples of concentrated clear serum on which the return date has expired six
months previously may be labeled and marketed in the regular manner, pro-
vided this is feasible within three years after the first serum composing the
batch is collected.
Paragraph 1, and paragraph 2 as amended, section 4, regulation 19, are re-
voked and in lieu thereof the following paragraphs are prescribed:
PARAGRAPH 1. All anti-hog-cholera serum except that which is exported to
a foreign country shall be tested for purity and potency by licensed estab-
lishments as prescribed by these regulations. When anti-hog-cholera serum
which is exported as aforesaid has not been tested as prescribed by these
regulations the containers thereof shall be labeled distinctively.
PAR. 2. Licensed establishments shall furnish all pigs used in testing
anti-hog-cholera serum. Eight healthy pigs, susceptible to hog cholera and
weighing not less than 40 pounds nor more than 90 pounds each, except as
provided in sections 7, 8, and 9 of this regulation, shall be used for testing
each batch of serum as defined in paragraph 1, section 3, of this regulation,
as amended.
Rule C, paragraph 2, section 5, regulation 19, is amended by adding subdivi-
sion 3, to read as follows:
3. When two or more of the serum-treated pigs become sick during the
test period, not more than one of which becomes sick on or before the third
day after inoculation and recovers before the test animals are released by a
veterinary inspector as provided in this regulation.
Paragraph 2, section 6, regulation 19, is revoked and in lieu thereof the follow-
ing paragraDh is prescribed:







3

PARAGRAPH 2. Anti-hog-cholera serum, the test of which has shown it to
be "Unsatisfactory for potency" as defined in rule C of this regulation,
may be tested again as prescribed in sections 4 and 5 of this regulation.
Should the test again show the serum to be "Unsatisfactory for potency"
as defined in rule C of this regulation it shall not be released for marketing
unless and until the following requirements have been observed:
(a) Ordinary defibrinated-blood serum either shall be refined concen-
trated and tested, in a manner approved by the chief of bureau, or mixed
with other serum and tested as provided in section 7 of this regulation.
(b) Unconcentrated clear serum as defined in section 10 of this regula-
tion shall be mixed with other serum and tested as provided in section 7 of
this regulation.
(o) Concentrated clear serum as defined in section 10 of this regulation
either shall be tested again as provided in paragraph 2, section 7 of this
regulation, or mixed with other serum and tested as provided in section 7
aforesaid.
Paragraph 1, section 7, regulation 19, is revoked and in lieu thereof the fol-
lowing paragraph is prescribed:
PARAGRAPH 1. (a) Ordinary defibrinated-blood serum, the tests of which
have twice shown the product to be "Unsatisfactory for potency" as de-
fined in rule C of this regulation, but which is not "Unsatisfactory for
purity" as defined in rule F of this regulation and which is not refined and
concentrated as provided for in these regulations, before release for mar-
keting shall be mixed with other ordinary defibrinated-blood serum with
the view of increasing its potency, and, the final mixture shall consist of not
less than 50 per cent nor more than 60 per cent of the serum of doubtful
potency.
(b) Unconcentrated clear serum, the tests of which have twice shown
the product to be Unsatisfactory for potency" as defined in rule C of this
regulation, but which is not Unsatisfactory for purity" as defined in rule
F of this regulation, before release for marketing shall be mixed with a
sufficient quantity "of other clear serum to increase its percentage of true
serum content at least 9 points.
(c) Concentrated clear serum, the tests of which have shown the prod-
uct to be either two or three times Unsatisfactory for potency" as defined
in rule C of this regulation, but which is not "Unsatisfactory for purity"
as defined in rule F of this regulation, before release for marketing shall
be mixed with a sufficient quantity of other clear serum to increase its
percentage of true serum content at least 5 points.
Subdivisions (a.) and (b), paragraph 2, section 10, regulation 19, are revoked
and in lieu thereof the following subdivisions are prescribed:
(a) When unconcentrated clear, serum is prepared the completed prod-
uct shall contain not less than 67.20 per cent of true serum and cell fluid,
referred to in these regulations as "True serum," and shall represent not
more than 105 per cent of the defibrinated, hyperimmune blood used or not
more than 101.85 per cent of the whole hyperimmune blood used in the
preparation of the batch.
(b) When concentrated clear serum is prepared the completed product
shall contain not less than 84 per cent of true serum and represent not more /
than 84 per cent of the defibrinated, hyperimmune blood used, or 81.48 per
cent of the whole hyperimmune blood used in the preparation of the batch.
This amendment, for the purpose of identification, is desig-
[:EAL.] nated Amendment 5 to B. A. I. Order 276 and shall become and be
effective on and after March 1, 1929.
W. M. JARDINE,
Secretary of Agriculture.


U. S. GOVERNMENT PRINTING OriICE: IM





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