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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Resource Identifier:
aleph - 029845689
oclc - 85229282
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A4,5:Z-'I


B. A. Order 26. U.S. DEPOSITORY -


B. A. I. Order 276. U.S. DEOITORY


Issued October 10, 1922.


UNITED STATES DEPARTMENT OF AGRICULTURE.

Bureau of Animal Industry.
JOHN R. MOHLER, CHIEF OF BUREAU.


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 November 1, 1922.


CONTENTS.
Page.
Regulation 1. Definitions-------------------------------------------------- 2
Regulation 2. Licenses and inspections-------------------------------------- 3
Regulation 3. Permits ------------------------------------------------ 5
Regulation 4. Suspension or revocation of licenses and permits---__--- ---------- 6
Regulation 5. Notice to licensees and permittees----------------------------- 7
Regulation 6. Assignment of bureau employees-------------- ----------------- 7
Regulation 7. Facilities for inspection-------------------------------------- 7
Regulation 8. Sanitation -------------------------------------------------- 7
Regulation 9. Sterilization ------------------------------------------------ 9
Regulation 10. Storage--- -------------------------------------------------- 10
Regulation 11. Records ---------------------------------------------------- 10
Regulation 12. Labels-------------------------------------------- 10
Regulation 13. Collecting samples------------------------------------------- 12
Regulation 14. Production, testing, etc-------------------------------------- 12
Regulation 15. Retesting-------------------------------------------------- 12
Regulation 16. Reports ---------------------------------------------------- 13
Regulation 17. Animals ---------------------------------------------------- 13
Regulation 18. Hog-cholera virus---- ---------------------------------------- 18
Regulation 19. Anti-hog-cholera serum---_-------- ---------------------------- 23
Regulation 20. Bacterins, vaccines, toxins, etc--------------------------------- 33
Regulation 21. Admission of viruses, serums, toxins, and analogous products.------ 34
The virus-serum-toxin law-------------------------------------------------- 34


U. S. DEPARTMENTr OF AGRICULTURE,
OFFICE OF THE SECRETARY,
Washington, D. C., August 18, 1922.
Under authority of the act of Congress approved March 4, 1913.
entitled "An act making appropriations for the Department of
Agriculture for the fiscal year ending June 30, 1914" (37 Stat.
832), the following regulations are hereby issued for the purpose
of enforcing the provisions of said act 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. These regulations, which for the purpose of
identification are designated as B. A. I. Order 276, shall become
and be effective on and after November 1, 1922, except that any
establishment may until December 31, 1922, continue to use the
phrase "U. S. Released" on its products in the manner provided
for the use thereof in B. A. I. Order 265.
HENRY C. WALLACE,
Secretary of Agriculture.
8177-22- 1


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REGULATION i.-DEFINITIONS.
SEcTION 1. Paragraph 1. For the purpose of these regulations,
the following words, phrases, names, and terms shall be construed,
respectively, to mean: S
Paragraph 2. The virus-serum-toxin act of 1913: "An act mak-
ing appropriations for the Department of Agriculture for the
fiscal year ending June 30, 1914," approved March 4, 1913 (37
Stat. 832).
Paragraph 3. Viruses, serums, toxins and analogous products,
or veterinary biologics: All viruses, serums, toxins, and analogous 4
products, such as antitoxins, vaccines, tuberculins, malleins, live
microorganisms, killed microorganisms, or bacterins, and products
of microorganisms which are intended for use in the treatment of
domestic animals.
Paragraph 4. The department: The United States Department of
Agriculture.
Paragraph 5. The bureau: The Bureau of Animal Industry of
the United States Department of Agriculture.
Paragraph 6. Bureau employee: Any officer, agent, or other indi-
vidual employed in the Bureau of Animal Industry who is au-
thorized by the chief of the bureau to do any work or perform any
duty in connection with the execution of the provisions of the
virus-serum-toxin act of 1913.
Paragraph 7. Veterinary inspector: A veterinary inspector of
the Bureau of Animal Industry.
Paragraph 8. Lay inspector: A lay inspector of the Bureau of
Animal Industry. 0
Paragraph 9. Licensed establishment: Any establishment owned I
or operated by a person, firm, or corporation holding an unexpired
unsuspended, and unrevoked license issued by the Secretary oi
Agriculture for the preparation of any virus, serum, toxin, or
analogous product.
Paragraph 10. Official station: One or more licensed establish-
ments included under a single supervision.
Paragraph 11. Inspector in charge: An inspector assigned to
supervise and perform official work at an official station and who
reports directly to the chief of the bureau.
Paragraph 12. Person: Natural persons, individuals, firms, part-
nerships, corporations, companies, societies, and associations and
every agent, officer, or employee of any thereof. This term shall
import both the plural and the singular, as the case may be.
Paragraph 13. Hog-cholera virus: The clear serum, plasma, or
defibrinated blood derived from pigs sick of hog cholera and free
from other communicable disease or diseases.
Paragraph 14. Hyperimmunizing virus: Hog-cholera virus pre-
pared for hyperimmunizing hogs which are immune to hog cholera.
Paragraph 15. Simultaneous virus: Hog-cholera virus prepared
for inoculating hogs which are to be injected simultaneously with
anti-hog-cholera serum for the immunization of those animals
against hog cholera.
Paragraph 16. Anti-hog-cholera serum: The clear serum, plasma,
or defibrinated blood, or derivatives thereof, containing the protec- I
tire principles derived from immune hogs which have been hyperim-








munized by an intravenous injection of at least 5 cubic centimeters,
per pound body weight, of the virus of hog cholera.
Paragraph 17. Immediate or true container: The unit, bottle, vial,
ampul, tube, or other receptacle, or container in which any virus,
serum, toxin, or analogous product is customarily sold or distributed.
Paragraph 18. Serial number: The number given each batch of
virus, serum, toxin, or analogous product to identify the said virus,
serum, toxin, or analogous product with the records of preparation
thliereof.
Paragraph. 19. Return date: The date placed upon trade labels
affixed to or used in connection with immediate or true containers of
viruses, serums, toxins, and analogous products by producers to in-
dicate the limit of time during which the said products may be ex-
pected to retain their full strength or potency.
Paragraph 20. U. S. Released: That veterinary biologics so
marked have been prepared and tested in accordance with the pro-
visions of these regulations and that when thus prepared, tested, and
marked, they were not found to be worthless, contaminated, danger-
ous. or harmful.
REGULATION 2.-LICENSES AND INSPECTIONS.
SECTION 1. Every establishment in the United States at which any
virus, serum, toxin, or analogous product is prepared for sale, barter,
or exchange in the District of Columbia or in any Territory of or
place under the jurisdiction of the United States, or for shipment
or delivery for shipment from any State or Territory or the District
of Columbia to any other State or Territory or the District of
Columbia, shall hold an unexpired, unsuspended, and unrevoked
license, issued by the Secretary of Agriculture, and shall have in-
spection under these regulations.
SECTION 2. All viruses, serums, toxins, and analogous products
produced at licensed establishments shall be prepared, handled.
stored, marked, received for transportation, and transported as re-
quired by these regulations.
SECTION 3. Paragraph 1. The proprietor or operator of each estab-
lishment of the kind specified in section 1 of this regulation shall
make application in writing to the Secretary of Agriculture for a
license. When one proprietor conducts more than one establish-
ment, a separate application shall be made for a license for each
establishment. Blank forms of application will be furnished upon
request addressed to the Bureau of Animal Industry, Washington,
D.C.
Paragraph 2. Triplicate copies of plans, properly drawn to scale,
and of specifications, including plumbing and drainage of estab-
lishments, together with triplicate copies of all labels and advertis-
ing matter to be used in connection with or relating to all viruses,
serums, toxins, and analogous products prepared therein, shall ac-
company the application for a license, unless these plans, specifica-
tions, labels, and advertising matter have already been approved in
writing by the bureau.
Paragraph 3. In case of change in ownership or location while an
application is pending, or after a license has been issued, a new appli-
cation shall be made.








SECTION 4. Paragraph 1. A license will not be issued unless the
condition of the establishment and the methods of preparation are
such as reasonably to insure that the products will accomplish the
object for which they are intended and that they are not worthless,
contaminated, dangerous, or harmful.
Paragraph 2. A license will not be issued unless and until the
establishment is prepared to operate under the direct supervision of
a competent person trained in bacteriological technic or in the prep-.
aration of viruses, serums, toxins, or analogous products named in
the application.
Paragraph 3. A license will not be issued for the preparation of
any virus, serum, toxin, or analogous product if advertised so as to
mislead or deceive the purchaser, or if the package or container in
which the same is intended to be sold, bartered, exchanged, or shipped
bears or contains any statement, design, or device which is false or
misleading in any particular.
SECTION 5. Paragraph 1. A license will be issued only after inspec-
tion of the establishment by a bureau employee has shown that the
condition and equipment of the establishment and the methods of
preparing, handling, and storing products are in conformity with
these regulations.
Paragraph 2. Licenses shall be numbered and shall be in the fol-
lowing form:
UNITED STATES VETERINARY LICENSE No.
WASHINGTON, D. C.,---------------, 19--
This is to certify that, pursuant to the terms of the act of Congress approved
March 4, 1913 (37 Stat. 832), 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,--------------------
is hereby licensed to maintain at----------------------- an establishment for
the preparation of-------------------
This license is subject to termination as provided in the regulations made
under the authority contained in said act approved March 4, 1913, and also
to suspension or revocation if the licensee violates or fails to comply with any
provision of the said act or the regulations made thereunder.
--------_-------_---------,
Secretary of Agriculture.
Countersigned:
Chief, Bureau of Animal Industry.
Paragraph 3. Two or more licenses may bear the same number
when they are issued to firms under the same ownership or control,
provided a serial letter is added when necessary, to identify each
license.
Paragraph 4. Should a licensed establishment discontinue the pro-
duction of any virus, serum, toxin, or analogous product, the license
of such establishment shall be returned to the bureau for termina-
tion and a new license issued covering such products named therein
as the establishment shall continue to produce. Should an establish-
ment be engaged in the preparation of products under a number of
licenses issued from time to time by the department, the licenses
shall be returned to the bureau at its request for termination and a
new license issued covering all the products embraced in the returned
licenses which the establishment shall continue to produce.







SECTION 6. Paragraph 1. No viruses, serums, toxins, or analogous
products shall be prepared in whole or in part in a licensed estab-
lishment by any other licensed establishment unless authorized in
advance by the chief of bureau.
Paragraph 2. Each licensed establishment shall be separate and
distinct from any unlicensed establishment in which any virus,
serum, toxin, or analogous product is prepared or handled.
Paragraph 3. When a license is issued the bureau shall inform the
proprietor or operator of the establishment of the requirements of
these regulations. If the establishment, at the time the license is
issued, has in possession any viruses, serums, toxins, or analogous
products, which have not theretofore been prepared and of which
the containers have not been theretofore marked in compliance with
these regulations, the identity of the same shall be maintained and
they shall not be shipped or delivered for shipment from one State
or Territory or the District of Columbia to another State or Terri-
tory or the District of Columbia, or otherwise dealt with as products
prepared under these regulations. The establishment shall adopt
and enforce all necessary measures and shall comply with all such
directions as the chief of bureau may prescribe for carrying out the
purposes of this paragraph.
REGULATION 3.-PERMITS.
SECTION 1. Each importer of viruses, serums, toxins, or analogous
products shall hold an unexpired, unsuspended, and unrevoked per-
mit issued by the Secretary of Agriculture.
SECTION 2. Paragraph 1. Each importer of viruses, serums, toxins,
and analogous products shall make application in writing to the
Secretary of Agriculture for a permit. The application shall specify
the port or ports of entry at which the imported articles will be
cleared through the customs. Blank forms of application will be
furnished upon request addressed to the Bureau of Animal Industry,
Washington, D. C.
Paragraph 2. Each application for a permit shall be accompanied
by the affidavit of the actual manufacturer produced before an
American consular officer, giving the city or town where the viruses,
serums, toxins, or analogous products mentioned therein are pre-
pared, and stating that said products are not worthless, contami-
nated, dangerous, or harmful; whether the products were derived
from animals, and, if so derived, the name of the species, and that
such animals have not been exposed to any infectious or contagious
disease, except as may have been essential in the preparation of the
products and as specified in the affidavit.
Paragraph 3. Each application for a permit shall be accompanied
by the written consent of the actual manufacturer that properly
accredited employees of the department shall have the privilege of
inspecting, without previous notification, all parts of the establish-
ment at which such viruses, serums, toxins, or analogous products are
prepared, and all processes of and all records kept relative to the
preparation of such products at such times as may be demanded by
the aforesaid employees.
Paragraph 4. Each application for permit shall be accompanied
by triplicate copies of all labels and advertising matter.








SSECTION 3. A permit will not be issued for the importation of any
viruses, serums, toxins, or analogous products if advertised so as
to mislead or deceive the purchaser, or if the package or container
in which the same is intended to be sold, bartered, exchanged, shipped,
or imported bears or contains any statement, design, or device which
is false or misleading in any particular.
SECTION 4. Paragraph 1. Permits shall be numbered and shall be
in the following form:
UNITED STATES VETERINARY PERMIT NO. ----
WASHINGTON, D. C., ---------------, 19---
This is to certify that, pursuant to the terms of the act of Congress approved
March 4, 1913 (37 Stat. 832), 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, ----- ----------
State of ----------------------. is hereby authorized, so far as the jurisdic-
tion of the Department of Agriculture is concerned, to import------------
manufactured by ---------------------- of -----------------------, into
the United States through.the port of ------------------------during the
calendar year 19_._
This permit is subject to suspension or revocation if the permitted violates
or fails to comply with the provisions of the said act approved March 4. 1913,
or of the regulations made thereunder.
--------- -_- - _- - - _---- --
Secretary of Agriculture.
Countersigned:
Chief, Bureau of Animal Industry.
Paragraph 2. Each permit shall terminate at the end of the cal-
endar year for which it is issued.
REGULATION 4.-SUSPENSION OR REVOCATION OF LICENSES AND
PERMITS.
SECTION 1. Licenses or permits may be suspended or revoked after
opportunity for hearing has been accorded the licensee or permitted
if it appears-
(1) That the construction of the establishment in which the
viruses, serums, toxins, or analogous products are prepared is defec-
tive, or that the establishment is improperly conducted;
(2) That the methods of preparation are faulty, or that the said
products contain impurities or lack potency;
(3) That the products are labeled so as to mislead or deceive the
purchaser in any particular;
(4) That the license or permit is used to facilitate or effect the
preparation, sale, barter, exchange, shipment, or importation of any
worthless, contaminated, dangerous, or harmful viruses, serums,
toxins, or analogous products; or
(5) That the licensee or permitted has violated or failed to comply
with any provision of the virus-serum-toxin act of 1913, or ot the
rules and regulations made thereunder.
SECTION 2. All hearings shall be private and at times and places
designated by the Secretary of Agriculture. The parties interested
may appear in person or by attorney, and may submit oral or written
evidence on the questions involved. Upon request and by paying the
cost, the person involved will be furnished with a copy of the trans-
script of the hearing.








REGULATION 5.-NOTICE TO LICENSEES AND PERMITTEES.
SECTION 1. If at any time it appears that the preparation,, sale,
barter, exchange, shipment, or importation of any virus, serum, toxin,
or analogous product by any person holding a license or permit may
be dangerous in the treatment of domestic animals, the Secretary of
Agriculture will so notify the licensee or permitted, and unless and
until the Secretary of Agriculture shall otherwise direct, no person,
so notified, shall thereafter prepare, sell, barter, or exchange, nor
shall thereafter ship, offer for shipment, or import any of such
product.
REGULATION 6.-ASSIGNMENT OF BUREAU EMPLOYEES.

SECTION 1. Any bureau employee, as defined in these regulations.
shall be permitted to enter any establishment licensed under these
regulations at any hour during the daytime or nighttime; and such
bureau employee shall be permitted to inspect without previous noti-
fication the entire premises of the establishment, including all build-
ings, compartments, and other places, and all equipment, such as
chemicals, instruments, apparatus, and the like, as well as the meth-
ods used in the manufacture of, and all records maintained relative
to. viruses, serums, toxins, or analogous products.
SECTION 2. Eaci bureau employee, as defined in these regulations,
will be furnished with a numbered official badge, which he shall not
allow to leave his possession. This badge shall be sufficient iden-
tification to entitle him to admittance at all regular entrances and to
all parts of the licensed establishment and premises and to any
place at any time for the purpose of making an inspection pursuant
to section 1 of this regulation.
REGULATION 7.-FACILITIES FOR INSPECTION.

SECTION 1. When required by the chief of bureau or the inspector
in charge, the following facilities, and such others as may be essen-
tial to efficient conduct of inspection, shall be furnished by each
licensed establishment:
(a) Satisfactory pens, equipment, and assistance for conducting
tests required in accordance with these regulations.
(b) Suitable rooms, compartments, or receptacles in such number
and places as may be necessary for holding any viruses, serums,
toxins, or analogous products for treatment or testing required in
accordance with these regulations. Such rooms, compartments, or
receptacles shall be equipped for secure locking and shall be held
under locks furnished by the department, and the keys of such locks
shall not leave the custody of bureau employees.
(c) Suitable containers satisfactorily equipped for thoroughly
mixing batches of anti-hog-cholera serum and hog-cholera virus.
(d) Thermometers which will register temperatures accurately
and satisfactorily for use as required by these regulations.
REGULATION 8.-SANITATION.
SECTION 1. Paragraph 1. Triplicate copies of plans properly
drawn to scale, and of specifications, including plumbing and drain-







age, for remodeling plants of licensed establishments and for new
structures, should be submitted to the chief of bureau in advance of
construction.
Paragraph 2. Stables or other premises for animals used in the
production of testing of viruses, serums, toxins, or analogous prod-
ucts shall be properly ventilated and lighted, appropriately drained,
and guttered, and kept in good sanitary condition.
Paragraph 3. Animals infected with or exposed to any infec-
tious, contagious, or communicable disease shall be properly segre-
gated.
Paragraph 4. Licensed establishments shall be so located as to
avoid the spread of disease, and suitable arrangements shall be
made for the disposal of all refuse.
Paragraph 5. Direct communication to licensed establishments
shall not be maintained from public stockyards, abattoir pens, or
other places in which animals are received or held for any purpose.
Paragraph 6. All viruses, serums, toxins, and analogous products
shall be prepared, handled, and distributed with due sanitary pre-
cautions, and all viruses, serums, toxins, or analogous products
shipped or delivered for shipment shall be securely packed.
SECTION 2. Pwaagraph 1. The floors, walls, ceilings, partitions,
posts, doors, and all other parts of all structures at licensed establish-
ments shall be of such material, construction, and finish as can be
readily and thoroughly cleaned.
Paragraph 2. Separate rooms or compartments shall be provided
for preparing, handling, and storing virulent or attenuated micro-
organisms or toxins.
Paragraph 3. All rooms and compartments shall have abundant
light and sufficient ventilation to insure sanitary and hygienic condi-
tions.
SEcTION 3. Paragraph 1. Each licensed establishment shall have
dressing rooms and toilet rooms and urinals sufficient in number,
ample in size, conveniently located, properly ventilated, and meeting
all requirements as to sanitary construction and equipment. These
rooms, etc., shall be separate from rooms and compartments in which
any viruses, serums, toxins, or analogous products are prepared, J
handled, or stored.
Paragraph 2. Each licensed establishment shall have modern lava-
tory accommodations, including running hot and cold water, soap,
towels, and the like. These shall be located at such places in estab-
lishments as may be essential to assure cleanliness of all persons
handling viruses, serums, toxins, or analogous products.
SEcTION 4. There shall be an efficient drainage and plumbing
system for the establishment and premises, and all drains and gutters
shall be properly installed with approved traps and vents.
SECTION 5. The water supply, both hot and cold. shall .be ample
and clean. Adequate facilities shall be provided for the distribution
of water in each establishment and for the washing of all equipment,
containers, machinery, instruments, other apparatus, and animals
used in the preparation, handling or storing of any viruses, serums,
toxins, or analogous products.
SECTION 6. All equipment, containers, instruments, and other ap-
paratus used in the preparation, handling, or storing of any virus,
serum, toxin, or analogous product shall be of such material, con-







struction, and design as can be readily and thoroughly cleaned and
sterilized, and such equipment, containers, instruments, and other
apparatus shall be handled so as to insure freedom from contami-
nation. Equipment, containers, instruments, and other apparatus
used for preparing, handling, or storing virulent or attenuated
microorganisms or toxins shall not be used for handling, preparing,
or storing other forms of biological products.
SECTION 7. All establishment employees who handle viruses,
serums, toxins, or analogous products shall keep their hands and
clothing clean. The hands of such employees shall not come into
contact with any viruses, serums, toxins, or analogous products, or
with any part of the equipment, containers, instruments, or other
apparatus, which after sterilization may come into contact with any
such products.
SECTION 8. Caps, gowns, and other outer clothing worn by persons
while handling any viruses, serums, toxins, or analogous products,
or by those who enter any room, compartment, or place where any
such products are being handled, shall be of clean, white material
whenever practicable.
SECTION 9. The outer premises of every licensed establishment,
embracing docks, driveways, approaches, yards, pens, chutes, and
alleys, shall be drained properly and kept in a clean and orderly con-
dition. The accumulation, on the premises of an establishment, of
any material in which flies may breed is forbidden. No nuisance
shall be allowed in any licensed establishment or on its premises.
SECTION 10. Every practicable precaution shall be taken to keep
establishments free of flies, rats, mice, and other vermin.
SECTION 11. All parts of the carcasses of animals producing vi-
ruses, all dead animals, all refuse, and all worthless, contaminated,
dangerous, or harmful viruses, serums, toxins, or analogous products,
shall be incinerated or otherwise destroyed by establishments in ac-
cordance with methods approved by the chief of bureau.
SECTION 12. All rooms, compartments, and other places used for
preparing, handling, or storing viruses, serums, toxins, or analogous
products shall be kept clean and sanitary, and all equipment, con-
tainers, instruments and other apparatus used in preparing, han-
dling, or storing any such products shall be thoroughly cleaned and
sterilized before use.
SECTION 13. Smoking or expectorating in any room, compartment,
or place in which viruses, serums, toxins, or analogous products are
prepared, handled, or stored is prohibited.
REGULATION 9.-STERILIZATION.
SECTION 1. Paragraph 1. All equipment, containers, instruments,
and other apparatus, before being used in preparing, handling, or
storing viruses, serums, toxins, or other analogous products, except
as prescribed in the following paragraph, shall be thoroughly steri-
lized by live steam at a temperature of at least 120 C. for not less
than one-half hour, or by dry heat at a temperature of at least 160
C. for not less than one hour. If for any reason such methods of
sterilization are impracticable, then a process known to be equally
efficacious in destroying microorganisms and their spores may be
substituted after approval by the chief of bureau.
8177-22--2






10


Paragraph 2. Instruments used in connection with the bleeding of
virus pigs and hyperimmune hogs, and other like equipment, of
establishments manufacturing hog-cholera virus and anti-hog-
cholera serum, which are found to be damaged by exposure to the
degree of heat prescribed in the preceding paragraph, after having
been thoroughly cleaned may be sterilized by boiling for not less
than 15 minutes, provided apparatus satisfactory to the inspector in
charge is furnished for this purpose.
Paragraph 3. Licensed establishments shall furnish satisfactory
means for insuring that autoclaves and other sterilizers operate
efficiently and as required by this regulation. Either efficient auto-
matic temperature-recording gauges or iodid of starch, prepared as
approved by the chief of bureau as a temperature indicator, shall be
used in the operation of autoclaves and other steam sterilizers. Such
gauges likewise shall be attached to dry-heat sterilizers unless they
can be and are effectively operated under the direct supervision of
a bureau employee while he is engaged on other inspection work
requiring his attention. Charts used on these gauges shall be made
available at all times for examination by bureau employees.
REGULATION io.-STORAGE.
SECTION 1. Viruses, serums, toxins, and analogous products which
may be injuriously affected by exposure to light or to high temper-
ature shall be stored in a dark, cold chamber or refrigerator at a
temperature of not to exceed 55 F. All dealers in the District of
-Columbia or any Territory or in any place under the jurisdiction of
the United States shall keep such products protected from light
and under refrigeration until sold or otherwise disposed of.
REGULATION I.-RECORDS.
SECTION 1. Paragraph 1. Permanent detailed records of the
sources of the preparation, of tests for purity and potency, and of
methods of preservation of each batch of virus, serum, toxin, and
analogous products shall be kept by each licensed establishment and
by each manufacturer producing such products for importation into
the United States.
Paragraph 2. Permanent detailed records in a form satisfactory
to the chief of the bureau shall be maintained by each licensed estab-
lishment and by each importer, showing the sale, shipment, or other
disposition of the viruses, serums, toxins, and analogous products
handled.
REGULATION 12.-LABELS.
SEcTION 1. Paragraph 1. Each immediate or true container of
viruses, serums, toxins, or analogous products, prepared for sale,
barter, exchange, or shipment by any licensed establishment or im-
porter into the United States, shall bear a trade label as hereinafter
described.
Paragraph 2. No container of virus, serum, toxin, or analogous
product shall bear a trade label unless and until the product contained
therein shall have been prepared in compliance with these regulations
and not found to be worthless, contaminated, dangerous, or harmful,






11


except that containers of antihog-cholera serum and hog-cholera
virus prepared as aforesaid may' be labeled and marked before the
products are released for marketing, provided such labeling and
marking are done under the direct supervision of a bureau employee
and the products immediately thereafter placed under bureau lock,
where they will be held until released for marketing. No person
shall have access to the compartment in which such labeled or marked
products are held under lock except in the immediate presence of a
bureau employee.
Paragraph 3. No person shall apply or affix, or cause to be applied
or affixed, any trade label, stamp, or mark to any container of hog-
cholera virus or antihog-cholera serum, prepared or received in a
licensed establishment except in compliance with these regulations.
Suitable tags or labels of a distinct design should be used for identi-
fying all biologics while in course of preparation.
SECTION 2. Paragraph 1. Trade labels shall bear the true name of
the product contained in the package, and this name shall be identical
with that given in the license under which the product is prepared.
The name shall also be so lettered and placed as to give equal promi-
nence to each word composing it. Such labels shall also bear the
name and address of the manufacturer and the license or permit
number assigned by the department. The license number and
permit shall be shown in either of the following forms, r.spec-
tively: "U. S. Veterinary License No. ," or "U. S. Vet. License
No. --," and "U. S. Veterinary Permit No. -- ," or U. S. Vet.
Permit No. --." These labels shall bear all other information re-
quired by the chief of bureau, and may also bear any other statement
not false or misleading, and which has been approved by the bureau.
Paragraph 2. Each trade label shall bear a serial number, affixed
by the manufacturer, by which the product can be identified with the
records of preparation.
Paragraph 3. Each trade label shall bear a return date affixed be-
fore the product is removed from the establishments. The date
shown shall be a date after which the manufacturer does not guiar-
antee the product to be of full strength or potency.
Paragraph 4. All trade labels affixed to or used in connection with
each immediate or true container shall bear a dosage table and full
instructions governing the use of the product.
Paragraph 5. Trade labels affixed to the immediate or true con-
tainers of viruses and products prepared from attenuated organisms
shall bear, in addition to the statements required by the preceding
paragraphs of this section, the following, prominently placed and
lettered:" CAUTION-BURN TInS CONTAINER AND ALL UNUSED CON-
TENTS."
Paragraph 6. When any virus, serum, toxin, or analogous product
is prepared by a licensed establishment, or imported for a person
other than the one to whom a license or permit has been issued, and
the name and address of the distributor, as well as that of the manu-
facturer, is to appear on the trade labels of the containers thereof,
a statement shall be made on the labels indicating that the virus,
serum, toxin, or analogous product is distributed by such person.
The name and address of this person shall not appear in any form






12


or manner indicating that the distributor is the producer of the
product, and operating under the license as shown on the label.
The terms "Distributor," "Distributors," "Distributed by," or
equivalent terms may be used if prominently placed and lettered, in
connection with the name and address of the distributing person,
provided the same are not used so as to be either false or misleading.
Reference to the distributing person shall be made by name and
address only.
Paragraph 7. Copies of all trade labels before use shall be sub-
mitted to the bureau for examination and approval. These labels
shall be submitted in triplicate, quadruplicate, or quintruplicate, as
may be indicated. Triplicate copies of new trade labels in the form
of sketches, proofs, or photographic copies should be submitted,
through the inspector in charge, to the bureau for approval.
REGULATION 13.-COLLECTING SAMPLES.
SECTION 1. Paragraph 1. Samples of viruses, serums, toxins, and
analogous products shall be collected by authorized officers, agents, or
employees of the department.
Paragraph 2. Samples may be purchased in the open market, and
the marks, brands, or tags upon the package or wrapper thereof shall
be noted. The collector shall note the names of the vendor and
agent of the vendor who made the sale. together with the date of
purchase. The collector shall purchase representative samples.
Paragraph 3. All samples or parts of samples shall be sealed by
the collector and marked with identifying marks.
REGULATION 14.-PRODUCTION, TESTING, ETC.
SECTION 1. Except as otherwise provided in these regulations, all
viruses, serums, toxins, and analogous products shall be prepared,
handled, stored, marked, treated, and tested by licensed establish-
ments in accordance with methods prescribed by the Chief of the
Bureau of Animal Industry.
REGULATION xs.-RETESTING.
I
SECTION 1. Viruses, serums, toxins, and analogous products, the
containers of which bear United States veterinary license numbers or
United States veterinary permit numbers, or any other mark required
by these regulations, shall be subject to inspection at any time or
place. If, as a result of such inspection, it appears that any such
product, even though prepared in a licensed establishment or im-
ported under permit issued by the Secretary, is worthless, con-
taminated, dangerous, or harmful, the Secretary shall give notice
thereof to the manufacturer or importer and to any jobbers, dealers,
or other persons known to have any of such product in their posses-
sion. Unless and until the Secretary shall otherwise direct, no person
so notified shall thereafter sell, barter, or exchange in any place under
the jurisdiction of the United States nor shall thereafter ship or
deliver for shipment from any State, Territory, or the District of
Columbia to any other State, Territory, or the District of Columbia,
any of such product.






13


REGULATION x6.-REPORTS.
SECTIoN 1. Paragraph 1. Reports of the work of inspection carried
on in every licensed establishment shall be forwarded to the bureau
by the inspector in charge in such form and manner as may be speci-
fied by the chief of bureau.
Paragraph 2. Each licensed establishment shall furnish to bureau
employees accurate information as to all matters needed by them
for making their reports pursuant to paragraph 1 of this section,
and shall submit such reports as may be required by the chief of
bureau.
REGULATION xi.-ANIMALS.
SECTION 1. Paragraph 1. Licensed establishments which procure
animals from public stockyards, abattoir pens, or similar places
shall afford opportunity for all hogs, cattle, sheep, and goats ad-
mitted to the premises of such establishments to range in contact
with other animals as prescribed in section 3 of this regulation.
Paragraph 2. Cattle, sheep, and goats from whatever source, ex-
cept "contact calves" and those admitted by certificate as permitted
by section 5 of this regulation upon admission to the premises of
licensed establishments, shall be afforded opportunity to range in
contact with other animals as prescribed in section 3 hereof.
SECTION 2. Paragraph 1. Licensed establishments shall provide
suitable pens to be known as "receiving pens" through which all
hogs, cattle, sheep, and goats shall pass in accordance with the
provisions of this regulation before they shall be admitted to any
other part of the premises.
Paragraph 2. Licensed establishments shall provide healthy calves
in thrifty condition and ranging from 3 to 12 months of age for
use as contact animals in receiving pels. They shall be referred
to as "contact calves."
Paragraph 3. Each contact calf shall have the left ear thereof
pierced with a hole not less than three-fourths inch in diameter
and to the right ear of each animal shall be attached a serially num-
bered metal tag.
SECTION 3. Paragraph 1. All animals covered by section 1 of this
regulation, except hogs, shall be held in receiving pens for at least
48 hours as prescribed in paragraph 2 of this section, and not less
than two contact calves shall be used for each lot of 20 animals
or less in the same pen.
Paragraph 2. All hogs which are admitted to the premises of
licensed establishments under the provisions of section 1, para-
graph 1, of this regulation, shall be held in receiving pens for at
least 24 hours after admission to the premises, with the exception
of pigs which are used in testing the potency and purity of anti-
hog-cholera serum and the virulence of hog-cholera virus, in which
case six hours will be sufficient; and during this time all these ani-
mals shall be allowed free range and contact with not less than
two contact calves for each lot of 200 hogs or less in the receiving
pens. Hogs immune to hog cholera may be removed from the re-
ceiving pens for hyperimmunization at any time while being held
as aforesaid, provided, they are returned to the receiving pens
immediately after this operation.






14 -

SECTION 4. Paragraph 1. All surviving contact calves shall be
held in the receiving pens of licensed establishments for at least
one month from date of admission to receiving pens as contact
calves.
Paragraph 2. The removal of contact calves from receiving pens
shall be so arranged that one animal of each group of two will
be replaced at the expiration of one month and the other at the
expiration of two months.
Paragraph 3. Removal of contact calves from receiving pens
shall be accomplished so that the animal last furnished for the pur-
pose may be used for the maximum time permitted by the preced-
ing paragraphs of this section. No contact calf shall be used as
such more than once, but may be used for testing simultaneous
virus after release as a contact animal.
Paragraph 4. Contact calves shall be carefully examined by a
veterinary inspector as frequently as may be necessary to detect evi-
dence of disease.
SECTION 5. Establishments, licensed to prepare anti-hog-cholera
serum or hog-cholera virus, which procure no animals from public
stockyards, abattoir pens, or similar places shall furnish a properly
executed certificate in the following form covering each lot or ship-
ment of animals offered for admission to the premises thereof, or in
lieu of this said animals shall be held in contact with calves as pre-
scribed in section 3 of this regulation. These certificates shall be
signed by an authorized representative of the licensed establishment.
-------- - -* 19
calves which are offered for
This is to certify that--------------------- hogs
admission to the establishment of the---------------------------------
Co. are from the farm or premises of --------- __---------, in the State of
--------------, county of ---------------, township of --------------,
and to the best of our knowledge and belief were on said farm or premises at
least 21 days prior to this date, and were not exposed to any infectious, con-
tagious, or communicable disease, and no new stock was brought on to the
said farm or premises during that time. The said animals have not been in
or transported through any public stockyards, abattoir pens, or similar places,
nor have they been exposed to any infectious, contagious, or communicable
disease since their removal from said farm or premises.
(Signed) --------- ---------- -------------- Co.,
Per ----------
SECTION 6. Paragraph 1. All animals presented for admission t(,
the premises of establishments licensed to prepare anti-hog-cholera
serum or hog-cholera virus shall be examined by a veterinary in-
spector as soon as practicable after they are received and before
their removal from the receiving pens in order to determine their
physical condition. No animal shall be removed from receiving pens
without examination by and the permission of a veterinary inspector.
Paragraph 2. After examination, if the animals are permitted to
remain upon the premises and to enter, the holding pens of the
establishment, they shall be given serially numbered metal tags,
either prior to or at the time of inoculation or hyperimmunization.
Paragraph 3. All tags used for the identification of animals shall
be attached to the ears of the animals in a manner satisfactory to
the inspector in charge. The tags so attached shall be the means
of assisting in identifying the animals so long as they remain on the
premises.






15


Paragraph 4. All tags which are used to identify animals shall be
furnished and attached by the licensed establishment except that,
when so ordered by the chief of bureau, only tags furnished by the
Bureau of Animal Industry shall be used for tagging pigs and
calves used for testing anti-hog-cholera serum and hog-cholera virus,
and when said tags are not in actual use they shall be held at all
times in the custody of a bureau employee.
Paragraph 5. The left ear of each animal used in testing the
purity and potency of viruses, serums, toxins, and analogous products
shall be pierced, if of sufficient size to admit of'the procedure, when
the test is started, with a hole of not less than three-fourths inch in
diameter, except when pigs are used in testing hog-cholera virus for
purity as prescribed in paragraphs 8, 9, and 10, section 4, Regula-
tion 18 of this order, their right ears shall be pierced as aforesaid.
Animals bearing marks of the above-described character shall not
be presented by licensed establishments for use in testing the purity
and potency of any virus, serum, toxin, or analogous product, except
that "contact calves" after release as prescribed in section 4 of this
regulation and serum-treated pigs in anti-hog-cholera serum tests
after release as prescribed in paragraphs 6 and 7, section 4, Regu-
lation 19 of this order may be used once for testing hog-cholera
virus for purity, provided they are healthy and their right ears then
are pierced as aforesaid. Furthermore, animals with either ear re-
moved or mutilated so as to prevent the detection of these identifying
marks shall not be used in any test. if the missing or mutilated ears
are needed to determine the suitability of the animals for test pur-
poses as described herein. The piercing of the ears of animals must
be accomplished in the manner prescribed in this order or in such
manner as may be prescribed by the chief of bureau.
SECTION 7. Animals used in the production or testing of viruses.
serums, toxins, or analogous products shall not be treated with bio-
logical products other than those which are incidental to the prepara-
tion and testing of the products prepared from or tested upon said
animals, except with the approval of and in such manner as may be
prescribed by the chief of bureau.
SECTION 8. Paragraph 1. If for any reason hyperimmune hogs are
practically the only animals held upon the premises of a licensed
establishment, they shall be caused to range in contact with calves in
the manner prescribed in section 3 of this regulation for a period of
at least 10 days prior to their being subjected to carotid or final
bleeding.
Paragraph 2. All animals with which hyperimmune hogs have
been held in contact as prescribed in this section shall be held on the
premises of the licensed establishment and under the observation of
a bureau employee for at least two weeks after the hyperimmune
hogs have been destroyed.
Paragraph 3. If at any time the bureau requires that hyperimmune
hogs be subjected to the tail-bleeding process only, those surviving
shall be held under the supervision of a bureau employee for at least
two weeks after the last tail bleeding has been collected, but this
shall not operate to prevent post-mortem examinations of the
animals from being made as required by these regulations.
SECTION 9. Paragraph 1. Hogs, cattle, sheep, or goats shall not
be removed from the premises of establishments licensed to produce





16

anti-hog-cholera serum or hog-cholera virus without the written
permission of the inspector in charge.
Paragraph 2. Permission to remove animals from the premises
of establishments as described in the preceding paragraph will be
given by the inspector in charge under the following conditions, pro-
vided the removal of said animals is accomplished in such a manner
as will preclude the dissemination of disease.
(a) Animals named in paragraph 1 of this section that are not in
a healthy condition as determined by a veterinary inspector, except
when affected with a communicable disease other than hog cholera
and tuberculosis, may be removed from establishments for immedi-
ate slaughter in a federally inspected abattoir if they are transported
thereto by truck, wagon, or similar means and not by rail, provided
they are properly marked for identification and the inspector in
charge of meat inspection is given due notice thereof in advance.
If a federally inspected abattoir is not accessible as aforesaid,
the slaughter of said animals may be conducted in any convenient
unofficial abattoir provided the licensed establishment signifies its
willingness in writing to dispose of the carcasses under the pro-
visions of the meat-inspection regulations and as directed by a veteri-
nary inspector after a post-mortem examination has been conducted
by him.
(b) Hogs that are in a healthy condition as determined by a
veterinary inspector may be removed from establishments provided
they are or have been treated or vaccinated and disinfected as pre-
scribed in paragraphs 3 and 4 of this section. Such hogs need not
be vaccinated or disinfected by the establishment when removed for
immediate slaughter in a federally inspected abattoir or to a public
stockyards from which no hogs are permitted to be removed for pur-
poses other than immediate slaughter without vaccination and dis-
infection under bureau supervision. When hogs are removed to
abattoirs or public stockyards without vaccination and disinfection
as aforesaid, the licensed establishment shall furnish the bureau with
a certificate from the consignee of the animals at the abattoir or
public stockyards showing their slaughter therein or receipt thereby,
respectively. If the animals are not disinfected, they shall not be
transported by rail or driven over public highways which are not
traversed by animals from stockyards or similar places.
(c) Calves that are in a healthy condition as determined by a
veterinary inspector may be removed from establishments after
disinfection as described in subdivision (a), paragraph 4 of this sec-
tion, except that when removed to an abattoir without passing
through stockyards, or over public highways which are not traversed
by animals from public stockyards or similar places, the animals
need not be so disinfected provided the licensed establishment fur-
nishes the bureau with a certificate from the consignee of the animals
at the abattoir showing their slaughter therein.
(d) Pigs which survive inoculation and exposure to hog cholera
for the production of hog-cholera virus, surviving pigs which have
been used for testing hog-cholera virus, and surviving control pigs
in tests of anti-hog-cholera serum may be removed from establish-
ments not earlier than 15 days subsequent to the time of inoculation
and exposure as aforesaid, provided they are healthy, as determined






17


by a veterinary inspector, and are first given the serum-alone treat-
ment as described in subdivision (a), paragraph 3, and are dis-
infected as set forth in subdivision (b), paragraph 4 of this section,
except that when removed for immediate slaughter or to public
stockyards as defined in subdivision (b) of this paragraph, said
animals need not be so treated or disinfected.
(e) Hyperimmune hogs, or those treated in a similar manner, and
pigs which have been used for testing anti-hog-cholera serum may
be removed from establishments not earlier than 21 days subsequent
to the time of hyperimmunization or inoculation, provided they are
healthy, as determined by a veterinary inspector, and are disinfected
as prescribed in subdivision (b), of paragraph 4 of this section, except
that when removed for immediate slaughter or to public stockyards
as set forth in subdivision (b) of this paragraph, said animals need
not be so disinfected.
Paragraph 3. All hogs which require treatment or vaccination as
defined in the preceding paragraph of this section shall be treated
as follows:
(a) Serum-alone method. The serum used shall have been pre-
pared and released for marketing at an establishment holding a
license from the Secretary of Agriculture and the dose employed
shall conform to that required in Regulation 19 of this order.
(b) Simultaneous-inoculation method.-The serum and virus used
shall have been prepared at an establishment holding a license from
the Secretary of Agriculture and the doses shall be not less than
those required in Regulations 18 and 19 of this order. After receiv-
ing this treatment they shall be held under the supervision of a
bureau employee for a period of at least 21 days, except when treated
with virus and serum released for marketing.
Paragraph 4. All animals which require disinfection as defined in
paragraph 2 of this section shall be treated as follows:
(a) The feet, legs, and soiled portions of the body of calves to be
removed from establishments shall be cleaned and disinfected with a
2 per cent aqueous solution of cresol compound, U. S. P., or permitted
substitute therefore, and these animals shall then be held in non-
infectious pens on the premises of the establishment until they are
dry before being loaded for transportation.
(b) Hogs shall be disinfected in a 2 per cent aqueous solution of
cresol compound, U. S. P., or a permitted substitute therefore, and be
held in noninfectious pens on the premises for at least three hours
before being loaded for transportation, except that hogs transported
in trucks, wagons, or by similar means may be removed as soon after
disinfection as they are observed by a veterinary inspector to be
thoroughly dry, if said animals are not made wet before their
removal from the premises.
SECTION 10. Except as otherwise provided in these regulations,
all animals used by licensed establishments in the preparation or
testing of veterinary biologics shall meet such requirements as may
be prescribed by the chief of bureau and deemed by him necessary
to prevent the preparation and sale of any worthless, contaminated,
dangerous, or harmful viruses, serums, toxins, or analogous prod-
ucts.


8177-22----3






18


SEcnoN 11. Each licensed establishment shall adopt such meas-
ures as the chief of bureau shall from time to time prescribe for
carrying out the provisions of this regulation.
REGULATION i8.-H'OG-CHOLERA VIRUS
SECTION 1. Paragraph 1. All operations incident to the produc-
tion of hog-cholera virus shall be conducted under the supervision
of a bureau employee. Each licensed establishment shall notify the
inspector in charge or his assistant a reasonable time in advance
whenever any operations are to be conducted.
Paragraph 2. Pigs which are used in the production of hog-
cholera virus shall be healthy, and the temperature of each animal
shall be accurately taken and permanently recorded by the establish-
ment immediately before inoculation when in the opinion of the
inspector in charge this is necessary to determine the health of the
animals. Each animal shall be subjected to a careful examination
by a veterinary inspector immediately prior to inoculation.
Paragraph 3. Temperatures of all pigs used to produce hog-
cholera virus shall be correctly taken and recorded by licensed estab-
lishments each day subsequent to the fourth day after inoculation
and at such other times as the inspector in charge may deem neces-
sary. The temperature of each pig invariably shall be taken and
recorded on each day the animal is slow or visibly sick.
Paragraph 4. Pigs from which virus for the inoculation of other
pigs in the production of virus is derived shall weigh not more
than 100 pounds each. Hog-cholera virus of licensed establishments
shall not be used for inoculating pigs for the production of virus
later than 15 days after the date of its collection, but such virus
which is not more than 60 days old and which has been held con-
tinuously by licensed establishments at a temperature of not more
than 55 F. (12.8 C.) may be made suitable for said inoculation
purposes by passing it through pigs of the same weights and in the
same manner as prescribed in paragraph 3, section 1, Regulation 21
of these regulations. The virus derived from these pigs may be
used for hyperimmunization if the animals react as prescribed in the
following paragraph of this section.
Paragraph 5. Pigs from which blood is to be collected for the pro-
duction of hog-cholera virus shall be killed only after permission has
been given by a veterinary inspector who has observed them to mani-
fest well-marked and increasingly grave symptoms of hog cholera
only, attended with progressively abnormal temperatures com-
mon to the acute type of this disease. These pigs shall be free from
other communicable diseases, except as provided in paragraph 9 of
this section.
Paragraph 6. All pigs from which hog-cholera virus is derived
shall be subjected to a post-mortem examination by a veterinary in-
spector, except that trained lay inspectors may conduct these exami-
nations oni hyperimmunizing virus pigs subject to review by a veteri-
nary inspector, who should make all decisions on questionable
matters.
Paragraph 7. Hog-cholera virus derived from pigs which become
visibly sick within three days after the time they are admitted to the





19


premises of licensed establishments shall be destroyed as provided in
section 11, Regulation 8, under the supervision of a bureau employee.
Paragraph 8. Hog-cholera virus derived from pigs which upon
post-mortem examination do not show lesions sufficient for a veteri-
nary inspector to make a positive diagnosis of hog cholera, when con-
sidered with the ante-mortem behavior of the animal, or which are
found to be so affected with any infectious, contagious, or communi-
cable disease, or in such condition as to render the virus contaminated,
shall be destroyed as provided in section 11, Regulation 8, under the
supervision of a bureau employee. Virus passed by bureau em-
ployees may be destroyed as aforesaid at the discretion of the estab-
lishment.
Paragraph 9. Hog-cholera virus derived from pigs which are
found to be affected with tuberculosis shall be destroyed as provided
in section 11, Regulation 8, under the supervision of a bureau em-
ployee, unless the lesions are slight or are localized, and are calcified
or encapsulated. Hog-cholera virus derived from pigs affected as
described shall not be marketed.
Paragraph 10. All records shall indicate clearly the particular ani-
mal, or group of animals, from which each batch of hog-cholera
virus is derived. The amount collected and the total amount after
phenolization should be separately recorded.
Paragraph 11. Hog-cholera virus shall not be removed from the
premises of a licensed establishment unless the virus has been pre-
pared in accordance with the provisions of these regulations.
Paragraph 12. No immediate or true container of hog-cholera virus
shall be filled in whole or in part, and no trade label shall be affixed
to such container except under the supervision of a bureau employee.
Paragraph 13. The following special facilities, and such others as
may be required by the chief of bureau, shall be provided by each
establishment licensed to prepare hog-cholera virus:
(a) Separate operating rooms.
(b) A separate room in which the animals shall be washed, cleaned,
and otherwise prepared before being taken into the operating room.
(c) A separate room for conducting autopsies.
(d) A separate room for the preparation and mixing of virus.
(e) A separate room for washing and sterilizing equipment.
f) Clean cloths which shall be kept damp when in use, to be used
for covering pigs during all operations incident to the collection of
hog-cholera virus.
(g) All outside doors, openings, and windows shall be equipped
with dust screens.
Paragraph 14. All persons immediately before entering the oper-
ating or laboratory rooms of an establishment licensed to prepare
hog-cholera virus when these rooms are in use, shall change their
outer clothing or cover it by the use of clean gowns or other satis-
factory garments.
SECTION 2. Paragraph 1. For use in the production of hyperim-
munizing virus, licensed establishments shall inoculate young pigs
weighing not more than 145 pounds each with at least 2 cubic centi-
meters of a virulent strain of hog-cholera virus, except that when
sickness from pen infection is manifested by the animals after the
fourth day subsequent to admission to the premises, they need not
be so inoculated.





20


SParagraph 2. Hyperimmunizing virus shall be collected only from
pigs which are observed by a veterinary inspector to be visibly sick
with hog cholera and which manifest well-marked and increasingly
grave symptoms thereof attended with progressively abnormal tem-
peratures common to the acute type of this disease.
SECTION 3. Paragraph 1. For use in the production of simultane-
ous virus, licensed establishments shall inoculate young pigs, weigh-
ing not less than 40 pounds nor more than 100 pounds each, with at
least 2 cubic centimeters of a virulent strain of hog-cholera virus.
Paragraph 2. Simultaneous virus shall not be collected from pigs
which become visibly sick on or before the third day, or subsequent
to the sixth day after the time of inoculation. The physical condi-
tion of pigs from which simultaneous virus is col elected shall be
recorded daily on and after the third day subsequent to inoculation.
Paragraph 3. Simultaneous virus and hog-cholera virus intended
for the inoculation of pigs for any purpose shall be collected only
from pigs which are observed by a veterinary inspector to be visibly
sick with hog cholera within six days after the time of inoculation
and which manifest well-marked and increasingly grave symptoms
of hog cholera attended with progressively abnormal temperatures
common to the acute type of this disease.
Paragraph 4. Simultaneous virus and virus intended for inocula-
tion purposes shall be defibrinated promptly after collection, and
immediately thereafter chilled and maintained at a temperature not
to exceed 55 F. (12.8 C.).
Paragraph. 5. Should it become necessary under the provisions of
these regulations to require the heating of simultaneous virus to pre-
vent the possibility of disseminating infections, this shall be accoinm-
plished in such manner as may be prescribed by the chief of bureau.
Paragraph 6. Simultaneous virus which has been heated, as pro-
vided in the preceding paragraph, shall not be handled thereafter in.
a manner which will expose the product to contamination.
Paragraph 7. Simultaneous virus shall be tested for virulence by
inoculating in the axillary space or intramuscularly with 2 cubic
centimeters of the virus to be tested, each of four or more pigs which
are susceptible to hog cholera. Should not less than 75 per cent of
the pigs thus inoculated become affected with hog cholera as required
for pigs inoculated to furnish simultaneous virus, the test will be
declared "Satisfactory for virulence." Should this test be found un.
satisfactory a retest may be made.
Paragraph 8. Pigs selected for testing the virulence of simul-
taneous virus shall be inoculated within eight hours after their
admission to the premises. The quarters where these pigs are held
during the test shall be isolated as completely as feasible from.
quarters occupied by other pigs exposed to or sick with hog cholera.
All reasonable precautions shall be taken to prevent infection of
these pigs from sources other than by inoculation. Such precau,
tions shall include a thorough cleaning and disinfeation of the
pens in which the pigs are held on the premises, and a disinfection
of these animals after they are placed in holding pens. The dis-
infection of these pens and the test pigs shall be accomplished with.
a 2 per cent aqueous solution of cresol compound, U. S. P., or by
such methods as shall be approved by the chief of' bureau.







SECTION 4. Paragraph 1. Simultaneous virus shall be collected
in batches of not to exceed 20,000 cubic centimeters each and each
batch shall be mixed thoroughly in a single container before
phenolization, and by constant agitation during the bottling process.
Paragraph 2. After mixing, but before phenolization, a repre-
sentative sample of each batch, consisting of at least 15 cubic
centimeters of the mixture, shall be taken by a bureau employee.
This sample shall be known as the "virus-test sample."
Paragraph 3. Simultaneous virus which has been mixed as pro-
vided in this section, after withdrawal of the virus-test sample,'"
shall have added to it a sufficient quantity of a 5 per cent solution
of phenol so that the virus will contain one-half of 1 per cent phenol
by volume. This phenolization must be accomplished with ac-
curacy and in a manner which will prevent undesirable changes in
the product. After thorough mixing in a single container, a repre-
sentative sample, consisting of at least 100 cubic centimeters, col-
lected in three containers, shall be taken by a bureau employee.
This sample shall be known as the "virus-stock sample."
Paragraph 4. Simultaneous virus which has been mixed and
phenolized, as provided in this section, together with the virus-
stock sample and the unused residue of the virus-test sample, shall
be placed under bureau lock and held as provided under subdivi-
sion (b), section 1, of Regulation 7 until such time as required test
has shown the batch of virus to be virulent as prescribed in para-
graph 7, section 3, of this regulation and free from contamination.
Paragraph 5. At least one container of the virus-stock sample
shall be held unopened under bureau lock, in the manner provided
in Regulation 7, for at least three months after the expiration of
the latest return date shown upon the trade labels affixed to the
immediate or true containers of the product corresponding to the
virus-stock sample. The virus-test sample described in paragraph
2 of this section shall be used to determine the freedorrm from con-
tamination of each batch of simultaneous virus.
Paragraph 6. Two healthy calves, with mouths free from abra-
sions, and not less than 3 nor more than 12 months old, or three
healthy pigs immunized by the simultaneous treatment against hog
cholera for at least 21 days, shall be furnished by the establish-
ment for inoculation with the virus-test sample.
Paragraph 7. All animals used for the testing of simultaneous
virus shall be inoculated only under the supervision of a veter-
inary inspector, and shall be marked as provided in paragraphs
2, 3, 4, and 5, section 6, of Regulation 17.
Paragraph 8. Each of the animals selected for testing the purity
of simultaneous virus shall be inoculated by injecting 5 cubic
centimeters of the virus-test sample into either the auricular or the
jugular vein within 24 hours after the virus is collected.
Paragraph 9. Animals inoculated for the purpose of determining
the purity of simultaneous virus as provided in the preceding para-
graph shall be held under the observation of a veterinary inspector
for a period of at least seven days. Should foot-and-mouth disease
appear in the United States the said animals shall be held under the
observation of a veterinary inspector for 10 days or longer, at the
discretion of the inspector in charge.





22


Paragraph 10. If the animals which are treated with hog-cholera
virus as prescribed in the preceding paragraph of this section do
not manifest symptoms of any infectious, contagious, or communi-
cable disease except as hereinafter provided, the test will be declared
"Satisfactory for purity," and if the product has been found "satis-
factory for virulence," as defined in paragraph 7, section 3, of this
regulation, it will be released for marketing. Should any of the
animals in the test succumb or should more than one develop hog
cholera, another test should be made as in the first instance, except
that not less than 15 cubic centimeters of the virus should be used for
the inoculation of each animal if the virus contains preservative.
Paragraph 11. Simultaneous virus found to be worthless or con-
taminated shall be destroyed as provided in section 11, Regulation
S, under the supervision of a bureau employee.
SECTION 5. Paragraph 1. Each immediate or true container of
hog-cholera virus which has been tested and not found to be worth-
less or contaminated may bear over the opening of its neck a paper
cap attached by the establishment and on which may appear the words,
-, U. S. Released." Whenever caps bearing the aforesaid words are
applied, they shall be serially numbered and bear the license legend
of the establishment properly separated from the words and num-
ber aforesaid. It shall be affixed only after approval thereof by the
bureau and under the supervision of a bureau employee. When these
caps are not in use they shall be held under bureau lock. Strong,
flexible bands perforated as hereinafter described shall be used to
hold the aforesaid caps securely over the openings of the containers
of the product. All perforations of said bands shall consist of the
number of the license under which the product is produced, a number
assigned to the batch to which the perforated band is affixed, and the
last figure in the number used for indicating the calendar year.
(Illustration: 190.18.2-=License No. 190; batch 18; year 1922.) The
perforating machine when not in use for perforating bands as afore-
said shall be held under bureau lock.
Paragraph 2. The trade label on each immediate or true container
of simultaneous virus shall bear the date of manufacture, which date
shall be the day on which the virus is collected.
Pa;ragraph 3. The return date placed upon the label of each im-
mediate or true container of simultaneous virus shall be a date within
60 days after the date of manufacture.
Paragraph 4. Trade labels affixed to or used in connection with the
immediate or true containers of hog-cholera virus shall show plainly
the amount of the contents of said containers.
Paragraph 5. Trade labels affixed to or used in connection with
each immediate or true container of simultaneous virus shall bear a
dosage table in which the doses recommended are not less than those
appearing in the following table:
Weight. Minimum dose.
Pigs weighing 45 pounds or less ----------------------- 1 c. c.
Pigs weighing more than 45 pounds- --------------- 2 c. c.
Paragraph 6. No hog-cholera virus shall be released for marketing
unless and until all information required by these regulations has
been affixed to the containers thereof under the supervision of a
bureau employee.






23


REGULATION z9.-ANTI-HOG-CHOLERA SERUM.
SECTION 1. Paragraph 1. All operations incident to the production
of anti-hog-cholera serum shall be conducted under the supervision
of a bureau employee. Each licensed establishment shall notify the
inspector in charge, or an assistant, a reasonable time in advance
whenever any operations are to be conducted. '
Paragraph 2. Principle: Pigs that develop hog cholera of a well-
marked and progressive type attended with progressively abnormal
temperatures produce hog-cholera virus of great virulence, and when
hogs properly immunized against hog cholera for a sufficient length
of time are injected intravenously with massive quantities of such
virus their blood serum is possessed of superior protective propor-
ties against hog cholera. Therefore, these principal facts should
form the basis of all methods of producing anti-hog-cholera serum
and hog-cholera virus as well as of all regulations governing their
production.
SECTION 2. Paragraph 1. Anti-hog-cholera serum shall be derived
only from hyperimmune hogs which have been immune to hog
cholera for at least 90 days prior to hyperimmunization.
Paragraph 2. Anti-hog-cholera serum shall be derived only from
hyperimmune hogs which have been subjected to not more than 4
successive bleedings after each hyperimmunization. The first bleed-
ing shall take place not earlier than 10 days after hyperimmuniza-
tion, subsequent 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 hyperimmunization.
Paragraph 3. Hogs which are used to produce anti-hog-cholera
serum shall be healthy at the time of hype'rimmunization, this fact
to be determined by a careful examination made by a veterinary in-
spector prior to hyperimmunization. The temperature and weight
of each animal shall be accurately obtained and recorded by the
establishment before hyperimmunization.
Paragraph 4. All hogs which are used to produce anti-hog-cholera
serum at each hyperimmunization shall receive a single intravenous
injection of at least 5 cubic centimeters of hog-cholera virus for each
pound of the animal's weight.
Paragraph 5. The temperatures of all hogs used to produce anti-
hog-cholera serum shall be accurately taken with reliable thermom-
eters and recorded by licensed establishments either on the afternoon
before or on the day of bleeding and at such other times as the in-
spector in charge may deem necessary. All temperatures shall be
taken under normal conditions on groups of hogs to be bled on the
same date and without undue delay. Clean, light quarters equipped
with a temperature chute and all other needed facilities for expedit-
ing the work and satisfactory inspection shall be provided.
Paragraph 6. All hogs which are used to produce anti-hog-cholera
serum shall be subjected to a careful examination by a veterinary in-
spector immediately prior to each bleeding. Only those hogs shall
be bled for serum which are found to have a temperature of less than
104' F. and are free from infectious, contagious, or communicable
diseases or other abnormal conditions.
Paragraph 7. Anti-hcg-cholera serum derived from hogs which
after hyperinmmuinization manifest symptoms indicative of an affec-





24


tion of a constitutional character other than those usually observed
immediately following hyperimmunization shall not be mixed with
other serum unless after consideration of the prevailing conditions
this action is permitted by the chief of bureau. Such serum, if col-
lected only from hogs as prescribed in the preceding paragraph, may
be mixed alone and tested as prescribed in this regulation, and if, as
a result of this test, the product is found satisfactory, it may be
marketed. Otherwise the serum will be destroyed, as provided in
section 11, Regulation 8, under the supervision of a bureau employee.
Paragraph 3. All hogs from which anti-hog-cholera serum is de-
rived shall be subjected to a post-mortem examination by a bureau
employee. Should conditions warrant the procedure, trained lay
inspectors may be authorized by the inspector in charge to make pre-
liminary examinations as aforesaid, but the carcasses of these hogs
should be retained for final examination by a veterinary inspector,
and the viscera of all that bear evidence of any abnormality must also
be subjected to examination in like manner. If, as a result of such
examination, it is found that any hog is so affected with any infec-
tious, contagious, or communicable disease or is in such condition as
to render the serum worthless, contaminated, dangerous, or harmful,
the serum collected from such hogs shall be destroyed by the estab-
lishment, as provided in section 11, Regulation 8, under the supervi-
sion of a bureau employee, except that serum derived from tuber-
culous hogs need not be so destroyed when the lesions are slight or
are localized and are calcified or encapsulated, or when the product
from tuberculous hogs is clarified and heated or tested by methods
approved by the chief of bureau, or when refined and heated or tested
as aforesaid.
Paragraph 9. Anti-hog-cholera serum derived from each hyper-
immune hog shall be kept separate and apart from other serum except
when heated as prescribed in paragraph 11 of this section, until it
has been determined by post-mortem examination that the hog from
which the serum is derived is not so affected with any infectious, con-
tagious, or communicable disease or is in such condition as to render
the serum worthless, contaminated, dangerous, or harmful.
Paragraph 10. When anti-hog-cholera serum is heated as described
in the following paragraph the serum derived from each hyperim-
mune hog may be mixed with serum from other hyperimmune hogs
immediately after collection, provided the final batch or mixture is
prepared and handled as prescribed in the following paragraph of
this section.
Paragraph 11. Heating of anti-hog-cholera serum shall be con-
ducted under the supervision of a bureau employee and in a manner
in which the product and the entire container thereof will be sub-
jected to a temperature ranging from 59 to 60 C. for 30 minutes.
Paragraph 12. Anti-hog-cholera serum which has been heated as
provided in the preceding paragraph shall not be handled thereafter
in a manner which will expose the product to contamination. Final
mixtures or batches of anti-hog-cholera serum shall contain relative
proportions of the several bleedings. Single bleedings from each
bog shall not be divided or become a part of two or more batches
unless the serum is subjected to heat as described in paragraph 11 of
this section.






25

Paragraph 13. Whenever practicable, all the blood from a given
number of hyperimmune hogs should be placed in the same batch,
but. in order. that the batch may closely approximate 100,000 cubic
centimeters, as many individual bleedings of any one hog's blood
as required for this purpose may be used and the remainder, if any,
of such individual hog's blood should be placed in another single
batch. In selecting a bleeding for this purpose the one which will
cause the batch most closely to approximate 100.000 cubic centimeters
should be used.
Paragraph 14. Anti-hog-cholera serum which is to constitute a
batch or portion thereof may be strained into a single container,
after which the amount should be accurately determined.
Paragraph 1.5. Ordinary defibrinated blood anti-hog-cholera
serum shall have added thereto a sufficient quantity of a 5 per cent
solution of phenol to make the completed serum contain one-half
of 1 per cent phenol by volume. Clear anti-hog-cholera serum shall
be preserved likewise, unless otherwise permitted by the chief of
bureau.
Paragraph 16. Phenolization of anti-hog-cholera serum must be
accomplished with accuracy, and in a manner which will prevent
the occurrence of undesirable changes in the product.
Paragraph 17. All records shall indicate clearly the particular
hog or group of hogs from which each batch of serum or portion
thereof is derived. The amount prepared for phenolization and the
total amount after phenolization shall be separately recorded.
SECTION 3. Paragraph 1. Anti-hog-cholera serum prior to testing
shall be collected in batches of not more than approximately 100.000
cubic centimeters each. which shall be thoroughly mixed in a single
container, by constant agitation during the bottling process. After
mixing and phenolizing, a representative sample consisting of at
least 375 cubic centimeters collected in three containers of not less
than 125 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
placed under bureau lock, as provided under subdivision (b) section
1. Regulation 7. and so held until such time as the tests required by
these regulations have been completed, and have indicated that
the serum is not worthless, contaminated, dangerous, or harmful.
Paragraph 2. If the serum is released, one of the three containers
of the test sample thereof shall be held under bureau lock for at
least six months after the latest return date shown on the trade
labels affixed to the immediate or true containers of the serum of
which the test sample is a part.
Paragraph 3. Test samples of anti-hog-cholera serum on which
the return date has expired six months previously may be labeled
and marketed in the regular manner, provided it is feasible, within
two years after the first serum composing the batch is collected.
When not feasible, and it is desired to market the serum, the
samples should be mixed and assigned a serial number. This mix-
ture may be tested alone or it may be mixed with other untested
serum and tested as prescribed in sections 4 and 5 of this regulation
provided the latter does not represent more than 50 per cent of the
serum contained in the final mixture. The return date to be affixed





26

to the containers of mixtures of test samples should not exceed one
year from the date of conclusion of a satisfactory test for potency.
SECTION 4. Paragraph 1. All anti-hog-cholera serum shall be tested
for purity and potency by licensed establishments as prescribed by
these regulations.
Paragraph 2. For use in testing each batch of 100,000 cubic centi-
meters of anti-hog-cholera serum or less, eight healthy pigs. sus-
ceptible to hog cholera and weighing not less than 40 pounds and not
more than 90 pounds each, shall be furnished by the establishment,
except as provided in sections 7, 8, and 9 of this regulation.
Paragraph 3. Each of the eight pigs furnished for the test shall
be injected with 2 cubic centimeters of hog-cholera virus; of these
pigs, five shall receive 20 cubic centimeters of the serum which is
to be tested. Three of the pigs shall receive no serum and shall serve
as controls. The virus and serum injections shall be made simul-
taneously, the virus being injected into the left axillary space, and
the serum into the right. The same virus shall be used for the
inoculation of all pigs in the test and shall be selected and adminis-
tered by a veterinary inspector.
Paragraph 4. A veterinary inspector shall indicate the pigs which
shall receive serum with virus and those which shall receive the
virus only in each serum test.
Paragraph 5. All surviving pigs used for testing a batch of serum
shall be subjected to the same conditions throughout the test period
and shall be held in a single pen or inclosure throughout this period
except when it is evident that a test of serum will be declared "No
test" or "Unsatisfactory for potency," the test pigs, with the per-
mission of a bureau employee, may be removed from the original
test pen and placed with other pigs of the same class in a common
pen for the purpose of releasing test pen space for other tests.
Paragraph 6. The period for holding surviving pigs under the
observation of a bureau employee, while being used for testing the
potency and purity of anti-hog-cholera serum as described in this
regulation, shall be not less than 21 days immediately following
their inoculation for this purpose, and as much longer as the inspector
in charge deems necessary to render proper judgment of the results
of the test. If not more than one serum-treated pig succumbs within
15 days after inoculation, however, or if it becomes necessary to
retest a batch of serum for purity only, 15 days immediately follow-
ing the inoculation of the pigs will constitute the period for testing
the purity of the product.
Paragraph 7. Pigs in serum tests shall be held under the obser-
vation of a veterinary inspector and shall not be removed from the
test unless and until released by such an inspector, who will permit
their removal after they have served their purpose in the test as
prescribed in this regulation.
Paragraph 8. The temperature of each pig used in a test of anti-
hog-cholera serum shall be taken and recorded shortly before each
test is started.
Paragraph 9. Temperatures of control pigs and "slow" or sick
serum-treated pigs in serum tests, excepting known "Unsatisfactory
tests" and" No tests," shall be taken daily throughout the test period,
but not on Sundays and holidays when these days are of no particular
consequence to the proper disposition of the test, and an accurate






27


report of these temperatures shall be rendered by the establishment
to the inspector in charge as he may direct.
Paragraph 10. When serum-treated pigs do not manifest "slow-
ness" or symptoms of sickness their temperatures need not be taken
except when required by the inspector in charge or his assistant to
determine more accurately the true physical condition of the animals
under observation.
Paragraph 11. Simultaneous virus or its equivalent of high viru-
lence and in sufficient quantities to meet the nteds shall be furnished
by licensed establishments for use as the inspector in charge may
deem advisable for inoculating pigs in serum tests. Virus furnished
by licensed establishments shall not be used in a serum test if it has
been collected for more than 30 days previous to the inauguration of
the test, but tests of virus required by these regulations shall not
operate to prevent the use of the product in serum tests at any time
within 30 days after its collection.
Paragraph 12. Hog-cholera virus furnished by the Bureau of
Animal Industry may be used in inoculating pigs in tests whenever
the inspector in charge deems this procedure advisable, and when-
ever conditions in previous tests of any batch of serum have indi-
cated some deficiency in either the virus or serum used.
SECTION 5. Paragraph 1. The following principle and rules are
declared for a guide in judging the results of serum tests:
Principle: It is practically impossible in many cases to differenti-
ate accurately between hog cholera, pneumonia, and other conditions
affecting hogs without the aid of an autopsy as well as applied labora-
tory technic and certain experiments which may be necessary to
determine the causative agent responsible for the condition. There-
fore, when healthy pigs are selected for testing anti-hog-cholera
serum anv abnormal condition which may arise in the pigs sIb)se-
quent to their inoculation should be regarded as due either to the
virus used or, in the case of the serum-treated pigs, to the fact that
the serum does not protect, unless the condition is definitely known
or can be shown to be due to some other cause.
Paragraph 2. The following rules shall be observed in disposing
of anti-hog-cholera serum which has been subjected to the tests pre-
scribed by these regulations:
Rule A. The purpose of control pigs in serum tests will be to
furnish information as to the virulence of the virus used for inocu-
lating the animals and to indicate whether the pigs furnished are
properly susceptible to hog cholera. As an aid for determining the
fulfillment of this purpose the following conditions shall obtain:
1. At least two of the control pigs shall become visibly sick of hog
cholera subsequent to the third day of the test period and within
seven days after the test is inaugurated.
2. At least two of the control pigs which become sick as described
in the preceding paragraph of this rule shall manifest well-marked
and increasingly grave symptoms of hog cholera attended with pro-
gressively abnormal temperatures common to the acute type of this
disease.
3. At least two of the control pigs, which become sick as described
int the preceding paragraphs of this rule, shall show lesions upon
post-mortem examination sufficient for a veterinary inspector to





28


make a positive diagnosis of hog cholera, when considered with the
ante-mortem behavior of these animals.
Rule B. A serum test will be declared "Satisfactory for potency"
whea at least two of the control pigs react as described in rule A of
this regulation and any one of the following conditions obtains:
1. When all the serum-treated pigs remain well throughout the
test period.
2. When not more than one of the serum-treated pigs becomes
visibly sick after the time of inoculation and fully recovers before,
the test animals are released by a veterinary inspector as provided in
this regulation. Such a sick pig, however, will not be regarded as
having fully recovered until it has been in an apparently normal,
condition for at least three days.
Rule C. A serum test will be declared "Unsatisfactory for po-
tency" when at least two of the control pigs react as described in
rule A of this regulation and any one of the following conditions
obtains:
1. When one of the serum-treated pigs becomes visibly sick
subsequent to the third day after the time of inoculation and is
found not to have fully recovered before the test animals are re-
leased by a veterinary inspector as provided in this regulation.
2. When two or more of the serum-treated pigs become visibly
sick subsequent to the third day after the time of inoculation.
Rule D. 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 these
regulations.
1. When one of the serum-treated pigs becomes visibly sick on
or before the third day after the time of inoculation and fails to
recover within the test period.
2. When two or more of the serum-treated pigs or 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 rule A of this regulation.
4. When two or all of the control pigs do not show lesions of hog
cholera upon post-mortem examination as described in rule A of
this regulation.
5. When two or all of the control pigs manifest symptoms of hog
cholera within seven days as described in rule A of this regulation
but do not become sick to the degree described in said rule.
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.
Rule E. A serum test will be declared "Satisfactory for purity"
when the following condition obtains:
1. When not more than one of the serum-treated pigs in the test
develops an abscess at the site of the serum injection and no symp-
toms of any infectious, contagious, or communicable disease other
than hog cholera are manifested by any of the animals in the test.
Rule F. A serum test will be declared "Unsatisfactory for pur-
ity when either of the following conditions obtains:






29


1. When abscesses which are not definitely known to be due to
causes other than the serum used develop at the sites of the serum
injections in more than one of the serum-treated pigs.
2. When during the test period any of the serum-treated test
pigs develop symptoms of any infectious, contagious, or communi-
cable disease (other than hog cholera) which is due to the serum
used.
Rule G. A serum test will be declared "No test for purity"
when any one of the following conditions obtains, but such action
will not operate to prevent a retest under the provisions of these
regulations.
1. When two or more of the serum-treated pigs succumb within
15 days after the time of inoculation.
2. When the serum-treated pigs develop during the test period
symptoms of any infectious, contagious, or communicable dis-
ease (other than hog cholera) which is not caused by the serum
used.
3. When a condition obtains in any of the test pigs which is not
otherwise covered in this section.
SECTION 6. Paragraph 1. Anti-hog-cholera serum may be released
for marketing as hereinafter prescribed when the tests required by
this regulation are found to be satisfactory as defined in rules B
and E hereof, provided the product is recommended for use in doses
not less than those appearing in the following table. This table shall
be a part of trade labels, wrappers, and the like, affixed to or used
in connection with each immediate or true container of the product.
Weight. Minimum dose.
Sucking pigs--------------------------------------- 20 c. c.
Pigs 20 to 40 pounds-------------------------------- 30 c. c.
Pigs 40 to 90 pounds--------------------------------- 35 c.c.
Pigs 90 to 120 pounds------------------------------- 45 c. c.
Hogs 120 to 150 pounds------------------------------ 55 c.c.
Hogs 150 to 180 pounds-------------------------------- 65 c.c.
Hogs 180 pounds and over---------------------------- 75 c. c.
Paragraph 2. Anti-hog-cholera serum the test of which has proved
it to be "Unsatisfactory for potency," as defined in rule C of this
regulation, may be tested again as described in sections 4 and 5 of
this regulation. Should the second test prove to be "Satisfactory
for potency," as defined in rule B, the serum may be released for
marketing under the condition set forth in paragraph 1 of this sec-
tion. If the test is again found "Unsatisfactory for potency," as
defined in rule C, the serum shall not be marketed unless and until it
is either refined, concentrated, and tested in a manner approved by
the chief of bureau, or mixed with other serum and tested as pro-
vided in section 7 of this regulation.
SECTION 7. Paragraph 1. Anti-hog-cholera serum found twice
"Unsatisfactory for potency" as described in rule C of this regula-
tion but which is "Satisfactory for purity" as described in rule E
hereof may be mixed with other anti-hog-cholera 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 in the case of ordinary defibrinated-blood serum.
Clear serum found Unsatisfactory for potency" as aforesaid should
not be mixed with other serum except as may be permitted by the
chief of bureau.






30


Paragraph 2. Anti-hog-cholera serum which has been mixed as
provided in the preceding paragraph shall be tested as outlined in
sections 4 and 5 of this regulation, with the exception that 11 pigs in.
lieu of 8 shall be used and 8 of these shall receive serum.
Paragraph 3. A second test, conducted in the same manner as be-
fore, may be made of serum mixed as provided in paragraph 1 of
this section, should the results of the test of the mixture be declared
- Unsatisfactory for potency." Should the second test also prove
to be Unsatisfactory for potency" the product shall not be mar-
keted unless and until it is refined, concentrated, and tested in a
manner approved by the chief of bureau.
SECTION 8. Paragraph 1. Should abscesses develop at the sites of
the serum inoculations in any of the pigs used for testing serum as
provided in this regulation, the following rules shall apply:
(a) Judgment of the results of tests made on pigs to determine the
potency of anti-hog-cholera serum will be rendered irrespective of
those conditions found which are regarded as an index to the purity
of the product.
(b) Should the results of a test of anti-hog-cholera serum be de-
clared Satisfactory for purity," and it is found necessary to sub-
ject the batch of serum to a retest to determine its potency, judgment
concerning the purity of the product shall be based upon the first
test unless evidence is found subsequent to such test which indicates
that the serum is in fact contaminated.
(c) Anti-hog-cholera serum which has been found "Unsatisfac-
tory for purity" as defined in subdivision 1, rule F, of this regula-
tion, may be tested again for purity upon eight pigs, provided each
pig receives a single injection, in the axillary space, of at least 20
cubic centimeters of the product to be tested. Immune pigs may be
used for this test, provided the product has already been found
S" satisfactory for potency."
SECTION 9. Paragraph 1. Anti-hog-cholera serum which has been
found twice "Unsatisfactory for purity" as defined in subdivision 1,
rule F, of this regulation, but which is Satisfactory for potency,"
as prescribed in rule B hereof, may be tested again with the view
of ascertaining whether it is in fact contaminated with pus-producing
organisms, by treating 50 hogs on the premises of the manufacturing
establishment. The serum shall be administered under the super-
vision of a bureau employee, and each hog treated shall receive a
single injection, in the axillary space, of not less than 25 cubic centi-
meters of the product to be tested.
Paragraph 2. Animals used for testing serum as prescribed in
paragraph 1 of this section shall be held under the supervision of
a bureau employee for at least 15 days, and each animal carefully
examined at the sites of the inoculations to determine whether the
product has caused abscess formation. Serum tested as prescribed
in this section will be disposed of as approved by the chief of bureau.
SECTION 10. Paragraph 1. Blood derived from hyperimmune hogs
and ordinary defibrinated blood anti-hog-cholera serum may be
clarified or refined and concentrated by licensed establishments, pro-
vided methods used to accomplish this are approved by the chief of
bureau.







Paragrapth 2. When hyperimmune blood and ordinary defibrinated
blood anti-hog-cholera serum that has not been found Unsatisfac-
tory for potency" are to be clarified or refined, the following require-
ments shall be observed:
(a) When unconcentrated clear serum is prepared, the completed
product shall contain not less than 65 per cent of true serum and
shall represent not more than 98 per cent of the original volume of
ordinary serum refined or the possible yield of ordinary serum ob-
tainable under these regulations from the hyperimmune blood used.
(b) When concentrated clear serum is prepared, the completed
product shall contain not less than 80 per cent of true serum and
represent not more than 78 per cent of the original volume of ordi-
nary serum refined, or the possible yield of ordinary serum obtainable
under these regulations from the hyperimmune blood used.
(c) When whole blood is clarified, 3 per cent shall be allowed for
fibrin contained therein when calculating the possible yield of ordi-
nary serum.
(d) Unconcentrated clear serum shall be tested as prescribed in
sections 4 and 5 of this regulation and the immediate or true con-
tainers thereof bear recommendations for minimum doses prescribed
in paragraph 1, section 6, hereof.
(e) Concentrated clear serum shall be tested as prescribed in sec-
tions 4 and 5 of this regulation except that if it is desired to market
the product in doses smaller than those indicated in paragraph 1.
section 6, of this regulation, the pigs in the test shall receive 15) cubic
centimeters of the product to be tested.
Paragraph 3. Ordinary defibrinated blood anti-hog-cholera serum
which has been found "Unsatisfactory for potency" or Unsatis-
factory for purity," or which is derived from tuberculous hogs. may
be refined and concentrated by licensed establishments in accord-
ance with methods approved by the chief of bureau, provided solu-
tions other than those necessary and permitted in the refinement of
the product are not added to serum previously found "Unsatisfac-
tory for potency." The completed product shall be tested as pro-
vided in sections 4 and 5 of this regulation and when derived from
tuberculous hogs shall be heated as prescribed in paragraph 11, sec-
tion 2, of this regulation, or tested on guinea pigs, as approved by
the chief of bureau. The immediate or true containers of the
product shall bear a minimum dosage table applicable under the pro-
visions of this regulation except that serum which before refinement
and concentration was declared "Unsatisfactory for potency" shall
bear a dosage table only in accord with the terms of paragraph 1.
section 6, hereof.
Paragraph 4. Should the tests required by this regulation be found
"Satisfactory for potency" and "Satisfactory for purity," as de-
fined in rules B and E hereof, and the test pigs receive doses of the
serum as prescribed in subdivision (e), paragraph 2. of this section,
the product may be marketed if it is recommended for use in doses
not less than those appearing in the following table. This table
shall be a part of trade labels, wrappers, and the like, affixed to or
used in connection with each immediate or true container of the
product:






32


Weight. Minimum dose.
Sucking pigs-------------- -------------------- 15 c. c.
Pigs 20 to 40 pounds---------------------------- 25 c.c.
Pigs 40 to 90 pounds ----------------------------- 30 c. c.
Pigs 90 to 120 pounds--------------------------- 35 c.c.
Hogs 120 to 150 pounds ------------------------- 45 c.c.
Hogs 150 to 180 pounds--------------------------- 50 c.c.
Hogs 180 pounds and over---- --------------------60 c. c.
SECTION 11. Paragraph 1. Each immediate or true container of
anti-hog-cholera serum which has been tested and not found to be
worthless, contaminated, dangerous, or harmful may bear over the
opening of its neck a paper cap attached by the establishment and
on which may appear the words "U. S. Released." Whenever caps
bearing the aforesaid words are applied they shall be serially num-
bered and bear the license legend of the establishment properly
separated from the words and number aforesaid. It shall be affixed
only after approval thereof by the bureau and under the supervision
of a bureau employee. When these caps are not in use as described
they shall be held under bureau lock. Strong, flexible bands, per-
forated as hereinafter described, shall be used to hold the aforesaid
caps securely over the openings of the containers of the product.
All perforations of said bands shall consist of the number of the
license under which the product is produced; a number assigned to
the batch to which the perforated band is affixed; and the last figure
in the number used for indicating the calendar year. The perforat-
ing machine, when not in use for perforating bands as aforesaid,
shall be held under bureau lock.
Paragraph 2. The return date placed upon trade labels of anti-
hog-cholera serum shall be a date not more than two years after the
(late of bleeding. The date of bleeding shall be regarded as the date
upon which the first serum was collected, which is a part of the
batch.
P'acgraph 3. Should the return date of any batch of anti-hog-
cholera serum expire before the serum is used, the serum should be
retested, and if found "Satisfactory for potency and Satisfactory
for purity," as defined in rules B and E hereof, the return date may
be extended for one year from the date of conclusion of the retest
for potency.
Paragraph 4. Should a batch of anti-hog-cholera serum not be
found "Satisfactory for potency" or "Satisfactory for purity" before
the expiration of two years from the date of collection of the oldest
serum in the batch, or not in time to allow it to be used before the
expiration of two years, the return date will be limited to six months
from the date of conclusion of a satisfactory test for potency.
Paragraph 5. Trade labels affixed to or used in connection with
the immediate or true containers of anti-hog-cholera serum shall
plainly show the quantity of the contents of said containers.
Pa;ragraph 6. No immediate or true container of anti-hog-cholera
serum shall be filled in whole or in part, and no trade label shall be
affixed to such containers, except under the supervision of a bureau
employee.
Paragraph 7. Anti-hog-cholera serum shall not be removed from
the premises of a licensed establishment unless it has been prepared
in accordance with the provisions of these regulations.





33

Paragraph 8. No anti-hog-cholera serum shall be released for
marketing unless and until all the information required by these
regulations has been affixed to the containers thereof under the super-
vision of a bureau employee.
SECTION 12. The following special facilities and such others as
may be required by the chief of bureau shall be provided by each
establishment licensed to prepare anti-hog-cholera serum.
(a) Separate operating rooms.
(b) A separate room in which the hog shall be washed, cleaned,
and otherwise prepared before being taken into the operating room.
(c) A separate room for conducting autopsies.
(d) A separate room for the preparation and mixing of serum.
(e) A separate room for washing and sterilizing equipment.
(f) Clean cloths, which shall be kept damp when in use, to be
used for covering hogs during all operations incident to the collec-
tion of anti-hog-cholera serum.
(g) All outside doors, windows, or other openings shall be
equipped with dust screens.
SECTION 13. All persons immediately before entering the operating
or laboratory rooms of an establishment licensed to prepare anti-
hog-cholera serum when these rooms are in use shall change their
outer clothing or effectively cover the same by the use of gowns or
other satisfactory garments.
REGULATION 20.-BACTERINS, VACCINES, TOXINS, ETC.
I
SECTION 1. Paragraph 1. Viruses entering into the preparation of
,bacterins, vaccines, or toxins shall be derived from animals which are
affected with no disease other than that for which the bacterins, vac-
cines, or toxins are intended to be used.
Paragraph 2. All bacterins, vaccines, and toxins shall be derived
from the specific cause of the diseases for which they are intended to
be used or from the secondary invaders of the respective diseases.
SECTION 2. Paragraph 1. The return date on the trade labels of
blackleg vaccine prepared from attenuated Bacillus chauveaui, or
blackleg muscle virus, shall be a date not more than one and one-half
years later than the date on which the preparation of the product is
completed, Without regard to the filling of final containers.
Paragraph 2. The return date on the trade labels of anthrax vac-
cine prepared by the Pasteur method shall be a date not more than
three months later than that on which the preparation of the product
is completed without regard to the filling of final containers.
Paragraph 3. Trade labels affixed to or used in connection with the
immediate or true containers of tuberculin shall bear a statement
indicating the equivalent of Koch's old tuberculin (K. 0. T.) con-
tained in each cubic centimeter, disk, etc., of the product as marketed.
Such labels shall also bear recommendations regarding the minimum
dose to be administered, and this dose for subcutaneous use shall be
not less than the equivalent of 0.5 gram of Koch's old tuberculin.
Tuberculin intended for subcutaneous, intracutaneous, or cutaneous
use shall be filtered'through germ-proof filters before being marketed.
SECTION 3. The immunity unit for measuring the strength of
tetanus antitoxin shall be 10 times the least quantity of antitetanic






34 1

serum necessary to save the life of a 350-gram guinea pig for 96
hours against'the official-test dose of the standard toxin furnished
by the hygienic Laboratory of the United States Public Health
Service. The number of the immunity units recommended for the
prevention of tetanus in a horse shall be at least 500 units.
S
REGUI ANALOGOUS PRODUCTS.
A
SECTION 1. Paragraph 1. No virus, serum, toxin, or analogous
product which has not been prepared, handled, stored, and marketed
in accordance with these regulations, and no virus, serum, toxin,
or analogous product which is worthless, contaminated, dangerous,
or harmful shall be brought on to the premises of any licensed
establishment.
Paragraph 2. Hog-cholera virus and anti-hog-cholera serum pre-
pared by the Bureau of Animal Industry will be admitted to
licensed establishments for use as prescribed in these regulations
or as may be approved by the chief of bureau.
Paragraph 3. Hog-cholera virus procured from outbreaks of hog
cholera on farms that are free from other communicable diseases
will be admitted to licensed establishments when desired for use in
propagating a new strain to be used in inoculating virus. Before
such virus is used in the production of -simultaneous virus *br
hyperimmunizing virus, however, pigs weighing from 30 to 80
pounds shall be inoculated therewithJ with the view of determining
whether the purity and virulence of the product are satisfactory.
The virus should be passed through pigs as described until its
virulence and purity are satisfactory or the product should be
destroyed.
Paragraph 4. Anti-hog-cholera serum and hog-cholera virus col-
lected by licensed establishments and suitable for use under these
regulations may be transported from one licensed establishment to
another or between units of the same establishment provided these
products are properly packed. If said products are not completed
and labeled as prescribed by these regulations they shall be so
packed or iced that a temperature of not more than 55 F. will be
maintained therein during transportation and the containers thereof
shall be sealed by a bureau employee, this seal to be broken by such
an employee at the point of destination.
THE VIRUS-SERUM-TOXIN LAW.
[Extract from An act making appropriations for the Department of Agriculture for the
fiscal year ending June thirtieth, nineteen hundred and fourteen," approved March 4,
1913 (37 Stat, 832).]
That from and after July first, nineteen hundred and thirteen, it shall be
unlawful for any person, firm, or corporation to prepare, sell, barter, or exchange
in the District of Columbia, or in the Territories. or in any place under the
jurisdiction of the United States, or to ship or deliver for shipment from one
State or Territory or the District of Columbia to any other State or Territory
or the District of Columbia, any worthless, contaminated, dangerous, or harm-
fult virus, serum, toxin, or analogous product intended for use in the treatment
of domestic animals, and no person, firm, or corporatIon shall prepare, sell,
barter, exchange, or ship as aforesaid any virus, serum, toxin, or analogous
product manufactured within the United States and intended for use in the
treatment of domestic animals, unless and until the said virus, serum, toxip, or


9 *




35


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* *



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analogous product shall have been prepared, under and in compliance with
regulations prescribed by the Secretary of Agriculture, at an establishment
holding an unsuspended and unrevoked license issued by the Secretary of
Agriculture as hereinafter authorized. That the importation into the United
States, without a permit from the Secretary of Agriculture, of any virus, serum.
toxin, or analogous product for use in the treatment of domestic animals, and
the importation of any worthless, contaminated, dangerous, or harmful virus.
serum, toxin, or analogous product for use in the treatment of domestic animals.
are hereby prohibited. The Secretary of Agriculture is hereby authorized
to cause the Bureau of Animal Industry to examine and inspect all viruses.
serums, toxins,'and analogous products; for use in the treatment of domestic
animals, which are being imported or offered for importation into the 'United
States, to determine whether such viruses, serums, toxins, and analogous prod-
ucts are worthless, contaminated, dangerous, or harmful, and if it shall appear
that any such virus, serum, toxin, or analogous product, for use in the treat-
minent of domestic animals, is worthless, contaminated, dangerous, or harmful.
the same shall be denied entry and shall be destroyed or returned at the expense
of the owner or importer. That the Secretary of Agriculture be, and hereby is,
authorized to make and promulgate from time to time such rules and regula-
tions as may be necessary to prevent the preparation, sale, barter, exchange,
or shipment as aforesaid of any worthless, contaminated, dangerous, or harm-
ful virus, serum, toxin, or analogous product for use in the treatment of domestic
animals, and to issue, suspend, and revoke licenses for the maintenance of
establishments for the preparation of viruses, serums, toxins, and analogous
products, for use in the treatment of domestic animals, intended for sale, barter,
exchange, or shipment as aforesaid. The Secretary of Agriculture is hereby
authorized to issue permits for the importation into the United States of viruses.
serums, toxins, and analogous products, for use in the treatment of domestic
animals, which are not worthless, contaminated, dangerous, or harmful. All
licenses issued under authority of this Act to establishments where such viruses,
serums, toxins, or analogous products are prepared for sale, barter, exchange.
or shipment as aforesaid, shall be issued on condition that the licensee shall
permit the inspection of such establishments and of such products and their
preparation; and the Secretary of Agriculture may suspend or revoke any per-
mit or license issued under authority of this Act, after opportunity for hearing
has been granted the licensee or importer, when the Secretary of Agriculture
is satisfied that such license or permit is being used to facilitate or effect the
preparation, sale, barter, exchange, or shipment as aforesaid, or the importa-
tion into ,the United States of any worthless, contaminated, dangerous, or harm-
ful virus, serum, toxin, or analogous product for use in the treatment of
domestic animals. That any officer, agent, or employee of the Department of
Agriculture duly authorized by the Secretary of Agriculture for the purpose
may, at any hour during the daytime or nighttime, enter and inspect any estab-
lishment licensed under this Act where any virus, serum, toxin, or analogous
product for use in the treatment of domestic animals is prepared for sale, barter.
exchange, or shipment as aforesaid. That any person, firm, or corporation
who shall violate any of the provisions of this Act shall be deemed guilty of a
misdemeanor, and shall, upon conviction, be punished by a fine of not exceeding
$1,000 or by imprisonment not exceeding one year, or by both such fine and
imprisonment, in the discretion of the court.


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