two of the control pigs react as described in paragraph (a) of this section and the following condition obtains:

(1) One or more of the serum-treated pigs become visibly sick subsequent to the third day after the time of inoculation, or the fourth day, if the third day falls on a Sunday or holiday, and fail to recover fully before the test animals are released by the supervising inspector.

(d) Test; conditions under which serum to be declared "no test for potency." Serum will be declared "no test for potency" when any one of the following conditions obtains, but such action will not prevent a retest under the provisions of the regulations:

(1) One or more of the serum-treated pigs become visibly sick on or before the third day after the time of inoculation, or the fourth day, if the third day falls on a Sunday or holiday, and fail to recover within the test period.

(2) Two or more of the control pigs become visibly sick on or before the third day after the time of inoculation, or the fourth day, if the third day falls on a Sunday or holiday.

(3) Two or more of the control pigs do not manifest symptoms of hog cholera as described in paragraph (a) of this section.

(4) Two or more of the control pigs do not show lesions of hog cholera upon post mortem examination as described in paragraph (a) of this section.

(5) Two or more of the control pigs manifest symptoms of hog cholera within 7 days as described in paragraph (a) of this section but do not become sick to the degree described in said paragraph.

(6) Any of 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) A condition obtains in any of the test pigs which is not otherwise covered in this section.

(e) Test; when serum to be declared "satisfactory for purity." Serum will be declared “satisfactory for purity" when the following condition obtains:

(1) Not more than one of the serumtreated pigs in a test develops an abscess at the site of the serum injection and no symptoms of any infectious, contagious, or communicable disease other than hog cholera are manifested by any of the animals in the test.

(f) Test; conditions under which serum to be declared “unsatisfactory for purity." Serum will be declared "unsatisfactory for purity" when either of the following conditions obtains:

(1) 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) During the test period any of the serum-treated test pigs develop symptoms of any infectious, contagious, or communicable disease (other than hog cholera) which is due to the serum used.

(g) Test; conditions under which serum to be declared "no test for purity." Serum will be declared "no test for purity" when any one of the following conditions obtains, but such action will not prevent a retest under the provisions of the regulations.

(1) Two or more of the serum-treated pigs succumb within 14 days after the time of inoculation.

(2) Any of 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.

(3) A condition obtains in any of the test pigs which is not otherwise covered in this section.

§ 119.59 Retests when serum found “unsatisfactory for potency.'

99

When a test of anti-hog-cholera serum, prepared at a licensed establishment, has shown it to be "unsatisfactory for potency," the serum may be tested Should again as prescribed in § 119.51. this retest show the serum to be "unsatisfactory for potency" it may be so retested again, and if still found "unsatisfactory for potency" the serum shall be destroyed or otherwise disposed of as prescribed by the Director.

§ 119.60 Tests for purity.

Should abscesses develop at the sites of the serum inoculations in any of the pigs used at licensed establishments for testing serum as provided in this part, 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 conditions found which are regarded as an index to the purity of the product.

(b) If anti-hog-cholera serum upon testing is declared "satisfactory for

anti-hog-cholera

serum

(b) When produced at a licensed establishment has twice been found "unsatisfactory for purity," as defined in § 119.58, but is "satisfactory for potency," as provided in § 119.58, it may be tested again to ascertain whether it is contaminated with pus-producing organisms by treating 50 hogs on the premises of the licensed establishment. The serum shall be administered under the supervision of an inspector, and each hog treated shall receive a single injection, in the axillary space, of not less than 25 cc. of the product to be tested. Serum tested as provided in this paragraph shall be destroyed or otherwise disposed of or used as prescribed by the Director.

§ 119.62 Purity test animals; holding period.

Animals used for testing serum as provided in § 119.61 at licensed establishments shall be held under the supervision of an inspector for at least 14 days, and be carefully examined at the sites of inoculations to determine whether the serum has caused abscess formation.

§ 119.63 Minimum dosage.

Anti-hog-cholera serum or hog cholera antibody-concentrate may be marketed if, upon testing, as provided in Parts 101 to 122 of this subchapter, it is found "satisfactory for potency" and "satisfactory for purity," provided the label on the true container thereof contains recommendations for use as specifiled in this section:

(a) For use in preventive vaccination, the minimum dose shall be 10 cc or more of anti-hog-cholera serum or 5 cc or more of hog cholera antibody-concentrate when used with modified live virus

hog-cholera vaccine, plus the following statement: "If immediate protection against hog cholera is desired or movement of the animals from the premises is anticipated within 21 days following immunization, 15 cc or more of anti-hogcholera serum or 71⁄2 cc or more of hog cholera antibody-concentrate should be administered simultaneously with the vaccine."

(b) Export labels only may contain recommendations for use with simultaneous virus in doses not less than those appearing in the following table:

Weight

Suckling pigs..

Pigs 20 to 40 pounds..
Pigs 40 to 90 pounds..
Pigs 90 to 120 pounds.
Hogs 120 to 150 pounds.
Hogs 150 to 180 pounds.
Hogs 180 pounds and over.

Anti-hog- Antibodycholera

serum minimum dose (cc)

[27 F.R. 11937, Dec. 4, 1962]

concen

trate minimum dose (cc)

10

15

17.5

45

22.5

27.5

32.5

75

37.5

§ 119.64 Marking anti-hog-cholera serum "U.S. Released."

Each immediate or true container of anti-hog-cholera serum produced at a licensed establishment, and which has been tested and found not to be worthless, contaminated, dangerous, or harmful may have a cap affixed which, if approved by the Director, may bear the words "U.S. Released." These caps shall be affixed to the aforesaid containers only under the supervision of an inspector and shall be held under Division lock except when needed for this purpose.

§ 119.65 Expiration date.

The expiration date shown on labels of anti-hog-cholera serum produced at licensed establishments shall not exceed 3 years from the date on which the first serum of the batch is collected, except as provided in § 119.66.

§ 119.66 Extension of expiration date.

Should the expiration date of any batch of anti-hog-cholera serum produced at licensed establishments expire before the serum is used, the serum may be retested, and if found "satisfactory for potency" and "satisfactory for purity," as defined in § 119.58 (b) and (e), the expiration date may be extended for 1 year from the date of conclusion of the retest for potency. Should a batch of anti-hog

cholera serum not be found "satisfactory for potency" or "satisfactory for purity" before the expiration of 3 years from the date of collection of the oldest serum in the batch, or should it not be so found in time to allow it to be used before the expiration of said 3 years, the expiration date will be limited to 6 months from the date of conclusion of a satisfactory test for potency.

§ 119.67 Requirements for filling and labeling.

No immediate or true container of anti-hog-cholera serum shall be filled in whole or in part, and no label shall be affixed to such a container at licensed establishments, except under the supervision of an inspector.

§ 119.68 Conditions for release and removal.

Anti-hog-cholera serum shall not be removed from the premises of a licensed establishment unless it has been prepared as required by Parts 101 to 122 of this subchapter and no such serum shall be released for marketing unless and until all the information required by Parts 101 to 122 of this subchapter has been affixed to the containers thereof under the supervision of an inspector.

PART 120-APPROVED FEED LOTS

Sec.

120.1

120.2

120.3

120.4

120.5

120.6

120.7

120.8

120.9

120.10 120.11

Approval required.

Application for approval.
Feed lot approval.

Listing of approved feed lots.

Deletion from list of approved feed lots.

Admitting pigs to premises.

Method of identification.

Vaccination in approved feed lots.

Records of vaccination and disposi

tion.

Removal of animals.

Dead animals, removal.

AUTHORITY: The provisions of this Part 120 issued under 37 Stat. 832-833; 21 U.S.C. 151-158.

SOURCE: The provisions of this Part 120 appear at 27 F.R. 11937, Dec. 4, 1962.

§ 120.1 Approval required.

In order to be designated as an approved feed lot, a feed lot shall meet the requirements set forth in this part and be approved by the Director, Animal Inspection and Quarantine Division. Prior to final determination, the Director shall obtain the recommendations of the appropriate official of the State in which

such feed lot is located. Any person desiring to have his feed lot designated as an approved feed lot shall make written application for such designation to the Director in accordance with the provisions of § 120.2.

§ 120.2 Application for approval.

The application for approval of a feed lot shall contain the following information: The name of the owner of the feed lot, the name of the person responsible for its operations, whether the application is for approval as a Category A or Category B approved feed lot, the location of the premises, the types of operations on the premises and adjoining premises, the approximate number of animals to be maintained on the premises, whether animals are fed grain, or cooked garbage, method used for identifying animals, the percentage of animals sold to anti-hog-cholera serum producers with names of such producers, the disposition of hogs not sold to such producers, and a justification or reasons why such feed lot operations will not endanger other swine or impair the HogCholera Eradication Program.

§ 120.3 Feed lot approval.

Before a feed lot is approved by the Director, an inspection shall be made to determine whether such lot meets the requirements of this part. A feed lot shall not be approved unless, in the opinion of the Director, its location and method of operation will not endanger other swine or impair the Hog-Cholera Eradication Program. The volume of swine handled for anti-hog-cholera serum producers must be sufficient to warrant approval as a Category A approved feed lot.

lot is no longer adequate to effectuate the purposes of the regulations of this part, or the lot's location or method of operation endangers other swine or impairs the Hog-Cholera Eradication Program or is not operated in accordance with the provisions of this part. In the event of the deletion of a feed lot, all animals remaining in the lot shall be disposed of in accordance with §§ 120.9 and 120.10, and incoming animals shall not be vaccinated as provided in § 120.8 with virulent virus.

§ 120.6 Admitting pigs to premises.

Pigs for feeding purposes may be purchased vaocinated or unvaccinated from any source. Upon receipt, such pigs shall be vaccinated or revaccinated and identified. If pigs are received from a licensed establishment they need not be revaccinated.

§ 120.7 Method of identification.

All tags or other methods used for identification of animals shall be applied in such a manner that identification may be maintained. Tags, if used, shall be of a distinctive design or color so as to differentiate them from identification used for official vaccinates under the Hog-Cholera Eradication Program. § 120.8 Vaccination in approved feed

lots.

Virulent virus shall not be used on the premises of a Category B approved feed lot. All vaccinations with virulent virus in Category A approved feed lots shall be performed by a competent and responsible agent or employee of a licensee or a feed lot operator. Virulent virus to be used in such vaccination will be released to the licensee by permit issued by an inspector in charge on written application therefor. All such virus shall be accounted for by the licensee, feed lots, or authorized agents or employees. § 120.9 Records of vaccination and disposition.

(a) Records of vaccination and disposition of all animals shall be maintained by each operator of an approved feed lot on forms approved by the Department and made available to such operators. A copy of such records shall be furnished to the inspector.

(b) An inventory of animals showing the daily admission to and removal from the premises of all animals shall be maintained by the operator of an approved feed lot.

(c) Records described in paragraphs (a) and (b) of this section shall be retained for a period of one year.

§ 120.10 Removal of animals.

(a) Swine shall not be removed from an approved feed lot without a permit issued by the inspector in charge in response to a written application therefor. Removal of animals will be permitted by the inspector in charge under the following conditions provided such removal is accomplished in a manner as to preclude the dissemination of disease:

(1) Swine are in a healthy condition as determined by veterinary inspection. (2) Swine are transported directly to an abattoir for immediate slaughter or to an establishment producing anti-hogcholera serum. Such transportation shall be by truck, wagon, or similar means and not by rail.

(3) Swine are removed not earlier than 30 days after vaccination with virulent hog-cholera virus.

(b) A certificate of receipt from the consignee of such animals shall be furnished to the inspector in charge by the operator of the feed lot.

§ 120.11 Dead animals, removal.

Dead animals to be removed from an approved feed lot shall be removed only to a rendering plant. Trucks used for this purpose shall have water tight bodies and be covered by a suitable covering to prevent flies from reaching the carcasses. Identification tags shall be removed from all dead animals before removal and turned over to an inspector.

NOTE: The record keeping and/or reporting requirements contained herein have been approved by the Bureau of the Budget in accordance with the Federal Reports Act of 1942.

Except as specifically authorized by Parts 101 to 122 of this subchapter, no biological product which has not been prepared, handled, stored, and marked in accordance with Parts 101 to 122 of this subchapter and no biological product which is worthless, contaminated, dangerous, or harmful shall be brought onto the premises of any licensed establishment. § 121.2

Division virus and serum.

Hog-cholera virus and anti-hog-cholera serum prepared by the Division will be admitted to licensed establishments for use as prescribed in Parts 101 to 122 of this subchapter or as may be approved by the Director.

§ 121.3

Virus from outbreaks.

Hog-cholera virus procured from outbreaks of hog cholera on farms that are free from other communicable diseases will be admitted to licensed establishments by the inspector in charge when requested by the licensee for use in propagating a new strain of virus for inoculating purposes. Before such virus is used in the production of simultaneous virus or hyperimmunizing virus, it shall be injected into pigs weighing from 40 to 90 pounds to determine whether the purity and virulence of the product are satisfactory. The virus shall be passed through pigs as provided in Parts 101 to 122 of this subchapter until its virulence and purity are satisfactory; otherwise, the product shall be destroyed as provided in § 108.16 of this subchapter. § 121.4 Transportation between licensed

establishments.

Anti-hog-cholera serum and hogcholera virus, spleens, and other organs, collected in licensed establishments, and suitable for use under Parts 101 to 122 of this subchapter, may be transported from one licensed establishment to another or between units of the same establishment provided these products are properly packed. Such products and materials must be packed or iced so that a proper temperature will be maintained during transportation. The containers shall be sealed by an authorized inspector, and such seals shall be broken only by such an inspector at the point of destination; otherwise, the products and materials shall be refused admission at

transported.

No organisms or vectors shall be imported into the United States or transported from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia without a permit issued by the Secretary and in compliance with the terms thereof: Provided, That no permit shall be required under this section for importation of organisms for which an import permit has been issued pursuant to Part 102 of this subchapter or for transportation of organisms produced at establishments licensed under Part 102 of this subchapter. As a condition of issuance of permits under this section, the permittee shall agree in writing to observe the safeguards prescribed by the Director for public protection with respect to the particular importation or transportation.

[28 F.R. 7896, Aug. 2, 1963]

§ 122.2 Application for permits.

The Secretary may issue, at his discretion, a permit as specified in § 122.1 when proper safeguards are set up as provided in § 122.1 to protect the public. Application for such a permit shall be made in advance of shipment, and each permit shall specify the name and address of the consignee, the true name and character of each of the organisms or vectors involved, and the use to which each will be put.