[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.33]

[Page 608-609]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 113_STANDARD REQUIREMENTS--Table of Contents
 
Sec.  113.33  Mouse safety tests.

    One of the mouse safety tests provided in this section shall be 
conducted when such test is prescribed in a Standard Requirement or in 
the filed Outline of Production for a biological product recommended for 
animals other than poultry: Provided, That if the inherent nature of one 
or more ingredients makes the biological product lethal or toxic for 
mice but not lethal or toxic for the animals for which it is 
recommended, the licensee shall demonstrate the safety of such product 
by an acceptable test written into such Outline of Production.
    (a) Final container samples of completed product from live virus 
vaccines shall be tested for safety using young adult mice in accordance 
with the test provided in this paragraph.
    (1) Vaccine, prepared for use as recommended on the label, shall be 
tested. Eight mice shall be inoculated intracerebrally with 0.03 ml and 
eight mice shall be inoculated intraperitoneally with 0.5 ml. Both 
groups shall be observed for 7 days.

[[Page 609]]

    (2) If unfavorable reactions attributable to the product occur in 
two or more mice in either group during the observation period, the 
serial or subserial is unsatisfactory. If unfavorable reactions which 
are not attributable to the product occur in two or more mice in either 
group, the test shall be declared inconclusive and may be repeated: 
Provided, That, if the test is not repeated, the serial or subserial 
shall be declared unsatisfactory.
    (b) Bulk or final container samples of completed product from liquid 
products, such as but not limited to antiserums and bacterins, shall be 
tested for safety in accordance with the test provided in this 
paragraph.
    (1) Unless otherwise prescribed in the Standard Requirement or 
approved in a filed Outline of Production for the product, a 0.5 ml dose 
shall be injected intraperitoneally or subcutaneously into eight mice 
and the animals observed for 7 days.
    (2) If unfavorable reactions attributable to the product occur in 
any of the mice during the observation period, the serial or subserial 
is unsatisfactory. If unfavorable reactions which are not attributable 
to the product occur, the test shall be declared inconclusive and may be 
repeated: Provided, That, if the test is not repeated, the serial or 
subserial shall be declared unsatisfactory.

[38 FR 34727, Dec. 18, 1973, as amended at 39 FR 16857, May 10, 1974]