[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR101.5]

[Page 592-594]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 101_DEFINITIONS--Table of Contents
 
Sec. 101.5  Testing terminology.

    Terms used when evaluating biological products shall mean:

[[Page 593]]

    (a) Standard Requirement. Test methods, procedures, and criteria 
established by Animal and Plant Health Inspection Service for evaluating 
biological products to be pure, safe, potent, and efficacious, and not 
to be worthless, contaminated, dangerous, or harmful under the Act.
    (b) Log. Logarithm computed to the base 10.
    (c) Pure or purity. Quality of a biological product prepared to a 
final form relatively free of extraneous micro-organisms and extraneous 
material (organic or inorganic) as determined by test methods or 
procedures established by Animal and Plant Health Inspection Service in 
Standard Requirements or in the approved Outline of Production for such 
product, but free of extraneous microorganisms or material which in the 
opinion of the Administrator adversely affects the safety, potency, or 
efficacy of such product.
    (d) Safe or safety. Freedom from properties causing undue local or 
systemic reactions when used as recommended or suggested by the 
manufacturer.
    (e) Sterile or sterility. Freedom from viable contaminating 
microorganisms as demonstrated by procedures prescribed in part 113 of 
this subchapter, Standard Requirements, and approved Outlines of 
Production.
    (f) Potent or potency. Relative strength of a biological product as 
determined by test methods or procedures as established by Animal and 
Plant Health Inspection Service in Standard Requirements or in the 
approved Outline of Production for such product.
    (g) Efficacious or efficacy. Specific ability or capacity of the 
biological product to effect the result for which it is offered when 
used under the conditions recommended by the manufacturer.
    (h) Dose. The amount of a biological product recommended on the 
label to be given to one animal at one time.
    (i) Vaccinate. An animal which has been inoculated, injected, or 
otherwise administered a biological product being evaluated.
    (j) Control animal. An animal, which may be referred to as a 
control, used in a test procedure for purposes of comparison or to add 
validity to the results.
    (k) Day. Time elapsing between any regular working hour of one day 
and any regular working hour of the following day.
    (l) No test. A test which produces inconclusive or invalid results 
and therefore, cannot be used to evaluate a biological product.
    (m) Healthy. Apparently normal in all vital functions and free of 
signs of disease.
    (n) Unfavorable reactions. Overt adverse changes which occur in 
healthy test animals subsequent to initiation of a test and manifested 
during the observation period prescribed in the test protocol which are 
attributable either to the biological product being tested or to factors 
unrelated to such product as determined by the responsible individual 
conducting the test.
    (o) Master reference. A Master Reference is a reference whose 
potency is correlated, directly or indirectly, to host animal 
immunogenicity. The Master Reference may be used as the working 
reference in in vitro tests for relative potency. The Master Reference 
may also be used to establish the relative potency of a serial of 
product used in requalification studies and to establish the relative 
potency of working references. The preparation of a Master Reference as 
described in a filed Outline of Production may be:
    (1) A completed serial of vaccine or bacterin prepared in accordance 
with a filed Outline of Production;
    (2) A purified preparation of a protective immunogen or antigen; or
    (3) A nonadjuvanted harvested culture of microorganisms.
    (p) Working reference. A Working Reference is the reference 
preparation that is used in the in vitro test for the release of serials 
of product. Working References may be:
    (1) Master References; or
    (2) Serials of product that have been prepared and qualified, in a 
manner acceptable to Animal and Plant Health Inspection Service for use 
as reference preparations.
    (q) Qualifying serial. (1) A serial of biological product used to 
test for immunogenicity when the Master or

[[Page 594]]

Working Reference is a purified antigen or nonadjuvanted harvest 
material. Qualifying serials shall be produced in accordance with the 
filed Outline of Production, tested for immunogenicity in accordance 
with methods deemed appropriate by the Animal and Plant Health 
Inspection Service, and have a geometric mean relative potency, when 
compared to the Master Reference, of not greater than 1.0 as established 
by: independent parallel line assays with five or more replicates; or 
other valid assay methods for determining relative antigen content which 
demonstrate linearity, specificity, and reproducibility at least 
equivalent to the parallel line assay and are acceptable to the Animal 
and Plant Health Inspection Service.
    (2) Qualifying serials used to requalify or extend the dating period 
of a Master Reference shall be determined to be immunogenic in 
accordance with methods deemed appropriate by the Animal and Plant 
Health Inspection Service as provided in paragraph (a)(1) of this 
section, and, in addition, shall be within their permitted dating period 
and have been prepared in accordance with the production method 
described in the currently filed Outline of Production.
    (r) Immunogenicity. The ability of a biological product to elicit an 
immune response in animals as determined by test methods or procedures 
acceptable to the Animal and Plant Health Inspection Service.

[38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 41 
FR 6751, Feb. 13, 1976; 43 FR 3701, Jan. 27, 1978; 56 FR 66782, 66783 
Dec. 26, 1991; 62 FR 19037, Apr. 18, 1997]