[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR160.90]



[Page 149-150]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                 Subpart E_Testing Facilities Operation

 

Sec.  160.90  Animal and other test system care.



    (a) There shall be standard operating procedures for the housing, 

feeding, handling, and care of animals and other test systems.

    (b) All newly received test systems from outside sources shall be 

isolated and their health status or appropriateness for the study shall 

be evaluated. This evaluation shall be in accordance with acceptable 

veterinary medical practice or scientific methods.

    (c) At the initiation of a study, test systems shall be free of any 

disease or condition that might interfere with the purpose or conduct of 

the study. If during the course of the study, the test systems contract 

such a disease or condition, the diseased test systems should be 

isolated, if necessary. These test systems may be treated for disease or 

signs of disease provided that such treatment does not interfere with 

the study. The diagnosis, authorization of treatment, description of 

treatment,



[[Page 150]]



and each date of treatment shall be documented and shall be retained.

    (d) Warm-blooded animals, adult reptiles, and adult terrestrial 

amphibians used in laboratory procedures that require manipulations and 

observations over an extended period of time or in studies that require 

these test systems to be removed from and returned to their test system-

housing units for any reason (e.g., cage cleaning, treatment, etc.), 

shall receive appropriate identification (e.g., tattoo, color code, ear 

tag, ear punch, etc.). All information needed to specifically identify 

each test system within the test system-housing unit shall appear on the 

outside of that unit. Suckling mammals and juvenile birds are excluded 

from the requirement of individual identification unless otherwise 

specified in the protocol.

    (e) Except as specified in paragraph (e)(1) of this section, test 

systems of different species shall be housed in separate rooms when 

necessary. Test systems of the same species, but used in different 

studies, should not ordinarily be housed in the same room when 

inadvertent exposure to test, control, or reference substances or test 

system mixup could affect the outcome of either study. If such mixed 

housing is necessary, adequate differentiation by space and 

identification shall be made.

    (1) Plants, invertebrate animals, aquatic vertebrate animals, and 

organisms that may be used in multispecies tests need not be housed in 

separate rooms, provided that they are adequately segregated to avoid 

mixup and cross contamination.

    (2) [Reserved]

    (f) Cages, racks, pens, enclosures, aquaria, holding tanks, ponds, 

growth chambers, and other holding, rearing and breeding areas, and 

accessory equipment, shall be cleaned and sanitized at appropriate 

intervals.

    (g) Feed, soil, and water used for the test systems shall be 

analyzed periodically to ensure that contaminants known to be capable of 

interfering with the study and reasonably expected to be present in such 

feed, soil, or water are not present at levels above those specified in 

the protocol. Documentation of such analyses shall be maintained as raw 

data.

    (h) Bedding used in animal cages or pens shall not interfere with 

the purpose or conduct of the study and shall be changed as often as 

necessary to keep the animals dry and clean.

    (i) If any pest control materials are used, the use shall be 

documented. Cleaning and pest control materials that interfere with the 

study shall not be used.

    (j) All plant and animal test systems shall be acclimatized to the 

environmental conditions of the test, prior to their use in a study.