[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: 40CFR160.43]



[Page 147-148]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                          Subpart C_Facilities

 

Sec.  160.43  Test system care facilities.



    (a) A testing facility shall have a sufficient number of animal 

rooms or other test system areas, as needed, to ensure: proper 

separation of species or test systems, isolation of individual projects, 

quarantine or isolation of animals or other test systems, and routine or 

specialized housing of animals or other test systems.

    (1) In tests with plants or aquatic animals, proper separation of 

species can be accomplished within a room or area by housing them 

separately in different chambers or aquaria. Separation of species is 

unnecessary where the protocol specifies the simultaneous exposure of 

two or more species in the same chamber, aquarium, or housing unit.

    (2) Aquatic toxicity tests for individual projects shall be isolated 

to the extent necessary to prevent cross-contamination of different 

chemicals used in different tests.

    (b) A testing facility shall have a number of animal rooms or other 

test system areas separate from those described in paragraph (a) of this 

section to ensure isolation of studies being done with test systems or 

test, control, and reference substances known to be biohazardous, 

including volatile substances, aerosols, radioactive materials, and 

infectious agents.

    (c) Separate areas shall be provided, as appropriate, for the 

diagnosis, treatment, and control of laboratory test system diseases. 

These areas shall provide effective isolation for the housing of test 

systems either known or suspected of being diseased, or of being 

carriers of disease, from other test systems.

    (d) Facilities shall have proper provisions for collection and 

disposal of contaminated water, soil, or other spent materials. When 

animals are housed, facilities shall exist for the collection and 

disposal of all animal waste and refuse or for safe sanitary storage of 

waste before removal from the testing facility. Disposal facilities 

shall be so provided and operated as to minimize



[[Page 148]]



vermin infestation, odors, disease hazards, and environmental 

contamination.

    (e) Facilities shall have provisions to regulate environmental 

conditions (e.g., temperature, humidity, photoperiod) as specified in 

the protocol.

    (f) For marine test organisms, an adequate supply of clean sea water 

or artificial sea water (prepared from deionized or distilled water and 

sea salt mixture) shall be available. The ranges of composition shall be 

as specified in the protocol.

    (g) For freshwater organisms, an adequate supply of clean water of 

the appropriate hardness, pH, and temperature, and which is free of 

contaminants capable of interfering with the study, shall be available 

as specified in the protocol.

    (h) For plants, an adequate supply of soil of the appropriate 

composition, as specified in the protocol, shall be available as needed.