[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: 40CFR160.1]



[Page 142-143]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  160.1  Scope.









                      Subpart A_General Provisions



Sec.

160.1 Scope.

160.3 Definitions.

160.10 Applicability to studies performed under grants and contracts.

160.12 Statement of compliance or non-compliance.

160.15 Inspection of a testing facility.

160.17 Effects of non-compliance.



                  Subpart B_Organization and Personnel



160.29 Personnel.

160.31 Testing facility management.

160.33 Study director.

160.35 Quality assurance unit.



                          Subpart C_Facilities



160.41 General.

160.43 Test system care facilities.

160.45 Test system supply facilities.

160.47 Facilities for handling test, control, and reference substances.

160.49 Laboratory operation areas.

160.51 Specimen and data storage facilities.



                           Subpart D_Equipment



160.61 Equipment design.

160.63 Maintenance and calibration of equipment.



                 Subpart E_Testing Facilities Operation



160.81 Standard operating procedures.

160.83 Reagents and solutions.

160.90 Animal and other test system care.



            Subpart F_Test, Control, and Reference Substances



160.105 Test, control, and reference substance characterization.

160.107 Test, control, and reference substance handling.

160.113 Mixtures of substances with carriers.



              Subpart G_Protocol for and Conduct of a Study



160.120 Protocol.

160.130 Conduct of a study.



[[Page 143]]



160.135 Physical and chemical characterization studies.



Subparts H-I [Reserved]



                      Subpart J_Records and Reports



160.185 Reporting of study results.

160.190 Storage and retrieval of records and data.

160.195 Retention of records.



    Authority: 7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 136w; 

21 U.S.C. 346a, 348, 371, Reorganization Plan No. 3 of 1970.



    Source: 54 FR 34067, Aug. 17, 1989, unless otherwise noted.







    (a) This part prescribes good laboratory practices for conducting 

studies that support or are intended to support applications for 

research or marketing permits for pesticide products regulated by the 

EPA. This part is intended to assure the quality and integrity of data 

submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 

U.S.C. 136a, 136c, 136f, 136q and 136v(c)) and sections 408 and 409 of 

the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a, 348).

    (b) This part applies to any study described by paragraph (a) of 

this section which any person conducts, initiates, or supports on or 

after October 16, 1989.