[Code of Federal Regulations]

[Title 40, Volume 31]

[Revised as of July 1, 2006]

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

[CITE: 40CFR792.17]



[Page 36]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 792_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  792.17  Effects of non-compliance.



    (a) The sponsor or any other person who is conducting or has 

conducted a test to fulfill the requirements of a testing consent 

agreement or a test rule issued under section 4 of TSCA will be in 

violation of section 15 of TSCA if:

    (1) The test is not being or was not conducted in accordance with 

any requirement of this part;

    (2) Data or information submitted to EPA under this part (including 

the statement required by Sec.  792.12) include information or data that 

are false or misleading, contain significant omissions, or otherwise do 

not fulfill the requirements of this part; or

    (3) Entry in accordance with Sec.  792.15 for the purpose of 

auditing test data or inspecting test facilities is denied. Persons who 

violate the provisions of this part may be subject to civil or criminal 

penalties under section 16 of TSCA, legal action in United States 

district court under section 17 of TSCA, or criminal prosecution under 

18 U.S.C. 2 or 1001.

    (b) EPA, at its discretion, may not consider reliable for purposes 

of showing that a chemical substance or mixture does not present a risk 

of injury to health or the environment any study which was not conducted 

in accordance with this part. EPA, at its discretion, may rely upon such 

studies for purposes of showing adverse effects. The determination that 

a study will not be considered reliable does not, however, relieve the 

sponsor of a required test of the obligation under any applicable 

statute or regulation to submit the results of the study to EPA.

    (c) If data submitted to fulfill a requirement of a testing consent 

agreement or a test rule issued under section 4 of TSCA are not 

developed in accordance with this part, EPA may determine that the 

sponsor has not fulfilled its obligations under section 4 of TSCA and 

may require the sponsor to develop data in accordance with the 

requirements of this part in order to satisfy such obligations.



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