40 CFR 160.15 - Inspection of a testing facility.

§ 160.15 Inspection of a testing facility.

(a) A testing facility shall permit an authorized employee or duly designated representative of EPA or FDA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies to which this part applies. The records inspection and copying requirements should not apply to quality assurance unit records of findings and problems, or to actions recommended and taken, except that EPA may seek production of these records in litigation or formal adjudicatory hearings.

(b) EPA will not consider reliable for purposes of supporting an application for a research or marketing permit any data developed by a testing facility or sponsor that refuses to permit inspection in accordance with this part. The determination that a study will not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to EPA.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
Presidential Documents

Reorganization ... 1970 Plan No. 3

Title 40 published on 2015-08-22

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 40 CFR Part 160 after this date.

  • 2016-12-05; vol. 81 # 233 - Monday, December 5, 2016
    1. 81 FR 87509 - Notification of Submission to the Secretary of Agriculture; Pesticides; Removal of Obsolete Information
      GPO FDSys XML | Text
      Notification of submission to the Secretary of Agriculture.
      40 CFR Parts 152, 153, 155, 156, 160, 165, 168, 170, and 172