Skip to main content
 
CFR › Title 40 › Chapter I › Subchapter E › Part 160 › Subpart E › Section 160.81

40 CFR 160.81 - Standard operating procedures.

prev | next
§ 160.81
Standard operating procedures.
(a) A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management.
(b) Standard operating procedures shall be established for, but not limited to, the following:
(1) Test system area preparation.
(2) Test system care.
(3) Receipt, identification, storage, handling, mixing, and method of sampling of the test, control, and reference substances.
(4) Test system observations.
(5) Laboratory or other tests.
(6) Handling of test systems found moribund or dead during study.
(7) Necropsy of test systems or postmortem examination of test systems.
(8) Collection and identification of specimens.
(9) Histopathology.
(10) Data handling, storage and retrieval.
(11) Maintenance and calibration of equipment.
(12) Transfer, proper placement, and identification of test systems.
(c) Each laboratory or other study area shall have immediately available manuals and standard operating procedures relative to the laboratory or field procedures being performed. Published literature may be used as a supplement to standard operating procedures.
(d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.

Title 40 published on 2012-07-01

no entries appear in the Federal Register after this date.

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
USC : Title 7 - AGRICULTURE

§ 136a - Registration of pesticides

§ 136c - Experimental use permits

§ 136d - Administrative review; suspension

§ 136f - Books and records

§ 136j - Unlawful acts

§ 136t - Delegation and cooperation

§ 136v - Authority of States

§ 136w - Authority of Administrator

USC : Title 21 - FOOD AND DRUGS

§ 346a - Tolerances and exemptions for pesticide chemical residues

§ 348 - Food additives

§ 371 - Regulations and hearings

Presidential Documents

Reorganization ... 1970 Plan No. 3