FDA Good Laboratory Practice, 21 CFR Part 58 — Pest Control Materials in Nonclinical Studies

Citation

21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies (Food and Drug Administration). Read on the eCFR (Title 21 current through the September 22, 2026 issue) on September 24, 2026.

What It Says (Verbatim)

§58.1(a), Scope, first sentence:

“(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.”

§58.90(i), Animal care:

“(i) If any pest control materials are used, the use shall be documented. Cleaning and pest control materials that interfere with the study shall not be used.”

§58.43(d), Animal care facilities, second sentence:

“Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.”

What It Means in Plain Language

Part 58 applies only to nonclinical laboratory studies within §58.1(a). Where a laboratory does run such a study, the pest control rule is short and strict: every use of a pest control material is documented, and nothing that interferes with the study is used at all.

Who It Applies To

Testing facilities conducting nonclinical laboratory studies within the scope of §58.1. This reference does not state that any particular Utah institution conducts GLP studies.

Documentation Evidence

• A record of each pest control material used in or around the study facility
• The basis for concluding that each material does not interfere with the study

Confidence Notes

HIGH confidence. Read from the eCFR on September 24, 2026.