21 C.F.R. § 112.145
What requirements apply to testing the environment for Listeria species or L. monocytogenes?
Cite as 21 C.F.R. § 112.145 (2026)
All of the following testing requirements apply for the growing, harvesting, packing, and holding environment for
Listeria
species or
L. monocytogenes.
(a) You must establish and implement a written environmental monitoring plan that is designed to identify
L. monocytogenes
if it is present in the growing, harvesting, packing, or holding environment.
(b) Your written environmental monitoring plan must be directed to sampling and testing for either
Listeria
species or
L. monocytogenes.
(c) Your written environmental monitoring plan must include a sampling plan that specifies:
(1) What you will test collected samples for (
i.e., Listeria
species or
L. monocytogenes
);
(2) How often you will collect environmental samples, which must be no less than monthly, and at what point during production you will collect the samples; and
(3) Sample collection sites; the number and location of sampling sites must be sufficient to determine whether measures are effective and must include appropriate food contact surfaces and non-food-contact surfaces of equipment, and other surfaces within the growing, harvesting, packing, and holding environment.
(d) You must aseptically collect environmental samples and test them for
Listeria
species or
L. monocytogenes
using a method as set forth in § 112.152.
(e) Your written environmental monitoring plan must include a corrective action plan that, at a minimum, requires you to take the actions in § 112.146, and details when and how you will accomplish those actions, if the growing, harvesting, packing, or holding environment tests positive for
Listeria
species or
L. monocytogenes.
- Cross-references to the CFR
- 112.146112.152.