---
kind: "section"
citation: "40 C.F.R. § 159.188"
title: "40"
number: "159.188"
heading: "Failure of performance information."
url: "https://uscodex.org/cfr/40/159.188"
---

# §159.188. Failure of performance information.

- (a) **Microorganisms that pose a risk to human health.** Information must be submitted which concerns either incidents described in [paragraph (a)(1)](#a-1) of this section or a study described in [paragraph (a)(2)](#a-2) of this section:
  - (1) **Information which concerns an incident which meets all of the following conditions—**
    - (i) The registrant has been informed that a pesticide product may not have performed as claimed against target microorganisms.
    - (ii) The possible failures of the pesticide to perform as claimed involved the use against microorganisms which may pose a risk to human health.
    - (iii) **The pesticide product's use site is other than residential.**
    - (iv) The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
  - (2) A study which indicates that the pesticide may not perform in accordance with one or more claims made by the registrant regarding uses intended for control of microorganisms tha may pose a risk to human health, including any of the public health antimicrobials identified in [part 161](/cfr/40/part161.md) of this chapter.
- (b) **Animals that pose a risk to human health.** For the purposes of this section, any animal (including insects) poses a risk to human health if it may cause disease in humans, either directly or as a disease vector; produce toxins that are harmful to humans; or cause direct physical harm to humans. Information must be submitted which concerns either incidents described in [paragraph (b)(1)](#b-1) of this section or a study described in [paragraph (b)(2)](#b-2) of this section.
  - (1) **Information which concerns an incident which meets all of the following conditions—**
    - (i) The registrant has been informed by municipal, State, or Federal public health officials that a pesticide product may not have performed as claimed against target animals.
    - (ii) The possible failures of the pesticide to perform as claimed involved the use against animals that pose a risk to human health.
    - (iii) The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
  - (2) A study which indicates that the pesticide may not perform in accordance with one or more claims by the registrant regarding uses intended for control of animals that pose a risk to human health, including any of the public health pesticides identified in [part 158](/cfr/40/part158.md) of this chapter.
- (c) **Development of pesticide resistance.** Information must be submitted concerning substantiation of any incident of a pest having developed resistance to any pesticide (both public health and non-public health) that occurred under conditions of use, application rates and methods specified on the label if either of the following conditions is met:
  - (1) The survival of the suspected pesticide-resistant pest was significantly higher than that of a known susceptible pest when both the suspected resistant and susceptible pests were treated with the pesticide under controlled conditions.
  - (2) **Biochemical tests or DNA sequencing indicate that the pest is resistant to the pesticide.**

## Notes

### Amendments

[63 FR 49388, Sept. 19, 1997, as amended at 72 FR 61029, Oct. 26, 2007]

### Authority

Authority: 7 U.S.C. 136-136y.

### Source

Source: 63 FR 49388, Sept. 19, 1997, unless otherwise noted.

### Amendments

[63 FR 49388, Sept. 19, 1997, as amended at 72 FR 61029, Oct. 26, 2007]