[Code of Federal Regulations]
[Title 40, Volume 20]
[Revised as of July 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR159.188]

[Page 141-142]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 159--STATEMENTS OF POLICIES AND INTERPRETATIONS--Table of Contents
 
     Subpart D--Reporting Requirements for Risk/Benefit Information
 
Sec. 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) of this section or a study described in paragraph (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 that may pose a risk to human 
health, including any of the public health antimicrobials identified in 
part 158 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) of this section 
or a study described in paragraph (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 of 
this chapter.

[[Page 142]]

    (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.