[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

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.

    (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



[[Page 142]]



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.