[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: 40CFR159.153]

[Page 129-130]
 
                   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. 159.153   Definitions.

    (a) For the purposes of reporting information pursuant to FIFRA 
section 6(a)(2), the definitions set forth in FIFRA section 2 and in 40 
CFR part 152 apply to this part unless superseded by a definition in 
paragraph (b) of this section.
    (b) For purposes of reporting information pursuant to FIFRA section 
6(a)(2), the following definitions apply only to this part:
    Established level means a tolerance, temporary tolerance, food 
additive regulation, action level, or other limitation on pesticide 
residues imposed by law, regulation, or other authority.
    Formal Review means Special Review, Rebuttable Presumption Against 
Registration (RPAR), FIFRA section 6(c) suspension proceeding, or FIFRA 
section 6(b) cancellation proceeding, whether completed or not.
    Hospitalization means admission for treatment to a hospital, clinic 
or other health care facility. Treatment as an out-patient is not 
considered to be hospitalization.
    Maximum contaminant level (MCL) means the maximum permissible level, 
established by EPA, for a contaminant in water which is delivered to any 
user of a public water system.
    Non-target organism means any organism for which pesticidal control 
was either not intended or not legally permitted by application of a 
pesticide.

[[Page 130]]

    Pesticide means a pesticide product which is or was registered by 
EPA, and each active ingredient, inert ingredient, impurity, metabolite, 
contaminant or degradate contained in, or derived from, such pesticide 
product.
    Qualified expert means one who, by virtue of his or her knowledge, 
skill, experience, training, or education, could be qualified by a court 
as an expert to testify on issues related to the subject matter on which 
he or she renders a conclusion or opinion. Under Rule 702 of the Federal 
Rules of Evidence, a person may be qualified as an expert on a 
particular matter by virtue of ``knowledge, skill, experience, training, 
or education.'' In general, EPA wants registrants to report information 
when a person has relevant expert credentials, e.g., a medical doctor 
giving a medical opinion, a plant pathologist giving an opinion on plant 
pathology, etc.
    Registrant includes any person who holds, or ever held, a 
registration for a pesticide product issued under FIFRA section 3 or 
24(c).
    Similar species means two or more species belonging to the same 
general taxonomic groups: The general taxonomic groups for purposes of 
this requirement are: mammals, birds, reptiles, amphibians, fish, 
aquatic invertebrates, insects, arachnids, aquatic plants (including 
macrophyte, floating, and submerged plants), and terrestrial (all non-
aquatic) plants.
    Water reference leve means the level specified in paragraph (1) or 
(2) of this definition, whichever is lower.
    (1) Ten percent of the maximum contaminant level (MCL) established 
by EPA, or if no MCL has been established by EPA, 10 percent of the most 
recent draft or final long-term health advisory level (HAL) established 
by EPA, or if EPA has not published or proposed an MCL or HAL, the 
lowest detectable amount of the pesticide.
    (2) The ambient water quality criteria for the protection of aquatic 
life, established by EPA pursuant to section 304(a) of the Clean Water 
Act.

[62 FR 49388, Sept. 19, 1997, as amended at 63 FR 33582, June 19, 1998]