[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: 40CFR159.153] [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to FIFRA section 6(a)(2), the definitions set forth in FIFRA section 2 and in 40 CFR part 152 apply to this part unless superseded by a definition in paragraph (b) of this section.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 [[Page 130]] 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. 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]