[Code of Federal Regulations] [Title 40, Volume 23] [Revised as of July 1, 2007] From the U.S. Government Printing Office via GPO Access [CITE: 40CFR158.490] [Page 117-119] TITLE 40--PROTECTION OF ENVIRONMENT CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents Subpart D_Data Requirement Tables Sec. 158.490 Wildlife and aquatic organisms data requirements. (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the wildlife and aquatic organisms data requirements and the substance to be tested. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ General use patterns Test substance ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference ---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No. Food crop Nonfood Food Crop Nonfood Food crop Nonfood outdoor use MP EP ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Avian and mammalian testing Avian oral LD50 (preferably (1) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 71-1 mallard or bobwhite). Avian dietary LC50 (preferably (1) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 71-2 mallard and bobwhite). Wild mammal toxicity.......... (2) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 71-3 Avian reproduction (preferably (3) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 71-4 mallard and bobwhite). Simulated and actual field (2) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 71-5 testing--mammals and birds. Aquatic organism testing Freshwater fish LC50 (1), (7) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 72-1 (preferably rainbow and bluegill). Acute LC50 freshwater (1), (7) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 72-2 invertebrates (preferably Daphnia). Acute LC50 estuarine and (4), (7) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 72-3 marine organisms. Fish early life stage and (5) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 72-4 aquatic invertebrate life- cycle. Fish--life-cycle.............. (6) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 72-5 [[Page 118]] Aquatic organism accumulation. (8) CR CR CR CR ......... ......... CR CR ......... TGAI, PAI, or TGAI, PAI, or 72-6 degradation degradation product. product. Simulated or actual field (2) CR CR CR CR ......... ......... CR CR ......... TEP TEP 72-7 testing--aquatic organisms. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Key: R=Required; CR=Conditonally required; [ ]=Brackets (ie. [R], [CR]) indicate data requirements that apply when an experimental use permit is being sought; TGAI=Techical grade of the active ingredient; TEP=Typical end-use product; PAI=``Pure'' active ingredient. (b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section. (1)(i) Data are required as follows to support manufacturing use products and those end-use products for indoor use for which there is no registered manufacturing use product: (A) Solid formulation indoor use products require avian oral LD50 (bobwhite), avian dietary LC50 (bobwhite), freshwater fish LC50 (rainbow trout) and acute LC50 freshwater invertebrate (Daphnia). (B) Liquid formulation indoors use products require all tests listed under (b)(1)(i) of this section except the avian oral LD50. (ii) Data are not required to support: (A) Indoor end-use products consisting of a gas/highly volatile liquid or a highly reactive solid. (B) Indoor end-use products for which there is a manufacturing use product registration. (2) Tests required on a case-by-case basis depending on the results of lower tier studies such as acute and subacute testing, intended use pattern, and pertinent environmental fate characteristics. (3) Data required if one or more of the following criteria are met: (i) Birds may be subjected to repeated or continued exposure to the pesticide or any of its major metabolite degradation products, especially preceding or during the breeding season. (ii) The pesticide or any of its major metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in avian feed. (iii) The pesticide or any of its major metalolites or degradation products is stored or accumulated in plant animal tissues, as indicated by its octanol/water partition coefficient, accumulation studies, metabolic release and retention studies, or as indicated by structural similarity to known bioaccumulative chemicals. (iv) Any other information, such as that derived from mammalian reproduction studies that indicates the reproduction in terrestrial vertebrates may be adversely affected by the anticipated use of the pesticide product. Note: Prior to conducting this test to support the registration of an avicide, the applicant should consult the Agency. (4) Data required if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations because of its expected use or mobility pattern. (5) Data from fish early life-stage tests or life-cycle tests with aquatic invertebrates (on whichever species is most sensitive to the pesticide as determined from the results of the acute toxicity tests) are required if the product is applied directly to water or expected to be transported to water from the intended use site, and when any one or more of the following conditions apply: (i) If the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity. (ii) If any LC 50 or EC 50 value determined in acute toxicity testing is less than 1 mg/l; or (iii) If the estimated environmental concentration in water is equal to or greater than 0.01 of any EC 50 or LC 50 determined in acute toxicity testing. (iv) If the actual or estimated environmental concentration in water resulting from use is less than 0.01 of any EC50 or LC50 determined in acute toxicity testing and any of the following conditions exist: (A) Studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected. (B) Physiochemical properties indicate cumulative effects. (C) The pesticide is persistent in water (e.g., half-life in water greater than 4 days). (6) Data are required if end-use product is intended to be applied directly to water or expected to transport to water from the intended use site, and when any of the following conditions apply: (i) if the estimated environmental concentration is equal to or greater than one-tenth of the no-effect level in the fish early life-stage or invertebrate life-cycle test. (ii) If studies of other organisms indicate the reproductive physiology of fish may be affected. NOTE: The applicant should consult the Agency prior to these tests to support the registration of a pesticide. (7) Data from testing with the applicant's end-use product or a typical end-use product is required to support the registration of each end-use product which meets any one of the following conditions: (i) The end-use pesticide will be introduced directly not an aquatic environment when used as directed. (ii) The LC50 or EC50 of the technical grade of active ingredient is equal to or less than the maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment when the end-use pesticide is used as directed. [[Page 119]] (iii) An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms. (8) Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic organisms. [49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, and amended at 58 FR 34203, June 23, 1993]