Topramezone; Pesticide Tolerances, 46410-46419 [05-15604]

Download as PDF 46410 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a ‘‘significant energy action’’ under that order because it is not a ‘‘significant regulatory action’’ under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321–4370f), and have made a preliminary determination that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore we believe this rule should be categorically excluded, VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 under figure 2–1, paragraph 34 (g) from further environmental documentation. This temporary rule establishes a regulated navigation area and as such is covered by this paragraph. A final ‘‘Environmental Analysis Check List’’ and a final ‘‘Categorical Exclusion Determination’’ are available in the docket where indicated under ADDRESSES. Comments on this section will be considered before we make the final decision on whether the rule should be categorically excluded from further environmental review. List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and record keeping requirements, Security measures, Waterways. I For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: I Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add § 165.T09.102 to read as follows: I § 165.T09.102 Temporary Regulated Navigation Area between mile markers 296.1 and 296.7 of the Chicago Sanitary and Ship Canal located near Romeoville, IL. (a) Location. The following is a Regulated Navigation Area: All waters of the Chicago Sanitary and Ship Canal, Romeoville, IL beginning at the north side of Romeo Road Bridge Mile Marker 296.1, and ending at the south side of the Aerial Pipeline Mile Marker 296.7. (b) Effective period: This rule is effective from 12 p.m. (local) June 30, 2005 through 12 p.m. (local) December 31, 2005. (c) Regulations. (1) The general regulations contained in 33 CFR 165.13 apply. (2) All vessels are prohibited from loitering in the regulated navigation area. Vessels may enter this section of the waterway with the sole purpose of transiting to the other side, and must maintain headway throughout the transit. All personnel on open decks must wear a Coast Guard approved Type I personal flotation device while in the regulated navigation area until subsequent field testing determines the waters in this area do not pose significant risk to human life. Vessels may not moor or lay up on the right or PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 left descending banks. Towboats may not make or break tows. Vessels may not pass (meet or overtake) in the regulated navigation area and must make a SECURITE call when approaching the barrier to announce intentions and work out passing arrangements on either side. Commercial tows transiting the barrier must be made up with wire rope to ensure electrical connectivity between all segments of the tow. (3) All persons and vessels shall comply with this rule and any additional instructions of the Ninth Coast Guard District Commander, or his designated representative. Dated: June 30, 2005. R.J. Papp, Jr., Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District. [FR Doc. 05–15781 Filed 8–9–05; 8:45 am] BILLING CODE 4910–15–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP–2005–0156; FRL–7726–9] Topramezone; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for residues of topramezone in or on field corn, pop corn, sweet corn, kidney, and liver. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective August 10, 2005. Objections and requests for hearings must be received on or before October 11, 2005. ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP–2005– 0156. All documents in the docket are listed in the EDOCKET index at http:/ /www.epa.gov/edocket. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either E:\FR\FM\10AUR1.SGM 10AUR1 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305–5805. FOR FURTHER INFORMATION: Joanne I. Miller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460–0001; telephone number: (703) 305–6224; e-mail address: miller.joanne@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using EDOCKET (http:/ /www.epa.gov/edocket/), you may VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http:// www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/ opptsfrs/home/guidelin.htm/. II. Background and Statutory Findings In the Federal Register of June 11, 2003 (68 FR 34950) (FRL–7310–4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3F6568) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.612 be amended by establishing tolerances for residues of the herbicide topramezone, [3-(4,5-dihydro-isoxazol-3-yl)-4methanesulfonyl-2-methylphenyl)-(5hydroxyl-1-methyl-1H-pyrazol-4yl)methanone, in or on corn, field, forage; corn, field, grain; corn, field, stover; corn, pop, grain; corn, pop, stover; corn, sweet, forage; corn, sweet, kernal plus cob with husks removed; corn, sweet, stover; cattle, kidney; cattle, liver; goat, kidney; goat, liver; hog, kidney; hog, liver; horse, kidney; horse, liver; sheep, kidney; and sheep, liver at 0.05; 0.01; 0.05; 0.01; 0.05; 0.05; 0.01; 0.05; 0.02; 0.70; 0.20; 0.70; 0.20; 0.70; 0.20; 0.70; 0.20; and 0.70 parts per million (ppm), respectively. That notice included a summary of the petition prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 46411 of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....’’ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL–5754– 7). III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of topramezone on cattle, kidney at 0.05 ppm; cattle, liver at 0.15 ppm; corn, field, forage at 0.05 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 0.05 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.05 ppm; corn, sweet, forage at 0.05 ppm; corn, sweet, kernal plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 0.05 ppm; goat, kidney at 0.05 ppm; goat, liver at 0.15 ppm; horse, kidney at 0.05 ppm; horse, liver at 0.15 ppm; sheep, kidney at 0.05 ppm; and sheep, liver at 0.15 ppm, respectively. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by topramezone are discussed in Table 1. of this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed . E:\FR\FM\10AUR1.SGM 10AUR1 46412 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type Results 870.3100 90-Day oral toxicity--rodents (rat) NOAEL = 1.1 milligrams/kilogram/day (mg/kg/day) males (M) and 2.1 mg/kg/day females (F) LOAEL = 2.1 mg/kg/day for males based on diffuse degeneration in the pancreas and was not established for females 870.3100 90-Day oral toxicity--rodents (mouse) NOAEL = 2,289/3,010 mg/kg/day (M/F) LOAEL = was not established 870.3150 90-Day oral toxicity--nonrodents (dog) NOAEL = 535/1,712 mg/kg/day (M/F) LOAEL = 1,511 mg/kg/day for males based on decreased body-weight gain, impaired food efficiency, and inflammation of the urinary bladder and was not established for females 870.3200 28-Day dermal toxicity (rat) NOAEL = 100/300 mg/kg/day (M/F) LOAEL = 300 mg/kg/day males based on thyroid follicular cell hypertrophy and 1,000 mg/kg/day females based on thyroid follicular cell hypertrophy 870.3700 Prenatal developmental-rodents (rat) Maternal NOAEL = not established Maternal LOAEL = 100 mg/kg/day based on decreased body-weight gains Developmental NOAEL = not established Developmental LOAEL = 100 mg/kg/day based on decreased fetal body weight and increased incidences of skeletal variation 870.3700 Prenatal developmental-nonrodents (rabbit) Maternal NOAEL = not established Maternal LOAEL = 0.5 mg/kg/day based on increased serum tyrosine level Developmental NOAEL = 0.5 mg/kg/day Developmental LOAEL = 5 mg/kg/day based on alterations in skeletal ossification sites and increased number of pairs of ribs 870.3700 Prenatal developmental-nonrodents (rabbit) Maternal NOAEL = not established Maternal LOAEL = 1.5 mg/kg/day based on increased serum tyrosine level Developmental NOAEL = not established Developmental LOAEL = 1.5 mg/kg/day based on an increased incidence of absent kidney and ureter and increased incidences of supernumerary thoracic vertebrae and supernumerary 13th rib 870.3700 Prenatal developmental-nonrodents (rabbit) Maternal NOAEL = 5.0 mg/kg/day Maternal LOAEL = was not established Developmental NOAEL = not established Developmental LOAEL = 1.5 mg/kg/day for N33 and N17/CFR 1–2 based on increased presence of supernumerary thoracic vertebrae and supernumerary 13th rib. No effect was observed for N17/CFR 3 at 0.5 mg/kg/day (the only dose tested) 870.3700 Prenatal developmental-nonrodents (rabbit) Maternal NOAEL = 450 mg/kg/day Maternal LOAEL = not established Developmental NOAEL = not established Developmental LOAEL = 5 mg/kg/day based on visceral findings (fluid-filled abdomen, pale liver, and dark content of the stomach and intestines) and alterations in skeletal development (i.e. incomplete ossification of the vertebrae and talus, and supernumerary thoracic vertebrae and 13th rib) 870.3700 Prenatal developmental-nonrodents (rabbit) Maternal NOAEL = 150 mg/kg/day Maternal LOAEL = 450 mg/kg/day based on decreased body-weight, body-weight gains, food consumption, and increased incidences of abortion and lack of defecation Developmental NOAEL = not established Developmental LOAEL = 50 mg/kg/day based on decreased fetal weight and increased incidence of visceral malformations, and skeletal malformations, variations, and unclassified abnormalities 870.3700 Prenatal developmental-nonrodents (rabbit) Maternal NOAEL = 450 mg/kg/day Maternal LOAEL = not established Developmental NOAEL = 0.5 mg/kg/day Developmental LOAEL = 5 mg/kg/day based on increased presence of 27 pre-sacral vertebrae and increased an incidence of full supernumerary 13th rib VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\10AUR1.SGM 10AUR1 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations 46413 TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued Guideline No. Study Type Results 870.3700 Prenatal developmental-nonrodents (rabbit) Maternal NOAEL = 450 mg/kg/day Maternal LOAEL = not established Developmental NOAEL = not established Developmental LOAEL = 50 mg/kg/day based on an increased incidence of extra sternebral ossification sites and supernumerary 13th rib 870.3700 Prenatal developmental-nonrodents (mouse) Maternal NOAEL = not established Maternal LOAEL = 30 mg/kg/day based on increased serum tyrosine level Developmental NOAEL = 1,000 mg/kg/day Developmental LOAEL = not established 870.3800 Reproduction and fertility effects (rat) Parental/Systemic NOAEL = 0.4/0.5 mg/kg/day (M/F) Parental/Systemic LOAEL = 4.2/4.6 mg/kg/day (M/F) based on decreased bodyweight, body-weight gain in males, increased thyroid and kidney weights of both sexes, and microscopic findings in eyes, kidney, and thyroid of both sexes Reproductive NOAEL = 426.8/471.9 mg/kg/day (M/F) Reproductive LOAEL = not established Offspring NOAEL = 0.4/0.5 mg/kg/day (M/F) Offspring LOAEL = 4.2/4.6 mg/kg/day (M/F) based on decreased pup weight and weight gain in F2 male and female pups and increased time to preputial separation in the F1 males 870.4100 Chronic toxicity--rodents (rat) NOAEL = 0.4/0.5 mg/kg/day (M/F) LOAEL = 3.9/5.3 mg/kg/day (M/F) based on corneal opacity and pannus and chronic keratitis in both sexes, and thyroid hypertrophy in males 870.4100 Chronic toxicity--dogs NOAEL = 2.9/15.4 (M/F) mg/kg/day LOAEL = 15.3 mg/kg/day (M) based on increased incidence of thyroid C-cell hyperplasia and 92 mg/kg/day (F) based on decreased body-weight, body-weight gain, and food efficiency 870.4200 Carcinogenicity--rats NOAEL = 0.4/0.5 mg/kg/day (M/F) LOAEL = 3.6/4.7 mg/kg/day (M/F) based on increased incidences of corneal opacity, decreased body-weight and body-weight gains (males only) and histopathological evaluations in the thyroids, pancreas, and eyes of both sexes Neoplastic pathology showed increased incidences of follicular cell adenomas in the thyroid glands of both sexes 870.4300 Carcinogenicity--mice NOAEL = not established LOAEL = 19/26 mg/kg/day (M/F) based on decreased body-weight and body-weight gains in males No evidence of carcinogenicity 870.5100 Gene mutation No indication of a mutagenic response in any strain at any level up to cytotoxic concentrations either with or without S9 activation 870.5100 Gene mutation Based on these considerations, it was concluded that there was confirmed evidence of a mutagenic response in S. typhimurium TA98 in the nonactivated portion of both the plate incorporation and preincubation assays. The effect was, however, observed at high concentrations (≥ 3,000 µg/plate-plate incorporation and ≥ 2,500 µg/plate-preincubation). It was further concluded that the mutagenic effect was likely due to impurities in the test article because: 1) The response was seen at high concentrations including and exceeding the limit dose, 2) bacterial gene mutation assays conducted with other lots of the test material were negative up to the limit dose (see Master Record Identification (MRID) Nos. 45902225 through 45902227, and 3) the active ingredient (a.i.) used in the current study has the lowest percentage of purity (95.8% versus 97.7 to 99.3% a.i. for the other lots) 870.5300 In vitro mammalian cell gene mutation No indication that topramezone induced a mutagenic response, either in the presence of absence of S9 activation 870.5375 In vitro mammalian chromosome aberration Topramezone-induced a clastogenic response in the presence of S9 activation with significant effects recorded only at an insoluble limit concentration 870.5395 In vivo mouse bone morrow micronucleus No evidence that topramezone was clastogenic or aneugenic 870.5550 Unscheduled DNA synthesis (UDS) No evidence that topramezone-induced UDS, as determined by radioactive tracer procedures (nuclear silver grain counts) at any concentration tested VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\10AUR1.SGM 10AUR1 46414 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued Guideline No. Study Type Results 870.6200 Acute neurotoxicity screening battery (rat) NOAEL= 2,000 mg/kg/day, no neurotoxicity observed 870.6200 Subchronic neurotoxicity (rat) No neurotoxicity observed Systemic NOAEL = not established LOAEL = 4.2/5/0 mg/kg/day (M/F) based on elevated levels of granular casts and transitional epithelial cells in the urinary sediment of the males, increased incidences of corneal clouding in females, minimal diffuse degeneration of the pancreas (both sexes), and slight to moderate flaky colloid in the thyroid of the males 870.6300 Developmental neurotoxicity (rat) Maternal NOAEL = not established Maternal LOAEL = 8 mg/kg/day based on corneal opacities Offspring NOAEL = not established Offspring LOAEL = 8 mg/kg/day based on decreased auditory startle reflex response 870.7485 Metabolism and pharmacokinetics Absorption of [14C]-topramezone following a single oral dose was rapid but limited, with the highest plasma concentrations observed at 1 hour (first time point measured). Oral absorption is estimated to be approximately 20% of the administered dose. The majority of the dose was recovered within 48 hours in the feces (73– 91% dose) and urine (8–29% dose) 870.7600 Dermal penetration The majority of the applied dose for each group was not absorbed (91.0–98.3% dose), with the greatest amount of the non-absorbed material being recovered from the skin wash (90.8–96.0% dose). Absorbed radioactivity was low and accounted for 0.16–2.60% of the dose for all groups for all exposures B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. Three other types of safety or uncertainty factors may be used: ‘‘Traditional uncertainty factors;’’ the ‘‘special FQPA safety factor;’’ and the ‘‘default FQPA safety factor.’’ By the term ‘‘traditional uncertainty factor,’’ EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 additional safety factor for the protection of infants and children. The term ‘‘special FQPA safety factor’’ refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The ‘‘default FQPA safety factor’’ is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor). For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor. For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10-5), one in a million (1 X 10-6), or one in ten million (1 X 10-7). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ‘‘point of departure’’ in which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for topramezone used for human risk assessment is shown in Table 2. of this unit: E:\FR\FM\10AUR1.SGM 10AUR1 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations 46415 TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TOPRAMEZONE FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment, Interspecies and Intraspecies and any Traditional UF Special FQPA SF and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary (Females 13–50 years of age) NOAEL = 0.5 mg/kg/day UF = 100 Acute RfD = 0.005 mg/kg/day Special FQPA SF = 1X aPAD = acute RfD ÷ Special FQPA SF = 0.005 mg/kg/day Developmental Toxicity Study in Rabbits LOAEL = 5 mg/kg/day based on alterations in skeletal ossification sites and increased number of pairs of ribs Acute Dietary (General population including infants and children) An endpoint of concern for the general population attributable to a single dose was not identified in the hazard database Chronic Dietary (All populations) NOAEL= 0.4 mg/kg/day UF = 100 Chronic RfD = 0.004 mg/kg/ day Cancer (oral, dermal, inhalation) In accordance with the EPA Final Guidelines for Carcinogen Risk Assessment (March 29, 2005), EPA classified topramezone as ‘‘not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.’’ EPA determined that quantification of human cancer risk is not required since the NOAEL (0.4 mg/kg/day) for non-cancer risk assessment is not expected to alter thyroid hormone homeostasis nor result in thyroid tumor formation Topramezone inhibits the 4hydroxyphenylpyruvate dioxygenase (4HPPD) enzyme in the metabolism of tyrosine. Inhibition of this enzyme results in increased serum tyrosine levels and eventually in adverse effects in the animal with increased incidences of corneal opacity, decreased bodyweight, and body-weight gains. The petitioner conducted eight rabbit studies to determine the NOAEL for increased serum tyrosine levels as well as determine the NOAELs for systemic maternal and fetal developmental toxicity endpoints that are not based on tyrosine measurements. There are well established NOAELs and LOAELs for the standard endpoints for maternal and developmental toxicity in rabbits. Currently, it is not known what level of inhibition of the 4-HPPD enzyme results in an adverse effect. Therefore, the observation of enzyme inhibition in the absence of systemic toxicity in maternal animals or soft tissue or skeletal alterations in pups/ offspring are being considered to be a biomarker of exposure, not an adverse effect. None of the data in the submitted studies permit a determination of the percentage of increased tyrosine levels that result in detrimental or adverse effects. The lowest maternal LOAEL observed in the numerous rabbit developmental toxicity studies was 0.5 mg/kg/day. It is not clear, however, that this value is actually a LOAEL because it is based on increased serum tyrosine levels. In this study it could not be determined what VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 Special FQPA SF = 1X cPAD = chronic RfD ÷ Special FQPA SF = 0.004 mg/kg/day dose would not induce increased serum tyrosine levels. In fact, in no study could a ‘‘no effect’’ level be determined for increased serum tyrosine levels in dams. However, a maternal NOAEL of 5 mg/kg/day was observed in another study based on systemic toxicity; in this study tyrosine measurements were not performed. This study has the lowest maternal NOAEL for systemic toxicity among the eight rabbit developmental toxicity studies. Tyrosine levels were not measured for fetuses in any of the rabbit developmental studies. There was a clear developmental toxicity NOAEL of 0.5 mg/kg/day, based on skeletal variations observed at 5 mg/kg/day. The acute RfD for females 13–49 years of age is based on a NOAEL of 0.5 mg/ kg/day for alterations in skeletal ossification sites in rabbits. The chronic RfD is based on the NOAEL of 0.4 mg/ kg/day in the carcinogenicity study in rats. In this study the LOAEL was based on increased incidence of corneal opacities, decrease in body weight gain, liver, pancreas, and thyroid effects seen at 3.6 mg/kg/day. C. Exposure Assessment 1. Dietary exposure from food and feed uses. No tolerances have been established (40 CFR 180.612) previously for the residues of topramezone. Risk assessments were conducted by EPA to assess dietary exposures from topramezone in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 Carcinogenicity Study in Rats LOAEL = 3.6 mg/kg/day based on increased incidences of corneal opacity, decreased body-weight and body-weight gains in males and histopathological evaluations in the thyroid, pancreas, and eyes of both sexes if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one-day or single exposure. In conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM), which incorporates food consumption data as reported by respondents in the United States Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: For the acute analyses, tolerance-level residues were assumed for all food commodities with proposed topramezone tolerances, and it was assumed that all of the crops included in the analysis were treated. Percent crop treated (PCT) and/or anticipated residues were not used in the acute risk assessment. ii. Chronic exposure. In conducting the chronic dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEMFCIDTM), which incorporates food consumption data as reported by respondents in the USDA 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for E:\FR\FM\10AUR1.SGM 10AUR1 46416 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations the chronic exposure assessments: For the chronic analyses, tolerance-level residues were assumed for all food commodities with current or proposed topramezone tolerances, and it was assumed that all of the crops included in the analysis were treated. PCT and/ or anticipated residues were not used in the chronic risk assessment. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for topramezone in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of topramezone. The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/ EXAMS (a tier 2 model) for a screeninglevel assessment for surface water. The GENEEC model is a subset of the PRZM/ EXAMS model that uses a specific highend runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs), which are the model estimates of a pesticide’s concentration in water. EECs derived from these models are used to quantify drinking water exposure and risk as a %RfD or %PAD. VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 Based on the PRZM/EXAMS and SCIGROW models, the EECs of topramezone for acute exposures are estimated to be 0.77 parts per billion (ppb) for surface water and 0.0671 ppb for ground water. The EECs for chronic exposures are estimated to be 0.14 ppb for surface water and 0.0671 ppb for ground water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Topramezone is not registered for use on any sites that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to topramezone and any other substances and topramezone does not appear to produce a toxic metabolite produced by other substances. However, EPA is aware of other herbicides that inhibit the 4-HPPD enzyme (i.e. mesotrione and isoxaflutole). Topramezone, isoxaflutole and mesotrione are known to cause tyrosinemia. To ensure that the potential cumulative effects from these pesticides are not of concern EPA examined three factors: • The extent to which the uses of these pesticides overlap. • The exposure assumptions used in the risk assessments for each of the pesticides. • The risk characterization for each pesticide. As explained Unit III.C.4.i.,ii., and iii., this analysis suggests both that the individual risk characterizations for each pesticide are highly overstated and that cumulative exposure to these pesticides, even if they are later determined to share a common mechanism, is unlikely to pose a risk of concern. i. Pesticide uses. Topramezone, mesotrione, and isoxaflutole are broadspectrum herbicides used to control grassy and broadleaf weeds in corn (the mesotrione label does not list grasses on the label). All three active ingredients PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 are in the phenylpyrazolyl ketone class of chemicals and share the same mode of herbicidal action. They inhibit the 4HPPD enzyme and thereby impair caroteniod biosynthesis in the chlorophyll synthesis pathway, leading to the breakdown in chloroplasts. Therefore no more than one of these active ingredients would be applied to the same field in the same growing season. Topramezone is used postemergent, mesotrione is used pre- and post-emergent, and isoxaflutole is used pre-plant and pre-emergent. The current PCT information for field corn indicates a 5–10% PCT for isoxaflutole and 10– 15% PCT for mesotrione. Sweet corn PCT is < 2.5 for both chemicals. Maximum PCT projections for topramezone on field corn and sweet corn, made by assuming that it will surely not overtake the current leader(s) among herbicides on those crops (i.e. atrazine), are 68 and 60, respectively. ii. Exposure assumptions. Highlyconservative assumptions were used for the aggregate (food + water) risk assessments for each individual assessment. First, it was assumed that 100% of the corn crop was treated with all three of the pesticides. Second, each of the exposure assessments assumed all corn in the diet would have residues present at the tolerance level. In fact, residue data indicates that very low levels of residues were detected in the grain for all three pesticides. iii. Risk characterization. Even with the highly-conservative assumptions, the individual aggregate risk for each of the active ingredients is as follows: • The topramezone chronic dietary risk estimates (food + water) were < 1% of the cPAD for the U.S. population and 1.2% of the cPAD for the most highly exposed population subgroup (children 3–5 years old). • The mesotrione chronic dietary risk estimates (food + water) were 15% of the cPAD for the U.S. population and 45% of the cPAD for the most highlyexposed population subgroup (all infants (< 1 year old)). • The chronic dietary risk estimates (food + water) for residues of the 4HPPD inhibitors (isoxaflutole + RPA 202248) were 18% of the cPAD for the U.S. population and 40% of the cPAD for the most highly-exposed population subgroup (children 3–5 years old). In fact, even if one were to calculate the chronic dietary risk for all three herbicides by combining the individual exposures and using the most sensitive endpoint, the risk would not exceed the level of concern. These pesticides do not share a common acute adverse effect. E:\FR\FM\10AUR1.SGM 10AUR1 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations Accordingly, because the use patterns, exposure assumptions, and risk characterizations for the three pesticides do not suggest that any potential cumulative effect would be at a level of concern, EPA concludes it has adequately considered the potential cumulative effects of topramezone and the pesticides for which it may possibly share a common mechanism of toxicity. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http:// www.epa.gov/pesticides/cumulative/. D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. Increased sensitivity of the young. There is a potential of increased quantitative susceptibility following in utero and/or pre-/post-natal exposure in the developmental toxicity and developmental neurotoxicity studies in rats because a NOAEL for parental or offspring systemic toxicity was not established. However, the current NOAEL of 0.5 mg/kg/day for an acute RfD would provide a 200-fold lower dose based on the most sensitive endpoint. In a developmental neurotoxicity (DNT) study in rats, decreased auditory startle reflex was seen at the LOAEL of 8 mg/kg/day in the presence of maternal toxicity manifested as corneal opacity. Therefore, the VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 susceptibility in this study could not be assessed. However, the NOAEL for the chronic RfD is 0.4 mg/kg/day based on the most critical tyrosine-mediated effects which is 20-fold lower than the LOAEL for the DNT study. There is no evidence of increased susceptibility following pre-/post-natal exposure to rats in the two-generation reproduction study. 3. Conclusion. There is a complete toxicity data base for topramezone and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Although there is the potential for increased quantitative sensitivity in the young from exposure to topramezone, the RfDs selected for evaluating the safety of exposure provide a wide margin of safety for the effects seen in the young. Accordingly, the additional 10X factor for the protection of infants and children is removed. E. Aggregate Risks and Determination of Safety 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and drinking water to topramezone will occupy 1.4 % of the aPAD for females 13 years and older. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to topramezone from food and drinking water will utilize 0.6 % of the cPAD for the U.S. population, 0.9 % of the cPAD for all infants (< 1 year old), and 1.2 % of the cPAD for children 3– 5 years old. Topramezone is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency’s level of concern. 3. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to topramezone residues. IV. Other Considerations A. Analytical Enforcement Methodology A proposed enforcement methodology (liquid chromatography (LC)/mass spectrometry (MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@epa.gov. PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 46417 B. International Residue Limits There are currently no established Codex, Canadian, or Mexican maximum residue limits (MRLs) for topramezone. V. Conclusion Therefore, the tolerance is established for residues of topramezone, [3-(4,5dihydro-3-isoxazolyl)-2-methyl-4(methylsulfonyl)phenyl](5-hydroxy-1methyl-1H-pyrazol-4-yl)methanone, in or on cattle, kidney at 0.05 ppm; cattle, liver at 0.15 ppm; corn, field, forage at 0.05 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 0.05 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.05 ppm; corn, sweet, forage at 0.05 ppm; corn, sweet, kernal plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 0.05 ppm; goat, kidney at 0.05 ppm; goat, liver at 0.15 ppm; horse, kidney at 0.05 ppm; horse, liver at 0.15 ppm; sheep, kidney at 0.05 ppm; and sheep, liver at 0.15 ppm, respectively. VI. Objections and Hearing Requests Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of FFDCA provides essentially the same process for persons to ‘‘object’’ to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of FFDCA. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP–2005–0156 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 11, 2005. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the E:\FR\FM\10AUR1.SGM 10AUR1 46418 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor’s contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564–6255. 2. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP–2005–0156, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via email to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). VII. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risk (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.’’ ‘‘Policies that have federalism implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.’’ This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any ‘‘tribal implications’’ as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.’’ ‘‘Policies that have tribal implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.’’ This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a E:\FR\FM\10AUR1.SGM 10AUR1 Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 26, 2005. James Jones, Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.612 is added to read as follows: I § 180.612 Topramezone; tolerances for residues. (a) General. (1) Tolerances are established for residues of the herbicide topramezone, [3-(4,5-dihydro-3isoxazolyl)-2-methyl-4(methylsulfonyl)phenyl](5-hydroxy-1methyl-1H-pyrazol-4-yl)methanone, in or on the following raw agricultural commodities: Parts per million Commodity Cattle, kidney ............................ Cattle, liver ................................ Corn, field, forage ..................... Corn, field, grain ....................... Corn, field, stover ..................... Corn, pop, grain ........................ Corn, pop, stover ...................... Corn, sweet, forage .................. Corn, sweet, kernel plus cob with husks removed .............. Corn, sweet, stover .................. Goat, kidney ............................. Goat, liver ................................. Horse, kidney ............................ Horse, liver ............................... Sheep, kidney ........................... Sheep, liver ............................... 0.05 0.15 0.05 0.01 0.05 0.01 0.05 0.05 0.01 0.05 0.05 0.15 0.05 0.15 0.05 0.15 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] VerDate jul<14>2003 13:34 Aug 09, 2005 Jkt 205001 (d) Indirect or inadvertent residues. [Reserved] 46419 [FR Doc. 05–15604 Filed 8–9–05; 8:45 am] DC 20460–0001; telephone number: (703) 305–6224; e-mail address: miller.joanne@epa.gov. BILLING CODE 6560–50–S SUPPLEMENTARY INFORMATION: I. General Information ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP–2004–0139; FRL–7724–8] Aminopyralid; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for free and conjugated residues of aminopyralid in or on grass and wheat commodities; and residues of aminopyralid in or meat; fat and meat byproducts, excluding kidney; of cattle, goat, and sheep, and milk. Dow AgroSciences, LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective August 10, 2005. Objections and requests for hearings must be received on or before October 11, 2005. ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under docket identification (ID) number OPP–2004– 0139. All documents in the docket are listed in the EDOCKET index at http:/ /www.epa.gov/edocket/. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: JoanneMiller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using EDOCKET (http:/ /www.epa.gov/edocket/), you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http:// www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines athttp://www.epa.gpo/ opptsfrs/home/guidelin.htm/. II. Background and Statutory Findings In the Federal Register of June 2, 2004 (69 FR 31106–31110) (FRL–7359–3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. E:\FR\FM\10AUR1.SGM 10AUR1

Agencies

[Federal Register Volume 70, Number 153 (Wednesday, August 10, 2005)]
[Rules and Regulations]
[Pages 46410-46419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15604]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0156; FRL-7726-9]


Topramezone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
topramezone in or on field corn, pop corn, sweet corn, kidney, and 
liver. BASF Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 10, 2005. Objections and 
requests for hearings must be received on or before October 11, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0156. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either

[[Page 46411]]

electronically in EDOCKET or in hard copy at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION: Joanne I. Miller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-6224; e-mail address: miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/
guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of June 11, 2003 (68 FR 34950) (FRL-7310-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3F6568) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.612 be amended by 
establishing tolerances for residues of the herbicide topramezone, [3-
(4,5-dihydro-isoxazol-3-yl)-4-methanesulfonyl-2-methylphenyl)-(5-
hydroxyl-1-methyl-1H-pyrazol-4-yl)methanone, in or on corn, field, 
forage; corn, field, grain; corn, field, stover; corn, pop, grain; 
corn, pop, stover; corn, sweet, forage; corn, sweet, kernal plus cob 
with husks removed; corn, sweet, stover; cattle, kidney; cattle, liver; 
goat, kidney; goat, liver; hog, kidney; hog, liver; horse, kidney; 
horse, liver; sheep, kidney; and sheep, liver at 0.05; 0.01; 0.05; 
0.01; 0.05; 0.05; 0.01; 0.05; 0.02; 0.70; 0.20; 0.70; 0.20; 0.70; 0.20; 
0.70; 0.20; and 0.70 parts per million (ppm), respectively. That notice 
included a summary of the petition prepared by BASF Corporation, the 
registrant. There were no comments received in response to the notice 
of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of topramezone on 
cattle, kidney at 0.05 ppm; cattle, liver at 0.15 ppm; corn, field, 
forage at 0.05 ppm; corn, field, grain at 0.01 ppm; corn, field, stover 
at 0.05 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.05 
ppm; corn, sweet, forage at 0.05 ppm; corn, sweet, kernal plus cob with 
husks removed at 0.01 ppm; corn, sweet, stover at 0.05 ppm; goat, 
kidney at 0.05 ppm; goat, liver at 0.15 ppm; horse, kidney at 0.05 ppm; 
horse, liver at 0.15 ppm; sheep, kidney at 0.05 ppm; and sheep, liver 
at 0.15 ppm, respectively.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the toxic effects caused by topramezone are discussed in Table 1. of 
this unit as well as the no observed adverse effect level (NOAEL) and 
the lowest observed adverse effect level (LOAEL) from the toxicity 
studies reviewed .

[[Page 46412]]



                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity--      NOAEL = 1.1 milligrams/kilogram/day (mg/kg/
                                          rodents (rat)               day) males (M) and 2.1 mg/kg/day females
                                                                      (F)
                                                                     LOAEL = 2.1 mg/kg/day for males based on
                                                                      diffuse degeneration in the pancreas and
                                                                      was not established for females
----------------------------------------
870.3100                                 90-Day oral toxicity--      NOAEL = 2,289/3,010 mg/kg/day (M/F)
                                          rodents (mouse)            LOAEL = was not established
----------------------------------------
870.3150                                 90-Day oral toxicity--      NOAEL = 535/1,712 mg/kg/day (M/F)
                                          nonrodents (dog)           LOAEL = 1,511 mg/kg/day for males based on
                                                                      decreased body-weight gain, impaired food
                                                                      efficiency, and inflammation of the
                                                                      urinary bladder and was not established
                                                                      for females
----------------------------------------
870.3200                                 28-Day dermal toxicity      NOAEL = 100/300 mg/kg/day (M/F)
                                          (rat)                      LOAEL = 300 mg/kg/day males based on
                                                                      thyroid follicular cell hypertrophy and
                                                                      1,000 mg/kg/day females based on thyroid
                                                                      follicular cell hypertrophy
----------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = not established
                                          rodents (rat)              Maternal LOAEL = 100 mg/kg/day based on
                                                                      decreased body-weight gains
                                                                     Developmental NOAEL = not established
                                                                     Developmental LOAEL = 100 mg/kg/day based
                                                                      on decreased fetal body weight and
                                                                      increased incidences of skeletal variation
----------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = not established
                                          nonrodents (rabbit)        Maternal LOAEL = 0.5 mg/kg/day based on
                                                                      increased serum tyrosine level
                                                                     Developmental NOAEL = 0.5 mg/kg/day
                                                                     Developmental LOAEL = 5 mg/kg/day based on
                                                                      alterations in skeletal ossification sites
                                                                      and increased number of pairs of ribs
----------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = not established
                                          nonrodents (rabbit)        Maternal LOAEL = 1.5 mg/kg/day based on
                                                                      increased serum tyrosine level
                                                                     Developmental NOAEL = not established
                                                                     Developmental LOAEL = 1.5 mg/kg/day based
                                                                      on an increased incidence of absent kidney
                                                                      and ureter and increased incidences of
                                                                      supernumerary thoracic vertebrae and
                                                                      supernumerary 13\th\ rib
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = 5.0 mg/kg/day
                                          nonrodents (rabbit)        Maternal LOAEL = was not established
                                                                     Developmental NOAEL = not established
                                                                     Developmental LOAEL = 1.5 mg/kg/day for N33
                                                                      and N17/CFR 1-2 based on increased
                                                                      presence of supernumerary thoracic
                                                                      vertebrae and supernumerary 13\th\ rib. No
                                                                      effect was observed for N17/CFR 3 at 0.5
                                                                      mg/kg/day (the only dose tested)
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = 450 mg/kg/day
                                          nonrodents (rabbit)        Maternal LOAEL = not established
                                                                     Developmental NOAEL = not established
                                                                     Developmental LOAEL = 5 mg/kg/day based on
                                                                      visceral findings (fluid-filled abdomen,
                                                                      pale liver, and dark content of the
                                                                      stomach and intestines) and alterations in
                                                                      skeletal development (i.e. incomplete
                                                                      ossification of the vertebrae and talus,
                                                                      and supernumerary thoracic vertebrae and
                                                                      13\th\ rib)
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = 150 mg/kg/day
                                          nonrodents (rabbit)        Maternal LOAEL = 450 mg/kg/day based on
                                                                      decreased body-weight, body-weight gains,
                                                                      food consumption, and increased incidences
                                                                      of abortion and lack of defecation
                                                                     Developmental NOAEL = not established
                                                                     Developmental LOAEL = 50 mg/kg/day based on
                                                                      decreased fetal weight and increased
                                                                      incidence of visceral malformations, and
                                                                      skeletal malformations, variations, and
                                                                      unclassified abnormalities
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = 450 mg/kg/day
                                          nonrodents (rabbit)        Maternal LOAEL = not established
                                                                     Developmental NOAEL = 0.5 mg/kg/day
                                                                     Developmental LOAEL = 5 mg/kg/day based on
                                                                      increased presence of 27 pre-sacral
                                                                      vertebrae and increased an incidence of
                                                                      full supernumerary 13\th\ rib
----------------------------------------------------------------------------------------------------------------

[[Page 46413]]

 
870.3700                                 Prenatal developmental--    Maternal NOAEL = 450 mg/kg/day
                                          nonrodents (rabbit)        Maternal LOAEL = not established
                                                                     Developmental NOAEL = not established
                                                                     Developmental LOAEL = 50 mg/kg/day based on
                                                                      an increased incidence of extra sternebral
                                                                      ossification sites and supernumerary
                                                                      13\th\ rib
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = not established
                                          nonrodents (mouse)         Maternal LOAEL = 30 mg/kg/day based on
                                                                      increased serum tyrosine level
                                                                     Developmental NOAEL = 1,000 mg/kg/day
                                                                     Developmental LOAEL = not established
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 0.4/0.5 mg/kg/day
                                          effects (rat)               (M/F)
                                                                     Parental/Systemic LOAEL = 4.2/4.6 mg/kg/day
                                                                      (M/F) based on decreased body-weight, body-
                                                                      weight gain in males, increased thyroid
                                                                      and kidney weights of both sexes, and
                                                                      microscopic findings in eyes, kidney, and
                                                                      thyroid of both sexes
                                                                     Reproductive NOAEL = 426.8/471.9 mg/kg/day
                                                                      (M/F)
                                                                     Reproductive LOAEL = not established
                                                                     Offspring NOAEL = 0.4/0.5 mg/kg/day (M/F)
                                                                     Offspring LOAEL = 4.2/4.6 mg/kg/day (M/F)
                                                                      based on decreased pup weight and weight
                                                                      gain in F2 male and female pups and
                                                                      increased time to preputial separation in
                                                                      the F1 males
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity--rodents   NOAEL = 0.4/0.5 mg/kg/day (M/F)
                                          (rat)                      LOAEL = 3.9/5.3 mg/kg/day (M/F) based on
                                                                      corneal opacity and pannus and chronic
                                                                      keratitis in both sexes, and thyroid
                                                                      hypertrophy in males
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity--dogs      NOAEL = 2.9/15.4 (M/F) mg/kg/day
                                                                     LOAEL = 15.3 mg/kg/day (M) based on
                                                                      increased incidence of thyroid C-cell
                                                                      hyperplasia and 92 mg/kg/day (F) based on
                                                                      decreased body-weight, body-weight gain,
                                                                      and food efficiency
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity--rats       NOAEL = 0.4/0.5 mg/kg/day (M/F)
                                                                     LOAEL = 3.6/4.7 mg/kg/day (M/F) based on
                                                                      increased incidences of corneal opacity,
                                                                      decreased body-weight and body-weight
                                                                      gains (males only) and histopathological
                                                                      evaluations in the thyroids, pancreas, and
                                                                      eyes of both sexes
                                                                     Neoplastic pathology showed increased
                                                                      incidences of follicular cell adenomas in
                                                                      the thyroid glands of both sexes
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity--mice       NOAEL = not established
                                                                     LOAEL = 19/26 mg/kg/day (M/F) based on
                                                                      decreased body-weight and body-weight
                                                                      gains in males
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation               No indication of a mutagenic response in
                                                                      any strain at any level up to cytotoxic
                                                                      concentrations either with or without S9
                                                                      activation
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation               Based on these considerations, it was
                                                                      concluded that there was confirmed
                                                                      evidence of a mutagenic response in S.
                                                                      typhimurium TA98 in the nonactivated
                                                                      portion of both the plate incorporation
                                                                      and preincubation assays. The effect was,
                                                                      however, observed at high concentrations
                                                                      (>= 3,000 [mu]g/plate-plate incorporation
                                                                      and >= 2,500 [mu]g/plate-preincubation).
                                                                      It was further concluded that the
                                                                      mutagenic effect was likely due to
                                                                      impurities in the test article because: 1)
                                                                      The response was seen at high
                                                                      concentrations including and exceeding the
                                                                      limit dose, 2) bacterial gene mutation
                                                                      assays conducted with other lots of the
                                                                      test material were negative up to the
                                                                      limit dose (see Master Record
                                                                      Identification (MRID) Nos. 45902225
                                                                      through 45902227, and 3) the active
                                                                      ingredient (a.i.) used in the current
                                                                      study has the lowest percentage of purity
                                                                      (95.8% versus 97.7 to 99.3% a.i. for the
                                                                      other lots)
----------------------------------------------------------------------------------------------------------------
870.5300                                 In vitro mammalian cell     No indication that topramezone induced a
                                          gene mutation               mutagenic response, either in the presence
                                                                      of absence of S9 activation
----------------------------------------------------------------------------------------------------------------
870.5375                                 In vitro mammalian          Topramezone-induced a clastogenic response
                                          chromosome aberration       in the presence of S9 activation with
                                                                      significant effects recorded only at an
                                                                      insoluble limit concentration
----------------------------------------------------------------------------------------------------------------
870.5395                                 In vivo mouse bone morrow   No evidence that topramezone was
                                          micronucleus                clastogenic or aneugenic
----------------------------------------------------------------------------------------------------------------
870.5550                                 Unscheduled DNA synthesis   No evidence that topramezone-induced UDS,
                                          (UDS)                       as determined by radioactive tracer
                                                                      procedures (nuclear silver grain counts)
                                                                      at any concentration tested
----------------------------------------------------------------------------------------------------------------

[[Page 46414]]

 
870.6200                                 Acute neurotoxicity         NOAEL= 2,000 mg/kg/day, no neurotoxicity
                                          screening battery (rat)     observed
----------------------------------------------------------------------------------------------------------------
870.6200                                 Subchronic neurotoxicity    No neurotoxicity observed
                                          (rat)                      Systemic NOAEL = not established
                                                                     LOAEL = 4.2/5/0 mg/kg/day (M/F) based on
                                                                      elevated levels of granular casts and
                                                                      transitional epithelial cells in the
                                                                      urinary sediment of the males, increased
                                                                      incidences of corneal clouding in females,
                                                                      minimal diffuse degeneration of the
                                                                      pancreas (both sexes), and slight to
                                                                      moderate flaky colloid in the thyroid of
                                                                      the males
----------------------------------------------------------------------------------------------------------------
870.6300                                 Developmental               Maternal NOAEL = not established
                                          neurotoxicity (rat)        Maternal LOAEL = 8 mg/kg/day based on
                                                                      corneal opacities
                                                                     Offspring NOAEL = not established
                                                                     Offspring LOAEL = 8 mg/kg/day based on
                                                                      decreased auditory startle reflex response
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Absorption of [\14\C]-topramezone following
                                          pharmacokinetics            a single oral dose was rapid but limited,
                                                                      with the highest plasma concentrations
                                                                      observed at 1 hour (first time point
                                                                      measured). Oral absorption is estimated to
                                                                      be approximately 20% of the administered
                                                                      dose. The majority of the dose was
                                                                      recovered within 48 hours in the feces (73-
                                                                      91% dose) and urine (8-29% dose)
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration          The majority of the applied dose for each
                                                                      group was not absorbed (91.0-98.3% dose),
                                                                      with the greatest amount of the non-
                                                                      absorbed material being recovered from the
                                                                      skin wash (90.8-96.0% dose). Absorbed
                                                                      radioactivity was low and accounted for
                                                                      0.16-2.60% of the dose for all groups for
                                                                      all exposures
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-\5\), one in a million (1 X 10-\6\), or one in 
ten million (1 X 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' in 
which carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer = point of departure/exposures) is calculated.
    A summary of the toxicological endpoints for topramezone used for 
human risk assessment is shown in Table 2. of this unit:

[[Page 46415]]



     Table 2.--Summary of Toxicological Dose and Endpoints for Topramezone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of  NOAEL = 0.5 mg/kg/day    Special FQPA SF = 1X     Developmental Toxicity
 age)                                  UF = 100...............  aPAD = acute RfD /        Study in Rabbits
                                       Acute RfD = 0.005 mg/kg/  Special FQPA SF =       LOAEL = 5 mg/kg/day
                                        day.                     0.005 mg/kg/day.         based on alterations
                                                                                          in skeletal
                                                                                          ossification sites and
                                                                                          increased number of
                                                                                          pairs of ribs
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population         An endpoint of concern for the general population attributable to a
 including infants and children)                  single dose was not identified in the hazard database
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 0.4 mg/kg/day     Special FQPA SF = 1X     Carcinogenicity Study
                                       UF = 100...............  cPAD = chronic RfD /      in Rats
                                       Chronic RfD = 0.004 mg/   Special FQPA SF =       LOAEL = 3.6 mg/kg/day
                                        kg/day.                  0.004 mg/kg/day.         based on increased
                                                                                          incidences of corneal
                                                                                          opacity, decreased
                                                                                          body-weight and body-
                                                                                          weight gains in males
                                                                                          and histopathological
                                                                                          evaluations in the
                                                                                          thyroid, pancreas, and
                                                                                          eyes of both sexes
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)           In accordance with the EPA Final Guidelines for Carcinogen Risk
                                         Assessment (March 29, 2005), EPA classified topramezone as ``not likely
                                           to be carcinogenic to humans at doses that do not alter rat thyroid
                                           hormone homeostasis.'' EPA determined that quantification of human
                                          cancer risk is not required since the NOAEL (0.4 mg/kg/day) for non-
                                             cancer risk assessment is not expected to alter thyroid hormone
                                                    homeostasis nor result in thyroid tumor formation
----------------------------------------------------------------------------------------------------------------

    Topramezone inhibits the 4-hydroxyphenylpyruvate dioxygenase (4-
HPPD) enzyme in the metabolism of tyrosine. Inhibition of this enzyme 
results in increased serum tyrosine levels and eventually in adverse 
effects in the animal with increased incidences of corneal opacity, 
decreased body-weight, and body-weight gains. The petitioner conducted 
eight rabbit studies to determine the NOAEL for increased serum 
tyrosine levels as well as determine the NOAELs for systemic maternal 
and fetal developmental toxicity endpoints that are not based on 
tyrosine measurements.
    There are well established NOAELs and LOAELs for the standard 
endpoints for maternal and developmental toxicity in rabbits. 
Currently, it is not known what level of inhibition of the 4-HPPD 
enzyme results in an adverse effect. Therefore, the observation of 
enzyme inhibition in the absence of systemic toxicity in maternal 
animals or soft tissue or skeletal alterations in pups/offspring are 
being considered to be a biomarker of exposure, not an adverse effect. 
None of the data in the submitted studies permit a determination of the 
percentage of increased tyrosine levels that result in detrimental or 
adverse effects.
    The lowest maternal LOAEL observed in the numerous rabbit 
developmental toxicity studies was 0.5 mg/kg/day. It is not clear, 
however, that this value is actually a LOAEL because it is based on 
increased serum tyrosine levels. In this study it could not be 
determined what dose would not induce increased serum tyrosine levels. 
In fact, in no study could a ``no effect'' level be determined for 
increased serum tyrosine levels in dams. However, a maternal NOAEL of 5 
mg/kg/day was observed in another study based on systemic toxicity; in 
this study tyrosine measurements were not performed. This study has the 
lowest maternal NOAEL for systemic toxicity among the eight rabbit 
developmental toxicity studies. Tyrosine levels were not measured for 
fetuses in any of the rabbit developmental studies. There was a clear 
developmental toxicity NOAEL of 0.5 mg/kg/day, based on skeletal 
variations observed at 5 mg/kg/day.
    The acute RfD for females 13-49 years of age is based on a NOAEL of 
0.5 mg/kg/day for alterations in skeletal ossification sites in 
rabbits. The chronic RfD is based on the NOAEL of 0.4 mg/kg/day in the 
carcinogenicity study in rats. In this study the LOAEL was based on 
increased incidence of corneal opacities, decrease in body weight gain, 
liver, pancreas, and thyroid effects seen at 3.6 mg/kg/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No tolerances have 
been established (40 CFR 180.612) previously for the residues of 
topramezone. Risk assessments were conducted by EPA to assess dietary 
exposures from topramezone in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a one-day or single exposure.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), which incorporates food consumption 
data as reported by respondents in the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII), and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the acute exposure assessments: For the acute analyses, tolerance-level 
residues were assumed for all food commodities with proposed 
topramezone tolerances, and it was assumed that all of the crops 
included in the analysis were treated. Percent crop treated (PCT) and/
or anticipated residues were not used in the acute risk assessment.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for

[[Page 46416]]

the chronic exposure assessments: For the chronic analyses, tolerance-
level residues were assumed for all food commodities with current or 
proposed topramezone tolerances, and it was assumed that all of the 
crops included in the analysis were treated. PCT and/or anticipated 
residues were not used in the chronic risk assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for topramezone in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of topramezone.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) to estimate pesticide concentrations in surface 
water and SCI-GROW, which predicts pesticide concentrations in ground 
water. In general, EPA will use GENEEC (a tier 1 model) before using 
PRZM/EXAMS (a tier 2 model) for a screening-level assessment for 
surface water. The GENEEC model is a subset of the PRZM/EXAMS model 
that uses a specific high-end runoff scenario for pesticides. GENEEC 
incorporates a farm pond scenario, while PRZM/EXAMS incorporate an 
index reservoir environment in place of the previous pond scenario. The 
PRZM/EXAMS model includes a percent crop area factor as an adjustment 
to account for the maximum percent crop coverage within a watershed or 
drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 
topramezone for acute exposures are estimated to be 0.77 parts per 
billion (ppb) for surface water and 0.0671 ppb for ground water. The 
EECs for chronic exposures are estimated to be 0.14 ppb for surface 
water and 0.0671 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Topramezone is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to topramezone and any other 
substances and topramezone does not appear to produce a toxic 
metabolite produced by other substances. However, EPA is aware of other 
herbicides that inhibit the 4-HPPD enzyme (i.e. mesotrione and 
isoxaflutole). Topramezone, isoxaflutole and mesotrione are known to 
cause tyrosinemia. To ensure that the potential cumulative effects from 
these pesticides are not of concern EPA examined three factors:
     The extent to which the uses of these pesticides overlap.
     The exposure assumptions used in the risk assessments for 
each of the pesticides.
     The risk characterization for each pesticide.
    As explained Unit III.C.4.i.,ii., and iii., this analysis suggests 
both that the individual risk characterizations for each pesticide are 
highly overstated and that cumulative exposure to these pesticides, 
even if they are later determined to share a common mechanism, is 
unlikely to pose a risk of concern.
    i. Pesticide uses. Topramezone, mesotrione, and isoxaflutole are 
broad-spectrum herbicides used to control grassy and broadleaf weeds in 
corn (the mesotrione label does not list grasses on the label). All 
three active ingredients are in the phenylpyrazolyl ketone class of 
chemicals and share the same mode of herbicidal action. They inhibit 
the 4-HPPD enzyme and thereby impair caroteniod biosynthesis in the 
chlorophyll synthesis pathway, leading to the breakdown in 
chloroplasts. Therefore no more than one of these active ingredients 
would be applied to the same field in the same growing season. 
Topramezone is used post-emergent, mesotrione is used pre- and post-
emergent, and isoxaflutole is used pre-plant and pre-emergent. The 
current PCT information for field corn indicates a 5-10% PCT for 
isoxaflutole and 10-15% PCT for mesotrione. Sweet corn PCT is < 2.5 for 
both chemicals. Maximum PCT projections for topramezone on field corn 
and sweet corn, made by assuming that it will surely not overtake the 
current leader(s) among herbicides on those crops (i.e. atrazine), are 
68 and 60, respectively.
    ii. Exposure assumptions. Highly-conservative assumptions were used 
for the aggregate (food + water) risk assessments for each individual 
assessment. First, it was assumed that 100% of the corn crop was 
treated with all three of the pesticides. Second, each of the exposure 
assessments assumed all corn in the diet would have residues present at 
the tolerance level. In fact, residue data indicates that very low 
levels of residues were detected in the grain for all three pesticides.
    iii. Risk characterization. Even with the highly-conservative 
assumptions, the individual aggregate risk for each of the active 
ingredients is as follows:
     The topramezone chronic dietary risk estimates (food + 
water) were < 1% of the cPAD for the U.S. population and 1.2% of the 
cPAD for the most highly exposed population subgroup (children 3-5 
years old).
     The mesotrione chronic dietary risk estimates (food + 
water) were 15% of the cPAD for the U.S. population and 45% of the cPAD 
for the most highly-exposed population subgroup (all infants (< 1 year 
old)).
     The chronic dietary risk estimates (food + water) for 
residues of the 4-HPPD inhibitors (isoxaflutole + RPA 202248) were 18% 
of the cPAD for the U.S. population and 40% of the cPAD for the most 
highly-exposed population subgroup (children 3-5 years old).
    In fact, even if one were to calculate the chronic dietary risk for 
all three herbicides by combining the individual exposures and using 
the most sensitive endpoint, the risk would not exceed the level of 
concern. These pesticides do not share a common acute adverse effect.

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    Accordingly, because the use patterns, exposure assumptions, and 
risk characterizations for the three pesticides do not suggest that any 
potential cumulative effect would be at a level of concern, EPA 
concludes it has adequately considered the potential cumulative effects 
of topramezone and the pesticides for which it may possibly share a 
common mechanism of toxicity.
    For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://
www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Increased sensitivity of the young. There is a potential of 
increased quantitative susceptibility following in utero and/or pre-/
post-natal exposure in the developmental toxicity and developmental 
neurotoxicity studies in rats because a NOAEL for parental or offspring 
systemic toxicity was not established. However, the current NOAEL of 
0.5 mg/kg/day for an acute RfD would provide a 200-fold lower dose 
based on the most sensitive endpoint. In a developmental neurotoxicity 
(DNT) study in rats, decreased auditory startle reflex was seen at the 
LOAEL of 8 mg/kg/day in the presence of maternal toxicity manifested as 
corneal opacity. Therefore, the susceptibility in this study could not 
be assessed. However, the NOAEL for the chronic RfD is 0.4 mg/kg/day 
based on the most critical tyrosine-mediated effects which is 20-fold 
lower than the LOAEL for the DNT study. There is no evidence of 
increased susceptibility following pre-/post-natal exposure to rats in 
the two-generation reproduction study.
    3. Conclusion. There is a complete toxicity data base for 
topramezone and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. Although there 
is the potential for increased quantitative sensitivity in the young 
from exposure to topramezone, the RfDs selected for evaluating the 
safety of exposure provide a wide margin of safety for the effects seen 
in the young. Accordingly, the additional 10X factor for the protection 
of infants and children is removed.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and 
drinking water to topramezone will occupy 1.4 % of the aPAD for females 
13 years and older.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
topramezone from food and drinking water will utilize 0.6 % of the cPAD 
for the U.S. population, 0.9 % of the cPAD for all infants (< 1 year 
old), and 1.2 % of the cPAD for children 3-5 years old.
    Topramezone is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    3. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to topramezone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A proposed enforcement methodology (liquid chromatography (LC)/mass 
spectrometry (MS)) is available to enforce the tolerance expression. 
The method may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for topramezone.

V. Conclusion

    Therefore, the tolerance is established for residues of 
topramezone, [3-(4,5-dihydro-3-isoxazolyl)-2-methyl-4-
(methylsulfonyl)phenyl](5-hydroxy-1-methyl-1H-pyrazol-4-yl)methanone, 
in or on cattle, kidney at 0.05 ppm; cattle, liver at 0.15 ppm; corn, 
field, forage at 0.05 ppm; corn, field, grain at 0.01 ppm; corn, field, 
stover at 0.05 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 
0.05 ppm; corn, sweet, forage at 0.05 ppm; corn, sweet, kernal plus cob 
with husks removed at 0.01 ppm; corn, sweet, stover at 0.05 ppm; goat, 
kidney at 0.05 ppm; goat, liver at 0.15 ppm; horse, kidney at 0.05 ppm; 
horse, liver at 0.15 ppm; sheep, kidney at 0.05 ppm; and sheep, liver 
at 0.15 ppm, respectively.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0156 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before October 
11, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the

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grounds for the objections (40 CFR 178.25). If a hearing is requested, 
the objections must include a statement of the factual issue(s) on 
which a hearing is requested, the requestor's contentions on such 
issues, and a summary of any evidence relied upon by the objector (40 
CFR 178.27). Information submitted in connection with an objection or 
hearing request may be claimed confidential by marking any part or all 
of that information as CBI. Information so marked will not be disclosed 
except in accordance with procedures set forth in 40 CFR part 2. A copy 
of the information that does not contain CBI must be submitted for 
inclusion in the public record. Information not marked confidential may 
be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0156, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted