Propiconazole; Pesticide Tolerance, 55300-55307 [06-8064]

Download as PDF 55300 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations Commodity Parts per million Banana ........................... Beet, sugar, dried pulp ... Beet, sugar, molasses .... Beet, sugar, roots ........... Beet, sugar, tops ............ Bushberry subgroup 13B Cattle, meat byproducts Citrus, dried pulp ............ Citrus, oil ......................... Cranberry ........................ Fruit, citrus, group 10 ..... Fruit, stone, group 12 ..... Goat, meat byproducts ... Grain, aspirated fractions Grape1 ............................ Horse, meat byproducts Peanut ............................ Pecan .............................. Sheep, meat byproducts Wheat, forage ................. Wheat, grain ................... Wheat, hay ..................... Wheat, straw ................... 0.3 1.0 0.4 0.3 9.0 0.3 0.05 5.0 40.0 0.5 1.0 1.0 0.05 6.0 1.0 0.05 0.1 0.05 0.05 4.0 0.1 8.0 8.0 1There are no United States registrations for grape as of August 2006. * * * * * [FR Doc. 06–7957 Filed 9–21–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY I. General Information 40 CFR Part 180 [EPA–HQ–OPP–2006–0347; FRL–8092–1] Propiconazole; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. rwilkins on PROD1PC63 with RULES_1 AGENCY: SUMMARY: This regulation establishes or revises tolerances for combined residues of propiconazole and its metabolites containing the dichlorobenzoic acid (DCBA) moiety expressed as parent compound in or on various commodities; and inadvertent residues in or on alfalfa, forage and alfalfa, hay. Syngenta Crop Protection, Inc. and Interregional Research Project No. 4 (IR4), 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 September 22, 2006. Objections and requests for hearings must be received on or before November 21, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2006–0347. All documents in the VerDate Aug<31>2005 16:03 Sep 21, 2006 Jkt 208001 docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., 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 in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The 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: Mary Waller, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–9354; e-mail address: waller.mary@epa.gov. SUPPLEMENTARY 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 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at https:// www.gpoaccess.gov/ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the 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. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2006–0347 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 November 21, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA–HQ–OPP–2006–0347, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, E:\FR\FM\22SER1.SGM 22SER1 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations rwilkins on PROD1PC63 with RULES_1 excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305– 5805. II. Background and Statutory Findings In the Federal Register of May 3, 2006 (71 FR 26084) (FRL–8060–2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP) 2F6371 and 5F4498 by Syngenta Crop Protection, Inc., and PP 6E4788, 7E4860, and 8E4931 by Interregional Research Project No. 4 (IR-4). The petitions requested that 40 CFR 180.434 be amended by establishing a tolerance for combined residues of the fungicide propiconazole, 1-[[2-(2,4dichlorophenyl)-4-propyl-1,3-dioxolan2-yl] methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4dichlorobenzoic acid and expressed as parent compound in or on leafy vegetables (Subgroup 4B) at 5.0 parts per million (ppm) (PP 6E4788); cranberry at 1.0 ppm (PP 7E4860); Mint at.3.0 ppm (PP 8E4931); and under PP 2F6371, almond, hulls and onion, green at 8.0 ppm; berries (Group 13) and legume vegetables (Group 6) at 1.0 ppm; foliage of legume vegetables (Group 7)/ sorghum/soybean, forage and sugar beet, tops at 10.0 ppm; carrot, roots/ pistachios/nuts, tree (Group 14) at 0.2 ppm; foliage of legume vegetable (Group 7)/soybean, hay at 32.0 ppm; onion, dry bulb/corn, grain/sugar beet, roots at 0.3 ppm; sorghum, grain/grain cereal group (except corn, rice, and sorghum), bran at 2.5 ppm; sorghum, stover at 15.0 ppm; soybean, seed/grain, cereal group (except corn, rice, and sorghum), hay/ sugar beet, dried pulp at 2.0 ppm; strawberry at 1.5 ppm; grain, cereal group (except corn, rice, and sorghum) (Group 15), forage/sugar beet, molasses at 3.0 ppm; grain, cereal group (except corn, rice, and sorghum), straw at 13.0 ppm; grain, cereal group (except corn, rice, and sorghum)/corn, oil at 0.5 ppm; rice, bran and hulls at 28.0 ppm; and aspirated grain fraction at 17.0 ppm. Further, the petition requested existing tolerances be amended for corn, forage at 4.0 ppm; corn, stover at 25.0 ppm; rice, grain at 7.0 ppm; and rice, straw at 18.0 ppm. Additionally, PP 5F4498, requested inadvertent residues for alfalfa, forage and hay at 0.1 ppm. That notice included a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing. Upon completing review of the current propiconazole database, the VerDate Aug<31>2005 16:03 Sep 21, 2006 Jkt 208001 Agency concluded that the appropriate tolerance levels for propiconazole residues in or on pending crops and livestock commodities should be established as follow: On grain, aspirated fractions at 30 ppm; almond, hulls at 7.0 ppm; barley, grain at 0.3 ppm; barley, hay at 1.4 ppm; barley, straw at 10 ppm; barley, bran at 0.6 ppm; cattle, fat at 0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat byproducts, except liver and kidney at 0.05 ppm; leafy petioles, subgroup 4B at 5.0 ppm; Berry group 13 at 1.0 ppm; carrot, roots at 0.25 ppm; corn, field, forage at 12 ppm; corn, sweet, forage at 6.0 ppm; corn, field, grain at 0.2 ppm; corn, pop, grain at 0.2 ppm; corn, field, stover at 30 ppm; corn, pop, stover at 30 ppm; corn, sweet, stover at 30 ppm; goat, fat at 0.05 ppm; goat, meat at 0.05 ppm; goat, meat byproducts, except liver and kidney at 0.05 ppm; hog, kidney at 0.2 ppm; hog, liver at 0.2 ppm; horse, fat at 0.05 ppm; horse, meat at 0.05 ppm; horse, meat byproducts, except liver and kidney at 0.05 ppm; spearmint, tops at 3.5 ppm; peppermint, tops at 3.5 ppm; oat, forage at 1.7 ppm; oat, grain at 0.3 ppm; oat, hay at 1.4 ppm; oat, straw at 10 ppm; onion, bulb at 0.2 ppm; onion, green at 9.0 ppm; pistachio at 0.1 ppm; rice, bran at 15 ppm; rice, grain at 7.0 ppm; rice, hulls at 20 ppm; rice, straw at 18 ppm; rye, grain at 0.3 ppm; rye, forage at 1.7 ppm; rye, straw at 10 ppm; rye, bran at 0.6 ppm; sorghum, grain, forage at 12 ppm; sorghum, grain, grain at 3.5 ppm; sorghum, grain, stover at 15 ppm; sheep, fat at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat byproducts, except liver and kidney at 0.05 ppm; soybean, forage at 11 ppm; soybean, hay at 30 ppm; soybean, seed at 2.0 ppm; strawberry at 1.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.3 ppm; beet, sugar, tops at 10 ppm; beet, sugar, molasses at 1.5 ppm; nut, tree, group 14 at 0.1 ppm; wheat, bran at 0.6 ppm; wheat, forage at 1.7 ppm; wheat, grain at 0.3 ppm; wheat, hay at 1.4 ppm; wheat, straw at 10 ppm; cranberry at 1.0 ppm; and inadvertent residues in or on alfalfa, forage at 0.1 ppm and alfalfa, hay at 0.1 ppm. The Agency concluded that there are insufficient data to establish tolerances legume vegetables (Group 6); foliage of legume vegetables (Group 7); cereal group (except corn, rice, and sorghum) (Group 15). For additional information refer to www.regulations.gov Docket No. EPA– HQ–OPP–2006–0347–0008. EPA is also deleting several established tolerances in 40 CFR 180.434(a), (b), and (c) that are no longer needed as a result of this action. PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 55301 The revisions to 180.434(a) are as follows: • Delete celery at 5.0 ppm. Replaced with leafy petioles, subgroup 4B at 5.0 ppm. • Delete pecans at 0.1 ppm. Replaced with nut, tree, group 14 at 0.1 ppm. The revisions to 180.434(b) are as follows: • Delete the time-limited tolerance for blueberry at 1.0 ppm. Replaced with Berry group 13 at 1.0 ppm, under 40 CFR 180.434(a). • Delete the time-limited tolerance for cranberry; grain, aspirated fractions; sorghum, grain, grain; sorghum, grain, stover; soybean; soybean, forage; and soybean, hay. All are being replaced by permanent tolerances. • Delete time-limited tolerance for dry bean; dry bean forage; and dry bean hay since these tolerances have expired. The revisions to 180.434(c) are as follows: • Delete mint, tops (leaves and stems) at 0.3 ppm. Replaced with spearmint, tops at 3.5 ppm and peppermint, tops at 3.5 ppm under 40 CFR 180.434(a). 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 the FFDCA and a complete description of the risk assessment process, see https:// www.epa.gov/fedrgstr/EPA-PEST/1997/ November/Day-26/p30948.htm. 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 E:\FR\FM\22SER1.SGM 22SER1 55302 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations rwilkins on PROD1PC63 with RULES_1 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 combined residues of propiconazole and its metabolites containing the dichlorobenzoic acid (DCBA) moiety expressed as parent compound on grain, aspirated fractions at 30 ppm; almond, hulls at 7.0 ppm; barley, grain at 0.3 ppm; barley, hay at 1.4 ppm; barley, straw at 10 ppm; barley, bran at 0.6 ppm; cattle, fat at 0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat byproducts, except liver and kidney at 0.05 ppm; leafy petioles, subgroup 4B at 5.0 ppm; Berry group 13 at 1.0 ppm; carrot, roots at 0.25 ppm; corn, field, forage at 12 ppm; corn, sweet, forage at 6.0 ppm; corn, field, grain at 0.2 ppm; corn, pop, grain at 0.2 ppm; corn, field, stover at 30 ppm; corn, pop, stover at 30 ppm; corn, sweet, stover at 30 ppm; goat, fat at 0.05 ppm; goat, meat at 0.05 ppm; goat, meat byproducts, except liver and kidney at 0.05 ppm; hog, kidney at 0.2 ppm; hog, liver at 0.2 ppm; horse, fat at 0.05 ppm; horse, meat at 0.05 ppm; horse, meat byproducts, except liver and kidney at 0.05 ppm; spearmint, tops at 3.5 ppm; peppermint, tops at 3.5 ppm; oat, forage at 1.7 ppm; oat, grain at 0.3 ppm; oat, hay at 1.4 ppm; oat, straw at 10 ppm; onion, bulb at 0.2 ppm; onion, green at 9.0 ppm; pistachio at 0.1 ppm; rice, bran at 15 ppm; rice, grain at 7.0 ppm; rice, hulls at 20 ppm; rice, straw at 18 ppm; rye, grain at 0.3 ppm; rye, forage at 1.7 ppm; rye, straw at 10 ppm; rye, bran at 0.6 ppm; sorghum, grain, forage at 12 ppm; sorghum, grain, grain at 3.5 ppm; sorghum, grain, stover at 15 ppm; sheep, fat at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat byproducts, except liver and kidney at 0.05 ppm; soybean, forage at 11 ppm; soybean, hay at 30 ppm; soybean, seed at 2.0 ppm; strawberry at 1.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.3 ppm; beet, sugar, tops at 10 ppm; beet, sugar, molasses at 1.5 ppm; nut, tree, group 14 at 0.1 ppm; wheat, bran at 0.6 ppm; wheat, forage at 1.7 ppm; wheat, grain at 0.3 ppm; wheat, hay at 1.4 ppm; wheat, straw at 10 ppm; cranberry at 1.0 ppm; and inadvertent residues in or on alfalfa, forage at 0.1 ppm and alfalfa, hay at 0.1 ppm. EPA’s assessment of exposures and risks associated with establishing the tolerance follows. 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 VerDate Aug<31>2005 16:03 Sep 21, 2006 Jkt 208001 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 propiconazole as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies can be found at www.regulations.gov Docket No. EPA–HQ–OPP–2006–0347– 0005; pages 35–42. 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. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify nonthreshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at https://www.epa.gov/ pesticides/health/human.htm. A summary of the toxicological endpoints for propiconazole used for human risk assessment is discussed at www.regulations.gov Docket No. EPA– HQ–OPP–2006–0347–0004; pages 23– 25. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.434) for the combined residues of propiconazole and its metabolites containing the dichlorobenzoic acid (DCBA) moiety expressed as parent compound, in or on a variety of raw agricultural commodities. Tolerances are also established for residues of propiconazole and its metabolites containing the dichlorobenzoic acid (DCBA) moiety expressed as parent PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 compound in or on milk as well as fat, meat, kidney, liver and meat by products of cattle, goats, hogs, horse, and sheep. Some of these existing tolerances are being revised as a result of this action. Risk assessments were conducted by EPA to assess dietary exposures from propiconazole 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 1–day or single exposure. In conducting the acute dietary exposure 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 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: Tolerance levels and one hundred percent of the crops were treated for all proposed new uses, revised uses, and existing uses. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the DEEM-FCIDTM, which incorporates food consumption data as reported by respondents in the USDA 1994–1996 and 1998 nationwide CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance levels and 100% of the crops were treated for all proposed new uses, revised uses, and existing uses. iii. Cancer. Propiconazole has been classified as a group C (possible human carcinogen). The Agency concluded that the chronic risk assessment, making use of the chronic population adjusted dose (cPAD), is protective of any potential carcinogenic risk. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for propiconazole 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 propiconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment E:\FR\FM\22SER1.SGM 22SER1 rwilkins on PROD1PC63 with RULES_1 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations can be found at https://www.epa.gov/ oppefed1/models/water/index.htm. A registrant drinking water monitoring study showed very few detections among a total of 38 selected community water systems in 12 states. The Agency concluded that the sampling scheduling of this monitoring study is not rigorous enough to be used for water assessment. Since the monitoring studies did not provide good quality data, this drinking water assessment is based on the model predicted drinking water concentrations. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening concentration in Ground Water (SCIGROW) models, the estimated environmental concentrations (EECs) of propiconazole for acute exposures are estimated to be 55.8 parts per billion (ppb) for surface water and 0.64 ppb for ground water. The EECs for chronic exposures are estimated to be 21.6 ppb for surface water and 0.64 ppb for ground water. To estimate surface water for each specific use, the maximum allowable label rate was input into PRZM/EXAMS. The output concentrations were without percent cropped area (PCA) consideration. The final estimated drinking water concentrations were then adjusted with the proper PCA. Except the uses of soybean (0.41 ppb) and wheat (0.56 ppb), other uses assume the default PCA of 0.87 ppb. Among these modeling results, turf use gives the highest acute concentration of 55.78 ppb (Microgram/liter (µg/L)). For the chronic exposure, turf use has the highest concentration of 21.61 ppb (µg/L). The EECs in ground water were calculated using the Tier I SCI-GROW model. SCI-GROW is neither scenarionor crop-specific. The only input requirements are application rate, number of applications, Koc, and aerobic soil metabolism half-life. The higher estimated concentrations are associated with the higher rate. Turf use has the highest concentration of 0.64 µg/L (ppb). Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEMFCID(TM)). For acute dietary risk assessment, the peak water concentration value of 55.8 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the annual average concentration of 21.6 ppb was used to access the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to non- VerDate Aug<31>2005 16:03 Sep 21, 2006 Jkt 208001 occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Propiconazole is currently registered for use on the following residential nondietary sites: Ground covers; turf and ornamentals in lawns and golf courses; ornamentals trees (injection); shade trees (outdoor spray); herbaceous plants; ornamental woody shrubs and vines and antimicrobial uses in paint and wood protection treatment. The risk assessment was conducted using the following residential exposure assumptions: Homeowners can be exposed to propiconazole through dermal and inhalation routes while applying home use products. All risk calculations were conducted using the maximum turf application rate (1.8 lb ai/acre). The anticipated use patterns and current labeling indicate three major residential exposure scenarios based on the types of equipment and techniques that can potentially be used to make propiconazole applications. The quantitative exposure/risk assessment developed for residential handlers is based on these scenarios: • Mixer/Loader/applying liquids and wettable powder in water soluble packets via low pressure handwand. • Mixer/Loader/applying liquids and wettable powder in water soluble packets via hose-end sprayer. • Applying treated paint using airless sprayer and hose-end spray. Residential handler exposure scenarios are considered to be shortterm only due to the infrequent uses associated with homeowner products. The existing residential use patterns result in post application dermal exposures to adults, and dermal and oral exposures to infants and children. These exposure scenarios are considered short term only, due to the fact that: i. Post-application exposures were calculated using propiconazole as the parent compound; ii. Compound specific turf transferable residue (TTR) data indicate that at the Indiana, California, and Pennsylvania test sites, average total propiconazole residues declined to below the minimum quantifiable limit (MQL) by 14, 10 and 8 days after treatment, respectively. These dissipation rates, combined with label specific use rates and frequency of use specifications, reinforce the hand to mouth short-term exposure scenario; iii. For short term exposure to children 1–2 years old, the driving factors for this risk assessment are hand to mouth, object to mouth, and dermal PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 55303 exposure. Soil ingestion is insignificant (margin of exposure (MOE) >300,000) compared to these factors, indicating that the post application scenario should be short term only. Although both residential and antimicrobial uses result in incidental oral and dermal exposure to children, the highest incidental oral and dermal exposure scenarios are from residential use on turf, which were used in the short term aggregate risk assessment. In addition to using the EPA’s Standard Operational Procedure (SOP) for residential assessment, the study specific turf transferable residue (TTR) was used to estimate exposures. The EPA combined exposures resulting from separate post-application exposure scenarios when it is likely they can occur simultaneously based on the usepattern and the behavior associated with the exposed population. The assumptions used for each of the scenarios separately are considered to account for potential high levels of exposure (i.e., time spent outdoors, dislodgeable residues) therefore, combining all these activities together is considered a very high end estimate of exposure. Propiconazole is classified as a non-volatile chemical; therefore a residential inhalation post-application assessment was not assessed. The only residential use scenario that will result in potential intermediate term exposure to propiconazole is post application exposure to children from wood treatment (antimicrobial use) from incidental oral and dermal contact activities. 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.’’ Propiconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between this pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some E:\FR\FM\22SER1.SGM 22SER1 55304 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations rwilkins on PROD1PC63 with RULES_1 induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA’s procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA’s website at https://www.epa.gov/ pesticides/cumulative. Propiconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including propiconazole, EPA conducted a human health risk assessment for exposure to 1,2,4triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency’s complete risk assessment is found in the propiconazole reregistration docket at www.regulations.gov, Docket ID number EPA–HQ–OPP–2005–0497–0013. 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 database 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 VerDate Aug<31>2005 16:03 Sep 21, 2006 Jkt 208001 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. Prenatal and postnatal sensitivity. There is low concern for pre- and/or postnatal toxicity resulting from exposure to propiconazole. In the developmental toxicity study in rats, the EPA considered the fetal effects observed in this study at a dose lower than that evoking maternal toxicity to be quantitative evidence of increased susceptibility of fetuses to in utero exposure to propiconazole. In the developmental toxicity study in rabbits, the Agency determined that neither quantitative nor qualitative evidence of increased susceptibility of fetuses to in utero exposure to propiconazole was observed in this study. In the 2– generation reproduction study in rats, neither quantitative nor qualitative evidence of increased susceptibility of neonates (as compared to adults) to preand/or postnatal exposure to propiconazole was observed in the study. Since there is quantitative evidence of increased susceptibility of the young following exposure to propiconazole in the developmental rat study, the Agency performed a Degree of Concern Analysis to: i. Determine the LOC for the effects observed when considered in the context of all available toxicity data; and ii. Identify any residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment of this chemical. If residual uncertainties are identified, then EPA examines whether these residual uncertainties can be addressed by a special FQPA safety factor and, if so, the size of the factor needed. In the developmental rat study, quantitative susceptibility was evidenced as increased incidence of rudimentary ribs, unossified sternebrae, as well as increased incidence of shortened and absent renal papillae and increased cleft palate at (90 mg/kg/day) a dose lower than that evoking maternal toxicity (severe clinical toxicity at 300 mg/kg/ day). Considering the overall toxicity profile and the doses and endpoints selected for risk assessment for propiconazole, the EPA characterized the degree of concern for the effects PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 observed in this study as low, noting that there is a clear no observed adverse effect level (NOAEL) and wellcharacterized dose response for the developmental effects observed. No residual uncertainties were identified. The NOAEL for developmental effects in this study (30 mg/kg/day) is used as the basis for the acute Reference dose (aRfD) for the female 13–50 population subgroup as well as for short-term incidental oral, dermal and inhalation endpoints. For all other toxicity endpoints established for propiconazole, a NOAEL lower than this developmental NOAEL is used. 3. Conclusion. There is a complete toxicity data base for propiconazole and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. There is low concern for pre- and/or postnatal toxicity resulting from exposure to propiconazole. In the developmental toxicity study in rats the fetal effects observed were seen at a dose lower than that evoking maternal toxicity. These effects were considered to be quantitative evidence of increased susceptibility of fetuses to in utero exposure to propiconazole. Therefore, as discussed above a Degree of Concern Analysis was conducted and the EPA concluded that the degree of concern for the effects observed in this study was low and no residual uncertainties were identified. EPA determined that the 10X SF to protect infants and children should be 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 water to propiconazole will occupy 6% of the acute Population Adjusted Dose (aPAD) for the U.S. population, 5% of the aPAD for females 13 years and older, 14% of the aPAD for all infants (<1 year old), the subpopulation at greatest exposure, and 13% of the aPAD for children 1–2 years old. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the aPAD. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to propiconazole from food and water will utilize 6% of the chronic Population Adjusted Dose (cPAD) for the U.S. population, 14% of the cPAD for all infants (<1 year old), and 14% of the cPAD for children 1–2 years old, the subpopulation at greatest exposure. Based the use pattern, chronic residential exposure to residues of propiconazole is not expected. E:\FR\FM\22SER1.SGM 22SER1 rwilkins on PROD1PC63 with RULES_1 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Propiconazole is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for propiconazole. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water and residential exposures aggregated result in aggregate MOEs for children 1–2 years old of 1,100 for hand to mouth activity on turf; 4,500 for object to mouth activity on turf; 330,000 for soil ingestion; 210 for high contact turf activities; and 410 from the antimicrobial use of propiconazole in treated wood. The food, water and residential exposures aggregated for children 1–2 years old following postapplication of propiconazole result in an aggregate MOE of 160 for high contact activities. The corresponding aggregate MOE for adults following post-application exposure is 330. These aggregate MOEs do not exceed the Agency’s LOC for aggregate exposure to food, water and residential uses. Therefore, EPA does not expect shortterm aggregate exposure to exceed the Agency’s LOC. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Propiconazole is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for propiconazole. Using the exposure assumptions described in this unit for intermediateterm exposures, EPA has concluded that food, water and residential exposures aggregated result in an aggregate MOE of 120 for combined exposures from incidental oral and dermal contact activities for children 1–2 years old. These aggregate MOEs do not exceed the Agency’s LOC for aggregate exposure to food, water and residential uses. Therefore, EPA does not expect intermediate-term aggregate exposure to exceed the Agency’s LOC. 5. Aggregate cancer risk for U.S. population. The Agency considers the chronic aggregate risk assessment, VerDate Aug<31>2005 16:03 Sep 21, 2006 Jkt 208001 making use of the cPAD, to be protective of any aggregate cancer risk. See Unit III.E.2. 6. 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 propiconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (a gas chromatography (GC) method using electron capture detection (Method AG-454) 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. B. International Residue Limits The Codex Alimentarius Commission has established several maximum residue limits (MRLs) for propiconazole in/on various raw agricultural commodities. The Codex MRLs are expressed in terms of propiconazole per se. In addition, both Canada and Mexico have established MRLs/tolerances on several commodities which also have U.S. tolerances. The U.S. tolerance expression includes all metabolites determined as 2,4-dichloro-benzoic acid. In conjunction with the reregistration process EPA intends to revise the expression to propiconazole per se. To the extent possible, for the present petitions, U.S. tolerances have been numerically harmonized with Codex, Canadian, and Mexican MRLs; however, differences in use patterns and the supporting residue data have precluded reducing many tolerances. A summary of Codex MRLs, Canadian MRLs, and Mexican tolerances and the corresponding U.S. tolerances for propiconazole is discussed at www.regulations.gov Docket No. EPA– HQ–OPP–2006–0347–0004; pages 53– 54. V. Conclusion Therefore, tolerances are established for combined residues of propiconazole and its metabolites containing the dichlorobenzoic acid (DCBA) moiety expressed as parent compound in or on grain, aspirated fractions at 30 ppm; almond, hulls at 7.0 ppm; barley, grain at 0.3 ppm; barley, hay at 1.4 ppm; barley, straw at 10 ppm; barley, bran at 0.6 ppm; cattle, fat at 0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 55305 byproducts, except liver and kidney at 0.05 ppm; leafy petioles, subgroup 4B at 5.0 ppm; Berry group 13 at 1.0 ppm; carrot, roots at 0.25 ppm; corn, field, forage at 12 ppm; corn, sweet, forage at 6.0 ppm; corn, field, grain at 0.2 ppm; corn, pop, grain at 0.2 ppm; corn, field, stover at 30 ppm; corn, pop, stover at 30 ppm; corn, sweet, stover at 30 ppm; goat, fat at 0.05 ppm; goat, meat at 0.05 ppm; goat, meat byproducts, except liver and kidney at 0.05 ppm; hog, kidney at 0.2 ppm; hog, liver at 0.2 ppm; horse, fat at 0.05 ppm; horse, meat at 0.05 ppm; horse, meat byproducts, except liver and kidney at 0.05 ppm; spearmint, tops at 3.5 ppm; peppermint, tops at 3.5 ppm; oat, forage at 1.7 ppm; oat, grain at 0.3 ppm; oat, hay at 1.4 ppm; oat, straw at 10 ppm; onion, bulb at 0.2 ppm; onion, green at 9.0 ppm; pistachio at 0.1 ppm; rice, bran at 15 ppm; rice, grain at 7.0 ppm; rice, hulls at 20 ppm; rice, straw at 18 ppm; rye, grain at 0.3 ppm; rye, forage at 1.7 ppm; rye, straw at 10 ppm; rye, bran at 0.6 ppm; sorghum, grain, forage at 12 ppm; sorghum, grain, grain at 3.5 ppm; sorghum, grain, stover at 15 ppm; sheep, fat at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat byproducts, except liver and kidney at 0.05 ppm; soybean, forage at 11 ppm; soybean, hay at 30 ppm; soybean, seed at 2.0 ppm; strawberry at 1.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.3 ppm; beet, sugar, tops at 10 ppm; beet, sugar, molasses at 1.5 ppm; nut, tree, group 14 at 0.1 ppm; wheat, bran at 0.6 ppm; wheat, forage at 1.7 ppm; wheat, grain at 0.3 ppm; wheat, hay at 1.4 ppm; wheat, straw at 10 ppm; cranberry at 1.0 ppm; and inadvertent residues in or on alfalfa, forage at 0.1 ppm and alfalfa, hay at 0.1 ppm. VI. 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 E:\FR\FM\22SER1.SGM 22SER1 rwilkins on PROD1PC63 with RULES_1 55306 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 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 Risks (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 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 VerDate Aug<31>2005 16:03 Sep 21, 2006 Jkt 208001 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. VII. 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 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: September 12, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I 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 180.434 is revised to read as follows: I PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 § 180.434 residue. Propiconazole; tolerances for (a) General. Tolerances are established for the combined residues of the fungicide 1-[[2-(2,4-dichlorophenyl)4-propyl-1,3-dioxolan-2-yl] methyl]-1H1,2,4-triazole and its metabolites determined as 2,4-dichlorobenzoic acid and expressed as parent compound in or on the following commodities: Commodity Almond, hulls .................. Banana ........................... Barley, bran .................... Barley, grain ................... Barley, hay ...................... Barley, straw ................... Beet, sugar, dried pulp ... Beet, sugar, molasses .... Beet, sugar, roots ........... Beet, sugar, tops ............ Berry, group 13 ............... Carrot, roots .................... Cattle, fat ........................ Cattle, kidney .................. Cattle, liver ...................... Cattle, meat .................... Cattle, meat byproducts, except liver and kidney 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 ........ Fruit, stone, group 12 ..... Goat, fat .......................... Goat, kidney ................... Goat, liver ....................... Goat, meat ...................... Goat, meat byproducts, except liver and kidney Grain, aspirated fractions Grass, forage .................. Grass, hay ...................... Grass, straw ................... Hog, kidney ..................... Hog, liver ........................ Horse, fat ........................ Horse, kidney .................. Horse, liver ..................... Horse, meat .................... Horse, meat byproducts, except liver and kidney Leaf petioles, subgroup 4B ................................ Milk ................................. Mushroom ....................... Nut, tree, group 14 ......... Oat, forage ...................... Oat, grain ........................ Oat, hay .......................... Oat, straw ....................... Onion, bulb ..................... Onion, green ................... Peanut ............................ Peanut, hay .................... Peppermint, tops ............ Pineapple ........................ E:\FR\FM\22SER1.SGM 22SER1 Parts per million 7.0 0.2 0.6 0.3 1.4 10 1.0 1.5 0.3 10 1.0 0.25 0.05 2.0 2.0 0.05 0.05 12 0.2 30 0.2 30 6.0 0.1 30 1.0 0.05 2.0 2.0 0.05 0.05 30 0.5 0.5 40 0.2 0.2 0.05 2.0 2.0 0.05 0.05 5.0 0.05 0.1 0.1 1.7 0.3 1.4 10 0.2 9.0 0.2 20 3.5 0.1 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations Commodity Parts per million Pistachio ......................... Rice, bran ....................... Rice, grain ...................... Rice, hulls ....................... Rice, straw ...................... Rye, bran ........................ Rye, forage ..................... Rye, grain ....................... Rye, straw ....................... Sheep, fat ....................... Sheep, kidney ................. Sheep, liver ..................... Sheep, meat ................... Sheep, meat byproducts, except liver and kidney Sorghum, grain, forage ... Sorghum, grain, grain ..... Sorghum, grain, stover ... Soybean, forage ............. Soybean, hay .................. Soybean, seed ................ Spearmint, tops .............. Strawberry ...................... Wheat, bran .................... Wheat, forage ................. Wheat, grain ................... Wheat, hay ..................... Wheat, straw ................... 0.1 15 7.0 20 18 0.6 1.7 0.3 10 0.05 2.0 2.0 0.05 40 CFR Part 180 [EPA–HQ–OPP–2006–0170; FRL–8092–2] Buprofezin; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: [FR Doc. 06–8064 Filed 9–21–06; 8:45 am] SUMMARY: This regulation establishes a tolerance for combined residues or residues of buprofezin in or on almond hulls; cotton, gin byproducts: Cottonseed; and tomato. Nichino America, Inc., Linden Park Suite 501, 4550 New Linden Hill Road, Wilmington, DE 19908 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 September 22, 2006. Objections and requests for hearings must be received on or before November 21, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2006–0170. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., 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 in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The 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: Kevin Sweeney, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–5063; e-mail address: sweeney.kevin@epa.gov. BILLING CODE 6560–50–S SUPPLEMENTARY INFORMATION: 0.05 12 3.5 15 11 30 2.0 3.5 1.3 0.6 1.7 0.3 1.4 10 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. A tolerance with regional registration, as defined in §180.1(m), is established for residues of 1-[[2-(2,4dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4dichlorobenzoic acid and expressed as parent compound, in or on the following commodities: Commodity Parts per million Cranberry ........................ Rice, wild ........................ 1.0 0.5 (d) Indirect or inadvertent residues. Tolerances are established for the combined residues of the fungicide 1[[2-(2,4-dichlorophenyl)-4-propyl-1,3dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4dichlorobenzoic acid and expressed as parent compound in or on the following commodities when present therein as a result of application of propiconazole to growing crops in paragraphs (a) and (c) of this section: Commodity rwilkins on PROD1PC63 with RULES_1 ENVIRONMENTAL PROTECTION AGENCY Parts per million Alfalfa, forage ................. Alfalfa, hay ...................... VerDate Aug<31>2005 16:03 Sep 21, 2006 0.1 0.1 Jkt 208001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 55307 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. 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? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at https:// www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at https://www.epa.gpo/ opptsfrs/home/guidelin.htm C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the 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 E:\FR\FM\22SER1.SGM 22SER1

Agencies

[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Rules and Regulations]
[Pages 55300-55307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8064]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0347; FRL-8092-1]


Propiconazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes or revises tolerances for combined 
residues of propiconazole and its metabolites containing the 
dichlorobenzoic acid (DCBA) moiety expressed as parent compound in or 
on various commodities; and inadvertent residues in or on alfalfa, 
forage and alfalfa, hay. Syngenta Crop Protection, Inc. and 
Interregional Research Project No. 4 (IR-4), 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 September 22, 2006. Objections and 
requests for hearings must be received on or before November 21, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0347. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., 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 in the electronic docket at https://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The 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: Mary Waller, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; e-mail address: waller.mary@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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the 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. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0347 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 November 21, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0347, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday,

[[Page 55301]]

excluding legal holidays). Special arrangements should be made for 
deliveries of boxed information. The Docket telephone number is (703) 
305-5805.

II. Background and Statutory Findings

    In the Federal Register of May 3, 2006 (71 FR 26084) (FRL-8060-2), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of pesticide petitions (PP) 2F6371 
and 5F4498 by Syngenta Crop Protection, Inc., and PP 6E4788, 7E4860, 
and 8E4931 by Interregional Research Project No. 4 (IR-4). The 
petitions requested that 40 CFR 180.434 be amended by establishing a 
tolerance for combined residues of the fungicide propiconazole, 1-[[2-
(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-
triazole and its metabolites determined as 2,4-dichlorobenzoic acid and 
expressed as parent compound in or on leafy vegetables (Subgroup 4B) at 
5.0 parts per million (ppm) (PP 6E4788); cranberry at 1.0 ppm (PP 
7E4860); Mint at.3.0 ppm (PP 8E4931); and under PP 2F6371, almond, 
hulls and onion, green at 8.0 ppm; berries (Group 13) and legume 
vegetables (Group 6) at 1.0 ppm; foliage of legume vegetables (Group 
7)/ sorghum/soybean, forage and sugar beet, tops at 10.0 ppm; carrot, 
roots/pistachios/nuts, tree (Group 14) at 0.2 ppm; foliage of legume 
vegetable (Group 7)/soybean, hay at 32.0 ppm; onion, dry bulb/corn, 
grain/sugar beet, roots at 0.3 ppm; sorghum, grain/grain cereal group 
(except corn, rice, and sorghum), bran at 2.5 ppm; sorghum, stover at 
15.0 ppm; soybean, seed/grain, cereal group (except corn, rice, and 
sorghum), hay/sugar beet, dried pulp at 2.0 ppm; strawberry at 1.5 ppm; 
grain, cereal group (except corn, rice, and sorghum) (Group 15), 
forage/sugar beet, molasses at 3.0 ppm; grain, cereal group (except 
corn, rice, and sorghum), straw at 13.0 ppm; grain, cereal group 
(except corn, rice, and sorghum)/corn, oil at 0.5 ppm; rice, bran and 
hulls at 28.0 ppm; and aspirated grain fraction at 17.0 ppm. Further, 
the petition requested existing tolerances be amended for corn, forage 
at 4.0 ppm; corn, stover at 25.0 ppm; rice, grain at 7.0 ppm; and rice, 
straw at 18.0 ppm. Additionally, PP 5F4498, requested inadvertent 
residues for alfalfa, forage and hay at 0.1 ppm. That notice included a 
summary of the petition prepared by Syngenta Crop Protection, Inc., the 
registrant. There were no comments received in response to the notice 
of filing.
    Upon completing review of the current propiconazole database, the 
Agency concluded that the appropriate tolerance levels for 
propiconazole residues in or on pending crops and livestock commodities 
should be established as follow: On grain, aspirated fractions at 30 
ppm; almond, hulls at 7.0 ppm; barley, grain at 0.3 ppm; barley, hay at 
1.4 ppm; barley, straw at 10 ppm; barley, bran at 0.6 ppm; cattle, fat 
at 0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat byproducts, except 
liver and kidney at 0.05 ppm; leafy petioles, subgroup 4B at 5.0 ppm; 
Berry group 13 at 1.0 ppm; carrot, roots at 0.25 ppm; corn, field, 
forage at 12 ppm; corn, sweet, forage at 6.0 ppm; corn, field, grain at 
0.2 ppm; corn, pop, grain at 0.2 ppm; corn, field, stover at 30 ppm; 
corn, pop, stover at 30 ppm; corn, sweet, stover at 30 ppm; goat, fat 
at 0.05 ppm; goat, meat at 0.05 ppm; goat, meat byproducts, except 
liver and kidney at 0.05 ppm; hog, kidney at 0.2 ppm; hog, liver at 0.2 
ppm; horse, fat at 0.05 ppm; horse, meat at 0.05 ppm; horse, meat 
byproducts, except liver and kidney at 0.05 ppm; spearmint, tops at 3.5 
ppm; peppermint, tops at 3.5 ppm; oat, forage at 1.7 ppm; oat, grain at 
0.3 ppm; oat, hay at 1.4 ppm; oat, straw at 10 ppm; onion, bulb at 0.2 
ppm; onion, green at 9.0 ppm; pistachio at 0.1 ppm; rice, bran at 15 
ppm; rice, grain at 7.0 ppm; rice, hulls at 20 ppm; rice, straw at 18 
ppm; rye, grain at 0.3 ppm; rye, forage at 1.7 ppm; rye, straw at 10 
ppm; rye, bran at 0.6 ppm; sorghum, grain, forage at 12 ppm; sorghum, 
grain, grain at 3.5 ppm; sorghum, grain, stover at 15 ppm; sheep, fat 
at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat byproducts, except 
liver and kidney at 0.05 ppm; soybean, forage at 11 ppm; soybean, hay 
at 30 ppm; soybean, seed at 2.0 ppm; strawberry at 1.3 ppm; beet, 
sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.3 ppm; beet, 
sugar, tops at 10 ppm; beet, sugar, molasses at 1.5 ppm; nut, tree, 
group 14 at 0.1 ppm; wheat, bran at 0.6 ppm; wheat, forage at 1.7 ppm; 
wheat, grain at 0.3 ppm; wheat, hay at 1.4 ppm; wheat, straw at 10 ppm; 
cranberry at 1.0 ppm; and inadvertent residues in or on alfalfa, forage 
at 0.1 ppm and alfalfa, hay at 0.1 ppm. The Agency concluded that there 
are insufficient data to establish tolerances legume vegetables (Group 
6); foliage of legume vegetables (Group 7); cereal group (except corn, 
rice, and sorghum) (Group 15). For additional information refer to 
www.regulations.gov Docket No. EPA-HQ-OPP-2006-0347-0008.
    EPA is also deleting several established tolerances in 40 CFR 
180.434(a), (b), and (c) that are no longer needed as a result of this 
action.
    The revisions to 180.434(a) are as follows:
     Delete celery at 5.0 ppm. Replaced with leafy petioles, 
subgroup 4B at 5.0 ppm.
     Delete pecans at 0.1 ppm. Replaced with nut, tree, group 
14 at 0.1 ppm.
    The revisions to 180.434(b) are as follows:
     Delete the time-limited tolerance for blueberry at 1.0 
ppm. Replaced with Berry group 13 at 1.0 ppm, under 40 CFR 180.434(a).
     Delete the time-limited tolerance for cranberry; grain, 
aspirated fractions; sorghum, grain, grain; sorghum, grain, stover; 
soybean; soybean, forage; and soybean, hay. All are being replaced by 
permanent tolerances.
     Delete time-limited tolerance for dry bean; dry bean 
forage; and dry bean hay since these tolerances have expired.
    The revisions to 180.434(c) are as follows:
     Delete mint, tops (leaves and stems) at 0.3 ppm. Replaced 
with spearmint, tops at 3.5 ppm and peppermint, tops at 3.5 ppm under 
40 CFR 180.434(a).
    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 the FFDCA and a complete 
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

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

[[Page 55302]]

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 combined residues of propiconazole and 
its metabolites containing the dichlorobenzoic acid (DCBA) moiety 
expressed as parent compound on grain, aspirated fractions at 30 ppm; 
almond, hulls at 7.0 ppm; barley, grain at 0.3 ppm; barley, hay at 1.4 
ppm; barley, straw at 10 ppm; barley, bran at 0.6 ppm; cattle, fat at 
0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat byproducts, except 
liver and kidney at 0.05 ppm; leafy petioles, subgroup 4B at 5.0 ppm; 
Berry group 13 at 1.0 ppm; carrot, roots at 0.25 ppm; corn, field, 
forage at 12 ppm; corn, sweet, forage at 6.0 ppm; corn, field, grain at 
0.2 ppm; corn, pop, grain at 0.2 ppm; corn, field, stover at 30 ppm; 
corn, pop, stover at 30 ppm; corn, sweet, stover at 30 ppm; goat, fat 
at 0.05 ppm; goat, meat at 0.05 ppm; goat, meat byproducts, except 
liver and kidney at 0.05 ppm; hog, kidney at 0.2 ppm; hog, liver at 0.2 
ppm; horse, fat at 0.05 ppm; horse, meat at 0.05 ppm; horse, meat 
byproducts, except liver and kidney at 0.05 ppm; spearmint, tops at 3.5 
ppm; peppermint, tops at 3.5 ppm; oat, forage at 1.7 ppm; oat, grain at 
0.3 ppm; oat, hay at 1.4 ppm; oat, straw at 10 ppm; onion, bulb at 0.2 
ppm; onion, green at 9.0 ppm; pistachio at 0.1 ppm; rice, bran at 15 
ppm; rice, grain at 7.0 ppm; rice, hulls at 20 ppm; rice, straw at 18 
ppm; rye, grain at 0.3 ppm; rye, forage at 1.7 ppm; rye, straw at 10 
ppm; rye, bran at 0.6 ppm; sorghum, grain, forage at 12 ppm; sorghum, 
grain, grain at 3.5 ppm; sorghum, grain, stover at 15 ppm; sheep, fat 
at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat byproducts, except 
liver and kidney at 0.05 ppm; soybean, forage at 11 ppm; soybean, hay 
at 30 ppm; soybean, seed at 2.0 ppm; strawberry at 1.3 ppm; beet, 
sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.3 ppm; beet, 
sugar, tops at 10 ppm; beet, sugar, molasses at 1.5 ppm; nut, tree, 
group 14 at 0.1 ppm; wheat, bran at 0.6 ppm; wheat, forage at 1.7 ppm; 
wheat, grain at 0.3 ppm; wheat, hay at 1.4 ppm; wheat, straw at 10 ppm; 
cranberry at 1.0 ppm; and inadvertent residues in or on alfalfa, forage 
at 0.1 ppm and alfalfa, hay at 0.1 ppm. EPA's assessment of exposures 
and risks associated with establishing the tolerance follows.

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 propiconazole as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at 
www.regulations.gov Docket No. EPA-HQ-OPP-2006-0347-0005; pages 35-42.

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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at https://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for propiconazole used for 
human risk assessment is discussed at www.regulations.gov Docket No. 
EPA-HQ-OPP-2006-0347-0004; pages 23-25.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.434) for the combined residues of propiconazole 
and its metabolites containing the dichlorobenzoic acid (DCBA) moiety 
expressed as parent compound, in or on a variety of raw agricultural 
commodities. Tolerances are also established for residues of 
propiconazole and its metabolites containing the dichlorobenzoic acid 
(DCBA) moiety expressed as parent compound in or on milk as well as 
fat, meat, kidney, liver and meat by products of cattle, goats, hogs, 
horse, and sheep. Some of these existing tolerances are being revised 
as a result of this action. Risk assessments were conducted by EPA to 
assess dietary exposures from propiconazole 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 1-day or single exposure.
    In conducting the acute dietary exposure 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 the acute exposure assessments: 
Tolerance levels and one hundred percent of the crops were treated for 
all proposed new uses, revised uses, and existing uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: Tolerance levels and 100% of the crops were 
treated for all proposed new uses, revised uses, and existing uses.
    iii. Cancer. Propiconazole has been classified as a group C 
(possible human carcinogen). The Agency concluded that the chronic risk 
assessment, making use of the chronic population adjusted dose (cPAD), 
is protective of any potential carcinogenic risk.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for propiconazole 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 propiconazole. Further information regarding EPA 
drinking water models used in pesticide exposure assessment

[[Page 55303]]

can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
    A registrant drinking water monitoring study showed very few 
detections among a total of 38 selected community water systems in 12 
states. The Agency concluded that the sampling scheduling of this 
monitoring study is not rigorous enough to be used for water 
assessment. Since the monitoring studies did not provide good quality 
data, this drinking water assessment is based on the model predicted 
drinking water concentrations.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
propiconazole for acute exposures are estimated to be 55.8 parts per 
billion (ppb) for surface water and 0.64 ppb for ground water. The EECs 
for chronic exposures are estimated to be 21.6 ppb for surface water 
and 0.64 ppb for ground water.
    To estimate surface water for each specific use, the maximum 
allowable label rate was input into PRZM/EXAMS. The output 
concentrations were without percent cropped area (PCA) consideration. 
The final estimated drinking water concentrations were then adjusted 
with the proper PCA. Except the uses of soybean (0.41 ppb) and wheat 
(0.56 ppb), other uses assume the default PCA of 0.87 ppb. Among these 
modeling results, turf use gives the highest acute concentration of 
55.78 ppb (Microgram/liter ([micro]g/L)). For the chronic exposure, 
turf use has the highest concentration of 21.61 ppb ([micro]g/L).
    The EECs in ground water were calculated using the Tier I SCI-GROW 
model. SCI-GROW is neither scenario- nor crop-specific. The only input 
requirements are application rate, number of applications, 
Koc, and aerobic soil metabolism half-life. The higher 
estimated concentrations are associated with the higher rate. Turf use 
has the highest concentration of 0.64 [micro]g/L (ppb). Modeled 
estimates of drinking water concentrations were directly entered into 
the dietary exposure model (DEEM-FCID(\TM\)). For acute dietary risk 
assessment, the peak water concentration value of 55.8 ppb was used to 
access the contribution to drinking water. For chronic dietary risk 
assessment, the annual average concentration of 21.6 ppb was used to 
access the contribution to drinking 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).
    Propiconazole is currently registered for use on the following 
residential non-dietary sites: Ground covers; turf and ornamentals in 
lawns and golf courses; ornamentals trees (injection); shade trees 
(outdoor spray); herbaceous plants; ornamental woody shrubs and vines 
and antimicrobial uses in paint and wood protection treatment. The risk 
assessment was conducted using the following residential exposure 
assumptions:
    Homeowners can be exposed to propiconazole through dermal and 
inhalation routes while applying home use products. All risk 
calculations were conducted using the maximum turf application rate 
(1.8 lb ai/acre). The anticipated use patterns and current labeling 
indicate three major residential exposure scenarios based on the types 
of equipment and techniques that can potentially be used to make 
propiconazole applications. The quantitative exposure/risk assessment 
developed for residential handlers is based on these scenarios:
     Mixer/Loader/applying liquids and wettable powder in water 
soluble packets via low pressure handwand.
     Mixer/Loader/applying liquids and wettable powder in water 
soluble packets via hose-end sprayer.
     Applying treated paint using airless sprayer and hose-end 
spray.
    Residential handler exposure scenarios are considered to be short-
term only due to the infrequent uses associated with homeowner 
products.
    The existing residential use patterns result in post application 
dermal exposures to adults, and dermal and oral exposures to infants 
and children. These exposure scenarios are considered short term only, 
due to the fact that:
    i. Post-application exposures were calculated using propiconazole 
as the parent compound;
    ii. Compound specific turf transferable residue (TTR) data indicate 
that at the Indiana, California, and Pennsylvania test sites, average 
total propiconazole residues declined to below the minimum quantifiable 
limit (MQL) by 14, 10 and 8 days after treatment, respectively. These 
dissipation rates, combined with label specific use rates and frequency 
of use specifications, reinforce the hand to mouth short-term exposure 
scenario;
    iii. For short term exposure to children 1-2 years old, the driving 
factors for this risk assessment are hand to mouth, object to mouth, 
and dermal exposure. Soil ingestion is insignificant (margin of 
exposure (MOE) >300,000) compared to these factors, indicating that the 
post application scenario should be short term only. Although both 
residential and antimicrobial uses result in incidental oral and dermal 
exposure to children, the highest incidental oral and dermal exposure 
scenarios are from residential use on turf, which were used in the 
short term aggregate risk assessment.
    In addition to using the EPA's Standard Operational Procedure (SOP) 
for residential assessment, the study specific turf transferable 
residue (TTR) was used to estimate exposures. The EPA combined 
exposures resulting from separate post-application exposure scenarios 
when it is likely they can occur simultaneously based on the use-
pattern and the behavior associated with the exposed population. The 
assumptions used for each of the scenarios separately are considered to 
account for potential high levels of exposure (i.e., time spent 
outdoors, dislodgeable residues) therefore, combining all these 
activities together is considered a very high end estimate of exposure. 
Propiconazole is classified as a non-volatile chemical; therefore a 
residential inhalation post-application assessment was not assessed.
    The only residential use scenario that will result in potential 
intermediate term exposure to propiconazole is post application 
exposure to children from wood treatment (antimicrobial use) from 
incidental oral and dermal contact activities.
    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.''
    Propiconazole is a member of the triazole-containing class of 
pesticides. Although conazoles act similarly in plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between this pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same, or essentially the same sequence of 
major biochemical events (EPA, 2002). In conazoles, however, a variable 
pattern of toxicological responses is found. Some are hepatotoxic and 
hepatocarcinogenic in mice. Some

[[Page 55304]]

induce thyroid tumors in rats. Some induce developmental, reproductive, 
and neurological effects in rodents. Furthermore, the conazoles produce 
a diverse range of biochemical events including altered cholesterol 
levels, stress responses, and altered DNA methylation. It is not 
clearly understood whether these biochemical events are directly 
connected to their toxicological outcomes. Thus, there is currently no 
evidence to indicate that conazoles share common mechanisms of toxicity 
and EPA is not following a cumulative risk approach based on a common 
mechanism of toxicity for the conazoles. For information regarding 
EPA's procedures for cumulating effects from substances found to have a 
common mechanism of toxicity, see EPA's website at https://www.epa.gov/
pesticides/cumulative.
    Propiconazole is a triazole-derived pesticide. This class of 
compounds can form the common metabolite 1,2,4-triazole conjugates 
(triazole alanine and triazole acetic acid). To support existing 
tolerances and to establish new tolerances for triazole-derivative 
pesticides, including propiconazole, EPA conducted a human health risk 
assessment for exposure to 1,2,4-triazole, triazole alanine, and 
triazole acetic acid resulting from the use of all current and pending 
uses of any triazole-derived fungicide. The risk assessment is highly 
conservative, screening-level evaluation in terms of hazards associated 
with common metabolites (e.g., use of a maximum combination of 
uncertainty factors) and potential dietary and non-dietary exposures 
(i.e., high end estimates of both dietary and non-dietary exposures). 
In addition, the Agency retained the additional 10X FQPA safety factor 
for the protection of infants and children. The assessment includes 
evaluations of risks for various subgroups, including those comprised 
of infants and children. The Agency's complete risk assessment is found 
in the propiconazole reregistration docket at www.regulations.gov, 
Docket ID number EPA-HQ-OPP-2005-0497-0013.

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 database 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. Prenatal and postnatal sensitivity. There is low concern for 
pre- and/or postnatal toxicity resulting from exposure to 
propiconazole. In the developmental toxicity study in rats, the EPA 
considered the fetal effects observed in this study at a dose lower 
than that evoking maternal toxicity to be quantitative evidence of 
increased susceptibility of fetuses to in utero exposure to 
propiconazole. In the developmental toxicity study in rabbits, the 
Agency determined that neither quantitative nor qualitative evidence of 
increased susceptibility of fetuses to in utero exposure to 
propiconazole was observed in this study. In the 2-generation 
reproduction study in rats, neither quantitative nor qualitative 
evidence of increased susceptibility of neonates (as compared to 
adults) to pre- and/or postnatal exposure to propiconazole was observed 
in the study. Since there is quantitative evidence of increased 
susceptibility of the young following exposure to propiconazole in the 
developmental rat study, the Agency performed a Degree of Concern 
Analysis to:
    i. Determine the LOC for the effects observed when considered in 
the context of all available toxicity data; and
    ii. Identify any residual uncertainties after establishing toxicity 
endpoints and traditional uncertainty factors to be used in the risk 
assessment of this chemical. If residual uncertainties are identified, 
then EPA examines whether these residual uncertainties can be addressed 
by a special FQPA safety factor and, if so, the size of the factor 
needed. In the developmental rat study, quantitative susceptibility was 
evidenced as increased incidence of rudimentary ribs, unossified 
sternebrae, as well as increased incidence of shortened and absent 
renal papillae and increased cleft palate at (90 mg/kg/day) a dose 
lower than that evoking maternal toxicity (severe clinical toxicity at 
300 mg/kg/day). Considering the overall toxicity profile and the doses 
and endpoints selected for risk assessment for propiconazole, the EPA 
characterized the degree of concern for the effects observed in this 
study as low, noting that there is a clear no observed adverse effect 
level (NOAEL) and well-characterized dose response for the 
developmental effects observed. No residual uncertainties were 
identified. The NOAEL for developmental effects in this study (30 mg/
kg/day) is used as the basis for the acute Reference dose (aRfD) for 
the female 13-50 population subgroup as well as for short-term 
incidental oral, dermal and inhalation endpoints. For all other 
toxicity endpoints established for propiconazole, a NOAEL lower than 
this developmental NOAEL is used.
    3. Conclusion. There is a complete toxicity data base for 
propiconazole and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. There is low 
concern for pre- and/or postnatal toxicity resulting from exposure to 
propiconazole. In the developmental toxicity study in rats the fetal 
effects observed were seen at a dose lower than that evoking maternal 
toxicity. These effects were considered to be quantitative evidence of 
increased susceptibility of fetuses to in utero exposure to 
propiconazole. Therefore, as discussed above a Degree of Concern 
Analysis was conducted and the EPA concluded that the degree of concern 
for the effects observed in this study was low and no residual 
uncertainties were identified. EPA determined that the 10X SF to 
protect infants and children should be 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 water 
to propiconazole will occupy 6% of the acute Population Adjusted Dose 
(aPAD) for the U.S. population, 5% of the aPAD for females 13 years and 
older, 14% of the aPAD for all infants (<1 year old), the subpopulation 
at greatest exposure, and 13% of the aPAD for children 1-2 years old. 
Therefore, EPA does not expect the aggregate exposure to exceed 100% of 
the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
propiconazole from food and water will utilize 6% of the chronic 
Population Adjusted Dose (cPAD) for the U.S. population, 14% of the 
cPAD for all infants (<1 year old), and 14% of the cPAD for children 1-
2 years old, the subpopulation at greatest exposure. Based the use 
pattern, chronic residential exposure to residues of propiconazole is 
not expected.

[[Page 55305]]

 Therefore, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Propiconazole is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for propiconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water and residential 
exposures aggregated result in aggregate MOEs for children 1-2 years 
old of 1,100 for hand to mouth activity on turf; 4,500 for object to 
mouth activity on turf; 330,000 for soil ingestion; 210 for high 
contact turf activities; and 410 from the antimicrobial use of 
propiconazole in treated wood. The food, water and residential 
exposures aggregated for children 1-2 years old following post-
application of propiconazole result in an aggregate MOE of 160 for high 
contact activities. The corresponding aggregate MOE for adults 
following post-application exposure is 330. These aggregate MOEs do not 
exceed the Agency's LOC for aggregate exposure to food, water and 
residential uses. Therefore, EPA does not expect short-term aggregate 
exposure to exceed the Agency's LOC.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Propiconazole is currently registered for use(s) that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for propiconazole.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food, water and 
residential exposures aggregated result in an aggregate MOE of 120 for 
combined exposures from incidental oral and dermal contact activities 
for children 1-2 years old. These aggregate MOEs do not exceed the 
Agency's LOC for aggregate exposure to food, water and residential 
uses. Therefore, EPA does not expect intermediate-term aggregate 
exposure to exceed the Agency's LOC.
    5. Aggregate cancer risk for U.S. population. The Agency considers 
the chronic aggregate risk assessment, making use of the cPAD, to be 
protective of any aggregate cancer risk. See Unit III.E.2.
    6. 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 propiconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a gas chromatography (GC) method 
using electron capture detection (Method AG-454) 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

    The Codex Alimentarius Commission has established several maximum 
residue limits (MRLs) for propiconazole in/on various raw agricultural 
commodities. The Codex MRLs are expressed in terms of propiconazole per 
se. In addition, both Canada and Mexico have established MRLs/
tolerances on several commodities which also have U.S. tolerances. The 
U.S. tolerance expression includes all metabolites determined as 2,4-
dichloro-benzoic acid. In conjunction with the reregistration process 
EPA intends to revise the expression to propiconazole per se. To the 
extent possible, for the present petitions, U.S. tolerances have been 
numerically harmonized with Codex, Canadian, and Mexican MRLs; however, 
differences in use patterns and the supporting residue data have 
precluded reducing many tolerances. A summary of Codex MRLs, Canadian 
MRLs, and Mexican tolerances and the corresponding U.S. tolerances for 
propiconazole is discussed at www.regulations.gov Docket No. EPA-HQ-
OPP-2006-0347-0004; pages 53-54.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
propiconazole and its metabolites containing the dichlorobenzoic acid 
(DCBA) moiety expressed as parent compound in or on grain, aspirated 
fractions at 30 ppm; almond, hulls at 7.0 ppm; barley, grain at 0.3 
ppm; barley, hay at 1.4 ppm; barley, straw at 10 ppm; barley, bran at 
0.6 ppm; cattle, fat at 0.05 ppm; cattle, meat at 0.05 ppm; cattle, 
meat byproducts, except liver and kidney at 0.05 ppm; leafy petioles, 
subgroup 4B at 5.0 ppm; Berry group 13 at 1.0 ppm; carrot, roots at 
0.25 ppm; corn, field, forage at 12 ppm; corn, sweet, forage at 6.0 
ppm; corn, field, grain at 0.2 ppm; corn, pop, grain at 0.2 ppm; corn, 
field, stover at 30 ppm; corn, pop, stover at 30 ppm; corn, sweet, 
stover at 30 ppm; goat, fat at 0.05 ppm; goat, meat at 0.05 ppm; goat, 
meat byproducts, except liver and kidney at 0.05 ppm; hog, kidney at 
0.2 ppm; hog, liver at 0.2 ppm; horse, fat at 0.05 ppm; horse, meat at 
0.05 ppm; horse, meat byproducts, except liver and kidney at 0.05 ppm; 
spearmint, tops at 3.5 ppm; peppermint, tops at 3.5 ppm; oat, forage at 
1.7 ppm; oat, grain at 0.3 ppm; oat, hay at 1.4 ppm; oat, straw at 10 
ppm; onion, bulb at 0.2 ppm; onion, green at 9.0 ppm; pistachio at 0.1 
ppm; rice, bran at 15 ppm; rice, grain at 7.0 ppm; rice, hulls at 20 
ppm; rice, straw at 18 ppm; rye, grain at 0.3 ppm; rye, forage at 1.7 
ppm; rye, straw at 10 ppm; rye, bran at 0.6 ppm; sorghum, grain, forage 
at 12 ppm; sorghum, grain, grain at 3.5 ppm; sorghum, grain, stover at 
15 ppm; sheep, fat at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat 
byproducts, except liver and kidney at 0.05 ppm; soybean, forage at 11 
ppm; soybean, hay at 30 ppm; soybean, seed at 2.0 ppm; strawberry at 
1.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.3 
ppm; beet, sugar, tops at 10 ppm; beet, sugar, molasses at 1.5 ppm; 
nut, tree, group 14 at 0.1 ppm; wheat, bran at 0.6 ppm; wheat, forage 
at 1.7 ppm; wheat, grain at 0.3 ppm; wheat, hay at 1.4 ppm; wheat, 
straw at 10 ppm; cranberry at 1.0 ppm; and inadvertent residues in or 
on alfalfa, forage at 0.1 ppm and alfalfa, hay at 0.1 ppm.

VI. 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

[[Page 55306]]

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 Risks (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 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.

VII. 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 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: September 12, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.434 is revised to read as follows:


Sec.  180.434   Propiconazole; tolerances for residue.

    (a) General. Tolerances are established for the combined residues 
of the fungicide 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] 
methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound in or on the 
following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
 Almond, hulls.......................................                7.0
Banana...............................................                0.2
Barley, bran.........................................                0.6
Barley, grain........................................                0.3
Barley, hay..........................................                1.4
Barley, straw........................................                 10
Beet, sugar, dried pulp..............................                1.0
Beet, sugar, molasses................................                1.5
Beet, sugar, roots...................................                0.3
Beet, sugar, tops....................................                 10
Berry, group 13......................................                1.0
Carrot, roots........................................               0.25
Cattle, fat..........................................               0.05
Cattle, kidney.......................................                2.0
Cattle, liver........................................                2.0
Cattle, meat.........................................               0.05
Cattle, meat byproducts, except liver and kidney.....               0.05
Corn, field, forage..................................                 12
Corn, field, grain...................................                0.2
Corn, field, stover..................................                 30
Corn, pop, grain.....................................                0.2
Corn, pop, stover....................................                 30
Corn, sweet, forage..................................                6.0
Corn, sweet, kernel plus cob with husks removed......                0.1
Corn, sweet, stover..................................                 30
Fruit, stone, group 12...............................                1.0
Goat, fat............................................               0.05
Goat, kidney.........................................                2.0
Goat, liver..........................................                2.0
Goat, meat...........................................               0.05
Goat, meat byproducts, except liver and kidney.......               0.05
Grain, aspirated fractions...........................                 30
Grass, forage........................................                0.5
Grass, hay...........................................                0.5
Grass, straw.........................................                 40
Hog, kidney..........................................                0.2
Hog, liver...........................................                0.2
Horse, fat...........................................               0.05
Horse, kidney........................................                2.0
Horse, liver.........................................                2.0
Horse, meat..........................................               0.05
Horse, meat byproducts, except liver and kidney......               0.05
Leaf petioles, subgroup 4B...........................                5.0
Milk.................................................               0.05
Mushroom.............................................                0.1
Nut, tree, group 14..................................                0.1
Oat, forage..........................................                1.7
Oat, grain...........................................                0.3
Oat, hay.............................................                1.4
Oat, straw...........................................                 10
Onion, bulb..........................................                0.2
Onion, green.........................................                9.0
Peanut...............................................                0.2
Peanut, hay..........................................                 20
Peppermint, tops.....................................                3.5
Pineapple............................................                0.1

[[Page 55307]]

 
Pistachio............................................                0.1
Rice, bran...........................................                 15
Rice, grain..........................................                7.0
Rice, hulls..........................................                 20
Rice, straw..........................................                 18
Rye, bran............................................                0.6
Rye, forage..........................................                1.7
Rye, grain...........................................                0.3
Rye, straw...........................................                 10
Sheep, fat...........................................               0.05
Sheep, kidney........................................                2.0
Sheep, liver.........................................                2.0
Sheep, meat..........................................               0.05
Sheep, meat byproducts, except liver and kidney......               0.05
Sorghum, grain, forage...............................                 12
Sorghum, grain, grain................................                3.5
Sorghum, grain, stover...............................                 15
Soybean, forage......................................                 11
Soybean, hay.........................................                 30
Soybean, seed........................................                2.0
Spearmint, tops......................................                3.5
Strawberry...........................................                1.3
Wheat, bran..........................................                0.6
Wheat, forage........................................                1.7
Wheat, grain.........................................                0.3
Wheat, hay...........................................                1.4
Wheat, straw.........................................                 10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration, as defined in Sec. 180.1(m), is established for 
residues of 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound, in or on the 
following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
 Cranberry...........................................                1.0
Rice, wild...........................................                0.5
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established 
for the combined residues of the fungicide 1-[[2-(2,4-dichlorophenyl)-
4-propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its 
metabolites determined as 2,4-dichlorobenzoic acid and expressed as 
parent compound in or on the following commodities when present therein 
as a result of application of propiconazole to growing crops in 
paragraphs (a) and (c) of this section:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
 Alfalfa, forage.....................................                0.1
Alfalfa, hay.........................................                0.1
------------------------------------------------------------------------


[FR Doc. 06-8064 Filed 9-21-06; 8:45 am]
BILLING CODE 6560-50-S
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