Federal Register/Vol. 68, No. 182/Friday, September

Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations 54827

include regulations that have List of Subjects in 40 CFR Part 180 (d) Indirect and inadvertant residues. ‘‘substantial direct effects on the States, Environmental protection, [Reserved] on the relationship between the national Administrative practice and procedure, [FR Doc. 03–23853 Filed 9–18–03; 8:45 am] government and the States, or on the Agricultural commodities, Pesticides BILLING CODE 6560–50–S distribution of power and and pests, Reporting and recordkeeping responsibilities among the various requirements. levels of government.’’ This final rule ENVIRONMENTAL PROTECTION directly regulates growers, food AGENCY processors, food handlers and food Dated: September 10, 2003. 40 CFR Part 180 retailers, not States. This action does not James Jones, alter the relationships or distribution of [OPP–2003–0300; FRL–7324–9] power and responsibilities established Director, Office of Pesticide Programs. by Congress in the preemption Therefore, 40 CFR chapter I is S-Metolachlor; Pesticide Tolerances provisions of section 408(n)(4) of the amended as follows: AGENCY: Environmental Protection FFDCA. For these same reasons, the PART 180—[AMENDED] Agency (EPA). Agency has determined that this rule ACTION: Final rule. does not have any ‘‘tribal implications’’ 1. The authority citation for part 180 as described in Executive Order 13175, continues to read as follows: SUMMARY: This regulation establishes entitled Consultation and Coordination tolerances for combined residues of the Authority: 21 U.S.C. 321(q), 346(a) and herbicide S-metolachlor and its with Indian Tribal Governments (65 FR 371. 67249, November 6, 2000). Executive metabolites in or on asparagus; carrot, 2. Section 180.592 is added to read as Order 13175, requires EPA to develop roots; horseradish; onion, green; follows: an accountable process to ensure rhubarb; and swiss chard. The ‘‘meaningful and timely input by tribal § 180.592 Butafenacil; tolerances for Interregional Research Project Number 4 officials in the development of residues. (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic regulatory policies that have tribal (a) General. (1) Tolerances are Act (FFDCA), as amended by the Food implications.’’ ‘‘Policies that have tribal established for residues of the herbicide Quality Protection Act (FQPA) of 1996. implications’’ is defined in the butafenacil, (1,1-dimethyl-2-oxo-2-(2- Executive Order to include regulations propenyloxy)ethyl 2-chloro-5-[3,6- DATES: This regulation is effective that have ‘‘substantial direct effects on dihydro-3-methyl-2,6-dioxo-4- September 19, 2003. Objections and one or more Indian tribes, on the (trifluoromethyl)-1(2H)-pyrimidinyl] requests for hearings, identified by relationship between the Federal benzoate) in or on the following raw docket ID number OPP–2003–0300, must be received on or before November Government and the Indian tribes, or on agricultural commodities: 18, 2003. the distribution of power and responsibilities between the Federal Commodity Parts per million ADDRESSES: Written objections and hearing requests may be submitted Government and Indian tribes.’’ This Cotton, gin byproducts ... 10 rule will not have substantial direct electronically, by mail, or through hand Cotton, undelinted seed 0.50 delivery/courier. Follow the detailed effects on tribal governments, on the instructions as provided in Unit VI. of relationship between the Federal (2) Tolerances are established for the SUPPLEMENTARY INFORMATION. Government and Indian tribes, or on the residues of the herbicide butafenacil, FOR FURTHER INFORMATION CONTACT: distribution of power and (1,1-dimethyl-2-oxo-2-(2- responsibilities between the Federal Hoyt Jamerson, Registration Division propenyloxy)ethyl 2-chloro-5-[3,6- (7505C), Office of Pesticide Programs, Government and Indian tribes, as dihydro-3-methyl-2,6-dioxo-4- Environmental Protection Agency, 1200 specified in Executive Order 13175. (trifluoromethyl)-1(2H)-pyrimidinyl] Pennsylvania Ave., NW.,Washington, Thus, Executive Order 13175 does not benzoate) and its metabolite CGA- DC 20460–0001; telephone number: apply to this rule. 293731 (1-carboxy-1-methylethyl 2- (703) 308–9368; e-mail chloro-5-[3,6-dihydro-3-methyl-2,6- address:[email protected]. VIII. Congressional Review Act dioxo-4-(trifluoromethyl)-1(2H)- SUPPLEMENTARY INFORMATION: The Congressional Review Act, 5 pyrimidinyl] benzoate), in or on the U.S.C. 801 et seq., as added by the Small following livestock commodities: I. General Information Business Regulatory Enforcement Commodity Parts per million A. Does this Action Apply to Me? Fairness Act of 1996, generally provides You may be potentially affected by that before a rule may take effect, the Cattle, kidney ...... 0.05 agency promulgating the rule must Cattle, liver ...... 0.50 this action if you are an agricultural submit a rule report, which includes a Goats, kidney ...... 0.05 producer, food manufacturer, or copy of the rule, to each House of the Goats, liver ...... 0.50 pesticide manufacturer. Potentially Congress and to the Comptroller General Hog, kidney ...... 0.05 affected entities may include, but are Hog, liver ...... 0.50 not limited to: of the United States. EPA will submit a Horse, kidney ...... 0.05 • Crop production (NAICS 111) report containing this rule and other Horse, liver ...... 0.50 • Animal production (NAICS 112) required information to the U.S. Senate, Sheep, kidney ...... 0.05 • Food manufacturer (NAICS 311) the U.S. House of Representatives, and Sheep, liver ...... 0.50 • Pesticide manufacturer (NAICS the Comptroller General of the United 32532) States prior to publication of this final (b) Section 18 emergency exemptions. This listing is not intended to be rule in the Federal Register. This final [Reserved] exhaustive, but rather provides a guide rule is not a ‘‘major rule’’ as defined by (c) Tolerances with regional for readers regarding entities likely to be 5 U.S.C. 804(2). registrations. [Reserved] affected by this action. Other types of

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entities not listed in this unit could also issued a notice pursuant to section 408 EPA performs a number of analyses to be affected. The North American of FFDCA, 21 U.S.C. 346a, as amended determine the risks from aggregate Industrial Classification System by FQPA (Public Law 104–170), exposure to pesticide residues. For (NAICS) codes have been provided to announcing the filing of pesticide further discussion of the regulatory assist you and others in determining petitions (4E4420, 7E4916, 8E5029, requirements of section 408 of the whether this action might apply to 8E5030, 9E6055, and 2E6374) by IR-4, FFDCA and a complete description of certain entities. If you have any 681 U.S. Highway #1 South, North the risk assessment process, see the final questions regarding the applicability of Brunswick, NJ 08902–3390. That notice rule on Bifenthrin Pesticide Tolerances, this action to a particular entity, consult included a summary of the petitions November 26, 1997 (62 FR 62961) (FRL– the person listed under FOR FURTHER prepared by Syngenta Crop Protection, 5754–7). INFORMATION CONTACT. Swing Road, Greensboro, NC 27641, the III. Aggregate Risk Assessment and B. How Can I Get Copies of this registrant. There were no comments Determination of Safety received in response to the notice of Document and Other Related Consistent with section 408(b)(2)(D) Information? filing. The petitions requested that 40 CFR of the FFDCA, EPA has reviewed the 1. Docket. EPA has established an 180.368 be amended by establishing available scientific data and other official public docket for this action tolerances for combined residues of the relevant information in support of this under docket identification (ID) number herbicide S-metolachlor, acetamid, 2- action. EPA has sufficient data to assess OPP–2003–0300. The official public chloro-N-(2-ethyl-6-methylphenyl)-N-(2- the hazards of and to make a docket consists of the documents methoxy-1-methylethyl)-, (S) and its determination on aggregate exposure, specifically referenced in this action, metabolites, determined as the consistent with section 408(b)(2) of the any public comments received, and derivatives, 2-[(2-ethyl-6- FFDCA, for tolerances for combined other information related to this action. methylphenyl)amino]-1-propanol (CGA- residues of S-metolachlor and its Although a part of the official docket, 37913) and 4-(2-ethyl-6-methylphenyl)- metabolites on asparagus at 0.10 ppm; the public docket does not include 2-hydroxy-5-methyl-3-morpholinone carrot, roots at 0.20 ppm; horseradish at Confidential Business Information (CBI) (CGA-49751), each expressed as the 0.20 ppm; onion, green at 0.20 ppm; or other information whose disclosure is parent compound, in or on asparagus at rhubarb at 0.10 ppm; and swiss chard at restricted by statute. The official public 0.1 part per million (ppm) (9E6055); 0.10 ppm. EPA’s assessment of docket is the collection of materials that carrot, roots at 0.1 ppm (7E4916); exposures and risks associated with is available for public viewing at the horseradish at 0.1 ppm (7E4916); onion, establishing the tolerances follows. Public Information and Records green at 0.2 ppm (2E6374); pepper, bell Integrity Branch (PIRIB), Rm. 119, A. Toxicological Profile at 0.50 ppm (4E4420); pepper, nonbell Crystal Mall #2, 1921 Jefferson Davis Metolachlor is a choroacetanilide at 0.50 ppm (4E4420); rhubarb at 0.1 Hwy., Arlington, VA. This docket herbicide that was first registered as a ppm (8E5029); and swiss chard at 0.1 facility is open from 8:30 a.m. to 4 p.m., pesticide in 1976. Metolachlor is a ppm (8E5030). IR-4 subsequently Monday through Friday, excluding legal racemic mixture consisting of 50% each revised 7E4916 to propose tolerances for holidays. The docket telephone number of the R-enantiomer (CGA 77101) and carrot, roots at 0.20 ppm and horse is (703) 305–5805. the S-enantiomer (CGA 77102). The S- 2. Electronic access. You may access radish at 0.20 ppm. IR-4 also withdrew enantiomer is the herbicidally active this Federal Register document 4E4420 for pepper. IR-4 plans to submit isomer. S-metolachlor is also a racemic electronically through the EPA Internet a pesticide petition proposing a mixture comprised of 88% S- under the ‘‘Federal Register’’ listings at tolerance for fruiting vegetable group, enantiomer and 12% R-enantiomer. The http://www.epa.gov/fedrgstr/. A which includes bell and nonbell pepper, Agency has determined that S- frequently updated electronic version of later in 2003. metolachlor has either comparable or 40 CFR part 180 is available at http// Section 408(b)(2)(A)(i) of the FFDCA decreased toxicity as compared to www.access.gpo.gov/nara/cfr/ allows EPA to establish a tolerance (the racemic metolachlor. cfrhtml_00/Title_40/ 40cfr180_00.html, legal limit for a pesticide chemical EPA has evaluated the available a beta site currently under development. residue in or on a food) only if EPA toxicity data and considered its validity, An electronic version of the public determines that the tolerance is ‘‘safe.’’ completeness, and reliability as well as docket is available through EPA’s Section 408(b)(2)(A)(ii) of the FFDCA the relationship of the results of the electronic public docket and comment defines ‘‘safe’’ to mean that ‘‘there is a studies to human risk. EPA has also system, EPA Dockets. You may use EPA reasonable certainty that no harm will considered available information Dockets at http://www.epa.gov/edocket/ result from aggregate exposure to the concerning the variability of the to submit or view public comments, pesticide chemical residue, including sensitivities of major identifiable access the index listing of the contents all anticipated dietary exposures and all subgroups of consumers, including of the official public docket, and to other exposures for which there is infants and children. The nature of the access those documents in the public reliable information.’’ This includes toxic effects caused by S-metolachlor as docket that are available electronically. exposure through drinking water and in well as the no observed adverse effect Although not all docket materials may residential settings, but does not include level (NOAEL) and the lowest observed be available electronically, you may still occupational exposure. Section adverse effect level (LOAEL) from the access any of the publicly available 408(b)(2)(C) of the FFDCA requires EPA toxicity studies reviewed are discussed docket materials through the docket to give special consideration to in Unit III.A. of the Federal Register of facility identified in Unit I.B.1. Once in exposure of infants and children to the April 2, 2003 (68 FR 15945) (FRL–7299– the system, select ‘‘search,’’ then key in pesticide chemical residue in 8). the appropriate docket ID number. establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that B. Toxicological Endpoints II. Background and Statutory Findings no harm will result to infants and The dose at which the NOAEL from In the Federal Register of August 13, children from aggregate exposure to the the toxicology study identified as 2003 (68 FR 48373) (FRL–7320–9), EPA pesticide chemical residue....’’ appropriate for use in risk assessment is

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used to estimate the toxicological level C. Exposure Assessment metolachlor are expected to have similar of concern (LOC). However, the LOAEL 1. Dietary exposure from food and degradation pathways and rates in soil is sometimes used for risk assessment if feed uses. Tolerances established for and water environments. This no NOAEL was achieved in the metolachlor (40 CFR 180.368(a)(1) and assessment includes concentrations of toxicology study selected. An (c)) currently cover residues of S- parent metolachlor/S-metolachlor and uncertainty factor (UF) is applied to metolachlor on the same commodities the degradates metolachlor ethane reflect uncertainties inherent in the for the same use pattern when the sulfonic acid (ESA) and metolachlor extrapolation from laboratory animal maximum labeled use rate of S- oxanilic acid (OA). Although it was data to humans and in the variations in metolachlor is approximately 35% less determined that the ESA and OA sensitivity among members of the than the historical use rate of metabolites appear to be less toxic than human population as well as other metolachlor. Tolerances have also been parent metolachlor/S-metolachlor, they unknowns. An UF of 100 is routinely established (40 CFR 180.368(a)(2)) for are included in this risk assessment used, 10X to account for interspecies the combined residues of S-metolachlor, since they were found in greater differences and 10X for intraspecies in or on a variety of raw agricultural abundance than the parent in water differences. monitoring studies. No surface or For dietary risk assessment (other commodities. Time-limited tolerances are established for metolachlor and S- ground water monitoring studies that than cancer) the Agency uses the UF to specifically target metolachlor/S- calculate an acute or chronic reference metolachlor (40 CFR 180.368(b)) in support of section 18 emergency metolachlor were available for the dose (aRfD or cRfD) where the RfD is drinking water assessment. As a result, equal to the NOAEL divided by the exemptions. Risk assessments were conducted by EPA to assess combined the drinking water assessment for parent appropriate UF (RfD = NOAEL/UF). metolachlor/S-metolachlor is based Where an additional safety factors (SF) dietary exposures from metolachlor and S-metolachlor in food as follows: primarily on monitoring data from the is retained due to concerns unique to following sources: The U.S. Geological the FQPA, this additional factor is i. Acute exposure. Acute dietary risk assessments are performed for a food- Survey (USGS) National Water Quality applied to the RfD by dividing the RfD Assessment (NAWQA) data base, the by such additional factor. The acute or use pesticide if a toxicological study has indicated the possibility of an effect of U.S. EPA STORET data base, the chronic Percent Adjusted Dose (aPAD or Acetochlor Registration Partnership cPAD) is a modification of the RfD to concern occurring as a result of a 1 day or single exposure. In conducting this (ARP) data base, and two USGS accommodate this type of FQPA SF. reservoir monitoring studies. For non-dietary risk assessments acute dietary risk assessment, EPA used The Agency uses the FQPA Index (other than cancer) the UF is used to the Dietary Exposure Evaluation Model Reservoir Screening Tool (FIRST) or the determine the LOC. For example, when (DEEM) software with the Food 100 is the appropriate UF (10X to Commodity Intake Database (FCID) Pesticide Root Zone Model/Exposure account for interspecies differences and which incorporates food consumption Analysis Modeling System (PRZM/ 10X for intraspecies differences) the data as reported by respondents in the EXAMS), to produce estimates of LOC is 100. To estimate risk, a ratio of U.S. Department of Agriculture (USDA) pesticide concentrations in an index the NOAEL to exposures (margin of 1994–1996 and 1998 nationwide reservoir. The SCI-GROW model is used exposure (MOE) = NOAEL/exposure) is Continuing Surveys of Food Intake by to predict pesticide concentrations in calculated and compared to the LOC. Individuals (CSFII) and accumulated shallow ground water. For a screening- The linear default risk methodology exposure to the chemical for each level assessment for surface water EPA (Q*) is the primary method currently commodity. A conservative Tier 1 acute will use FIRST (a Tier 1 model) before used by the Agency to quantify dietary exposure assessment was using PRZM/EXAMS (a Tier 2 model). carcinogenic risk. The Q* approach conducted for all labeled metolachlor The FIRST model is a subset of the assumes that any amount of exposure and all labeled and proposed S- PRZM/EXAMS model that uses a will lead to some degree of cancer risk. metolachlor food uses using 100% crop specific high-end runoff scenario for A Q* is calculated and used to estimate treated (CT) and tolerance level pesticides. FIRST and PRZM/EXAMS risk which represents a probability of residues. incorporate an index reservoir occurrence of additional cancer cases ii. Chronic exposure. In conducting environment, and include a PC area (e.g., risk is expressed as 1 x 10-6 or one this chronic dietary risk assessment, factor as an adjustment to account for in a million). Under certain specific EPA used the DEEM software with the the maximum PC coverage within a circumstances, MOE calculations will FCID which incorporates food watershed ordrainage basin. be used for the carcinogenic risk consumption data as reported by The acute estimated environmental assessment. In this non-linear approach, respondents in the USDA 1994–1996 concentration (EEC) of 77.6 parts per a ‘‘point of departure.’’ is identified and 1998 nationwide CSFII and billion (ppb) was selected from the below which carcinogenic effects are accumulated exposure to the chemical NAWQA data base, and the chronic EEC not expected. The point of departure is for each commodity. A conservative of 4.3 ppb was selected from the typically a NOAEL based on an Tier 1 combined, chronic dietary maximum annual time weighted mean endpoint related to cancer effects exposure assessment was conducted for from the NAWQA data. These values though it may be a different value all labeled metolachlor and all labeled represent the estimated concentration of derived from the dose response curve. and proposed S-metolachlor food uses parent metolachlor/S-metolachlor in To estimate risk, a ratio of the point of using 100% CT and tolerance level surface water, and are supported by the departure to exposure (MOEcancer = point residues. metolachlor concentrations from the of departure/exposures) is calculated. A 2. Dietary exposure from drinking National Contaminant Occurrence Data summary of the toxicological endpoints water. The environmental fate data base base representing analysis of treated for S-metolachlor used for human risk is complete for S-metolachlor. Parent drinking water, as well as from model assessment is discussed in Unit III.B. of metolachlor/S-metolachlor appear to be predictions using PRZM/EXAMS. When the final rule published in the Federal moderately persistent to persistent, and the monitoring data and modeling data Register of April 2, 2003 (68 FR 15945) range from mobile to highly mobile in are considered together, there is a (FRL–7299–8). different soils. Metolachlor and S- general agreement between the various

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sources of information used in the models to quantify drinking water Exposure Policy 12 (Science Advisory assessment. exposure and risk as a percent reference Panel on Exposure, February 22, 2001). Acute and chronic concentrations of dose (%RfD) or percent population The exposure and risk estimates for the parent metolachlor/S-metolachlor are adjusted dose (%PAD). Instead drinking three residential exposure scenarios are not expected to exceed 5.5 ppb in water levels of comparison (DWLOCs) assessed for the day of application (day ground water (based on SCI-GROW are calculated and used as a point of ‘‘0’’) since children will likely contact modeling). SCI-GROW estimates the comparison against the model estimates the lawn immediately following upper bound ground water of a pesticide’s concentration in water. application. The following estimates/ concentrations of pesticides likely to DWLOCs are theoretical upper limits on assumptions were used in the risk occur when the pesticide is used at the a pesticide’s concentration in drinking assessment: (1) A single application at maximum allowable rate in areas with water in light of total aggregate exposure the maximum label rate of 2.47 lb active ground water vulnerable to to a pesticide in food, and from ingredient/acre for S-metolachlor, (2) contamination. Estimates were based on residential uses. Since DWLOCs address exposure duration for children is two applications to corn/turf for a total total aggregate exposure to metolachlor/ assumed to be 2 hours per day, (3) the of 4 lbs. active ingredient/acre (the S-metolachlor they are further discussed exposed child’s weight is 15 kg (33 maximum application rate). in the aggregate risk sections in Unit pounds), and (4) turf transferable Acute and chronic estimates of III.E. residue (TTR) value of 5%, and object- metolachlor ESA in surface water (based 3. From non-dietary exposure. The to-mouth residue value of 20% of the on FIRST modeling) are 31.9 ppb and term ‘‘residential exposure’’ is used in application rate assumed. 22.8 ppb, respectively. Acute and this document to refer to non- 4. Cumulative effects from substances chronic estimates of metolachlor OA in occupational, non-dietary exposure with a common mechanism of toxicity. surface water are 91.4 ppb and 65.1 ppb, (e.g., for lawn and garden pest control, Section 408(b)(2)(D)(v) of the FFDCA respectively. The application rate used indoor pest control, termiticides, and requires that, when considering whether for metolachlor ESA and OA in the flea and tick control on pets). There is to establish, modify, or revoke a model was estimated by converting the potential for post-application tolerance, the Agency consider maximum label rates for each use by the exposure to adults and children ‘‘available information’’ concerning the maximum percentage of degradate resulting from the use of S-metolachlor cumulative effects of a particular found in fate studies. In addition, each on residential lawns. Post-application pesticide’s residues and ‘‘other application rate was corrected for exposures from various activities substances that have a common molecular weight differences of each following lawn treatment are considered mechanism of toxicity.’’ EPA has degradate. Acute and chronic estimates to be the most common and significant examined the common mechanism of metolachlor ESA in ground water in residential settings. Post-application potential for S-metolachlor and has (based on SCI-GROW modeling, turf/ exposure is considered to be short-term concluded that S-metolachlor should corn scenario) are not expected to (1– days of exposure), based on label not be included with the exceed 65.8 ppb. This value is directions limiting application to one chloroacetanilide pesticides designated considered representative of both peak time per season. as a ‘‘Common Mechanism Group.’’ The and long-term average concentrations A short-term dermal risk assessment Agency’s position is that only some because of the inherent transport nature was not conducted since no systemic chloroacetanailides, namely acetochlor, of ground water (generally slow toxicity was observed at the limit dose alachlor and butachlor should be movement from the source of of 1,000 milligrams/kilogram/day (mg/ considered as a ‘‘Common Mechanism contamination both laterally and kg/day) following dermal application Group’’ due to their ability to cause horizontally). Acute and chronic and there is no concern for nasal turbinate tumors. Although estimates of metolachlor OA in ground developmental toxicity in rats and metolachlor does distribute to the nasal water (also based on the turf/corn rabbits. Post-application inhalation turbinates, and might produce a scenario) are not expected to exceed exposure is also expected to be minimal quinonimine, it is not apparent from the 31.7 ppb. Monitoring data suggest that since S-metolachlor is only applied available data that metolachlor shares the SCI-GROW estimates for outdoors, the vapor pressure is low and the same target site in the nasal tissue metolachlor ESA and OA are slightly the label specifies that residents should as acetochlor, alachlor, and butachlor. over estimating the potential impact of not reenter treated areas until after the For information regarding EPA’s metolachlor/S-metolachlor use on spray has dried. efforts to determine which chemicals ground water. The following post-application have a common mechanism of toxicity None of these models include incidental oral scenarios following and to evaluate the cumulative effects of consideration of the impact processing application to lawns and turf have been such chemicals, see the policy (mixing, dilution, or treatment) of raw identified: (1) Short-term oral exposure statements released by EPA’s Office of water for distribution as drinking water to toddlers and children following Pesticide Programs concerning common would likely have on the removal of hand-to-mouth exposure; (2) short-term mechanism determinations and pesticides from the source water. The oral exposure to toddlers and children procedures for cumulating effects from primary use of these models by the following object-to-mouth exposure; (3) substances found to have a common Agency at this stage is to provide a short-term oral exposure to toddlers and mechanism on EPA’s website at http:// coarse screen for sorting out pesticides children following soil ingestion. The www.epa.gov/pesticides/cumulative/. for which it is highly unlikely that Health Effect Division Standard drinking water concentrations would Operating Procedures for Residential D. Safety Factor for Infants and ever exceed human health levels of Exposure Assessments (Draft, December Children concern. 18, 1997) were used as a guideline for 1. In general. Section 408 of the Since the models used are considered the residential post-application FFDCA provides that EPA shall apply to be screening tools in the risk assessment. Also, standard values for an additional tenfold margin of safety assessment process, the Agency does turf transferable residues, turf transfer for infants and children in the case of not use estimated environmental coefficients, and hand-to-mouth threshold effects to account for prenatal concentrations (EECs) from these activities were used as amended by and postnatal toxicity and the

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completeness of the data base on and residential uses, the Agency with reasonable certainty that exposures toxicity and exposure unless EPA calculates DWLOCs which are used as a to the pesticide in drinking water (when determines that a different margin of point of comparison against the model considered along with other sources of safety will be safe for infants and estimates of a pesticide’s concentration exposure for which EPA has reliable children. Margins of safety are in water (EECs). DWLOC values are not data) would not result in unacceptable incorporated into EPA risk assessments regulatory standards for drinking water. levels of aggregate human health risk at either directly through use of a margin DWLOCs are theoretical upper limits on this time. Because EPA considers the of exposure (MOE) analysis or through a pesticide’s concentration in drinking aggregate risk resulting from multiple using uncertainty (safety) factors in water in light of total aggregate exposure exposure pathways associated with a calculating a dose level that poses no to a pesticide in food and residential pesticide’s uses, levels of comparison in appreciable risk to humans. uses. In calculating a DWLOC, the 2. Prenatal and postnatal sensitivity. drinking water may vary as those uses Agency determines how much of the change. If new uses are added in the There is no indication of quantitative or acceptable exposure (i.e., the PAD) is future, EPA will reassess the potential qualitative increased susceptibility of available for exposure through drinking impacts of residues of the pesticide in rats or rabbits to in utero and/or water e.g., allowable chronic water postnatal exposure in the available exposure (mg/kg/day) = cPAD - (average drinking water as a part of the aggregate toxicity data. food + residential exposure). This risk assessment process. 3. Conclusion. There is a complete allowable exposure through drinking 1. Acute risk. The acute aggregate risk toxicity data base and exposure data are water is used to calculate a DWLOC. assessment addresses potential exposure complete or are estimated based on data A DWLOC will vary depending on the from combined residues of metolachlor/ that reasonably accounts for potential toxic endpoint, drinking water S-metolachlor on food and total residues exposures. The FQPA Safety Factor for consumption, and body weights. Default of metolachlor/S-metolachlor plus ESA the protection of infants and children body weights and consumption values and OA degradates in drinking water has been reduced to 1X because: (1) The (surface water and ground water). Using toxicology data base is complete for the as used by the U.S. EPA Office of Water FQPA assessment. (2) there is no are used to calculate DWLOCs: 2 liter the exposure assumptions discussed in indication of quantitative or qualitative (L)/70 kg (adult male), 2L/60 kg (adult this unit for acute exposure, the acute increased susceptibility of rats or rabbits female), and 1L/10 kg (child). Default dietary exposure from food to to in utero and/or postnatal exposure to body weights and drinking water metolachlor/S-metolachlor will occupy metolachlor in the available toxicity consumption values vary on an <1% of the aPAD for the U.S. data. (3) a developmental neurotoxicity individual basis. This variation will be population and all other population study is not required for metolachlor. (4) taken into account in more refined subgroups. In addition, there is the dietary (food and drinking water) screening-level and quantitative potential for acute dietary exposure to and non-dietary exposure (residential) drinking water exposure assessments. metolachlor/S-metolachlor and the ESA assessments will not under estimate the Different populations will have different and OA degradates in drinking water. potential exposures for infants and DWLOCs. Generally, a DWLOC is After calculating DWLOCs and calculated for each type of risk children from the use of metolachlor. comparing them to the EECs for surface assessment used: Acute, short-term, water and ground water, EPA does not E. Aggregate Risks and Determination of intermediate-term, chronic, and cancer. Safety expect the aggregate exposure to exceed When EECs for surface water and 100% of the aPAD, as shown in the To estimate total aggregate exposure ground water are less than the following Table 1: to a pesticide from food, drinking water, calculated DWLOCs, EPA concludes

TABLE 1.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO METOLACHLOR/S-METOLACHLOR

Surface Ground Acute Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC DWLOC kg) (Food) (ppb) (ppb) (ppb) U.S.population 3.0 <1 200.9 103 104856.1 Infants <1 year 3.0 <1 200.9 103 29931.45 Children 1 to 2 years old 3.0 <1 200.9 103 29917.76 Females 13 to 49 years old 3.0 <1 200.9 103 89915.55

2. Chronic risk. The chronic aggregate residential exposure to S-metolachlor. for chronic dietary exposure to risk assessment addresses potential EPA has concluded that chronic metolachlor/S-metolachlor and ESA and exposure from combined residues of exposure to metolachlor/S-metolachlor OA degradates in drinking water. After metolachlor/S-metolachlor on food and from food will utilize 2% of the cPAD calculating DWLOCs and comparing total residues of metolachlor/S- for the U.S. population, 4% of the cPAD them to the EECs for surface water and metolachlor plus ESA and OA for children 1 to 2 years old, the ground water, EPA does not expect the degradates in drinking water (surface subpopulations at greatest exposure and aggregate exposure to exceed 100% of water and ground water). There are no 1% of the cPAD for females 13 to 49 the cPAD, as shown in the following residential uses that result in chronic years old. In addition, there is potential Table 2:

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TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO METOLACHLOR/S-METOLACHLOR

Surface Ground Chronic Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC DWLOC day (Food) (ppb) (ppb) (ppb) U.S. population 0.1 2 92.2 103 3442.50 Infants <1 year 0.1 2 92.2 103 977.20 Children 1 to 2 years 0.1 4 92.2 103 959.75 Females 13 to 49 years 0.1 1 92.2 103 2962.11

3. Short-term risk. Short-term short-term exposures for metolachlor short-term DWLOCs were calculated aggregate exposure takes into account and S-metolachlor. and compared to the EECs for chronic residential exposure plus chronic Using the exposure assumptions exposure of metolachlor/S-metolachlor exposure to food and water (considered described in this unit for short-term and ESA and OA degradates in ground to be a background exposure level). exposures, EPA has concluded that food water and surface water. After and residential exposures aggregated calculating DWLOCs and comparing S-metolachlor is currently registered result in an aggregate MOE of 1,000 for them to the EECs for surface water and for use that could result in short-term children 1 to 2 years. This aggregate ground water, EPA does not expect residential exposure and the Agency has MOE does not exceed the Agency’s level short-term aggregate exposure to exceed determined that it is appropriate to of concern for aggregate exposure to the Agency’s level of concern, as shown aggregate chronic food and water and food and residential uses. In addition, in the following Table 3:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO METOLACHLOR/S-METOLACHLOR

Aggregate Aggregate Surface Ground Short-Term Population Subgroup MOE (Food Level of Con- Water EEC Water EEC DWLOC +Residential) cern (LOC) (ppb) (ppb) (ppb) Children 1 to 2 years old 1,000 100 92.2 103.3 4,000

5. Aggregate cancer risk for U.S. on the recovery of metolachlor through at 0.20 ppm; horseradish at 0.20 ppm; population. The NOAEL that was Multi-residue Method Testing Protocols. onion, green at 0.20 ppm; rhubarb at established based on tumors in rats (15 The FDA PEST DATA data base 0.10 ppm; swiss chard at 0.10 ppm. mg/kg/day) is comparable to the NOAEL indicates that metolachlor is completely of 9.7 mg/kg/day selected for cRfD. recovered through Method 302, PAM VI. Objections and Hearing Requests Therefore, the chronic dietary end point Vol. I (3rd ed., revised 10/97). Under section 408(g) of the FFDCA, as The method may be requested from: is protective for cancer dietary amended by the FQPA, any person may exposure. Chief, Analytical Chemistry Branch, file an objection to any aspect of this Environmental Science Center, 701 6. Determination of safety. Based on regulation and may also request a these risk assessments, EPA concludes Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; e- hearing on those objections. The EPA that there is a reasonable certainty that procedural regulations which govern the no harm will result to the general mail address: residue [email protected]. submission of objections and requests population, and to infants and children B. International Residue Limits for hearings appear in 40 CFR part 178. from aggregate exposure to metolachlor/ S-metolachlor residues. No maximum residue limits for either Although the procedures in those metolachlor or S-metolachlor have been regulations require some modification to IV. Other Considerations established or proposed by Codex, reflect the amendments made to the A. Analytical Enforcement Methodology Canada, or Mexico for any agricultural FFDCA by the FQPA, EPA will continue commodity; therefore, there are no to use those procedures, with The Pesticide Analytical Manual compatibility issues with this action. appropriate adjustments, until the (PAM) Vol. II, lists a Gas V. Conclusion necessary modifications can be made. Chromatography (GC)/NPD method The new section 408(g) of the FFDCA (Method I) for determining residues in/ Therefore, tolerances are established provides essentially the same process on plants and a GC/Mass Spectrometry for combined residues of S-metolachlor for persons to ‘‘object’’ to a regulation Detection (MSD) method (Method II ) for acetamid, 2-chloro-N-(2-ethyl-6- for an exemption from the requirement determining residues in livestock methylphenyl)-N-(2-methoxy-1- of a tolerance issued by EPA under new commodities. These methods determine methylethyl)-, (S) and its metabolites, section 408(d) of FFDCA, as was residues of metolachlor and its determined as the derivatives, 2-[(2- provided in the old sections 408 and metabolites as either CGA-37913 or ethyl-6-methylphenyl)amino]-1- CGA-49751 following acid hydrolysis. propanol (CGA-37913) and 4-(2-ethyl-6- 409 of the FFDCA. However, the period Field trial data were obtained using methylphenyl)-2-hydroxy-5-methyl-3- for filing objections is now 60 days, adequate GC/NPD methods (AG-338 or morpholinone (CGA-49751), each rather than 30 days. AG-612), which are modifications of expressed as the parent compound, in or Method I. Adequate data are available on asparagus at 0.10 ppm; carrot, roots

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A. What Do I Need to Do to File an 5697, by e-mail at response to a petition submitted to the Objection or Request a Hearing? [email protected], or by mailing a Agency. The Office of Management and You must file your objection or request for information to Mr. Tompkins Budget (OMB) has exemptedthese types request a hearing on this regulation in at Registration Division (7505C), Office of actions from review under Executive accordance with the instructions of Pesticide Programs, Environmental Order 12866, entitled Regulatory provided in this unit and in 40 CFR part Protection Agency, 1200 Pennsylvania Planning and Review (58 FR 51735, 178. To ensure proper receipt by EPA, Ave., NW., Washington, DC 20460– October 4, 1993). Because this rule has you must identify docket ID number 0001. been exempted from review under If you would like to request a waiver OPP–2003–0300 in the subject line on Executive Order 12866 due to its lack of of the tolerance objection fees, you must the first page of your submission. All significance, this rule is not subject to mail your request for such a waiver to: requests must be in writing, and must be Executive Order 13211, Actions James Hollins, Information Resources mailed or delivered to the Hearing Clerk Concerning Regulations That and Services Division (7502C), Office of Significantly Affect Energy Supply, on or before November 18, 2003. Pesticide Programs, Environmental 1. Filing the request. Your objection Distribution, or Use (66 FR 28355, May Protection Agency, 1200 Pennsylvania must specify the specific provisions in 22, 2001). This final rule does Ave., NW., Washington, DC 20460– the regulation that you object to, and the notcontain any information collections 0001. subject to OMB approval under the grounds for the objections (40 CFR 3. Copies for the Docket. In addition Paperwork Reduction Act (PRA), 44 178.25). If a hearing is requested, the to filing an objection or hearing request U.S.C. 3501 et seq., or impose any objections must include a statement of with the Hearing Clerk as described in enforceable duty or contain any the factual issues(s) on which a hearing Unit VI.A., you should also send a copy unfunded mandate as described under is requested, the requestor’s contentions of your request to the PIRIB for its on such issues, and a summary of any inclusion in the official record that is Title II of the Unfunded Mandates evidence relied upon by the objector (40 described in Unit I.B.1. Mail your Reform Act of 1995 (UMRA) (Public CFR 178.27). Information submitted in copies, identified by docket ID number Law 104–4). Nor does it require any connection with an objection or hearing OPP–2003–0300, to: Public Information special considerations under Executive request may be claimed confidential by and Records Integrity Branch, Order 12898, entitled Federal Actions to marking any part or all of that Information Resources and Services Address Environmental Justice in information as CBI. Information so Division (7502C), Office of Pesticide Minority Populations and Low-Income marked will not be disclosed except in Programs, Environmental Protection Populations (59 FR 7629, February 16, accordance with procedures set forth in Agency, 1200 Pennsylvania Ave., NW., 1994); or OMB review or any Agency 40 CFR part 2. A copy of the Washington, DC 20460–0001. In person action under Executive Order 13045, information that does not contain CBI or by courier, bring a copy to the entitled Protection of Children from must be submitted for inclusion in the location of the PIRIB described in Unit Environmental Health Risks and Safety public record. Information not marked I.B.1. You may also send an electronic Risks (62 FR 19885, April 23, 1997). confidential may be disclosed publicly copy of your request via e-mail to: opp- This action does not involve any by EPA without prior notice. [email protected]. Please use an ASCII technical standards that would require Mail your written request to: Office of file format and avoid the use of special Agency consideration of voluntary the Hearing Clerk (1900C), characters and any form of encryption. consensus standards pursuant to section Environmental Protection Agency, 1200 Copies of electronic objections and 12(d) of the National Technology Pennsylvania Ave., NW., Washington, hearing requests will also be accepted Transfer and Advancement Act of 1995 DC 20460–0001. You may also deliver on disks in WordPerfect 6.1/8.0 or (NTTAA), Public Law 104–113, section your request to the Office of the Hearing ASCII file format. Do not include any 12(d) (15 U.S.C. 272 note). Since Clerk in Rm.104, Crystal Mall #2, 1921 CBI in your electronic copy. You may tolerances and exemptions that are Jefferson Davis Hwy., Arlington, VA. also submit an electronic copy of your established on the basis of a petition The Office of the Hearing Clerk is open request at many Federal Depository under section 408(d) of the FFDCA, from 8 a.m. to 4 p.m., Monday through Libraries. such as the tolerances in this final rule, Friday, excluding legal holidays. The do not require the issuance of aproposed telephone number for the Office of the B. When Will the Agency Grant a rule, the requirements of the Regulatory Hearing Clerk is (703) 603–0061. Request for a Hearing? Flexibility Act (RFA) (5 U.S.C. 601 et 2. Tolerance fee payment. If you file A request for a hearing will be granted seq.) do not apply. In addition, the an objection or request a hearing, you if the Administrator determines that the Agency has determined that this action must also pay the fee prescribed by 40 material submitted shows the following: will not have a substantial direct effect CFR 180.33(i) or request a waiver of that There is a genuine and substantial issue on States, on the relationship between fee pursuant to 40 CFR 180.33(m). You of fact; there is a reasonable possibility the national government and the States, must mail the fee to: EPA Headquarters that available evidence identified by the or on the distribution of power and Accounting Operations Branch, Office requestor would, if established resolve responsibilities among the various of Pesticide Programs, P.O. Box one or more of such issues in favor of levels of government, as specified in 360277M, Pittsburgh, PA 15251. Please the requestor, taking into account Executive Order 13132, entitled identify the fee submission by labeling uncontested claims or facts to the Federalism (64 FR 43255, August 10, it ‘‘Tolerance Petition Fees.’’ contrary; and resolution of the factual 1999). Executive Order 13132 requires EPA is authorized to waive any fee issues(s) in the manner sought by the EPA to develop an accountable process requirement ‘‘when in the judgement of requestor would be adequate to justify to ensure ‘‘meaningful and timely input the Administrator such a waiver or the action requested (40 CFR 178.32). by State and local officials in the refund is equitable and not contrary to development of regulatory policies that the purpose of this subsection.’’ For VII. Statutory and Executive Order have federalism implications.’’ ‘‘Policies additional information regarding the Reviews that have federalism implications’’ is waiver of these fees, you may contact This final rule establishes tolerances defined in the Executive Order to James Tompkins by phone at (703) 305– under section 408(d) of the FFDCA in include regulations that have

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‘‘substantial direct effects on the States, Government and the Indian tribes, or on rule is not a ‘‘major rule’’ as defined by on the relationship between the national the distribution of power and 5 U.S.C. 804(2). government and the States, or on the responsibilities between the Federal List of Subjects in 40 CFR Part 180 distribution of power and Government and Indian tribes.’’ This responsibilities among the various rule will not have substantial direct Environmental protection, levels of government.’’ This final rule effects on tribal governments, on the Administrative practice and procedure, directly regulates growers, food relationship between the Federal Agricultural commodities, Pesticides processors, food handlers and food Government and Indian tribes, or on the and pests, Reporting and recordkeeping retailers, not States. This action does not distribution of power and requirements. alter the relationships or distribution of responsibilities between the Federal Dated: September 12, 2003. Government and Indian tribes, as power and responsibilities established Debra Edwards, by Congress in the preemption specified in Executive Order 13175. Thus, Executive Order 13175 does not Director, Registration Division, Office of provisions of section 408(n)(4) of the Pesticide Programs. FFDCA. For these same reasons, the apply to this rule. Therefore, 40 CFR chapter I is Agency has determined that this rule VIII. Congressional Review Act amended as follows: does not have any ‘‘tribal implications’’ The Congressional Review Act, 5 as described in Executive Order 13175, U.S.C. 801 et seq., as added by the Small PART 180— [AMENDED] entitled Consultation and Coordination Business Regulatory Enforcement with Indian Tribal Governments (65 FR Fairness Act of 1996, generally provides 1. The authority citation for part 180 67249, November 6, 2000). Executive that before a rule may take effect, the continues to read as follows: Order 13175, requires EPA to develop agency promulgating the rule must Authority: 21 U.S.C. 321(q), 346(a) and an accountable process to ensure submit a rule report, which includes a 371. ‘‘meaningful and timely input by tribal copy of the rule, to each House of the 2. Section 180.368 is amended by officials in the development of Congress and to the Comptroller General alphabetically adding commodities to regulatory policies that have tribal of the United States. EPA will submit a the table in paragraph (a)(2) to read as implications.’’ ‘‘Policies that have tribal report containing this rule and other follows: implications’’ is defined in the required information to the U.S. Senate, Executive Order to include regulations the U.S. House of Representatives, and § 180.368 Metolachlor; tolerances for that have ‘‘substantial direct effects on the Comptroller General of the United residues. one or more Indian tribes, on the States prior to publication of this final (a) * * * relationship between the Federal rule in the Federal Register. This final (2) * * *

Commodity Parts per million

Asparagus ...... 0.10 ***** Carrot, roots ...... 0.20 ***** Horseradish ...... 0.20 Onion, green ...... 0.20 ***** Rhubarb ...... 0.10 ***** Swiss chard ...... 0.10 *****

* * * * * on field corn, soybeans, and sugarcane, electronically, by mail, or through hand [FR Doc. 03–24014 Filed 9–16–03; 4:08 pm] and the combined residues of flufenpyr- delivery/courier. Follow the detailed BILLING CODE 6560–50–S ethyl and its metabolite, S-3153 acid-4- instructions as provided in Unit VI. of OH; [2-chloro-4-hydroxy-5-[5-methyl-6- the SUPPLEMENTARY INFORMATION. oxo-4-(trifluoromethyl)-1-(6H)- FOR FURTHER INFORMATION CONTACT: ENVIRONMENTAL PROTECTION pyridazinyl]-phenoxy]-acetic acid, free Joanne I. Miller, Registration Division AGENCY and conjugated, in or on field corn (7505C), Office of Pesticide Programs, forage and field corn stover. Valent USA 40 CFR Part 180 Environmental Protection Agency, 1200 Corporation requested this tolerance Pennsylvania Ave., NW., Washington, [OPP–2003–0166; FRL–7325–4] under the Federal Food, Drug, and DC 20460–0001; telephone number: Cosmetic Act (FFDCA), as amended by (703) 305–6224; e-mail address: Flufenpyr-Ethyl; Pesticide Tolerance the Food Quality Protection Act (FQPA) [email protected]. of 1996. AGENCY: Environmental Protection DATES: SUPPLEMENTARY INFORMATION: Agency (EPA). This regulation is effective September 19, 2003. Objections and I. General Information ACTION: Final rule. requests for hearings, identified by A. Does this Action Apply to Me? SUMMARY: This regulation establishes a docket ID number OPP–2003–0166, tolerance for residues of flufenpyr-ethyl; must be received on or before November You may be potentially affected by acetic acid, [2-chloro-4-fluoro-5-[5- 18, 2003. this action if you are an agricultural methyl-6-oxo-4-(trifluoromethyl)-1-(6H)- ADDRESSES: Written objections and producer, food manufacturer, or pest pyridazinyl]-phenoxy]-ethyl ester], in or hearing requests may be submitted manufacturer. Potentially affected

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