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TABLE 2.—ANIMAL FEED—Continued TABLE 3—REFINED SUGARS even after treatment at a 10X rate. on corn was included in Chemical Commodity Chemical Commodity the OP preliminary CRA to assess its potential for contaminating drinking Oxydemeton methyl Alfalfa, green Chlorpyrifos (40 CFR Beets, sugar, molas- water. In the preliminary CRA, no (40 CFR part Alfalfa, hay, for seed part 180.342) ses drinking water risks were indicated Beets, sugar, roots 180.330) Beans, lima, forage even when high relative potency values Beans, snap forage Beets, sugar, tops Disulfoton (40 CFR Beets, sugar, roots were used (a screening relative potency Clover, chaff, for part 180.183) Sugarcane factor (RPF) of 25 was used, which is seed approximately 200 times greater than Clover, green Ethoprop (40 CFR Sugarcane the recently calculated RPF for this Clover, hay, for part 180.262) pesticide). Therefore, the following seed three chlorethoxyfos corn tolerances are Corn, fodder Naled (40 CFR part Beets, sugar, roots 180.215) considered reassessed: corn, pop, grain; Corn, forage corn, field, grain; and corn, sweet Mint, hay (K+CWHR) (i.e., kernel plus cob with Sorghum, forage Oxydemeton methyl Beets, sugar Sorghum, milled (40 CFR part husks removed). 180.330) fraction (except IV. Approach for Identifying Other flour) Phorate (40 CFR Beets, sugar, roots Non-Contributor Categories part 180.206) Sugarcane Phorate (40 CFR Beets, sugar, tops EPA is evaluating other potential non- part 180.206) Corn, forage Terbufos (40 CFR Beets, sugar, roots contributor tolerances. For example, it is Sorghum, fodder part 180.352) possible that non-contributor Wheat, fodder, determinations could be made for green certain categories or types of tolerances Wheat, straw Category 4 -- Use Pattern Consideration EPA has determined that an for foods that are reported to have little Phosmet (40 CFR Alfalfa additional small number (five) of OP or no consumption, or where few or no part 180.261) Almonds, hulls tolerances can be reassessed now based residues are detected. In evaluating Peas, forage on the way the pesticides are used. candidate tolerances, EPA would Peas, hay For the following two pesticide active consider all relevant data and factors, ingredients, cadusafos and including information from the Propetamphos (for- Animal feed propetamphos, negligible, if any, individual OP aggregate risk merly 40 CFR part exposures (including in drinking water) assessments, before making a 186.510) are expected due to the nature of their reassessment determination. Terbufos (40 CFR Beets, sugar, tops use patterns. Each pesticide has one The Agency seeks comment about the part 180.352) Corn, field, fodder tolerance, and both are considered use of the approach described here and Corn, field, forage reassessed. the factors that are relevant to Corn, pop, fodder • Cadusafos (40 CFR part 180.461): reassessment determinations based on Corn, pop, forage One import tolerance on bananas. this approach. EPA will announce the Corn, sweet, fodder Cadusafos is used exclusively on reassessment of non-contributor Corn, sweet, forage imported bananas. No detectable food tolerances on the Agency’s internet Sorghum, fodder residues are expected from this use website (www.epa.gov/pesticides/ Sorghum, forage based on the nature of the use pattern cumulative). (e.g., when the pesticide is typically List of Subjects Category 3--Refined Sugars applied) and a consideration of the As discussed in the OP preliminary nature of the commodity (i.e., the Environmental protection, Chemicals, CRA, negligible OP residues are protective peel of the banana fruit). Pesticides and pests. • Propetamphos (40 CFR part expected to occur for refined sugars Dated: May 14, 2002. produced from beets and sugarcane 180.541): One tolerance for processed food. Propetamphos is used only as a Lois Rossi, based on available monitoring data Director, Special Review and Reregistration (USDA’s PDP and FDA’s TDS) and the crack and crevice treatment. It is not allowed to be used in structures that Division, Office of Pesicide Programs. nature of the refining process. PDP has [FR Doc. 02–12713 Filed 5–21–02; 8:45 am] analyzed high fructose corn syrup and children or the elderly occupy, including homes, schools, day-cares, BILLING CODE 6560–50–S found no pesticide residues. The TDS hospitals, and nursing homes with the has analyzed refined sugar and maple exception of areas of food service within sugar and found no OP residues in 26 those structures when food is covered or ENVIRONMENTAL PROTECTION market basket surveys. Knowledge of removed prior to treatment. As the AGENCY the highly refined nature of sugars and result of these restrictions, exposure is syrups also supports the conclusion that expected to be negligible. [OPP–2002–0046; FRL–6836–4] negligible residues are expected to occur Chlorethoxyfos (40 CFR part 180.486) in refined sugars from sugarcane and is a soil insecticide that is applied at Notice of Filing a Pesticide Petition To sugar beets. The following 10 tolerances planting to corn, and no detectable food Establish a Tolerance fora Certain listed in Table 3 are considered residues are expected from this use. The Pesticide Chemical in or on Food reassessed: chlorethoxyfos IRED states that field AGENCY: Environmental Protection trials showed no residues (less than 0.01 Agency (EPA). ppm) of the parent in any of the corn ACTION: raw agricultural commodities analyzed, Notice.

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SUMMARY: This notice announces the B. How Can I Get Additional Information Resources and Services amendment of the pesticide petition (PP Information, Including Copies of this Division (7502C), Office of Pesticide 6F3344) proposing the establishment of Document and Other Related Programs (OPP), Environmental regulations for residues of a certain Documents? Protection Agency, Rm. 119, Crystal pesticide chemical in or on various food 1. Electronically. You may obtain Mall #2, 1921 Jefferson Davis Highway, commodities. electronic copies of this document, and Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through DATES: Comments, identified by docket certain other related documents that might be available electronically, from Friday, excluding legal holidays. The control number OPP–2002–0046, must PIRIB telephone number is (703) 305– be received on or before June 21, 2002. the EPA Internet Home Page at http:// www.epa.gov/. To access this 5805. ADDRESSES: Comments may be document, on the Home Page select 3. Electronically. You may submit submitted by mail, electronically, or in ‘‘Laws and Regulations’’ ‘‘Regulation your comments electronically by e-mail person. Please follow the detailed and Proposed Rules,’’ and then look up to: [email protected], or you can instructions for each method as the entry for this document under the submit a computer disk as described provided in Unit I. C. of the ‘‘Federal Register—Environmental above. Do not submit any information electronically that you consider to be SUPPLEMENTARY INFORMATION. To ensure Documents.’’ You can also go directly to CBI. Avoid the use of special characters proper receipt by EPA, it is imperative the Federal Register listings at http:// and any form of encryption. Electronic that you identify docket control number www.epa.gov/fedrgstr/. 2. In person. The Agency has submissions will be accepted in OPP–2002–0046 in the subject line on Wordperfect 6.1/8.0 or ASCII file the first page of your response. established an official record for this action under docket control number format. All comments in electronic form FOR FURTHER INFORMATION CONTACT: By OPP–2002–0046. The official record must be identified by docket control mail: Treva Alston, Registration consists of the documents specifically number OPP–2002–0046. Electronic Division (7505C), Office of Pesticide referenced in this action, any public comments may also be filed online at Programs, Environmental Protection comments received during an applicable many Federal Depository Libraries. Agency, 1200 Pennsylvania Ave., NW., comment period, and other information D. How Should I Handle CBI That I Washington, DC 20460; telephone related to this action, including any Want to Submit to the Agency? number: (703) 308–8373; e-mail address: information claimed as confidential Do not submit any information [email protected]. business information (CBI). This official record includes the documents that are electronically that you consider to be SUPPLEMENTARY INFORMATION: physically located in the docket, as well CBI. You may claim information that you submit to EPA in response to this I. General Information as the documents that are referenced in those documents. The public version of document as CBI by marking any part or A. Does this Action Apply to Me? the official record does not include any all of that information as CBI. information claimed as CBI. The public Information so marked will not be You may be affected by this action if version of the official record, which disclosed except in accordance with you are an agricultural producer, food includes printed, paper versions of any procedures set forth in 40 CFR part 2. manufacturer or pesticide manufacturer. electronic comments submitted during In addition to one complete version of Potentially affected categories and an applicable comment period, is the comment that includes any entities may include, but are not limited available for inspection in the Public information claimed as CBI, a copy of to: Information and Records Integrity the comment that does not contain the Branch (PIRIB), Rm. 119, Crystal Mall information claimed as CBI must be NAICS Examples of poten- #2, 1921 Jefferson Davis Highway, submitted for inclusion in the public Categories tially affected enti- version of the official record. codes ties Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal Information not marked confidential Industry 111 Crop production holidays. The PIRIB telephone number will be included in the public version 112 Animal production is (703) 305–5805. of the official record without prior 311 Food manufacturing notice. If you have any questions about C. How and to Whom Do I Submit 32532 Pesticide manufac- CBI or the procedures for claiming CBI, turing Comments? please consult the person identified You may submit comments through under FOR FURTHER INFORMATION CONTACT. This listing is not intended to be the mail, in person, or electronically. To exhaustive, but rather provides a guide ensure proper receipt by EPA, it is E. What Should I Consider as I Prepare for readers regarding entities likely to be imperative that you identify docket My Comments for EPA? control number OPP–2002–0046 in the affected by this action. Other types of subject line on the first page of your You may find the following entities not listed in the table could also response. suggestions helpful for preparing your be affected. The North American 1. By mail. Submit your comments to: comments: Industrial Classification System Public Information and Records 1. Explain your views as clearly as (NAICS) codes have been provided to Integrity Branch (PIRIB), Information possible. assist you and others in determining Resources and Services Division 2. Describe any assumptions that you whether or not this action might apply (7502C), Office of Pesticide Programs used. to certain entities. If you have questions (OPP), Environmental Protection 3. Provide copies of any technical regarding the applicability of this action Agency, 1200 Pennsylvania Ave., NW., information and/or data you used that to a particular entity, consult the person Washington, DC 20460. support your views. listed under FOR FURTHER INFORMATION 2. In person or by courier. Deliver 4. If you estimate potential burden or CONTACT. your comments to: Public Information costs, explain how you arrived at the and Records Integrity Branch (PIRIB), estimate that you provide.

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5. Provide specific examples to Dow AgroSciences LLC, 9330 Zionsville pathway is the loss of an allyl group illustrate your concerns. Road, Indianapolis, IN 46268 proposing, followed by oxidation to form 6. Make sure to submit your pursuant to section 408(d) of the Federal dichloroacetic . There is also comments by the deadline in this Food, , and Cosmetic Act (FFDCA), extensive incorporation into natural notice. 21 U.S.C. 346a(d), to amend 40 CFR part constituents. EPA has previously 7. To ensure proper receipt by EPA, 180 by re-establishing the time-limited determined that dichlormid is the be sure to identify the docket control tolerances for residues of dichlormid in residue of concern for tolerance setting number assigned to this action in the or on the raw agricultural commodity purposes. subject line on the first page of your corn (forage, grain, stover) at 0.05 parts 2. Analytical method. An adequate response. You may also provide the per million (ppm). Zeneca Ag Products enforcement method for residues of name, date, and Federal Register requested these tolerances under the dichlormid in corn has been developed citation. Federal Food, Drug, and Cosmetic Act, and validated by the Analytical as amended by the Food Quality Chemical Laboratory (ACL) of EPA. II. What Action is the Agency Taking? Protection Act of 1996. A Notice of Analysis is carried out using gas EPA has received a pesticide petition Filing was submitted and published in chromatography with nitrogen selective as follows proposing the establishment the Federal Register of September 16, thermionic detection. The limit of and/or amendment of regulations for 1998 (63 FR 49568) (FRL–6025–8). determination is 0.01 ppm. residues of a certain pesticide chemical Based on the data submitted by Zeneca, 3. Magnitude of residues. Fifteen field in or on various food commodities the Agency determined that only time- trials in field corn with dichlormid were under section 408 of the Federal Food, limited tolerances for these residues submitted and reviewed. The submitted Drug, and Comestic Act (FFDCA), 21 could be established. The final rule was data support the time-limited tolerance U.S.C. 346a. EPA has determined that published on March 27, 2000 (65 FR level of 0.05 ppm for all corn this petition contains data or 16143) (FRL–6498–7) with the time- commodities. information regarding the elements set limited tolerances expiring on March B. Toxicological Profile forth in section 408(d)(2); however, EPA 27, 2002. To establish permanent has not fully evaluated the sufficiency tolerances the following studies are 1. Acute toxicity. Dichlormid has low of the submitted data at this time or required: (1) Chronic Feeding Study in acute toxicity as indicated by a range of whether the data support granting of the Dogs, (2) 2-Generation Reproductive studies including: A rat acute oral study petition. Additional data may be needed Study in Rats, (3) General with an LD50 of 2,816 milligram/ before EPA rules on the petition. Study, and (4) Subchronic Neurotoxicity kilogram (mg/kg) for males and 2,146 Study, (5) various product chemistry mg/kg for females, respectively; a rat List of Subjects data-color, physical state, water acute dermal study with an LD50 of > Environmental protection, ; (6) animal metabolism 2,040 mg/kg and a rabbit acute dermal > Agricultural commodities, Feed studies, (7) crop field trials, and (8) study with an LD50 of 5,000 mg/kg; a > additives, Food additives, Pesticides rotational crop study (Confined Study). rat inhalation study with an LD50 of 5.5 and pests, Reporting and recordkeeping Zeneca committed to fulfill these data mg/L; a primary eye irritation study in requirements. gaps. These time-limited tolerances the rabbit showing mild ocular irritation; a primary dermal irritation Dated: May 3, 2002. expired on March 27, 2002. On November 9, 2000, Zeneca Ag study in the rabbit showing severe skin Peter Caulkins, Products sold certain parts of its irritation; and, a skin sensitization study Acting Director, Registration Division, Office business to Dow AgroSciences. In which showed that dichlormid was a of Pesticide Programs. connection with the sale, Zeneca Ag mild skin sensitizer in the guinea pig. Summary of Petition products tranferred all rights, title, and 2. Genotoxicity. Dichlormid was not interest in dichlormid to Dow mutagenic in a range of assays The petitioner summary of the including the Salmonella/microsome pesticide petition is printed below as AgroSciences.Dow AgroSciences has petitioned the Agency to re-establish (Ames) assay, the human lymphocyte required by section 408(d)(3) of the cytogenetic assay (both assays with and FFDCA. The summary of the petition time-limited tolerances to allow for continued data generation. EPA has without metabolic activation) and an was prepared by the petitioner and unscheduled DNA synthesis (DNA represents the view of the petitioners. determined that the petition contains data or information regarding the repair) assay in hepatocytes. In the The summary may have been edited by L5178Y mouse lymphoma assay small EPA if the terminology used was elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully increases in mutant frequency were unclear, the summary contained observed only at cytotoxic extraneous material for clarification, or evaluated the sufficiency of the submitted data at this time or whether concentrations and were not considered the summary unintentionally made the the data supports granting of the to be significant. In vivo, dichlormid reader conclude that the findings petition. Additional data may be needed was negative in the mouse micronucleus reflected EPA’s position and not the before EPA rules on the petition. test and in the rat unscheduled DNA position of the petitioner. The petition synthesis assay when tested at the summary announces the availability of A. Residue Chemistry maximum tolerated dose. a description of the analytical methods 1. Plant metabolism. The qualitative 3. Reproductive and developmental available to EPA for the detection and nature of the residue in plants is toxicity. In a developmental toxicity measurement of the pesticide chemical adequately understood based on a study study, rats were dosed orally by gavage residues or an explanation of why no depicting the metabolism of dichlormid with 0, 10, 40, or 160 mg/kg/day. The such method is needed. in corn plants. The metabolism of no observed adverse effect level Dow AgroSciences LLC dichlormid in corn is extensive and (NOAEL) for maternal toxicity was 10 occurs via two metabolic pathways. In mg/kg/day based on a reduction in PP 6F3344 one pathway dichlormid is de- bodyweight gain and food consumption EPA has received an amendment of chlorinated and oxidized to generate at 40 and 160 mg/kg/day. The the pesticide petition (PP 6F3344) from N,N-diallyl glycolamide. An alternative developmental NOAEL was determined

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to be 40 mg/kg/day based on marginal muscle with an associated increase in Based on available chronic toxicity fetotoxic effects, including extra 14th plasma creatine kinase and alkaline data, the Reference Dose (RfD) for ribs probably due to maternal stress, phosphatase activity between 6 and 10 dichlormid is 0.07 mg/kg/day. This RfD slight sternebra misalignment and some weeks. is based on the 2–year feeding study in centra unossified, at 160 mg/kg/day. In a 14–week rat inhalation study, rats with an NOAEL of 7 mg/kg/day. An In a developmental toxicity study, groups of 18 male and 18 female uncertainty factor of 100 was used to rabbits were dosed orally by gavage with Sprague-Dawley CD rats were subjected account for interspecies extrapolation 0, 5, 30, or 180 mg/kg/day. The lowest to a whole body exposure of 0, 2.0, 19.9, and intraspecies variability. The 2–year 3 observed adverse effect level (LOAEL) or 192.5 mg/m for 6 hours per day, 5 rat study is consistent with, but for both maternal and fetotoxicity was days per week. The NOAEL was 2.0 mg/ supersedes, the 90–day rat study. The 3 180 mg/kg/day characterized by reduced m based on histopathologic tissue 2–year rat NOAEL of 7 mg/kg/day lies body weight gain and food consumption alterations to the nasal olfactory 3 between 1.8 and 18 mg/kg/day derived and a small increase in post- epithelium at 19.9 and 192.5 mg/m , from the NOAEL and LOAEL figures of implantation loss, an increased number suggesting that dichlormid was a mild 20 and 200 ppm, respectively, for the of early resorptions, a decreased number irritant to the nasal cavity. An increase most recent 90-day rat study. Thus, the of fetuses per litter and evidence of in relative liver, kidney, and lung overall NOAEL in the rat for both fetotoxicity (partial ossification and weights at 19.9 and 192.5 mg/m3 was misshapen/fused sternebrae). The not supported by gross or chronic and subchronic exposure NOAEL for both maternal and histopathological observations. should be regarded as 7 mg/kg/day. developmental toxicity was 30 mg/kg/ 5. Chronic toxicity. Rats (64/sex/ Based on the proposed Guidelines for day. group) were fed diets containing 0, 20, Carcinogenic Risk Assessment (July In a 2–generation reproduction study 100, or 500 ppm dichlormid (0, 1.3, 6.5, 1999), dichlormid is not likely to be a in rats fed diets of 0, 15, 75, and 500 32.8 mg/kg/day for males and 0, 1.5, 7.5, human carcinogen and a margin of ppm of dichlormid, dietary 37.1 mg/kg/day for females) for up to 2 exposure (MOE) approach should be administration of 500 ppm dichlormid years. At 500 ppm in both males and used for human risk assessment. (48.5 mg/kg/day) for two successive females, there were treatment-related 6. Animal metabolism. Dichlormid generations resulted in decreased effects on growth and food was well absorbed, extensively bodyweights and increased liver consumption, minor reductions in metabolized and eliminated mainly in weights in parents and pups of both plasma triglycerides and in males, the urine within 24 hours. A significant generations. There were no effects on increased liver weights, accompanied by proportion of the dose, up to 11%, was reproductive performance or hepatocyte vaculolation and exhaled as CO2. Two routes of reproductive organs at dose levels up to pigmentation effects. In females there biotransformation have been identified. and including 500 ppm dichlormid. was a slight overall increase in One route involved the formation of an There were no toxicologically malignant tumors, primarily uterine alcohol N,N-diallylglycolamide before significant effects in parents or offspring adenocarcinomas, at 500 ppm, but this subsequent oxidation to N,N- at a dose level of 75 ppm dichlormid specific increase was within the diallyloxamic acid, a major metabolite (>7.4 mg/kg/day). spontaneous incidence observed in present in the urine and feces of both 4. Subchronic toxicity. In a historical data. It was concluded that sexes. N,N-diallylglycolamide also subchronic toxicity study, groups of 12 there was no evidence of oncogenicity male and 12 female Wistar-derived associated with dichlormid treatment. undergoes further biotransformation to alpk:ApfSD rats were fed diets The NOAEL for chronic toxicity was minor dechlorinated metabolites. In the containing 0, 20, 200, or 2,000 ppm 100 ppm (6.5 and 7.5 mg/kg/day for second metabolic pathway dichlormid for 90 days. Significant males and females, respectively). dichloroacetic acid present in the urine reductions in bodyweight gain and food In an 18-month oncogenicity study, of both sexes is formed either directly consumption were seen in male and mice (55/sex/group) were fed from dichlormid or indirectly by female rats receiving 2,000 ppm dichlormid at doses of 0, 10, 50, or 500 transformation of N-allyl-2,2-dichloro- dichlormid and, to a lesser degree, in ppm (0, 1.4, 7.0, 70.7 mg/kg for males N-(2,3-dihydroxypropyl)acetamide. females at 200 ppm. The liver was and 0, 1.84, 9.2, 92.4 mg/kg for females). Entero-hepatic recirculation plays a identified as the principal target organ At 500 ppm there was a slight increase major role in the distribution, (enlargement, increased APDM activity in mortality for females from week 64 metabolism and excretion of in females, centrilobular hypertrophy, onwards, and bodyweights and food dichlormid. The elimination as CO2, the increased bile duct pigmentation) in the utilization were reduced in males, and, even elimination in urine over the first 2,000 ppm group. The NOAEL was 20 to a lesser extent in females. Also, mice 24 hours, and wide distribution of ppm (equivalent to approximately 1.8 fed 500 ppm dichlormid showed non- retained radioactivity indicates some mg/kg/day - see discussion under neoplastic changes which were minor incorporation into endogenous Chronic toxicity in Unit 2.B.5 of this and consisted of changes in severity or metabolic processes. document) and the LOAEL was 200 incidence of common spontaneous 7. Metabolite toxicology. No unique findings. Based on these effects, the ppm, based on reduced bodyweight gain plant or soil metabolites have been chronic NOAEL was 50 ppm (7.0 and and food consumption and a marginal identified that warrant a separate increase in APDM activity in females 9.2 mg/kg/day for males and females, toxicological assessment. and liver enlargement in males. respectively). There was a marginal In a 90–day dog feeding study, increase in Harderian gland adenomas 8. Endocrine disruption. There is no previously submitted and accepted by in males at 500 ppm, but this was overall trend in the toxicology database EPA, animals were dosed (4 dogs/sex/ considered to reflect the variable that indicates that dichlormid would dose) at 0, 1, 5, 25, and 50 mg/kg/day. spontaneous tumor rate seen in this have endocrine disrupting activity. The The NOAEL was 5 mg/kg/day and the strain and sex of mouse. It was mammalian and ecotoxicology LOAEL 25 mg/kg/day based on reduced concluded there was no evidence of databases do not indicate significant bodyweight gain, increased liver weight oncogenicity associated with adverse effects associated with and degenerative changes in voluntary dichlormid treatment. endocrine disrupter activity.

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C. Aggregate Exposure reliable information to suggest that day. The effects on resorptions at this 1. Food. In conducting a chronic dichlormid has any toxic effects that dose were observed in dams which dietary risk assessment, reference is arise from toxic mechanisms common to showed an average weight loss (-3.8 made to the conservative assumptions other substances. Therefore, a gram) during the treatment period made by EPA: Dichlormid time-limited consideration of common mechanism compared with an average weight gain tolerances (65 FR 16143, March 27, and cumulative effects with other in controls of 272 gram. Also, a 2000), 100% crop-treated, and that all substances is not appropriate for multigeneration study has now been commodities contain residues at the dichlormid. completed and, therefore, an additional tolerance or proposed tolerance. The E. Safety Determination safety factor should no longer be analysis was determined using the necessary. 1. U.S. population—i. Chronic risk. Additional uncertainty factors are not Novigen Dietary Exposure Evaluation Using the conservative exposure Model (DEEM Version 6.2) software and warranted for the safety of infants and assumptions described earlier, and children as reliable data support the the United States Department of based on the completeness and Agriculture (USDA) Nationwide appropriate use of a 100-fold reliability of the toxicity data base for uncertainty factor (MOE) to account for Continuing Surveys of Food Intake by dichlormid, the theoretical maximum Individuals (CSFII) survey that was interspecies extrapolation and residue concentration (TMRC) for the intraspecies variability. However, using conducted from 1994 through 1996. general U.S. population is calculated to 2. Drinking water. Dichlormid is very the conservative exposure assumptions be 0.00009 mg/kg/day, or 4.1% of the above for the determination in the rapidly degraded in soil (laboratory cPAD (0.0022 mg/kg/day). The most measured aerobic half-life of 8 days) and general population, it is concluded that highly exposed subgroup are children the percentage of cPAD that will be applied at a maximum rate of 0.5 lb/ aged 1-6 years with a TMRC of 0.000211 acre, so despite only exhibiting utilized by aggregate exposure to mg/kg/day, or 9.6% of the cPAD. The dichlormid is 9.6% for children aged 1- moderate adsorption to soil (Koc 36-49), RfD represents the level at or below the leaching potential for dichlormid to 6 years (the group at highest risk). which daily aggregate dietary exposure Therefore, based on the completeness reach ground water is expected to be over a lifetime will not pose appreciable low. The impact of the interactive and reliability of the toxicity database risks to human health. Dow and the conservative exposure processes of adsorption and degradation AgroSciences concludes that there is a on leaching have been assessed using assessment, it is concluded that there is reasonable certainty that no harm will a reasonable certainty that no harm will EPA mathematical models of pesticide result from aggregate exposure to result to infants and children from movement in soil. Drinking water dichlormid residues. aggregate exposure to dichlormid estimate concentrations (DWEC) were ii. Acute risk. The acute toxicity of calculated for ground water using dichlormid is low and there are no residues. Screening Concentration in Ground concerns for acute-dietary, F. International Tolerances Water (SCI-GROW) modeling, and occupational, or non-occupational A Maximum Residue Level has not surface water estimate concentrations exposures to dichlormid. were calculated using Generic Estimated 2. Infants and children. In assessing been established for dichlormid by the Environmental Concentration (GENEEC) the potential for additional sensitivity of Codex Alimentarius Commission. modeling. These models predict a infants and children to residues of [FR Doc. 02–12849 Filed 5–21–02; 8:45 am] ground water concentration of 0.05 ppb dichlormid, data from developmental BILLING CODE 6560–50–S and surface water concentrations of 27.3 toxicity studies in the rat and rabbit ppb for an instantaneous peak and 26.9 have been considered. The ppb for a 56–day average. However, the developmental toxicity studies are ENVIRONMENTAL PROTECTION interim Agency policy in March 2000, designed to evaluate adverse effects on AGENCY allowed the average 56–day GENEEC the developing organism resulting from [OPP–2002–0050; FRL–6836–8] values to be divided by 3 (9.0 ppb) to maternal pesticide exposure during obtain a value for chronic risk gestation. There was no evidence to Pesticide Emergency Exemptions; assessments. Drinking water levels of suggest that dichlormid was a Agency Decisions and State and concern (DWLOC) were then calculated developmental toxicant in either the rat Federal Agency Crisis Declarations for both chronic and acute exposure. or rabbit. It was also observed that there These DWLOC values are all was no risk below maternally toxic AGENCY: Environmental Protection comfortably below the water exposure doses as the NOAEL for developmental Agency (EPA). estimates obtained from the screening effects in the rat was 40 mg/kg/day, ACTION: Notice. level model GENEEC. Dow compared to the maternal NOAEL of 10 AgroSciences does not expect exposure mg/kg/day and, in the rabbit study, the SUMMARY: EPA has granted or denied to dichlormid residues in drinking NOAEL for both maternal and emergency exemptions under water to be a concern. developmental effects was 30 mg/kg/ theFederal Insecticide, Fungicide, and 3. Non-dietary exposure. The general day. EPA previously concluded in the Rodenticide Act (FIFRA) for use of population is not expected to be March 27, 2000 Federal Register that pesticides as listed in this notice. The exposed to dichlormid through non- the additional 10x safety factor should exemptions or denials were granted dietary routes since dichlormid is used be retained due to the qualitative during the period January 1, 2002 to only on agricultural crops and is not evidence of increased susceptibility March 31, 2002 to control unforseen used in or around the home. demonstrated following in utero pest outbreaks. exposure in the prenatal developmental FOR FURTHER INFORMATION CONTACT: See D. Cumulative Effects toxicity in rabbits and an incomplete each emergency exemption or denial for The potential for cumulative effects of toxicity data base. It should be noted the name of a contact person. The dichlormid and other substances that that in the rabbit developmental toxicity following information applies to all have a common mechanism of toxicity study, the LOAEL for both maternal and contact persons: Team Leader, have been considered. There is no developmental toxicity was 180 mg/kg/ Emergency Response Team, Registration

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