Environmental Protection Agency (EPA).
This regulation establishes tolerances for residues of spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate) in or on grape; grape, raisin; grape, juice; fruit, citrus, crop group 10; citrus, oil; citrus, juice; fruit, pome, crop group 11; apple, wet pomace; fruit, stone, crop group 12; nut, tree, crop group 14; almond, hulls; and pistachio; and for residues of spirodiclofen and its free enol metabolite (3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one) in or on cattle, fat; cattle, meat byproducts; cattle, meat; goat, fat; goat, meat byproducts; goat, meat; sheep, fat; sheep, meat byproducts; sheep, meat; horse, fat; horse, meat byproducts; horse, meat; milk; and milk, fat. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
This regulation is effective July 13, 2005. Objections and requests for hearings must be received on or before September 12, 2005.
To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP-2005-0075. All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall#2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Rita Kumar, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8291; e-mail address: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
- Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
- Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
- Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
- Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document and Other Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of February 18, 2004 (69 FR 7632) (FRL-7343-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F6469) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the insecticide spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3]-en-4-yl 2,2-dimethylbutanoate), in or on citrus fruit group at 0.3 parts per million (ppm), citrus pulp, dried, at 0.4 ppm, citrus oil at 20 ppm, pome fruit group at 0.8 ppm, pome fruit pomace, wet, at 6.0 ppm, stone fruit group at 1.0 ppm, tree nut group at 0.05 ppm, almond hulls at 20 ppm, pistachios at 0.05 ppm, grape at 2.0 ppm and grape, raisin at 4.0 ppm; and for combined residues of spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3]-en-4-yl 2,2-dimethylbutanoate), and/or its enol metabolite, 3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one, in or on cattle, fat, at 0.01 ppm and cattle, meat by-products, at 0.05 parts per million (ppm). That notice included a summary of the petition prepared by Bayer CropScience, the registrant. There were no comments received in response to the notice of filing.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA Start Printed Page 40203determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of spirodiclofen on grape at 2.0 ppm; grape, raisin at 4.0 ppm; grape, juice at 2.4 ppm; citrus, fruit, crop group 10 at 0.50 ppm; citrus, oil at 20 ppm; citrus, juice at 0.60 ppm; fruit, pome, crop group 11 at 0.80 ppm; apple, wet pomace at 2.0 ppm; fruit, stone, crop group 12 at 1.0 ppm; nut, tree, crop group 14 at 0.10 ppm; almond, hulls at 20 ppm; pistachio at 0.10 ppm; and for combined residues of spirodiclofen and its free enol metabolite BAJ 2510 in or on cattle, meat and cattle, fat at 0.02 ppm; cattle, meat byproducts at 0.10 ppm; goat, meat and goat, fat at 0.02 ppm; goat, meat byproducts at 0.10 ppm; sheep, meat and sheep, fat at 0.02 ppm; sheep, meat byproducts at 0.10 ppm; horse, meat and horse, fat at 0.02 ppm; horse, meat byproducts at 0.10 ppm; milk at 0.01 ppm, and milk, fat at 0.03 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.
Spirodiclofen has low acute toxicity via oral, dermal, or inhalation route. It is not an eye or dermal irritant. However, it is a potential skin sensitizer. The nature of the toxic effects caused by spirodiclofen are discussed in Table 1 of this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.
|Guideline No.||Study Type||Results|
|870.3100||Subchronic oral - rat||For males, NOAEL = 32.1 milligram/kilogram/day (mg/kg/day), LOAEL = 166.9 mg/kg/day based on increased incidence and severity of small cytoplasmic vacuolation in the cortex of adrenal glands, decreased cholesterol (week 5 and 13), and decreased triglycerides (week 5), For females, NOAEL = 8.1 mg/kg/day, LOAEL = 47.1 mg/kg/day based on increased incidence of small cytoplasmic vacuolation in the cortex of adrenal glands|
|870.3100||Subchronic oral - mouse||For males, NOAEL = 15 mg/kg/day, LOAEL= 164 mg/kg/day based on an increased incidence of hypertrophic Leydig cells in the testes For females, NOAEL = 30 mg/kg/day, LOAEL = 234 mg/kg/day based on an increased incidence of cytoplasmic vacuolation of the adrenal cortex|
|870.3150||Subchronic oral - dog||For males, NOAEL = 7.7 mg/kg/day, LOAEL = 26.6 mg/kg/day based on decreased body weight gains, increased liver and adrenal weights, decreased prostate weights, and histopathology findings in the adrenal glands, testes, epididymis, thymus, and prostates For females, NOAEL ≤8.4 mg/kg/day. LOAEL = 8.4 mg/kg/day based on increased adrenal gland weight (two out of four animals) which coincided with histopathology findings (cytoplasmic vacuoles in the Zona fasciculata of the adrenal glands)|
|Start Printed Page 40204|
|870.3200||21-Day dermal toxicity - rat||NOAEL is 1,000 mg/kg/day (highest dose tested (HDT)); however, the histopathology was not appropriately conducted as required by the guideline. The study did not examine all of the tissues, especially the possible target organs (i.e., uterus, prostate, etc)|
|870.3700||Prenatal developmental - rat||Maternal: NOAEL = 1,000 mg/kg/day (HDT) Developmental: NOAEL = 300 mg/kg/day, LOAEL = 1,000 mg/kg/day based on an increased incidence of slight dilatation of the renal pelvis|
|870.3700||Prenatal developmental - rabbit||Maternal: NOAEL = 100 mg/kg/day, LOAEL = 300 mg/kg/day based on body weight loss and decreased food consumption Developmental: NOAEL = 1,000 mg/kg/day (HDT)|
|870.3800||Reproduction and fertility effects - rat||Parental/system: For males: NOAEL = 5.2-6.4 mg/kg/day, LOAEL = 26.2- 30.2 mg/kg/day based on decreased body weight in F males; decreased absolute and relative liver weight in F0 males; decreased cholesterol and triglycerides in F1 males; and increased severity of adrenal cortical vacuolation in F1 males. For females, NOAEL = 5.5-7.0 mg/kg/day, LOAEL = 27.6-34.4 mg/kg/day based on decreased unesterified fatty acids in F1 females, and increased severity of adrenal cortical vacuolation in F0 and F1 females Reproductive: For males: NOAEL = 26.2-30.2 mg/kg/day, LOAEL = 134.8- 177.6 mg/kg/day based on delayed sexual maturation; decreased testicular spermatid and epididymal sperm counts (oligospermia); and atrophy of the testes, epididymides, prostate and seminal vesicles. For females: NOAEL = 27.6-34.4 mg/kg/day, LOAEL = 139.2-192.7 mg/kg/day based on increased severity of ovarian luteal cell vacuolation/degeneration Offspring: NOAEL = 5.2-6.4 (M)/5.5-7.0 (F) mg/kg/day, LOAEL = 26.2-30.2 (M)/ 27.6-34.4(F) mg/kg/day based on decreased body weight and weight gain in F1 male and female pups|
|870.4100||Chronic toxicity - dog||NOAEL = 1.38 (M)/1.52(F) mg/kg/day, LOAEL = 4.33(M)/4.74 (F) mg/kg/day based on increased relative adrenal weights in both sexes, increased relative testis weight in males and histopathology findings in the adrenal gland of both sexes|
|Start Printed Page 40205|
|870.4200||Carcinogenicity - mouse||NOAEL = 4.1(M)/5.1(F) mg/kg/day, LOAEL = 610 (M) mg/kg/day based on increased absolute and relative liver and adrenal weights, decreased absolute and relative kidney weight, enlarged adrenal gland, discolored testis, adrenal gland vacuolization, interstitial cell degeneration of the testes. For females, LOAEL = 722 mg/kg/day based on increased absolute and relative adrenal weight, decreased absolute and relative kidney weight, increased incidences of adrenal gland pigmentation, and adrenal vacuolization. Hepatocellular adenoma and carcinoma|
|870.4300||Chronic toxicity - rat||For males: NOAEL = 14.7 mg/kg/day, LOAEL = 110.1 mg/kg/day based on decreased body weights, decreased body weight gain, increased APh levels, decreased cholesterol and triglyceride levels, increased vacuolated jejunum enterocytes, and increased incidences of Leydig cell hyperplasia For females: NOAEL = 19.9 mg/kg/day, LOAEL = 152.9 mg/kg/day based on decreased body weights, decreased body weight gain, increased APh levels, increased TSH, uterus nodules, and increased vacuolated jejunum enterocytes testes Leydig cell adenoma in males, uterine adenoma and/or adenocarcinoma in females|
|870.5100||Gene mutation - Salmonella typhimurium||There was no evidence of increased revertant colonies above control in 5 Salmonella strains (TA1535, TA1537, TA1538, TA100, TA98) ± S9 at concentrations up to 5,000 μg/plate|
|870.5300||In vitro mammalian gell gene mutation||Negative, tested in Chinese Hamster lung fibroblast V79 cells at concentrations up to 300 μg/mL - S9 and +S9. Cytotoxicity was observed at ≥15 μg/mL -S9 and 80 μg/mL +S9|
|870.5375||In vitro mammalian chromosome aberration||Negative, tested in Chinese hamster lung (V79) cells at concentrations 5-80 μg/mL or 0.75-12 μg/mL -S9 or 10-160 μg/mL +S9|
|870.5395||In vivo mouse bone morrow micronucleus||Negative, tested at a dose 800 mg/kg (MTD). Clinical signs and cytotoxicity were seen at 800 mg/kg|
|870.6200||Acute neurotoxicity - rat||NOAEL = 2,000 mg/kg/day, no neurotoxicity observed|
|870.6200||Subchronic neurotoxicity - rat||NOAEL = 70.3(M)/87.3(F) mg/kg/day. LOAEL = 1088.8(M)/1306.5(F) mg/kg/day based on decreased body weights, food consumption, and increased urine staining in both sexes and decreased motor and locomotor activity (week 4) in females only|
|Start Printed Page 40206|
|870.6300||Developmental neurotoxicity||Maternal NOAEL = 135.9/273.8 mg/kg/day LOAEL = Not established Offspring NOAEL = Not established LOAEL = 6.5/14.0 mg/kg/day based on effects in memory phase of the water maze test in PND 60 females The study classification is reserved for the guideline requirement pending receipt of additional morphometric measurements for the low and mid dose groups|
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used: “ Traditional uncertainty factors;” the “special FQPA safety factor;” and the “default FQPA safety factor.” By the term “traditional uncertainty factor,” EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term “special FQPA safety factor” refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The “default FQPA safety factor” is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10-5), one in a million (1 X 10-6), or one in ten million (1 X 10-7). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated.
A summary of the toxicological endpoints for spirodiclofen used for human risk assessment is shown in Table 2 of this unit:
|Exposure Scenario||Dose Used in Risk Assessment, UF||Special FQPA SF* and Level of Concern for Risk Assessment||Study and Toxicological Effects|
|Acute Dietary||Acute RfD = Not established||An effect of concern attributable to a single dose was not identified|
|Chronic dietary (all populations)||LOAEL = 6.5 mg/kg/day UF = 1,000 Chronic RfD = 0.0065 mg/kg/day||FQPA SF = 1X cPAD = Chronic RfD/FQPA SF = 0.0065 mg/kg/day||Developmental Neurotoxicity Study - Rat LOAEL of 6.5 mg/kg/day based on decreased retention (memory) in females on day 60 in the water maze at all doses|
|Cancer (Oral, dermal, inhalation)||Classification: “Likely to be Carcinogenic to Humans” with Q1* (mg/kg/day)-1 = 1.49 x 10-2|
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have not been established for (40 CFR 180.000) for the residues of spirodiclofen, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from spirodiclofen in food as follows:
i. Acute exposure. Acute quantitative dietary 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. No appropriate single-dose endpoint was available for the acute oral exposure of the general population, including infants and children. Therefore, an acute quantitative dietary assessment was not performed.
ii. Chronic exposure. In conducting the chronic and cancer dietary risk assessment EPA used the Lifeline (version 2.0) and Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM), both of 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 chronic exposure assessments: The chronic and cancer analyses were refined through the use of average field trial residues, experimentally determined processing factors, and projected average percent crop treated estimates. These averages were based on the typical average of all insecticides used to control all pests on the specific crop.
The projected average percent crop treated estimates were provided for apple, peach, grape, orange, and grapefruit. These averages were based on the typical average of all insecticides used to control all pests on the specific crop. The Agency determined that it is appropriate to translate the projected percent crop treated estimates for peach, apple, and grapefruit to the remaining crops in the stone fruit, pome fruit, and citrus crop groups, respectively.
Since the analysis made use of average residues derived from crop field trial studies (maximum application rate and minimum preharvest interval (PHI)), incorporated maximum theoretical processing factors for juice, and surface drinking water estimates which assumed 87% of the basin cropped and 100% of the cropped area treated at the maximum rate (citrus, pecan, apple, peach, and grape), the Agency concluded that the exposure estimates are unlikely to underestimate actual exposure.
iii. Cancer. The Agency has classified spirodiclofen as “likely to be carcinogenic to humans.” Quantification of cancer risk used a Q1*(mg/kg/day)-1 of 1.49 x 10-2 in human equivalents based on male rat testes Leydig cell adenoma.
As indicated above, the chronic and cancer analyses incorporated average field trial residues; processing factors from the apple, grape, plum, and orange processing studies (DEEM-FCIDTM (ver. 7.76) default processing factors assumed for juice commodities); projected average percent crop treated estimates; and the SCI-GROW and/or PRZM-EXAMS drinking water estimates.
DEEM-FCIDTM resulted in similar chronic and cancer risk estimates (all included drinking water), but due to differing drinking water assumptions, the result was a higher risk estimate using DEEM-FCIDTM. Based on a critical commodity analysis conducted in DEEM-FCIDTM, the major contributors to the cancer risk were water (34% of the total exposure), orange (20% of the total exposure) and apple (16% of the total exposure).
iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows:
A routine chronic dietary exposure analysis for spirodiclofen was based on projected PCT for the following crops: Grapefruit - 20%; oranges except temple - 10%; grapes - 4%; peaches - 12%; apples - 13%. These are typical averages of all insecticides used to control all pests on the specific crop, taken from the Agricultural Chemical Usage 2003 Fruit Summary report published by United States Department of Agriculture National Agriculture Statistics Service (USDA/NASS). The projected percent crop treated estimates for peach, apple, and grapefruit were applied to the remaining crops in the stone fruit, pome fruit, and citrus crop groups, respectively.
The Agency believes that the three conditions previously discussed have been met. With respect to Condition 1, EPA finds that the PCT information described in Unit. C for spirodiclofen is reliable and has a valid basis. These are average usage figures of all insecticides used on the crops in question. EPA has not taken into account whether the insecticide use was directed against the pest that spirodiclofen controls but instead has averaged each insecticide's total usage. Thus, these averages are likely to overstate spirodiclofen use because many insecticides are effective against several pests and total usage of these pesticides will be significantly higher than an insecticide, such as spirodiclofen, which is used primarily against a single pest. For acute risk assessment, the highest percentages of the insecticide used on the specific crop without naming a specific pest, taken from USDA/NASS Agricultiral Chemical Usage 2003 Fruit Summary was used. This indicates the maximum use of an insecticide. Spirodiclofen use could be much lower than this because its use is targeted at a single pest and there exist other equally efficacious pesticides, that treat mites only, that are priced competitively with spirodiclofen. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which spirodiclofen may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure Start Printed Page 40208analysis and risk assessment for spirodiclofen 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 spirodiclofen.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentrations in Groundwater (SCI-GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of spirodiclofen (total residue including its three metabolites: Spirodiclofen-enol, spirodiclofen-ketohydroxy, and spirodiclofen-dihydroxy) for acute exposures are estimated to be 22.86 parts per billion (ppb) for surface water and 0.44 ppb for ground water. The EECs for chronic (non-cancer) exposures are estimated to be 4.99 ppb for surface water and 0.44 ppb for ground water. The EECs for chronic (cancer) exposures are estimated to be 1.67 ppb for surface water and 0.44 for ground water.
3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Spirodiclofen is not registered for use on any sites that would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to spirodiclofen and any other substances and spirodiclofen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that spirodiclofen has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility following in utero and/or prenatal/postnatal exposure in the developmental toxicity studies in rabbits and 2-generation reproduction studies in rats.
In the DNT study, toxicity in the offspring (effects in the memory phase of the water maze test at post natal day 60 in females) was observed in the absence of maternal toxicity, indicating increased susceptibility.
3. Conclusion. The 10X FQPA Safety Factor was retained for the use of LOAEL in a critical study in calculating the reference dose for chronic risk.
E. Aggregate Risks and Determination of Safety
1. Acute risk. There is no risk from acute dietary exposure, as an appropriate single-dose endpoint was not identified for the acute oral exposure of the general population, including infants and children.
2. Chronic risk. To assess aggregate chronic risk, drinking water estimates were incorporated directly into the dietary analysis, rather than using back-calculated drinking water levels of comparison (DWLOCs). To better evaluate aggregate risk associated with exposure through food and drinking water, EPA is no longer comparing Estimated Drinking Water Concentration (EDWCs) generated by water quality models with Drinking Water Levels of Comparison (DWLOC). Instead, EPA is now directly incorporating the actual water quality model output concentrations into the risk assessment. This method of incorporating water concentrations into our aggregate assessments relies on actual CSFII-reported drinking water consumptions and more appropriately reflects the full distribution of drinking water concentrations. Using the exposure assumptions described in this unit for chronic exposure, the LifelineTM chronic risk estimates (including drinking water) were less than the Agency's level of concern at ≤6.1% chronic population-adjusted dose (cPAD); children 1-2 years old were the most highly exposed population. The DEEM-FCIDTM chronic risk estimates (including drinking water) were also less than the Agency's level of concern at ≤8.0% cPAD; all infants (<1 year old) were the most highly exposed population. EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of this unit:Start Printed Page 40209
|Population Subgroup||cPAD (mg/kg/day)||Chronic Exposure (mg/kg/day)||%cPAD|
|General U.S. population||0.000177||0.000092||3.7||1.4|
|All Infants (< 1 year old)||0.000517||0.000259||8.0||4.0|
|Children (1-2 years old)||0.000515||0.000397||7.9||6.1|
|Children (3-5 years old)||0.000379||0.000290||5.8||4.5|
|Children (6-12 years old)||0.000209||0.000132||3.2||2.0|
|Youth (13-19 years old)||0.0065||0.000129||0.000067||2.0||1.0|
|Adults (20-49 years old)||0.000140||0.000068||2.2||1.0|
|Adults (50+ years old)||0.000150||0.000069||2.3||1.1|
|Females (13-49 years old)||0.000144||0.000077||2.2||1.2|
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).
Spirodiclofen is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.
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).
Spirodiclofen is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Under the reasonable certainty of no harm standard, in FFDCA section 408(b)(2)(A)(ii), cancer risks must be no greater than negligible. EPA has consistently interpreted negligible cancer risks to be risks within the range of an increased cancer risk of 1 in 1 million. Risks as high as 3 in 1 million have been considered to be within this risk range. To assess aggregate cancer risk, drinking water estimates were incorporated directly into the dietary analysis, as explained above in section 2 for chronic risk. Lifeline and DEEM are capable of combining exposure from food and drinking water sources for an estimate of aggregate risk from all dietary sources. Cancer aggregate risk was calculated for the U.S. population only. The LifelineTM cancer risk estimates with drinking water estimates included was 1.36 in 1 million. Using DEEM-FCIDTM, the cancer risk estimate with drinking water was 1.59 in 1 million. DEEM-FCIDTM resulted in in a higher cancer risk estimate due to differing drinking water assumptions. Lifeline permits incorporation of the entire PRZM-EXAMS distribution when conducting a cancer analysis while DEEM-FCIDTM permits only a point estimate. The estimated cancer risk of 1.59 in 1 million is within the negligible risk range. The Agency also notes that the cancer risk estimates were generated using average residues derived from crop field trial studies (maximum application rate and minimum preharvest interval), incorporated maximum theoretical processing factors for juice, and incorporated surface drinking water estimates which assumed 87% of the basin was cropped and 100% of the cropped area was treated at the maximum rate. EPA concludes that the estimated cancer risk within the range of a risk of 1 in 1 million and therefore is negligible. A summary of aggregate cancer risk is given in Table 4 of this unit:
|Population Subgroup||Q1*||Cancer Exposure (mg/kg/day)||Cancer Risk|
|General U.S. population1||0.0149||0.000177||0.000092||1.59 x 10-6||1.36 x 10-6|
|1 differences between DEEM-FCIDTM and LifelineTM cancer risk estimates due to differences in the water estimates permitted in each program; DEEM-FCIDTM permits only a single point drinking water estimate when conducting a cancer analysis; LifelineTM permits incorporation of the entire PRZM-EXAMS distribution and incorporation of the SCI-GROW point estimate|
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 spirodiclofen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (HPLC/MS-MS) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: email@example.com.
B. International Residue Limits
There are no Codex or Mexican maximum residue limits (MRLs) in/on the requested crops.
The following confirmatory data are needed:
Toxicology. In the developmental neurotoxicity study, additional morphometric analyses of the caudate putamen, parietal cortex, hippocampal gyrus, and dentate gyrus at the mid and low doses are requested for both sexes.
Residue chemistry. Apple (juice) and grape (juice) processing studies which monitor for residue of spirodiclofen, BAJ2510, 3-OH-enol, and 4-OH-enol. Default factors were used for the risk assessment, and these studies are needed to refine the risk.
Therefore, the tolerance is established for residues of spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate) on grape at 2.0 ppm; grape, raisin at 4.0 ppm; grape, juice at 2.4 ppm; citrus, fruit, crop group 10 at 0.50 ppm; citrus, oil at 20 ppm; citrus, juice at 0.60 ppm; fruit, pome, crop group 11 at 0.80 ppm; apple, wet pomace at 2.0 ppm; fruit, stone, crop group 12 at 1.0 ppm; nut, tree, crop group 14 at 0.10 ppm; almond, hulls at 20 ppm; pistachio at 0.10 ppm; and for combined residues of spirodiclofen and its free enol metabolite BAJ 2510 in or on cattle, meat and cattle, fat at 0.02 ppm; cattle, meat byproducts at 0.10 ppm; goat, meat and goat, fat at 0.02 ppm; goat, meat byproducts at 0.10 ppm; sheep, meat and sheep, fat at 0.02 ppm; sheep, meat byproducts at 0.10 ppm; horse, meat and horse, fat at 0.02 ppm; horse, meat byproducts at 0.10 ppm; milk at 0.01 ppm, and milk, fat at 0.03 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2005-0075 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 September 12, 2005.
1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP-2005-0075, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via e-mail to: firstname.lastname@example.org. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of Start Printed Page 40211significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety 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.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a 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).Start List of Subjects
List of Subjects in 40 CFR Part 180
- Environmental protection
- Administrative practice and procedure
- Agricultural commodities
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: June 30, 2005.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:End Amendment Part Start Part
PART 180—AMENDEDEnd Part Start Amendment Part
1. The authority citation for part 180 continues to read as follows:End Amendment Part Start Amendment Part
2. Section 180.608 is added to read as follows:End Amendment Part
(a) General. (1) Tolerances are established for residues of spirodiclofen per se (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate) in or on the following plant commodities:
|Commodity||Parts per million|
|Apple, wet pomace||2.0|
|Fruit, citrus, crop group 10||0.50|
|Fruit, pome, crop group 11||0.80|
|Fruit, stone, crop group 12||1.0|
|Nut, tree, crop group 14||0.10|
(2) Tolerances are established for residues of spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate) and its free enol metabolite BAJ 2510 (3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one) in or on the following livestock commodities:
|Commodity||Parts per million|
|Cattle, meat byproducts||0.10|
|Goat, meat byproducts||0.1|
|Horse, meat byproducts||0.1|
|Sheep. meat byproducts||0.1|
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]Start Printed Page 40212
(d) Indirect or inadvertent residues. [Reserved]End Supplemental Information
[FR Doc. 05-13774 Filed 7-12-05; 8:45 am]
BILLING CODE 6560-50-S