Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Dinotefuran,
[Federal Register: March 23, 2005 (Volume 70, Number 55)]
[Rules and Regulations]
[Page 14535-14546]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr05-6]
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0003; FRL-7695-5]
Dinotefuran; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for combined residues of dinotefuran, [N-methyl-N'-nitro-N''-((tetrahydro-3- furanyl)methyl)guanidine] and its metabolites DN [1-methyl-3- (tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-(tetrahydro-3- furylmethyl)urea], expressed as dinotefuran in or on vegetable, fruiting, group 8; vegetable, cucurbit, group 9; brassica, head and stem, subgroup 5A; grape; grape, raisin; potato; potato, chips; potato, granules/flakes; tomato, paste; cotton, undelinted seed; cotton, gin byproducts; and for residues of dinotefuran, [N-methyl-N'-nitro-N''- ((tetrahydro-3-furanyl)methyl)guanidine] alone in or on cattle meat, fat, and meat byproducts (mbyp); goat meat, fat, and mbyp; hog meat, fat, and mbyp; horse meat, fat, and mbyp; sheep meat, fat, and mbyp; and milk. Mitsui Chemicals, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective March 23, 2005. Objections and requests for hearings must be received on or before May 23, 2005.
ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under docket identification (ID) number OPP-2005-0003. 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.
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: kumar.rita@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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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;
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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.
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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.gov/opptsfrs/home/guidelin.htm/ .
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Background and Statutory Findings
In the Federal Register of July 2, 2003 FR 39547-39554) (FRL-7312- 8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions (PP 2F6427 and 3F6566) by Mitsui Chemicals, Inc., Chiyoda-ku, Tokyo, Japan. The petitions requested that 40 CFR 180.603 be amended by establishing tolerances for combined residues of the insecticide dinotefuran, [N- methyl-N'-nitro-N''-((tetrahydro-3-furanyl)methyl)guanidine] and its metabolites DN [1-methyl-3-(tetrahydro-3-furylmethyl)guanidine] and UF
[1-methyl-3-(tetrahydro-3-furylmethyl)urea] , expressed as dinotefuran as follows: (PP 3F6566) in or on fruiting vegetables at 0.7 parts per million (ppm); tomato paste at 1.0 ppm; cucurbit at 0.5 ppm; head and stem brassica vegetables at 1.4 ppm; grape at 0.8 ppm; raisin at 2.5 ppm; potato at 0.05 ppm; potato, chips at 0.10 ppm; granules at 0.15 ppm; cattle, goat, hog, horse and sheep fat, meat, and byproducts, and milk at 0.05 ppm; and (PP 2F6427) in or on cotton seed undelinted at 0.2 ppm; and cotton gin byproducts at 7.0 ppm. That notice included a summary of the petition prepared by Mitsui Chemicals Inc., the registrant. One comment was received from a private citizen, in support of this notice.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information''. This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue* * * .''
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances in the Federal Register of November 26, 1997 (62 FR 62961) (FRL-5754-7).
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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 tolerances for combined residues of dinotefuran, [N-methyl-N'-nitro-N''-((tetrahydro-3- furanyl)methyl)guanidine] and its metabolites DN [1-methyl-3- (tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-(tetrahydro-3- furylmethyl)urea], expressed as dinotefuran on fruiting vegetables, group 8 at 0.7 ppm; tomato paste at 1.0 ppm; cucurbit at 0.5 ppm; head and stem brassica vegetables at 1.4 ppm; grape at 0.8 ppm, raisin at 2.5 ppm, potato at 0.05 ppm, potato, chips at 0.10 ppm, potato, granules/flakes at 0.15 ppm; cotton seed undelinted at 0.4 ppm, cotton gin byproducts at 7.0 ppm; and for residues of dinotefuran, [N-methyl- N'-nitro-N''-((tetrahydro-3-furanyl)methyl)guanidine] alone in or on cattle meat, fat, and meat byproducts (mbyp) at 0.05 ppm; goat meat, fat, and mbyp at 0.05 ppm; hog meat, fat, and mbyp at 0.05 ppm; horse meat, fat, and mbyp at 0.05 ppm; sheep meat, fat, and mbyp 0.05 ppm; and milk at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.
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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. The nature of the toxic effects caused by dinotefuran 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.
Table 1.--Subchronic, Chronic, and Other Toxicity
Guideline No.
Study Type
Results
870.3100
90-Day oral toxicity in NOAEL: 38/384 (M/F) mg/kg/day rats
LOAEL: 384 (M) mg/kg/day based on adrenal histopathology; 1,871 (F) mg/kg/day based on decreased body weight/body weight gain, changes in hematology/clinical chemistry, changes in organ weights, and adrenal histopathology
[[Page 14537]]
870.3100
90-Day oral toxicity in NOAEL: 4,442/5,414 (M/F) mg/kg/day mice
LOAEL: 10,635/11,560 (M/F) mg/kg/day, based on decreased body weight, body weight gain
870.3150
90-Day oral toxicity in NOAEL: 307/not determined (M/F) mg/kg/day dogs
LOAEL: 862 (M) mg/kg/day, based on body weight gain, hemorrhagic lymph nodes; 300 mg/kg/day (no effects seen)
870.3800
Reproduction and fertility Parental/systemic effects (rats)
NOAEL: 241/268 (M/F) mg/kg/day LOAEL: 822/907 (M/F) mg/kg/day, based on decreased food consumption, weight gain in males, soft feces in females, and decreasedspleen weights in both sexes Reproductive (tentative) NOAEL: 241/268 (M/F) mg/kg/day LOAEL: 822/907 (M/F) mg/kg/day, based on decreased uterine weights and microscopic alterations in the uterus and vagina of F0 females, decreased numbers of primordial follicles in F1 females, altered estrous cyclicity in F0 and F1 females, increase in abnormal sperm morphology in F0 and F1 males, decreased testicular sperm count in F0 males, and decreased sperm motility in F1 males Developmental NOAEL: 241/268 (M/F) mg/kg/day LOAEL: 822-935/907-1005 (M/F) mg/kg/day based on decreased body weights, body weight gains, and spleen weights in F1 and F2 males and females, decreased thymus weights in F2 males and females, and decreased forelimb grip strength (F1 males) or hindlimb grip strength (F1 females)
870.4100
Chronic toxicity (rats) See 870.4300 combined chronic toxicity/ carcinogenicity (rats)
870.4100
Chronic toxicity (dogs) NOAEL: >20/22 (M/F) mg/kg/day LOAEL: 20/108 (M/F) mg/kg/day based on decreased thymus weight, decreased food efficiency, body weight, and body weight gain in females, decreased thymus weight in males
870.4200
Carcinogenicity (rats) See 870.4300 combined chronic toxicity/ carcinogenicity (rats)
870.4200
Carcinogenicity (mice) NOAEL: S9 up to 16,000 test
[mu]g/plate
870.5100
Bacterial reverse mutation Negative, S9 up to limit dose test
of 5,000 [mu]g/plate
870.5300
In vitro mammalian cell Negative, S9 up to 2002 [mu]g/ gene mutation test
mL (mouse lymphoma L5178Y cells)
870.5375
In vitro mammalian
Negative for clastogenic/aneugenic activity chromosome aberration up to 2000 [mu]g/mL (CHL/IU cells) test
870.5395
In vivo mammalian
Negative at oral doses up to 1,080 mg/kg/ cytogenics -micronucleus day for 2 days assay
870.6200
Acute neurotoxicity
NOAEL: 750 (M), 325 (F) mg/kg/day screening battery
LOAEL: 1,500 (M), 750 (F) mg/kg/day based on decreased motor activity on day 1
870.6200
Subchronic neurotoxicity NOAEL: 33/40 (M/F) mg/kg/day screening battery
LOAEL: 327/400 (M/F) mg/kg/day based on increased motor activity during week 2
870.7485
Metabolism and
Absorption was >90% regardless of dose. The pharmacokinetics (rats) radiolabel was widely distributed through the body and was completely excreted within 168 hours of treatment. Urine was the primary elimination route, accounting for 88-99.8%. Excretion into the urine was rapid, being 84-99% complete within 24 hours of treatment. Absorption of the radioactivity was linear within the dose range of 50 and 1,000 mg/kg. Elimination of radioactivity was fast for all groups with a T1/2 ranging from 3.64 to 15.2 hours for the low and high doses, respectively. Radioactivity was rapidly transferred from maternal blood to milk and widely distributed in the fetal tissues. The Cmax for milk and fetal tissues was detected 0.5 hours after maternal treatment. The concentrations of radioactivity in fetal tissue and maternal milk declined quickly and were below detection limits 24 hours post-treatment. After IV or oral treatment, 75-93% of the administered radiolabeled test material, or nearly 93-97% of total urinary radiolabel, was excreted unchanged in the urine. The parent compound was also the primary component in the plasma, milk, bile, feces, and most tissues collected 4- 8 hours after treatment and at both dose levels. Less than 10% of the parent compound was metabolized into numerous minor metabolites that were not well resolved by High Performance Liquid Chromotography (HPLC) or 2D-TLC. For all parameters measured in this study, no sex or dose-related differences or label position effects were found.
Special study
Neonatal rat metabolism After a single oral 50 mg/kg dose of (G- study (12-day old rat 14C) MTI-446 to 12-day old rats, pups)
absorption was high (absorption could not be adequately determined but may have approached 80%) and the radiolabel was widely distributed within the body. Approximately 32-36% of the administered dose was excreted within 4 hours of treatment. Urine was the primary elimination route as indirectly evidenced by finding high radioactive areas in the kidneys and bladder by whole body autoradiography. No areas of tissue sequestration were found and no gender- related differences were identified. The test material was essentially not metabolized, the parent compound accounting for >97% of the radiolabel in the excreta, plasma, kidneys, and stomach, and nearly 61-83% in intestines (and contents), and liver.
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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
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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 (UF) 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 (aRfD or cRfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional UFs 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, margin of exposure (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 dinotefuran used for human risk assessment is shown in the following Table 2.
Table 2.--Summary of Toxicological Dose and Endpoints for Dinotefuran for Use in Human Risk Assessment
Special FQPA SF and Exposure/Scenario
Dose Used in Risk Level of Concern for Study and Toxicological Assessment, UF
Risk Assessment
Effects
Acute dietary (General population NOAEL = 125 mg/kg/day FQPA SF = 1
Developmental toxicity including infants and children) UF = 100............... aPAD = acute RfD / FQPA study in rabbits Acute RfD = 1.25 mg/kg/ SF = 1.25 mg/kg/day. LOAEL = 300 mg/kg/day day.
based on clinical signs in does (prone position, panting, tremor, erythema) seen following a single dose.
Chronic dietary (All populations) LOAEL= 20 mg/kg/day FQPA SF = 1
Chronic toxicity study UF = 1,000............. cPAD = chronic RfD / in dogs Chronic RfD = 0.02 mg/ FQPA SF = 0.02 mg/kg/ LOAEL = 20 mg/kg/day kg/day.
day.
based on decreased thymus weight in males
Short-term incidental oral (1 to 30 NOAEL= 33 mg/kg/day Residential LOC for MOE Subchronic days)
= 100
neurotoxicity study in Occupational = NA...... rats LOAEL = 327 mg/kg/day based on increased motor activity during week 2
Intermediate-term incidental oral (1 NOAEL= 22 mg/kg/day Residential LOC for MOE Chronic toxicity study to 6 months)
=100
in dogs Occupational = NA...... LOAEL = 108 mg/kg/day based on decreased body weight and body weight gain in females
Short-term dermal (1 to 30 days) No quantitation
Residential LOC for MOE No quantitation required.
= NA
required. No systemic Occupational LOC for toxicity was seen at MOE = NA.
the limit dose in a 28- day dermal toxicity study in which neurotoxicity was evaluated. No developmental toxicity concerns.
Intermediate-term dermal (1 to 6 Oral study NOAEL = 22 Residential LOC for MOE Chronic toxicity study months)
mg/kg/day (dermal
= 100
in dogs absorption rate = 30%) Occupational LOC for LOAEL = 108 mg/kg/day MOE =100.
based on decreased body weight and body weight gain in females
Long-term dermal (>6 months)
Oral study LOAEL = 20 Residential LOC for MOE Chronic toxicity study mg/kg/day (dermal
= 1,000
in dogs absorption rate = 30%) Occupational LOC for LOAEL = 20 mg/kg/day MOE = 1,000.
based on decreased thymus weight in males
Short-term inhalation (1 to 30 days) Inhalation study LOAEL= Residential LOC for MOE 28-day Inhalation 60 mg/kg/day
= 1,000
toxicity study in rats Occupational LOC for LOAEL = 60 mg/kg/day MOE = 1,000.
based on decreased body weight gain in males
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Intermediate-term inhalation (1 to 6 Inhalation study LOAEL Residential LOC for MOE 28-day Inhalation months)
= 60 mg/kg/day
=1,000
toxicity study in rats Occupational LOC for LOAEL = 60 mg/kg/day MOE = 1,000.
based on decreased body weight gain in males
Long-term inhalation (>6 months) Oral study LOAEL= 20 mg/ Residential LOC for MOE Chronic toxicity study kg/day (inhalation = 1,000
in dogs absorption rate = Occupational LOC for LOAEL = 20 mg/kg/day 100%)
MOE = 1,000.
based on decreased thymus weight in males
Cancer (oral, dermal, inhalation) NA
NA
Not required; no evidence of carcinogenicity.
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not applicable.
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Exposure Assessment
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Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.603) for the combined residues of dinotefuran and its metabolites, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from dinotefuran in food as follows:
i. Acute exposure. Acute 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.
In conducting the acute dietary risk assessment EPA used the DEEMTMsoftware with the FCID, which incorporates food consumption data as reported by respondents in the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: The dietary risk analyses incorporated tolerance level residues and assumed 100% of the crops had been treated with dinotefuran. The acute risk estimates are below the Agency's level of concern (TMsoftware with the FCID, which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The dietary risk analyses incorporated tolerance level residues and assumed 100% of the crops had been treated with dinotefuran. The chronic risk estimates are below the Agency's level of concern (waterto determine the DWLOCIntermediate-termfor children. Compared with the Estimated Drinking Water Concentrations (EDWCs), EPA's calculated aggregate intermediate-term DWLOC does not exceed the Agency's level of concern for the subgroup population of children 1 to 2 years old. The aggregate risk assessment for intermediate-term exposure to children is summarized in the following Table 5.
Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure of Children to Dinotefuran
Average
Ground Surface NOAEL/mg/kg/ Target
Max
Food Residential Aggregate MOE Max Water Water Water Intermediate- Population
day
MOE\1\ Exposure\2\ Exposure Exposure\3\ (food & Exposure\5\ EEC\6\ EEC\6\ Term DWLOC\7\ mg/kg/day mg/kg/day mg/kg/day residential)\4\ mg/kg/day [mu]g/L [mu]g/L [mu]g/L
Children (3-5 years old)
22
100
0.22 0.011 0.037
460
0.17
5.1
21
1,700
\1\ The target MOE of 100 is based on the standard inter- and intra-species safety factors, 10x for intra-species variability and 10x for inter-species extrapolation. \2\ Maximum exposure (mg/kg/day) = NOAEL/Target MOE
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\3\ Residential exposure to children playing on treated lawns (combined dermal + oral hand-to-mouth + oral object-to-mouth + oral soil ingestion) \4\ Aggregate MOE = [NOAEL/(Avg. Food Exposure + Residential Exposure)] \5\ Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Exposure) \6\ The use site producing the highest level was used; i.e., turf. \7\ DWLOC ([mu]g/L) = [Maximum water exposure (mg/kg/day) x body weight (10 kg)]/[Water exposure (1L) x 10-3 mg/[mu]g]
ii. Intermediate term aggregate risk for adults. For adults, the worst case intermediate-term aggregate risk assessment includes the following scenarios: (1) Dermal and inhalation exposures to residential handlers (i.e. M/L/A of liquids to lawns by hose-end sprayers); (2) dermal postapplication exposures on treated lawns;, and (3) oral dietary exposures (i.e. food + drinking water). Based on the toxicity endpoint information, the acceptable MOEs are not all identical. The intermediate-term inhalation endpoint has a UF/MOE of 1,000, because a NOAEL was not reached and a LOAEL was used instead, while the assessments for incorporating food, water and dermal exposures have UFs/MOEs of 100. In this case, the aggregate risk index (ARI) method was used to calculate DWLOC values for the adult aggregate intermediate-term risk assessment.
The highest estimated average (chronic) dietary exposure for adults occurred with the general U.S. population (i.e. 0.0042 mg/kg/day). The adult residential combined risks from dermal (ARI = 17) and inhalation (ARI = 970) exposures to residential handlers and dermal postapplication exposures (ARI = 12) on treated lawns were combined.
The intermediate-term aggregate risk including drinking water exposure can be calculated using the ARI method for aggregating exposure. The equations are solved for MOEwaterto determine the DWLOC Intermediate-termfor adults. Compared with the EDWCs, EPA's calculated aggregate intermediate-term DWLOC does not exceed Agency's level of concern for the general U.S. population. The aggregate risk assessment for intermediate-term exposure to adults is summarized in the following Table 6.
Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure of Adults to Dinotefuran.
Residential ARIs\3\
Ground Target
ARI
Applicators Postapplic Max Water Water Surface Intermediate- Population
ARI\1\ Food\2\ ------------------------ ation Exposure EDWC\5\ Water EDWC Term DWLOC\6\ Dermal Inhalation Dermal ARI\4\ [mu]/L [mu]/L
[mu]/L Exposure Exposure Exposure
Females (14-49 years old)
1
116
17
970
12
1.18
5.1
21
5,600
\1\ ARI (Aggregate Risk Index) = MOE Calculated/MOEAceeptable \2\ 2 ARIFood = [22 / 0.0019] / 100 = 116 \3\ ARIdermal = MOEcalculated/100 and, ARIinhal = MOE inhal/1,000 \4\ ARIWater = 1/[1/1- (1/ARIResidential aplicator dermal) + (1/ARIResidential applicator inhalation) + (1/ARIPostapplication dermal)] \5\ The use site producing the highest level was used; i.e. turf. \6\ DWLOC ([mu]/L) = [Maximum water exposure (mg/kg/day) x body weight (60 kg)]/[Water exposure (2 L) x 10-3 mg/[mu]g] where Maximum water exposure = NOAEL (22) / [ARIWater (1.18) x 100] = 0.1866 mg/kg/day
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Aggregate cancer risk for U.S. population. Dinotefuran is not expected to pose a cancer risk.
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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 dinotefuran residues.
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Other Considerations
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Analytical Enforcement Methodology
Adequate enforcement methodology for plant commodities (High Performance Liquid Chromatography (HPLC)/Mass Spectrometry (MS); HPLC/ Ultraviolet (UV); and HPLC/MS/MS) is available to enforce the tolerance expression. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
A livestock enforcement method is needed to enforce the proposed tolerances of dinotefuran on milk, meat, and meat byproducts. The Liquid Chromatography (LC)/MS/MS method, which was used for the analysis of samples collected from the cow feeding study, may be used for tolerance enforcement. The independent laboratory validation and radiovalidation data are currently under review by the Agency.
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International Residue Limits
There are currently no established Codex, Canadian, or Mexican maximum residue limits for residues of dinotefuran in/on plant or livestock commodities.
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Conclusion
Therefore, the tolerance is established for combined residues of dinotefuran, [N-methyl-N'-nitro-N''-((tetrahydro-3- furanyl)methyl)guanidine] and its metabolites DN [1-methyl-3- (tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-(tetrahydro-3- furylmethyl)urea], expressed as dinotefuran, in or on vegetable, fruiting, group 8 at 0.7 ppm; vegetable, cucurbit, group 9 at 0.5 ppm; Brassica, head and stem, subgroup 5A at 1.4 ppm; grape at 0.9 ppm; grape, raisin at 2.5 ppm; potato at 0.05 ppm; potato, chips at 0.1 ppm; potato, granules/flakes at 0.15 ppm; tomato, paste at 1.0 ppm; cotton, undelinted seed at 0.4 ppm; cotton, gin byproducts at 8.0 ppm; and for residues of dinotefuran alone in or on cattle, meat at 0.5 ppm; cattle, fat at 0.05 ppm; cattle meat byproducts (mbyp) at 0.05 ppm; goat, meat at 0.05 ppm; goat, fat at 0.05 ppm; goat mbyp at 0.05 ppm; hog, meat at 0.05 ppm; hog, fat at 0.05 ppm; hog mbyp at 0.05 ppm; horse, meat at 0.05 ppm; horse, fat at 0.05 ppm; horse, mbyp at 0.05 ppm; milk at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, fat at 0.05 ppm; and sheep, mbyp at 0.05 ppm.
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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.
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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-2005-0003 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 May 23, 2005.
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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.
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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-2005-0003, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.
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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).
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Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety 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
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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.
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Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: February 25, 2005. Lois Rossi, Director, Registration Division, Office of Pesticide Programs.
0 Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0 2. Section 180.603 is revised to read as follows:
Sec. 180.603 Dinotefuran; tolerances for residues.
(a) General. (1) Tolerances are established for the combined residues of Dinotefuran, [N-methyl-N'-nitro-N''-((tetrahydro-3- furanyl)methyl)guanidine] and its metabolites DN [1-methyl-3- (tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-(tetrahydro-3- furylmethyl)urea], expressed as dinotefuran.
Parts per Commodity
million
Brassica, head and stem, subgroup 5A.......................
1.4 Cotton, undelinted seed....................................
0.4 Cotton, gin byproducts.....................................
8.0 Grape......................................................
0.9 Grape, raisin..............................................
2.5 Potato.....................................................
0.05 Potato, chips..............................................
0.1 Potato, granules/flakes....................................
0.15 Tomato, paste..............................................
1.0 Vegetable, fruiting, group 8...............................
0.7 Vegetable, cucubit, group 9................................
0.5 Vegetable, leafy, except Brassica, group 4.................
5.0
(2) Tolerances are established for residues of dinotefuran N- methyl-N'-nitro-N''-tetrahydro-3-furanyl)methyl)guanidine in/on the following commodities:
Parts per Commodity
million
Cattle, fat................................................
0.05 Cattle, mbyp...............................................
0.05 Cattle, meat...............................................
0.05 Goat, fat..................................................
0.05 Goat, mbyp.................................................
0.05 Goat, meat.................................................
0.05 Hog, fat...................................................
0.05 Hog, mbyp..................................................
0.05 Hog, meat..................................................
0.05 Horse, fat.................................................
0.05 Horse, mbyp................................................
0.05 Horse, meat................................................
0.05 Milk.......................................................
0.05 Sheep, fat.................................................
0.05 Sheep, mbyp................................................
0.05 Sheep, meat................................................
0.05
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 05-5620 Filed 3-22-05; 8:45 am]
BILLING CODE 6560-50-S
