[Federal Register: September 24, 2004 (Volume 69, Number 185)]
[Rules and Regulations]
[Page 57197-57207]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se04-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0315; FRL-7680-1]
Dimethenamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
dimethenamid in or on onions (dry bulb), garlic, shallots (dry bulb),
tuberous and corm vegetables, sugar beets, garden beets, and
horseradish. Interregional Research Project No. 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
In addition, this regulatory action is part of the tolerance
reassessment requirements of section 408(q) of the FFDCA 21 U.S.C.
346a(q), as amended by the FQPA of 1996. By law, EPA is required to
reassess all tolerances in existence on August 2, 1996 by August 2006.
This regulatory action will count for thirteen reassessments towards
this August 2006 deadline.
DATES: This regulation is effective September 24, 2004. Objections and
requests for hearings must be received on or before November 23, 2004.
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-2004-0315. 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 South
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: Jim Tompkins, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone
number: (703) 305-5697; e-mail address: tompkins.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
[[Page 57198]]
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 March 12, 2003 (68 FR11850) (FRL-7295-
9), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0E6196) by Interregional Research Project No. 4 (IR-4), Technology
Centre of New Jersey, Rutgers, the State University of New Jersey, 681
U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The
petition requested that 40 CFR 180.464 be amended by establishing a
tolerance for residues of the herbicide dimethenamid, (R,S)-2-chloro-N-
[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethyl-thien-3-yl)-acetamide, in
or on onions (dry bulb), garlic, shallots (dry bulb), tuberous and corm
vegetables, sugar beets, garden beets, and horseradish at 0.01 parts
per million (ppm). That notice included a summary of the petition
prepared by IR-4, the registrant. There were no comments received in
response to the notice of filing.
Dimethenamid was originally registered as a mixture of R and S-
isomers (50:50, S:R), and tolerances for the 50:50 mixture were
established for dry beans, field corn, sweet corn, peanuts, sorghum,
and soybean. Manufacture of the 50:50 mixture has ceased and has been
replaced by a mixture (dimethenamid-P) that is enriched in the
biologically active S-isomer (90:10, S:R). Registration of the original
50:50 mixture will be cancelled when existing stock is depleted.
Currently, both dimethenamid (50:50, S:R) and dimethenamid-P (90:10,
S:R) are used. The petition sought to have tolerances established on a
non-isomer specific bases. The existing toxicological and residue
chemistry databases are established primarily on studies conducted with
the 50:50 mixture. To address the uncertainty concerning qualitative or
quantitative toxicological difference(s) between the original 50:50
mixture and the enriched 90:10 mixture, EPA reviewed several
toxicological studies conducted using both products. EPA concluded that
the dimethenamid toxicology database is adequate for the risk
assessment of both dimethenamid and dimethenamid-P. Therefore, 40 CFR
180.464 is being revised to include tolerances for residues resulting
from application of both dimethenamid (50:50, S:R) and dimethenamid-P
(90:10, S:R).
In addition, existing tolerances for dimethenamid were reassessed
as part of the tolerance reassessment requirements of section 408(q) of
the FFDCA 21 U.S.C. 346a(q), as amended by the FQPA of 1996. By law,
EPA is required to reassess all tolerances in existence on August 2,
1996 by August 2006.
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 (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 dimethenamid on
onions (dry bulb), garlic, shallots (dry bulb), tuberous and corm
vegetables, sugar beets, garden beets, and horseradish at 0.01 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. The nature of the toxic effects caused by dimethenamid 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
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Guideline No. Study Type Results
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870.1100 Acute oral/rats [Sprague LD50 = 429 mg/kg for males LD50 = 531 mg/kg
Dawley] dimethenamid-P for females
(90:10 S:R isomers) LD50 = 480 mg/kg for both sexes
Toxicity category II
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870.1100 Acute oral/rats [Sprague LD50 = 500 mg/kg. The mean for both sexes
Dawley] dimethenamid Toxicity category II
(50:50 S:R isomers)
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[[Page 57199]]
870.1200 Acute dermal/rabbits LD50 = > 2,000 mg/kg
dimethenamid-P (90:10 S:R Toxicity category III
isomers)
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870.1200 Acute dermal/rabbits LD50 = > 2,000 mg/kg
dimethenamid (50:50 S:R Toxicity category III
isomers)
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870.1300 Acute inhalation [Sprague LC50 = 2.2 mg/L
Dawley] dimethenamid-P Toxicity category III
(90:10 S:R isomers)
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870.1300 Acute inhalation/rats LC50 = 4.99 mg/L
[Wistar] dimethenamid Toxicity category III
(50:50 S:R isomers)
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870.2400 Acute eye irritation Minimally irritating
rabbits dimethenamid-P Toxicity category III
(90:10 S:R isomers)
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870.2400 Acute eye irritation/ Minimally irritating
rabbits dimethenamid Toxicity category III
(50:50 S:R isomers)
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870.2500 Acute dermal irritation Minimally irritating
rabbits dimethenamid-P Toxicity category IV
(90:10 S:R isomers)
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870.2500 Acute dermal irritation/ Minimally irritating
rabbits dimethenamid Toxicity category IV
(50:50 S:R isomers)
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870.2600 Skin sensitization [Guinea Mild skin senstizer
Pigs] dimethenamid-P
(90:10 S:R isomers)
----------------------------------------------------------------------------------------------------------------
870.2600 Skin sensitization [Guinea Mild skin senstizer
Pigs] dimethenamid (50:50
S:R isomers)
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870.3100 Subchronic Feeding/Sprague NOAEL= 37/40(M/F) mg/kg/day [500 ppm]
Dawley Rat dimethenamid-P LOAEL= 110/125 (M/F) mg/kg/day [1,500 ppm]
(90:10 S:R isomers) based on decreased body weight (bwt) and
bwt gain in males and females, increased
gamma-glutamyl transferase in both sexes,
increased cholesterol in males, increased
absolute and relative liver weight and
periportal hepatocytic hypertrophy and
periportal eosinophilic inclusions in
males, centrilobular hypertrophy in
females and liver necrosis in females
----------------------------------------------------------------------------------------------------------------
870.3100 Subchronic Feeding/Sprague NOAEL= 33.5/40.1 (M/F) mg/kg/day [500 ppm]
Dawley rat dimethenamid LOAEL= 98/119 (m/f) mg/kg/day [1,500 ppm]
(50:50 S:R isomers) based on decreased bwt and bwt gain,
increased total protein in males; in
females, increased cholesterol, increased
liver weight and centrilobular hepatocytic
enlargement
----------------------------------------------------------------------------------------------------------------
870.3150 Subchronic oral toxicity NOAEL = 4.72/4.98 (M/F) mg/kg/day [100 ppm
(dog) dimethenamid (50:50 ]
S:R isomers) LOAEL = 33.6/39.7 (M/F) mg/kg/day [750 ppm]
based on decreased bwt and bwt gain in
females, increased relative liver weight
in both sexes, increased periportal
vacuolation in both sexes and dilation of
liver sinusoids in females
----------------------------------------------------------------------------------------------------------------
870.3200 21/28-Day dermal toxicity NOAEL = 50 mg/kg/day
(rabbit) dimethenamid LOAEL = 150 mg/kg/day based on decreased
(50:50 S:R isomers) blood phosphate in both sexes [15% at
150mg/kg/day and 15% at 500 mg/kg/day] [p
< 0.05]
----------------------------------------------------------------------------------------------------------------
870.3250 Subchronic dermal toxicity Not required
dimethenamid (50:50 S:R
isomers)
----------------------------------------------------------------------------------------------------------------
870.3465 Subchronic inhalation Not required
toxicity es) dimethenamid
(50:50 S:R isomers)
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[[Page 57200]]
870.3700 Prenatal developmental in Maternal NOAEL = None
(Sprague Dawley rats) LOAEL = 25 mg/kg/day based on bwt decrement
dimethenamid-P (90:10 S:R on Gestation Day 13-19(Gday) (no single
isomers) dose effect) and body weight gain decrease
and food consumption decrease GDay 6-16
and 6-9, respectively
Developmental NOAEL = 25 mg/kg/day
LOAEL=150 mg/kg/day based on ossification
delays in the pubis and at 300 mg/kg/day
ossification delays in the pubis, sternal
centra, incidences of microphthalmia,
umbilical hernia and at 400 mg/kg/day
increased post implantation loss in a
range-finding study
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental in Maternal NOAEL = 50 mg/kg/day
(Sprague Dawley rats) LOAEL = 215 mg/kg/day based on bwt
dimethenamid (50:50 S:R decrement on GDay 12 (but not a single
isomers) dose effect) and bwt decrement and food
consumption decrease, both GDay 6-9 and 6-
16
Developmental NOAEL = 215 mg/kg/day
LOAEL= 425 mg/kg/day based on increased
post implantation loss
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal Developmental Maternal NOAEL = 75 mg/kg/day
(NZW/Rabbit) dimethenamid LOAEL = 150 mg/kg/day based on slight bwt
(50:50 S:R isomers) decrement (80g, GDay 12-15), bwt loss (75g
GDay 15-19) and 2 abortions and in a 20
litter/group range-finding study, death
(13/20) and abortions (7/20) at 250 mg/kg/
day
Developmental NOAEL = 75 mg/kg/day
LOAEL = 150 mg/kg/day based on SS fetal
incidence of irregular parietals and hyoid
angulated. Litter incidence was nominally
elevated by 50% and 100%, respectively,
and nominally increase post implantation
loss (double control)
----------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and fertility Parental/Systemic NOAEL = M/F 36/40 mg/kg/
effects (Wistar day [500 ppm]
rats)dimethenamid (50:50 LOAEL =M/F 150/160 mg/kg/day [2,000 ppm]
S:R isomers) based on decrease bwt, bwt gain, food
consumption and absolute and relative
liver weight increase
Reproductive NOAEL = M/F 150/160 mg/kg/day
[2,000 ppm]
LOAEL = None
Offspring NOAEL = 40 mg/kg/day [500 ppm]
LOAEL = 160 mg/kg/day [2,000 ppm] based on
f1 pup weight decrement at LDay 21 and f2
pup weight decrease at LDay day 7 and 2
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity (Rat) Satisfied by data for 870.4300
dimethenamid (50:50 S:R
isomers)
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity (dog) NOAEL = M/F 10.1/9.1 mg/kg/day [250 ppm]
dimethenamid (50:50 S:R LOAEL = M/F 48.7/49.3 mg/kg/day [1,250 ppm]
isomers) based on decreased bwt and bwt gains [43%
to 60%, 0-26 wk] both sexes 100% in males
wk 26-52] alkaline phosphatase increased
in females 109-2185 through out study and
80% in males. Portal vacuolation in males;
vacuoles not lipid or glycogen
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity (rat Satisfied by data for 870.4300
dimethenamid (50:50 S:R
isomers)
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity (mouse) NOAEL = 300 ppm (M/F: 40.8/40.1 mg/kg/day)
dimethenamid (50:50 S:R LOAEL = 1,500 ppm (M/F: 205/200 mg/kg/day)
isomers) based on decreased bwt gain in both sexes
No treatment related tumors were seen at
adequate doses
----------------------------------------------------------------------------------------------------------------
870.4300 Chronic/carc-inogenicity NOAEL = 100 ppm [M/F: 5.1/6.8 mg/kg/day]
(Sprague Dawley rat) LOAEL = 7,000 ppm [M/F: 36/49 mg/kg/day]
dimethenamid (50:50 S:R based on decreased bwt and bwt gain in
isomers) both sexes and microscopic hepatic lesions
in both sexes. A dose related increased
incidence of liver tumors in males (benign
and malignant combined) were seen at the
1,500 ppm dose both exceeding slightly
historical controls. Dimethenamid (50:50
S:R isomers) characterized as a Group C -
possible human carcinogen. For the purpose
of risk assessment, the MOE approach will
be used for human risk assessment)
----------------------------------------------------------------------------------------------------------------
870.5100 Bacterial Reverse mutation S. typhimurium exposed to 500-4,000 [mu]g/
dimethenamid-P (90:10 S:R plate +/- S9
isomers) E. coli exposed to 20-5,000 [mu]g/plate +/-
S9 using the standard plate incorporation
method or 4-2,500 [mu]g/plate +/- S9 using
the pre-incubation modification to the
standard test. Highest doses were
cytotoxic
All assays were negative
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[[Page 57201]]
870.5100 Bacterial Reverse mutation Exposed to 20-5,000 [mu]g/plate in a plate
dimethenamid-P (90:10 S:R incorporation assay. Marginal cytotoxicity
isomers) at limit dose of 5,000 [mu]g/plate +/- S9
Assays were negative with both bacteria +/-
S9
----------------------------------------------------------------------------------------------------------------
870.5100 Bacterial Reverse mutation Repeat of MRID 44123502. S.
dimethenamid-P (90:10 S:R typhimurium TA100 was exposed to 100-5,000
isomers) [mu]g/plate +/- S9
Assay was negative
----------------------------------------------------------------------------------------------------------------
870.5100 Bacterial Reverse mutation Exposed to 100-5,000 [mu]g/plate, +/- S9,
dimethenamid-P (90:10 S:R in a plate incorporation assay.
isomers) Insolubility seen at 333 and 5,000 [mu]g/
plate, but no toxicity at any dose +/- S9
Assays were negative with both bacteria +
S9, however, - S9 induced 1.5 fold
increases at 333 [mu]g/plate and 4.1 fold
increases in reverents in TA100 strain at
5000 [mu]g/plate. This mutagenic response
was reproducible at 100 to 5,000 [mu]g/
plate
----------------------------------------------------------------------------------------------------------------
870.5100 Bacterial Reverse mutation Strains tested at 1000-10,000 [mu]g/plate,
dimethenamid-P (90:10 S:R S9 and 1,000-6,500 [mu]g/plate, + S9.
isomers) Cytotoxicity and precipitation were noted
at higher doses
Test was negative, +/- S9
----------------------------------------------------------------------------------------------------------------
870.5300 Mammalian cell mutation Chinese hamster ovary (CHO) cells were
dimethenamid-P (90:10 S:R exposed to 100-400 [mu]g/mL, - S9, and 100-
isomers) 450 [mu]g/mL, + S9. Slight cytotoxicity
was seen at the highest dose and severe
toxicity was seen at >= 500 [mu]g/mL
Test was negative for mutagenic effects, +/-
S9
----------------------------------------------------------------------------------------------------------------
870.5395 Mouse erythrocyte CD-1 mice dosed at 710 mg/kg in two daily
micronucleus test doses. LD50 = 1,417 mg/kg. Bone marrow
dimethenamid (50:50 S:R erythrocytes harvested 24 and 48 hours
isomers) later
Test negative
----------------------------------------------------------------------------------------------------------------
870.5395 Mouse erythrocyte Mice dosed 0-1,000 mg/kg in single doses.
micronucleus test Mice showed no toxicity; only one mouse
dimethenamid (50:50 S:R died
isomers) Test negative
----------------------------------------------------------------------------------------------------------------
870.5375 Chromosomal aberration Cells in 125-150 [mu]g/mL, - S9 and 400 to
test dimethenamid (50:50 500 [mu]g/mL, + S9; all doses were
S:R isomers) cytotoxic. Study needs repeating at none
cytotoxic doses.
Test considered equivocally positive
----------------------------------------------------------------------------------------------------------------
870.5550 Unscheduled DNA Cell in 1.0-100 nl/mL. No cytotoxicity was
(deoxyribonucleic acid) seen
Synthesis (UDS) in rat Test was negative
hepatocytes dimethenamid
(50:50 S:R isomers)
----------------------------------------------------------------------------------------------------------------
870.5550 UDS in rat hepatocytes Fisher 344 rat administered SAN 582H doses
dimethenamid (50:50 S:R of 158 or 500 mg/kg. Sampled 2-4 and 12-14
isomers) hours after dosing. Only 0.2-3.6% cells in
repair, but negative control was less than
zero
Test was negative for UDS at 158 and 500 mg/
kg
----------------------------------------------------------------------------------------------------------------
870.5550 UDS in rat hepatocytes SAN 582H administered at 0.01 to 50 [mu]g/
dimethenamid (50:50 S:R mL. Unscheduled DNA synthesis was seen
isomers) well below cytotoxic doses. Unequivocally
positive for UDS
Test positive
----------------------------------------------------------------------------------------------------------------
870.5550 UDS in rat hepatocytes SAN 582H administered at 0.0128 to 1,000
dimethenamid (50:50 S:R [mu]g/mL to rat primary cultures of
isomers) hepatocytes. Doses at 1,000 [mu]g/mL were
cytotoxic. No UDS was noted
Test negative for UDS
----------------------------------------------------------------------------------------------------------------
870.5450 Dominant Lethal Male Charles River (CR) rats (40-55)
dimethenamid (50:50 S:R administered SAN 582H in single oral doses
isomers) of 275, 550, or 1,100 mg/kg were mated
starting at 10 weeks to 40-55 female
undosed CR rats. Increased dead implants
at week 1 and week 2 may suggest a
dominant lethal effect. These were mostly
late implant deaths, which some
consultants claim are not characteristic
of a dominant lethal effect
----------------------------------------------------------------------------------------------------------------
870.5450 Dominant Lethal Male Sprague Dawley rats (40-60)
dimethenamid (50:50 S:R administered SAN 582H in single oral doses
isomers) of 275, 550, or 1,100 mg/kg were mated
starting the day after dosing in Trial 1
and 2 days after dosing in Trial 2 to 80-
120 female undosed Sprague Dawley rats .
Each male was mated to 2 females over a
five day sequence. Results equivocal
Note: Both the high dose rabbit and rat
developmental studies showed increased
late and early resorptions
----------------------------------------------------------------------------------------------------------------
[[Page 57202]]
870.5375 Cytogenetics in CHO cells CHO cells were exposed to 2-120 [mu]g/mL -
dimethenamid-P(90:10 S:R S9; cytotoxic at >= 120 [mu]g/mL. CHO
isomers) cells were exposed to 15-120 [mu]g/mL +
S9; cytotoxic at >= 500 [mu]g/mL
Assay was negative +/- S9
----------------------------------------------------------------------------------------------------------------
870.5395 Cytogenetics; mouse Mice (5/sex) were exposed to i.p.
erythrocyte microncleus injections of 103, 205, 410 mg/kg
test dimethenamid-P Assay was negative, indicating no
(90:10 S:R isomers) clastogenic or aneugenic response
----------------------------------------------------------------------------------------------------------------
870.5550 UDS in mammalian cell Cells tested at 7.8-125 [mu]g/mL.
culture dimethenamid-P Cytotoxicity and insolubility were seen at
(90:10 S:R isomers) >= 250 [mu]g/mL
Test was negative for UDS
----------------------------------------------------------------------------------------------------------------
870.6200 Acute neurotoxicity Not required
screening battery
dimethenamid-P (90:10 S:R
isomers)
----------------------------------------------------------------------------------------------------------------
870.6200 Acute neurotoxicity Not required
screening battery
dimethenamid (50:50 S:R
isomers)
----------------------------------------------------------------------------------------------------------------
870.6200 Subchronic neurotoxicity Not required
screening battery
dimethenamid-P (90:10 S:R
isomers)
----------------------------------------------------------------------------------------------------------------
870.6300 Developmental Not required
neurotoxicity
dimethenamid-P (90:10 S:R
isomers)
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Not required
pharmacokinetics
(species) dimethenamid-P
(90:10 S:R isomers)
----------------------------------------------------------------------------------------------------------------
870.7600 Dermal penetration Not required
(species) dimethenamid-P
(90:10 S:R isomers)
----------------------------------------------------------------------------------------------------------------
870.7600 Dermal penetration Not required
(species) dimethenamid
(50:50 S:R isomers)
----------------------------------------------------------------------------------------------------------------
B. Toxicological Endpoint
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
[[Page 57203]]
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 dimethenamid used for
human risk assessment is shown in Table 2. of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Dimethenamid for Use in Human Risk Assessment.
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-49 years of NOAEL = 75 mg/kg/day FQPA SF = 1X Developmental Toxicity
age) Based on [RS] data UF = 100............... aPAD = acute RfD / FQPA in rabbits
Acute RfD = 0.75 mg/kg/ SF = 0.75 mg/kg/day. Maternal; LOAEL = 150
day. mg/kg/day based on
abortions and
decreased body weight
gain and food
consumption
Developmental; LOAEL =
150 mg/kg/day based on
post-implantation loss
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL= 5 mg/kg/day FQPA SF = 1X Chronic/rats
Based on [RS] data UF = 100............... cPAD = chronic RfD / LOAEL = M/F; 36/49 mg/
Chronic RfD = 0.05 mg/ FQPA SF = 0.05 mg/kg/ kg/day based on
kg/day. day. decreased body weight
and body weight gain
in both sexes,
increased food
conversion ratios in
females, and increased
microscopic hepatic
lesions in both sexes
----------------------------------------------------------------------------------------------------------------
Carcinogenicity Based on [RS] data Classified as a Group C N/A Chronic risk assessment
(possible human protective of any
carcinogen) potential carcinogenic
risk
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.464) for the residues of dimethenamid, in or on
a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from dimethenamid 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 one-day
or single exposure. In conducting the acute dietary risk assessment EPA
used the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID\TM\), which incorporates food
consumption data as reported by respondents in the United States
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 residue
estimate for each food commodity was the tolerance for that crop (0.01
ppm) and each crop was assessed as if 100% of the crop has been treated
with dimethenamid.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCID\TM\, 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 residue estimate for each food commodity was the
tolerance for that crop (0.01 ppm) and each crop was assessed as if
100% of the crop has been treated with dimethenamid.
iii. Cancer. Dimethenamid (50:50 S:R isomers) was classified as a
group ``C'' (possible human carcinogen). The Agency concluded that the
chronic risk assessment, making use of the cPAD, to be protective of
any potential carcinogenic risk. Dimethenamid is at best a weak
carcinogen. An intermediate dose showed marginally significant results
(p = 0.056) with liver adenomas one species (rat) and one sex (males).
The incidence of liver tumors was just slightly increased from the
level in the historical control data. Higher doses did not demonstrate
the occurrence of liver adenomas significantly different from the
controls. No dose-related tumors were seen in the mouse carcinogenicity
study, and a battery of mutagenicity studies with dimethenamid-P (90:10
S:R isomers) were negative or equivocal for genetic mutations including
unscheduled DNA synthesis.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for dimethenamid 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 dimethenamid.
[[Page 57204]]
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and SCI-GROW, which predicts pesticide concentrations in
groundwater. In general, EPA will use GENEEC (a tier 1 model) before
using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for
surface water. The GENEEC model is a subset of the PRZM/EXAMS model
that uses a specific high-end runoff scenario for pesticides. GENEEC
incorporates a farm pond scenario, while PRZM/EXAMS incorporate an
index reservoir environment in place of the previous pond scenario. The
PRZM/EXAMS model includes 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.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to dimethenamid they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of
dimethenamid for acute exposures are estimated to be 49 parts per
billion (ppb) for surface water and 0.42 ppb for groundwater. The EECs
for chronic exposures are estimated to be 7.9 ppb (non-cancer exposure)
and 5.1 ppb (cancer exposure) for surface water and 0.42 ppb for
groundwater.
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).
Dimethenamid 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 dimethenamid and any other
substances. Dimethenamid 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 dimethenamid 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 Office of Pesticide Programs
(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 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. No offspring pre- or
postnatal susceptibility to either dimethenamid (50:50 S:R isomers) or
dimethenamid-P (90:10 S:R isomers) was seen in a rabbit or two rat
developmental studies and reproduction study. There is low concern for
pre- or postnatal toxicity since the developmental effects from the [S]
and [RS] mixture are similar and occur at similar doses.
3. Conclusion. There is a complete toxicity data base for
dimethenamid and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the safety factor for dimethenamid should be 100 (10X safety
factor for interspecies extrapolation and 10X for intraspecies
variation). The additional FQPA SF was removed taking into account the
low concerns and lack residual uncertainties with regard to prenatal
and postnatal toxicity and the completeness of the toxicity and
exposure data base.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative
[[Page 57205]]
drinking water exposure assessments. Different populations will have
different DWLOCs. Generally, a DWLOC is calculated for each type of
risk assessment used: Acute, short-term, intermediate-term, chronic,
and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. The dimethenamid aPAD is 0.75 mg/kg/day (applicable
to child bearing females only (females 13-49 years old) (Table 3.). The
estimated acute (one day) aggregate exposure of females 13-49 years of
age (0.006857 mg/kg/day) utilizes less than 1% of the dimethenamid
aPAD. For the other population subgroups, an appropriate acute endpoint
attributed to a single dose was not available in the toxicity data base
including the developmental toxicity studies.
Table 3.--Aggregate Risk Assessment for Acute Exposure to Dimethenamid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-49 yrs 0.75 < 1% 49 0.42 22,294
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. The dimethenamid cPAD is 0.05 mg/kg/day. The
estimated chronic aggregate exposure is the same as the chronic dietary
exposure because dimethenamid has no residential uses. The chronic
dietary exposure utilizes less than 1% of the cPAD for all population
subgroups except infants less than 1 year old, which utilizes less than
2% of the dimethenamid cPAD. The chronic DWLOC was acceptable for
chronic exposure to surface and groundwater (Table 4.).
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Dimethenamid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.05 < 1 7.9 0.42 1,494
----------------------------------------------------------------------------------------------------------------
All infants (< 1 yr.) 0.05 < 2 7.9 0.42 494
----------------------------------------------------------------------------------------------------------------
Children 1-2 yrs. 0.05 < 1 7.9 0.42 497
----------------------------------------------------------------------------------------------------------------
Children 3-5 yrs. 0.05 < 1 7.9 0.42 248
----------------------------------------------------------------------------------------------------------------
Children 6-12 yrs. 0.05 < 1 7.9 0.42 249
----------------------------------------------------------------------------------------------------------------
Youth 13-19 yrs. 0.05 < 1 7.9 0.42 249
----------------------------------------------------------------------------------------------------------------
Adults 20-49 yrs. 0.05 < 1 7.9 0.42 1,494
----------------------------------------------------------------------------------------------------------------
Adults 50+ yrs. 0.024 < 1 7.9 0.42 719
----------------------------------------------------------------------------------------------------------------
Females 13-49 yrs. 0.024 < 1 7.9 0.42 719
----------------------------------------------------------------------------------------------------------------
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).
Dimethenamid 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).
Dimethenamid 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. The Agency considers
the chronic aggregate risk assessment, making use of the cPAD, to be
protective of any aggregate cancer risk. See Table 4., Unit III.E.2.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to dimethenamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (AM-0884-0193-1) is available to
enforce the tolerance expression. AM-0884-0193-1 is a GC method using
an HP-1 or HP-5 column and mass selective detection (MSD). The method
may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
[[Page 57206]]
B. International Residue Limits
There are no Codex maximum residue levels (MRL's) for dimethenamid.
C. Conditions
There are no conditions of registration for establishment of
tolerances on: onions (dry bulb), garlic, shallots (dry bulb), tuberous
and corm vegetables, sugar beets, garden beets, and horseradish.
V. Conclusion
Therefore, the tolerance is established for residues of
dimethenamid, (R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-
dimethyl-thien-3-yl)-acetamide, in or on onions (dry bulb), garlic,
shallots (dry bulb), tuberous and corm vegetables, sugar beets, garden
beets, and horseradish at 0.01 ppm. This action results in the
reassessment of thirteen tolerances as follows: bean, dry, seed at 0.01
ppm; corn, forage at 0.01 ppm; corn, grain at 0.01 ppm; corn, stover at
0.01 ppm; corn, sweet, fodder (stover) at 0.01 ppm; corn, sweet, forage
at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 0.01
ppm; peanut at 0.01 ppm; peanut, hay at 0.01 ppm; sorghum, grain,
fodder at 0.01 ppm; sorghum, grain, forage at 0.01 ppm; sorghum, grain
at 0.01 ppm; and soybeans at 0.01 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-2004-0315 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
23, 2004.
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 14\th\ 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-2004-0315, 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.
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
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
[[Page 57207]]
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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 14, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.464 is amended as follows:
a. By revising paragraph (a).
b. By removing and reserving paragraph (b).
Sec. 180.464 Dimethenamid, 2-chloro-N-[(1-methyl-2-methoxy)ethyl]-N-
(2,4-dimethylthien-3-yl)-acetamide.
(a) General. Tolerances are established for residues of the
herbicide dimethenamid, 1(R,S)-2-chloro-N-[(1-methyl-2-methoxy)ethyl]-
N-(2,4-dimethylthien-3-yl)-acetamide, applied as either the 90:10 or
50:50 S:R isomers, in or on the following food commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Bean, dry, seed............................................ 0.01
Beet, garden, roots........................................ 0.01
Beet, garden, tops......................................... 0.01
Beet, sugar, dried pulp.................................... 0.01
Beet, sugar, molasses...................................... 0.01
Beet, sugar, roots......................................... 0.01
Beet, sugar, tops.......................................... 0.01
Corn, field, forage........................................ 0.01
Corn, field, grain......................................... 0.01
Corn, field, stover........................................ 0.01
Corn, pop, forage.......................................... 0.01
Corn, pop, grain........................................... 0.01
Corn, pop, stover.......................................... 0.01
Corn, sweet, forage........................................ 0.01
Corn, sweet, kernal plus cob with husks removed............ 0.01
Corn, sweet, stover........................................ 0.01
Garlic..................................................... 0.01
Onion, dry bulb............................................ 0.01
Peanut, hay................................................ 0.01
Peanut, nutmeat............................................ 0.01
Shallot, bulb.............................................. 0.01
Sorghum, grain............................................. 0.01
Sorghum, grain, forage..................................... 0.01
Sorghum, grain, stover..................................... 0.01
Soybean, seed.............................................. 0.01
Tuberous and corm vegetables............................... 0.01
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
[FR Doc. 04-21501 Filed 9-23-04; 8:45 am]
BILLING CODE 6560-50-S