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/ 2003
/ April
/ Wednesday, April 30, 2003
[Federal Register: April 30, 2003 (Volume 68, Number 83)]
[Rules and Regulations]
[Page 23038-23046]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap03-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0077; FRL-7297-9]
Mefenpyr-Diethyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for the combined
residues of mefenpyr-diethyl also known chemically as 1-(2,4-
dichlorophenyl)-4,5-dihydro-5-methyl-1H-pyrazole-3,5-dicarboxylic acid,
diethyl ester in or on wheat and barley commodities. Bayer CropScience
formerly doing business as Aventis CropScience and/or AgrEvo Company
requested this tolerance 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 April 30, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0077,
must be received on or before June 30, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone
number: (703) 308-8380; e-mail address: gandhi.bipin@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:
[sbull] Industry (NAICS 111), e.g., crop production
[sbull] Industry (NAICS 112), e.g., animal production
[sbull] Industry (NAICS 311), e.g., food manufacturing
[sbull] Industry (NAICS 32532), e.g., pesticide manufacturing
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0077. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., 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.
2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html
, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
[[Page 23039]]
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of September 26, 1997 (62 FR 50610) (FRL-
5740-2), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (PP 7F4850) by AgrEvo. Since 1997, by a
series of mergers, AgrEvo became Aventis Crop Science and then Bayer
CropScience. That notice included a summary of the petition prepared by
AgrEvo, now doing business as Bayer CropScience, 2 T.W. Alexander Dr.,
Research Triangle Park, NC 27709. There were no comments received in
response to the notice of filing.
The petition requested that 40 CFR 180.509 be amended by
establishing permanent tolerances for the combined residues of the
herbicide safener, mefenpyr-diethyl, 1-(2,4-dichlorophenyl)-4,5-
dihydro-5-methyl-1H-pyrazole-3,5-dicarboxylic acid, diethyl ester, in
or on wheat and barley commodities.
In the Federal Register of August 8, 1997 (62 FR 42678) (FRL-5731-
7), EPA, on its own initiative, pursuant to section 408(e) and (1)(6)
of the FFDCA, established time-limited tolerances for the inert
ingredient herbicide safener, mefenpyr-diethyl, and its 2,4-
dichlorophenyl-pyrazoline metabolites in or on wheat grain and wheat
straw. This action was in response to EPA's granting of an emergency
exemption under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing use of mefenpyr-diethyl on wheat
grain and wheat straw in North Dakota and Montana.
Similarly, mefenpyr-diethyl time-limited tolerances were
established by the Agency in the Federal Register of September 9, 1998
(63 FR 48116) (FRL-6024-7), in or on barley grain, barley hay, barley
straw, and the processed by-products of barley grain: pearled barley,
bran and flour. This action was in response to EPA's granting of an
emergency exemption under FIFRA section 18 authorizing use of mefenpyr-
diethyl on barley in North Dakota.
These time-limited tolerances have been extended as the petitioner
has continued data generation. (See the Federal Register of May 6, 1998
(63 FR 24939) (FRL-5788-1); the Federal Register of November 22, 1999
(64 FR 63711) (FRL-6385-5); and the Federal Register of December 14,
2001 (66 FR 64768) (FRL-6814-2)). The extensions of these time-limited
tolerances were consistent with the safety standard (FFDCA section
408(b)(2)) and FIFRA section 18. Currently, the time-limited tolerances
under 40 CFR 180.509(b) expire on December 31, 2003. As the permanent
tolerances are established, these emergency exemption time-limited
tolerances are no longer necessary and will be revoked.
Section 408(b)(2)(A)(i) of the 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 the 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 the 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 the 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 the 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 the FFDCA, for tolerances for combined residues of
mefenpyr-diethyl on wheat and barley commodities. EPA's assessment of
exposures and risks associated with establishing the tolerances
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 mefenpyr-diethyl
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 Subchronic feeding NOAEL = 89.3/105.4
studies in mouse mg/kg/day
(milligram/
kilogram/day),
male and female (M/
F)
LOAEL = 449.0/
523.5 mg/kg/day (M/
F) based on
decreased body and
kidney weight,
increased liver
weight and
hepatocyte
hypertrophy in
males; decreased
bilirubin and
increased lactic
acid dehydrogenase
values in females
------------------------------------------------------------------------
[[Page 23040]]
870.3100 Subchronic feeding NOAEL = 206.7/223.0
studies in rats mg/kg/day (M/F)
LOAEL = 660.6/708.9
mg/kg/day(M/F)
based on decreased
body weight (bwt)
gains; decreased
erythrocyte
counts, hemoglobin
and hematocrit
values; and
increased
reticulocyte
counts and mean
corpuscular volume
------------------------------------------------------------------------
870.3150 Subchronic feeding- NOAEL = 80.5/81.2
dogs mg/kg/day (M/F)
LOAEL = 341.0/
336.1 mg/kg/day (M/
F) based on
increased absolute
and relative liver
weights and
alkaline
phosphatase
activities in both
sexes; focal liver
lesions in
females; slight
anemia in both
sexes; decrease in
mean bwt and bwt
gain in females
and decreased food
consumption in
both sexes
------------------------------------------------------------------------
870.3200 28-Day dermal NOAEL = 1,000 mg/
toxicity (rat) kg/day highest
dose tested (HDT)
LOAEL was not
determined, but
would be greater
than the NOAEL
------------------------------------------------------------------------
870.3700 Developmental Maternal NOAEL <
toxicity in 1,000 mg/kg/day
rodents (rat) Maternal LOAEL =
1,000 mg/kg/day
based on decrease
in body weight
gain and food
efficiency during
the first week of
treatment and on
increase in
absolute and
relative spleen
weights
Developmental NOAEL
= 1,000 mg/kg/day
Developmental LOAEL
= Not determined
but would be
greater than the
NOAEL. Note that
only one dose was
tested
------------------------------------------------------------------------
870.3700 Postnatal Maternal NOAEL <
developmental 1,000 mg/kg/day
toxicity in Maternal NOAEL =
rodents (rat) 1,000 mg/kg/day
based on decrease
in bwt gain and
food efficiency
during the first
week of treatment
Developmental NOAEL
< 1,000 mg/kg/day
Developmental LOAEL
= 1,000 mg/kg/day
based on marginal
decreases in fetal
bwt and bwt gain
during lactation.
Note that only one
dose was tested
------------------------------------------------------------------------
870.3700 Developmental Maternal NOAEL= 100
Toxicity in mg/kg/day
nonrodents Maternal LOAEL =
(rabbit) 250 mg/kg/day
based on higher
rate of abortions
and marginal
decreases in body-
weight gain, food
efficiency index
and food
consumption
Developmental
NOAEL = 100 mg/kg/
day
LOAEL = 250 mg/kg/
day based on
higher rate of
abortions
------------------------------------------------------------------------
870.3800 Reproduction and Parental-Offspring/
fertility effects Systemic NOAEL =
57.3/76.0 mg/kg/
day (M/F)
Parental-Offspring/
Systemic LOAEL=
306.0/392.0 mg/kg/
day (M/F) based on
decrease mean bwt
and mean bwt gain
in parents and
offspring and an
increase in mean
spleen weight an
increase in the
severity (but not
in the incidence)
of splenic
extramedullary
hematopoiesis in
females.
Reproductive NOAEL
= 306.0/392.0 mg/
kg/day (M/F): HDT
Reproductive LOAEL
was not determined
but would be
greater than the
NOAEL
------------------------------------------------------------------------
870.4100 Chronic-feeding NOAEL = 51.4/57.6
toxicity-dogs mg/kg/day (M/F)
LOAEL = 260.2/
282.2 mg/kg/day (M/
F) based on high
ALP levels and
increased absolute
and relative liver
weights in both
sexes and grade 1
(minimal)
intrahepatic
cholestasis in the
liver: 2/sex
------------------------------------------------------------------------
870.4300 Chronic Toxicity- NOAEL = 48.5/60.0
Carcinogenicity mg/kg/day (M/F)
rats LOAEL = 251.6/
318.0 mg/kg/day (M/
F) based on
significant
increases in
reticulocyte
counts
------------------------------------------------------------------------
870.4300 Carcinogenicity NOAEL = 350.8/463.4
mice mg/kg/day (M/F)
LOAEL = (M/F) not
determined,
however, study
considered
adequate for
carcinogenicity
based on results
of subchronic
study
------------------------------------------------------------------------
870.5265 Gene Mutation Non-mutagenic with
Salmonella and E. or without
Coli activation
------------------------------------------------------------------------
870.5300 Gene Mutation Non-mutagenic with
HGPRT with V79 or without
cells activation
------------------------------------------------------------------------
870.5375 Chinese Hamster No clastogenic
Lung Fibroblast response with or
Assay without activation
------------------------------------------------------------------------
[[Page 23041]]
870.5395 Micronucleus Assay No clastogenic
response at any
dose or sacrifice
time
------------------------------------------------------------------------
870.5550 Unschedule DNA No clear evidence
synthesis of genotoxicity.
However, study not
acceptable
------------------------------------------------------------------------
870.7485 Metabolism and Single dose of 1 or
pharmacokinetics 100 mg/kg bwt:
Urinary excretion
76-88% of
administered
radioactivity with
59-72% excreted
within first 24
hours. Fecal
excretion ranged
from 13-32%. 83-
91% of
administered dose
excreted (urine
and feces) by 24
hours and 91 to >
99% excreted by 48
hours. At least 68-
88% of
administered dose
absorbed. Recovery
in tissues/animal:
0.24% of
administered
radioactivity
(range: 0.07 -
0.51%). General
order of
concentration
plasma > whole
blood > lungs >
subcutaneous fat >
heart > kidneys >
retroperitoneal
fat > liver >
gonads > pancreas
> skeletal muscle.
No volatile
radioactivity
detected 0-24
hours after
dosing. Between
100-106% of
administered
radioactivity
recovered.
Single dose of 1
or 100 mg/kg bwt:
Radioactivity
rapidly excreted:
total of 78-92%
excreted by 48
hours. Renal
excretion
predominant route
of elimination (65-
72% by 48 hours),
indicating that at
least 65-72% of
the administered
dose was absorbed.
None of test
material found in
its original form
in urine. Three
metabolites
identified in
urine: 13-26% of
the radioactivity
was recovered in
the feces by 48
hours. The same
three metabolites
identified in
urine were also
present in the
feces: Proposed
metabolic steps:
Consecutive
hydrolysis
(saponification)
of the two
carboxylic acid
ester groups and a
decarboxylation of
one of the
carboxylic groups,
resulting in an
aromatization of
the pyrazoline
ring.
Enterohepatic
circulation is
unlikely to play a
major role. In
males, there
appears to be
either lower
intestinal
absorption or a
higher biliary
excretion when
compared to
females.
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). 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.
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 the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF)
is retained due to concerns unique to the FQPA, 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 FQPA SF.
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.
A summary of the toxicological endpoints for mefenpyr-diethyl used
for human risk assessment is discussed in this unit: The Agency has
determined that there is no acute toxicological concern. No appropriate
endpoint was identified from oral toxicity studies including the
developmental toxicity studies in rats and rabbits. No short-term or
intermediate-term dermal or systemic toxicity was observed up to 1,000
mg/kg/day and no development effects were observed in the developmental
rat study at 1,000 mg/kg/day. Therefore, no endpoint was identified for
risk assessment for the short- and intermediate-term risk assessments.
Based on the current use-pattern (i.e. one application per season)
long-term exposure via the dermal route is not expected. Therefore, a
long-term dermal end-point was not identified. Similarly, no endpoint
was identified for carcinogenicity since this chemical is not
classified as a human carcinogen.
For chronic dietary risk assessment the NOAEL of 57.3 mg/kg/day in
a 2-generation reproduction toxicity study was identified as an
appropriate end point. Taking into account the UF of 100, the chronic
RfD is 0.57 mg/kg/day (NOAEL 57.3/ UF 100 = 0.57). The Agency has used
a FQPA Factor of 1 and therefore, the chronic population adjusted dose
(PAD) is 0.57 mg/kg/day (RfD 0.57/FQPA 1 = 0.57) for mefenpyr-diethyl.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
previously established (40 CFR 180.509(b)) under FIFRA section 18, the
Emergency Exemption Program, for the combined residues of mefenpyr-
diethyl. To establish permanent tolerances, risk assessments were
conducted by EPA to assess dietary exposures from mefenpyr-diethyl 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.
An acute dietary risk assessment was not performed because no
appropriate acute toxicological endpoint could be identified in any of
the oral toxicity studies including the developmental studies in rats
and rabbits.
ii. Chronic exposure. The chronic dietary exposure assessment was
conducted using the Dietary Exposure Evaluation Model software with the
[[Page 23042]]
Food Commodity Intake Database (DEEM-FCID[reg], Version 1.3), which
incorporates consumption data from USDA's Continuing Survey of Food
Intakes by Individuals (CSFII), 1994-1996 and 1998. The 1994-96 and
1998 data are based on the reported consumption of more than 20,000
individuals over two non-consecutive survey days. Foods ``as consumed''
(e.g., apple pie) are linked to EPA-defined food commodities (e.g.
apples, peeled fruit - cooked; fresh or not specified (N/S); baked; or
wheat flour - cooked; fresh or N/S, baked) using publicly available
recipe translation files developed jointly by USDA/ARS and EPA.
Consumption data are averaged for the entire U.S. population and within
population subgroups for chronic exposure assessment, but are retained
as individual consumption events for acute exposure assessment.
For chronic exposure and risk assessment, an estimate of the
residue level in each food or food-form (e.g., orange or orange juice)
on the food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form. The resulting residue
consumption estimate for each food/food form is summed with the residue
consumption estimates for all other food/food forms on the commodity
residue list to arrive at the total average estimated exposure.
Exposure is expressed in mg/kg bwt/day and as a percent of the cPAD.
This procedure is performed for each population subgroup.
The DEEM-FCID[reg] analyses estimate the dietary exposure of the
U.S. population and various population subgroups. The analysis assumed
tolerance-level residues. No processing studies were required due to
the fact that field trials conducted at exaggerated rate (greater than
5X) showed no detectable residues in wheat and barley grains.
Therefore, no tolerance is needed for processed commodities. A default
processing factor of 1.92 was used for dried beef in this dietary
exposure analysis. No other commodities in this analysis used DEEM
default processing factors. No percent crop treated or anticipated
residues were used.
iii. Cancer. The Agency has determined that mefenpyr-diethyl is
``not likely to be a human carcinogen.'' This was based on weight-of-
the-evidence from negative rat and mouse carcinogenicity studies as
well as negative mutagenicity studies. Therefore, a carcinogenic
dietary assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for mefenpyr-diethyl 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 mefenpyr-diethyl.
The Agency used the FQPA Index Reservoir Screening Tool (FIRST) to
produce estimates of pesticide concentrations in an index reservoir.
The screening concentration in ground water (SCI-GROW2) model is used
to predict pesticide concentrations in shallow ground water. FIRST is a
tier 1 model that uses a specific high-end runoff scenario for
pesticides. It incorporates an index reservoir environment, but does
include a percent crop area factor as an adjustment to account for the
maximum percent crop coverage within a watershed or drainage basin.
Neither FIRST nor SCI-GROW2 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 models by the
Agency at this stage is to provide a coarse screen for sorting out
pesticides for which it is highly unlikely that drinking water
concentrations would ever exceed human health levels of concern.
Since FIRST and SCI-GROW2 is considered to be a screening tool in
the risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models 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 mefenpyr-diethyl, they are
further discussed in the aggregate risk sections see Unit III.E.
The EECs for a single application of mefenpyr-diethyl at an
exaggerated rate of 0.090 kg/hectare (ha) (0.080 lb/acre) results in
the peak and chronic concentrations of combined parent and metabolites
of 5 parts per billion (ppb) and 3 ppb, respectively for surface water
and 4 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Mefenpyr-diethyl is
not registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
EPA does not have, at this time, available data to determine
whether mefenpyr-diethyl has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
mefenpyr-diethyl 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 mefenpyr-diethyl 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines 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.
2. Prenatal and postnatal sensitivity. In the prenatal
developmental toxicity study in rats, no evidence of developmental
toxicity was seen, even in the presence of maternal toxicity. In the
developmental toxicity study in
[[Page 23043]]
rabbits, developmental toxicity was seen in the presence of maternal
toxicity. A higher rate of abortions occurred at the highest dose level
tested (250 mg/kg/day). An examination of the individual litter data
provided no evidence as to whether or not the higher rate was due to
maternal toxicity or developmental toxicity. Therefore, both the
maternal and developmental NOAELs and LOAELs were based on this effect.
In the 2-generation reproduction study and in the postnatal
developmental toxicity study in rats, effects in the offspring were
observed only at or above treatment levels which caused parental
toxicity. Developmental (Offspring) effects in these two studies
consisted of decreases in bwt and bwt gain of the pups in the presence
of either decreased bwt and bwt gain or hematopoietic effects in the
parents. There does not appear to be any increased susceptibility in
rats or rabbits to in utero and/or postnatal exposure to mefenpyr-
diethyl. Developmental effects were only observed at levels which were
parentally toxic.
3. Conclusion. There is a complete toxicity data base for mefenpyr-
diethyl and exposure data are complete or are estimated based on data
that reasonably accounts for potential exposures. EPA determined that
the 10X safety factor to protect infants and children should be
removed. The FQPA factor is removed (i.e., reduced to 1) because there
is no indication of increased susceptibility to infants and children,
dietary exposure estimates are likely to result in an overestimate of
the actual exposure, estimates for ground and surface source drinking
water exposure are upper-bound concentrations and there are currently
no registered residential uses and thus, this type of exposure to
infants and children is not expected.
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 the model estimates of
a pesticide's concentration in water (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 bwts. Default bwts and consumption values as used by
EPA are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60
kg (adult female), and 1L/10 kg (child). Default bwts and drinking
water consumption values vary on an individual basis. This variation
will be taken into account in more refined screening-level and
quantitative 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, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which the Agency has reliable data)
would not result in unacceptable levels of aggregate human health risk
at this time. Because the Agency 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, the Agency 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. No acute endpoint was identified, therefore, no
acute risk is expected.
2. Chronic risk. EPA has concluded that exposure to mefenpyr-
diethyl from food will utilize less than 1% of the cPAD for the U.S.
population and all population subgroups. (Table 2). There are no
residential uses for mefenpyr-diethyl that result in chronic
residential exposure to mefenpyr-diethyl. The following table
represents the results of the Tier 1 chronic dietary (food only)
exposure analysis for mefenpyr-diethyl proposed uses on barley and
wheat.
Table 2.--Exposure and risk estimates for dietary (food only) exposure
to mefenpyr-diethyl.
------------------------------------------------------------------------
Estimated
Dietary
Population Subgroup Exposure, % cPAD
mg/kg bwt/
day
------------------------------------------------------------------------
U.S. population 0.000113 <1%
------------------------------------------------------------------------
All infants (< 1 year) 0.000068 <1%
------------------------------------------------------------------------
Children (1-2 years) 0.000295 <1%
------------------------------------------------------------------------
Children (3-5 years) 0.000273 <1%
------------------------------------------------------------------------
Children (6-12 years) 0.000186 <1%
------------------------------------------------------------------------
Youth (13-19 years) 0.000107 <1%
------------------------------------------------------------------------
Adults (20-49 years) 0.000091 <1%
------------------------------------------------------------------------
Females (13-49 years) 0.000082 <1%
------------------------------------------------------------------------
Adults (50+ years) 0.000074 <1%
------------------------------------------------------------------------
This exposure analysis and cPAD represents a conservative estimate
of dietary (food only) exposure and risk from the use of mefenpyr-
diethyl on barley and wheat. Further refinement, through the use of
anticipated residues, percent-of-crop treated estimates and/or
monitoring data, would result in a reduction in the exposure estimates
and the associated risk. However, in this analysis, even without
further refinement, the risk estimate for all population subgroups is
less than 1% of the cPAD. This is below the Agency's level of concern
(100% of the cPAD) for the general U.S. population and all population
subgroups.
However, there is potential for chronic dietary exposure to
mefenpyr-diethyl in drinking water. The EECs for surface water and
ground water are less than the DWLOC. Thus, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in Table 3
below.
[[Page 23044]]
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Mefenpyr-Diethyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD (mg/kg/ % cPAD Water EEC Water EEC Chronic
day) (food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.57 0.000113 3 4 20,000
---------------------------------------------------------------------------
All infants (< 1 year old) 0.57 0.00007 3 4 5,700
---------------------------------------------------------------------------
Children (1-2 years old) 0.57 0.000295 3 4 5,700
---------------------------------------------------------------------------
Females (13-49 years old) 0.57 0.00008 3 4 17,000
----------------------------------------------------------------------------------------------------------------
3. Short-term risk and intermediate-term risk. Mefenpyr-diethyl is
not registered for use on any sites that would result in residential
exposure.
4. Aggregate cancer risk for U.S. population. Mefenpyr-diethyl is
not classified as a human carcinogen and thus is not expected to pose a
cancer risk.
5. 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 mefenpyr-diethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The petitioner has submitted an analytical method for mefenpyr-
diethyl and its metabolites in wheat and barley using Gas
Chromatography with a Mass Selective Detection (GC/MSD). This
enforcement method has been reviewed by the Agency and fulfills the
guidelines.
The petitioner also submitted an analytical method for mefenpyr-
diethyl and its metabolites in Beef Liver also using GC/MSD. The
petitioner also submitted an Independent Laboratory Validation of the
method.
Adequate enforcement methodology GC/MSD is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX, Canadian or Mexican limits for residues of
mefenpyr-diethyl in wheat and barley. However, Italy has established an
MRL (maximum residue limit) of 0.05 ppm in wheat grain for residues of
mefenpyr-diethyl and its metabolites which is consistent with the wheat
grain tolerance established today.
C. Conditions
Based on the residue uptake results of the confined rotational
studies at 90 gram/hectare (0.80 lb/acre) residue uptakes, the Agency
would usually establish a 30-day plantback interval for leafy,
fruiting, and root vegetables, and 12-month plantback interval for all
other crops other than wheat and barley, which can be replanted at any
time. However, at this time, the petitioner has indicated that the
application rate will not exceed 30 gram/hectare or 0.0267 lb/acre.
Given this reduction to one-third of the application rate used in the
study, the Agency believes that a 30-day plantback interval is
appropriate for all crops except cereal grains and grasses. The plant
back interval for cereal grains and grasses, except wheat and barley,
(which can be replanted at any time) is 12-months.
V. Conclusion
Therefore, tolerances are established for the combined residues of
mefenpyr-diethyl, 1-(2,4-dichlorophenyl)-4,5-dihydro-5-methyl-1H-
pyrazole-3,5-dicarboxylic acid, diethyl ester, in or on wheat and
barley commodities.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the 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
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the 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 the 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-2003-0077 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 June 30,
2003.
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 (1900C),
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 Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you
[[Page 23045]]
must also pay the fee prescribed by 40 CFR 180.33(i) or request a
waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee
to: EPA Headquarters Accounting Operations Branch, Office of Pesticide
Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the
fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. 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 Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0077, 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 Unit I.B.1. 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 the
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 the 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 the 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
[[Page 23046]]
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: April 17, 2003.
Peter Caulkins,
Acting 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), 346(a) and 371.
0
2. Section 180.509 is revised to read as follows:
Sec. 180.509 Mefenpyr-diethyl; tolerance for residues.
(a) General. Tolerances are established for residues of the
herbicide safener mefenpyr-diethyl (1-(2,4-dichlorophenyl)-4,5-dihydro-
5-methyl-1H-pyrazole-3,5-dicarboxylic acid, diethyl ester) and its 2,4-
dichlorophenyl-pyrazoline metabolites at a rate of 0.0267 pound safener
per acre per growing season in or on following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, grain.............................................. 0.05
Barley, hay................................................ 0.2
Barley, straw.............................................. 0.5
Cattle, meat byproducts.................................... 0.1
Goat, meat byproducts...................................... 0.1
Hog, meat byproducts....................................... 0.1
Horse, meat byproducts..................................... 0.1
Sheep, meat byproducts..................................... 0.1
Wheat, forage.............................................. 0.2
Wheat, grain............................................... 0.05
Wheat, hay................................................. 0.2
Wheat, straw............................................... 0.5
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 03-10263 Filed 4-29-03; 8:45 am]
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