S-metolachlor; Pesticide Tolerance, 51505-51510 [E6-14443]
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Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / Rules and Regulations
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.572 is amended by:
i. In paragraph (a)(1), in the table, by
removing the commodities ‘‘peach’’ and
‘‘nectarine’’; revising the tolerance
levels for the commodities ‘‘cattle, fat’’;
‘‘goat, fat’’; ‘‘hog, fat’’; ‘‘horse, fat’’; and
‘‘sheep, fat’’ and by alphabetically
adding commodities ‘‘fruit, stone, group
12, except 12’’; ‘‘pea, garden,
succulent’’; ‘‘pea, edible podded,
succulent’’; and ‘‘vegetable, tuberous
and corm’’; and
ii. In paragraph (b), in the table, by
removing the commodity tomato.
The amendments read as follows.
I
§ 180.572 Bifenazate; tolerances for
residues.
(a)(1) * * *
Parts per
million
Commodity
*
*
*
*
Cattle, fat ..................................
*
*
*
*
Fruit, stone, group 12, except
plum ......................................
Goat, fat ....................................
*
*
*
*
Hog, fat .....................................
*
*
*
*
Horse, fat ..................................
*
*
*
*
Pea, garden, succulent .............
Pea, edible podded, succulent
*
*
*
*
Plum ..........................................
Sheep, fat .................................
*
*
*
*
*
0.10
*
2.5
0.10
*
0.10
*
0.10
*
0.20
4.0
*
0.20
0.10
*
Vegetable, tuberous and corm,
subgroup 1C .........................
*
*
*
*
0.10
*
This regulation is effective
August 30, 2006. Objections and
requests for hearings must be received
on or before October 30, 2006, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0292. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (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 in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The 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:
Shaja R. Brothers, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–3194; e–mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
FR Doc. E6–14427 Filed 8–29–06; 8:45 am
I. General Information
BILLING CODE 6560–50–S
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.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0292; FRL–8090–2]
S-metolachlor; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
jlentini on PROD1PC65 with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of Smetolachlor in or on pumpkin, and
squash, winter. Interregional Research
Project Number 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).
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51505
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e–CFR site at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm
C. Can I File an Objection or Hearing
Request?
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.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2006–0292 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 October 30, 2006.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
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Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / Rules and Regulations
jlentini on PROD1PC65 with RULES
EPA–HQ–OPP–2006–0292, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on–
line instructions for submitting
comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of April 21,
2006 71 FR 20663 FRL–8064–6, EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 5E7015) by IR–4,
681 Highway 1 South, North Brunswick,
NJ 08902–3390. The petition requested
that 40 CFR 180.368(a)(3) be amended
by establishing tolerances for combined
residues of the herbicide S–metolachlor,
S–2–chloro–N–(2–ethyl–6–
methylphenyl)–N–(2–methoxy–1–
methylethyl)acetamide], its R–
enantiomer, and its metabolites,
determined as the derivatives, 2–[2–
ethyl–6–methylphenyl)amino]–1–
propanol and 4–(2–ethyl–6–
methylphenyl)–2–hydroxy–5–methyl–
3–morpholinone, in or on pumpkin and
squash, winter at 1.0 part per million
(ppm), respectively. The tolerances were
subsequently amended to 0.1 ppm for
raw agricultural commodities
previously mentioned. This notice
included a summary of the petition
prepared by Syngenta, the registrant.
There were no comments received in
response to the notice of filing.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
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
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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 the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA–PEST/1997/
November/Day–26/p30948.htm.
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 tolerances for combined
residues of S–metolachlor on pumpkin
at 0.1 ppm, and squash, winter at 0.1
ppm. EPA’s assessment of exposure and
risk 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. Specific
information on the studies received and
the nature of the toxic effects caused by
metolachlor and S–metolachlor as well
as the no–observed–adverse–effect–level
(NOAEL) and the lowest–observed–
adverse–effect–level (LOAEL) from the
toxicity studies can be found at
www.regulations.gov (Docket No. EPA–
HQ–OPP– 2006–0292–0003; pages 5364).
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, 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
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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.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for metolachlor and Smetolachlor used for human risk
assessment is discussed at
www.regulations.gov (Docket No. EPA–
HQ–OPP–2006–0292; pages 20-21).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.368) for the
combined residues of S-metolachlor, in
or on a variety of raw agricultural
commodities. Meat, milk, poultry and
egg tolerances have also been
established. Risk assessments were
conducted by EPA to assess dietary
exposures from S-metolachlor in food as
follows:
Both the acute and chronic analyses
assume tolerance-level residues on all
crops with established, pending, or
proposed tolerances for metolachlor
and/or S-metolachlor. In cases where
separate tolerance listings occur for both
metolachlor and S-metolachlor on the
same commodity, the higher value of
the two is used in the analyses.
i. Acute exposure. Quantitative acute
dietary exposure and 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
exposure assessment EPA used the
Dietary Exposure Evaluation Model
software with the Food Commodity
Intake Database (DEEM-FCIDTM), which
incorporates food consumption data as
reported by respondents in the USDA
1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated
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exposure to the chemical for each
commodity. The following assumptions
were made for the acute exposure
assessments: An acute dietary analysis
for S-metolachlor was conducted using
tolerance level residues and 100 % crop
treated (CT) for all existing and
proposed uses.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM-FCIDTM), which incorporates
food consumption data as reported by
respondents in the USDA 1994-1996
and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to
the chemical for each commodity. The
following assumptions were made for
the chronic exposure assessments: A
chronic dietary analysis for Smetolachlor was conducted using
tolerance level residues and 100 %CT
data for all existing and proposed uses.
iii. Cancer. Metolachlor has been
classified as a Group C, possible human
carcinogen based on liver tumors in rats
at the highest dose tested (HDT). The
chronic NOAEL of 15 mg/kg/day that
was established based on tumors in the
rat (seen at the HDT of 150 mg/kg/day)
is comparable to the NOAEL of 9.7 mg/
kg/day selected for establishing the
chronic reference dose for metolachlor.
EPA has concluded that the chronic
dietary PAD is protective for cancer
dietary risk. Therefore, a separate cancer
aggregate risk assessment was not
conducted.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for smetolachlor 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 s-metolachor. Further
information regarding EPA drinking
water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
A drinking water assessment was
conducted based on monitoring data
from several sources, as well as on Tier
1 FIRST and SCI-GROW modeling
results. This assessment is a worst-case
scenario and demonstrates high end
numbers. The analytical methods used
to obtain the monitoring data are not
able to distinguish between metolachlor
and S-metolachlor; therefore, the
estimated environmental concentrations
(EECs) presented in this risk assessment
are representative of both racemic
metolachlor and S-metolachlor.
EECs for metolachlor and Smetolachlor were calculated for both the
parent compound and the
ethanesulfonic acid (ESA) and oxanilic
acid (OA) degradates. Although it was
determined by the EPA that the ESA
and OA metabolites appear to be less
toxic than parent metolachlor, they are
included in the risk assessment since
they were found in greater abundance
than the parent in water monitoring
studies.
The crops with the highest maximum
seasonal application rates are turf (Smetolachlor only) and corn (racemic
metolachlor and S-metolachlor) with a
maximum seasonal application rate of
4.0 lbs ai/A. Based on PRZM/EXAMS
51507
modeling the maximum peak and
annual average concentrations of
metolachlor/ S-metolachlor in surface
water were 199 ug/l and 9.2 ug/l,
respectively. Based on FIRST modeling
results, the estimate of the drinking
water concentration from surface water
sources of metolachlor ESA, a major
degradate of metolachlor, is not likely to
exceed 31.9 ug/L for the annual peak
concentration and 22.8 ug/L for the
annual average exposure for use on turf/
corn at a maximum annual application
rate of 4.0 lbs ai/A. Based on FIRST
modeling results, the estimate of the
drinking water concentration from
surface water sources of metolachlor
OA, another major degradate of
metolachlor, is not likely to exceed 91.4
ug/L for the annual peak concentration
and 65.1 ug/L for the annual average
exposure for use on turf/corn at a
maximum annual application rate of 4.0
lbs ai/A (ground application with no
spray drift).
The SCI-GROW screening model was
used to estimate groundwater
concentrations. The estimated
concentration of metolachlor/ Smetolachlor in drinking water from
shallow groundwater sources is 5.5 ug/
l for application on corn at a seasonal
maximum rate of 4.0 lbs ai/A. This
concentration is appropriate for both the
peak and annual average exposures. The
EEC for metolachlor degradate ESA
based on metolachlor use on turf/corn is
not expected to exceed 65.8 ug/l for
peak and annual average exposures. The
EEC for metolachlor OA from
metolachlor use on turf/corn is not
expected to exceed 31.7 ug/l for peak
and annual average exposures.
TABLE 1: METOLACHLOR EEC’S
Surface Water (peak)
Surface Water (average)
Ground Water
Parent
199
9.2
5.5
metolachlor ESA
31.9
22.8
65.8
metolachlor OA
91.4
65.1
31.7
322.3
97.1
103.0
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Total EECs (ppb)
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model (DEEMFCIDTM). For acute dietary risk, since
the surface water EDWCs are higher
than the groundwater EDWC, the peak
concentration of 322.3 ppb was used to
access the contribution to drinking
water. For chronic dietary risk
assessment, since the ground water
EDWCs are higher than the surface
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water EDWC the ground water
concentration of 103.0 ppb was used to
access the contribution to drinking
water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
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The formulated S-metolachlor enduse product is labeled under the trade
name Pennant MAGNUMTM (EPA Reg.
No. 100-950) to distinguish the new
product from the original metolachlor
formulation named PennantTM (EPA
Reg. No. 100-691). Pennant
MAGNUMTM (7.62 lbs. active ingredient
per gallon) is labeled for use on
commercial (sod farm) and residential
warm-season turfgrasses and other
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noncrop land including golf courses,
sports fields, and ornamental gardens.
Although not labeled as a restricted-use
pesticide, Pennant MAGNUMTM, as
currently marketed, is not intended for
homeowner purchase or use (intended
for use by professionals). On this basis,
with regard to the requirements of
FQPA, metolachlor and S-metolachlor
are assessed only for post application
exposure and risk. Pennant
MAGNUMTM and PennantTM are both
emulsifiable concentrates (EC).
For this risk assessment, small
children are the population group of
concern. Although the type of site that
S-metolachlor may be used on varies
from golf courses to ornamental gardens,
the scenario chosen for risk assessment
(residential turf use) represents what the
Agency considers the likely upper-end
of possible exposure. Post application
exposures from various activities
following lawn treatment are considered
to be the most common and significant
in residential settings. Since toxicity
was not observed in a dermal toxicity
study, up to a dose level of 1,000 mg/
kg/day, the only parameter of risk
addressed in this assessment is the
possible oral exposure of small children
from treated turf, or soil.
The estimate for hand-to-mouth
exposure on the day of treatment is
0.037 mg/kg/day (MOE = 1,400) for Smetolachlor and 0.06 mg/kg/day (MOE
= 840) for metolachlor. (MOE estimates
are based on the short-term NOAEL of
50 mg/kg/day).
The estimate for object-to-mouth
exposure on the day of treatment is
0.0092 mg/kg/day (MOE = 5,400) for Smetolachlor and 0.015 mg/kg/day (MOE
= 3,300) for metolachlor. (MOE
estimates are based on the short-term
NOAEL of 50 mg/kg/day).
The estimate for soil ingestion
exposure on the day of treatment is
0.00012 mg/kg/day (MOE = 400,000) for
S-metolachlor and 0.0002 mg/kg/day
(MOE = 250,000) for metolachlor. (MOE
estimates are based on the short-term
NOAEL of 50 mg/kg/day).
The estimate for hand-to-mouth,
object-to-mouth, and soil ingestion
combined (on the day of treatment) is
0.046 mg/kg/day (MOE = 1,100) for Smetolachlor and 0.075 mg/kg/day (MOE
= 670) for metolachlor. (MOE estimates
are based on the short-term NOAEL of
50 mg/kg/day).
The MOE estimates are greater than
100 and indicate that the potential
metolachlor/S-metolachlor exposure (to
children) associated with residential use
is not of concern. Although considered
an upper-bound, the exposure estimate
for the three scenarios, combined, is
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recommended for aggregate (residential,
food, and drinking water) risk estimates.
4. Cumulative effects from 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.’’
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 Smetolachlor and any other substances
and S-metolachlor 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 S-metolachlor 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 concerning common
mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s website at https://
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—
i. Metolachlor. The prenatal
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developmental studies in the rat and
rabbit revealed no evidence of a
qualitative or quantitative susceptibility
in fetal animals. In the rabbit prenatal
developmental toxicity study, at 360
mg/kg/day, maternal animals had
persistent anorexia and decreased body
weight gain; the NOAEL was 120 mg/kg/
day. In the rat prenatal developmental
toxicity study, frank toxicity [death,
clinical signs (clonic and/or tonic
convulsions, excessive salivation, urinestained abdominal fur and/or excessive
salivation) and decreased body weight
gain] was observed at the limit dose of
1,000 mg/kg/day in maternal animals;
the NOAEL was 300 mg/kg/day. The
developmental effects at 1,000 mg/kg/
day included slightly decreased number
of implantations per dam, decreased
number of live fetuses/dam, increased
number of resorptions/dam and
significant decrease in mean fetal body
weight.
In the two-generation reproduction
study in rats, there was no evidence of
parental or reproductive toxicity at
approximately 80 mg/kg/day, the HDT.
At this dose, there was a minor decrease
in fetal body weight beginning at
lactation day 4; the NOAEL was
approximately 25 mg/kg/day. Since a
similar body weight decrease was not
seen on lactation day zero, the cause of
the effect on later lactation days is most
likely due to exposure of the pups to
metolachlor in the diet and/or milk and
therefore is not evidence of an increased
quantitative susceptibility in post-natal
animals.
ii. S-metolachlor. There was no
evidence of increased quantitative or
qualitative fetal susceptibility in the
prenatal developmental studies in rats
and rabbits. In the rat, maternal toxicity
[increased clinical signs of toxicity
(pushing head through bedding) and
decreased body weights/body weight
gains, food consumption and food
efficiency was observed at 500 mg/kg/
day; the NOAEL was 50 mg/kg/day.
There were no developmental effects at
1,000 mg/kg/day, the HDT. In the rabbit,
clinical signs of toxicity (little/none/soft
stool) were observed at 100 mg/kg/day;
the NOAEL was 20 mg/kg/day. No
developmental effects were observed at
500 mg/kg/day, the HDT.
3. Conclusion. There is a complete
toxicity data base for S-metolachlor and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. EPA
determined that the 10X SF to protect
infants and children should be reduced
to 1X for the following reasons:
i. The toxicology database is complete
for the FQPA assessment.
E:\FR\FM\30AUR1.SGM
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Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / Rules and Regulations
ii. There is no indication of
quantitative or qualitative increased
susceptibility of rats or rabbits to in
utero and/or postnatal exposure to
metolachlor or S-metolachlor in the
available toxicity data.
iii. A developmental neurotoxicity
study is not required for metolachlor or
S-metolachlor.
iv. The dietary (food and drinking
water) and non-dietary exposure
(residential) assessments will not
underestimate the potential exposures
for infants and children from the use of
metolachlor or S-metolachlor.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to Smetolachlor will occupy <1% of the
51509
drinking water, and short-term, nonoccupational (residential) pathways of
exposure for a duration of 1 to 30 days.
Potential short-term, nonoccupational risk scenarios for Smetolachlor consist of oral exposure of
children to treated lawns only. In this
aggregate short-term risk assessment,
exposure from food, drinking water, and
residential lawns has been considered.
The exposure to food and water has
already been considered in the chronic
dietary risk assessment. Since only
children have the potential for nonoccupational, short-term risk, they are
the only population subgroup for which
an aggregate short-term risk assessment
was conducted. Toddlers’ S-metolachlor
incidental oral exposure is assumed to
include hand-to-mouth exposure,
object-to-mouth exposure and exposure
through incidental ingestion of soil.
aPAD for the US population and other
population subgroups, and 2% of the
aPAD for all infants <1 year old. EPA
does not expect the aggregate exposure
to exceed 100% of the aPAD.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to S-metolachlor from
food and water will utilize 4% of the
cPAD for the U.S. population, 10% of
the cPAD for all infants < 1 year old,
and 8% of the cPAD for children 1-2
years old. EPA does not expect the
aggregate exposure to exceed 100% of
the cPAD.
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). A
short-term aggregate risk assessment
considers potential exposure from food,
TABLE 2.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO S-METOLACHLOR
Short-Term Scenario
Population
NOAEL mg/
kg/day
All infants <1 yr old
Average
Food and
Water Exposure mg/kg/
day
LOC1
50
Residential
Exposure
mg/kg/day2
Aggregate
MOE (food,
water and
residential)3
0.010003
0.046
890
100
1
The level of concern (LOC) MOE is 100, based on inter- and intra-species safety factors totaling 100.
Residential Exposure = [Incidental Oral exposure from all possible sources-combined hand-to-mouth, object-to-mouth, and soil ingestion oral
exposure]. No residential oral exposure is expected for adults
3 Aggregate MOE = [NOAEL ÷ (Avg Food and Water Exposure + Residential Exposure)]
2
4. Aggregate cancer risk for U.S.
population. S-metolachlor is classified
as classified as a Group C, possible
human carcinogen. EPA has concluded
that the chronic dietary PAD is
protective for cancer dietary risk and, as
noted above, chronic exposure is below
the chronic dietary PAD.
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 Smetolachlor residues.
IV. Other Considerations
jlentini on PROD1PC65 with RULES
A. Analytical Enforcement Methodology
Adequate methodology is available for
enforcing the current and proposed
tolerances. The Pesticide Analytical
Manual (PAM, Vol. II) lists a GC/NPD
method (Methods I) for determining
residues in/on plants and a GC/MSD
method (Method II) for determining
residues in livestock commodities.
These methods determine residues of Smetolachlor and its metabolites as either
CGA-37913 or CGA-49751 following
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16:32 Aug 29, 2006
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acid hydrolysis. A modified version of
this method (Syngenta Method No.
1848-01) which uses liquid
chromotography/mass spectrometry/
mass spectrometry (LC/MS/MS) has also
been used. Adequate data are available
on the recovery of metolachlor through
Multi-residue Method Testing Protocols.
The FDA PESTDATA database indicates
that S-metolachlor is completely
recovered through Method 302, PAM
Vol. I.
B. International Residue Limits
There are currently no Codex,
Canadian or Mexican MRLs for Smetolachlor; therefore there are no
international harmonization issues for
these actions.
V. Conclusion
Therefore, the tolerances are
established for combined residues of Smetolachlor, S-2-chloro-N-(2-ethyl-6methylphenyl)-N-(2-methoxy-1methylethyl)acetamide], its Renantiomer, and its metabolites,
determined as the derivatives, 2-[2ethyl-6-methylphenyl)amino]-1propanol and 4-(2-ethyl-6-
PO 00000
Frm 00089
Fmt 4700
Sfmt 4700
methylphenyl)-2-hydroxy-5-methyl-3morpholinone, in or on pumpkin and
squash, winter at 0.1 ppm.
VI. 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
E:\FR\FM\30AUR1.SGM
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jlentini on PROD1PC65 with RULES
51510
Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / Rules and Regulations
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
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16:32 Aug 29, 2006
Jkt 208001
‘‘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.
VII. 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: August 23, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.368 is amended in
paragraph (a)(3) by adding commodities
to the table to read as follows:
I
PO 00000
Frm 00090
Fmt 4700
Sfmt 4700
§ 180.368 Metolachlor; tolerances for
residues.
(a)* * *
(3) * * *
Commodity
*
Parts per million
*
*
*
*
Pumpkin
*
*
*
*
0.1
*
Squash, winter
*
*
*
*
0.1
*
*
*
*
*
*
[FR Doc. E6–14443 Filed 8–29–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0537; FRL–8086–2]
Ethofumesate; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of the
herbicide, ethofumesate in or on carrot,
roots (with regional restrictions for use
in the States of Washington and
Oregon), beet, garden, tops and beet,
garden, roots; onion, bulb; garlic, bulb;
shallot, bulb; and shallot, fresh leaves.
The Interregional Research Project #4
(IR-4), 681 Highway 1 South, North
Brunswick, NJ 08902–3390 requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
DATES: This regulation is effective
August 30, 2006. Objections and
requests for hearings must be received
on or before October 30, 2006, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0537. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (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
E:\FR\FM\30AUR1.SGM
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Agencies
[Federal Register Volume 71, Number 168 (Wednesday, August 30, 2006)]
[Rules and Regulations]
[Pages 51505-51510]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14443]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0292; FRL-8090-2]
S-metolachlor; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of S-metolachlor in or on pumpkin, and squash, winter. Interregional
Research Project Number 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).
DATES: This regulation is effective August 30, 2006. Objections and
requests for hearings must be received on or before October 30, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0292. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The 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: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@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.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/guidelin.htm
C. Can I File an Objection or Hearing Request?
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. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0292 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 October 30, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number
[[Page 51506]]
EPA-HQ-OPP-2006-0292, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of April 21, 2006 71 FR 20663 FRL-8064-6,
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 5E7015)
by IR-4, 681 Highway 1 South, North Brunswick, NJ 08902-3390. The
petition requested that 40 CFR 180.368(a)(3) be amended by establishing
tolerances for combined residues of the herbicide S-metolachlor, S-2-
chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], its R-enantiomer, and its metabolites,
determined as the derivatives, 2-[2-ethyl-6-methylphenyl)amino]-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, in or on pumpkin and squash, winter at 1.0 part per
million (ppm), respectively. The tolerances were subsequently amended
to 0.1 ppm for raw agricultural commodities previously mentioned. This
notice included a summary of the petition prepared by Syngenta, the
registrant. There were no comments received in response to the notice
of filing.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA 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 the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
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 tolerances for combined residues of S-
metolachlor on pumpkin at 0.1 ppm, and squash, winter at 0.1 ppm. EPA's
assessment of exposure and risk 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. Specific information on the studies received and the nature
of the toxic effects caused by metolachlor and S-metolachlor as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies can be found at
www.regulations.gov (Docket No. EPA-HQ-OPP- 2006-0292-0003; pages 53-
64).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, 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.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at https://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for metolachlor and S-
metolachlor used for human risk assessment is discussed at
www.regulations.gov (Docket No. EPA-HQ-OPP-2006-0292; pages 20-21).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.368) for the combined residues of S-
metolachlor, in or on a variety of raw agricultural commodities. Meat,
milk, poultry and egg tolerances have also been established. Risk
assessments were conducted by EPA to assess dietary exposures from S-
metolachlor in food as follows:
Both the acute and chronic analyses assume tolerance-level residues
on all crops with established, pending, or proposed tolerances for
metolachlor and/or S-metolachlor. In cases where separate tolerance
listings occur for both metolachlor and S-metolachlor on the same
commodity, the higher value of the two is used in the analyses.
i. Acute exposure. Quantitative acute dietary exposure and 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 exposure 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 USDA 1994-1996 and 1998
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII),
and accumulated
[[Page 51507]]
exposure to the chemical for each commodity. The following assumptions
were made for the acute exposure assessments: An acute dietary analysis
for S-metolachlor was conducted using tolerance level residues and 100
% crop treated (CT) for all existing and proposed uses.
ii. Chronic exposure. In conducting the chronic dietary exposure
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 USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: A chronic dietary analysis for S-metolachlor was conducted
using tolerance level residues and 100 %CT data for all existing and
proposed uses.
iii. Cancer. Metolachlor has been classified as a Group C, possible
human carcinogen based on liver tumors in rats at the highest dose
tested (HDT). The chronic NOAEL of 15 mg/kg/day that was established
based on tumors in the rat (seen at the HDT of 150 mg/kg/day) is
comparable to the NOAEL of 9.7 mg/kg/day selected for establishing the
chronic reference dose for metolachlor. EPA has concluded that the
chronic dietary PAD is protective for cancer dietary risk. Therefore, a
separate cancer aggregate risk assessment was not conducted.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for s-metolachlor 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 s-metolachor. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
A drinking water assessment was conducted based on monitoring data
from several sources, as well as on Tier 1 FIRST and SCI-GROW modeling
results. This assessment is a worst-case scenario and demonstrates high
end numbers. The analytical methods used to obtain the monitoring data
are not able to distinguish between metolachlor and S-metolachlor;
therefore, the estimated environmental concentrations (EECs) presented
in this risk assessment are representative of both racemic metolachlor
and S-metolachlor.
EECs for metolachlor and S-metolachlor were calculated for both the
parent compound and the ethanesulfonic acid (ESA) and oxanilic acid
(OA) degradates. Although it was determined by the EPA that the ESA and
OA metabolites appear to be less toxic than parent metolachlor, they
are included in the risk assessment since they were found in greater
abundance than the parent in water monitoring studies.
The crops with the highest maximum seasonal application rates are
turf (S-metolachlor only) and corn (racemic metolachlor and S-
metolachlor) with a maximum seasonal application rate of 4.0 lbs ai/A.
Based on PRZM/EXAMS modeling the maximum peak and annual average
concentrations of metolachlor/ S-metolachlor in surface water were 199
ug/l and 9.2 ug/l, respectively. Based on FIRST modeling results, the
estimate of the drinking water concentration from surface water sources
of metolachlor ESA, a major degradate of metolachlor, is not likely to
exceed 31.9 ug/L for the annual peak concentration and 22.8 ug/L for
the annual average exposure for use on turf/corn at a maximum annual
application rate of 4.0 lbs ai/A. Based on FIRST modeling results, the
estimate of the drinking water concentration from surface water sources
of metolachlor OA, another major degradate of metolachlor, is not
likely to exceed 91.4 ug/L for the annual peak concentration and 65.1
ug/L for the annual average exposure for use on turf/corn at a maximum
annual application rate of 4.0 lbs ai/A (ground application with no
spray drift).
The SCI-GROW screening model was used to estimate groundwater
concentrations. The estimated concentration of metolachlor/ S-
metolachlor in drinking water from shallow groundwater sources is 5.5
ug/l for application on corn at a seasonal maximum rate of 4.0 lbs ai/
A. This concentration is appropriate for both the peak and annual
average exposures. The EEC for metolachlor degradate ESA based on
metolachlor use on turf/corn is not expected to exceed 65.8 ug/l for
peak and annual average exposures. The EEC for metolachlor OA from
metolachlor use on turf/corn is not expected to exceed 31.7 ug/l for
peak and annual average exposures.
Table 1: Metolachlor EEC's
----------------------------------------------------------------------------------------------------------------
Surface Water (peak) Surface Water (average) Ground Water
----------------------------------------------------------------------------------------------------------------
Parent 199 9.2 5.5
----------------------------------------------------------------------------------------------------------------
metolachlor ESA 31.9 22.8 65.8
----------------------------------------------------------------------------------------------------------------
metolachlor OA 91.4 65.1 31.7
----------------------------------------------------------------------------------------------------------------
Total EECs (ppb) 322.3 97.1 103.0
----------------------------------------------------------------------------------------------------------------
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\). For acute
dietary risk, since the surface water EDWCs are higher than the
groundwater EDWC, the peak concentration of 322.3 ppb was used to
access the contribution to drinking water. For chronic dietary risk
assessment, since the ground water EDWCs are higher than the surface
water EDWC the ground water concentration of 103.0 ppb was used to
access the contribution to drinking 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).
The formulated S-metolachlor end-use product is labeled under the
trade name Pennant MAGNUM\TM\ (EPA Reg. No. 100-950) to distinguish the
new product from the original metolachlor formulation named Pennant\TM\
(EPA Reg. No. 100-691). Pennant MAGNUM\TM\ (7.62 lbs. active ingredient
per gallon) is labeled for use on commercial (sod farm) and residential
warm-season turfgrasses and other
[[Page 51508]]
noncrop land including golf courses, sports fields, and ornamental
gardens. Although not labeled as a restricted-use pesticide, Pennant
MAGNUM\TM\, as currently marketed, is not intended for homeowner
purchase or use (intended for use by professionals). On this basis,
with regard to the requirements of FQPA, metolachlor and S-metolachlor
are assessed only for post application exposure and risk. Pennant
MAGNUM\TM\ and Pennant\TM\ are both emulsifiable concentrates (EC).
For this risk assessment, small children are the population group
of concern. Although the type of site that S-metolachlor may be used on
varies from golf courses to ornamental gardens, the scenario chosen for
risk assessment (residential turf use) represents what the Agency
considers the likely upper-end of possible exposure. Post application
exposures from various activities following lawn treatment are
considered to be the most common and significant in residential
settings. Since toxicity was not observed in a dermal toxicity study,
up to a dose level of 1,000 mg/kg/day, the only parameter of risk
addressed in this assessment is the possible oral exposure of small
children from treated turf, or soil.
The estimate for hand-to-mouth exposure on the day of treatment is
0.037 mg/kg/day (MOE = 1,400) for S-metolachlor and 0.06 mg/kg/day (MOE
= 840) for metolachlor. (MOE estimates are based on the short-term
NOAEL of 50 mg/kg/day).
The estimate for object-to-mouth exposure on the day of treatment
is 0.0092 mg/kg/day (MOE = 5,400) for S-metolachlor and 0.015 mg/kg/day
(MOE = 3,300) for metolachlor. (MOE estimates are based on the short-
term NOAEL of 50 mg/kg/day).
The estimate for soil ingestion exposure on the day of treatment is
0.00012 mg/kg/day (MOE = 400,000) for S-metolachlor and 0.0002 mg/kg/
day (MOE = 250,000) for metolachlor. (MOE estimates are based on the
short-term NOAEL of 50 mg/kg/day).
The estimate for hand-to-mouth, object-to-mouth, and soil ingestion
combined (on the day of treatment) is 0.046 mg/kg/day (MOE = 1,100) for
S-metolachlor and 0.075 mg/kg/day (MOE = 670) for metolachlor. (MOE
estimates are based on the short-term NOAEL of 50 mg/kg/day).
The MOE estimates are greater than 100 and indicate that the
potential metolachlor/S-metolachlor exposure (to children) associated
with residential use is not of concern. Although considered an upper-
bound, the exposure estimate for the three scenarios, combined, is
recommended for aggregate (residential, food, and drinking water) risk
estimates.
4. Cumulative effects from 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.''
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 S-metolachlor and any
other substances and S-metolachlor 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 S-metolachlor 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 concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at https://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--i. Metolachlor. The prenatal
developmental studies in the rat and rabbit revealed no evidence of a
qualitative or quantitative susceptibility in fetal animals. In the
rabbit prenatal developmental toxicity study, at 360 mg/kg/day,
maternal animals had persistent anorexia and decreased body weight
gain; the NOAEL was 120 mg/kg/day. In the rat prenatal developmental
toxicity study, frank toxicity [death, clinical signs (clonic and/or
tonic convulsions, excessive salivation, urine-stained abdominal fur
and/or excessive salivation) and decreased body weight gain] was
observed at the limit dose of 1,000 mg/kg/day in maternal animals; the
NOAEL was 300 mg/kg/day. The developmental effects at 1,000 mg/kg/day
included slightly decreased number of implantations per dam, decreased
number of live fetuses/dam, increased number of resorptions/dam and
significant decrease in mean fetal body weight.
In the two-generation reproduction study in rats, there was no
evidence of parental or reproductive toxicity at approximately 80 mg/
kg/day, the HDT. At this dose, there was a minor decrease in fetal body
weight beginning at lactation day 4; the NOAEL was approximately 25 mg/
kg/day. Since a similar body weight decrease was not seen on lactation
day zero, the cause of the effect on later lactation days is most
likely due to exposure of the pups to metolachlor in the diet and/or
milk and therefore is not evidence of an increased quantitative
susceptibility in post-natal animals.
ii. S-metolachlor. There was no evidence of increased quantitative
or qualitative fetal susceptibility in the prenatal developmental
studies in rats and rabbits. In the rat, maternal toxicity [increased
clinical signs of toxicity (pushing head through bedding) and decreased
body weights/body weight gains, food consumption and food efficiency
was observed at 500 mg/kg/day; the NOAEL was 50 mg/kg/day. There were
no developmental effects at 1,000 mg/kg/day, the HDT. In the rabbit,
clinical signs of toxicity (little/none/soft stool) were observed at
100 mg/kg/day; the NOAEL was 20 mg/kg/day. No developmental effects
were observed at 500 mg/kg/day, the HDT.
3. Conclusion. There is a complete toxicity data base for S-
metolachlor and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF to protect infants and children should be reduced to 1X
for the following reasons:
i. The toxicology database is complete for the FQPA assessment.
[[Page 51509]]
ii. There is no indication of quantitative or qualitative increased
susceptibility of rats or rabbits to in utero and/or postnatal exposure
to metolachlor or S-metolachlor in the available toxicity data.
iii. A developmental neurotoxicity study is not required for
metolachlor or S-metolachlor.
iv. The dietary (food and drinking water) and non-dietary exposure
(residential) assessments will not underestimate the potential
exposures for infants and children from the use of metolachlor or S-
metolachlor.
E. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to S-metolachlor will occupy <1% of the aPAD for the US population and
other population subgroups, and 2% of the aPAD for all infants <1 year
old. EPA does not expect the aggregate exposure to exceed 100% of the
aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to S-
metolachlor from food and water will utilize 4% of the cPAD for the
U.S. population, 10% of the cPAD for all infants < 1 year old, and 8%
of the cPAD for children 1-2 years old. EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.
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). A short-term aggregate
risk assessment considers potential exposure from food, drinking water,
and short-term, non-occupational (residential) pathways of exposure for
a duration of 1 to 30 days.
Potential short-term, non-occupational risk scenarios for S-
metolachlor consist of oral exposure of children to treated lawns only.
In this aggregate short-term risk assessment, exposure from food,
drinking water, and residential lawns has been considered. The exposure
to food and water has already been considered in the chronic dietary
risk assessment. Since only children have the potential for non-
occupational, short-term risk, they are the only population subgroup
for which an aggregate short-term risk assessment was conducted.
Toddlers' S-metolachlor incidental oral exposure is assumed to include
hand-to-mouth exposure, object-to-mouth exposure and exposure through
incidental ingestion of soil.
Table 2.--Aggregate Risk Assessment for Short-Term Exposure to S-metolachlor
----------------------------------------------------------------------------------------------------------------
Short-Term Scenario
--------------------------------------------------------------------
Average
Population Food and Residential Aggregate MOE
NOAEL mg/kg/ LOC\1\ Water Exposure mg/ (food, water
day Exposure mg/ kg/day\2\ and
kg/day residential)\3\
----------------------------------------------------------------------------------------------------------------
All infants <1 yr old 50 100 0.010003 0.046 890
----------------------------------------------------------------------------------------------------------------
\1\ The level of concern (LOC) MOE is 100, based on inter- and intra-species safety factors totaling 100.
\2\ Residential Exposure = [Incidental Oral exposure from all possible sources-combined hand-to-mouth, object-to-
mouth, and soil ingestion oral exposure]. No residential oral exposure is expected for adults
\3\ Aggregate MOE = [NOAEL / (Avg Food and Water Exposure + Residential Exposure)]
4. Aggregate cancer risk for U.S. population. S-metolachlor is
classified as classified as a Group C, possible human carcinogen. EPA
has concluded that the chronic dietary PAD is protective for cancer
dietary risk and, as noted above, chronic exposure is below the chronic
dietary PAD.
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 S-metolachlor residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methodology is available for enforcing the current and
proposed tolerances. The Pesticide Analytical Manual (PAM, Vol. II)
lists a GC/NPD method (Methods I) for determining residues in/on plants
and a GC/MSD method (Method II) for determining residues in livestock
commodities. These methods determine residues of S-metolachlor and its
metabolites as either CGA-37913 or CGA-49751 following acid hydrolysis.
A modified version of this method (Syngenta Method No. 1848-01) which
uses liquid chromotography/mass spectrometry/mass spectrometry (LC/MS/
MS) has also been used. Adequate data are available on the recovery of
metolachlor through Multi-residue Method Testing Protocols. The FDA
PESTDATA database indicates that S-metolachlor is completely recovered
through Method 302, PAM Vol. I.
B. International Residue Limits
There are currently no Codex, Canadian or Mexican MRLs for S-
metolachlor; therefore there are no international harmonization issues
for these actions.
V. Conclusion
Therefore, the tolerances are established for combined residues of
S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], its R-enantiomer, and its metabolites,
determined as the derivatives, 2-[2-ethyl-6-methylphenyl)amino]-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, in or on pumpkin and squash, winter at 0.1 ppm.
VI. 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
[[Page 51510]]
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review
or any Agency action under Executive Order 13045, entitled Protection
of Children from Environmental Health Risks and Safety Risks (62 FR
19885, April 23, 1997). This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and
exemptions that are established on the basis of a petition under
section 408(d) of FFDCA, such as the tolerance in this final rule, do
not require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VII. 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: August 23, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.368 is amended in paragraph (a)(3) by adding commodities
to the table to read as follows:
Sec. 180.368 Metolachlor; tolerances for residues.
(a)* * *
(3) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Pumpkin 0.1
* * * * *
Squash, winter 0.1
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-14443 Filed 8-29-06; 8:45 am]
BILLING CODE 6560-50-S