Acetochlor; Pesticide Tolerances, 47445-47451 [E9-21845]
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Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Rules and Regulations
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
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VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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).
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[FR Doc. E9–22163 Filed 9–15–09; 8:45 am]
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Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0002; FRL–8434–1]
Acetochlor; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of acetochlor,
including its metabolites and
degradates, in or on cotton, gin
byproducts; cotton, undelinted seed;
List of Subjects in 40 CFR Part 180
soybean, meal; and soybean, seed.
Environmental protection,
Monsanto Company requested these
Administrative practice and procedure,
tolerances under the Federal Food,
Agricultural commodities, Pesticides
Drug, and Cosmetic Act (FFDCA). This
and pests, Reporting and recordkeeping regulation also removes the existing
requirements.
tolerance for indirect or inadvertent
residues of acetochlor on soybean, seed.
Dated: August 25, 2009.
DATES: This regulation is effective
Lois A. Rossi,
September 16, 2009. Objections and
Director, Registration Division, Office of
requests for hearings must be received
Pesticide Programs.
on or before November 16, 2009, and
■ Therefore, 40 CFR chapter I is
must be filed in accordance with the
amended as follows:
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
PART 180—[AMENDED]
SUPPLEMENTARY INFORMATION).
■ 1. The authority citation for part 180
ADDRESSES: EPA has established a
continues to read as follows:
docket for this action under docket
Authority: 21 U.S.C. 321(q), 346a and 371.
identification (ID) number EPA–HQ–
OPP–2009–0002. All documents in the
■ 2. In § 180.589, the table to paragraph
docket are listed in the docket index
(a)(1) is amended by alphabetically
available at https://www.regulations.gov.
adding an entry for ‘‘coffee, green bean,
Although listed in the index, some
imported’’, by revising the entry for
information is not publicly available,
‘‘banana, import’’ and by removing the
e.g., Confidential Business Information
entry for ‘‘cucumber’’ with the limit of
(CBI) or other information whose
0.20 ppm and the entry for ‘‘vegetable,
disclosure is restricted by statute.
root, subgroup 1A, except sugar beet,
Certain other material, such as
garden beet, radish, and turnip’’ with
copyrighted material, is not placed on
the limit of 0.7 ppm. The added and
the Internet and will be publicly
revised entries read as follows:
available only in hard copy form.
Publicly available docket materials are
§ 180.589 Boscalid; tolerances for
available in the electronic docket at
residues.
https://www.regulations.gov, or, if only
(a)* * *(1) * * *
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
Parts per
Commodity
million
One Potomac Yard (South Bldg.), 2777
S. Crystal Dr., Arlington, VA. The
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Docket Facility is open from 8:30 a.m.
Banana, import \1\ ....................
0.40 to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
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Facility telephone number is (703) 305–
Coffee, green bean, import \1\ ..
0.05 5805.
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FOR FURTHER INFORMATION CONTACT:
Susan Stanton, Registration Division
1No US registrations as of September 16,
(7505P), Office of Pesticide Programs,
2009.
Environmental Protection Agency, 1200
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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 those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide 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 electronically
available documents 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 EPA′s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office′s e-CFR
cite 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.gov/opptsfrs/home/
guidelin.htm.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. 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
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proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2009–0002 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
as required by 40 CFR part 178 on or
before November 16, 2009.
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 this copy,
identified by docket ID number EPA–
HQ–OPP–2009–0002, 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 Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’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 Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of April 8,
2009 (74 FR 15971) (FRL–8407–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP 8F7443 and PP
8F7448) by Monsanto Company, 1300 I
St., NW., Suite 450 East, Washington DC
20052. The petitions requested that 40
CFR 180.470 be amended by
establishing tolerances for combined
residues of the herbicide acetochlor, 2chloro-2’-methyl-6’-ethyl-Nethoxymethylacetanilide, and its
metabolites containing either the 2ethyl-6-methyl-aniline (EMA) or the 2(1-hydroxyethyl)-6-methyl-aniline
(HEMA) moiety, to be expressed as
acetochlor equivalents, in or on cotton,
gin byproducts; and cotton, undelinted
seed at 4.0 parts per million (ppm) and
0.6 ppm, respectively (PP 8F7443); and
soybean, seed at 1.0 ppm (PP 8F7448).
That notice referenced a summary of the
petition prepared by Monsanto
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Company, the registrant, which is
available to the public in the docket,
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
Based upon review of the data
supporting the petition, EPA has
determined that a tolerance for residues
of acetochlor and its metabolites is also
required on soybean, meal at 1.2 ppm.
EPA has also revised the tolerance
expression for acetochlor to clarify the
chemical moieties that are covered by
the tolerances and specify how
compliance with the tolerances is to be
measured. The reasons for these changes
are explained in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
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. . . .’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
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 for the petitioned-for
tolerances for residues of acetochlor,
including its metabolites and
degradates, on cotton, gin byproducts at
4.0 ppm; cotton, undelinted seed at 0.6
ppm; soybean, meal at 1.2 ppm; and
soybean, seed at 1.0 ppm. EPA’s
assessment of exposures and risks
associated with establishing 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
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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.
Acetochlor has low acute toxicity by
the oral, dermal, and inhalation routes
of exposure and is mildly irritating to
the eyes. The results of two dermal
irritation studies indicate that it is a
mild to strong skin irritant. Acetochlor
is also a strong dermal sensitizer.
Evidence of neurotoxicity was
observed in acute and subchronic
neurotoxicity screening studies in rats,
developmental toxicity studies in rats,
and subchronic and chronic studies in
dogs. In addition to the nervous system,
the major target organs affected in
subchronic and chronic studies in rats,
dogs and mice exposed to acetochlor are
the liver, thyroid (secondary to liver),
kidney, testes, and erythrocytes.
Species-specific target organs include
the nasal olfactory epithelium in rats
and the lungs in mice.
There is no evidence of increased
qualitative or quantitative susceptibility
of fetuses or offspring to acetochlor
exposure in the developmental and
reproduction toxicity studies in rats and
rabbits. In two developmental toxicity
studies in rats, fetal effects (increased
early resorptions, postimplantation loss,
and decreased fetal weight) occurred at
doses that also resulted in maternal
toxicity (mortality, clinical signs of
toxicity, and decreased maternal body
weight gain). In two rabbit
developmental toxicity studies there
were no adverse fetal effects at the
highest doses tested (HDT) (190
milligrams/kilogram/day (mg/kg/day)
and 300 mg/kg/day); whereas maternal
toxicity (body weight loss) was seen at
50 mg/kg/day in one study. In three
reproduction toxicity studies in rats,
offspring effects (decreased pup weights
in the first two studies; decreased pup
weights, decreased F2 litter size at birth,
and focal hyperplasia and polypoid
adenomata in nasal epithelium of adult
F1 offspring at study termination in the
third study) occurred at the same or
higher doses than those resulting in
parental toxicity (decreased body weight
or weight gain in the first two studies;
focal hyperplasia and polypoid
adenomata in nasal epithelium of adult
F1 offspring at study termination in the
third study). There was no evidence of
reproductive toxicity observed at any
dose tested in two of the three
reproductive toxicity studies in rats.
The third reproduction study in rats
showed a decreased number of
implantations at the HDT of 1,750 ppm.
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There was evidence of carcinogenicity
in studies conducted with acetochlor in
rats and mice. A 23–month mouse
carcinogenicity study showed weak
evidence for increased benign lung
tumors in females, and a 78–week study
showed weak evidence for increased
benign lung tumors in males. The
increases were considered equivocal,
based on increases in benign tumors
only, inconsistent dose-responses
between the two studies,
inconsistencies in the responses of
males and females between the two
studies, lack of pre-neoplastic lung
lesions in the 23–month study (while
the 78–week study showed an increase
in bronchiolar hyperplasia), and the
variable incidence of lung tumors
known to occur in older mice.
Two carcinogenicity studies in rats
showed an increase in nasal epithelial
tumors and thyroid follicular cell
tumors. Thyroid tumor incidence was
relatively low, and there was evidence
that the tumors were due to disruption
of thyroid-pituitary homeostasis. There
are acceptable mode of action data for
the rat tumors (nasal olfactory epithelial
tumors and thyroid follicular cell
tumors) which are adequate to support
a non-linear, margin of exposure (MOE),
approach for assessment of cancer risk.
The data show that, like the related
compounds, alachlor and butachlor,
tumor formation is dependent upon
local cytotoxicity secondary to oxidative
damage by a reactive quinone imine
intermediate. The mechanistic data on
nasal tumorigenesis of acetochlor in the
rat, when considered together with the
mutagenicity data on acetochlor and
consistent findings in mechanistic and
mutagenicity studies on the closely
related compound alachlor, are
considered adequate to demonstrate a
cytotoxic, non-mutagenic mode of
tumor induction.
Because a clear mode of action was
demonstrated for the rat tumors, EPA
based the cancer classification on the
data from the mouse. Given the
weakness of these data (benign lung
tumors in male and female mice and
histiocytic sarcomas in female mice),
EPA has classified acetochlor as having
‘‘Suggestive Evidence of Carcinogenic
Potential’’ and determined that linear
quantification of carcinogenic potential
would not be appropriate for the mouse
tumors. The rat nasal tumors, with a
point of departure (POD) of 10 mg/kg/
day, are the most sensitive effect for
cancer risk. The chronic population
adjusted dose (cPAD), based on the noobserved-adverse-effect level (NOAEL)
of 2.0 mg/kg/day from the chronic dog
study, will be protective of both noncancer and cancer effects, including rat
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nasal tumors, thyroid tumors, and
mouse tumors.
Specific information on the studies
received and the nature of the adverse
effects caused by acetochlor as well as
the NOAEL and the lowest-observedadverse-effect level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
Acetochlor Human Health Risk
Assessment for Proposed New Use of
Acetochlor on Cotton and Soybeans,
page 41 in docket ID number EPA–HQ–
OPP–2009–0002.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological POD is identified as
the basis for derivation of reference
values for risk assessment. The POD
may be defined as the highest dose at
which no adverse effects are observed
(the NOAEL) in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
cannot be determined, the lowest dose
at which adverse effects of concern are
identified (the LOAEL) or a Benchmark
Dose (BMD) approach is sometimes
used for risk assessment. Uncertainty/
safety factors (UFs) are used in
conjunction with the POD to take into
account 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. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and cPAD. The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-term, intermediate-term,
and chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
MOE called for by the product of all
applicable UFs is not exceeded. This
latter value is referred to as the level of
concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for acetochlor used for
human risk assessment can be found at
https://www.regulations.gov in the
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document Acetochlor Human Health
Risk Assessment for Proposed New Use
of Acetochlor on Cotton and Soybeans
page 25 in docket ID number EPA–HQ–
OPP–2009–0002.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to acetochlor, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
acetochlor tolerances in 40 CFR
180.470. EPA assessed dietary
exposures from acetochlor in food as
follows:
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 1–day or single
exposure.
In estimating acute dietary exposure,
EPA used food consumption
information from the U.S. Department of
Agriculture (USDA) 1994–1996 and
1998 Nationwide Continuing Surveys of
Food Intakes by Individuals (CSFII). As
to residue levels in food, EPA assumed
that residues are present in all
commodities at the tolerance level and
that 100% of commodities are treated
with acetochlor. Dietary Exposure
Evaluation Model 7.81 (DEEMTM 7.81)
default concentration factors were used
to estimate residues of acetochlor in
processed commodities.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
assumed that residues are present in
soybeans and cotton at the tolerance
level and that 100% of cotton and
soybeans are treated with acetochlor.
For existing uses of acetochlor, EPA
assumed average field trial levels and
100 percent crop treated (PCT).
DEEMTM 7.81 default concentration
factors were used to estimate residues of
acetochlor in processed commodities.
iii. Cancer. Based on the results of
carcinogenicity studies in rats and mice,
EPA classified acetochlor as having
‘‘Suggestive Evidence of Carcinogenic
Potential’’ but determined that the
chronic risk assessment will be
protective of both non-cancer and
cancer effects. Therefore, a separate
exposure assessment to evaluate cancer
risk is unnecessary.
iv. Anticipated residue and PCT
information. EPA used anticipated
residues derived from the results of field
trials in the chronic dietary exposure
assessment. EPA did not use PCT
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information in the acute or chronic
exposure assessments.
Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and
information on the anticipated residue
levels of pesticide residues in food and
the actual levels of pesticide residues
that have been measured in food. If EPA
relies on such information, EPA must
require pursuant to FFDCA section
408(f)(1) that data be provided 5 years
after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such Data CallIns as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for acetochlor in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of acetochlor.
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.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS), the estimated
drinking water concentration (EDWC) of
acetochlor for acute exposures is
estimated to be 75 parts per billion
(ppb) for surface water. The EDWC for
chronic exposures for non-cancer
assessments is estimated to be 4.8 ppb
for surface water. Residues of parent
acetochlor in ground water are expected
to be insignificant compared to residues
in surface water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 75 ppb was used
to assess the contribution to drinking
water. For chronic dietary risk
assessment, the water concentration of
value 9.5 ppb was used to assess the
contribution to drinking water. This
value is higher than the modeled EDWC
for chronic exposures (4.8 ppm) and
was derived from preliminary modeling
that was subsequently refined. Since
chronic exposure estimates using the
higher value are below EPA′s LOC, EPA
did not revise the dietary exposure
assessment to reflect the final modeled
EDWC.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
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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).
Acetochlor is not registered for any
specific use patterns that would result
in residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
The chloroacetanilides have been
evaluated by the Agency and the FIFRA
Scientific Advisory Panel (SAP) as a
related group of chemicals for this
purpose. Acetochlor is included in a
Cumulative Assessment Group (CAG) of
Chloroacetanilide pesticides.
Structurally related chloroacetanilides
include acetochlor, alachlor, butachlor,
propachlor and metolachlor. For
purposes of a cumulative risk
assessment, it was determined that the
common mechanism of toxicity group
consists of alachlor, acetochlor and
butachlor. Butachlor is excluded from
the group for risk assessment purposes
at present since there are no registered
uses or tolerances for this chemical in
the United States. The group was
selected based on common endpoints of:
i. Nasal turbinate tumors in rats, and
a known mechanism of toxicity for
development of these tumors.
ii. Induction of hepatic UDPGlucuronosyl Transferase (UDPGT),
which results in increased incidence of
thyroid follicular cell tumors secondary
to disruption of pituitary-thyroid
homeostasis. Thyroid effects were not
included in the final cumulative
assessment of the chloroacetanilide
herbicides because they were
determined to occur at excessively toxic
dose levels, and therefore were not
considered relevant to human risk
assessment. Nasal tumors represent the
most sensitive endpoint for both
compounds.
An updated cumulative risk
assessment of the Chloroacetanilide
CAG pesticides, acetochlor and alachlor,
was conducted in April 2007. The risk
assessment ‘‘ACETOCHLOR/
ALACHLOR: Revised Cumulative Risk
Assessment for the Chloroacetanilides
to Support the Proposed New Uses on
Alachlor and Acetochlor’’. PP 8F05000
and 8F5025 (Alachlor), PP 6F4791,
1F6263 and 5F6918 (Acetochlor) is
available in the docket established for
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this action (EPA–HQ–OPP–2009–0002).
Based on the most recent
Chloroacetanilide CAG cumulative risk
assessment, cumulative risk is not of
concern. A revised quantitative
cumulative assessment was not
conducted for the current assessment of
proposed new uses for acetochlor,
because the proposed new uses on
cotton and soybeans would not affect
the cumulative risk results. Acetochlor
is a very minor contributor to
cumulative risk when compared to
alachlor, and the proposed new uses
(cotton and soybeans) are minor
contributors to acetochlor dietary risk.
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 EPA’s website at
https://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) 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 database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
The prenatal and postnatal toxicity
database for acetochlor includes two rat
and two rabbit developmental toxicity
studies and three reproduction toxicity
studies in rats. As discussed in Unit
III.A., there was no evidence of
qualitative or quantitative susceptibility
of fetuses or offspring to acetochlor
exposure in any of these studies.
3. Conclusion. EPA has determined
that the FQPA safety factor of 10X must
be retained as a database UF for
acetochlor acute risk assessment. This
decision is based on the following
findings:
i. The toxicity database for acetochlor
is incomplete. Additional data
pertaining to acetochlor’s potential to
cause developmental neurotoxicity
(DNT) or immunotoxicity are
outstanding.
ii. Evidence of neurotoxicity was
observed in acute and subchronic
neurotoxicity screening studies in rats,
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developmental toxicity studies in rats,
and subchronic and chronic studies in
dogs. Frank neuropathology was seen in
a chronic study in the dog. EPA has
required a DNT study in rats to assess
susceptibility of offspring to neurotoxic
effects relative to adult animals. Results
of the DNT study could impact the
current dose selected for assessing acute
oral exposure, since the NOAEL used
for acute dietary risk assessment (150
mg/kg/day) is greater than the NOAEL
from a reproductive toxicity study (21
mg/kg/day) for acetochlor, and the DNT
study will likely be conducted at dose
levels similar to those of the
reproductive toxicity study. The results
of the DNT study are not expected to
impact the dose selected for chronic risk
assessment, which is based on the lower
NOAEL of 2.0 mg/kg/day from the
chronic dog study.
iii. In accordance with 40 CFR part
158 Toxicology Data requirements, an
immunotoxicity study (870.7800) is
required for acetochlor. In the absence
of specific immunotoxicity studies, EPA
has evaluated the available acetochlor
toxicity data to determine whether an
additional database UF is needed to
account for potential immunotoxicity.
There are no indications in the available
studies that organs associated with
immune function, such as the thymus
and spleen, are affected by acetochlor,
and acetochlor does not belong to a
class of chemicals (e.g., the organotins,
heavy metals, or halogenated aromatic
hydrocarbons) that would be expected
to be immunotoxic.
iv. There is no evidence that
acetochlor results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in offspring in the 2-generation
reproduction studies.
v. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% crop
treated and tolerance-level residues or
average residue levels derived from
reliable field trials. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to acetochlor in
drinking water. Residential exposure to
acetochlor is not expected. These
assessments will not underestimate the
exposure and risks posed by acetochlor.
After weighing this evidence, EPA
retains significant uncertainty regarding
potential neurotoxic effects in infants
and children but does not have such
concerns for immunotoxicity. Given the
findings of neurotoxicity and the
uncertainty regarding the sensitivity of
fetal and neonatal animals to neurotoxic
effects, EPA has concluded that it lacks
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reliable data to remove the FQPA 10X
safety factor for acute exposures. For
chronic exposures, EPA concludes that
reliable data show that removal of the
FQPA 10X factor will be safe for infants
and children. Three factors predominate
here. First, given the expected dosing in
the DNT study, that study is unlikely to
affect the cPAD, even if effects were
seen at the lowest dose tested. Second,
there is no evidence of increased
susceptibility in multiple studies in
multiple species. Third, although
neurotoxic effects have been observed in
the database, at lower doses the more
significant effects are not related to
neurotoxicity.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing
the estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. Using the exposure assumptions
discussed in this unit for acute
exposure, the acute dietary exposure
from food and water to acetochlor will
occupy 11% of the aPAD for infants less
than 1 year old, the population group
receiving the greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to acetochlor from
food and water will utilize 6% of the
cPAD for infants less than 1 year old,
the population group receiving the
greatest exposure. There are no
residential uses for acetochlor.
3. Short-term/intermediate-term risk.
Short-term and intermediate-term
aggregate exposure take into account
short-term or intermediate-term
residential exposure plus chronic
exposure from food and water
(considered to be a background
exposure level). Acetochlor is not
registered for any use patterns that
would result in residential exposure.
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47449
Therefore, the short-term or
intermediate-term aggregate risk is the
sum of the risk from exposure to
acetochlor through food and water and
will not be greater than the chronic
aggregate risk.
4. Aggregate cancer risk for U.S.
population. As explained in Unit III.A.,
risk assessments based on the endpoint
selected for chronic risk assessment are
considered to be protective of any
potential carcinogenic risk from
exposure to acetochlor. Based on the
results of the chronic risk assessment
discussed above in Unit E.2., EPA
concludes that acetochlor 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, or to infants and children
from aggregate exposure to acetochlor
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high performance liquid
chromatography (HPLC) method with
oxidative coulometric electrochemical
detection (OCED)) 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; email address: residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX, Canadian or
Mexican maximum residue limits
established for residues of acetochlor on
cotton or soybean commodities.
C. Revisions to Petitioned-For
Tolerances
The registrant proposed a tolerance
for residues of acetochlor and its
metabolites on soybean, seed at 1.0
ppm. Based on processing data for
soybean showing the potential for
residues of acetochlor to concentrate in
soybean meal (1.2X), EPA determined
that a tolerance is also needed for
soybean, meal at 1.2 ppm.
Tolerances for acetochlor are
currently expressed in terms of
‘‘residues of acetochlor; 2-chloro-2’methyl-6-ethyl-Nethoxymethylacetanilide, and its
metabolites containing the ethyl methyl
aniline (EMA) moiety and the
hydroxyethyl methyl aniline (HEMA)
moiety, to be analyzed as acetochlor and
expressed as acetochlor equivalents.’’
EPA is revising the tolerance expression
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for existing tolerances and the new
tolerances on cotton and soybeans to
clarify the chemical moieties that are
covered by the tolerances and specify
how compliance with the tolerances is
to be measured. The revised tolerance
expression makes clear that the
tolerance covers ‘‘residues of acetochlor,
including its metabolites and
degradates,’’ and that compliance with
the tolerance levels will be determined
by measuring only ‘‘acetochlor, 2chloro-2’-methyl-6-ethyl-Nethoxymethylacetanilide, and its
metabolites containing the EMA moiety
and the HEMA moiety. Both parent and
the named metabolites shall be
determined as EMA and HEMA, and
calculated as the stoichiometric
equivalents of acetochlor.’’
EPA has determined that it is
reasonable to make this change final
without prior proposal and opportunity
for comment, because public comment
is not necessary, in that the change has
no substantive effect on the tolerance,
but rather is merely intended to clarify
the existing tolerance expression.
sroberts on DSKD5P82C1PROD with RULES
V. Conclusion
Therefore, tolerances are established
for residues of acetochlor, including its
metabolites and degradates, on cotton,
gin byproducts at 4.0 ppm; cotton,
undelinted seed at 0.6 ppm; soybean,
meal at 1.2 ppm; and soybean, seed at
1.0 ppm. Compliance with these
tolerance levels is to be determined by
measuring only acetochlor, 2-chloro-2’methyl-6-ethyl-Nethoxymethylacetanilide, and its
metabolites containing the EMA moiety
and the HEMA moiety. Both parent and
the named metabolites shall be
determined as EMA and HEMA, and
calculated as the stoichiometric
equivalents of acetochlor.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
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 final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
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16:10 Sep 15, 2009
Jkt 217001
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., 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).
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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
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that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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 31, 2009.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.470 is amended by
revising the introductory text in
paragraphs (a) and (d); alphabetically
adding the entries cotton, gin
byproducts; cotton, undelinted seed;
soybean, meal; and soybean, seed to the
table in paragraph (a), and by removing
the entry for ‘‘soybean, seed’’ from the
table in paragraph (d) to read as follows.
■
§ 180.470 Acetochlor; tolerances for
residues.
(a) General. Tolerances are
established for residues of acetochlor,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only
acetochlor, 2-chloro-2’-methyl-6-ethylN-ethoxymethylacetanilide, and its
metabolites containing the ethyl methyl
aniline (EMA) moiety and the
hydroxyethyl methyl aniline (HEMA)
moiety. Both parent and the named
metabolites shall be determined as ethyl
methyl aniline (EMA) and hydroxyethyl
methyl aniline (HEMA), and calculated
as the stoichiometric equivalents of
acetochlor, in or on the following
commodities:
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Commodity
47451
Parts per million
*
*
*
*
*
Cotton, gin byproducts .................................................................................................................
Cotton, undelinted seed ...............................................................................................................
*
*
*
*
*
Soybean, meal .............................................................................................................................
Soybean, seed .............................................................................................................................
*
*
*
*
*
(d) Indirect or inadvertent residues.
Tolerances are established for indirect
or inadvertent residues of acetochlor,
including its metabolites and
degradates, in or on the raw agricultural
commodities in the table to this
paragraph when present therein as a
result of application of acetochlor to the
growing crops in the table to paragraph
(a) of this section. Compliance with the
tolerance levels specified below is to be
determined by measuring only
acetochlor, 2-chloro-2’-methyl-6-ethylN-ethoxymethylacetanilide, and its
metabolites containing the ethyl methyl
aniline (EMA) moiety and the
hydroxyethyl methyl aniline (HEMA)
moiety. Both parent and the named
metabolites shall be determined as ethyl
methyl aniline (EMA) and hydroxyethyl
methyl aniline (HEMA), and calculated
as the stoichiometric equivalents of
acetochlor, in or on the following
commodities.
*
*
*
*
*
[FR Doc. E9–21845 Filed 9–15–09; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0251; FRL–8431–7]
Ametryn, Amitraz, Ammonium Soap
Salts of Higher Fatty Acids, Bitertanol,
Coppers, et al.; Tolerance Actions
sroberts on DSKD5P82C1PROD with RULES
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is revoking certain
tolerances/tolerance exemptions for the
fungicides pentachloronitrobenzene and
triadimenol; the herbicides ametryn,
fluazifop-p-butyl, and prometryn; the
insecticides amitraz and mineral oil; the
defoliant/desiccant sodium chlorate;
and the fungicide/algicide/herbicide
coppers. Also, EPA is modifying certain
tolerances for the fungicide bitertanol
and the insecticide malathion. In
addition, EPA is establishing new
tolerances/tolerance exemptions for the
fungicides coppers and
pentachloronitrobenzene; the herbicide
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prometryn; the insecticide malathion;
and the defoliant/desiccant sodium
chlorate; and revising the tolerance
expression for the ammonium salts of
higher fatty acids (ammonium soap
salts). The regulatory actions finalized
in this document are in follow-up to the
Agency’s reregistration program under
the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and tolerance
reassessment program under the Federal
Food, Drug, and Cosmetic Act (FFDCA),
section 408(q).
DATES: This regulation is effective
September 16, 2009. Objections and
requests for hearings must be received
on or before November 16, 2009, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0251. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
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 Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Joseph Nevola, Pesticide Re-evaluation
Division (7508P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 308-8037; e-mail address:
nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
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4.0
0.6
1.2
1.0
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 code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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 electronically
available documents 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 e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, 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
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Agencies
[Federal Register Volume 74, Number 178 (Wednesday, September 16, 2009)]
[Rules and Regulations]
[Pages 47445-47451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21845]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0002; FRL-8434-1]
Acetochlor; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
acetochlor, including its metabolites and degradates, in or on cotton,
gin byproducts; cotton, undelinted seed; soybean, meal; and soybean,
seed. Monsanto Company requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA). This regulation also removes the
existing tolerance for indirect or inadvertent residues of acetochlor
on soybean, seed.
DATES: This regulation is effective September 16, 2009. Objections and
requests for hearings must be received on or before November 16, 2009,
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-2009-0002. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@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 those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide 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 electronically available documents 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 EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
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.gov/opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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
[[Page 47446]]
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2009-0002 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 as required by 40 CFR part 178 on or before November 16,
2009.
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 this copy, identified by docket ID number
EPA-HQ-OPP-2009-0002, 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
8F7443 and PP 8F7448) by Monsanto Company, 1300 I St., NW., Suite 450
East, Washington DC 20052. The petitions requested that 40 CFR 180.470
be amended by establishing tolerances for combined residues of the
herbicide acetochlor, 2-chloro-2'-methyl-6'-ethyl-N-
ethoxymethylacetanilide, and its metabolites containing either the 2-
ethyl-6-methyl-aniline (EMA) or the 2-(1-hydroxyethyl)-6-methyl-aniline
(HEMA) moiety, to be expressed as acetochlor equivalents, in or on
cotton, gin byproducts; and cotton, undelinted seed at 4.0 parts per
million (ppm) and 0.6 ppm, respectively (PP 8F7443); and soybean, seed
at 1.0 ppm (PP 8F7448). That notice referenced a summary of the
petition prepared by Monsanto Company, the registrant, which is
available to the public in the docket, https://www.regulations.gov.
There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
determined that a tolerance for residues of acetochlor and its
metabolites is also required on soybean, meal at 1.2 ppm. EPA has also
revised the tolerance expression for acetochlor to clarify the chemical
moieties that are covered by the tolerances and specify how compliance
with the tolerances is to be measured. The reasons for these changes
are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
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. . .
.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 for the petitioned-for
tolerances for residues of acetochlor, including its metabolites and
degradates, on cotton, gin byproducts at 4.0 ppm; cotton, undelinted
seed at 0.6 ppm; soybean, meal at 1.2 ppm; and soybean, seed at 1.0
ppm. EPA's assessment of exposures and risks associated with
establishing 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.
Acetochlor has low acute toxicity by the oral, dermal, and
inhalation routes of exposure and is mildly irritating to the eyes. The
results of two dermal irritation studies indicate that it is a mild to
strong skin irritant. Acetochlor is also a strong dermal sensitizer.
Evidence of neurotoxicity was observed in acute and subchronic
neurotoxicity screening studies in rats, developmental toxicity studies
in rats, and subchronic and chronic studies in dogs. In addition to the
nervous system, the major target organs affected in subchronic and
chronic studies in rats, dogs and mice exposed to acetochlor are the
liver, thyroid (secondary to liver), kidney, testes, and erythrocytes.
Species-specific target organs include the nasal olfactory epithelium
in rats and the lungs in mice.
There is no evidence of increased qualitative or quantitative
susceptibility of fetuses or offspring to acetochlor exposure in the
developmental and reproduction toxicity studies in rats and rabbits. In
two developmental toxicity studies in rats, fetal effects (increased
early resorptions, postimplantation loss, and decreased fetal weight)
occurred at doses that also resulted in maternal toxicity (mortality,
clinical signs of toxicity, and decreased maternal body weight gain).
In two rabbit developmental toxicity studies there were no adverse
fetal effects at the highest doses tested (HDT) (190 milligrams/
kilogram/day (mg/kg/day) and 300 mg/kg/day); whereas maternal toxicity
(body weight loss) was seen at 50 mg/kg/day in one study. In three
reproduction toxicity studies in rats, offspring effects (decreased pup
weights in the first two studies; decreased pup weights, decreased F2
litter size at birth, and focal hyperplasia and polypoid adenomata in
nasal epithelium of adult F1 offspring at study termination in the
third study) occurred at the same or higher doses than those resulting
in parental toxicity (decreased body weight or weight gain in the first
two studies; focal hyperplasia and polypoid adenomata in nasal
epithelium of adult F1 offspring at study termination in the third
study). There was no evidence of reproductive toxicity observed at any
dose tested in two of the three reproductive toxicity studies in rats.
The third reproduction study in rats showed a decreased number of
implantations at the HDT of 1,750 ppm.
[[Page 47447]]
There was evidence of carcinogenicity in studies conducted with
acetochlor in rats and mice. A 23-month mouse carcinogenicity study
showed weak evidence for increased benign lung tumors in females, and a
78-week study showed weak evidence for increased benign lung tumors in
males. The increases were considered equivocal, based on increases in
benign tumors only, inconsistent dose-responses between the two
studies, inconsistencies in the responses of males and females between
the two studies, lack of pre-neoplastic lung lesions in the 23-month
study (while the 78-week study showed an increase in bronchiolar
hyperplasia), and the variable incidence of lung tumors known to occur
in older mice.
Two carcinogenicity studies in rats showed an increase in nasal
epithelial tumors and thyroid follicular cell tumors. Thyroid tumor
incidence was relatively low, and there was evidence that the tumors
were due to disruption of thyroid-pituitary homeostasis. There are
acceptable mode of action data for the rat tumors (nasal olfactory
epithelial tumors and thyroid follicular cell tumors) which are
adequate to support a non-linear, margin of exposure (MOE), approach
for assessment of cancer risk. The data show that, like the related
compounds, alachlor and butachlor, tumor formation is dependent upon
local cytotoxicity secondary to oxidative damage by a reactive quinone
imine intermediate. The mechanistic data on nasal tumorigenesis of
acetochlor in the rat, when considered together with the mutagenicity
data on acetochlor and consistent findings in mechanistic and
mutagenicity studies on the closely related compound alachlor, are
considered adequate to demonstrate a cytotoxic, non-mutagenic mode of
tumor induction.
Because a clear mode of action was demonstrated for the rat tumors,
EPA based the cancer classification on the data from the mouse. Given
the weakness of these data (benign lung tumors in male and female mice
and histiocytic sarcomas in female mice), EPA has classified acetochlor
as having ``Suggestive Evidence of Carcinogenic Potential'' and
determined that linear quantification of carcinogenic potential would
not be appropriate for the mouse tumors. The rat nasal tumors, with a
point of departure (POD) of 10 mg/kg/day, are the most sensitive effect
for cancer risk. The chronic population adjusted dose (cPAD), based on
the no-observed-adverse-effect level (NOAEL) of 2.0 mg/kg/day from the
chronic dog study, will be protective of both non-cancer and cancer
effects, including rat nasal tumors, thyroid tumors, and mouse tumors.
Specific information on the studies received and the nature of the
adverse effects caused by acetochlor as well as the NOAEL and the
lowest-observed-adverse-effect level (LOAEL) from the toxicity studies
can be found at https://www.regulations.gov in the document Acetochlor
Human Health Risk Assessment for Proposed New Use of Acetochlor on
Cotton and Soybeans, page 41 in docket ID number EPA-HQ-OPP-2009-0002.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological POD is identified as the basis for
derivation of reference values for risk assessment. The POD may be
defined as the highest dose at which no adverse effects are observed
(the NOAEL) in the toxicology study identified as appropriate for use
in risk assessment. However, if a NOAEL cannot be determined, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) or a Benchmark Dose (BMD) approach is sometimes used for risk
assessment. Uncertainty/safety factors (UFs) are used in conjunction
with the POD to take into account 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. Safety is assessed for acute and chronic dietary
risks by comparing aggregate food and water exposure to the pesticide
to the acute population adjusted dose (aPAD) and cPAD. The aPAD and
cPAD are calculated by dividing the POD by all applicable UFs.
Aggregate short-term, intermediate-term, and chronic-term risks are
evaluated by comparing food, water, and residential exposure to the POD
to ensure that the MOE called for by the product of all applicable UFs
is not exceeded. This latter value is referred to as the level of
concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for acetochlor used for
human risk assessment can be found at https://www.regulations.gov in the
document Acetochlor Human Health Risk Assessment for Proposed New Use
of Acetochlor on Cotton and Soybeans page 25 in docket ID number EPA-
HQ-OPP-2009-0002.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetochlor, EPA considered exposure under the petitioned-
for tolerances as well as all existing acetochlor tolerances in 40 CFR
180.470. EPA assessed dietary exposures from acetochlor in food as
follows:
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 1-day or single exposure.
In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intakes by Individuals
(CSFII). As to residue levels in food, EPA assumed that residues are
present in all commodities at the tolerance level and that 100% of
commodities are treated with acetochlor. Dietary Exposure Evaluation
Model 7.81 (DEEM\TM\ 7.81) default concentration factors were used to
estimate residues of acetochlor in processed commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that residues
are present in soybeans and cotton at the tolerance level and that 100%
of cotton and soybeans are treated with acetochlor. For existing uses
of acetochlor, EPA assumed average field trial levels and 100 percent
crop treated (PCT). DEEM\TM\ 7.81 default concentration factors were
used to estimate residues of acetochlor in processed commodities.
iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA classified acetochlor as having ``Suggestive
Evidence of Carcinogenic Potential'' but determined that the chronic
risk assessment will be protective of both non-cancer and cancer
effects. Therefore, a separate exposure assessment to evaluate cancer
risk is unnecessary.
iv. Anticipated residue and PCT information. EPA used anticipated
residues derived from the results of field trials in the chronic
dietary exposure assessment. EPA did not use PCT
[[Page 47448]]
information in the acute or chronic exposure assessments.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such Data Call-Ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for acetochlor in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of acetochlor. 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.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS), the estimated drinking water concentration (EDWC)
of acetochlor for acute exposures is estimated to be 75 parts per
billion (ppb) for surface water. The EDWC for chronic exposures for
non-cancer assessments is estimated to be 4.8 ppb for surface water.
Residues of parent acetochlor in ground water are expected to be
insignificant compared to residues in surface water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 75 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 9.5 ppb was used to assess
the contribution to drinking water. This value is higher than the
modeled EDWC for chronic exposures (4.8 ppm) and was derived from
preliminary modeling that was subsequently refined. Since chronic
exposure estimates using the higher value are below EPA's LOC, EPA did
not revise the dietary exposure assessment to reflect the final modeled
EDWC.
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). Acetochlor is not
registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
The chloroacetanilides have been evaluated by the Agency and the
FIFRA Scientific Advisory Panel (SAP) as a related group of chemicals
for this purpose. Acetochlor is included in a Cumulative Assessment
Group (CAG) of Chloroacetanilide pesticides. Structurally related
chloroacetanilides include acetochlor, alachlor, butachlor, propachlor
and metolachlor. For purposes of a cumulative risk assessment, it was
determined that the common mechanism of toxicity group consists of
alachlor, acetochlor and butachlor. Butachlor is excluded from the
group for risk assessment purposes at present since there are no
registered uses or tolerances for this chemical in the United States.
The group was selected based on common endpoints of:
i. Nasal turbinate tumors in rats, and a known mechanism of
toxicity for development of these tumors.
ii. Induction of hepatic UDP-Glucuronosyl Transferase (UDPGT),
which results in increased incidence of thyroid follicular cell tumors
secondary to disruption of pituitary-thyroid homeostasis. Thyroid
effects were not included in the final cumulative assessment of the
chloroacetanilide herbicides because they were determined to occur at
excessively toxic dose levels, and therefore were not considered
relevant to human risk assessment. Nasal tumors represent the most
sensitive endpoint for both compounds.
An updated cumulative risk assessment of the Chloroacetanilide CAG
pesticides, acetochlor and alachlor, was conducted in April 2007. The
risk assessment ``ACETOCHLOR/ALACHLOR: Revised Cumulative Risk
Assessment for the Chloroacetanilides to Support the Proposed New Uses
on Alachlor and Acetochlor''. PP 8F05000 and 8F5025 (Alachlor), PP
6F4791, 1F6263 and 5F6918 (Acetochlor) is available in the docket
established for this action (EPA-HQ-OPP-2009-0002). Based on the most
recent Chloroacetanilide CAG cumulative risk assessment, cumulative
risk is not of concern. A revised quantitative cumulative assessment
was not conducted for the current assessment of proposed new uses for
acetochlor, because the proposed new uses on cotton and soybeans would
not affect the cumulative risk results. Acetochlor is a very minor
contributor to cumulative risk when compared to alachlor, and the
proposed new uses (cotton and soybeans) are minor contributors to
acetochlor dietary risk.
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 EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for acetochlor includes two rat and two rabbit
developmental toxicity studies and three reproduction toxicity studies
in rats. As discussed in Unit III.A., there was no evidence of
qualitative or quantitative susceptibility of fetuses or offspring to
acetochlor exposure in any of these studies.
3. Conclusion. EPA has determined that the FQPA safety factor of
10X must be retained as a database UF for acetochlor acute risk
assessment. This decision is based on the following findings:
i. The toxicity database for acetochlor is incomplete. Additional
data pertaining to acetochlor's potential to cause developmental
neurotoxicity (DNT) or immunotoxicity are outstanding.
ii. Evidence of neurotoxicity was observed in acute and subchronic
neurotoxicity screening studies in rats,
[[Page 47449]]
developmental toxicity studies in rats, and subchronic and chronic
studies in dogs. Frank neuropathology was seen in a chronic study in
the dog. EPA has required a DNT study in rats to assess susceptibility
of offspring to neurotoxic effects relative to adult animals. Results
of the DNT study could impact the current dose selected for assessing
acute oral exposure, since the NOAEL used for acute dietary risk
assessment (150 mg/kg/day) is greater than the NOAEL from a
reproductive toxicity study (21 mg/kg/day) for acetochlor, and the DNT
study will likely be conducted at dose levels similar to those of the
reproductive toxicity study. The results of the DNT study are not
expected to impact the dose selected for chronic risk assessment, which
is based on the lower NOAEL of 2.0 mg/kg/day from the chronic dog
study.
iii. In accordance with 40 CFR part 158 Toxicology Data
requirements, an immunotoxicity study (870.7800) is required for
acetochlor. In the absence of specific immunotoxicity studies, EPA has
evaluated the available acetochlor toxicity data to determine whether
an additional database UF is needed to account for potential
immunotoxicity. There are no indications in the available studies that
organs associated with immune function, such as the thymus and spleen,
are affected by acetochlor, and acetochlor does not belong to a class
of chemicals (e.g., the organotins, heavy metals, or halogenated
aromatic hydrocarbons) that would be expected to be immunotoxic.
iv. There is no evidence that acetochlor results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in offspring in the 2-generation reproduction
studies.
v. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated and tolerance-level residues or average residue
levels derived from reliable field trials. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to acetochlor in drinking water. Residential
exposure to acetochlor is not expected. These assessments will not
underestimate the exposure and risks posed by acetochlor.
After weighing this evidence, EPA retains significant uncertainty
regarding potential neurotoxic effects in infants and children but does
not have such concerns for immunotoxicity. Given the findings of
neurotoxicity and the uncertainty regarding the sensitivity of fetal
and neonatal animals to neurotoxic effects, EPA has concluded that it
lacks reliable data to remove the FQPA 10X safety factor for acute
exposures. For chronic exposures, EPA concludes that reliable data show
that removal of the FQPA 10X factor will be safe for infants and
children. Three factors predominate here. First, given the expected
dosing in the DNT study, that study is unlikely to affect the cPAD,
even if effects were seen at the lowest dose tested. Second, there is
no evidence of increased susceptibility in multiple studies in multiple
species. Third, although neurotoxic effects have been observed in the
database, at lower doses the more significant effects are not related
to neurotoxicity.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
acetochlor will occupy 11% of the aPAD for infants less than 1 year
old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
acetochlor from food and water will utilize 6% of the cPAD for infants
less than 1 year old, the population group receiving the greatest
exposure. There are no residential uses for acetochlor.
3. Short-term/intermediate-term risk. Short-term and intermediate-
term aggregate exposure take into account short-term or intermediate-
term residential exposure plus chronic exposure from food and water
(considered to be a background exposure level). Acetochlor is not
registered for any use patterns that would result in residential
exposure. Therefore, the short-term or intermediate-term aggregate risk
is the sum of the risk from exposure to acetochlor through food and
water and will not be greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S. population. As explained in Unit
III.A., risk assessments based on the endpoint selected for chronic
risk assessment are considered to be protective of any potential
carcinogenic risk from exposure to acetochlor. Based on the results of
the chronic risk assessment discussed above in Unit E.2., EPA concludes
that acetochlor 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, or to infants and children from aggregate
exposure to acetochlor residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography (HPLC) method with oxidative coulometric electrochemical
detection (OCED)) 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 maximum residue limits
established for residues of acetochlor on cotton or soybean
commodities.
C. Revisions to Petitioned-For Tolerances
The registrant proposed a tolerance for residues of acetochlor and
its metabolites on soybean, seed at 1.0 ppm. Based on processing data
for soybean showing the potential for residues of acetochlor to
concentrate in soybean meal (1.2X), EPA determined that a tolerance is
also needed for soybean, meal at 1.2 ppm.
Tolerances for acetochlor are currently expressed in terms of
``residues of acetochlor; 2-chloro-2'-methyl-6-ethyl-N-
ethoxymethylacetanilide, and its metabolites containing the ethyl
methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline (HEMA)
moiety, to be analyzed as acetochlor and expressed as acetochlor
equivalents.'' EPA is revising the tolerance expression
[[Page 47450]]
for existing tolerances and the new tolerances on cotton and soybeans
to clarify the chemical moieties that are covered by the tolerances and
specify how compliance with the tolerances is to be measured. The
revised tolerance expression makes clear that the tolerance covers
``residues of acetochlor, including its metabolites and degradates,''
and that compliance with the tolerance levels will be determined by
measuring only ``acetochlor, 2-chloro-2'-methyl-6-ethyl-N-
ethoxymethylacetanilide, and its metabolites containing the EMA moiety
and the HEMA moiety. Both parent and the named metabolites shall be
determined as EMA and HEMA, and calculated as the stoichiometric
equivalents of acetochlor.''
EPA has determined that it is reasonable to make this change final
without prior proposal and opportunity for comment, because public
comment is not necessary, in that the change has no substantive effect
on the tolerance, but rather is merely intended to clarify the existing
tolerance expression.
V. Conclusion
Therefore, tolerances are established for residues of acetochlor,
including its metabolites and degradates, on cotton, gin byproducts at
4.0 ppm; cotton, undelinted seed at 0.6 ppm; soybean, meal at 1.2 ppm;
and soybean, seed at 1.0 ppm. Compliance with these tolerance levels is
to be determined by measuring only acetochlor, 2-chloro-2'-methyl-6-
ethyl-N-ethoxymethylacetanilide, and its metabolites containing the EMA
moiety and the HEMA moiety. Both parent and the named metabolites shall
be determined as EMA and HEMA, and calculated as the stoichiometric
equivalents of acetochlor.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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 31, 2009.
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 180.470 is amended by revising the introductory text in
paragraphs (a) and (d); alphabetically adding the entries cotton, gin
byproducts; cotton, undelinted seed; soybean, meal; and soybean, seed
to the table in paragraph (a), and by removing the entry for ``soybean,
seed'' from the table in paragraph (d) to read as follows.
Sec. 180.470 Acetochlor; tolerances for residues.
(a) General. Tolerances are established for residues of acetochlor,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only acetochlor, 2-chloro-2'-methyl-6-
ethyl-N-ethoxymethylacetanilide, and its metabolites containing the
ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline
(HEMA) moiety. Both parent and the named metabolites shall be
determined as ethyl methyl aniline (EMA) and hydroxyethyl methyl
aniline (HEMA), and calculated as the stoichiometric equivalents of
acetochlor, in or on the following commodities:
[[Page 47451]]
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Commodity Parts per million
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* * * * *
Cotton, gin byproducts........................................... 4.0
Cotton, undelinted seed.......................................... 0.6
* * * * *
Soybean, meal.................................................... 1.2
Soybean, seed.................................................... 1.0
----------------------------------------------------------------------------------------------------------------
* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent residues of acetochlor, including its
metabolites and degradates, in or on the raw agricultural commodities
in the table to this paragraph when present therein as a result of
application of acetochlor to the growing crops in the table to
paragraph (a) of this section. Compliance with the tolerance levels
specified below is to be determined by measuring only acetochlor, 2-
chloro-2'-methyl-6-ethyl-N-ethoxymethylacetanilide, and its metabolites
containing the ethyl methyl aniline (EMA) moiety and the hydroxyethyl
methyl aniline (HEMA) moiety. Both parent and the named metabolites
shall be determined as ethyl methyl aniline (EMA) and hydroxyethyl
methyl aniline (HEMA), and calculated as the stoichiometric equivalents
of acetochlor, in or on the following commodities.
* * * * *
[FR Doc. E9-21845 Filed 9-15-09; 8:45 am]
BILLING CODE 6560-50-S