Ethofumesate; Pesticide Tolerance, 51510-51516 [E6-14431]
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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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‘‘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
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§ 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
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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:
Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7610; e-mail address:
jackson.sidney@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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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
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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–2005–0537 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
EPA–HQ–OPP–2005–0537, 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) 3055805.
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II. Background and Statutory Findings
In the Federal Register of March 22,
2006 (71 FR 14522) (FRL–7767–8), 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) 3E6564, 3E6565
and 5E6914) by IR-4, 681 Highway 1
South, North Brunswick, NJ 08902–3390
on behalf of the registrant, Bayer
CropScience. The petition requested
that 40 CFR 180.345 be amended by
establishing tolerances for combined
residues of the herbicide ethofumesate
(2-ethoxy -2, 3-dihydro-3, 3-dimethyl-5benzofuranyl methanesulfonate) and its
metabolites 2-hydroxy-2,3-dihydro-3,3dimethyl-5-benzofuranyl
methanesulfonate and 2,3-dihydro-3,3dimethyl-2-oxo-5-benzofuranyl
methanesulfonate (both calculated as
the parent compound) in or on the raw
agricultural commodities: Carrots (with
regional restrictions for use in the States
of Washington and Oregon) at 10 parts
per million (ppm) (PP 3E6565), garden
beets tops at 4 ppm, garden beet roots
at 0.5 ppm (PP 3E6564), onion, dry bulb
at 0.30 ppm (PP 5E6914), garlic, bulb at
0.30 ppm (PP 5E6914), and shallot at
0.30 ppm (PP 5E6914). That notice
included a summary of the petitions
prepared by Bayer CropScience, P. O.
Box 12014, 2 T. W. Alexander Drive,
Research Triangle Park, NC 27709, the
registrant. There were no comments
received in response to the notice of
filing.
Supporting documents including the
Reregistration Eligibility Decision (RED)
for Ethofumesate, EPA 738-R-05-010,
Sept. 2005, can be viewed on-line along
with the Agency’s Human Health Risk
Assessment of ethofumesate and other
supporting documents at
www.regulations.gov under the index of
the docket for this action, Docket ID
number: EPA–HQ–OPP–2005–0537. The
Agency’s reregistration and tolerance
reassessment of ethofumesate are
completed. Due to its uses, risks, and
other factors, ethofumesate was
reviewed/reassessed through the
modified 4-Phase process as outlined in
the Federal Register on May 14, 2004
(69 FR 26819)(FRL–7357–9). Through
this process, EPA worked extensively
with stakeholders and the public to
reach the regulatory decisions for
ethofumesate.
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
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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.
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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 ethofumesate on: Carrot
(with regional restrictions for use in
Washington and Oregon) at 7.0 ppm,
beet, garden, tops at 4.0 ppm, beet,
garden, roots at 0.5 ppm, onion, dry
bulb at 0.25 ppm, garlic, bulb at 0.25
ppm, and shallot at 0.25 ppm. It can be
noted that the tolerance level for certain
commodities was revised, based on
current data evaluations and differ from
the proposed level presented in the
Notice of Filing on March 22, 2006 or
as recommended in the RED for
ethofumesate. These revisions include:
Carrot tolerance at 7.0 ppm, reduced
from 10.0 ppm; and garlic, bulb; onion,
dry bulb and shallot tolerances set at
0.25 ppm, reduced from 0.30 ppm.
EPA’s assessment of exposures and risks
associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
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
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subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
ethofumesate as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at www.regulations.gov.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at 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 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 ethofumesate used for
human risk assessment can be found in
the index of this document, Docket ID
number EPA–HQ–OPP–2005–0537,
entitled, ‘‘Human Health Risk
Assessment for Proposed Uses on
Onion, Bulb’’, (Table 3.4.15) (dated
April 24, 2006).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.345 for the
combined residues of ethofumesate, in
or on a variety of raw agricultural
commodities; plant commodities range
from 0.1 ppm in/on sugar beet roots to
1.0 ppm in/on sugar beet tops and grass
straw. Tolerances on animal
commodities including fat, meat and
meat byproducts are set at 0.05 ppm. A
process feeds tolerance in sugar beet
molasses is set at 0.5 ppm. Risk
assessments were conducted by EPA to
assess dietary exposures from
ethofumesate in food as follows:
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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.
No appropriate endpoint was
identified for the general population
and infants since no such effects were
identified in the toxicological studies
for ethofumesate; therefore, a
quantitative acute dietary exposure
assessment was not conducted for these
populations. For females, 13 plus years
of age, in conducting the acute dietary
(food + water) exposure assessment,
EPA used the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM-FCID(TM) Version 2.03), 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 acute exposure
assessments: A conservative acute
dietary assessment was performed using
tolerance level residues and 100 % crop
treated (PCT) in the assessment.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the DEEM-FCIDTM. The
following assumptions were made for
the chronic exposure assessments: A
conservative chronic dietary (food +
water) assessment was performed using
tolerance level residues and 100 PCT.
iii. Cancer. Ethofumesate is classified
as ‘‘not likely to be a human
carcinogen,’’ based on bioassays in the
rat and the mouse. An exposure
assessment for the purpose of assessing
cancer risk is not needed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
ethofumesate in drinking water. Because
the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
ethofumesate. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found https://www.epa.gov/
oppefed1/models/water/index.
Typically EPA evaluates the potential
for human exposure to pesticides in
drinking water through an assessment of
available surface water and ground
water monitoring data and modeling.
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For ethofumesate, no monitoring data
were available for use in this drinking
water assessment. Therefore, potential
human exposures to ethofumesate were
evaluated through modeling. Estimated
exposure concentrations (EECs) in
surface water were calculated using
Pesticide Root Zone Model/Exposure
Analyses Modeling System (PRZM/
EXAMS). Ground water concentrations
were modeled using screening
concentration in ground water (SCIGROW) (version 2.3). Drinking water
residues were then incorporated into the
DEEM-FCID(TM) into the food categories
‘‘water, direct, all sources’’ and ‘‘water,
indirect, all sources.’’ The Agency
concluded that degradates of
ethofumesate are of toxicological
equivalence to the parent. Because these
degradates were detected in
environmental fate studies in relatively
low amounts (10%), only the parent
needs to be assessed for drinking water.
Based on the PRZM/EXAMS - Index
Reservoir and SCI-GROW models, the
estimated environmental concentrations
(EECs) of ethofumesate for acute
exposures are estimated to be 154 parts
per billion (ppb) for surface water and
8.4 ppb for ground water. The EECs for
chronic exposures are estimated to be
45.5 ppb for for surface water and 8.4
ppb for ground water. Modeled
estimates of drinking water
concentrations were directly entered
into the dietary exposure model (DEEMFCIDTM). For the acute assessment, the
peak concentration of 154 ppb was used
to access the contribution to drinking
water; for the chronic assessment, the
annual mean value of 45.5 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).
Ethofumesate is currently registered
for use on the following residential nondietary sites: Turf grasses/lawns. The
risk assessment was conducted using
the following residential exposure
assumptions: All ethofumesate products
are intended for either agricultural use
or require professional application for
ornamental turf. For potential
ethofumesate residential postapplication exposure, the Agency
conducted screening level calculations
on the scenarios most likely to result in
highest possible exposure to this
herbicide. The other aspects of the turf
exposure scenario involve calculating
dose from non-dietary ingestion that
arises from the hand-to-mouth, object-
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to-mouth and soil ingestion pathways.
These processes are:
For toddlers: Incidental ingestion
(hand-to-mouth);
Incidental ingestion (turf-to-mouth);
Incidental ingestion (soil-to-mouth);
Incidental dermal;
For adults: Jazzercise (on treated turf).
EPA believes that this screening level
assessment will be protective of other
possible residential exposures to
ethofumesate such as golfing, and
mowing the lawn. Exposures were
calculated by considering the potential
sources of exposure then calculating
dermal exposure, and risks.
The Agency calculated Margin of
Exposure (MOE)s for each exposure
pathway and for all pathway
combinations.
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
ethofumesate and any other substances
and ethofumesate 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 ethofumesate 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 database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
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51513
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 UFs and/
or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
The Agency determined based on the
weight-of-the-evidence considerations
that there are no concerns or
uncertainties for prenatal and/or
postnatal toxicity resulting from
exposure to ethofumesate. There is
evidence for increased quantitative
susceptibility following in utero
exposure to rabbits. At 300 milligrams/
kilograms/day (mg/kg/day), no maternal
toxicity was reported but developmental
toxicity was observed as increased
resorptions, post-implantation loss and
skeletal abnormalities (incomplete
ossification of vertebral arches). No
evidence of increased susceptibility was
observed in the rat in either the
developmental or reproductive toxicity
study. In the rat developmental toxicity
study, no developmental effects were
reported at the highest dose tested (limit
dose of 1,000 mg/kg/day). In the 3generation rat reproductive toxicity
study, maternal, reproductive and
offspring toxicity were not observed at
any dose tested up to 5,000 ppm (396.8
and 462.5 mg/kg/day, males and
females, respectively).
The Agency concluded that although
increased prenatal quantitative
susceptibility was observed in the rabbit
developmental toxicity study, there is
no concern that the risk assessment will
not adequately safeguard against
potential prenatal and postnatal toxicity
because the developmental toxicity
NOAELs/LOAELs are well characterized
and are used as endpoints for risk
assessment for the appropriate
population subgroups.
3. Conclusion. The toxicity database
for ethofumesate is adequate in terms of
endpoint studies and dose response
information to characterize any
potential prenatal or postnatal risk for
infants and children. However, a 28–day
inhalation toxicity study has been
required to assess inhalation exposure,
due to the potential for inhalation
exposure during application. In the
absence of this study, the inhalation
exposure used a 100% default
assumption. Additionally, a dermal
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absorption (or penetration) study to
determine the dermal absorption
potential has been required since data
on dermal penetration of ethofumesate
are unavailable at this time. A default
assumption of 100% dermal absorption
was selected due to the unavailability of
comparative oral and dermal toxicity
data with a common endpoint in the
same species. There are several
uncertainties present in this risk
assessment:
i. While ethofumesate toxicological
databases are substantially complete,
confidence in several areas of the risk
assessment would improve with more
data. In addition to the requirement for
the 28–day inhalation study, data are
needed for residue chemistry (i.e, a new
cattle feeding study and recovery data
for metabolites) as well as for
metabolism (i.e. extensive field
rotational crop studies).
ii. The extrapolation from oral studies
for both the dermal and inhalation
portions of the risk assessment in
conjunction with a dose spacing
concern for the developmental study
used to develop residential or
occupational assessments for women
13+ years render a highly conservative
analysis.
iii. There are uncertainties associated
with the drinking water assessment but
the limitations related to modeling
drinking water exposure did not
contribute to an overall concern because
the highest aggregate food and water
values did not exceed Agency’s LOC.
Based on the available data, EPA is
confident that the values used in this
risk assessment are protective. No
increase in susceptibility of rats was
seen in developmental studies or in a rat
3-generation reproductive study.
Although increased prenatal
quantitative sensitivity was observed in
the rabbit developmental toxicity study,
the developmental toxicity NOAELs and
LOAELs are well characterized and are
used as endpoints for risk assessment
for the appropriate population
subgroups. The Agency evaluated the
potential for increased susceptibility of
infants and children from exposure to
ethofumesate as required by the FQPA
of 1996. All doses for risk assessment
purposes were assessed using UFs of
10X for interspecies extrapolation and
10X for intraspecies variability.
Acceptable developmental and
reproduction studies have been
submitted and reviewed.
The Agency evaluated the quality of
the exposure data to determine if the the
special FQPA (10X) Safety Factor can be
reduced based on the following
considerations:
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Dietary food exposure assessment
utilizes proposed tolerance level or
higher residues and 100 PCT
information for all commodities. By
using these screening-level assessments,
chronic exposures/risks will not be
underestimated.
Dietary drinking water assessment
(Tier 1 estimates) utilizes values
generated by model and associated
modeling parameters which are
designed to provide conservative, health
protective, high-end estimates of water
concentrations.
Residential exposure assessment
utilizes: Activity specific transfer
coefficients and chemical-specific turf
transferable residue (TTR) studies for
the post-application scenario. The
refined residential assessment is based
on reliable data and is unlikely to
underestimate exposure/risk.
The Agency concluded that there is
no concern for prenatal and/or postnatal
toxicity resulting from exposure to
ethofumesate. Therefore, no special
FQPA Safety Factor (i.e. 10X) is needed
since there are no residual uncertainties
for prenatal and/or postnatal toxicity.
Hence, a Safety Factor (1X) was applied.
E. Aggregate Risks and Determination of
Safety
In examining aggregate risk, the
Agency takes into account all available
reliable information concerning
exposures from pesticide residues in
food and other exposures including
drinking water and potential residential
exposure to pesticides from such uses as
lawn care applications (turf), golf course
and others. Aggregate risk assessment
considerations must also include
potential exposures from oral, dermal
and inhalation routes.
1. Acute risk. For the acute aggregate
risk scenario, food and drinking water
exposures were taken into account in
the dietary exposure assessment. The
estimated dietary exposures (food and
water) for females 13–49 years, the only
population subgroup of toxicological
concern identified at this time, at 4% of
the acute Population Adjusted Dose
(aPAD). The contribution of food and
food forms to this estimate, at the 95th
percentile, is 2.1%. A risk estimate that
is less than 100% of the aPAD, the dose
at which an individual could be
exposed on any given day with no
adverse health effects, does not exceed
the Agency’s LOC.
2. Chronic risk. For the chronic
aggregate risk scenario, food, drinking
water, and residential exposures were
taken into account. Chronic exposure in
residential settings is not expected and
the aggregate chronic assessment
included food and drinking water only.
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Since the dietary exposure assessment
already includes the highest chronic
exposure from the drinking water
modeling data, i.e., an estimated
maximum 1 in 10 year average
concentration of 45.5 ppb no further
calculations are necessary. The dietary
exposure estimate for all population
subgroups was <1% of the chronic
Population Adjusted Dose (cPAD) with
the most highly exposed subgroup being
all infants <1 yrs old. Risk estimates for
all population subgroups are below the
Agency’s LOC (100% of the cPAD).
3. Short- and intermediate-term
aggregate risk. Short- and Intermediateterm aggregate exposure takes into
account residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Ethofumesate is currently registered
for use that could result in short-term
residential exposure and the Agency has
determined that it is appropriate to
aggregate chronic food and water and
short-term exposures for ethofumesate.
For short- and intermediate-term
assessments, the oral, dermal and
inhalation pathways can be combined
due to the common toxicity endpoint
via the oral, dermal (oral equivalent)
and inhalation (oral equivalent) routes
for the appropriate population of
concern. For the short-and intermediateterm aggregate risk scenarios, food,
drinking water and residential
exposures are taken into account. The
aggregate short- and intermediate-term
MOEs, combining food, drinking water
and residential exposures ranged from
160 for all infants <1 yrs old to 270 for
the U.S. population. With the exception
of women of child-bearing years,
residential post-application MOEs for
toddlers and adults to ethofumesate on
treated turf, regardless of the pathway of
exposure, do not exceed the EPA’s LOC.
In the case of women of child-bearing
years, MOEs are 73 for 1.5 pounds
active ingedient/Acre (lb ai/A)
application rate for turf and 27 for the
3.0 lb ai/A application rate for turf. The
rate of 1.5 lb ai/A covers the majority of
uses; however, the label does permit a
3.0 lb ai/A rate specifically for
suppression of Bermuda grass in St
Augustine grass turf. While the
residential postapplication scenarios for
females resulted in apparent risks of
concern, the Agency believes that these
scenarios are very conservative and
unlikely to occur. The developmental
endpoint used to estimate risk for
females was based on a study with a
NOAEL (30 mg/kg/day) that is 10X
lower than the LOAEL (300 mg/kg/day);
therefore the NOAEL may be an artifact
of dose selection. Additionally, for the
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residential exposures, the endpoint is
oral while the assessed exposures are
dermal and conservative standard
operating procedure (SOP)-based default
assumptions such as 100% dermal
absorption, default turf transferable
residue dissipation assumptions,
contact with turf immediately posttreatment and maximum application
rates were used in this assessment.
Further, it should be noted that
estimated exposures are extremely
conservative due not only to assumption
of 100% dermal absorption but also
because they assume exposure at levels
immediately after application, maximal
levels of dermal exposure activity,
maximum dermal contact, and
maximum dermal surface contact areas.
Additionally, ethofumesate has minimal
lawncare and commercial turf uses,
which is the scenario where high
dermal exposure activities would occur.
The predominant use is on golf courses
and sod farms. High exposure activities
would likely not occur on a golf course.
Ethofumesate residues resulting from
sod farm application would likely
dissipate significantly before sod was
transplanted to residential or
commercial turf.
However, to address this concern, the
Agency is requiring a dermal absorption
study to permit more realistic
estimation of dermal absorption.
Nonetheless, Agency scientist’s consider
this a highly conservative estimate of
post-application risk for the population
females 13-49 years of age exposed to
ethofumesate on turf and based on the
available data, the EPA is confident that
the values used in this risk assessment
are protective.
4. Aggregate cancer risk for U.S.
population. Ethofumesate is classified
as ‘‘not likely to be a carcinogen to
humans’’ based on the lack of
carcinogenicity in the mouse
carcinogenicity study and lack of
convincing evidence for carcinogenicity
in the rat chronic toxicity/
carcinogenicity study. In addition, no
evidence of genotoxicity of
ethofumesate was observed in available
genotoxicity studies. Therefore,
ethofumesate is not expected to pose a
cancer risk and a cancer aggregate risk
assessment was not performed.
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 ethofumesate
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
A tolerance enforcement method is
listed as Method I in PAM Vol. II
(Section 108.345) for determining the
currently regulated residues in plants,
which include ethofumesate and its
metabolites (free and conjugated).
Residues are determined using gas
chromatography with flame ionization
detector (GC/FID) in the sulfur mode
with an internal standard. The reported
limit of quantification(LOQ) for each
analyte is 0.02 ppm.
Aequate enforcement methodology
(gas chromatography with flame
ionization detector (GC/FID)) 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 is currently no Codex,
Canadian, or Mexican maximum residue
levels (MRLs) established for
ethofumesate, therefore there are no
international harmonization issues for
this action.
V. Conclusion
Therefore, the tolerance is established
for combined residues of ethofumesate,
(2-ethoxy -2, 3-dihydro-3, 3-dimethyl-5benzofuranyl methanesulfonate) and its
metabolites 2-hydroxy-2,3-dihydro-3,3dimethyl-5-benzofuranyl
methanesulfonate and 2,3-dihydro-3,3dimethyl-2-oxo-5-benzofuranyl
methanesulfonate (both calculated as
the parent compound) in or on the raw
agricultural commodities: Carrot, roots
(with regional restrictions for us in the
States of Washington and Oregon) at 7.0
ppm; beet, garden, tops at 4 ppm; beet,
garden, roots at 0.5 ppm; onion, bulb at
0.25 ppm; garlic, bulb at 0.25 ppm;
shallot, bulb and shallot, fresh leaves at
0.25 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
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51515
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. The Agency hereby
certifies that this rule will not have
significant negative economic impact on
a substantial number of small entities.
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
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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).
jlentini on PROD1PC65 with RULES
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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16:32 Aug 29, 2006
Jkt 208001
Dated: August 23, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
FEDERAL COMMUNICATIONS
COMMISSION
I
Therefore, 40 CFR chapter I is
amended as follows:
[DA 06–1585; MB Docket No. 05–32; RM–
10988]
PART 180—[AMENDED]
Radio Broadcasting Services;
Homerville, GA and Jacksonville, FL
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
47 CFR Part 73
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
SUMMARY: At the request of Association
for the Studies of American Heritage
Corporation, the Audio Division allots
Channel 246A at Homerville, Georgia, as
that community’s second local aural
transmission service. To accommodate
the Homerville allotment, Station
WKQL(FM), Jacksonville, Florida,
Channel 245C, is reclassified to specify
operation on Channel 245C0. Channel
246A is allotted at Homerville with a
site restriction of 11.1 kilometers (6.9
§ 180.345 Ethofumesate; tolerances for
residues.
miles) northwest of the community at
coordinates 31–07–16 NL and 82–48–51
(a) General. (1) * * *
WL. Station WKQL(FM) is reclassified
to specify operation on Channel 245C0
Commodity
Parts per million
rather than Channel 245C, at
Beet, garden, roots .........
0.5 Jacksonville, Florida at its license
Beet, garden, tops ..........
4.0 coordinates 30–16–34 NL and 81–33–53
WL. 11.7 kilometers. A filing window
*
*
*
*
*
Garlic, bulb .....................
0.25 period for Channel 246A at Homerville
will not be opened at this time. Instead,
*
*
*
*
*
Onion, bulb .....................
0.25 the issue of opening this allotment for
Shallot, bulb ....................
0.25 auction will be addressed by the
Shallot, fresh leaves .......
0.25 Commission in a subsequent Order.
*
*
*
*
*
DATES: Effective September 25, 2006.
ADDRESSES: Secretary, Federal
*
*
*
*
*
Communications Commission, 445
Twelfth Street, SW., Washington, DC
(c) Tolerances with regional
20554.
registration. Tolerances with regional
registration as defined in 40 CFR
FOR FURTHER INFORMATION CONTACT:
180.1(m) are established for the
Victoria M. McCauley, Media Bureau,
combined residues of ethofumesate,(2(202) 418–2180.
ethoxy -2, 3-dihydro-3, 3-dimethyl-5SUPPLEMENTARY INFORMATION: This is a
benzofuranyl methanesulfonate) and its synopsis of the Commission’s Report
metabolites 2-hydroxy-2,3-dihydro-3,3and Order, MB Docket No. 05–32,
adopted August 9, 2006, and released
dimethyl-5-benzofuranyl
August 11, 2006. At the request of
methanesulfonate and 2,3-dihydro-3,3Association for the Studies of American
dimethyl-2-oxo-5-benzofuranyl
Heritage Corporation, the Audio
methanesulfonate (both calculated as
Division allots Channel 246A at
the parent compound) in or on the raw
Homerville, Georgia, as that
agricultural commodities:
community’s first local aural
transmission service. 70 FR 8333
Commodity
Parts per million
(February 18, 2005). The full text of this
Carrot, roots ....................
7.0 Commission decision is available for
inspection and copying during regular
business hours at the FCC’s Reference
*
*
*
*
*
Information Center, Portals II, 445
[FR Doc. E6–14431 Filed 8–29–06; 8:45 am]
Twelfth Street, SW., Room CY–A257,
BILLING CODE 6560–50–S
Washington, DC 20554. The complete
text of this decision may also be
purchased from the Commission’s
duplicating contractor, Best Copy and
2. Section 180.345 is amended as
follows:
i. In paragraph (a) by designating the
introductory text and table as paragraph
(a)(1) and by alphabetically adding
commodities to the table; and
ii. Paragraph (c) is amended by adding
text and a table.
The amendments read as follows:
I
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Agencies
[Federal Register Volume 71, Number 168 (Wednesday, August 30, 2006)]
[Rules and Regulations]
[Pages 51510-51516]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14431]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0537; FRL-8086-2]
Ethofumesate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
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
[[Page 51511]]
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: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7610; e-mail address: jackson.sidney@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-2005-0537 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 EPA-HQ-OPP-2005-0537, 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 March 22, 2006 (71 FR 14522) (FRL-7767-
8), 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)
3E6564, 3E6565 and 5E6914) by IR-4, 681 Highway 1 South, North
Brunswick, NJ 08902-3390 on behalf of the registrant, Bayer
CropScience. The petition requested that 40 CFR 180.345 be amended by
establishing tolerances for combined residues of the herbicide
ethofumesate (2-ethoxy -2, 3-dihydro-3, 3-dimethyl-5-benzofuranyl
methanesulfonate) and its metabolites 2-hydroxy-2,3-dihydro-3,3-
dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-
2-oxo-5-benzofuranyl methanesulfonate (both calculated as the parent
compound) in or on the raw agricultural commodities: Carrots (with
regional restrictions for use in the States of Washington and Oregon)
at 10 parts per million (ppm) (PP 3E6565), garden beets tops at 4 ppm,
garden beet roots at 0.5 ppm (PP 3E6564), onion, dry bulb at 0.30 ppm
(PP 5E6914), garlic, bulb at 0.30 ppm (PP 5E6914), and shallot at 0.30
ppm (PP 5E6914). That notice included a summary of the petitions
prepared by Bayer CropScience, P. O. Box 12014, 2 T. W. Alexander
Drive, Research Triangle Park, NC 27709, the registrant. There were no
comments received in response to the notice of filing.
Supporting documents including the Reregistration Eligibility
Decision (RED) for Ethofumesate, EPA 738-R-05-010, Sept. 2005, can be
viewed on-line along with the Agency's Human Health Risk Assessment of
ethofumesate and other supporting documents at www.regulations.gov
under the index of the docket for this action, Docket ID number: EPA-
HQ-OPP-2005-0537. The Agency's reregistration and tolerance
reassessment of ethofumesate are completed. Due to its uses, risks, and
other factors, ethofumesate was reviewed/reassessed through the
modified 4-Phase process as outlined in the Federal Register on May 14,
2004 (69 FR 26819)(FRL-7357-9). Through this process, EPA worked
extensively with stakeholders and the public to reach the regulatory
decisions for ethofumesate.
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
[[Page 51512]]
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
ethofumesate on: Carrot (with regional restrictions for use in
Washington and Oregon) at 7.0 ppm, beet, garden, tops at 4.0 ppm, beet,
garden, roots at 0.5 ppm, onion, dry bulb at 0.25 ppm, garlic, bulb at
0.25 ppm, and shallot at 0.25 ppm. It can be noted that the tolerance
level for certain commodities was revised, based on current data
evaluations and differ from the proposed level presented in the Notice
of Filing on March 22, 2006 or as recommended in the RED for
ethofumesate. These revisions include: Carrot tolerance at 7.0 ppm,
reduced from 10.0 ppm; and garlic, bulb; onion, dry bulb and shallot
tolerances set at 0.25 ppm, reduced from 0.30 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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 ethofumesate 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.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at 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 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 ethofumesate used for
human risk assessment can be found in the index of this document,
Docket ID number EPA-HQ-OPP-2005-0537, entitled, ``Human Health Risk
Assessment for Proposed Uses on Onion, Bulb'', (Table 3.4.15) (dated
April 24, 2006).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.345 for the combined residues of ethofumesate,
in or on a variety of raw agricultural commodities; plant commodities
range from 0.1 ppm in/on sugar beet roots to 1.0 ppm in/on sugar beet
tops and grass straw. Tolerances on animal commodities including fat,
meat and meat byproducts are set at 0.05 ppm. A process feeds tolerance
in sugar beet molasses is set at 0.5 ppm. Risk assessments were
conducted by EPA to assess dietary exposures from ethofumesate 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.
No appropriate endpoint was identified for the general population
and infants since no such effects were identified in the toxicological
studies for ethofumesate; therefore, a quantitative acute dietary
exposure assessment was not conducted for these populations. For
females, 13 plus years of age, in conducting the acute dietary (food +
water) exposure assessment, EPA used the Dietary Exposure Evaluation
Model software with the Food Commodity Intake Database (DEEM-FCID(\TM\)
Version 2.03), 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 acute exposure assessments: A conservative acute dietary
assessment was performed using tolerance level residues and 100 % crop
treated (PCT) in the assessment.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID\TM\. The following assumptions were
made for the chronic exposure assessments: A conservative chronic
dietary (food + water) assessment was performed using tolerance level
residues and 100 PCT.
iii. Cancer. Ethofumesate is classified as ``not likely to be a
human carcinogen,'' based on bioassays in the rat and the mouse. An
exposure assessment for the purpose of assessing cancer risk is not
needed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for ethofumesate in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of ethofumesate. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found https://www.epa.gov/oppefed1/models/water/index. Typically EPA
evaluates the potential for human exposure to pesticides in drinking
water through an assessment of available surface water and ground water
monitoring data and modeling.
[[Page 51513]]
For ethofumesate, no monitoring data were available for use in this
drinking water assessment. Therefore, potential human exposures to
ethofumesate were evaluated through modeling. Estimated exposure
concentrations (EECs) in surface water were calculated using Pesticide
Root Zone Model/Exposure Analyses Modeling System (PRZM/EXAMS). Ground
water concentrations were modeled using screening concentration in
ground water (SCI-GROW) (version 2.3). Drinking water residues were
then incorporated into the DEEM-FCID(\TM\) into the food categories
``water, direct, all sources'' and ``water, indirect, all sources.''
The Agency concluded that degradates of ethofumesate are of
toxicological equivalence to the parent. Because these degradates were
detected in environmental fate studies in relatively low amounts (10%),
only the parent needs to be assessed for drinking water.
Based on the PRZM/EXAMS - Index Reservoir and SCI-GROW models, the
estimated environmental concentrations (EECs) of ethofumesate for acute
exposures are estimated to be 154 parts per billion (ppb) for surface
water and 8.4 ppb for ground water. The EECs for chronic exposures are
estimated to be 45.5 ppb for for surface water and 8.4 ppb for ground
water. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\). For the acute
assessment, the peak concentration of 154 ppb was used to access the
contribution to drinking water; for the chronic assessment, the annual
mean value of 45.5 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).
Ethofumesate is currently registered for use on the following
residential non-dietary sites: Turf grasses/lawns. The risk assessment
was conducted using the following residential exposure assumptions: All
ethofumesate products are intended for either agricultural use or
require professional application for ornamental turf. For potential
ethofumesate residential post-application exposure, the Agency
conducted screening level calculations on the scenarios most likely to
result in highest possible exposure to this herbicide. The other
aspects of the turf exposure scenario involve calculating dose from
non-dietary ingestion that arises from the hand-to-mouth, object-to-
mouth and soil ingestion pathways. These processes are:
For toddlers: Incidental ingestion (hand-to-mouth);
Incidental ingestion (turf-to-mouth);
Incidental ingestion (soil-to-mouth);
Incidental dermal;
For adults: Jazzercise (on treated turf).
EPA believes that this screening level assessment will be
protective of other possible residential exposures to ethofumesate such
as golfing, and mowing the lawn. Exposures were calculated by
considering the potential sources of exposure then calculating dermal
exposure, and risks.
The Agency calculated Margin of Exposure (MOE)s for each exposure
pathway and for all pathway combinations.
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 ethofumesate and any other
substances and ethofumesate 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 ethofumesate 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 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. 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 UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. The Agency determined based
on the weight-of-the-evidence considerations that there are no concerns
or uncertainties for prenatal and/or postnatal toxicity resulting from
exposure to ethofumesate. There is evidence for increased quantitative
susceptibility following in utero exposure to rabbits. At 300
milligrams/kilograms/day (mg/kg/day), no maternal toxicity was reported
but developmental toxicity was observed as increased resorptions, post-
implantation loss and skeletal abnormalities (incomplete ossification
of vertebral arches). No evidence of increased susceptibility was
observed in the rat in either the developmental or reproductive
toxicity study. In the rat developmental toxicity study, no
developmental effects were reported at the highest dose tested (limit
dose of 1,000 mg/kg/day). In the 3-generation rat reproductive toxicity
study, maternal, reproductive and offspring toxicity were not observed
at any dose tested up to 5,000 ppm (396.8 and 462.5 mg/kg/day, males
and females, respectively).
The Agency concluded that although increased prenatal quantitative
susceptibility was observed in the rabbit developmental toxicity study,
there is no concern that the risk assessment will not adequately
safeguard against potential prenatal and postnatal toxicity because the
developmental toxicity NOAELs/LOAELs are well characterized and are
used as endpoints for risk assessment for the appropriate population
subgroups.
3. Conclusion. The toxicity database for ethofumesate is adequate
in terms of endpoint studies and dose response information to
characterize any potential prenatal or postnatal risk for infants and
children. However, a 28-day inhalation toxicity study has been required
to assess inhalation exposure, due to the potential for inhalation
exposure during application. In the absence of this study, the
inhalation exposure used a 100% default assumption. Additionally, a
dermal
[[Page 51514]]
absorption (or penetration) study to determine the dermal absorption
potential has been required since data on dermal penetration of
ethofumesate are unavailable at this time. A default assumption of 100%
dermal absorption was selected due to the unavailability of comparative
oral and dermal toxicity data with a common endpoint in the same
species. There are several uncertainties present in this risk
assessment:
i. While ethofumesate toxicological databases are substantially
complete, confidence in several areas of the risk assessment would
improve with more data. In addition to the requirement for the 28-day
inhalation study, data are needed for residue chemistry (i.e, a new
cattle feeding study and recovery data for metabolites) as well as for
metabolism (i.e. extensive field rotational crop studies).
ii. The extrapolation from oral studies for both the dermal and
inhalation portions of the risk assessment in conjunction with a dose
spacing concern for the developmental study used to develop residential
or occupational assessments for women 13+ years render a highly
conservative analysis.
iii. There are uncertainties associated with the drinking water
assessment but the limitations related to modeling drinking water
exposure did not contribute to an overall concern because the highest
aggregate food and water values did not exceed Agency's LOC. Based on
the available data, EPA is confident that the values used in this risk
assessment are protective. No increase in susceptibility of rats was
seen in developmental studies or in a rat 3-generation reproductive
study. Although increased prenatal quantitative sensitivity was
observed in the rabbit developmental toxicity study, the developmental
toxicity NOAELs and LOAELs are well characterized and are used as
endpoints for risk assessment for the appropriate population subgroups.
The Agency evaluated the potential for increased susceptibility of
infants and children from exposure to ethofumesate as required by the
FQPA of 1996. All doses for risk assessment purposes were assessed
using UFs of 10X for interspecies extrapolation and 10X for
intraspecies variability. Acceptable developmental and reproduction
studies have been submitted and reviewed.
The Agency evaluated the quality of the exposure data to determine
if the the special FQPA (10X) Safety Factor can be reduced based on the
following considerations:
Dietary food exposure assessment utilizes proposed tolerance level
or higher residues and 100 PCT information for all commodities. By
using these screening-level assessments, chronic exposures/risks will
not be underestimated.
Dietary drinking water assessment (Tier 1 estimates) utilizes
values generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations.
Residential exposure assessment utilizes: Activity specific
transfer coefficients and chemical-specific turf transferable residue
(TTR) studies for the post-application scenario. The refined
residential assessment is based on reliable data and is unlikely to
underestimate exposure/risk.
The Agency concluded that there is no concern for prenatal and/or
postnatal toxicity resulting from exposure to ethofumesate. Therefore,
no special FQPA Safety Factor (i.e. 10X) is needed since there are no
residual uncertainties for prenatal and/or postnatal toxicity. Hence, a
Safety Factor (1X) was applied.
E. Aggregate Risks and Determination of Safety
In examining aggregate risk, the Agency takes into account all
available reliable information concerning exposures from pesticide
residues in food and other exposures including drinking water and
potential residential exposure to pesticides from such uses as lawn
care applications (turf), golf course and others. Aggregate risk
assessment considerations must also include potential exposures from
oral, dermal and inhalation routes.
1. Acute risk. For the acute aggregate risk scenario, food and
drinking water exposures were taken into account in the dietary
exposure assessment. The estimated dietary exposures (food and water)
for females 13-49 years, the only population subgroup of toxicological
concern identified at this time, at 4% of the acute Population Adjusted
Dose (aPAD). The contribution of food and food forms to this estimate,
at the 95th percentile, is 2.1%. A risk estimate that is less than 100%
of the aPAD, the dose at which an individual could be exposed on any
given day with no adverse health effects, does not exceed the Agency's
LOC.
2. Chronic risk. For the chronic aggregate risk scenario, food,
drinking water, and residential exposures were taken into account.
Chronic exposure in residential settings is not expected and the
aggregate chronic assessment included food and drinking water only.
Since the dietary exposure assessment already includes the highest
chronic exposure from the drinking water modeling data, i.e., an
estimated maximum 1 in 10 year average concentration of 45.5 ppb no
further calculations are necessary. The dietary exposure estimate for
all population subgroups was <1% of the chronic Population Adjusted
Dose (cPAD) with the most highly exposed subgroup being all infants <1
yrs old. Risk estimates for all population subgroups are below the
Agency's LOC (100% of the cPAD).
3. Short- and intermediate-term aggregate risk. Short- and
Intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Ethofumesate is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for ethofumesate.
For short- and intermediate-term assessments, the oral, dermal and
inhalation pathways can be combined due to the common toxicity endpoint
via the oral, dermal (oral equivalent) and inhalation (oral equivalent)
routes for the appropriate population of concern. For the short-and
intermediate-term aggregate risk scenarios, food, drinking water and
residential exposures are taken into account. The aggregate short- and
intermediate-term MOEs, combining food, drinking water and residential
exposures ranged from 160 for all infants <1 yrs old to 270 for the
U.S. population. With the exception of women of child-bearing years,
residential post-application MOEs for toddlers and adults to
ethofumesate on treated turf, regardless of the pathway of exposure, do
not exceed the EPA's LOC.
In the case of women of child-bearing years, MOEs are 73 for 1.5
pounds active ingedient/Acre (lb ai/A) application rate for turf and 27
for the 3.0 lb ai/A application rate for turf. The rate of 1.5 lb ai/A
covers the majority of uses; however, the label does permit a 3.0 lb
ai/A rate specifically for suppression of Bermuda grass in St Augustine
grass turf. While the residential postapplication scenarios for females
resulted in apparent risks of concern, the Agency believes that these
scenarios are very conservative and unlikely to occur. The
developmental endpoint used to estimate risk for females was based on a
study with a NOAEL (30 mg/kg/day) that is 10X lower than the LOAEL (300
mg/kg/day); therefore the NOAEL may be an artifact of dose selection.
Additionally, for the
[[Page 51515]]
residential exposures, the endpoint is oral while the assessed
exposures are dermal and conservative standard operating procedure
(SOP)-based default assumptions such as 100% dermal absorption, default
turf transferable residue dissipation assumptions, contact with turf
immediately post-treatment and maximum application rates were used in
this assessment.
Further, it should be noted that estimated exposures are extremely
conservative due not only to assumption of 100% dermal absorption but
also because they assume exposure at levels immediately after
application, maximal levels of dermal exposure activity, maximum dermal
contact, and maximum dermal surface contact areas. Additionally,
ethofumesate has minimal lawncare and commercial turf uses, which is
the scenario where high dermal exposure activities would occur. The
predominant use is on golf courses and sod farms. High exposure
activities would likely not occur on a golf course. Ethofumesate
residues resulting from sod farm application would likely dissipate
significantly before sod was transplanted to residential or commercial
turf.
However, to address this concern, the Agency is requiring a dermal
absorption study to permit more realistic estimation of dermal
absorption. Nonetheless, Agency scientist's consider this a highly
conservative estimate of post-application risk for the population
females 13-49 years of age exposed to ethofumesate on turf and based on
the available data, the EPA is confident that the values used in this
risk assessment are protective.
4. Aggregate cancer risk for U.S. population. Ethofumesate is
classified as ``not likely to be a carcinogen to humans'' based on the
lack of carcinogenicity in the mouse carcinogenicity study and lack of
convincing evidence for carcinogenicity in the rat chronic toxicity/
carcinogenicity study. In addition, no evidence of genotoxicity of
ethofumesate was observed in available genotoxicity studies. Therefore,
ethofumesate is not expected to pose a cancer risk and a cancer
aggregate risk assessment was not performed.
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 ethofumesate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A tolerance enforcement method is listed as Method I in PAM Vol. II
(Section 108.345) for determining the currently regulated residues in
plants, which include ethofumesate and its metabolites (free and
conjugated). Residues are determined using gas chromatography with
flame ionization detector (GC/FID) in the sulfur mode with an internal
standard. The reported limit of quantification(LOQ) for each analyte is
0.02 ppm.
Aequate enforcement methodology (gas chromatography with flame
ionization detector (GC/FID)) 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 is currently no Codex, Canadian, or Mexican maximum residue
levels (MRLs) established for ethofumesate, therefore there are no
international harmonization issues for this action.
V. Conclusion
Therefore, the tolerance is established for combined residues of
ethofumesate, (2-ethoxy -2, 3-dihydro-3, 3-dimethyl-5-benzofuranyl
methanesulfonate) and its metabolites 2-hydroxy-2,3-dihydro-3,3-
dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-
2-oxo-5-benzofuranyl methanesulfonate (both calculated as the parent
compound) in or on the raw agricultural commodities: Carrot, roots
(with regional restrictions for us in the States of Washington and
Oregon) at 7.0 ppm; beet, garden, tops at 4 ppm; beet, garden, roots at
0.5 ppm; onion, bulb at 0.25 ppm; garlic, bulb at 0.25 ppm; shallot,
bulb and shallot, fresh leaves at 0.25 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 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. The Agency hereby certifies that this rule will not
have significant negative economic impact on a substantial number of
small entities. 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
[[Page 51516]]
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.
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2. Section 180.345 is amended as follows:
i. In paragraph (a) by designating the introductory text and table
as paragraph (a)(1) and by alphabetically adding commodities to the
table; and
ii. Paragraph (c) is amended by adding text and a table.
The amendments read as follows:
Sec. 180.345 Ethofumesate; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Beet, garden, roots.................................. 0.5
Beet, garden, tops................................... 4.0
* * * * *
Garlic, bulb......................................... 0.25
* * * * *
Onion, bulb.......................................... 0.25
Shallot, bulb........................................ 0.25
Shallot, fresh leaves................................ 0.25
* * * * *
------------------------------------------------------------------------
* * * * *
(c) Tolerances with regional registration. Tolerances with regional
registration as defined in 40 CFR 180.1(m) are established for the
combined residues of ethofumesate,(2-ethoxy -2, 3-dihydro-3, 3-
dimethyl-5-benzofuranyl methanesulfonate) and its metabolites 2-
hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and
2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate (both
calculated as the parent compound) in or on the raw agricultural
commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Carrot, roots........................................ 7.0
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-14431 Filed 8-29-06; 8:45 am]
BILLING CODE 6560-50-S