

[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Rules and Regulations]               
[Page 51510-51516]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au06-20]                         

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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.

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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 http://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 http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://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 http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm



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: http://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 http://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 http://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 
http://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 http://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 http://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 http://www.epa.gov/pesticides/cumulative
.


D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the 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.

0
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
