Document ID: EPA-HQ-OPP-2007-1192-0004
Agency: epa
Document Type: Rule
Title: Famoxadone; Pestice Tolerances
Posted Date: 2009-03-04T05:00Z

[Federal Register: March 4, 2009 (Volume 74, Number 41)]
[Rules and Regulations]               
[Page 9358-9365]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr09-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1192; FRL-8400-9]

 
Famoxadone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
famoxadone in or on caneberry subgroup 13-07A; cilantro, leaves; onion, 
bulb, subgroup 3-07A; onion, green, subgroup 3-07B; spinach; and 
vegetable, leafy, except Brassica, group 4, except spinach. It also 
removes existing tolerances on lettuce, head; and caneberry, subgroup 
13A that are superseded by the new tolerances on vegetable, leafy, 
except Brassica, group 4, except spinach; and caneberry subgroup 13-
07A. Interregional Research Project Number 4 (IR-4) requested these 
amendments under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 4, 2009. Objections and 
requests for hearings must be received on or before May 4, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-1192. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200

[[Page 9359]]

Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 305-5218; e-mail address: stanton.susan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
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 EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR site 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2007-1192 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before May 4, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-1192, 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 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of March 12, 2008 (73 FR 13225) (FRL-8354-
6), 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 
7E7280 and 7E7281) by Interregional Research Project Number 4 (IR-4), 
500 College Road East, Suite 201 W, Princeton, NJ 08540. The petitions 
requested that 40 CFR 180.587 be amended by establishing tolerances for 
residues of the fungicide, famoxadone, 3-anilino-5-methyl-5-(4-
phenoxyphenyl)-1,3-oxazolidine-2,4-dione, in or on leaf petioles, 
subgroup 4B at 25 parts per million (ppm) (PP 7E7280); leafy greens, 
subgroup 4A and cilantro at 50 ppm; bulb vegetables, group 3-07 at 40 
ppm; and caneberry, subgroup 13-07A at 10 ppm (all in PP 7E7281). IR-4 
also proposed in petition 7E7281 to remove the existing tolerances in 
40 CFR 180.587 for residues of the fungicide famoxadone in or on the 
food commodities lettuce, head; and caneberry, subgroup 13A, which 
would be superseded by the tolerances on leafy, greens, subgroup 4A; 
and caneberry, subgroup 13-07A. That notice referenced a summary of the 
petition prepared on behalf of IR-4 by E.I. du Pont de Nemours and 
Company, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA has 
determined that separate tolerances at different levels are needed for 
the bulb and green onion subgroups of bulb vegetables group 3-07. EPA 
has also determined that tolerances should be established on 
``vegetable, leafy, except Brassica, group 4, except spinach'' at 25 
ppm with a separate tolerance of 50 ppm on spinach, rather than the 
proposed tolerances on subgroups 4A at 50 ppm and 4B at 25 ppm. The 
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for residues of famoxadone on caneberry subgroup 13-07A at 
10 ppm; cilantro, leaves at 25.0 ppm; onion, bulb, subgroup 3-07A at 
0.45 ppm; onion, green, subgroup 3-07B at 40 ppm; spinach at 50 ppm; 
and vegetable, leafy, except Brassica, group 4, except spinach at 25 
ppm. EPA's

[[Page 9360]]

assessment of exposures and risks associated with establishing these 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Famoxadone has low acute toxicity by the oral, dermal and 
inhalation routes of exposure. It is a moderate eye and skin irritant 
but is not a dermal sensitizer. In subchronic and chronic feeding 
studies in rats, mice, dogs and cynomolgus monkeys, famoxadone 
generally caused decreased body weights and body weight gains, often 
accompanied by decreased food consumption and food efficiency. A mild 
regenerative hemolytic anemia was also regularly observed in these 
animals as evidenced by decreased erythrocyte counts, hemoglobin and/or 
hematocrit, increased reticulocytes, and other related changes in 
hematologic parameters. Famoxadone also induced a mild hepatotoxicity 
in treated animals characterized by elevated levels of clinical 
chemistry enzymes indicative of liver damage (increased alkaline 
phosphatase, alanine aminotransferase, aspartate aminotransferase, and/
or sorbitol dehydrogenase) and by histopathological lesions in the 
liver (single cell or focal necrosis, hepatocellular degeneration, 
diffuse fatty change, foci of eosinophilic cellular alteration, 
apoptosis and increased mitotic figures). Both the anemia and the 
hepatotoxicity were mild and did not significantly compromise the 
overall health status of the treated animals. In repeated dose studies 
the anemia, which occurred early in the studies, often appeared to be 
fully compensated for in the latter stages of the studies. Although the 
hepatotoxicity persisted throughout the duration of the studies, it was 
mild or moderate in intensity and not severe or life-threatening.
    Additional treatment-related effects were observed in dogs that 
were not observed in other species. In a 13-week feeding study, 
clinical signs of neurotoxicity (myotonic twitches) were observed in 
male and female dogs at the highest dose tested throughout the duration 
of the study. These twitches were not observed, however, at lower doses 
in the same study or in a 1-year feeding study in dogs. Also, in both 
male and female dogs, famoxadone induced treatment-related cataracts in 
the lens of the eye in the 13-week feeding study and in the 1-year 
feeding study. The eye effects were observed at dose levels below those 
at which any other effects were observed in any other species and 
served as the basis for many of the risk assessments in humans.
    There was no indication of increased quantitative or qualitative 
susceptibility of fetuses or offspring to famoxadone exposure in the 
developmental toxicity studies in rats and rabbits or the 2-generation 
reproduction toxicity study in rats. In a developmental toxicity study 
in rats, no developmental toxicity was observed in the fetuses at the 
highest dose tested. Transient decreases in body weight gain and food 
consumption were noted in the dams in this study. In a developmental 
toxicity study in rabbits, an increased incidence of abortions was 
observed. The does which aborted had markedly decreased body weight, 
body weight gain and food consumption. There was also an equivocal 
increase in percent postimplantation loss and mean number of 
resorptions per doe in this study. In the reproduction toxicity study 
in rats, offspring toxicity (decreased body weights for F1 and F2 pups 
throughout lactation) was noted at a dose that also resulted in 
parental toxicity (decreased body weight, body weight gain, and food 
consumption; and hepatotoxicity). No reproductive toxicity was observed 
in this study at the highest dose tested.
    In an acute neurotoxicity study in rats, there was equivocal 
evidence of a possible slight neurotoxic effect at the limit dose. In 
this study, an increased incidence of palpebral (eyelid) closure was 
observed, but only in males and only on day one. Other than this 
equivocal evidence and the clinical observations in the 13-week feeding 
study in dogs of myotonic twitching in the high dose male and female 
animals, there was no evidence of treatment-related neurotoxicity in 
the toxicity studies on famoxadone, including a subchronic 
neurotoxicity study in rats.
    In 28-day immunotoxicity studies in rats and mice, there was no 
evidence of immunotoxicity following exposure to famoxadone.
    In carcinogenicity studies in male and female rats and mice, 
famoxadone did not demonstrate any biologically significant evidence of 
carcinogenic potential. Famoxadone is classified as ``not likely to be 
carcinogenic to humans.''
     Specific information on the studies received and the nature of the 
adverse effects caused by famoxadone as well as the no-observed-
adverse-effect-level and the lowest-observed-adverse-effect-level from 
the toxicity studies can be found at http://www.regulations.gov in the 
document Famoxadone. Human Health Risk Assessment for the Proposed Food 
Use of Famoxadone on Bulb Vegetables, Crop Group 3; Leafy Greens, 
Subgroup 4A; Leaf Petioles, Subgroup 4B; and Cilantro at page 54 in 
docket ID number EPA-HQ-OPP-2007-1192.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for famoxadone used for 
human risk assessment can be found at http://www.regulations.gov in the 
document Famoxadone. Human Health Risk Assessment for the Proposed Food

[[Page 9361]]

Use of Famoxadone on Bulb Vegetables, Crop Group 3; Leafy Greens, 
Subgroup 4A; Leaf Petioles, Subgroup 4B; and Cilantro at page 31 in 
docket ID number EPA-HQ-OPP-2007-1192.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to famoxadone, EPA considered exposure under the petitioned-
for tolerances as well as all existing famoxadone tolerances in 40 CFR 
180.587. EPA assessed dietary exposures from famoxadone 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 such effects were 
identified in the toxicological studies for famoxadone; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture (USDA) 1994-1996, and 1998 Continuing Surveys of Food 
Intakes by Individuals (CSFII). As to residue levels in food, EPA used 
average residues from field trials for most plant commodities and 
anticipated residues based on the anticipated dietary burdens of 
livestock for animal commodities. Empirical processing factors were 
used to refine the residue estimates of processed tomato, pepper, 
potato and grape commodities. For leafy vegetables, empirically-derived 
reduction factors were applied to account for reduction of residues 
from washing and removal of outer leaves. Percent crop treated (PCT) 
and projected PCT estimates were used to further refine exposure 
estimates for many of the existing and new uses of famoxadone.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA classified famoxadone as ``not likely to be 
carcinogenic to humans;'' therefore, an exposure assessment for 
evaluating cancer risk is not needed for this chemical.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such Data Call-Ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Cucumbers 5%, peppers 5%, potatoes 5%, pumpkins 5%, squash 1%, 
tomatoes 10% and watermelons 1%.
    In most cases, EPA uses available data from U.S. Department of 
Agriculture/National Agricultural Statistics Service (USDA/NASS), 
proprietary market surveys, and the National Pesticide Use Database for 
the chemical/crop combination for the most recent 6 years. EPA uses an 
average PCT for chronic dietary risk analysis. The average PCT figure 
for each existing use is derived by combining available public and 
private market survey data for that use, averaging across all 
observations, and rounding to the nearest 5%, except for those 
situations in which the average PCT is less than one. In those cases, 
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA 
uses a maximum PCT for acute dietary risk analysis. The maximum PCT 
figure is the highest observed maximum value reported within the recent 
6 years of available public and private market survey data for the 
existing use and rounded up to the nearest multiple of 5%.
    The Agency used projected percent crop treated (PPCT) information 
for certain new crops (celery, lettuce, and spinach) as well as the 
currently registered crop, grapes. Since famoxadone has only been 
registered on grapes for 1 year, PCT estimates based on actual usage 
data were not deemed sufficient indicators of potential usage on 
grapes. The following PPCT estimates were used in the chronic dietary 
exposure assessment: Celery 39%, grapes (wine and table) 5%, grape 
(juice) 50%, lettuce (head) 67%, lettuce (other) 62%, and spinach 39%.
    EPA estimates PPCT for a new pesticide use by assuming that the 
percent crop treated (PCT) during the pesticide's initial 5 years of 
use on a specific use site will not exceed the average PCT of the 
dominant pesticide (i.e., the one with the greatest PCT) on that site 
over the three most recent surveys. Comparisons are only made among 
pesticides of the same pesticide type (i.e., the dominant fungicide on 
the use site is selected for comparison with a new fungicide). The PCTs 
included in the average may be each for the same pesticide or for 
different pesticides since the same or different pesticides may 
dominate for each year selected. Typically, EPA uses USDA/NASS data as 
the source for raw PCT data because it is publicly available and does 
not have to be calculated from other available data. When a specific 
use site is not surveyed by USDA/NASS, EPA uses proprietary data and 
calculates the estimated PCT.
    This estimated PPCT, based on the average PCT of the market leader, 
is appropriate for use in the chronic dietary risk assessment. This 
method of estimating a PPCT for a new use of a registered pesticide or 
a new pesticide produces a high-end estimate that is unlikely, in most 
cases, to be exceeded during the initial 5 years of actual use.
    The predominant factors that bear on whether the estimated PPCT 
could be exceeded are whether the new pesticide use is more efficacious 
or controls a broader spectrum of pests than the dominant pesticide(s), 
whether there are concerns with pest pressures as indicated in 
emergency exemption requests (http://www.epa.gov/opprd001/section18/) 
or other readily available information, and/or other factors based on 
analysis of additional information. All information readily available 
has been considered for famoxadone on celery, lettuce and spinach, and 
it is the opinion of EPA that it is unlikely that actual PCTs for 
famoxadone on these sites will exceed the corresponding estimated PPCTs 
during the next 5 years.
     A discussion of the factors considered in making this 
determination can be found in the document PPCT for the Use of 
Fungicide Famoxadone (PC 113202)

[[Page 9362]]

on celery (DP 357845), lettuce and spinach (DP 357847), and grapes (no 
BEAN). Additional Factors Revised in this Memorandum. The referenced 
document is available at www.regulations.gov in docket ID number EPA-
HQ-OPP-2007-1192.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which famoxadone may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for famoxadone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of famoxadone. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
famoxadone for acute exposures are estimated to be 6.2 parts per 
billion (ppb) for surface water and 0.01 ppb for ground water. EDWCs of 
famoxadone for chronic exposures for non-cancer assessments are 
estimated to be 0.189 ppb for surface water and 0.01 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.189 ppb was used to 
assess the contribution to drinking water. As explained in Unit 
III.C.1.i. an acute dietary risk assessment for famoxadone is 
unnecessary.
    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). Famoxadone is not 
registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found famoxadone to share a common mechanism of 
toxicity with any other substances, and famoxadone does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
famoxadone does not have 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 EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines, based on reliable data, that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicity database for famoxadone includes rat and rabbit developmental 
toxicity studies and a 2-generation reproduction toxicity study in 
rats. There was no evidence of increased quantitative or qualitative 
susceptibility of in utero rats or rabbits in the developmental 
toxicity studies or of offspring in the rat reproduction study.
    3. Conclusion. EPA has determined that the FQPA safety factor of 
10X must be retained as a database uncertainty factor for the chronic 
dietary exposure assessment. That decision is based on the following 
findings:
    i. Although the toxicity database for famoxadone is complete, there 
is uncertainty related to the 13-week feeding study in dogs that was 
selected to assess chronic dietary exposures to famoxadone. EPA has 
determined that the 10X FQPA safety factor must be retained to account 
for the uncertainty arising due to the lack of a NOAEL in this study 
and extrapolation from a subchronic to chronic exposure duration. A 10X 
uncertainty factor is considered to provide an adequate margin of 
safety during development, based on several considerations. First, the 
LOAEL appeared to be a threshold effect level based on the minimal 
findings observed. The endpoint (microscopic lens lesions, cataracts, 
in the eyes of female dogs) was of minimal severity at the lowest dose 
tested (1.4 milligrams/kilogram/day (mg/kg/day)). This finding would 
probably have very little effect on vision, and no evidence of 
cataracts was observed in the ophthalmologic examination. Second, 
although the microscopic data in the chronic dog study were not 
considered acceptable due to fixation artifact, there was no evidence 
of cataracts in the ophthalmologic examination at a similar dose (1.2 
mg/kg/day), suggesting that progression with time was minimal at that 
dose. Finally, there was no evidence of cataracts in monkeys 
administered famoxadone for 1-year at doses up to 1,000 mg/kg/day. The 
lack of cataracts in a primate species provides suggestive evidence 
that humans may be less sensitive than dogs for this effect.
    ii. There was equivocal evidence of a slight neurotoxic effect 
(eyelid closure) at the limit dose in the acute neurotoxicity study in 
rats, and myotonic twitching was noted at the high dose in male and 
female dogs in the 13-week feeding study. In this same study, one 
female dog in the high dose group also had convulsions and ataxia on 
day 34. Since there was no evidence of treatment-related neurotoxicity 
at lower doses in these studies or in any other famoxadone toxicity 
studies, including a subchronic neurotoxicity study in rats and the 1-
year feeding study in dogs, EPA has concluded that

[[Page 9363]]

there is not a concern for neurotoxicity from exposure to famoxadone, 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that famoxadone results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were refined for most 
commodities using reliable PCT/PPCT information and anticipated residue 
values calculated from valid field trial data. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to famoxadone in drinking water. Residential 
exposure to famoxadone is not expected. These assessments will not 
underestimate the exposure and risks posed by famoxadone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
famoxadone is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
famoxadone from food and water will utilize 65% of the cPAD for adult 
males, 20 years and older, the population group receiving the greatest 
exposure. There are no residential uses for famoxadone.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Famoxadone is 
not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term aggregate risk is the sum of the 
risk from exposure to famoxadone through food and water and will not be 
greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Famoxadone is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to famoxadone through food and water, which has already been addressed, 
and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Famoxadone is 
classified as ``not likely to be carcinogenic to humans'' and is, 
therefore, not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to famoxadone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography with Nitrogen 
Phosphorus Detection (GC/NPD)) is available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX maximum residue limits (MRLS) established for 
famoxadone on the commodities associated with these petitions.

C. Response to Comments

    Comments were received from a private citizen objecting to EPA's 
reliance on animal toxicity testing on the basis that it is inhumane 
and not indicative of the potential for pesticides to cause toxicity in 
humans. The Agency disagrees with the commenter's claims regarding 
animal testing. Since humans and animals have complex organ systems and 
mechanisms for the distribution of chemicals in the body, as well as 
processes for eliminating toxic substances from their systems, EPA 
relies on laboratory animals such as rats and mice to mimic the 
complexity of human and higher-order animal physiological responses 
when exposed to a pesticide. EPA is committed, however, to reducing the 
use of animals whenever possible. EPA-required studies include animals 
only when the requirements of sound toxicological science make the use 
of an animal absolutely necessary. The Agency's goal is to be able to 
predict the potential of pesticides to cause harmful effects to humans 
and wildlife by using fewer laboratory animals as models and EPA has 
been accepting data from alternative (to animals) test methods for 
several years. As progress is made on finding or developing non-animal 
test models that reliably predict the potential for harm to humans or 
the environment, EPA expects that it will need fewer animal studies to 
make safety determinations. Finally, because the commenter has not 
provided the Agency with a specific rationale (including supporting 
information) as to why the Agency's action is inconsistent with the 
legal standards in section 408 of FFDCA, EPA can not provide any more 
detailed response to the commenter's disagreement with the Agency's 
decision.

D. Revisions to Petitioned-For Tolerances

    IR-4 proposed a tolerance of 40 ppm on the crop group ``vegetable, 
bulb, group 3.'' Based on the results of field trials showing a greater 
than 5-fold difference in residues on bulb and green onions, EPA 
determined that separate tolerances are required for these subgroups. 
Therefore, EPA is establishing tolerances of 0.45 ppm on onion, bulb, 
subgroup 3-07A and 40 ppm on onion, green, subgroup 3-07B. EPA 
determined the appropriate tolerance levels for bulb and green onions 
based on analyses of the residue field trial data using the Agency's 
Tolerance Spreadsheet in accordance with the Agency's Guidance for 
Setting Pesticide Tolerances Based on Field Trial Data.
    IR-4 proposed tolerances on leaf petioles, subgroup 4B at 25 ppm 
and on leafy greens, subgroup 4A and cilantro, leaves at 50 ppm. Based 
on the results of field trial data indicating higher residues in 
spinach than the other members of subgroup 4A, EPA determined that a 
tolerance of 25 ppm would be adequate for members of the entire crop 
group 4 (including

[[Page 9364]]

subgroups 4A and 4B), except spinach, and cilantro leaves. Therefore, 
EPA is establishing tolerances of 25 ppm on vegetable, leafy, except 
Brassica, group 4, except spinach; 25 ppm on cilantro, leaves; and 50 
ppm on spinach.

V. Conclusion

    Therefore, tolerances are established for residues of famoxadone, 
3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione, in or 
on caneberry subgroup 13-07A at 10 ppm; cilantro, leaves at 25.0 ppm; 
onion, bulb, subgroup 3-07A at 0.45 ppm; onion, green, subgroup 3-07B 
at 40 ppm; spinach at 50 ppm; and vegetable, leafy, except Brassica, 
group 4, except spinach at 25 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 12, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

/0
2. Section 180.587 is amended by removing the tolerances for Caneberry, 
Subgroup 13A and Lettuce, head; and alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:

Sec.  180.587  Famoxadone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Caneberry subgroup 13-07A......................                       10
                                * * * * *
Cilantro, leaves...............................                       25
                                * * * * *
Onion, bulb, subgroup 3-07A....................                     0.45
Onion, green, subgroup 3-07B...................                       40
                                * * * * *
Spinach........................................                       50
                                * * * * *
Vegetable, leafy, except Brassica, group 4,                           25
 except spinach................................
------------------------------------------------------------------------

[[Page 9365]]

* * * * *
[FR Doc. E9-4357 Filed 3-3-09; 8:45 am]

BILLING CODE 6560-50-S