

[Federal Register: April 5, 2006 (Volume 71, Number 65)]
[Rules and Regulations]               
[Page 17014-17021]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ap06-17]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2004-0292; FRL-7772-8]

 
Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for combined residues 
of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-
3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy 
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate), expressed as parent compound, in or on 
bean, succulent, shelled; legume vegetables group, foliage, in crop 
group 7; mango (import); and papaya (import). This final rule also 
increases the tolerances for almond, hulls; pea and bean, dried 
shelled, except soybean, subgroup 6C; and strawberry. BASF Corporation 
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 April 5, 2006. Objections and 
requests for hearings must be received on or before June 5, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2004-0292. All documents in the 
docket are listed on the regulations.gov website. (EDOCKET, EPA's 
electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced Federal-wide electronic docket management and 
comment system located at http://www.regulations.gov. Follow the on-

line instructions.) Although listed in the index, some information is 
not publicly available, e.g., 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 either electronically through regulations.gov or in hard copy 
at the Public Information and Records Integrity Branch(PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 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: Tony Kish, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9443; e-mail address: kish.tony@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:

[[Page 17015]]

     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 and Other 
Related Information?

     In addition to using 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. A 

frequently updated electronic version of 40 CFR part 180 is available 
on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr.


II. Background and Statutory Findings

    In the Federal Register of August 27, 2004 (69 FR 52670) (FRL-7676-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of three pesticide petitions 
by BASF Corporation (0F6139, 2F6431, and 3F6581) of Research Triangle 
Park, NC 27709 and one petition (3E6774) by the Interregional Research 
Project Number 4 (IR-4), 681 US Highway 1 South, North 
Brunswick, NJ, 08902-3390. These petitions requested that 40 CFR 
180.582 be amended by establishing tolerances for combined residues of 
the fungicide pyraclostrobin and its desmethoxy metabolite, expressed 
as parent compound, in or on a large number of crops. Most, but not all 
of the proposed new tolerances requested in the four petitions 
mentioned in this unit were established in a final rule published in 
the Federal Register of October 29, 2004 (69 FR 63083) (FRL-7681-9). 
The following tolerances were requested, but not included in the 
October 29, 2004 final rule, and thus are included herein: Bean, 
succulent, shelled; legume vegetables group, foliage, in crop group 7; 
mango (import); and papaya (import).
    Additionally, in the Federal Register of February 15, 2006 (71 FR 
7955) (FRL-7759-4), EPA issued a notice pursuant to section 408(d)(3) 
of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a revised 
pesticide petition by BASF Corporation (5F6906) of Research Triangle 
Park, NC 27709. That notice included a summary of the pesticide 
petition prepared by BASF, the registrant. This petition requested that 
40 CFR 180.582 be amended by revising established tolerances for 
combined residues of the fungicide pyraclostrobin and its desmethoxy 
metabolite, expressed as parent compound, in or on pea and bean, dried 
shelled, except soybean, subgroup 6C, and strawberry.
    The October 29, 2004 final rule previously established tolerances 
for pea and bean, dried shelled, except soybean, subgroup 6C, and for 
strawberry. However, the existing 0.3 parts per million (ppm) tolerance 
in this rule for pea and bean, dried shelled, except soybean, subgroup 
6C, was based on submission of confirmatory field trial data. These 
confirmatory data were submitted and reviewed, and result in the 
tolerance being increased herein from 0.3 ppm to 0.5 ppm. Hence, a 
revised notice of filing/petition was submitted.
    Furthermore, the existing 1.5 ppm time-limited tolerance 
established for strawberry in that final rule expired December 31, 
2005. Upon this expiration, the tolerance reverted back to the 
permanent 0.4 ppm tolerance. Based on submission of recent field trial 
data, the permanent strawberry tolerance is being increased from 0.4 
ppm to 1.2 ppm. Hence, a revised notice of filing/petition was 
submitted. No comments were received on the notice of filing.
    In the Federal Register of January 27, 2006, (71 FR 4579) (FRL-
7758-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition by 
BASF Corporation (5F6906) of Research Triangle Park, NC 27709. That 
notice included a summary of the pesticide petition prepared by BASF, 
the registrant. This petition requested that 40 CFR 180.582 be amended 
by increasing the tolerance for combined residues of the fungicide 
pyraclostrobin and its desmethoxy metabolite, expressed as parent 
compound, in or on almonds, hulls. Comments were received on the notice 
of filing. EPA's response to these comments is discussed in Unit IV.C.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of 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 
pyraclostrobin and its desmethoxy metabolite, expressed as parent 
compound, on almond, hulls at 7.0 ppm; bean, succulent, shelled at 0.5 
ppm; legume vegetables group, foliage, in crop group 7, at 25 ppm; 
mango (import) at 0.1 ppm; papaya (import) at 0.1 ppm; pea and bean, 
dried shelled, except soybean, subgroup 6C at 0.5 ppm; and strawberry 
at 1.2 ppm.
    EPA's assessment of exposures and risks associated with 
establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also

[[Page 17016]]

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 pyraclostrobin as well as the 
no-observed-adverse-effect-levels (NOAELs) and the lowest-observed-
adverse-effect-levels (LOAELs) from the toxicity studies can be found 
in the October 29, 2004 final rule.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases.
    A summary of the toxicological endpoints for pyraclostrobin used 
for human risk assessment is discussed in Unit III.B. of the October 
29, 2004 final rule.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have 
previously been established (40 CFR 180.582) for the combined residues 
of pyraclostrobin and its desmethoxy metabolite, expressed as parent 
compound, in or on a variety of raw agricultural commodities. Risk 
assessments were conducted by EPA to assess dietary exposures from 
pyraclostrobin 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.
    The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated 
the individual food consumption as reported by respondents in the U.S. 
Department of Agriculture (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:
    Values corresponding to the HAFT (highest average field trial), 
instead of the tolerance level, were used for crops in the leafy 
vegetables crop group and for the dry shelled peas and beans subgroup. 
For all other crops, residue values corresponding to tolerance levels 
were used. A 100% percent crop treated (PCT) estimate was used for all 
crops.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM\TM\ software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), which incorporates food consumption 
data as reported by respondents in the USDA 1994-1996 and 1998 
Nationwide CSFII, and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments:
    Residues corresponding to tolerance level for all crops other than 
apple and pear (average values from field trials), and PCT were used in 
this assessment.
    iii. Cancer. The assessment assumed residues corresponding to 
tolerance level, or average residue from field trials (apple and pear), 
and PCT.
    iv. Anticipated residue and 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 chemicals that have been measured in food. If EPA 
relies on such information, EPA must pursuant to FFDCA section 
408(f)(1) require 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. Following the initial 
data submission, EPA is authorized to require similar data on a time 
frame it deems appropriate. For the present action, EPA will issue such 
data call-ins for information relating to anticipated residues as are 
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA 
section 408(f)(1). Such data call-ins will be required to be submitted 
no later than 5 years from the date of issuance of this tolerance.
    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 the Agency can make the following findings: Condition 1, 
that 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 such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if 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 in Table 1 of this unit.

                Table 1.--Values for Percent Crop Treated
------------------------------------------------------------------------
                 Commodity                               PCT
------------------------------------------------------------------------
                        Root and Tuber Vegetables
------------------------------------------------------------------------
Beet, garden                                41\*\
------------------------------------------------------------------------
Beet, sugar                                 55\*\
------------------------------------------------------------------------
Carrot                                      31\*\
------------------------------------------------------------------------
Potato                                      66\*\
------------------------------------------------------------------------
Radish                                      8\*\
------------------------------------------------------------------------
Sweet potato                                2\*\
------------------------------------------------------------------------
Yam                                         1\*\
------------------------------------------------------------------------
Other root and tuber                        6
------------------------------------------------------------------------
                             Bulb Vegetables
------------------------------------------------------------------------
Onion                                       17
------------------------------------------------------------------------
Other bulbs                                 17
------------------------------------------------------------------------
                            Leafy Vegetables
------------------------------------------------------------------------
Celery                                      44\*\
------------------------------------------------------------------------
Lettuce (leaf)                              58\*\
------------------------------------------------------------------------
Lettuce (head)                              58\*\
------------------------------------------------------------------------
Spinach                                     40\*\
------------------------------------------------------------------------
Swiss chard                                 9\*\
------------------------------------------------------------------------
Other leafy                                 5
------------------------------------------------------------------------
                           Brassica Vegetables
------------------------------------------------------------------------
Broccoli                                    7\*\
------------------------------------------------------------------------
Brussels sprouts                            43\*\
------------------------------------------------------------------------

[[Page 17017]]


Cabbage                                     40\*\
------------------------------------------------------------------------
Cauliflower                                 31\*\
------------------------------------------------------------------------
Other head and stem                         2
------------------------------------------------------------------------
Collards                                    41
------------------------------------------------------------------------
Kale                                        20\*\
------------------------------------------------------------------------
Mustard green                               15\*\
------------------------------------------------------------------------
Turnip green                                15\*\
------------------------------------------------------------------------
Other leafy                                 2
------------------------------------------------------------------------
                            Legume Vegetables
------------------------------------------------------------------------
Beans, lima                                 24\*\
------------------------------------------------------------------------
Beans, snap                                 36\*\
------------------------------------------------------------------------
Other beans, succulent                      1
------------------------------------------------------------------------
Beans, dry                                  1
------------------------------------------------------------------------
Peas, green or succulent                    1\*\
------------------------------------------------------------------------
Peas, dry                                   2\*\
------------------------------------------------------------------------
Soybean (dry)                               1\*\
------------------------------------------------------------------------
                           Fruiting Vegetables
------------------------------------------------------------------------
Pepper                                      18
------------------------------------------------------------------------
Tomato                                      18
------------------------------------------------------------------------
Other fruiting                              18
------------------------------------------------------------------------
                           Cucurbit Vegetables
------------------------------------------------------------------------
Cantaloupe                                  37
------------------------------------------------------------------------
Cucumber                                    37
------------------------------------------------------------------------
Other cucurbit vegetables                   37
------------------------------------------------------------------------
                              Citrus Fruits
------------------------------------------------------------------------
Grapefruit                                  6
------------------------------------------------------------------------
Oranges                                     6
------------------------------------------------------------------------
Other citrus                                6
------------------------------------------------------------------------
                               Pome Fruits
------------------------------------------------------------------------
Apple                                       41\*\
------------------------------------------------------------------------
Pears                                       49\*\
------------------------------------------------------------------------
Other pome                                  7
------------------------------------------------------------------------
                              Stone Fruits
------------------------------------------------------------------------
Cherry                                      53
------------------------------------------------------------------------
Peach                                       28
------------------------------------------------------------------------
Plum                                        28
------------------------------------------------------------------------
Other stone                                 28
------------------------------------------------------------------------
                                 Berries
------------------------------------------------------------------------
All berries                                 2
------------------------------------------------------------------------
                                Tree Nuts
------------------------------------------------------------------------
All nuts                                    1
------------------------------------------------------------------------
Pistachio                                   6
------------------------------------------------------------------------
                                 Grains
------------------------------------------------------------------------
Barley                                      2
------------------------------------------------------------------------
Corn, field                                 1\*\
------------------------------------------------------------------------
Corn, pop                                   2
------------------------------------------------------------------------
Corn, sweet                                 16\*\
------------------------------------------------------------------------
Rye                                         2
------------------------------------------------------------------------
Wheat (triticale)                           2
------------------------------------------------------------------------
                        Miscellaneous Commodities
------------------------------------------------------------------------
Banana/plantain                             100
------------------------------------------------------------------------
Grape                                       16
------------------------------------------------------------------------
Grape, raisin                               16
------------------------------------------------------------------------
Hop                                         48\*\
------------------------------------------------------------------------
Mango                                       100
------------------------------------------------------------------------
Papaya                                      100
------------------------------------------------------------------------
Peanut                                      19
------------------------------------------------------------------------
Mint                                        6\*\
------------------------------------------------------------------------
Strawberry                                  80
------------------------------------------------------------------------
Sunflower                                   3\*\
------------------------------------------------------------------------
        Edible Animal Tissue (Cattle, Goat, Hog, Horse and Sheep)
------------------------------------------------------------------------
 Meat                                       100
------------------------------------------------------------------------
Meat byproduct/kidney                       100
------------------------------------------------------------------------
Liver                                       100
------------------------------------------------------------------------
Fat                                         100
------------------------------------------------------------------------
Milk                                        100
------------------------------------------------------------------------
                             Drinking Water
------------------------------------------------------------------------
Water, direct                               100
------------------------------------------------------------------------
Water, indirect                             100
------------------------------------------------------------------------
\*\ Projected figures.

    The Agency believes that the three conditions listed in Unit 
III.C.1.iv have been met. With respect to Condition 1, PCT estimates 
for existing uses 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 2 and 3, 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 information on the regional 
consumption of food to which pyraclostrobin may be applied in a 
particular area.
    EPA estimates projected percent crop treated (PPCT) for a new 
pesticide use by assuming that the 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 types (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/National Agricultural Statistics Service (NASS) as the source for 
raw PCT data because it is publicly available and does not have to be 
calculated from available data sources. 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 factor that bears on whether the estimated PPCT could be 
exceeded is whether the new pesticide use is more efficacious or 
controls a broader spectrum of pests than the dominant pesticide(s). 
All information

[[Page 17018]]

currently available has been considered for pyraclostrobin, and based 
on that information EPA concludes that it is unlikely that actual PCT 
for pyraclostrobin will exceed the estimated PPCT during the next 5 
years.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for pyraclostrobin 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 pyraclostrobin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found in the October 29, 2004 final rule.
    Based on the Tier II Pesticide Root Zone Mode/Exposure Analysis 
Modeling System (PRZM/EXAMS) and Screening Concentration in Groundwater 
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs) 
of pyraclostrobin for acute exposures are estimated to be 10.2 parts 
per billion (ppb) for surface water and 0.02 ppb for ground water. The 
EDWCs for chronic exposures are estimated to be 0.8 ppb for surface 
water and 0.02 ppb for ground 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).
    Pyraclostrobin is currently registered for use on the following 
residential non-dietary sites: Residential and recreational turfgrass 
sites and golf course turf. The risk assessment was conducted using the 
following residential exposure assumptions: Residential and 
recreational turf applications are applied by professional pest control 
operators (PCOs) only, and therefore, residential handler exposure is 
not expected, and was not evaluated. There is, however, a potential for 
exposure to homeowners in residential settings from entering previously 
treated lawns where children might play and adults might work or play. 
As a result, risk assessments have been completed for postapplication 
scenarios. Recreational nonresidential exposures are expected to be 
similar to, or in many cases less than, those evaluated for residential 
postapplication exposure and risk; and therefore, a separate 
recreational nonresidential exposure assessment was not conducted. 
Refer to the October 29, 2004 final rule, for a detailed discussion of 
residential/recreational 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.''
    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 pyraclostrobin and any 
other substances and pyraclostrobin 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 pyraclostrobin 
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 
margin of exposure (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 SF, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no substantial 
evidence of increased prenatal or postnatal susceptibility following in 
utero exposure to rats. A complete discussion can be found in the 
October 29, 2004 final rule.
    3. Conclusion. There is an adequate toxicity database for the 
selection of doses and endpoints for use in risk assessment for 
pyraclostrobin. Exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA previously 
evaluated the available studies and established acute and chronic 
reference doses (RfDs), as well as doses and endpoints for the cancer 
and occupational and residential risk assessments. EPA has evaluated 
and reevaluated the potential for increased susceptibility of infants 
and children to pyraclostrobin and has concluded that there are 
reliable data to support reducing the FQPA SF to 1X for all potential 
pyraclostrobin exposure scenarios because the toxicity and exposure 
databases are adequate, there are no residual uncertainties for pre- or 
postnatal toxicity, and there is no substantial evidence of increased 
sensitivity of infants and children to pyraclostrobin. For a detailed 
discussion, refer to the October 29, 2004 final rule.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. The total combined MOEs from dietary (food + water) 
and non-occupational/residential exposures, are 100 and 160 for 
children 1-2 yrs, and the general U.S. population, respectively, and 
therefore are not of concern. This aggregate exposure risk assessment 
is considered a very conservative estimate, that should not 
underestimate risks, because of the following inputs:
    i. Dietary inputs primarily used tolerance level residues.
    ii. Crop specific (turf) screening level drinking water modeling 
data were used (i.e., Tier II surface water model).
    iii. Maximum application rates and minimum application intervals 
were used
    iv. Conservative standard operating procedures (SOPs) and upper 
level estimates of exposure were employed.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pyraclostrobin from food and drinking water will utilize 21% of the 
chronic population adjusted dose (cPAD) for the U.S. population, and 
33% of the cPAD for children 1-2 years of age, the most highly exposed 
population subgroup. Based on the use pattern, chronic residential 
exposure to

[[Page 17019]]

residues of pyraclostrobin is not expected. Drinking water was 
incorporated directly into the dietary assessment using the 1 in 10 
year annual mean concentration for surface water generated by the PRZM-
EXAMS model. EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD for any population subgroup.
    3. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Pyraclostrobin is currently registered for use(s) that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for pyraclostrobin.
    Using the exposure assumptions for intermediate-term exposures, EPA 
has concluded that food and residential exposures aggregated result in 
aggregate MOEs of 100 or above for all population subgroups. These 
aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food and residential uses.
    4. Aggregate cancer risk for U.S. population. The Agency has 
calculated aggregate MOEs (food and drinking water exposure) for 
pyraclostrobin. In general, acceptable study results indicate that 
pyraclostrobin is unlikely to be a carcinogen. However, the Agency has 
also concluded that the carcinogenicity data available for 
pyraclostrobin are inadequate to allow full assessment of the human 
carcinogenic potential of this pesticide because the highest dosing 
levels for females in the mouse carcinogenicity study were not great 
enough to produce significant toxicological effects (that is, the 
highest dose tested (HDT), is the NOAEL for female mice in this study). 
The company is performing an additional carcinogenicity study in female 
mice to remedy this deficiency. Because neither of the rat nor mouse 
cancer studies show any evidence of carcinogenicity, a non-threshold 
(Q-star) approach cannot be used to estimate cancer risk. Instead, a 
regulatory MOE has been chosen as a tool for bounding any potential 
chronic dietary cancer risk from pyraclostrobin that may exist. The 
regulatory MOE is derived from the HDT in female mice (a NOAEL of 32.8 
milligram/kilogram/day (mg/kg/day) and is 10 times higher than the 
NOAEL used for chronic non-cancer risk. The MOE for cancer is estimated 
to be 4,500. It is derived from the highest dose tested in female mice 
(32.8 mg/kg/day) in the inadequate mouse oncogenicity study, divided by 
the chronic dietary exposure (food + water) for the U.S. general 
population (0.00727 mg/kg/day). Drinking water was incorporated 
directly into the dietary assessment using the 1 in 30 annual mean 
concentration for surface water generated by the PRZM-EXAMS model.
    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 pyraclostrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/mass 
spectrometry) 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

    The Codex Alimentarius Commission has established maximum residue 
limits (MRLS) for pyraclostrobin in or on almond, hulls at 2.0 ppm; 
strawberry at 0.5 ppm; beans (dry) at 0.2 ppm; lentil (dry) at 0.5 ppm; 
and peas (dry) at 0.3 ppm. The U.S. tolerances differ from the Codex 
MRLS because the U.S. residue definitions include both the parent 
compound (pyraclostrobin), and its desmethoxy metabolite, whereas the 
Codex MRLS only include the parent compound.

C. Response to Comments

    Comments were received from B. Sachau on petition 5F6906 for 
almond, hulls. The comments stated general opposition to Agency 
approval of tolerances and exemptions other than zero, for pesticides. 
The commenter opposes any residue left on a treated crop. The comments 
contained no scientific data or evidence to rebut the Agency's 
conclusion that there is a reasonable certainty that no harm will 
result from aggregate exposure to pyraclostrobin, including all 
anticipated dietary exposures and other exposures for which there is 
reliable information. These same or similar comments from this 
responder have been addressed by the Agency on several prior occasions. 
See the October 29, 2004 and January 7, 2005 (70 FR 1349) (FRL-7691-4) 
final rules.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
pyraclostrobin and its desmethoxy metabolite, expressed as parent 
compound, in or on bean, succulent, shelled at 0.5 ppm; legume 
vegetables group, foliage, in crop group 7 at 25 ppm; mango (import) at 
0.1 ppm; and papaya (import) at 0.1 ppm.
    Existing tolerances are being increased almond, hulls from 1.6 ppm 
to 7.0 ppm; pea and bean, dried shelled, except soybean, subgroup 6C, 
from 0.3 ppm to 0.5 ppm; strawberry from 0.4 ppm to 1.2 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number HQ-EPA-OPP-2004-0292 in the subject line on 
the first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before June 5, 
2006.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40

[[Page 17020]]

CFR 178.27). Information submitted in connection with an objection or 
hearing request may be claimed confidential by marking any part or all 
of that information as CBI. Information so marked will not be disclosed 
except in accordance with procedures set forth in 40 CFR part 2. A copy 
of the information that does not contain CBI must be submitted for 
inclusion in the public record. Information not marked confidential may 
be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number HQ-EPA-OPP-2004-0292, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resource Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460--0001. In person or by courier, bring a copy to 
the location of the PIRIB described in ADDRESSES. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers, and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. 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

[[Page 17021]]

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: March 29, 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 180.582 is amended by:
0
a. Removing in the introductory text of paragraph (a)(1) the phrase 
``carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy 
metabolite methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl carbamate'' and adding in its place ``(carbamic 
acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy 
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate).''
0
b. Revising the commodities ``almond, hulls; pea and bean, dried 
shelled, except soybean, subgroup; and strawberry'' and adding 
alphabetically the remaining commodities listed below to the table in 
paragraph (a)(1). The amended table reads as set forth below.
0
c. Removing paragraph (a)(3).


Sec.  180.582  Pyraclostrobin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
 Almond, hulls.................................                      7.0
                                * * * * *
 Bean, succulent shelled.......................                      0.5
                                * * * * *
Mango\1\.......................................                      0.1
                                * * * * *
Papaya\1\......................................                      0.1
                                * * * * *
Pea and bean, dried shelled, except soybean,                         0.5
 subgroup 6C...................................
                                * * * * *
 Strawberry....................................                      1.2
                                * * * * *
Vegetables, foliage of legume, group 7.........                       25
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations on mango or papaya as of April 5,
  2006.

* * * * *

[FR Doc. 06-3262 Filed 4-4-06; 8:45 am]

BILLING CODE 6560-50-S
