[Federal Register Volume 69, Number 72 (Wednesday, April 14, 2004)]
[Rules and Regulations]
[Pages 19767-19774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8316]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0075; FRL-7353-1]


Boscalid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-
2-yl) in or on certain commodies and establishes a tolerance for the 
residues of boscalid in or on pome fruit crop group, group 11 at 3.0 
ppm, apple pomace, wet at 10.0 ppm, hops cones, dried at 35.0 ppm, 
soybean, vegetable at 2.0 ppm, soybean seed at 0.1 ppm, soybean hulls 
at 0.2 ppm and aspirated grain fractions at 3.0

[[Page 19768]]

ppm. BASF Corporation requested this tolerance 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 14, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2004-0075, 
must be received on or before June 14, 2004.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Cynthia Giles-Parker, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-7740; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2004-0075. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., 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.
    2. Electronic access. 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 at http://www.gpoaccess.gov/ecfr/, a beta site currently under development. To 
access the OPPTS Harmonized Guidelines referenced in this document, go 
directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of November 6, 2003 (68 FR 215) (FRL-7321-
1), 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 petitions (PP 
2F6434 and 3F6580) by BASF Corporation, P.O. Box 13528, Research 
Triangle Park, North Carolina 27708-2000. That notice included a 
summary of the petitions prepared by BASF Corporation, the registrant. 
There were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.589 be amended by 
establishing a tolerance for residues of the fungicide boscalid in or 
on pome fruit crop group, group 11 at 3.0 ppm, apple pomace, wet at 
20.0 ppm, hops cones, dried at 35.0 ppm, soybean, vegetable at 2.2 ppm, 
soybean seed at 0.1 ppm, soybean hulls at 0.2 ppm and soybean aspirated 
grain fractions at 2.5 ppm.
    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 the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

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 a tolerance for residues of boscalid. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance follows. This assessment involves adding tolerances for 
commodities of pome fruit crop group, group 11 at 3.0 ppm, apple 
pomace, wet at 10.0 ppm, hops cones, dried at 35.0 ppm, soybean, 
vegetable at 2.0 ppm,

[[Page 19769]]

soybean seed at 0.1 ppm, soybean hulls at 0.2 ppm and soybean aspirated 
grain fractions at 3.0 ppm.

A. Toxicological Profile

    EPA previously 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. The nature of the toxic effects caused by 
boscalid as well as the no-observed-adverse-effect-level (NOAEL) and 
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies reviewed are discussed in the Federal Register of July 30, 2003 
(68 FR 44640) (FRL-7319-6). No new information which would change the 
toxicological profile has been submitted or reviewed since the 
analysis.

B. Toxicological Endpoints

    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. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10x 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 x 
10-\5\), one in a million (1 x 10-\6\), or one in 
ten million (1 x 10 -\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for boscalid used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of July 30, 2003 (68 FR 44640) (FRL-
7319-6).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.589) for the residues of boscalid, in or on a 
variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from boscalid in food as 
follows:
    i. Acute exposure. Acute dietary 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 one-day 
or single exposure. There were no toxic effects attributable to a 
single dose. An endpoint of concern was not identified to quantitate 
acute dietary risk to the general population, including infants and 
children, or to the subpopulation females 13-50 years old. Therefore, 
there is no acute reference dose (aRfD) or acute population-adjusted 
dose (aPAD).
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model 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 Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments:
    The chronic dietary exposure analysis was performed using two 
separate models: DEEM- FCID\TM\ and Lifeline\TM\. The analysis was 
based on tolerance-level residues (in some cases modified by DEEM\TM\ 
(Version 7.81) default processing factors), and assume 100% crop 
treated. In both cases, the risk estimates are well below the Agency's 
level of concern for the general U.S. population and all population 
subgroups. The results of the DEEM-FCID\TM\ and Lifeline\TM\ analyses 
are comparable. The most highly exposed population subgroup from 
DEEM\TM\ is children 1-2 years, which has an exposure estimate of 0.057 
mg/kg/day, and utilizes 26% of the cPAD. The most highly exposed 
population subgroup from Lifeline\TM\ is also children 1-2 years, which 
has an exposure estimate of 0.053 mg/kg/day, and utilizes 24% of the 
cPAD.

[[Page 19770]]



                           Table 1.--Summary of Dietary Exposure and Risk for Boscalid
----------------------------------------------------------------------------------------------------------------
                                                               DEEM: Chronic Analysis       Lifeline: Chronic
                                                             --------------------------         Analysis
                                                                                       -------------------------
        Population Subgroup               Acute Analysis        Dietary                     Mean
                                                                Exposure      % cPAD      Exposure      % cPAD
                                                              (mg/kg/day)               (mg/kg/day)
----------------------------------------------------------------------------------------------------------------
 General U.S. Population                  Not applicable: No     0.014597          6.7      0.01378          6.3
                                      acute dietary endpoint
----------------------------------------------------------------------------------------------------------------
 All Infants (<1 year old)                Not applicable: No      0.03509           16      0.03421           16
                                      acute dietary endpoint
----------------------------------------------------------------------------------------------------------------
 Children 1-2 years old                   Not applicable: No     0.056809           26       0.0525           24
                                      acute dietary endpoint
----------------------------------------------------------------------------------------------------------------
 Children 3-5 years old                   Not applicable: No     0.039112           18      0.03983           18
                                      acute dietary endpoint
----------------------------------------------------------------------------------------------------------------
 Children 6-12 years old                  Not applicable: No     0.019162          8.8      0.01806          8.3
                                      acute dietary endpoint
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                     Not applicable: No      0.01046          4.8      0.00975          4.5
                                      acute dietary endpoint
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                    Not applicable: No     0.010351          4.7      0.01094            5
                                      acute dietary endpoint
----------------------------------------------------------------------------------------------------------------
 Adults 50+ years old                     Not applicable: No     0.010935            5      0.01121          5.1
                                      acute dietary endpoint
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                   Not applicable: No     0.010349          4.7      0.01191          5.5
                                      acute dietary endpoint
----------------------------------------------------------------------------------------------------------------

    iii. Cancer. The Agency determined that boscalid produced 
suggestive evidence of carcinogenicity, but not sufficient to assess 
human carcinogenic potential. This cancer classification was based on 
the following weight of evidence considerations. First, in male Wistar 
rats, there was a significant trend (but not pairwise comparison) for 
the combined thyroid adenomas and carcinomas. This trend was driven by 
the increase in adenomas. Second, in the female rats, there was only a 
borderline significant trend for thyroid adenomas (there were no 
carcinomas). Third, the mouse study was negative as were all of the 
mutagenic tests. Consistent with this weak evidence of carcinogenic 
effects, the Agency concluded that a dose-response assessment for 
cancer (either linear low-dose extrapolation or margin of exposure 
calculation) was not needed because boscalid was not expected to pose a 
carcinogenic risk.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for boscalid 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 boscalid.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow ground water. For a screening-level 
assessment for surface water EPA will use FIRST (a tier 1 model) before 
using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the 
PRZM/EXAMS model that uses a specific high-end runoff scenario for 
pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, and both models include a percent crop area factor as an 
adjustment to account for the maximum percent crop coverage within a 
watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead drinking water levels of comparison (DWLOCs) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to boscalid they are 
further discussed in the aggregate risk sections in Unit I.
    Based on the FIRST and SCI-GROW models, the EECs of boscalid for 
acute and chronic exposures for surface water are estimated to be 87.53 
parts per billion (ppb) and 25.77 ppb, respectively, and the ground 
water EEC is 0.63 ppb. Since the completion of the previous risk 
assessment for boscalid, the aerobic soil metabolism half lives used as 
input parameters for the FIRST and SCI-GROW models have been revised.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in

[[Page 19771]]

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).
    No new residental uses of boscalid are currently being registered 
that would increase non-dietary exposure. A non-occupational dermal 
post-application exposure/risk assessment for individuals golfing and 
harvesting fruit at ``U-pick'' farms and orchards was conducted in the 
previous occupational and residential exposure (ORE) assessment.
    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 boscalid and any other 
substances and boscalid 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 boscalid 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 OPP concerning common mechanism 
determinations and procedures for cumulating effects from substances 
found to have a common mechanism on EPA's web site 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 10-fold 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 data base 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 
an 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 uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. A complete discussion of the 
prenatal/postnatal sensitivity study was recently discussed in our 
final rule dated July 30, 2003 (68 FR 44640) (FRL-7319-6). No new 
information has been received to change this information. The Agency 
does restate the basic conclusion from that analysis. The Agency 
concluded that there are no residual uncertainties for pre- and post-
natal toxicity as the degree of concern is low for the susceptibility 
seen in the above studies, and the dose and endpoints selected for the 
overall risk assessments will address the concerns for the body weight 
effects seen in the offspring. Although the dose selected for overall 
risk assessments (21.8 mg/kg/day) is higher than the NOAELs in the 2-
generation reproduction study (10.1 mg/kg/day) and the developmental 
neurotoxicity study (14 mg/kg/day), these differences are considered to 
be an artifact of the dose selection process in these studies. For 
example, there is a 10-fold difference between the LOAEL (106.8 mg/kg/ 
day) and the NOAEL (10.1 mg/kg/day) in the 2-generation reproduction 
study. A similar pattern was seen with regard to the developmental 
neurotoxicity study, where there is also a 10-fold difference between 
the LOAEL (147 mg/kg/day) and the NOAEL (14 mg/kg/day). There is only a 
2-3 fold difference between the LOAEL (57 mg/kg/day) and the NOAEL 
(21.8 mg/kg/day) in the critical study used for risk assessment. 
Because the gap between the NOAEL and LOAEL in the 2-generation 
reproduction and developmental neurotoxicity studies was large and the 
effects at the LOAELs were minimal, the true no-observed-adverse- 
effect-level was probably considerably higher. Therefore, the selection 
of the NOAEL of 21.8 mg/kg/day from the 1-year dog study is 
conservative and appropriate for the overall risk assessments. In 
addition, the endpoints for risk assessment are based on thyroid 
effects seen in multiple species (mice, rats and dogs) and after 
various exposure durations (subchronic and chronic exposures) which 
were not observed at the LOAELs in either the 2-generation reproduction 
or the developmental neurotoxicity studies. Based on these data, the 
Agency concluded that there are no residual uncertainties for pre- and 
post-natal toxicity.
    3. Conclusion. There is a complete toxicity data base for boscalid 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. The submitted field trials 
performed on hops, pome fruit, and soybeans are adequate to support the 
recommended tolerances: Hops cones, dried (35 ppm), pome fruit (3.0 
ppm), apple pomace, wet (10 ppm), soybean vegetable (2.0 ppm), soybean 
seed (0.1 ppm), soybean hulls (0.2 ppm), soybean aspirated grain 
fractions (3.0 ppm). There is no evidence of susceptibility following 
in utero exposure to rats and there is low concern and no residual 
uncertainties in the developmental toxicity study in rabbits, in the 2-
generation reproduction study or in the developmental neurotoxicity 
study after establishing toxicity endpoints and traditional uncertainty 
factors to be used in the risk assessment. Based on these data and 
conclusions, EPA reduced the FQPA safety factor to 1X.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is

[[Page 19772]]

calculated for each type of risk assessment used: Acute, short-term, 
intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. As there were no toxic effects attributable to a 
single dose, an endpoint of concern was not identified to quantitate 
acute-dietary risk to the general population or to the subpopulation 
females 13-50 years old. Therefore, there is no acute reference dose 
(aRfD) or acute population-adjusted dose (aPAD) for the general 
population or females 13-50 years old. No acute risk is expected from 
exposure to boscalid.
    2. Chronic risk. The chronic dietary exposure analysis was based on 
tolerance-level residues (in some cases modified by DEEM (Version 7.81) 
default processing factors), and assume 100% crop treated. Even with 
these highly conservative assumptions, the risk estimates are well 
below the Agency's level of concern. The most highly exposed population 
subgroup from DEEM\TM\ is children 1-2 years, which has an exposure 
estimate of 0.057 mg/kg/day, and utilizes 26% of the cPAD. The most 
highly exposed population subgroup from Lifeline\TM\ is also children 
1-2 years, which has an exposure estimate of 0.053 mg/kg/day, and 
utilizes 24% of the cPAD.

                Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Boscalid
----------------------------------------------------------------------------------------------------------------
                                                                Maximum
                                                  Chronic       Chronic       Ground      Surface      Chronic
   Senario/Population Subgroup     cPAD mg/kg/      Food         Water        Water        Water       DWLOC\3\
                                       day       Exposure,   Exposure\1\,    EDWC\2\,     EDWC\2\,      (ppb)
                                                 mg/kg/day     mg/kg/day      (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                  0.218     0.014597        0.2034         0.63           26        7,100
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)               0.218      0.03509       0.18291         0.63           26        1,800
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                   0.218     0.056809       0.16119         0.63           26        1,600
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                  0.218     0.010349       0.20765         0.63           26       6,200
----------------------------------------------------------------------------------------------------------------
\1\Maximum chronic water exposure (mg/kg/day) = cPAD (mg/kg/day) - chronic food exposure from dietary exposure
  analysis (mg/kg/day).
\2\EDWCs from EFED studies.
\3\Chronic DWLOCs were calculated as follows:
Chronic DWLOC([mu]g/L) = [maximum chronic water exposure (mg/kg/day) x body weight (kg)]/[water consumption (L)
  x 10-\3\ mg/[mu]g]

    3. Short-term risk. The short-term aggregate risk assessment takes 
into account average exposure estimates from dietary consumption of 
boscalid (food and drinking water) and non-occupational uses (golf 
courses). Postapplication exposures from the proposed use on golf 
courses is considered short- term, and applies to adults and youth. 
Therefore, a short-term aggregate risk assessment was conducted. Since 
all endpoints are from the same study, exposures from different routes 
can be aggregated. Table 3 summarizes the results. The MOE from food 
and non-occupational uses is 1400, and the calculated short-term DWLOC 
is 6,100 ppb. Compared to the surface and ground water EDWCs, the 
DWLOCs are considerably greater. Therefore, short-term aggregate risk 
does not exceed HED=s level of concern.
    The MOE and DWLOC are considered to be representative for youth 
because youth and adults possess similar body surface area to weight 
ratios, and because the dietary exposure for youth (13-19 years old) is 
less than that of the general U.S. population.

                                         Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Boscalid
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Short-Term Scenario
                                  ----------------------------------------------------------------------------------------------------------------------
                                                                   Average                  Aggregate                                Surface
            Population              NOAEL    Target      Max         Food    Residential  MOE\4\ (food   Max Water    Ground Water    Water   Short-Term
                                    mg/kg/   MOE\1\  Exposure\2\   Exposure  Exposure\3\       and      Exposure\5\  EDWC\6\(units)  EDWC\6\  DWLOC\7,8\
                                     day              mg/kg/day   mg/kg/day   mg/kg/day   residential)   mg/kg/day                   (units)   ([mu]g/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S.                                  21.8      100      0.218     0.014597     0.0008          1400       0.2026           0.63       25.77  6,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\The target MOE for dermal is 100.
\2\Maximum Exposure (mg/kg/day) = NOAEL/Target MOE
\3\Residential Exposure = Dermal exposure from golf course only
\4\Aggregate MOE = [NOAEL ) (Avg Food Exposure + Residential Exposure)]
\5\Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Exposure)
\6\The crop producing the highest level was used.
\7\ DWLOC(Fg/L) = [maximum water exposure (mg/kg/day) x body weight (kg)]/ [water consumption (L) x 10-\3\ mg/[mu]g]
\8\Adult female body weight was used, which covers adult male risk. The dietary exposure for the U. S. population is higher than that of groups having
  residential (golf) exposure (i.e., adults, youth 13-19).


[[Page 19773]]

    4. Aggregate cancer risk for U.S. population. For the reason stated 
above, EPA does not expect boscalid to pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to boscalid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromotography) 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: [email protected].

B. International Residue Limits

    Boscalid is a relatively new fungicide. There are currently no 
pending or established Codex maximum residue limits (MRLs) for 
boscalid. There are also no Mexican MRLs. The previous risk assessment 
was performed as a joint review with PMRA/Canada. The tolerances were 
harmonized with respect to the residue of concern and tolerance level.

V. Conclusion

    Therefore, the tolerances are established for residues of boscalid 
in or on apple pomace, aspirated grain fractions at 3.0 ppm, wet at 
10.0 ppm, hops cones, dried at 35.0 ppm, pome fruit crop group, group 
11 at 3.0 ppm, soybean hulls at 0.2 ppm, soybean seed at 0.1 ppm, and 
soybean, vegetable at 2.0 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 OPP-2004-0075 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 14, 
2004.
    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 issues(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 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 (1900C), 
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 Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. 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 Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2004-0075, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services 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 Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. 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 issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

[[Page 19774]]

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 
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 31, 2004.
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 180.589 is amended by alphabetically adding commodities to 
the table in paragraph (a)(1) to read as follows:


Sec.  180.589  Boscalid; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Apple, wet, pomace.........................................           10
Aspirated grain fractions..................................          3.0
                                * * * * *
Fruit, pome, crop group, group 11..........................          3.0
                                * * * * *
Hops, cones, dried.........................................           35
                                * * * * *
Soybean, hulls.............................................          0.2
Soybean, seed..............................................          0.1
Soybean, vegetable.........................................          2.0
                                * * * * *
------------------------------------------------------------------------

* * * * *

0
3. Section 180.589 paragraph (d) is amended by removing tolerances for 
``Soybean, hulls,'' and ``Soybean, seed'' from the table.

[FR Doc. 04-8316 Filed 4-13-04; 8:45 am]
BILLING CODE 6560-50-S