Document ID: EPA-HQ-OPP-2009-0268-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Boscalid
Posted Date: 2010-05-28T04:00Z

[Federal Register: May 28, 2010 (Volume 75, Number 103)]
[Rules and Regulations]               
[Page 29901-29908]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my10-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0268; FRL-8826-4]

 
Boscalid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
boscalid in or on multiple commodities which are identified and 
discussed later in this document. This regulation additionally revises 
established tolerances in or on fruit, stone, group 12; hog, fat; 
poultry, fat; and poultry, meat byproducts. Finally, this regulation 
deletes the time-limited tolerance on tangerine as it expired on 
December 31, 2008. BASF Corporation requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 28, 2010. Objections and 
requests for hearings must be received on or before July 27, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0268. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Shaja Joyner, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-3194; e-mail address: joyner.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at www.gpoaccess.gov/ecfr.

[[Page 29902]]

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0268 on the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
July 27, 2010. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0268, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 19, 2009 (74 FR 41898) (FRL-8426-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP 
9F7527 and PP 9F7529 by BASF Corporation, Research Triangle Park, NC 
27709. PP 9F7527, which was incorrectly written as PP 9F7529 in the 
notice, requested that 40 CFR 180.589 be amended by establishing 
tolerances for residues of the fungicide boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or 
on alfalfa, forage at 35 part per million (ppm); alfalfa, hay at 85 
ppm; and citrus, crop group 10 at 2 ppm. PP 9F7529 requested to 
increase the existing tolerance in or on fruit, stone, group 12 from 
1.7 ppm to 5 ppm. That notice referenced a summary of the petition 
prepared by BASF Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised several proposed tolerances and has determined that separate 
tolerances are necessary for citrus, dried pulp and citrus, oil. The 
Agency has also revised several established livestock commodities. 
Finally, EPA has revised the tolerance expression for all established 
commodities to be consistent with current Agency policy. The reasons 
for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
. ''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for boscalid including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with boscalid 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Boscalid has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure, and it is not an eye or skin irritant. 
Following subchronic and chronic exposure to boscalid, the liver and 
thyroid appeared to be the target organs in several species. In mice, 
subchronic exposure to boscalid resulted in increased liver weights and 
an increased incidence of marked fatty changes in the liver. Subchronic 
and chronic studies in dogs resulted in increases in alkaline 
phosphatase levels as well as hepatic weights. In subchronic and 
chronic studies in rats, thyroid changes (including increases in 
weights and incidences of follicular cell hyperplasia and hypertrophy) 
were considered to have been the result of liver adaptive responses. 
Additionally, in three mechanistic rat studies, increases in liver 
microsomal activity, induction of total cytochrome P450 activity, and 
disruption of thyroid homeostasis (by decreasing circulating T3 and T4 
and increasing TSH resulting from hepatic microsomal 
glucuronyltransferase) were noted. The liver and thyroid effects were 
reversed with the cessation of test article administration.
    In the rabbit developmental toxicity study, abortions and early 
deliveries were observed in at the highest dose tested. Decreased pup 
body weights and/or body weight gains were noted in both the 2-
generation reproductive toxicity study in rats and in the rat 
developmental neurotoxicity (DNT) study at a level that did not induce 
parental toxicity.
    In two chronic/carcinogenicity studies in rats that were assessed 
together, statistically significant increases in thyroid follicular 
cell adenomas and significant differences in a pair-wise comparison 
with the controls were noted in males; thyroid hypertrophy and 
hyperplasia of follicular cells, as well as increased thyroid weights 
and mechanistic data were also noted. Female rats exhibited a slightly 
significant increase in thyroid follicular cell adenomas in these 
studies. A carcinogenicity study in mice

[[Page 29903]]

showed no evidence of tumor formation in either sex, and no evidence of 
malignancies or mutagenicity was found in the toxicity database for 
boscalid. Based on the overall weak evidence of carcinogenic effects, 
EPA has classified boscalid as having suggestive evidence of 
carcinogenicity.
    Specific information on the studies received and the nature of the 
adverse 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 can be found at http://
www.regulations.gov in document: ``Boscalid. Human Health Risk 
Assessment for Proposed Use on Alfalfa and Citrus (Crop Group 10), and 
for Proposed Increase in Tolerance on Stone Fruits (Crop Group 12).'' 
Pages 41-44 in docket ID number EPA-HQ-OPP-2009-0268.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level-generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD) and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
     A summary of the toxicological endpoints for boscalid used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1.--Summary of Toxicological Doses and Endpoints for Boscalid for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of    No appropriate endpoint attributable to a single dose was available in
 age; and general population               the current database, including the developmental toxicity studies.
 including infants and children)          Therefore, an aRfD and aPAD were not established for any population.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL = 21.8 mg/kg/day   Chronic RfD = 0.218 mg/  Combined results of
(All populations)....................  UFA = 10x..............   kg/day                   chronic rat,
                                       UFH = 10x..............  cPAD = 0.218 mg/kg/day.   carcinogenicity rat,
                                       FQPA SF = 1x...........                            and 1-year dog studies
                                                                                         LOAEL = 57 mg/kg/day
                                                                                          based on liver and
                                                                                          thyroid effects
----------------------------------------------------------------------------------------------------------------
Dermal short-term                      Dermal (or oral) study   LOC for MOE = 100        Combined results of
(1 to 30 days).......................   NOAEL = 21.8 mg/kg/day                            chronic rat,
                                        (dermal absorption                                carcinogenicity rat,
                                        rate = 15%)                                       and 1-year dog studies
                                        UFA = 10x.............                           LOAEL = 57 mg/kg/day
                                        UFH = 10x.............                            based on liver and
                                        FQPA SF = 1x..........                            thyroid effect.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)         Classification: Suggestive evidence of carcinogenicity. The cRfD is
                                        protective of cancer effects. Quantification of human cancer risk is not
                                                                       necessary.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).
FQPA SF = Food Quality Protection Act Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose.
MOE = margin of exposure.
LOC = level of concern.

    Additional information regarding the toxicological endpoints for 
boscalid used for human risk assessment can be found at http://
www.regulations.gov in docket ID numbers EPA-HQ-OPP-2009-0268 and EPA-
HQ-OPP-2005-0145.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to boscalid, EPA considered exposure under the petitioned-for 
tolerances as well as all existing boscalid tolerances in 40 CFR 
180.589. EPA assessed dietary exposures from boscalid in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for boscalid; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA utilized tolerance-level residues and assumed 100 
percent crop treated (PCT) data for all commodities.
    iii. Cancer. As discussed in Unit III.A., EPA has classified 
boscalid as having suggestive evidence of carcinogenicity due to some 
evidence of

[[Page 29904]]

thyroid follicular cell adenomas in male and female rats. Nonetheless, 
EPA concluded that the cPAD would be protective of these effects based 
on the following:
    The adenomas occurred at dose levels above the level used to 
establish the cPAD, statistically significant increases were only seen 
for benign tumors (adenomas) and not for malignant ones (carcinomas), 
the increase in adenomas in females was slight, and there was no 
concern for mutagenicity. EPA's estimate of chronic exposure as 
described above is relied upon to evaluate whether any exposure could 
exceed the cPAD and thus pose a cancer risk.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
boscalid. Tolerance level residues or 100 PCT were assumed for all food 
commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for boscalid in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of boscalid. Further information regarding EPA drinking 
water models used in pesticide exposure assessment can be found at 
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of boscalid for chronic 
exposures for non-cancer assessments are estimated to be 29.6 parts per 
billion (ppb) for surface water and 0.63 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 29.6 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Boscalid is currently registered for use on turf at golf courses 
and for use on several fruit commodities at ``pick-your-own'' (PYO) 
farms and orchards; therefore, post-application exposure to golfers and 
people harvesting fruit at PYO farms and orchards is possible. EPA 
assessed residential exposure using the following assumptions: For 
adult and adolescent (12 years of age or older) golfers, short-term 
post-application dermal exposure to turf treated with boscalid was 
assessed. PYO activities may result in potential acute post-application 
exposure to boscalid; however, because no adverse effects were noted in 
the boscalid toxicity database resulting from a single exposure to the 
chemical, a post-application exposure and risk assessment is not 
necessary for this scenario. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    EPA also notes that while adolescents are likely to represent the 
vast majority of youth who play golf on a routine basis, it is possible 
for younger children (less than 12 years old) to be exposed to golf 
course turf that has been treated with boscalid. However, assessing 
risk for younger golfers is difficult because of the uncertainties 
associated with the extrapolation of adult dermal exposure data and 
because of the increased likelihood of other behaviors that might 
contribute to exposure, such as incidental oral exposure resulting from 
contact with treated turf. Therefore, younger golfers were assessed 
qualitatively for this exposure scenario after selecting an appropriate 
target age of 5 years old to assess risk. The surface area to body 
weight ratio (SA/BW) for male children, when calculated and compared to 
that of the average adult, was found to be approximately 70% greater. 
Based on this parameter alone, the exposure to children could be almost 
twice that of the adult golfer; however, younger golfers are not 
expected to use the golf course for the same length of time as an 
adult. The shorter duration on the golf course for younger golfers 
offsets the higher SA/BW; therefore, risks from short-term post-
application exposures to young golfers are likely to be similar to 
risks for adult golfers.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
     EPA has not found boscalid to share a common mechanism of toxicity 
with 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 assumed that boscalid does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for boscalid includes rat and rabbit prenatal 
developmental toxicity studies, a 2-generation reproductive toxicity 
study in rats, and a DNT study in rats. No qualitative or quantitative 
evidence of increased susceptibility was noted in the developmental 
toxicity study in rats. However, in the 2-generation reproduction study 
in rats, body weight effects were seen in the mid and high doses in the 
second generation male pups. However, the degree of concern is low for 
the quantitative evidence of susceptibility seen in this study, since 
the body weight effects were seen in only one sex and only after dosing 
for two generations. Also, there is a clear NOAEL for the body weight 
effects seen in the rat 2-generation reproduction study, and EPA is 
regulating based on a POD below where these effects were seen.
    In the rat DNT study, transient body weight effects were seen in 
one sex at postnatal days 1-4 with the animals recovering by postnatal 
day 11. Body weight effects were also seen in the high dose, which was 
the limit dose. The degree of concern for these effects is low since 
the effects were either transient in nature or occurred at the limit 
dose, and EPA is regulating based on a POD below where these effects 
were seen. In the rabbit developmental study there was evidence of 
qualitative sensitivity;

[[Page 29905]]

however, fetal effects were seen only at the limit dose in the presence 
of maternal toxicity. Further, since EPA is regulating based on a POD 
which is an order of magnitude below where these effects were seen in 
the rabbit developmental study, EPA concludes that there is a low 
degree of concern for the qualitative sensitivity evidenced in the 
fetuses in the rabbit developmental study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for boscalid is complete, except for 
immunotoxicity testing. Recent changes to 40 CFR part 158 make 
immunotoxicity testing (OPPTS Guideline 870.7800) required for 
pesticide registration; however, the existing data are sufficient for 
endpoint selection for exposure/risk assessment scenarios, and for 
evaluation of the requirements under the FQPA. The available data for 
boscalid show no evidence of treatment-related effects on the immune 
system, and the Agency does not believe that conducting an 
immunotoxicity study will result in a lower point of departure than 
currently selected for overall risk assessment. Therefore, an 
additional database uncertainty factor to account for potential 
immunotoxicity does not need to be applied.
    ii. A rat DNT study is available which provides no indication that 
boscalid is a neurotoxic chemical, and there is no evidence of 
reproductive or developmental neurotoxicity in the toxicity database.
    iii. Data involving the testing of young animals did show increased 
quantitative sensitivity in the young with regard to body weight 
effects, and qualitative sensitivity was seen in one developmental 
study. However, clear NOAELs were identified for all of these effects. 
Moreover, the body weight effects at the LOAELs in these studies were 
either transient or inconsistent, and qualitative sensitivity occurred 
at the limit dose in the presence of maternal toxicity. Additionally, 
EPA is regulating based on a POD below where these effects are seen. 
EPA concludes that there are no residual uncertainties for prenatal 
and/or postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to boscalid in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of adult 
golfers, which is expected to be similar to potential post-application 
exposure of children. These assessments will not underestimate the 
exposure and risks posed by boscalid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the appropriate PODs to ensure 
that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
boscalid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
boscalid from food and water will utilize 37% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of boscalid is not 
expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Boscalid is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to boscalid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate MOE of 840 for the 
general U.S. population and an aggregate MOE of 1,140 for youth (13-19 
years old). As described above, the level of risk to younger golfers is 
expected to be similar. Because EPA's level of concern for boscalid is 
a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
boscalid is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
boscalid.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., EPA has concluded that the cPAD is 
protective of possible cancer effects. Given the results of the chronic 
risk assessment above, cancer risk resulting from exposure to boscalid 
is not of concern.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to boscalid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate gas chromatography with mass spectrometric detection (GC/
MS) and GC with electron capture (EC) methods are available to enforce 
boscalid tolerances in or on plant and livestock commodities, 
respectively. The methods 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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as

[[Page 29906]]

required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 
U.N. Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are currently no Codex, Canadian, or Mexican MRLs for 
residues of boscalid in or on alfalfa forage, alfalfa hay, or citrus 
fruits. However, there is a Codex MRL for stone fruits at 3 ppm and a 
Canadian MRL for stone fruits at 1.7 ppm. At this time, the revised 
U.S. tolerance on fruit, stone, group 12 at 3.5 ppm cannot be 
harmonized because residue field trial data support a tolerance that is 
higher than the Codex and Canadian MRLs. Codex and Canadian MRLs for 
boscalid also exist for various livestock commodities. However, because 
Codex and Canadian MRLs on boscalid do not exist for some animal feed 
commodities which have U.S. tolerances, the dietary burden of boscalid 
is higher for animals in the U.S., and U.S. livestock tolerances cannot 
be harmonized with equivalent Codex or Canadian MRLs at this time.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the data supporting the petition, EPA has 
revised the proposed tolerances on alfalfa, forage from 35 ppm to 30 
ppm; alfalfa, hay from 85 ppm to 65 ppm; fruit, citrus, group 10 from 
2.0 to 1.6 ppm; and fruit, stone, group 12 from 5.0 to 3.5 ppm. The 
Agency has also determined that individual tolerances are necessary for 
citrus, dried pulp at 4.5 ppm; and citrus, oil at 85 ppm because 
boscalid residues concentrate in these commodities. EPA revised these 
tolerance levels based on analysis of the residue field trial data 
using the Agency's Tolerance Spreadsheet in accordance with the 
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial 
Data. Because tolerances are being established on alfalfa forage and 
alfalfa hay under 40 CFR 180.589(a)(1), which applies to residues 
resulting from intentional or inadvertent use, EPA has also revised 
current inadvertent residue tolerance entries so that they exclude 
alfalfa, as follows: animal feed, nongrass, group 18, forage, except 
alfalfa and animal feed, nongrass, group 18, hay, except alfalfa.
    Additionally, EPA is modifying several tolerances for secondary 
residues in animal commodities. In conjunction with assessing potential 
residues in animal commodities from the proposed and established uses 
of boscalid, EPA has determined that the established tolerances for 
secondary residues in or on poultry and hog commodities need to be 
raised. Therefore, the Agency is increasing the established tolerances 
for hog, fat from 0.10 ppm to 0.20 ppm; poultry, fat from 0.05 ppm to 
0.20 ppm; and poultry, meat byproducts from 0.10 to 0.20 ppm. Finally, 
EPA has revised the tolerance expression to clarify (1) that, as 
provided in FFDCA section 408(a)(3), the tolerance covers metabolites 
and degradates of boscalid not specifically mentioned; and (2) that 
compliance with the specified tolerance levels is to be determined by 
measuring only the specific compounds mentioned in the tolerance 
expression.

V. Conclusion

    Therefore, tolerances are established for residues of boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or 
on alfalfa, forage at 30 ppm; alfalfa, hay at 65 ppm; fruit, citrus, 
group 10 at 1.6 ppm; citrus, dried pulp at 4.5 ppm; and citrus, oil at 
85 ppm. Additionally, previously established tolerances are revised for 
fruit, stone, group 12 at 3.5 ppm; hog, fat at 0.20 ppm; poultry, fat 
at 0.20 ppm; and poultry, meat byproducts at 0.20 ppm. Finally, this 
regulation deletes a time-limited tolerance on tangerine at 2.0 ppm, as 
it expired on December 31, 2008.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

[[Page 29907]]

List of Subjects in 40 CFR Part 180

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

    Dated: May 18, 2010
Daniel J. Rosenblatt
Acting 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:
    i. Revising the introductory text for paragraphs (a)(1) and (a)(2);
    ii. Revising the entry for ``Fruit, stone, group 12'' and 
alphabetically adding ``Alfalfa, forage''; ``Alfalfa, hay''; ``Citrus, 
dried pulp''; ``Citrus, oil''; and ``Fruit, citrus, group 10''; to the 
table in paragraph (a)(1);
    iii. Revising the entries for ``Hog, fat''; ``Poultry, fat''; and 
``Poultry, meat byproducts'' in the table in paragraph (a)(2);
    iv. Revising paragraph (b);
    v. Revising paragraph (d) introductory text and revising the 
entries for ``Animal feed, nongrass, group 18, forage'' and ``Animal 
feed, nongrass, group 18, hay'' in the table in paragraph (d) to read 
as follows:

Sec.  180.589  Boscalid; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide boscalid, including its metabolites and degradates, in or on 
the commodities listed below. Compliance with the tolerance levels 
specified below is to be determined by measuring only boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or 
on the following raw agricultural commodities:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage.....................                                30.0
------------------------------------------------------------------------
Alfalfa, hay........................                                65.0
------------------------------------------------------------------------
                                * * * * *
Citrus, dried pulp..................                                 4.5
------------------------------------------------------------------------
Citrus, oil.........................                                85.0
------------------------------------------------------------------------
                                * * * * *
Fruit, citrus, group 10.............                                 1.6
------------------------------------------------------------------------
                                * * * * *
Fruit, stone, group 12..............                                 3.5
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide 
boscalid, including its metabolites and degradates, in or on the 
commodities listed below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-
2-yl), and metabolites 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl) 
nicotinamide and glucuronic acid conjugate of 2-chloro-N-(4'-chloro-5-
hydroxy-biphenyl-2-yl) nicotinamide, calculated as the stoichiometric 
equivalent of boscalid in or on the following food commodities:

------------------------------------------------------------------------
             Commodity                       Parts per million
-----------------------------------------------------------------------
                                * * * * *
Hog, fat..........................                                0.20
------------------------------------------------------------------------
                                * * * * *
Poultry, fat......................                                0.20
------------------------------------------------------------------------
                                * * * * *
Poultry, meat byproducts..........                                0.20
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide boscalid, including its 
metabolites and degradates, in connection with use of the pesticide 
under section 18 emergency exemptions granted by EPA. Compliance with 
the tolerance level specified below is to be determined by measuring 
only boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-
biphenyl]-2-yl). This tolerance will expire and is revoked on the date 
specified in the following table:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Commodity                                   Parts per million                         Expiration/revocation date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endive, Belgian...........................................                                  16                                                  12/31/10
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 29908]]

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent residues of the fungicide boscalid, 
including its metabolites and degradates, in or on the commodities 
listed below. Compliance with the tolerance levels specified below is 
to be determined by measuring only boscalid, 3-pyridinecarboxamide, 2-
chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or on the following 
commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Animal feed, nongrass, group 18, forage, except                                                              1.0
 alfalfa..............................................
----------------------------------------------------------------------------------------------------------------
Animal feed, nongrass, group 18, hay, except alfalfa..                                                       2.0
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-12921 Filed 5-27-10; 8:45 am]
BILLING CODE 6560-50-S