
[Federal Register: September 16, 2009 (Volume 74, Number 178)]
[Rules and Regulations]               
[Page 47440-47445]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se09-5]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0624; FRL-8431-1]

 
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 coffee, green bean imported and amends the tolerance 
for banana, imported. BASF, Inc., requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation is also a 
removing tolerance for cucumber, and one tolerance for vegetable, root, 
subgroup 1A, except sugar beet, garden beet, radish, and turnip which 
are superceded with higher tolerances formerly published in the Federal 
Register of March 28, 2008 (73 FR 16553) (FRL-8354-4).

DATES: This regulation is effective September 16, 2009. Objections and 
requests for hearings must be received on or before November 16, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0624. 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: Bryant Crowe, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0025; e-mail address: crowe.bryant@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access

[[Page 47441]]

this Federal Register document electronically through the EPA Internet 
under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. 
You may also access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0624 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before November 16, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0624, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerances

    In the Federal Register of November 5, 2008 (73 FR 65849) (FRL-
8385-1), 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 
8E7366, PP 8E7367) by BASF Corporation, P.O. Box 13528, 26 Davis Drive, 
Research Triangle, NC 27709. The petitions requested that 40 CFR 
180.589 be amended by increasing the tolerance for residues of the 
fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro(1,1'-
biphenyl))-2-yl, in or on banana from 0.2 parts per million (ppm) to 
0.5 ppm (PP 8E7366), and establishing a tolerance for coffee, green 
bean at 0.05 ppm (PP 8E7367). That notice referenced a summary of the 
petitions prepared by BASF Corporation, the registrant, which is 
available to the public in the docket, http://www.regulations.gov. One 
comment was received from a private citizen. EPA's response to comment 
is discussed in Unit IV.C.
    Additionally, in this action EPA is correcting an error in a prior 
tolerance rulemaking for boscalid (73 FR 16553) (March 28, 2008). In 
that action, EPA amended the boscalid tolerances for cucumber and 
vegetable, root, subgroup 1A , except sugar beet, garden beet, radish, 
and turnip by increasing the level of each of those tolerances. 
Inadvertently, however, the revised tolerance levels were added to the 
CFR without removing the prior tolerances. This action removes the 
prior tolerances.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for residues of boscalid on banana, imported at 0.40 ppm, 
and coffee, green bean, imported at 0.05 ppm. EPA's assessment of 
exposures and risks associated with establishing tolerances follow.

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 is not an eye or skin irritant. 
Dermal sensitization could not be determined because the skin 
sensitization study was inadequate. The target organs for boscalid are 
the thyroid and liver.
    An acute endpoint was not selected because no adverse effects 
attributable to a single exposure to boscalid were seen in the 
database, including the developmental toxicity studies. The chronic 
dietary, incidental oral, dermal, and inhalation endpoints were all 
selected from three co-critical studies: The chronic rat study, the rat 
carcinogenicity study, and a 1-year feeding study in dogs. The dose 
selected for regulation of oral, dermal, and inhalation risk at all 
durations, for all populations, is the ``no- observed-adverse-effect 
level'' of 21.8 milligrams/kilogram/day (mg/kg/day) based on thyroid 
and hepatic toxicity seen in rats and dogs at higher dose levels.
    Boscalid is classified as exhibiting ``suggestive evidence of 
carcinogenicity.'' Evidence of carcinogenicity was seen in males 
(significant trend, and pair-wise at the high dose) and in females 
(trend only) in rats or mice or both; however, in both sexes no 
malignancies were seen. Only benign tumors were observed, and these 
occurred at dose levels above the dose level used to establish the 
chronic population adjusted dose (cPAD). Additionally, there is no 
concern for mutagencity. EPA has concluded that the cPAD is protective 
of any tumor response seen in the boscalid cancer studies.
    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-

[[Page 47442]]

adverse-effect-level (LOAEL) from the toxicity studies can be found at 
http://www.regulations.gov in the ``Boscalid - Human Health Risk 
Assessment of the Proposed Food Use of the Fungicide on Imported 
Coffee'' on pages 16-21 in docket ID number EPA-HQ-OPP-2008-0624.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which the 
NOAEL in the toxicology study identified as appropriate for use in risk 
assessment. However, if a NOAEL cannot be determined, the lowest dose 
at which adverse effects of concern are identified (the LOAEL) or a 
Benchmark Dose (BMD) approach is sometimes used for risk assessment. 
Uncertainty/safety factors (UFs) are used in conjunction with the POD 
to take into account uncertainties inherent in the extrapolation from 
laboratory animal data to humans and in the variations in sensitivity 
among members of the human population as well as other unknowns. Safety 
is assessed for acute and chronic dietary risks by comparing aggregate 
food and water exposure to the pesticide to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD are calculated by dividing the POD by all applicable UFs. 
Aggregate short-, intermediate-, and chronic-term risks are evaluated 
by comparing food, water, and residential exposure to the POD to ensure 
that the margin of exposure (MOE) called for by the product of all 
applicable UFs is not exceeded. This latter value is referred to as the 
Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm; http://www.epa.gov/oppfead1/trac/
science, and http://www.epa.gov/pesticides/trac/science/aggregate.pdf.
    A summary of the toxicological endpoints for boscalid used for 
human risk assessment can be found at http://www.regulations.gov in the 
``Boscalid - Human Health Risk Assessment of the Proposed Food Use of 
the Fungicide on Imported Coffee'' on pages 6-7 in docket ID number 
EPA-HQ-OPP-2008-0624.

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 part 
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 was not conducted.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII), and accumulated exposure to the 
chemical for each commodity. As to residue levels in food, EPA made the 
following assumption for the chronic exposure assessments: The 
assessment was based on tolerance level residues for existing uses, 
recommended tolerance levels for banana and coffee, and 100% crop 
treated assumptions.
    iii. Cancer. For the reasons set forth in Unit II.A., EPA has 
concluded that the cPAD is protective of any cancer effects with 
boscalid. 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.
    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.
    The current requests for an increased tolerance in banana, and a 
new use on coffee, do not affect the estimated drinking water 
concentrations (EDWCs) because both requests are for tolerances on 
imported commodities. As a result, the EDWCs used in the previous 
assessment ``Boscalid - Human Health Risk Assessment to support 
proposed new uses on fresh herbs (herbs subgroup 19A), avocado, black 
sapote, canistel, mamey sapote, mango, papaya, sapodilla, star apple 
and cotton'' on page 15 in docket ID number EPA-HQ-OPP-2008-0624 at 
http://www.regulations.gov were used in this assessment as well. The 
EDWCs were based on the turf use.
    Based on the First Index Reservoir Screening Tool (FIRST), and 
Screening Concentration in Ground Water (SCI-GROW) models, the EDWCs of 
boscalid for chronic exposures for non-cancer assessments are estimated 
to be 29.6 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 0.029 ppm 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 the following uses that could 
result in residential exposures: Golf course turf, strawberries, 
caneberries, and tree fruit grown at ``U-pick'' farms and orchards. EPA 
assessed residential exposure using the following assumptions: Dermal 
post-application exposure for golfers exposed to treated turf. The 
duration of exposure is anticipated to be short-term.
    Based on the low vapor pressure of boscalid (7 x 10-9 hPa), the 
outdoor nature of the uses, and the weight of evidence from available 
residue studies, the Agency does not anticipate post-application 
inhalation exposures from the currently approved uses of boscalid.
    In addition, U-pick activities are considered to be one-time (<1 
day) events. As no adverse effects were seen in the boscalid toxicity 
database resulting from a single exposure to the chemical a post-
application exposure assessment is not required for this scenario.
    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.''

[[Page 47443]]

    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. 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. 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 are 
seen.
    In the developmental neurotoxicity 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 are low since the effects are either transient in nature 
or occurred at the limit dose and EPA is regulating based on a POD 
below where these effects are seen.
    While qualitative sensitivity was seen in the rabbit developmental 
study, the 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 are 
seen in the rabbit developmental study, EPA concludes that the 
qualitative sensitivity evidenced in the fetuses in the rabbit 
developmental study does not require retention of the 10X children's 
safety factor.
    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 adequate for risk 
assessment, however an immunotoxicity study (OPPTS Guideline 870.7800) 
in rats and/or mice is required under the new 40 CFR part 158 data 
regulations. No indication of immunotoxicity was observed in the 
toxicity database; therefore, an additional 10X database uncertainty 
factor (UF) is not warranted.
    ii. There is no indication that boscalid is a neurotoxic chemical 
and there is no need for additional UFs to account for neurotoxicity. 
There is no evidence of neurotoxicity in the acute subchronic, or 
developmental neurotoxicity studies. The toxicity studies for boscalid 
demonstrate that, in general, the chemical has low mammalian toxicity, 
and the database reveals no reproductive, developmental, or 
developmental neurotoxicity concerns.
    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 pre- and/or 
post-natal toxicity.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA has conservatively estimated human exposure to boscalid, 
relying on worst case exposures in food (assuming all registered crops 
contain residues at the tolerance level), and conservative models, as 
well as pesticide-specific data, in estimating exposure from residues 
in drinking water, and from residential uses. 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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
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 33% of the cPAD for children 
1 to 2 years of age, 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 use(s) 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 aggregated result in aggregate MOEs of 950 
for the U.S. population, 1,200 for females 13-49 years old, and 1,300 
for youth 13-19 years old.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water

[[Page 47444]]

(considered to be a background exposure level). Because no intermediate 
term, non-occupational exposures are anticipated from the use of 
boscalid, an intermediate-term aggregate risk assessment is not 
required for boscalid.
    5. Aggregate cancer risk for U.S. population. Boscalid is 
classified as exhibiting ``suggestive evidence of carcinogenicity.'' 
Evidence of carcinogenicity was seen in males (significant trend, and 
pair-wise at the high dose) and in females (trend only); however, in 
both sexes no malignancies were seen. Only benign tumors were observed, 
and these occurred at dose levels above the dose level used to 
establish the cPAD. Additionally, there is no concern for mutagencity. 
Quantification of human cancer risk is not required. Aggregate cancer 
exposure and risk are not of concern. Therefore, an aggregate risk 
assessment was not conducted.
    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 enforcement methodologies high performance liquid 
chromatography/ultra violet (HPLC/UV), and liquid chromatography/mass 
spectrometry/tandem mass spectrometry (LC/MS/MS) are available to 
enforce the tolerance expressions. 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

    The Codex Alimentarius Commission has established a MRL for 
residues of boscalid in or on banana at 0.2 ppm, which is equivalent to 
the current U.S. tolerance. However, the recommended U.S. tolerance is 
higher than the Codex MRL. In the submitted field trials, residues 
above the Codex MRL were observed. As a result, it is not possible to 
harmonize the banana tolerance with the Codex MRL. There is a Codex 
Maximum Residue for the residues of boscalid in/on coffee beans at 0.05 
ppm.

C. Response to Comments

    One anonymous public comment was received on November 5, 2008. The 
commenter claimed that there was suggestive evidence of carcinogenic 
effects from boscalid but that EPA had not assessed these effects. In 
response, EPA notes that, for the reasons set forth in Unit II.A., EPA 
has concluded that boscalid cPAD provides an adequate margin of safety 
with regard to the benign tumors seen in cancer studies with boscalid.

D. Revisions to Petitioned-For Tolerances

    The petition requested that 40 CFR 180.589 be amended by increasing 
the tolerance for residues of boscalid in or on banana from 0.2 ppm to 
0.5 ppm. Based on the output from the tolerance spreadsheet, the Agency 
recommends in favor of the establishment of an import tolerance of 0.40 
ppm.
    Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 
553(b)(B), provides that, when an Agency for good cause finds that 
notice and public procedure are impracticable, unnecessary or contrary 
to the public interest, the Agency may issue a final rule without 
providing notice and an opportunity for public comment. EPA has 
determined that there is good cause for making today's technical 
correction final without prior proposal and opportunity for comment, 
because EPA is correcting an error in a prior tolerance rulemaking for 
boscalid (73 FR 16553) (March 28, 2008). In that action, EPA amended 
the boscalid tolerances for cucumber and vegetable, root, subgroup 1A , 
except sugar beet, garden beet, radish, and turnip by increasing the 
level of each of those tolerances. Inadvertently, however, the revised 
tolerance levels were added to the CFR without removing the prior 
tolerances. This action removes the prior tolerances. EPA finds that 
this constitutes good cause under 5 U.S.C. 553(b)(B).

V. Conclusion

    Therefore, tolerances are amended for residues of boscalid, in or 
on banana, imported at 0.40 ppm, and established for coffee, green 
bean, imported at 0.05 ppm. Additionally, the duplicate boscalid 
tolerances for cucumber at 0.20 ppm, and vegetable, root, subgroup 1A, 
except sugar beet, garden beet, radish, and turnip at 0.7 ppm are 
removed correcting the error in which these superceded tolerances were 
not deleted despite their amendment.

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 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.
    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

[[Page 47445]]

Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 
section 12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: August 25, 2009.
Lois A. 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. In Sec.  180.589, the table to paragraph (a)(1) is amended by 
alphabetically adding an entry for ``coffee, green bean, imported'', by 
revising the entry for ``banana, import'' and by removing the entry for 
``cucumber'' with the limit of 0.20 ppm and the entry for ``vegetable, 
root, subgroup 1A, except sugar beet, garden beet, radish, and turnip'' 
with the limit of 0.7 ppm. The added and revised entries read as 
follows:


Sec.  180.589  Boscalid; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Banana, import \\1\\.......................................         0.40
                                * * * * *
Coffee, green bean, import \\1\\...........................         0.05
                               * * * * *
------------------------------------------------------------------------
1No US registrations as of September 16, 2009.

* * * * *

[FR Doc. E9-22163 Filed 9-15-09; 8:45 am]

BILLING CODE 6560-50-S
