[Federal Register Volume 73, Number 159 (Friday, August 15, 2008)]
[Rules and Regulations]
[Pages 47841-47847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18946]



[[Page 47841]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1065; FRL-8375-4]


Forchlorfenuron; Permanent and Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a permanent tolerance for residues 
of forchlorfenuron in or on bushberry subgroup 13-07B requested by the 
IR-4 Project Headquarters, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. Time-limited tolerances are also being established 
under this regulation in support of experimental use permit 71049-EUP-4 
for residues of forchlorfenuron in or on almond, cherry, fig, pear, 
pistachio, plum/prune requested by KIM-C1, LLC c/o Siemer and 
Associates, Inc. 135 W. Shaw, Suite 102, Fresno, CA 93704. The time-
limited tolerances expire on December 31, 2011. IR-4 and KIM-C1, LLC 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective August 15, 2008. Objections and 
requests for hearings must be received on or before October 14, 2008, 
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 dockets for this action under docket 
identification (ID) numbers EPA-HQ-OPP-2007-0627 and EPA-HQ-OPP-2007-
1065. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. All 
documents in the docket are listed in the docket index available in 
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: Tawanda Maignan, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8050; e-mail address: <a href="/cdn-cgi/l/email-protection#e489858d838a858aca908593858a8085a4819485ca838b92"><span class="__cf_email__" data-cfemail="127f737b757c737c3c667365737c7673527762733c757d64">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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 an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-1065 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 October 14, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-1065, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of October 24, 2007 (72 FR 205) (FRL-8150-
8) and of February 13, 2008 (73 FR 30) (FRL-8351-5), EPA issued notices 
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of a pesticide petition (PP 7E7228) by the IR-4 
Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 
08540 and pesticide petition (PP 7F7246) by KIM-C1, LLC c/o Siemer and

[[Page 47842]]

Associates, Inc. 135 W. Shaw, Suite 102, Fresno, CA 93704, 
respectively. The petitions requested that 40 CFR 180.569 be amended by 
establishing permanent tolerances and time-limited tolerances for 
residues of the plant growth regulator forchlorfenuron, in or on 
bushberry subgroup 13B at 0.01 parts per million (ppm) (PP 7E8228) and 
almond, cherry, fig, pear, pistachio, plum/prune at 0.01 ppm (PP 
7F7246), respectively. Those notices referenced a summary of the 
petitions prepared by the registrants, Valent U.S.A. Corporation and 
KIM-C1, LLC, respectively which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filings.
    Based upon review of the data supporting the petitions, EPA has 
revised certain proposed tolerance levels and corrected commodity 
definitions as follow:
    The Agency determined that adequate data are available to support 
establishing a tolerance for the bushberry subgroup 13-07B. IR-4 
petitioned for a tolerance for bushberry subgroup 13B as well as 
individual tolerances on aronia berry, buffalo currant, Chilean guava, 
European barberry, highbush cranberry, honeysuckle, jostaberry, 
juneberry, lingonberry, native currant, salal, and sea buckthorn (PP 
7E7228). In the Federal Register of December 7, 2007 (72 FR 69150) 
(FRL-8340-6), EPA issued a final rule that revised the crop grouping 
regulations. As part of this action, EPA expanded and revised berries 
group 13. Changes to crop group 13 (berries) included adding new 
commodities, revising existing subgroups and creating new subgroups 
(including a bushberry subgroup 13-07B consisting of the commodities 
requested in PP 7E7228 and cultivars, varieties, and/or hybrids of 
these).
    EPA indicated in the December 7, 2007 final rule as well as the 
earlier May 23, 2007 proposed rule (72 FR 28920) (FRL-8126-6) that, for 
existing petitions for which a notice of filing had been published, the 
Agency would attempt to conform these petitions to the rule. Therefore, 
consistent with this rule, EPA is establishing a tolerance for the 
bushberry subgroup 13-07B. Bushberry subgroup 13-07B consists of the 
berries for which tolerances were requested in PP 7E7228.
    EPA concludes it is reasonable to revise the petitioned-for 
tolerances so that they agree with the recent crop grouping revisions 
because:
    <bullet> Although the subgroup includes several new commodities, 
these commodities were proposed as individual tolerances and are 
closely related minor crops which contribute little to overall dietary 
or aggregate exposure and risk.
    <bullet> Forchlorfenuron exposure from these added commodities was 
considered when EPA conducted the dietary and aggregate risk 
assessments supporting this action.
    <bullet> The representative commodities for the revised subgroup 
has not changed.

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 
permanent tolerances for residues of forchlorfenuron on bushberry 
subgroup 13-07B at 0.01 ppm and time-limited tolerances for residues of 
forchlorfenuron on almond, cherry, fig, pear, pistachio, plum/prune at 
0.01 ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Forchlorfenuron is not acutely toxic via the oral, dermal, and 
inhalation routes. Dose-related effects noted in the dog following 
subchronic and chronic exposure were generally limited to decreased 
body weight and body-weight gain. In the rat, the only organ that 
appeared to be affected was the kidney, which showed suppurative 
inflammation, suppurative pyelonephritis, non-suppurative interstitial 
nephritis, and cortical cysts following chronic exposure. Developmental 
toxicity (decreased fetal body weight) was observed in the rat only at 
a maternally-toxic dose. Forchlorfenuron did not induce any signs of 
reproductive toxicity or neurotoxic potential. The developmental 
toxicity studies in rats and rabbits, as well as the reproductive 
toxicity study in rats, did not demonstrate any prenatal or postnatal 
sensitivity. There was no evidence of neurotoxicity in any of the 
submitted studies. Forchlorfenuron is classified as not likely to be a 
human carcinogen and there is no concern for mutagenicity. There was no 
evidence of endocrine disruption in the forchlorfenuron database.
    Specific information on the studies received and the nature of the 
adverse effects caused by forchlorfenuron 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 Forchlorfenuron: Human Health Risk 
Assessment for Proposed Uses on the Bushberry Subgroup 13 B and to 
Support a Requested Experimental Use Permit on almonds, sweet cherries, 
figs, pears, pistachios and plums/prunes, in docket ID number EPA-HQ-
OPP-2007-1065.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account

[[Page 47843]]

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.
    A summary of the toxicological endpoints for forchlorfenuron used 
for human risk assessment is shown in Table 1 of this unit.

   Table 1.--Summary of Toxicological Doses and Endpoints for forchlorfenuron for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
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Acute dietary (all populations)           No appropriate endpoint attributable to a single exposure (dose) was
                                           identified from oral toxicity studies, including the developmental
                                                                        studies.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 7 mg/kg/day       Chronic RfD = 0.07 mg/   Chronic oral toxicity
(All populations)....................  UFA = 10x..............   kg/day                   study- rat
                                       UFH = 10x..............                           LOAEL = 93 mg/kg/day
                                       FQPA SF = 1x...........                            based on decreased
                                                                                          body weight/body-
                                                                                          weight gain/food
                                                                                          consumption, and
                                                                                          kidney toxicity
                                                                                          (suppurative
                                                                                          inflammation in males;
                                                                                          nonsuppurative
                                                                                          interstitial nephritis
                                                                                          in females)
----------------------------------------------------------------------------------------------------------------
Dermal short-term                      (oral) NOAEL = 100 mg/   LOC for MOE = 100        Developmental toxicity
(1 to 30 days).......................   kg/day                                            study - rabbit
                                       (Dermal absorption rate                           LOAEL = 125 mg/kg/day
                                        = 100%.                                           based on body-weight
                                       UFA = 10x..............                            loss during dosing
                                       UFH = 10x..............                            period in the range-
                                       FQPA SF = 1x...........                            finding study
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term               (Oral) NOAEL= 87 mg/kg/  LOC for MOE = 100        Chronic oral toxicity
(1 to 6 months)......................   day                                               study - dog
                                       (Dermal absorption rate                           LOAEL = 195 mg/kg/day
                                        = 100%).                                          based on decreased
                                       UFA = 10x..............                            body weight/body-
                                       UFH = 10x..............                            weight gain/food
                                       FQPA SF = 1x...........                            consumption
----------------------------------------------------------------------------------------------------------------
Dermal long-term                       (Oral) NOAEL = 7 mg/kg/  LOC for MOE = 100        Chronic oral toxicity
(>6 months)..........................   day                                               study - rat
                                       (Dermal absorption rate                           LOAEL = 93 mg/kg/day
                                        = 100%).                                          based on decreased
                                       UFA = 10x..............                            body weight/body-
                                       UFH = 10x..............                            weight gain/food
                                       FQPA SF = 1x...........                            consumption, and
                                                                                          kidney toxicity
                                                                                          (suppurative
                                                                                          inflammation in males;
                                                                                          nonsuppurative
                                                                                          interstitial nephritis
                                                                                          in females)
----------------------------------------------------------------------------------------------------------------
Inhalation short-term                  (oral)NOAEL= 100 mg/kg/  LOC for MOE = 100        Developmental toxicity
(1 to 30 days).......................   day                                               study - rabbit
                                       (Inhalation absorption                            LOAEL = 125 mg/kg/day
                                        rate = 100%).                                     based on body-weight
                                       UFA = 10x..............                            loss during dosing
                                       UFH = 10x..............                            period in the range-
                                       FQPA SF = 1x...........                            finding study
----------------------------------------------------------------------------------------------------------------
Inhalation intermediate-term           (Oral) study             LOC for MOE = 100        Chronic oral toxicity
(1 to 6 months)......................  NOAEL = 87 mg/kg/day...                            study - dog
                                       (inhalation absorption                            LOAEL = 195 mg/kg/day
                                        rate = 100%).                                     based on decreased
                                       UFA = 10x..............                            body weight/body-
                                       UFH = 10x..............                            weight gain/food
                                       FQPA SF = 1x...........                            consumption
----------------------------------------------------------------------------------------------------------------
Inhalation long-term                   (Oral) NOAEL = 7 mg/kg/  LOC for MOE = 100        Chronic oral toxicity
(>6 months)..........................   day                                               study - rat
                                       (inhalation absorption                            LOAEL = 93 mg/kg/day
                                        rate = 100%).                                     based on decreased
                                       UFA = 10x..............                            body weight/body-
                                       UFH = 10x..............                            weight gain/food
                                       FQPA SF = 1x...........                            consumption, and
                                                                                          kidney toxicity
                                                                                          (suppurative
                                                                                          inflammation in males;
                                                                                          nonsuppurative
                                                                                          interstitial nephritis
                                                                                          in females)
----------------------------------------------------------------------------------------------------------------

[[Page 47844]]

 
Cancer                                     Classification: Not likely to be a human carcinogen, based on two
(Oral, dermal, inhalation)...........                   adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. FQPA SF = FQPA Safety
  Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of
  exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to forchlorfenuron EPA considered exposure under the 
petitioned-for tolerances as well as all existing forchlorfenuron 
tolerances in (40 CFR 180.569). EPA assessed dietary exposures from 
forchlorfenuron 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 
forchlorfenuron; 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 
Departmemt of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA conducted a highly conservative chronic dietary exposure and risk 
assessment to support the new uses of forchlorfenuron. Tolerance level 
residues and 100 percent crop treated (PCT) information was 
incorporated into the assessment. Dietary Exposure Evaluation Model 
(DEEM version 7.81) default processing factors were used for apple 
juice, dried apples, dried pears, prune juice, cranberry juice, and 
grape juice. A processing factor was not used for raisins because a 
separate tolerance (resulting from an empirical processing study) is 
being recommended for this commodity. Additionally, the default 
processing factor was not used for prunes (dried plums) since data 
indicated that residues in prunes would not exceed the recommended plum 
tolerance.
    iii. Cancer. Forchlorfenuron has been classified as not likely to 
be carcinogenic based on carcinogenicity studies in the rat and mouse 
which showed no evidence of an increase in the incidence of tumors 
therefore a cancer dietary exposure and risk assessment is not 
required.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for forchlorfenuron. Tolerance level residues and/or 100 PCT were 
assumed for all existing and new 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 forchlorfenuron in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of forchlorfenuron. 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.
    Forchlorfenuron is persistent and moderately mobile in soils. 
Forchlorfenuron is also a substituted urea plant growth regulator that 
is essentially stable to all routes of dissipation except sensitized 
photodegradation in water. Based on the Pesticide Root Zone Model/
Exposure Analysis Modeling System (PRZM/EXAMS) and Screening 
Concentration in Ground Water (SCI-GROW) models, the Estimated 
Environmental Concentrations (EECs) of forchlorfenuron from the newly 
proposed use on bushberries and the uses on almonds, sweet cherries, 
figs, pears, plums and pistachios under the EUP will not exceed the 
EECs from the grape and kiwi uses previously assessed by the Agency in 
document titled Drinking Water Assessment for Forchlorfenuron for Grape 
and Kiwi Uses. Therefore, the Agency has incorporated the drinking 
water EEC from the grape and kiwi analysis directly into this dietary 
assessment.
    For chronic dietary risk assessment, the water concentration of 
value 0.003 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).
    Forchlorfenuron is not registered for any specific use patterns 
that would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not made a common mechanism of toxicity finding asto 
forchlorfenuron and any other substances and forchlorfenuron 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 forchlorfenuron 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 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.

[[Page 47845]]

    2. Prenatal and postnatal sensitivity. The developmental and 
reproductive toxicity studies showed no evidence of increased 
sensitivity or susceptibility of young rats or rabbits following pre- 
and/or postnatal exposure to forchlorfenuron.
    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 forchlorfenuron is complete.
    ii. There is no indication that forchlorfenuron is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that forchlorfenuron results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to forchlorfenuron 
in drinking water. EPA used similarly conservative assumptions to 
assess exposure to forchlorfenuron residues in food. These assessments 
will not underestimate the exposure and risks posed by forchlorfenuron.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (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, 
forchlorfenuron 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 
forchlorfenuron from food and water will utilize <1% of the cPAD for 
the general U.S. population and all subpopulations. There are no 
residential uses for forchlorfenuron.
    3. Short-term and intermediate-term risk. Short-term and 
Intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Forchlorfenuron is not registered for any use patterns that would 
result in short-term and intermediate-term residential exposure. 
Therefore, the short-term and intermediate-term aggregate risk, 
individually is the sum of the risk from exposure to forchlorfenuron 
through food and water, which has already been addressed, and will not 
be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Since forchlorfenuron 
has been classified as not likely to be carcinogenic, aggregate cancer 
risk is not a concern.
    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 or to infants and children from aggregate 
exposure to forchlorfenuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate high performance liquid chromatography/ultraviolet 
(HPLC/UV) method (Method <greek-i> CCRL-MTH-029) is available for 
enforcing tolerances of forchlorfenuron in/on members of the Bushberry 
Subgroup 13-07B and the commodities that are the subject of the 
proposed EUP. For this method, residues are extracted with methanol or 
acetone, diluted with water, and partitioned against hexane. Residues 
remaining in the aqueous fraction are then partitioned into 
dichloromethane (DCM) and if necessary further purified using a silica 
SPE cartridge. Residues are determined by HPLC/UV using external 
standards and residues are confirmed by liquid chromatography (LC) mass 
spectrometry (MS/MS) analysis. The validated limit of quantitation 
(LOQ) is 0.01 ppm for fruit and nut crops.

B. International Residue Limits

    There is no established or proposed Canadian, Mexican or Codex MRLs 
for residues of forchlorfenuron in plant commodities.

C. Revisions to Petitioned-For Tolerances

    The data submitted also supports a temporary tolerance of 0.15 
parts per million (ppm) for almond, hulls. Therefore, a tolerance for 
residues of forchlorfenuron on almond, hulls at 0.15 ppm is 
established.

V. Conclusion

    Therefore, a permanent tolerance is established for residues of 
forchlorfenuron, N-(2-chloro-4-pyridinyl)-N'-phenyl urea, in or on 
bushberry subgroup 13-07B at tolerance level 0.01.
    Also, time-limited tolerances are established for residues of 
forchlorfenuron, N-(2-chloro-4-pyridinyl)-N'-phenyl urea, in or on 
almond at 0.01 ppm, almond, hulls at 0.15 ppm, cherry, sweet at 0.01 
ppm, fig at 0.01 ppm, pear at 0.01 ppm, pistachio at 0.01 ppm and plum, 
prune, fresh at 0.01 ppm. A time limitation has been imposed because 
KIM-C1, LLC has submitted an application for an Experimental Use Permit 
and Temporary Tolerance for plant growth regulator Forchlorfenuron 
(CPPU), on six crops (almonds, cherry, fig, pear, pistachio, and plum/
prune) to permit experimental use under semi-commercial conditions, 
which will include collection of additional residue data where 
necessary to support permanent tolerances.

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, 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

[[Page 47846]]

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 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 8, 2008.
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 180.569 is amended by adding bushberry subgroup 13-07B in 
the table to paragraph (a)(1); and revising the table in paragraph 
(a)(2) to read as follows:


Sec.  180.569  Forchlorfenuron; tolerances for residues.

    (a) General (1) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Bushberry subgroup 13-07B                                           0.01
                                * * * * *
------------------------------------------------------------------------

    (2)* * *

----------------------------------------------------------------------------------------------------------------
                                                                                          Expiration/revocation
                           Commodity                               Parts per million               date
----------------------------------------------------------------------------------------------------------------
Almond........................................................                     0.01               12/31/2011
Almond, hulls.................................................                     0.15               12/31/2011
Cherry, sweet.................................................                     0.01               12/31/2011
Fig...........................................................                     0.01               12/31/2011
Pear..........................................................                     0.01               12/31/2011
Pistachio.....................................................                     0.01               12/31/2011
Plum, prune, fresh                                                                 0.01               12/31/2011
----------------------------------------------------------------------------------------------------------------


[[Page 47847]]

* * * * *
[FR Doc. E8-18946 Filed 8-14-08; 8:45 am]
BILLING CODE 6560-50-S


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