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[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Rules and Regulations]
[Pages 71459-71464]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29751]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0780; FRL-9326-4]

Prohexadione Calcium; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
prohexadione calcium in or on sweet cherry. BASF Corporation requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 18, 2011. Objections and 
requests for hearings must be received on or before January 17, 2012, 
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-2010-0780. 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: Rose Mary Kearns, Registration 
Division, Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 
telephone number: (703) 305-5611; email address: 
kearns.rosemary@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 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2010-0780 in 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 
January 17, 2012. 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-2010-0780, 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 October 27, 2010 (75 FR 66092) (FRL-
8848-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0F7765) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.547 be amended by 
establishing tolerances for residues of the plant growth regulator 
prohexadione calcium, calcium, 3-oxido-5-oxo-4-propionylcyclohex-3-
enecarboxylate, in or on sweet cherries at 0.50 parts per million 
(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 for these changes are explained in Unit IV.D. 
Based upon review of the data supporting the petition, EPA has lowered 
the tolerance from 0.5 ppm to 0.4 p.m. The reason 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

[[Page 71460]]

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 including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with prohexadione calcium 
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. Prohexadione calcium is not acutely toxic by the oral, 
dermal, and inhalation routes. It is moderately irritating to the eyes 
and skin and is not a dermal sensitizer.
    Following subchronic dietary exposures, no treatment-related 
effects were seen at doses up to the limit dose in mice, fore-stomach 
hyperplasia was seen only at very high doses in rats, and kidneys were 
the target organ for toxicity in the dogs. Following repeated dermal 
exposures for 28-days, no toxicity was seen at the limit dose of 1,000 
milligrams/kilogram/day (mg/kg/day). There was no evidence of 
neurotoxicity following acute or subchronic exposure to rats.
    Following chronic dietary exposures, toxicity was seen only at high 
doses in dogs, rats, and mice. There was no evidence of carcinogenicity 
in male and female mice or male and female rats.
    In the rat developmental toxicity study, no treatment-related 
maternal or developmental toxicity was seen at the limit dose. Three 
rabbit developmental toxicity studies are also available. In one study, 
maternal toxicity manifested as increased mortality, abortions, and 
decreases in body-weight gain was seen at the highest dose tested. 
However, no developmental toxicity was seen at the dose that caused 
maternal toxicity. The abortions were attributed to the maternal 
toxicity (i.e., mortality and decreased body-weight gain) and not to 
toxicity of the test material. In the second developmental toxicity 
study in rabbits, no maternal or developmental toxicity was seen at the 
highest dose tested. In the third study, maternal toxicity, manifested 
as premature deliveries, was seen as a dose where no developmental 
toxicity was seen. In the reproductive toxicity study with rats, 
parental toxicity (minimal mortality) occurred at a dose lower than the 
dose that caused decreases in body weight of the offspring. No 
reproductive toxicity was seen at the highest dose tested in this 
study. These results indicate no quantitative or qualitative increase 
in susceptibility of rats and rabbits to in utero and/or post-natal 
exposure to prohexadione calcium.
    Prohexadione calcium was non-carcinogenic in both the rat and 
mouse. Prohexadione calcium has been classified as ``not likely to be 
caricinogenic to humans'' based upon lack of evidence of 
carcinogenicity in rats and mice.
    Specific information on the studies received and the nature of the 
adverse effects caused by prohexadione calcium 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 the document Notice of Filing for Prohexadione 
Calcium at 66092 in docket ID number EPA-HQ-OPP-2010-0780. (See pages 
8012 in the HED Risk Assessment in the docket number for this rule).

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 prohexadione calcium 
used for human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Prohexadione Calcium for Use in Human Health Risk
                                                   Assessment
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                                        Dose used in risk    RfD, PAD, LOC for risk    Study and toxicological
         Exposure/scenario               assessment, UFs            assessment                 effects
----------------------------------------------------------------------------------------------------------------
Acute dietary......................  N/A...................  N/A...................  An appropriate endpoint
                                                                                      attributable to a single
                                                                                      dose (exposure) was not
                                                                                      seen in the toxicity
                                                                                      database.
Chronic dietary....................  NOAEL = 20 mg/kg/day..  Chronic RfD cPAD= 0.2   Chronic toxicity dog LOAEL
                                     UFA = 10X.............   mg/kg/day.              = 200 mg/kg/day based on
                                     UFH = 10X FQPA SF = 1X                           histopathological changes
                                                                                      in the kidneys (dilated
                                                                                      basophilic tubules) and
                                                                                      increased urinary volumn
                                                                                      and NA\+\ ion
                                                                                      concentrations.

[[Page 71461]]

 
Incidental oral short-term (1 to 30  NOAEL= 80 mg/kg/day...  LOC for MOE = 100       90 day oral toxicity dog
 days)- and Intermediate (1-6        UFA = 10X.............   (Residential).          LOAEL = 400 mg/kg/day
 Months)-Term.                       UFH = 10X.............                           based on moderate cortical
                                     FQPA SF = 1X..........                           areas of dilated
                                                                                      basophilic tubules in the
                                                                                      kidneys and decreased
                                                                                      potassium levels.
Short (1-30 days)- and intermediate  Oral Maternal NOAEL =   LOC for MOE = 100       Prenatal developmental
 (1 to 6 months)--Term Dermal         40 Estimated            (Occupational/          Toxicity--rabbit LOAEL =
 (Occupational/Residential).          absorption rate 25%.    Residential.            200 mg/kg/day based on
                                                                                      increased mortality,
                                                                                      abortions, and decreased
                                                                                      maternal body-weight gain.
Short-term (1 to 30 days)- and       Oral Maternal NOAEL =   LOC for MOE = 100.....  Prenatal developmental
 Intermediate (1-6 months)--Term      40 mg/kg/day                                    toxicity--rabbit LOAEL =
 Inhalation.                          (inhalation-                                    200 mg/kg/day based on
                                      absorption rate =                               increased mortality,
                                      100%).                                          abortions, and decreased
                                                                                      maternal body-weight gain.
Cancer (oral, dermal, inhalation...  Not likely human        N/A...................  No evidence of carcinogenic
                                      carcinogen.                                     potential.
----------------------------------------------------------------------------------------------------------------
\1\ UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH = potential variation
  in sensitivity among members of the human population (intraspecies), FQPA SF = FQPA Safety Factor, NOAEL = no-
  observed adverse-effect level, LOAEL = lowest-observed adverse-effect level, PAD = population-adjusted dose (a
  = acute, c = chronic) RfD = reference dose, MOE = margin of exposure; LOC = level of concern; NA = not
  applicable.
\2\ 25% Dermal-absorption factor--Derived from HIARC report 112600HA.002.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to prohexadione calcium, EPA considered exposure under the 
petitioned-for tolerances as well as all existing prohexadione calcium 
tolerances in 40 CFR 180.547. EPA assessed dietary exposures from 
prohexadione calcium 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 
prohexadione calcium 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 Continuing Survey 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA assumed Dietary Exposure Evaluation Model (DEEM) \TM\ (ver.7.81) 
default processing factors, 100 percent crop treated (PCT), and 
tolerance level residues for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that prohexadione calcium does not pose a cancer risk to 
humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for prohexadione calcium. Tolerance level residues 
and/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 prohexadione calcium in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of prohexadione calcium. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppfed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models the estimated drinking water concentrations (EDWCs) of 
prohexadione calcium for acute exposures are estimated to be 52.4 parts 
per billion for surface water and .158 ppb for ground water.
    For chronic exposures for non cancer assessments are estimated to 
be 9.1 ppb for surface water and 0.0158 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary assessment, the water concentration value of 52.4 
ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 9.1 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).
    Prohexadione calcium is currently registered for the following uses 
that could result in residential exposures: Residential lawns, 
ornamentals, athletic fields, parks, and golf courses. There is a 
potential for exposure in residential settings during the application 
process for homeowners who use products containing prohexadione 
calcium. There is also a potential for exposure of adults and children 
from entering prohexadione calcium-treated areas. EPA assessed 
residential exposure using the following assumptions: It has been 
determined that exposure to pesticide handlers is likely during the 
residential use of prohexadione calcium on lawns and ornamentals. 
Intermediate term exposures are not likely because of the intermittent 
nature of applications by homeowners. Adults were also assessed for 
potential short-term postapplication dermal exposure from contact with 
treated residential and recreational turf (home lawns, recreational 
fields, and golf courses). Youths, ages 10-12 years old, were selected 
as a representative population to assess postapplication dermal 
exposure from contact with treated residential and recreational turf 
(home lawns, fields, and golf courses). Children, ages 3-6 years old, 
were selected as a representative population to assess for 
postapplication dermal and incidental oral (hand-to-mouth, object-

[[Page 71462]]

to-mouth, and soil ingestion) exposure to residential turf/home lawns. 
For all residential scenarios, the short-term risk estimates (MOEs) do 
not exceed the Agency's LOC. 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.
    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 prohexadione calcium to share a common mechanism 
of toxicity with any other substances, and prohexadione calcium does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has assumed 
that prohexadione calcium 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 Web site 
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 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. There is no evidence 
(quantitative or qualitative) evidence of increased susceptibility 
following in utero exposures to rats and rabbits and following pre-and 
post-natal exposures to rats. In the developmental study in rats, no 
maternal or developmental toxicity was seen up to the limit dose. 
Additionally, three developmental studies in rabbits were available, 
and no developmental toxicity was seen in these studies. The abortions 
seen in one study were not due to treatment, but rather due to the 
severe maternal toxicity (deaths and decreased body-weight gain) 
observed in the dose. In the reproductive toxicity, offspring toxicity 
was seen at a dose higher than the dose that caused parental/systemic 
toxicity.
    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 prohexadione calcium is complete.
    ii. There is no evidence of neurotoxcity following acute and 
subchronic exposures and there was no evidence of increased 
susceptibility following in utero and pre/post natal exposures. 
Therefore, a developmental neurotoxicity study is not required.
    iii. The toxicology database for prohexadione calcium does not show 
any evidence of treatment-related effects on the immune system. The 
overall weight of evidence suggests that this chemical does not 
directly target the immune system. In addition, prohexadione calcium 
does not belong to a class of chemicals (e.g., the organotins, heavy 
metals, halogenated aromatic hydrocarbons) that would be expected to be 
immunotoxic. Although an immunotoxicity study is now required as a part 
of new data requirements in the 40 CFR part 158 for conventional 
pesticide registration, HED does not believe that conducting this study 
will result in a lower point of departure (POD) than that currently 
used for overall risk assessment; therefore, a database uncertainty 
factor (UFDB) is not needed to account for lack of these 
studies
    iv. There are no residual uncertainties for pre- and post-natal 
toxicity.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary exposure analysis is conservative in that 
tolerance-level residues, 100% crop treated, and modeled drinking water 
estimates were assumed. The residential exposure analysis is 
conservative since it is based on the residential Standard Operating 
Procedures (SOPs). The dietary and residential risk assessments are 
thus conservative and are not expected to underestimate risk. EPA made 
conservative (protective) assumptions in the ground water and surface 
water modeling used to assess exposure to prohexadione calcium in 
drinking water. EPA used similarly conservative assumptions to assess 
postapplication of children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks exposed by prohexadione calcium.

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-, intermediate-, 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, 
prohexadione calcium is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit or chronic exposure, EPA has concluded that the chronic exposure 
to prohexadione calcium from food and water will utilize 14% 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 
prohexadione calcium 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). Prohexadione 
calcium 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 prohexadione calcium. 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 aggregate MOEs of 340 or higher for all 
populations. Because EPA's level of concern for prohexadione calcium is 
a MOE of 100 or below, these MOEs are not of concern.

[[Page 71463]]

    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). Because no intermediate-term adverse effect was identified, 
prohexadione calcium is not expected to pose a intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, prohexadione calcium is not expected to pose a cancer risk to 
humans.
    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 prohexadione calcium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. A liquid chromatography with tandem mass 
spectrometry (LC/MS/MS) method (BASF Method 564/0) is available for the 
enforcement of the proposed tolerances or sweet cherries. EPA has 
determined that BASF Method 564/0 is a suitable enforcement method for 
fruit commodities, as defined in SOP No. ACB-019 (9/15/08).
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email 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 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.
    The Codex has not established a MRL for prohexadione calcium.

C. Revisions to Petitioned-For Tolerances

    EPA has determined that the tolerance level for prohexadione 
calcium residues in or on sweet cherry should be lowered from 0.50 ppm 
as requested in the petition to 0.40 ppm based on a review of the 
current prohexadione calcium database and utilizing the internationally 
(OECD) harmonized spreadsheet for calculating pesticide tolerances.
    Additonally, the Agency is modifying the tolerance expression for 
prohexadione calcium to clarify that, as provided in FFDCA section 
408(a)(3), the tolerance covers metabolites and degradates of 
prohexadione calcium not specifically mentioned; and 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, a tolerance is established for residues of prohexadione 
calcium, calcium 3-oxido-5-oco-4-propionylcyclohex-3-enecarboxylate, in 
or on sweet cherry at 0.40 ppm. The tolerance expression is also being 
revised to include metabolites and degradates.

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) (Pub. L. 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

[[Page 71464]]

and pests, Reporting and recordkeeping requirements.

    Dated: October 28, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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 180.547 is amended by:
0
i. Revising the introductory text to paragraph (a) and;
0
ii. Alphabetically adding the commodity Cherry, sweet, to the table in 
paragraph (a) to read as follows:

Sec.  180.547  Prohexadione calcium, tolerances for residues.

    (a) General. Tolerances are established for residues of the growth 
regulator, prohexadione calcium, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels specified below is to be determined by 
measuring only prohexadione calcium (calcium 3-oxido-5-oxo-4-
propionylcyclohex-3-enecarboxylate)'' in or on the following 
commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cherry, sweet..............................................         0.40
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-29751 Filed 11-17-11; 8:45 am]
BILLING CODE 6560-50-P
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