[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29751]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Prohexadione Calcium; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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)
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:
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
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
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
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
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
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
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
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
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
\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
\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-
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
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
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
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
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
iv. There are no residual uncertainties for pre- and post-natal
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.
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
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:
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.
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping requirements.
Dated: October 28, 2011.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.547 is amended by:
i. Revising the introductory text to paragraph (a) and;
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
* * * * *
Cherry, sweet.............................................. 0.40
* * * * *
* * * * *
[FR Doc. 2011-29751 Filed 11-17-11; 8:45 am]
BILLING CODE 6560-50-P