Forchlorfenuron; Permanent and Time-Limited Pesticide Tolerances, 47841-47847 [E8-18946]
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Federal Register / Vol. 73, No. 159 / Friday, August 15, 2008 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–1065; FRL–8375–4]
Forchlorfenuron; Permanent and TimeLimited Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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 timelimited tolerances expire on December
31, 2011. IR-4 and KIM-C1, LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
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 https://
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
https://www.regulations.gov, or, if only
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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:
maignan.tawanda@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://www.gpoaccess.gov/
ecfr.
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47841
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:
• Federal eRulemaking Portal: https://
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’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 IR4 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
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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, https://
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:
• Although the subgroup includes
several new commodities, these
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commodities were proposed as
individual tolerances and are closely
related minor crops which contribute
little to overall dietary or aggregate
exposure and risk.
• Forchlorfenuron exposure from
these added commodities was
considered when EPA conducted the
dietary and aggregate risk assessments
supporting this action.
• 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
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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-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
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
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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
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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 https://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 Uncertainty/
Safety Factors
Exposure/Scenario
Acute dietary (all populations)
RfD, PAD, LOC for Risk Assessment
Study and Toxicological Effects
No appropriate endpoint attributable to a single exposure (dose) was identified from oral toxicity studies, including the developmental studies.
NOAEL= 7 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.07 mg/kg/day
Chronic oral toxicity study- rat
LOAEL = 93 mg/kg/day based on
decreased body weight/bodyweight gain/food consumption,
and kidney toxicity (suppurative
inflammation in males; nonsuppurative interstitial nephritis in females)
Dermal short-term
(1 to 30 days)
(oral) NOAEL = 100 mg/kg/day
(Dermal absorption rate = 100%
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Developmental toxicity study - rabbit
LOAEL = 125 mg/kg/day based on
body-weight loss during dosing
period in the range-finding study
Dermal intermediate-term
(1 to 6 months)
(Oral) NOAEL= 87 mg/kg/day
(Dermal absorption rate = 100%)
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Chronic oral toxicity study - dog
LOAEL = 195 mg/kg/day based on
decreased body weight/bodyweight gain/food consumption
Dermal long-term
(>6 months)
(Oral) NOAEL = 7 mg/kg/day
(Dermal absorption rate = 100%)
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Chronic oral toxicity study - rat
LOAEL = 93 mg/kg/day based on
decreased body weight/bodyweight gain/food consumption,
and kidney toxicity (suppurative
inflammation in males; nonsuppurative interstitial nephritis in females)
Inhalation short-term
(1 to 30 days)
(oral)NOAEL= 100 mg/kg/day
(Inhalation absorption rate = 100%)
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Developmental toxicity study - rabbit
LOAEL = 125 mg/kg/day based on
body-weight loss during dosing
period in the range-finding study
Inhalation intermediateterm
(1 to 6 months)
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Chronic dietary
(All populations)
(Oral) study
NOAEL = 87 mg/kg/day
(inhalation absorption rate = 100%)
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Chronic oral toxicity study - dog
LOAEL = 195 mg/kg/day based on
decreased body weight/bodyweight gain/food consumption
Inhalation long-term
(>6 months)
(Oral) NOAEL = 7 mg/kg/day
(inhalation absorption rate = 100%)
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Chronic oral toxicity study - rat
LOAEL = 93 mg/kg/day based on
decreased body weight/bodyweight gain/food consumption,
and kidney toxicity (suppurative
inflammation in males; nonsuppurative interstitial nephritis in females)
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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FORCHLORFENURON FOR USE IN HUMAN RISK
ASSESSMENT—Continued
Exposure/Scenario
Cancer
(Oral, dermal, inhalation)
Point of Departure and Uncertainty/
Safety Factors
RfD, PAD, LOC for Risk Assessment
Study and Toxicological Effects
Classification: Not likely to be a human carcinogen, based on two adequate rodent carcinogenicity studies.
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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
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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 https://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-
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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 https://
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.
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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.
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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. Shortterm, intermediate-term, and chronicterm 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
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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 # 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.
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47845
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-4pyridinyl)-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-4pyridinyl)-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 semicommercial 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
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Federal Register / Vol. 73, No. 159 / Friday, August 15, 2008 / Rules and Regulations
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).
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
VII. Congressional Review Act
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.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
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
Authority: 21 U.S.C. 321(q), 346a and 371.
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:
I
§ 180.569 Forchlorfenuron; tolerances for
residues.
(a) General (1) * * *
Commodity
Parts per million
Bushberry subgroup 13–07B
0.01
*
*
*
*
*
(2)* * *
Commodity
sroberts on PROD1PC70 with PROPOSALS
Almond .....................................................................................................................................
Almond, hulls ...........................................................................................................................
Cherry, sweet ...........................................................................................................................
Fig ............................................................................................................................................
Pear .........................................................................................................................................
Pistachio ..................................................................................................................................
Plum, prune, fresh
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date
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0.15
0.01
0.01
0.01
0.01
0.01
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Federal Register / Vol. 73, No. 159 / Friday, August 15, 2008 / Rules and Regulations
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[FR Doc. E8–18946 Filed 8–14–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 541
[Docket No. NHTSA–2008–0049]
RIN 2127–AK31
Federal Motor Vehicle Theft Prevention
Standard; Final Listing of 2009 Light
Duty Truck Lines Subject to the
Requirements of This Standard and
Exempted Vehicle Lines for Model Year
2009
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation.
ACTION: Final rule.
sroberts on PROD1PC70 with PROPOSALS
AGENCY:
SUMMARY: This final rule announces
NHTSA’s determination that there are
no new model year (MY) 2009 light duty
truck lines subject to the parts-marking
requirements of the Federal motor
vehicle theft prevention standard
because they have been determined by
the agency to be high-theft or because
they have a majority of interchangeable
parts with those of a passenger motor
vehicle line. This final rule also
identifies those vehicle lines that have
been granted an exemption from the
parts-marking requirements because the
vehicles are equipped with antitheft
devices determined to meet certain
statutory criteria.
DATES: Effective Date: The amendment
made by this final rule is effective
August 15, 2008.
FOR FURTHER INFORMATION CONTACT: Ms.
Rosalind Proctor, Consumer Standards
Division, Office of International Policy,
Fuel Economy and Consumer Programs,
NHTSA, West Building, 1200 New
Jersey Avenue, SE., (NVS–131, Room
W43–302), Washington, DC 20590. Ms.
Proctor’s telephone number is (202)
366–0846. Her fax number is (202) 493–
0073.
SUPPLEMENTARY INFORMATION: On April
6, 2004, the agency published in the
Federal Register (69 FR 17960) a final
rule extending the parts-marking
requirements to certain vehicle lines
that were not previously subject to these
requirements, specifically (1) all lowtheft passenger car lines; (2) all lowtheft multipurpose passenger vehicle
(MPV) lines with a gross vehicle weight
rating (GVWR) of 6,000 pounds or less;
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17:44 Aug 14, 2008
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and (3) low-theft light-duty truck (LDT)
lines with a GVWR of 6,000 pounds or
less that have major parts that are
interchangeable with a majority of the
covered major parts of passenger cars or
MPVs. The high-theft vehicle lines that
were previously exempted under 49
CFR part 543 on the grounds that they
were equipped with an antitheft device
as standard equipment were unaffected
by the April 2004 final rule. The agency
also stated that it would continue to
grant exemptions for one vehicle line
per manufacturer per model year. The
final rule was effective September 1,
2006. The final rule included a phasein provision which required at least 50
percent of the production volume not
subject to the current parts marking
requirements (excluding light duty
trucks) to have been marked by
September 1, 2006. The remaining
production volume not subject to the
current parts marking requirements
must have been marked by September 1,
2007 (see 70 FR 28843, May 19, 2005).
The purpose of the theft prevention
standard (49 CFR part 541) is to reduce
the incidence of motor vehicle theft by
facilitating the tracing and recovery of
parts from stolen vehicles. The standard
seeks to facilitate such tracing by
requiring that vehicle identification
numbers (VINs), VIN derivative
numbers, or other symbols be placed on
major component vehicle parts. The
theft prevention standard requires motor
vehicle manufacturers to inscribe or
affix VINs onto covered original
equipment major component parts, and
to inscribe or affix a symbol identifying
the manufacturer and a common symbol
identifying the replacement component
parts for those original equipment parts,
on all vehicle lines subject to the
requirements of the standard.
Section 33104(d) provides that once a
line has become subject to the theft
prevention standard, the line remains
subject to the requirements of the
standard unless it is exempted under
§ 33106. Section 33106 provides that a
manufacturer may petition to have a
line exempted from the requirements of
§ 33104, if the line is equipped with an
antitheft device as standard equipment.
The exemption is granted if NHTSA
determines that the antitheft device is
likely to be as effective as compliance
with the theft prevention standard in
reducing and deterring motor vehicle
thefts.
The agency annually publishes the
names of those vehicle lines that have
been determined to be high theft
pursuant to 49 CFR part 541 and those
that are exempted from the theft
prevention standard under section
33104. Appendix A to Part 541
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47847
identifies those new light-duty truck
lines listed for the first time that will be
subject to the theft prevention standard
beginning in a given model year.
Appendix A–I to Part 541 identifies
those vehicle lines that are or have been
exempted from the theft prevention
standard.
On September 26, 2007, the final
listing of MY 2008 high-theft vehicle
lines was published in the Federal
Register (72 FR 54600). The final listing
identified that there again were no new
vehicle lines that became subject to the
theft prevention standard beginning
with the 2008 model year. For MY 2009,
there were no new light-duty truck lines
identified that became subject to the
theft prevention standard in accordance
with the procedures published in 49
CFR part 542.
For MY 2009, the list of lines that
have been exempted by the agency from
the parts-marking requirements of Part
541 includes nine vehicle lines newly
exempted in full. The nine exempted
vehicle lines are the Hyundai Genesis,
Mazda 5, Subaru Forester, Jeep
Wrangler, Chevrolet Equinox, Daimler
smart USA fortwo, Nissan Rogue, Ford
Escape, and Audi Q5.
We note that the agency removes from
the list being published in the Federal
Register each year certain vehicles lines
that have been discontinued more than
5 years ago. Therefore, the Chevrolet
Lumina/Monte Carlo (1996–1999) and
the Chevrolet Malibu (2001–2003) have
been removed from the Appendix A–I
listing. The agency will continue to
maintain a comprehensive database of
all exemptions on our Web site.
However, we believe that re-publishing
a list containing vehicle lines that have
not been in production for a
considerable period of time is
unnecessary.
The vehicle lines listed as being
exempt from the standard have
previously been exempted in
accordance with the procedures of 49
CFR part 543 and 49 U.S.C., 33106.
Therefore, NHTSA finds for good cause
that notice and opportunity for
comment on these listings are
unnecessary. Further, public comment
on the listing of selections and
exemptions is not contemplated by 49
U.S.C. Chapter 331. For the same
reasons, since this revised listing only
informs the public of previous agency
actions and does not impose additional
obligations on any party, NHTSA finds
for good cause that the amendment
made by this notice should be effective
as soon as it is published in the Federal
Register.
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]]>Agencies
[Federal Register Volume 73, Number 159 (Friday, August 15, 2008)]
[Rules and Regulations]
[Pages 47841-47847]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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 https://
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 https://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: maignan.tawanda@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://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:
Federal eRulemaking Portal: https://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'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, https://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:
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.
Forchlorfenuron exposure from these added commodities was
considered when EPA conducted the dietary and aggregate risk
assessments supporting this action.
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 https://
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 https://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
----------------------------------------------------------------------------------------------------------------
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 https://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 https://
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 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
