Forchlorfenuron; Pesticide Tolerances, 18467-18471 [2014-07103]
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Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations
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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal
Register. This action 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: March 21, 2014.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.434, add alphabetically the
following commodity to the table in
paragraph (a) to read as follows:
■
§ 180.434 Propiconazole; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
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Rapeseed subgroup 20A ..........
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[FR Doc. 2014–07100 Filed 4–1–14; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0011; FRL–9907–47]
Forchlorfenuron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of
forchlorfenuron in or on multiple
commodities which are identified and
discussed later in this document. KIM–
C1, LLC requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective April
2, 2014. Objections and requests for
hearings must be received on or before
June 2, 2014, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0011, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
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18467
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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 https://www.ecfr.gov/cgi-bin/textidx?&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–2013–0011 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 June 2, 2014. 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 (excluding
any Confidential Business Information
(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 the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2013–0011, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
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• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at
https://www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of February
15, 2013 (78 FR 11126) (FRL–9378–4),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 2F8104) by KIM–
C1, LLC, 2547 West Shaw Avenue, Suite
116, Fresno, CA 93711. The petition
requested that 40 CFR 180.569 be
amended by establishing tolerances for
residues of the plant growth regulator
forchlorfenuron, (N-(2-chloro-4pyridinyl)-Nb-phenylurea), in or on
almond; cherry, sweet; fig; pear;
pistachio; and plum, prune, fresh at 0.04
parts per million (ppm) and almond,
hulls at 0.15 ppm. That document
referenced a summary of the petition
prepared by KIM–C1, LLC, the
petitioner, which is available in the
docket, https://www.regulations.gov. A
comment was received on the notice of
filing. EPA’s response to that comment
is discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has
recommended that a tolerance of 0.01
ppm (excluding processed commodities)
be establish for almond; cherry, sweet;
fig; pear; pistachio; and plum, prune,
fresh. KIM–C1, LLC proposed the
petition to establish a tolerance of 0.04
ppm for the same commodities. The
reasons for these changes are explained
in Unit IV.D.
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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
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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 FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), 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 forchlorfenuron
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with forchlorfenuron 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.
Forchlofenuron 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. The
developmental toxicity studies in rats
and rabbits, as well as the reproductive
toxicity study in rats, did not
demonstrate any increased pre- or
postnatal sensitivity. There was no
evidence of neurotoxicity in any of the
submitted studies. Forchlorfenuron is
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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
Almond, Sweet Cherry, Fig, Pear,
Pistachio, and Plum/Prune in docket ID
number EPA–HQ–OPP–2013–0011
(pages 26–30).
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 https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for forchlorfenuron used for
human risk assessment is shown in the
following table.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FORCHLORFENURON FOR USE IN HUMAN HEALTH
RISK ASSESSMENT
Point of departure
and uncertainty/
safety factors
Exposure/scenario
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (General population including infants and children).
No appropriate endpoint attributable to a single exposure (dose) was identified from oral toxicity
studies, including the developmental studies; therefore an acute endpoint was not selected and
an acute dietary risk assessment is not required.
Chronic dietary (All populations) ...............
NOAEL = 7 mg/kg/
day.
UFA = 10x ...............
UFH = 10x ...............
FQPA SF = 1x ........
Cancer (Oral, dermal, inhalation) ..............
Classification: Not likely to be a human carcinogen, based on two adequate rodent carcinogenicity
studies.
Chronic RfD = 0.07
mg/kg/day.
cPAD = 0.07 mg/kg/
day.
Chronic oral toxicity study—rat
LOAEL = 93 mg/kg/day based on decreased body
weight/body-weight gain/food consumption, and kidney toxicity (suppurative inflammation in males;
nonsuppurative interstitial nephritis in females)
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference
dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies).
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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 Department of
Agriculture’s (USDA) 2003–2008
National Health and Nutrition
Examination Survey, What We Eat in
America (NHANES/WWEIA). As to
residue levels in food, EPA assumed
tolerance-level residues and 100% crop
treated. EPA noted that the temporary
tolerances in/on olive and apple have
expired; thus, these commodities were
not included in the assessment. Dietary
Exposure Evaluation Model (DEEM)
(Version 7.81) default processing factors
were used for dried pears, prune juice,
cranberry juice, and grape juice. A
processing factor was not used for
raisins because a separate tolerance has
been established for that commodity. In
addition, a processing factor was not
used for prunes (dried plums) because
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data show that residues of
forchlorfenuron in prunes are not likely
to exceed 0.01 ppm, the tolerance
established for fresh plums. A
processing factor was also not used for
dried figs because data show that
residues of forchlorfenuron in dried figs
are not likely to exceed the tolerance for
fresh figs.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that forchlorfenuron 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 forchlorfenuron. Tolerance-level
residues and/or 100% CT 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 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.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide
Root Zone Model Ground Water (PRZM
GW), the estimated drinking water
concentrations (EDWCs) of
forchlorfenuron for chronic exposures
for non-cancer assessments are
estimated to be 0.21 parts per billion
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(ppb) for surface water and 7.3 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 7.3 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 nonoccupational, 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 found forchlorfenuron to
share a common mechanism of toxicity
with 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
assumed that forchlorfenuron does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at
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E. Aggregate Risks and Determination of
Safety
D. Safety Factor for Infants and
Children
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https://www.epa.gov/pesticides/
cumulative.
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, 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. 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 currently not
registered for any use patterns that
could result in short-term and
intermediate-term residential exposure.
Because there is no short- or
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess short-term risk), no further
assessment of short- or intermediateterm risk is necessary. EPA relies on the
chronic dietary risk assessment for
evaluating short-term risk for
forchlorfenuron.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
forchlorfenuron is not expected to pose
a cancer risk to humans.
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.
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence of increased
susceptibility following in utero
exposure to forchlorfenuron in either
the rat or rabbit developmental toxicity
study nor is there any evidence of
increased susceptibility following in
utero and/or pre-/post-natal exposure in
the 2-generation reproduction study in
rats.
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.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues. 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 and risks posed by
forchlorfenuron. These assessments will
not underestimate the exposure and
risks posed by forchlorfenuron.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(High-Pressure Liquid Chromatography
with Ultraviolet/Visible (HPLC/UV)
method (Method # CCRL–MTH–029) is
available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations 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 forchlorfenuron.
C. Response to Comments
One comment was received in
response to the notice of filing of the
KIM–C1, LLC’s application. The
commenter objected to the increase of
chemical residues generally and
expressed concerns about the effects of
chemicals in general on humans and the
environment. The Agency understands
the commenter’s concerns regarding
toxic chemicals and their potential
effects on humans and environment.
Pursuant to its authority under the
FFDCA, and as discussed further in this
preamble, EPA conducted a
comprehensive assessment of
forchlorfenuron. Based on its
assessment of the available data, the
Agency has concluded that there is a
reasonable certainty that no harm will
result from aggregate exposure to
residues of forchlorfenuron.
D. Revisions to Petitioned-For
Tolerances
KIM–C1, LLC proposed tolerances for
almond; cherry, sweet; fig; pear;
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pistachio; and plum, prune, fresh at 0.04
ppm, stating that the proposed residue
level for each commodity was derived
using the Organisation for Economic Cooperation and Development (OECD)
MRL calculation procedures. EPA does
not concur that these are the appropriate
outputs from the OECD MRL calculation
procedures. All residue values for all
crops (not including processed
commodities) are less than the
analytical method limit of quantitation
(LOQ) of 0.01 ppm. When all inputs for
a commodity are less than the LOQ, also
known as ‘‘censored’’ values, the OECD
calculator recommends a tolerance level
at the method LOQ. Therefore, to be
consistent with the OECD MRL
calculation procedures, EPA is
recommending that a tolerance of 0.01
ppm be established for almond; cherry,
sweet; fig; pear; pistachio; and plum,
prune, fresh.
V. Conclusion
Therefore, tolerances are established
for residues of forchlorfenuron, (N-(2chloro-4-pyridinyl)-N-phenylurea), in or
on almond; cherry, sweet; fig; pear;
pistachio; and plum, prune, fresh at 0.01
ppm and in or on almond, hulls at 0.15
ppm. In addition, EPA is removing from
40 CFR 180.569(a)(2) the temporary
tolerances, which are superseded by the
permanent tolerances being established
in today’s action.
ehiers on DSK2VPTVN1PROD with RULES
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) 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
VerDate Mar<15>2010
14:28 Apr 01, 2014
Jkt 232001
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
Dated: March 21, 2014.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
VII. Congressional Review Act
[FR Doc. 2014–07103 Filed 4–1–14; 8:45 am]
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal
Register. This action 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.
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.569:
a. Revise paragraph (a) introductory
text.
■ b. Add alphabetically the
commodities to the table in paragraph
(a).
■ c. Remove paragraph (a)(2).
The revision and additions read as
follows:
■
■
§ 180.569 Forchlorfenuron; tolerances for
residues.
(a) General. Tolerances are
established for residues of
forchlorfenuron, 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 forchlorfenuron (N-(2chloro-4-pyridinyl)-N-phenylurea).
Parts per
million
Commodity
Almond ......................................
Almond, hulls ............................
0.01
0.15
*
*
*
*
Cherry, sweet ...........................
Fig .............................................
*
0.01
0.01
*
*
*
*
Pear ..........................................
Pistachio ...................................
Plum, prune, fresh ....................
*
0.01
0.01
0.01
*
*
*
*
*
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 761
[EPA–HQ–RCRA–2013–0396; FRL–9908–98–
OSWER]
RIN 2050–AG79
Polychlorinated Biphenyls (PCBs):
Manufacturing (Import) Exemption for
the Defense Logistics Agency (DLA)
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
E:\FR\FM\02APR1.SGM
02APR1
Agencies
[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Rules and Regulations]
[Pages 18467-18471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07103]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0011; FRL-9907-47]
Forchlorfenuron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
forchlorfenuron in or on multiple commodities which are identified and
discussed later in this document. KIM-C1, LLC requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 2, 2014. Objections and
requests for hearings must be received on or before June 2, 2014, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0011, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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 https://www.ecfr.gov/cgi-bin/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-2013-0011 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
June 2, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0011, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
[[Page 18468]]
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of February 15, 2013 (78 FR 11126) (FRL-
9378-4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2F8104) by KIM-C1, LLC, 2547 West Shaw Avenue, Suite 116, Fresno, CA
93711. The petition requested that 40 CFR 180.569 be amended by
establishing tolerances for residues of the plant growth regulator
forchlorfenuron, (N-(2-chloro-4-pyridinyl)-N[squ]-phenylurea), in or on
almond; cherry, sweet; fig; pear; pistachio; and plum, prune, fresh at
0.04 parts per million (ppm) and almond, hulls at 0.15 ppm. That
document referenced a summary of the petition prepared by KIM-C1, LLC,
the petitioner, which is available in the docket, https://www.regulations.gov. A comment was received on the notice of filing.
EPA's response to that comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
recommended that a tolerance of 0.01 ppm (excluding processed
commodities) be establish for almond; cherry, sweet; fig; pear;
pistachio; and plum, prune, fresh. KIM-C1, LLC proposed the petition to
establish a tolerance of 0.04 ppm for the same commodities. The reasons
for these changes are explained in Unit IV.D.
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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 forchlorfenuron including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with forchlorfenuron
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.
Forchlofenuron 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. The developmental toxicity studies in rats and
rabbits, as well as the reproductive toxicity study in rats, did not
demonstrate any increased pre- 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 Almond, Sweet Cherry, Fig, Pear,
Pistachio, and Plum/Prune in docket ID number EPA-HQ-OPP-2013-0011
(pages 26-30).
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for forchlorfenuron used
for human risk assessment is shown in the following table.
[[Page 18469]]
Table 1--Summary of Toxicological Doses and Endpoints for Forchlorfenuron for Use in Human Health Risk
Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population No appropriate endpoint attributable to a single exposure (dose) was
including infants and children). identified from oral toxicity studies, including the developmental
studies; therefore an acute endpoint was not selected and an acute
dietary risk assessment is not required.
--------------------------------------------------------------------------
Chronic dietary (All populations).... NOAEL = 7 mg/kg/day.... Chronic RfD = 0.07 mg/ Chronic oral toxicity
UFA = 10x.............. kg/day. study--rat
UFH = 10x.............. cPAD = 0.07 mg/kg/day.. 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)
--------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).... Classification: Not likely to be a human carcinogen, based on two
adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no observed adverse effect level. PAD = population
adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
population (intraspecies).
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
Department of Agriculture's (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA assumed tolerance-level residues and
100% crop treated. EPA noted that the temporary tolerances in/on olive
and apple have expired; thus, these commodities were not included in
the assessment. Dietary Exposure Evaluation Model (DEEM) (Version 7.81)
default processing factors were used for dried pears, prune juice,
cranberry juice, and grape juice. A processing factor was not used for
raisins because a separate tolerance has been established for that
commodity. In addition, a processing factor was not used for prunes
(dried plums) because data show that residues of forchlorfenuron in
prunes are not likely to exceed 0.01 ppm, the tolerance established for
fresh plums. A processing factor was also not used for dried figs
because data show that residues of forchlorfenuron in dried figs are
not likely to exceed the tolerance for fresh figs.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that forchlorfenuron 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 forchlorfenuron. Tolerance-level residues and/or
100% CT 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 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.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of
forchlorfenuron for chronic exposures for non-cancer assessments are
estimated to be 0.21 parts per billion (ppb) for surface water and 7.3
ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 7.3 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 found forchlorfenuron to share a common mechanism of
toxicity with 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 assumed that
forchlorfenuron does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at
[[Page 18470]]
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.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility following in utero exposure to forchlorfenuron
in either the rat or rabbit developmental toxicity study nor is there
any evidence of increased susceptibility following in utero and/or pre-
/post-natal exposure in the 2-generation reproduction study in rats.
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. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. 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 and risks posed
by forchlorfenuron. 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 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,
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. 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 currently not registered for any use patterns
that could result in short-term and intermediate-term residential
exposure. Because there is no short- or intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess short-term risk), no further assessment of
short- or intermediate-term risk is necessary. EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
forchlorfenuron.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, forchlorfenuron is not expected to pose a cancer risk to
humans.
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
Adequate enforcement methodology (High-Pressure Liquid
Chromatography with Ultraviolet/Visible (HPLC/UV) method (Method
CCRL-MTH-029) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
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 forchlorfenuron.
C. Response to Comments
One comment was received in response to the notice of filing of the
KIM-C1, LLC's application. The commenter objected to the increase of
chemical residues generally and expressed concerns about the effects of
chemicals in general on humans and the environment. The Agency
understands the commenter's concerns regarding toxic chemicals and
their potential effects on humans and environment. Pursuant to its
authority under the FFDCA, and as discussed further in this preamble,
EPA conducted a comprehensive assessment of forchlorfenuron. Based on
its assessment of the available data, the Agency has concluded that
there is a reasonable certainty that no harm will result from aggregate
exposure to residues of forchlorfenuron.
D. Revisions to Petitioned-For Tolerances
KIM-C1, LLC proposed tolerances for almond; cherry, sweet; fig;
pear;
[[Page 18471]]
pistachio; and plum, prune, fresh at 0.04 ppm, stating that the
proposed residue level for each commodity was derived using the
Organisation for Economic Co-operation and Development (OECD) MRL
calculation procedures. EPA does not concur that these are the
appropriate outputs from the OECD MRL calculation procedures. All
residue values for all crops (not including processed commodities) are
less than the analytical method limit of quantitation (LOQ) of 0.01
ppm. When all inputs for a commodity are less than the LOQ, also known
as ``censored'' values, the OECD calculator recommends a tolerance
level at the method LOQ. Therefore, to be consistent with the OECD MRL
calculation procedures, EPA is recommending that a tolerance of 0.01
ppm be established for almond; cherry, sweet; fig; pear; pistachio; and
plum, prune, fresh.
V. Conclusion
Therefore, tolerances are established for residues of
forchlorfenuron, (N-(2-chloro-4-pyridinyl)-N-phenylurea), in or on
almond; cherry, sweet; fig; pear; pistachio; and plum, prune, fresh at
0.01 ppm and in or on almond, hulls at 0.15 ppm. In addition, EPA is
removing from 40 CFR 180.569(a)(2) the temporary tolerances, which are
superseded by the permanent tolerances being established in today's
action.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: March 21, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.569:
0
a. Revise paragraph (a) introductory text.
0
b. Add alphabetically the commodities to the table in paragraph (a).
0
c. Remove paragraph (a)(2).
The revision and additions read as follows:
Sec. 180.569 Forchlorfenuron; tolerances for residues.
(a) General. Tolerances are established for residues of
forchlorfenuron, 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 forchlorfenuron
(N-(2-chloro-4-pyridinyl)-N-phenylurea).
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond..................................................... 0.01
Almond, hulls.............................................. 0.15
* * * * *
Cherry, sweet.............................................. 0.01
Fig........................................................ 0.01
* * * * *
Pear....................................................... 0.01
Pistachio.................................................. 0.01
Plum, prune, fresh......................................... 0.01
------------------------------------------------------------------------
* * * * *
[FR Doc. 2014-07103 Filed 4-1-14; 8:45 am]
BILLING CODE 6560-50-P