Fluridone; Pesticide Tolerances for Emergency Exemptions, 66715-66720 [2012-27066]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations
inserting USCG–2012–0965 in the
‘‘Keyword’’ box and then clicking
‘‘Search’’. They are also available for
inspection or copying at the Docket
Management Facility (M–30), U.S.
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
If
you have questions on this rule, call or
email David H. Sulouff, Chief, Bridge
Section, Eleventh Coast Guard District;
telephone 510–437–3516, email
David.H.Sulouff@uscg.mil If you have
questions on viewing the docket, call
Renee V. Wright, Program Manager,
Docket Operations, telephone 202–366–
9826.
FOR FURTHER INFORMATION CONTACT:
The City
of San Francisco requested a temporary
change to the operation of the Third
Street Drawbridge, mile 0.0, over China
Basin, at San Francisco, CA. The Third
Street Drawbridge navigation span
provides a vertical clearance of 7 feet
above Mean High Water in the closedto-navigation position. The draw opens
on signal if at least one hour notice is
given as required by 33 CFR 117.149.
Navigation on the waterway is
recreational.
The drawspan will be secured in the
closed-to-navigation position 9 a.m. to 6
p.m. on November 10, 2012, to allow
spectators to the RedBull Flugtag to
cross the bridge during the event. This
temporary deviation has been
coordinated with the waterway users.
No objections to the proposed
temporary deviation were raised. The
drawspan can be operated upon 30
minutes advance notice for emergencies
requiring the passage of waterway
traffic.
Vessels that can transit the bridge,
while in the closed-to-navigation
position, may continue to do so at any
time.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the designated time period. This
deviation from the operating regulations
is authorized under 33 CFR 117.35.
srobinson on DSK4SPTVN1PROD with
SUPPLEMENTARY INFORMATION:
Dated: October 23, 2012.
D.H. Sulouff,
Bridge Section Chief, Eleventh Coast Guard
District.
[FR Doc. 2012–27242 Filed 11–6–12; 8:45 am]
BILLING CODE 9110–04–P
VerDate Mar<15>2010
17:07 Nov 06, 2012
Jkt 229001
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2011–0492; FRL– 9749–4]
Approval and Promulgation of
Implementation Plans; California;
Determinations of Attainment for the
1997 8-Hour Ozone Standard
Environmental Protection
Agency (EPA).
ACTION: Withdrawal of direct final rule.
AGENCY:
66715
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements, Volatile
organic compounds.
Dated: October 29, 2012.
Jared Blumenfeld,
Regional Administrator, Region IX.
Accordingly, the amendment to 40
CFR 52.282 published in the Federal
Register on September 14, 2012 (77 FR
56775) on page 56782 is withdrawn as
of November 7, 2012.
[FR Doc. 2012–27054 Filed 11–6–12; 8:45 am]
BILLING CODE 6560–50–P
Due to the receipt of an
adverse comment, EPA is withdrawing
the September 14, 2012, direct final rule
that makes several determinations
relating to certain 1997 8-hour ozone
nonattainment areas in California. EPA
will address the comment in a
subsequent final action based upon the
proposed rulemaking action, also
published on September 14, 2012. EPA
will not institute a second comment
period on this action.
DATES: The direct final rule published at
77 FR 56775 on September 14, 2012, is
withdrawn as of November 7, 2012.
FOR FURTHER INFORMATION CONTACT: John
Ungvarsky, Air Planning Office, AIR–2,
EPA Region IX, 75 Hawthorne Street,
San Francisco, CA 94105–3901,
telephone number (415) 972–3963, or
email ungvarsky.john@epa.gov.
SUPPLEMENTARY INFORMATION: EPA is
withdrawing the September 14, 2012 (77
FR 56775), direct final rule that makes
several determinations relating to 1997
8-hour ozone nonattainment areas in
California and thereby suspending
certain attainment-related requirements
for as long as these areas continue to
meet the 1997 8-hour ozone national
ambient air quality standard. The
subject areas include Amador and
Calaveras Counties, Chico, Kern County,
Mariposa and Tuolumne Counties,
Nevada County, Sutter County, and
Ventura County. In the direct final rule,
EPA stated that if adverse comments
were received by October 15, 2012, the
rule would be withdrawn and not take
effect. On September 10, 2012, EPA
received a comment, which it interprets
as adverse and, therefore, EPA is
withdrawing the direct final rule. EPA
will address the comment in a
subsequent final action based upon the
proposed rulemaking action, also
published on September 14, 2012 (77 FR
56797). EPA will not institute a second
comment period on this action.
SUMMARY:
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0756; FRL–9366–8]
Fluridone; Pesticide Tolerances for
Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
fluridone in or on cotton. This action is
in response to EPA’s granting of an
emergency exemption under section 18
of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA)
authorizing use of the pesticide on
cotton. This regulation establishes a
maximum permissible level for residues
of fluridone in or on cotton
commodities. The time-limited
tolerances expire on December 31, 2014.
DATES: This regulation is effective
November 7, 2012. Objections and
requests for hearings must be received
on or before January 7, 2013, 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–2012–0756, 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
SUMMARY:
E:\FR\FM\07NOR1.SGM
07NOR1
66716
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Debra Rate, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 306–0309; email address:
rate.debra@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).
srobinson on DSK4SPTVN1PROD with
B. How Can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at: https://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under section 408(g) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
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–2012–0756 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before January 7, 2013. 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
VerDate Mar<15>2010
17:07 Nov 06, 2012
Jkt 229001
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–
2012–0756, 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.
• 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.
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 * * *.’’
Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
II. Background and Statutory Findings
EPA, on its own initiative, in
accordance with FFDCA sections 408(e)
and 408(l)(6) of, 21 U.S.C. 346a(e) and
346a(1)(6), is establishing time-limited
tolerances for residues of fluridone,
1-methyl-3-phenyl-5-(3(trifluoromethyl)phenyl)-4(1H)pyridinone, its metabolites and
degradates, in or on cotton, undelinted
seed at 0.1 parts per million (ppm).
These time-limited tolerances expire on
December 31, 2014.
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption granted by
EPA under FIFRA section 18. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on FIFRA section 18 related
time-limited tolerances to set binding
precedents for the application of FFDCA
section 408 and the safety standard to
other tolerances and exemptions.
Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption
from the requirement of a tolerance on
its own initiative, i.e., without having
received any petition from an outside
party.
III. Emergency Exemption for Fluridone
on Cotton and FFDCA Tolerances
This is the first section 18 request
received for the use of fluridone on
cotton. Since the introduction of
glyphosate resistant cotton in 1997,
twenty-one weed species have
developed resistance to glyphosate.
Glyphosate-resistant palmer amaranth is
the most serious of these species across
all the major agronomic crops in the
southern U.S. Glyphosate-resistant
palmer amaranth was confirmed in
Arkansas in 2006. Since 2006, it has
become the most severe weed problem
that Arkansas cotton producers face.
Greater than 95% of Arkansas cotton
and 80% of soybean contain the
glyphosate tolerant gene and thus
glyphosate is the base herbicide for
weed control. A significant economic
loss is expected to occur on nearly 25%
of acres grown or about 160,000 acres.
After having reviewed the Arkansas
emergency exemption application, EPA
determined that an emergency condition
exists for this State, and that the criteria
for approval of an emergency exemption
are met. EPA has authorized a specific
exemption under FIFRA section 18 for
the use of fluridone on cotton for
control of glyphosate-resistant palmer
amaranth in Arkansas.
As part of its evaluation of the
emergency exemption application, EPA
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
E:\FR\FM\07NOR1.SGM
07NOR1
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations
assessed the potential risks presented by
residues of fluridone in or on cotton. In
doing so, EPA considered the safety
standard in FFDCA section 408(b)(2),
and EPA decided that the necessary
tolerance under FFDCA section 408(l)(6)
would be consistent with the safety
standard and with FIFRA section 18.
Consistent with the need to move
quickly on the emergency exemption in
order to address an urgent non-routine
situation and to ensure that the resulting
food is safe and lawful, EPA is issuing
this tolerance without notice and
opportunity for public comment as
provided in FFDCA section 408(l)(6).
Although these time-limited tolerances
expire on December 31, 2014, under
FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts
specified in the tolerance remaining in
or on cotton, undelinted seed after that
date will not be unlawful, provided the
pesticide was applied in a manner that
was lawful under FIFRA, and the
residues do not exceed a level that was
authorized by these time-limited
tolerances at the time of that
application. EPA will take action to
revoke these time-limited tolerances
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances
are being approved under emergency
conditions, EPA has not made any
decisions about whether fluridone
meets FIFRA’s registration requirements
for use on cotton or whether permanent
tolerances for this use would be
appropriate. Under these circumstances,
EPA does not believe that this timelimited tolerance decision serves as a
basis for registration of fluridone by a
State for special local needs under
FIFRA section 24(c). Nor does this
tolerance by itself serve as the authority
for persons in any State other than
Arkansas to use this pesticide on the
applicable crops under FIFRA section
18 absent the issuance of an emergency
exemption applicable within that State.
For additional information regarding the
emergency exemption for fluridone,
contact the Agency’s Registration
Division at the address provided under
FOR FURTHER INFORMATION CONTACT.
IV. 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 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 expected as a result
of this emergency exemption request
and the time-limited tolerances for
66717
residues of fluridone on cotton,
undelinted seed at 0.1 ppm. EPA’s
assessment of exposures and risks
associated with establishing timelimited tolerances follows.
A. 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 non-threshold 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 fluridone used for human
risk assessment is shown in Table 1. of
this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLURIDONE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
NOAEL = 125 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1X
aRfD = 1.25 mg/kg/
day.
aPAD = 1.25 mg/kg/
day.
Developmental toxicity—rabbit.
LOAEL = 300 mg/kg/day based on increased incidences of
abortions.
Chronic dietary (All populations)
srobinson on DSK4SPTVN1PROD with
Acute dietary (females 13–49
years of age).
NOAEL = 15 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1X
cRfD = 0.15 mg/kg/
day.
cPAD = 0.15 mg/kg/
day.
2 yr. cancer study in mice.
LOAEL = 50 mg/kg/day based on increased alkaline phosphatase activity and increased incidence of heptocellular
hyperplasia.
VerDate Mar<15>2010
17:07 Nov 06, 2012
Jkt 229001
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
E:\FR\FM\07NOR1.SGM
07NOR1
66718
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLURIDONE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Incidental oral short-term (1–30
days) and intermediate-term
(1–6 months) oral, dermal,
and inhalation exposures.
NOAEL = 15 mg/kg/
day.
UFA = 10x
UFH = 10x
LOC for MOE = 100
Cancer (oral, dermal, inhalation).
Fluridone is classified as ‘‘not likely’’ to be a human carcinogen, based on the lack of evidence of carcinogenicity in mice and rats. Quantitative cancer risk assessment is not required.
Study and toxicological effects
2 yr. cancer study in mice (same as above).
srobinson on DSK4SPTVN1PROD with
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. 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).
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fluridone, EPA considered
exposure under the time-limited
tolerances established by this action as
well as all existing fluridone tolerances
in 40 CFR 180.420. EPA assessed dietary
exposures from fluridone in food as
follows:
i. Acute exposure. Such effects were
identified for fluridone. In estimating
acute dietary exposure for the
subpopulation, females 13–49 years,
EPA used food consumption
information from the United States
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, EPA used tolerance level
residues, DEEM (Ver. 7.81) default
processing factors (as necessary) and
100 percent crop treated (PCT) for all
commodities.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
used tolerance level residues, DEEM
(Ver. 7.81) default processing factors (as
necessary) and 100 PCT for all
commodities.
iii. Cancer. Based on the data
summarized in Unit IV.A., EPA has
concluded that fluridone 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 PCT
information. EPA did not use
anticipated residue or PCT information
in the dietary assessment for fluridone.
Tolerance level residues and 100 PCT
were assumed for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
VerDate Mar<15>2010
17:07 Nov 06, 2012
Jkt 229001
exposure analysis and risk assessment
for fluridone in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of fluridone.
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 FQPA Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCI–
GROW) models, the estimated drinking
water concentrations (EDWCs) of
fluridone for acute exposures are
estimated to be 9.6 parts per billion
(ppb) for surface water and 0.67 ppb for
ground water. EDWCs of fluridone for
chronic exposures for non-cancer
assessments are estimated to be 2.5 ppb
for surface water and 0.67 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 9.6 ppb was used
to assess the contribution to drinking
water. For chronic dietary risk
assessment, the water concentration of
value 2.5 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,
swimming in treated water, and flea and
tick control on pets).
Fluridone is currently registered for
one use that could result in residential
handler and residential post-application
exposures: Consumer use to control
aquatic weeds in ponds. EPA assessed
residential exposure using the following
assumptions: Residents or consumers
may experience short-term (1–30 days)
skin contact or inhalation exposures.
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
These exposures are assessed through
residential handler scenarios. Postapplication exposures of children and
adults through contact with treated
swimming ponds are also anticipated.
These exposures are expected to be
short- and intermediate-term (1–6
months) in duration through dermal,
ingestion, aural, buccal/sublingual, and
nasal/orbital exposure. All residential
handler and post-application scenarios
from the uses of fluridone have been
assessed and no risks of concern have
been identified (MOE ≤100). The
scenarios for residential handler and
post-application exposure (combined
dermal and inhalation) resulted in
MOEs of 1,800 and 23,000, respectively.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at: https://www.epa.gov/
pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found fluridone to share
a common mechanism of toxicity with
any other substances, and fluridone
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that fluridone 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
E:\FR\FM\07NOR1.SGM
07NOR1
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations
srobinson on DSK4SPTVN1PROD with
https://www.epa.gov/pesticides/
cumulative.
C. 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 SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
Based on the results in the
developmental toxicity studies in rats
and rabbits and in a three-generation
reproduction study, no increased
sensitivity of fetuses or pups (as
compared to adults) was demonstrated
for fluridone. There are no concerns or
residual uncertainties for prenatal/
postnatal toxicity following exposure to
fluridone.
3. Conclusion. EPA has determined
that reliable data show that 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 fluridone
is complete except for the lack of an
immunotoxicity study and a
neurotoxicity battery (i.e., acute and
subchronic neurotoxicity) that meets the
new data requirements in 40 CFR part
158 for conventional pesticide
registration. However, the existing
toxicology database for fluridone does
not show any evidence of treatmentrelated effects on either the nervous or
the immune system. In addition,
fluridone does not belong to any class
of compounds (e.g., the organotins,
heavy metals, or halogenated aromatic
hydrocarbons) that would be expected
to be immunotoxic. Based on the
currently available data for fluridone,
the Agency expects that findings from
the additional studies will not result in
a lower point of departure POD than
that currently in use for overall risk
assessment, and therefore, a database
uncertainty factor is not needed to
account for the lack of these studies.
ii. There is no indication that
fluridone is a neurotoxic chemical and
there is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
VerDate Mar<15>2010
17:07 Nov 06, 2012
Jkt 229001
iii. There is no evidence that
fluridone 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 assessment
utilized 100 PCT and tolerance-level
residues (established or recommended).
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to fluridone in drinking water. EPA
used similarly conservative assumptions
to assess post-application exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by fluridone.
D. 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. An adverse effect resulting from
a single oral exposure was identified for
only the subpopulation females 13–49
years. Using the exposure assumptions
described in this unit for acute
exposure, EPA has concluded that acute
exposure to fluridone from food and
water will utilize less than 1% of the
aPAD for females 13–49 years.
Therefore, fluridone 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 fluridone from
food and water will utilize 4% of the
cPAD for children 1–2 years, the
population group receiving the greatest
exposure. Based on the explanation in
the unit regarding residential use
patterns, chronic residential exposure to
residues of fluridone is not expected.
3. Short-and Intermediate-term risk.
Short- and intermediate-term aggregate
exposure takes into account short-term
residential exposure or intermediateterm residential exposure plus chronic
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
66719
exposure to food and water (considered
to be a background exposure level).
Fluridone is currently registered for
uses that could result in short- and
intermediate-term residential exposure,
and the Agency has determined that it
is appropriate to aggregate chronic
exposure through food and water with
short- and intermediate-term residential
exposures to fluridone.
Using the exposure assumptions
described in this unit for short-term and
intermediate-term exposures, EPA has
concluded the combined short-term
food, water, and residential exposures
and the intermediate-term food, water,
and residential exposures each result in
aggregate MOEs of 290 (liquids for
pouring applications + swimming
exposure) to 340 (liquids for garden
hose end sprayer + swimming
exposure). Because EPA’s level of
concern for fluridone is a MOE of 100
or below, these MOEs are not of
concern.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
fluridone is not expected to pose a
cancer risk to humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children,
from aggregate exposure to fluridone
residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies
(enzyme-linked immunosorbant assay
(ELISA), high performance liquid
chromatography with ultraviolet
detection (HLPC/UV), and liquid
chromatography with tandem mass
spectroscopy (LC–MSMS)) are 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).
E:\FR\FM\07NOR1.SGM
07NOR1
66720
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations
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 an MRL for fluridone.
VI. Conclusion
Therefore, time-limited tolerances are
established for residues of fluridone, 1methyl-3-phenyl-5-(3(trifluoromethyl)phenyl)-4(1H)pyridinone, including its metabolites
and degradates, in or on cotton,
undelinted seed at 0.1 ppm. This
tolerance expires on December 31, 2014.
VII. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA sections 408(e) and
408(l)(6). 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 in accordance with
FFDCA sections 408(e) and 408(l)(6),
such as the tolerances 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).
VIII. 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: October 26, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR part 180 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 § 180.420, revise paragraph (b) to
read as follows:
■
§ 180.420
residues.
Fluridone; tolerances for
*
*
*
*
*
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of the herbicide fluridone, 1methyl-3-phenyl-5-(3(trifluoromethyl)phenyl)-4(1H)pyridinone, including its metabolites
and degradates in or on the specified
agricultural commodities, resulting from
use of the pesticide pursuant to the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) section 18
emergency exemptions. Compliance
with the tolerance levels specified
below is to be determined by measuring
only fluridone. The tolerances expire on
the date specified in the table.
Commodity
Parts per
million
Expiration
date
Cotton, undelinted seed ...................................................................................................................................................
0.1
12/31/14
*
*
*
*
*
srobinson on DSK4SPTVN1PROD with
[FR Doc. 2012–27066 Filed 11–6–12; 8:45 am]
BILLING CODE 6560–50–P
VerDate Mar<15>2010
17:23 Nov 06, 2012
Jkt 229001
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
E:\FR\FM\07NOR1.SGM
07NOR1
]]>Agencies
[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Rules and Regulations]
[Pages 66715-66720]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27066]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0756; FRL-9366-8]
Fluridone; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of fluridone in or on cotton. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on cotton. This regulation establishes a maximum
permissible level for residues of fluridone in or on cotton
commodities. The time-limited tolerances expire on December 31, 2014.
DATES: This regulation is effective November 7, 2012. Objections and
requests for hearings must be received on or before January 7, 2013,
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-2012-0756, 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
[[Page 66716]]
information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Debra Rate, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 306-0309; email address: rate.debra@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:
[emsp14]Crop production (NAICS code 111).
[emsp14]Animal production (NAICS code 112).
[emsp14]Food manufacturing (NAICS code 311).
[emsp14]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 40 CFR
part 180 through the Government Printing Office's e-CFR site at: https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 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-
2012-0756 in the subject line on the first page of your submission. All
objections and requests for a hearing must be in writing, and must be
received by the Hearing Clerk on or before January 7, 2013. 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-2012-0756, 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.
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. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing time-limited tolerances for residues of fluridone, 1-
methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-pyridinone, its
metabolites and degradates, in or on cotton, undelinted seed at 0.1
parts per million (ppm). These time-limited tolerances expire on
December 31, 2014.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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 * *
*.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Fluridone on Cotton and FFDCA Tolerances
This is the first section 18 request received for the use of
fluridone on cotton. Since the introduction of glyphosate resistant
cotton in 1997, twenty-one weed species have developed resistance to
glyphosate. Glyphosate-resistant palmer amaranth is the most serious of
these species across all the major agronomic crops in the southern U.S.
Glyphosate-resistant palmer amaranth was confirmed in Arkansas in 2006.
Since 2006, it has become the most severe weed problem that Arkansas
cotton producers face. Greater than 95% of Arkansas cotton and 80% of
soybean contain the glyphosate tolerant gene and thus glyphosate is the
base herbicide for weed control. A significant economic loss is
expected to occur on nearly 25% of acres grown or about 160,000 acres.
After having reviewed the Arkansas emergency exemption application,
EPA determined that an emergency condition exists for this State, and
that the criteria for approval of an emergency exemption are met. EPA
has authorized a specific exemption under FIFRA section 18 for the use
of fluridone on cotton for control of glyphosate-resistant palmer
amaranth in Arkansas.
As part of its evaluation of the emergency exemption application,
EPA
[[Page 66717]]
assessed the potential risks presented by residues of fluridone in or
on cotton. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in FFDCA section 408(l)(6). Although these time-
limited tolerances expire on December 31, 2014, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on cotton, undelinted seed
after that date will not be unlawful, provided the pesticide was
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by these time-limited tolerances
at the time of that application. EPA will take action to revoke these
time-limited tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
fluridone meets FIFRA's registration requirements for use on cotton or
whether permanent tolerances for this use would be appropriate. Under
these circumstances, EPA does not believe that this time-limited
tolerance decision serves as a basis for registration of fluridone by a
State for special local needs under FIFRA section 24(c). Nor does this
tolerance by itself serve as the authority for persons in any State
other than Arkansas to use this pesticide on the applicable crops under
FIFRA section 18 absent the issuance of an emergency exemption
applicable within that State. For additional information regarding the
emergency exemption for fluridone, contact the Agency's Registration
Division at the address provided under FOR FURTHER INFORMATION CONTACT.
IV. 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 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 expected as a result of this emergency exemption request and
the time-limited tolerances for residues of fluridone on cotton,
undelinted seed at 0.1 ppm. EPA's assessment of exposures and risks
associated with establishing time-limited tolerances follows.
A. 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 non-threshold 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 fluridone used for
human risk assessment is shown in Table 1. of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Fluridone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-49 NOAEL = 125 mg/kg/ aRfD = 1.25 mg/kg/ Developmental toxicity--rabbit.
years of age). day. day. LOAEL = 300 mg/kg/day based on
UFA = 10x........... aPAD = 1.25 mg/kg/ increased incidences of
UFH = 10x........... day.. abortions.
FQPA SF = 1X........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 15 mg/kg/day cRfD = 0.15 mg/kg/ 2 yr. cancer study in mice.
UFA = 10x........... day. LOAEL = 50 mg/kg/day based on
UFH = 10x........... cPAD = 0.15 mg/kg/ increased alkaline phosphatase
FQPA SF = 1X........ day.. activity and increased incidence
of heptocellular hyperplasia.
[[Page 66718]]
Incidental oral short-term (1-30 NOAEL = 15 mg/kg/day LOC for MOE = 100.. 2 yr. cancer study in mice (same
days) and intermediate-term (1-6 UFA = 10x........... as above).
months) oral, dermal, and UFH = 10x...........
inhalation exposures.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Fluridone is classified as ``not likely'' to be a human carcinogen, based on
the lack of evidence of carcinogenicity in mice and rats. Quantitative
cancer risk assessment is not required.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 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).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluridone, EPA considered exposure under the time-limited
tolerances established by this action as well as all existing fluridone
tolerances in 40 CFR 180.420. EPA assessed dietary exposures from
fluridone in food as follows:
i. Acute exposure. Such effects were identified for fluridone. In
estimating acute dietary exposure for the subpopulation, females 13-49
years, EPA used food consumption information from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA used tolerance level residues, DEEM (Ver. 7.81)
default processing factors (as necessary) and 100 percent crop treated
(PCT) for all commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues, DEEM (Ver. 7.81) default processing factors (as necessary)
and 100 PCT for all commodities.
iii. Cancer. Based on the data summarized in Unit IV.A., EPA has
concluded that fluridone 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 PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
fluridone. Tolerance level residues and 100 PCT were assumed for all
food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluridone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluridone. 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 FQPA Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of fluridone for acute
exposures are estimated to be 9.6 parts per billion (ppb) for surface
water and 0.67 ppb for ground water. EDWCs of fluridone for chronic
exposures for non-cancer assessments are estimated to be 2.5 ppb for
surface water and 0.67 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 9.6 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 2.5 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, swimming in treated water, and flea and tick control on
pets).
Fluridone is currently registered for one use that could result in
residential handler and residential post-application exposures:
Consumer use to control aquatic weeds in ponds. EPA assessed
residential exposure using the following assumptions: Residents or
consumers may experience short-term (1-30 days) skin contact or
inhalation exposures. These exposures are assessed through residential
handler scenarios. Post-application exposures of children and adults
through contact with treated swimming ponds are also anticipated. These
exposures are expected to be short- and intermediate-term (1-6 months)
in duration through dermal, ingestion, aural, buccal/sublingual, and
nasal/orbital exposure. All residential handler and post-application
scenarios from the uses of fluridone have been assessed and no risks of
concern have been identified (MOE <=100). The scenarios for residential
handler and post-application exposure (combined dermal and inhalation)
resulted in MOEs of 1,800 and 23,000, respectively.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at: https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found fluridone to share a common mechanism of toxicity
with any other substances, and fluridone does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fluridone 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 66719]]
https://www.epa.gov/pesticides/cumulative.
C. 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 SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. Based on the results in the
developmental toxicity studies in rats and rabbits and in a three-
generation reproduction study, no increased sensitivity of fetuses or
pups (as compared to adults) was demonstrated for fluridone. There are
no concerns or residual uncertainties for prenatal/postnatal toxicity
following exposure to fluridone.
3. Conclusion. EPA has determined that reliable data show that 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 fluridone is complete except for the
lack of an immunotoxicity study and a neurotoxicity battery (i.e.,
acute and subchronic neurotoxicity) that meets the new data
requirements in 40 CFR part 158 for conventional pesticide
registration. However, the existing toxicology database for fluridone
does not show any evidence of treatment-related effects on either the
nervous or the immune system. In addition, fluridone does not belong to
any class of compounds (e.g., the organotins, heavy metals, or
halogenated aromatic hydrocarbons) that would be expected to be
immunotoxic. Based on the currently available data for fluridone, the
Agency expects that findings from the additional studies will not
result in a lower point of departure POD than that currently in use for
overall risk assessment, and therefore, a database uncertainty factor
is not needed to account for the lack of these studies.
ii. There is no indication that fluridone 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 fluridone 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 assessment utilized 100 PCT and
tolerance-level residues (established or recommended). EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fluridone in drinking water. EPA
used similarly conservative assumptions to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by fluridone.
D. 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. An adverse effect resulting from a single oral exposure
was identified for only the subpopulation females 13-49 years. Using
the exposure assumptions described in this unit for acute exposure, EPA
has concluded that acute exposure to fluridone from food and water will
utilize less than 1% of the aPAD for females 13-49 years. Therefore,
fluridone 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
fluridone from food and water will utilize 4% of the cPAD for children
1-2 years, the population group receiving the greatest exposure. Based
on the explanation in the unit regarding residential use patterns,
chronic residential exposure to residues of fluridone is not expected.
3. Short-and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short-term residential exposure
or intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Fluridone is currently registered for uses that could result in
short- and intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short- and intermediate-term residential exposures
to fluridone.
Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined
short-term food, water, and residential exposures and the intermediate-
term food, water, and residential exposures each result in aggregate
MOEs of 290 (liquids for pouring applications + swimming exposure) to
340 (liquids for garden hose end sprayer + swimming exposure). Because
EPA's level of concern for fluridone is a MOE of 100 or below, these
MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluridone is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to fluridone residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies (enzyme-linked immunosorbant
assay (ELISA), high performance liquid chromatography with ultraviolet
detection (HLPC/UV), and liquid chromatography with tandem mass
spectroscopy (LC-MSMS)) are 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).
[[Page 66720]]
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 an
MRL for fluridone.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
fluridone, 1-methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-
pyridinone, including its metabolites and degradates, in or on cotton,
undelinted seed at 0.1 ppm. This tolerance expires on December 31,
2014.
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA sections 408(e)
and 408(l)(6). 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 in accordance
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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).
VIII. 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: October 26, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 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. 180.420, revise paragraph (b) to read as follows:
Sec. [emsp14]180.420 Fluridone; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
herbicide fluridone, 1-methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-
4(1H)-pyridinone, including its metabolites and degradates in or on the
specified agricultural commodities, resulting from use of the pesticide
pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) section 18 emergency exemptions. Compliance with the tolerance
levels specified below is to be determined by measuring only fluridone.
The tolerances expire on the date specified in the table.
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Cotton, undelinted seed..................... 0.1 12/31/14
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-27066 Filed 11-6-12; 8:45 am]
BILLING CODE 6560-50-P
