Diflubenzuron; Pesticide Tolerances for Emergency Exemptions, 72352-72357 [E8-28308]
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Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Rules and Regulations
Original amendment submission
date
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November 19,
2007.
Date of final
publication
*
November 28,
2008.
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Revegetation Success Guidelines; Normal Husbandry Practices; Kansas Regulations: K.A.R. 47–4–
14a(c)(2), (d)(2)(A), (d)(3)(A); K.A.R. 47–5–5a(a)(4), (a)(5), (a)(9), and (a)(11) through (a)(13).
[FR Doc. E8–28337 Filed 11–26–08; 8:45 am]
§ 200.19
BILLING CODE 4310–05–P
2. On page 64508, in the second
column, in § 200.19, in amendment 5,
instruction B is corrected to read:
‘‘Removing paragraph (d) and
redesignating paragraphs (b) and (c) as
paragraphs (c) and (d), respectively.’’.
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DEPARTMENT OF EDUCATION
34 CFR Part 200
RIN 1810–AB01
[Docket ID ED–2008–OESE–0003]
Title I—Improving the Academic
Achievement of the Disadvantaged
Office of Elementary and
Secondary Education, Department of
Education.
ACTION: Final rule; correction.
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AGENCY:
SUMMARY: The Department of Education
is correcting a final regulation that was
published in the Federal Register on
October 29, 2008 (73 FR 64436). The
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public school choice, and supplemental
educational services.
DATES: Effective November 28, 2008.
FOR FURTHER INFORMATION CONTACT:
Zollie Stevenson, Jr., Director, Student
Achievement and School Accountability
Programs, Office of Elementary and
Secondary Education, U.S. Department
of Education, 400 Maryland Avenue,
SW., Room 3W230, Washington, DC
20202–6132. Telephone: (202) 260–
1824.
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request to the contact person listed
under this section.
SUPPLEMENTARY INFORMATION: In FR Doc.
E8–25270 appearing on page 64436 in
the Federal Register on October 29,
2008, the following corrections are
made:
§ 200.7
[Corrected]
1. On page 64508, in the first column,
in § 200.7, in amendment 3, instruction
D is removed.
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[Corrected]
Note: The official version of this document
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edition of the Federal Register and the Code
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Access at: https://www.gpoaccess.gov/nara/
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Dated: November 24, 2008.
Kerri L. Briggs,
Assistant Secretary for Elementary and
Secondary Education.
[FR Doc. E8–28266 Filed 11–26–08; 8:45 am]
BILLING CODE 4000–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0714; FRL–8388–9]
Diflubenzuron; Pesticide Tolerances
for Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
time-limited tolerances for combined
residues of diflubenzuron and its
metabolites p-chlorophenylurea and pchloroaniline in or on alfalfa, forage and
alfalfa, hay. This action is in response
to EPA’s granting of an emergency
exemption under section 18 of the
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Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing
use of the pesticide on alfalfa and mixed
grass/alfalfa fields. This regulation
establishes a maximum permissible
level for residues of diflubenzuron and
its metabolites p-chlorophenylurea and
p-chloroaniline, in these food
commodities. The time-limited
tolerances expire and are revoked on
December 31, 2011.
This regulation is effective
November 28, 2008. Objections and
requests for hearings must be received
on or before January 27, 2009, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION.
DATES:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0714. All documents in the
docket are listed in the docket index
available in https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Libby Pemberton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9364; e-mail address:
pemberton.libby@epa.gov.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Rules and Regulations
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
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B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. 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. The EPA procedural
regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2008–0714 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before January 27, 2009.
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In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2008–0714, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background and Statutory Findings
EPA, on its own initiative, in
accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e)
and 346a(1)(6), is establishing timelimited tolerances for combined
residues of the insecticide
diflubenzuron and its metabolites pchlorophenylurea and p-chloroaniline,
in or on alfalfa, forage and alfalfa, hay
at 6 parts per million (ppm). These timelimited tolerances expire and are
revoked on December 31, 2011. EPA
will publish a document in the Federal
Register to remove the revoked
tolerances from the CFR.
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 section 18 of FIFRA. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on section 18 related timelimited tolerances to set binding
precedents for the application of section
408 of FFDCA and the new safety
standard to other tolerances and
exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an
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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
Diflubenzuron on Alfalfa and FFDCA
Tolerances
The United States Department of
Agriculture, Animal and Plant Health
Inspection Service (USDA/APHIS)
requested the use diflubenzuron to
control Mormon crickets and
grasshoppers on alfalfa grown for hay to
protect pollinators of Spalding’s
catchfly, a threatened plant species
endemic to the proposed treatment area
in Montana. The alfalfa fields are
interspersed within the rangeland spray
blocks. EPA evaluated this request and
found that USDA/APHIS had identified
an emergency situation. Thus, EPA
concurred on the request.
In a separate action, the Oregon
Department of Agricultural (ODA)
declared a crisis emergency exemption
for use of diflubenzuron to control the
same pests on alfalfa grown for hay, and
mixed grass/alfalfa hay on June 30,
2008.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
combined residues of diflubenzuron in
or on alfalfa, forage and alfalfa, hay. In
doing so, EPA considered the safety
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standard in section 408(b)(2) of FFDCA,
and EPA decided that the necessary
tolerance under section 408(l)(6) of
FFDCA would be consistent with the
safety standard and with FIFRA section
18. EPA has previously evaluated the
use of diflubenzuron on alfalfa and
established time-limited tolerances
initially for a similar use in Federal
Register: September 20, 2002 (67 FR
59177), OPP–2002–0253; FRL–7273–7
in association with earlier emergency
exemption request. This notice reestablishes those time-limited
tolerances. 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 section
408(l)(6) of FFDCA. Although these
time-limited tolerances expire and are
revoked on December 31, 2011, under
section 408(l)(5) of FFDCA, residues of
the pesticide not in excess of the
amounts specified in the tolerance
remaining in or on alfalfa, forage and
alfalfa, hay 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 it meets
FIFRA’s registration requirements for
use on alfalfa, forage and alfalfa, hay 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
diflubenzuron by a State for special
local needs under FIFRA section 24(c).
Nor does this tolerance serve as the
basis for persons in any State other than
USDA/ODA to use this pesticide on
these crops under FIFRA section 18
absent the issuance of an emergency
exemption applicable within that State.
For additional information regarding the
emergency exemption for
diflubenzuron, contact the Agency’s
Registration Division at the address
provided under FOR FURTHER
INFORMATION CONTACT.
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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 section 408(b)(2)(D) of FFDCA, EPA
has reviewed the available scientific
data and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure expected as a result
of this emergency exemption request
and the time-limited tolerances for
combined residues of diflubenzuron on
alfalfa, forage and alfalfa, hay at 6 ppm.
EPA’s assessment of exposures and risk
associated with establishing timelimited tolerances follows.
A. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
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and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and
chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for diflubenzuron used for
human risk assessment is discussed in
Unit III. B. of the final rule published in
the Federal Register of September 19,
2002 (67 FR 59006) (FRL–7200–4).
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to diflubenzuron, EPA
considered exposure under the timelimited tolerances established by this
action as well as all existing
diflubenzuron tolerances in (40 CFR
180.377). EPA assessed dietary
exposures from diflubenzuron in food as
follows:
i. Acute exposure. No such effects
were identified in the toxicological
studies for diflubenzuron, 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 USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
used the established/recommended
tolerances for all food commodities, 100
percent crop treated (PCT) information
for all proposed and existing uses, and
Dietary Exposure Evaluation Model
(DEEMTM) Version 7.81 default
processing factors for some processed
commodities.
iii. Cancer. The Agency has classified
diflubenzuron as ‘‘Group E,’’ evidence
of non-carcinogenicity for humans,
based on lack of evidence of
carcinogenicity in rats and mice. There
are also two metabolites of
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diflubenzuron; PCA and CPU. PCA
tested positive for splenic tumors in
male rats and hepatocellular adenomas/
carcinomas in male mice in a National
Toxicology Program (NTP) study.
Therefore, EPA classified PCA as a
‘‘Group B2’’ probable human
carcinogen. The Agency determined for
those commodities that contained PCA
and CPU, the Q1* of PCA should be
used to calculate the cancer risk from
the sum of these two metabolites. Based
on the submitted metabolism studies,
there are two possible sources for
dietary exposure to PCA and CPU:
residues in mushrooms and residues in
milk and liver. Because human
exposure to PCA and CPU will not be
affected by the proposed new uses, and
EPA has previously concluded that
exposure to these compounds is safe,
therefore, the cancer dietary risk from
PCA and CPU will not be addressed in
this document. For a detailed discussion
on the exposure and risks to PCA and
CPU, please refer to the September,
2002 Federal Register document titled
Diflubenzuron; Pesticide Tolerances
(September 19, 2002, FR 67 59006);
https://www.epa.gov/fedrgstr/EPA-PEST/
2002/September/Day-19/p23818.htm.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for diflubenzuron in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
diflubenzuron. 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 Screening
Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
diflubenzuron and the major degradate
CPU for chronic exposures are estimated
to be 2.76 ppb for surface water and
0.208 ppb for ground water. Modeled
estimates of drinking water
concentrations were directly entered
into the dietary exposure model
DEEMTM-Food Commodity Intake
Database (FCID), Version 2.03). For
chronic dietary risk assessment, the
annual average concentration of 2.76
ppb was used to represent the drinking
water contribution to chronic dietary
exposure for diflubenzuron.
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,
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indoor pest control, termiticides, and
flea and tick control on pets).
Although there are no registered
homeowner uses, there are registered
uses for professional applications to
outdoor residential and recreational
areas to control mosquitoes, moths, and
other insects. However, the potential for
post-application residential exposure is
expected to be limited, due to the low
dermal absorption rate (0.5%) of
diflubenzuron, and since it is only
applied to the tree canopy, minimal
non-occupational exposure is expected.
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 diflubenzuron to
share a common mechanism of toxicity
with any other substances, and
diflubenzuron does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that diflubenzuron 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 the policy statements
released by EPA’s Office of Pesticide
Programs concerning common
mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s website at 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 developmental and
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reproductive toxicity studies, there is no
indication of increased susceptibility of
rats or rabbits to in utero or postnatal
exposure.
3. Conclusion. There is a complete
toxicity database for diflubenzuron and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. 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
diflubenzuron is complete.
ii. There is no indication that
diflubenzuron 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
diflubenzuron results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to diflubenzuron in drinking water. EPA
used similarly conservative assumptions
to assess postapplication exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by diflubenzuron. There are
currently no registered or proposed
residential (non-occupational) uses of
diflubenzuron for homeowners.
Although there are no registered
homeowner uses, there is potential for
professional applications to outdoor
residential and recreational areas.
However, the potential for postapplication residential exposures are
expected to be limited. Due to the low
dermal absorption rate (0.5%) of
diflubenzuron, and since it is only
applied to the tree canopy to control
gypsy moths and mosquitoes, minimal
bystander contact is expected.
D. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
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additional cancer cases 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 POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. No adverse effect resulting from
a single-oral exposure was identified,
therefore, no acute dietary endpoint was
selected. Therefore, diflubenzuron 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 diflubenzuron
from food and water will utilize 12% of
the cPAD for the U.S. population, 12%
of the cPAD for (all infants less than 1
year old) and 38% of the cPAD for
children 1-2 years old. There are no
residential uses for diflubenzuron that
result in chronic residential exposure.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Diflubenzuron is not registered for
any use patterns that would result in
residential exposure. Therefore, the
short-term aggregate risk is the sum of
the risk from exposure to diflubenzuron
through food and water.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
non-dietary, non-occupational exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Diflubenzuron is not registered for
any use patterns that would result in
intermediate-term residential exposure.
Therefore, the intermediate-term
aggregate risk is the sum of the risk from
exposure to diflubenzuron through food
and water, which has already been
addressed.
5. Aggregate cancer risk for U.S.
population. Based on the available
evidence, which included adequate
carcinogenicity studies in rats and mice,
and battery of negative mutagenicity
studies, diflubenzuron has been
classified as ‘‘Group E,’’ evidence of
non-carcinogenicity for humans, by the
Agency. As noted in Unit IV.B.1.iii. of
this document, the Agency has
concluded that human exposure to PCA
and CPU (metabolites of diflubenzuron)
will not be affected by the proposed
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14:57 Nov 26, 2008
Jkt 217001
new uses. EPA has previously found
aggregate exposure to these compounds
to be safe. (September 19, 2002, 67 FR
59006); at https://www.epa.gov/fedrgstr/
EPA-PEST/2002/September/Day-19/
p23818.htm.
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
diflubenzuron residues.
V. Other Considerations
A. Analytical Enforcement Methodology
There are adequate enforcement
methods, published in the Pesticide
Analytical Manual (PAM, Vol. II), for
determining diflubenzuron residues of
concern. In addition, a new analytical
methodology for plant commodities was
successfully validated by an
independent laboratory as well as by
Agency chemists at the Analytical
Chemistry Branch (ACB)/Biological and
Economics Analysis Division (BEAD) in
conjunction with an approved rice
petition (PP 8F4925). The new methods
were forwarded to the Food and Drug
Administration (FDA) for publication in
PAM Vol. II as Roman Numeral
Methods. These methods can separately
determine residues of diflubenzuron by
gas chromatography/electron-capture
detection (GC/ECD), CPU by GC/ECD,
and PCA by GC/mass spectrometry
(MS).
B. International Residue Limits
There are no Codex maximum residue
limits established for diflubenzuron on
alfalfa forage and hay.
VI. Conclusion
Therefore, time-limited tolerances are
established for combined residues of the
insecticide diflubenzuron, (N-[[(4chlorophenyl)amino]carbonyl]-2,6difluorobenzamide and its metabolites
4-chlorophenylurea and 4-chloroaniline,
in or on alfalfa, forage and alfalfa, hay
at 6 ppm. These tolerances expire and
are revoked on December 31, 2011.
VII. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under sections 408(e) and 408(l)(6) of
FFDCA in response to a petition
submitted to the Agency. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this final rule has been
exempted from review under Executive
Order 12866, this final rule is not
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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
sections 408(e) and 408(l)(6) of FFDCA,
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 section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
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that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: November 7, 2008.
Deborah McCall,
Acting 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 § 180.377(b), amend the table
under the heading ‘‘Expiration/
Revocation Date’’ by replacing the
phrase ‘‘6/30/07’’ to read ‘‘12/31/11’’ for
the entries ‘‘Alfalfa, forage’’ and
‘‘Alfalfa, hay.’’
■
[FR Doc. E8–28308 Filed 11–26–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 571
[Docket No. NHTSA–2007–29083; Docket
No. NHTSA–2007–28707]
Federal Motor Vehicle Safety
Standards: Tires; Correction,
Occupant Crash Protection; Correction
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation.
ACTION: Final rule; correcting
amendments.
dwashington3 on PROD1PC60 with RULES
AGENCY:
SUMMARY: This document corrects
Federal Motor Vehicle Safety Standard
(FMVSS) No. 139, New pneumatic
radial tires for light vehicles, which
specifies tire dimensions, test
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14:57 Nov 26, 2008
Jkt 217001
requirements, and labeling requirements
and which defines tire load ratings for
certain types of light vehicle tires. The
corrections relate to a definition for
snow tires and tire marking
requirements, which were inadvertently
removed. This document also corrects
FMVSS No. 208, Occupant Crash
Protection, with respect to specifying a
test tolerance for a procedure used to
test air bag suppression systems and low
risk deployment systems.
DATES: Effective December 29, 2008.
FOR FURTHER INFORMATION CONTACT: Ms.
Rebecca Yoon, Office of the Chief
Counsel, by telephone at (202) 366–
2992, by fax at (202) 366–3820, or by
mail at the following address: National
Highway Traffic Safety Administration,
U.S. Department of Transportation, 1200
New Jersey Avenue, SE., Washington,
DC 20590.
SUPPLEMENTARY INFORMATION:
FMVSS No. 139
FMVSS No. 139 specifies tire
dimensions, test requirements, and
labeling requirements, and defines tire
load ratings for new pneumatic radial
tires for use on certain motor vehicles
that have a gross vehicle weight rating
(GVWR) of 10,000 pounds or less. The
tire labeling requirements, S5.5(a)
through (h) of the standard, were
originally added to FMVSS No. 139 in
November 2002 to maintain consistent
labeling requirements for all tires for use
on light vehicles.1
S5.5(i), concerning the ‘‘Alpine
Symbol’’ for snow tires, was added to
FMVSS No. 139 in January 2006 to
allow manufacturers to certify snow
tires to special requirements for snow
tires, and to help consumers identify
those tires.2 However, the January 2006
amendments adding S5.5(i)
inadvertently did not reference this
subparagraph (i) in the introductory
paragraph of S5.5. To correct that
oversight, the agency issued an August
2007 final rule intending to amend only
the introductory paragraph of S5.5 to
specify that the subparagraphs included
(a) through (i).3 However, the rule
inadvertently removed the nine
subparagraphs (a) through (i) of S5.5.
This document corrects the CFR by
adding the inadvertently removed
paragraphs of FMVSS No. 139.
Additionally, in the August 2007 final
rule, the agency added a definition for
‘‘light truck (LT) tires’’ but inadvertently
removed the definition of ‘‘snow tire’’
from the list of definitions in S3. The
1 67
FR 69600 (Nov. 18, 2002).
FR 877 (Jan. 6, 2006).
3 72 FR 49207, 49209–10 (Aug. 28, 2007).
2 71
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72357
‘‘snow tire’’ definition is needed in the
standard to make clearer how the
standard applies to snow tires. This
document corrects the CFR by adding
the inadvertently removed snow tire
definition.
We are also correcting FMVSS No.
139 to address another labeling
requirement that had been inadvertently
omitted from the standard when
labeling requirements were moved from
FMVSS No. 119 to FMVSS No. 139.
This was the requirement that light
truck tires load range C, D, and E be
labeled with the tire load range
designation on both sides of the tire.
The agency did not intend to change
(delete) the requirement then in FMVSS
No. 119 that the tire load range
designation be labeled on the tires.4
Today’s document reinstates the
labeling requirement.
FMVSS No. 208
FMVSS No. 208 requires passenger
vehicles to be equipped with seat belts
and frontal air bags for the protection of
vehicle occupants in crashes. On July
24, 2007, NHTSA issued a final rule that
established test procedures for installing
child restraint systems (CRSs) to a child
restraint anchorage system in a front
passenger seating position in vehicles
certified to meet advanced air bag
requirements through the use of a
suppression system or low risk
deployment system.5
As part of the procedure for installing
child restraints with a rigid ratchet
mechanism built into the CRS, the
agency stated in the preamble that a
force of 475 ±25 Newtons (N) will be
applied to the CRS (72 FR at 40256,
columns 1 and 2). However,
S20.2.1.6.2(g) and S22.2.1.6.2(h) of the
regulatory text inadvertently did not
specify the tolerance of ±25 N. The lack
of a specified tolerance may prove to be
misleading and needs to be clarified.
This document corrects the CFR by
adding the ±25 N tolerance to those
sections of the standard.
List of Subjects in 49 CFR Part 571
Motor vehicles, Motor vehicle safety;
Reporting and recordkeeping
requirements; Tires.
■ Accordingly, 49 CFR part 571 is
corrected by making the following
correcting amendments:
4 Notice of proposed rulemaking (NPRM), 66 FR
65536, December 19, 2001. The only change to
FMVSS No. 119 labeling requirements discussed in
the preamble of the NPRM related to locating the
type of ply, cord, and tube on one sidewall only,
rather than both sides. 66 FR at 65564. Current tires
are labeled with the C, D, and E tire load range
designation on both sides of the tire.
5 72 FR 40252.
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Agencies
[Federal Register Volume 73, Number 230 (Friday, November 28, 2008)]
[Rules and Regulations]
[Pages 72352-72357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28308]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0714; FRL-8388-9]
Diflubenzuron; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
combined residues of diflubenzuron and its metabolites p-
chlorophenylurea and p-chloroaniline in or on alfalfa, forage and
alfalfa, hay. 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 alfalfa and mixed grass/alfalfa fields. This regulation establishes
a maximum permissible level for residues of diflubenzuron and its
metabolites p-chlorophenylurea and p-chloroaniline, in these food
commodities. The time-limited tolerances expire and are revoked on
December 31, 2011.
DATES: This regulation is effective November 28, 2008. Objections and
requests for hearings must be received on or before January 27, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0714. All documents in the
docket are listed in the docket index available in https://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9364; e-mail address: pemberton.libby@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 72353]]
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. 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.
The EPA procedural regulations which govern the submission of
objections and requests for hearings appear in 40 CFR part 178. 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-
2008-0714 in the subject line on the first page of your submission. All
requests must be in writing, and must be mailed or delivered to the
Hearing Clerk on or before January 27, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0714, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing
time-limited tolerances for combined residues of the insecticide
diflubenzuron and its metabolites p-chlorophenylurea and p-
chloroaniline, in or on alfalfa, forage and alfalfa, hay at 6 parts per
million (ppm). These time-limited tolerances expire and are revoked on
December 31, 2011. EPA will publish a document in the Federal Register
to remove the revoked tolerances from the CFR.
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 section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related time-limited tolerances to set binding precedents
for the application of section 408 of FFDCA and the new 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 Diflubenzuron on Alfalfa and FFDCA
Tolerances
The United States Department of Agriculture, Animal and Plant
Health Inspection Service (USDA/APHIS) requested the use diflubenzuron
to control Mormon crickets and grasshoppers on alfalfa grown for hay to
protect pollinators of Spalding's catchfly, a threatened plant species
endemic to the proposed treatment area in Montana. The alfalfa fields
are interspersed within the rangeland spray blocks. EPA evaluated this
request and found that USDA/APHIS had identified an emergency
situation. Thus, EPA concurred on the request.
In a separate action, the Oregon Department of Agricultural (ODA)
declared a crisis emergency exemption for use of diflubenzuron to
control the same pests on alfalfa grown for hay, and mixed grass/
alfalfa hay on June 30, 2008.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by combined residues of
diflubenzuron in or on alfalfa, forage and alfalfa, hay. In doing so,
EPA considered the safety
[[Page 72354]]
standard in section 408(b)(2) of FFDCA, and EPA decided that the
necessary tolerance under section 408(l)(6) of FFDCA would be
consistent with the safety standard and with FIFRA section 18. EPA has
previously evaluated the use of diflubenzuron on alfalfa and
established time-limited tolerances initially for a similar use in
Federal Register: September 20, 2002 (67 FR 59177), OPP-2002-0253; FRL-
7273-7 in association with earlier emergency exemption request. This
notice re-establishes those time-limited tolerances. 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 section 408(l)(6) of
FFDCA. Although these time-limited tolerances expire and are revoked on
December 31, 2011, under section 408(l)(5) of FFDCA, residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on alfalfa, forage and alfalfa, hay 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 it
meets FIFRA's registration requirements for use on alfalfa, forage and
alfalfa, hay 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
diflubenzuron by a State for special local needs under FIFRA section
24(c). Nor does this tolerance serve as the basis for persons in any
State other than USDA/ODA to use this pesticide on these crops under
FIFRA section 18 absent the issuance of an emergency exemption
applicable within that State. For additional information regarding the
emergency exemption for diflubenzuron, 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 section 408(b)(2)(D) of
FFDCA, EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerances for combined residues of diflubenzuron on
alfalfa, forage and alfalfa, hay at 6 ppm. EPA's assessment of
exposures and risk associated with establishing time-limited tolerances
follows.
A. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for diflubenzuron used
for human risk assessment is discussed in Unit III. B. of the final
rule published in the Federal Register of September 19, 2002 (67 FR
59006) (FRL-7200-4).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to diflubenzuron, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing
diflubenzuron tolerances in (40 CFR 180.377). EPA assessed dietary
exposures from diflubenzuron in food as follows:
i. Acute exposure. No such effects were identified in the
toxicological studies for diflubenzuron, 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 USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used the established/
recommended tolerances for all food commodities, 100 percent crop
treated (PCT) information for all proposed and existing uses, and
Dietary Exposure Evaluation Model (DEEM\TM\) Version 7.81 default
processing factors for some processed commodities.
iii. Cancer. The Agency has classified diflubenzuron as ``Group
E,'' evidence of non-carcinogenicity for humans, based on lack of
evidence of carcinogenicity in rats and mice. There are also two
metabolites of
[[Page 72355]]
diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in
male rats and hepatocellular adenomas/carcinomas in male mice in a
National Toxicology Program (NTP) study. Therefore, EPA classified PCA
as a ``Group B2'' probable human carcinogen. The Agency determined for
those commodities that contained PCA and CPU, the Q1* of PCA should be
used to calculate the cancer risk from the sum of these two
metabolites. Based on the submitted metabolism studies, there are two
possible sources for dietary exposure to PCA and CPU: residues in
mushrooms and residues in milk and liver. Because human exposure to PCA
and CPU will not be affected by the proposed new uses, and EPA has
previously concluded that exposure to these compounds is safe,
therefore, the cancer dietary risk from PCA and CPU will not be
addressed in this document. For a detailed discussion on the exposure
and risks to PCA and CPU, please refer to the September, 2002 Federal
Register document titled Diflubenzuron; Pesticide Tolerances (September
19, 2002, FR 67 59006); https://www.epa.gov/fedrgstr/EPA-PEST/2002/
September/Day-19/p23818.htm.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for diflubenzuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of diflubenzuron. 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 Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
diflubenzuron and the major degradate CPU for chronic exposures are
estimated to be 2.76 ppb for surface water and 0.208 ppb for ground
water. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model DEEM\TM\-Food Commodity Intake
Database (FCID), Version 2.03). For chronic dietary risk assessment,
the annual average concentration of 2.76 ppb was used to represent the
drinking water contribution to chronic dietary exposure for
diflubenzuron.
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).
Although there are no registered homeowner uses, there are
registered uses for professional applications to outdoor residential
and recreational areas to control mosquitoes, moths, and other insects.
However, the potential for post-application residential exposure is
expected to be limited, due to the low dermal absorption rate (0.5%) of
diflubenzuron, and since it is only applied to the tree canopy, minimal
non-occupational exposure is expected.
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 diflubenzuron to share a common mechanism of
toxicity with any other substances, and diflubenzuron does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
diflubenzuron 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 the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at 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 developmental
and reproductive toxicity studies, there is no indication of increased
susceptibility of rats or rabbits to in utero or postnatal exposure.
3. Conclusion. There is a complete toxicity database for
diflubenzuron and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. 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 diflubenzuron is complete.
ii. There is no indication that diflubenzuron 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 diflubenzuron results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to diflubenzuron in
drinking water. EPA used similarly conservative assumptions to assess
postapplication exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by diflubenzuron. There are currently no
registered or proposed residential (non-occupational) uses of
diflubenzuron for homeowners. Although there are no registered
homeowner uses, there is potential for professional applications to
outdoor residential and recreational areas. However, the potential for
post-application residential exposures are expected to be limited. Due
to the low dermal absorption rate (0.5%) of diflubenzuron, and since it
is only applied to the tree canopy to control gypsy moths and
mosquitoes, minimal bystander contact is expected.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of
[[Page 72356]]
additional cancer cases 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 POD to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified, therefore, no acute dietary endpoint was selected.
Therefore, diflubenzuron 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
diflubenzuron from food and water will utilize 12% of the cPAD for the
U.S. population, 12% of the cPAD for (all infants less than 1 year old)
and 38% of the cPAD for children 1-2 years old. There are no
residential uses for diflubenzuron that result in chronic residential
exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Diflubenzuron is not registered for any use patterns that would
result in residential exposure. Therefore, the short-term aggregate
risk is the sum of the risk from exposure to diflubenzuron through food
and water.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term non-dietary, non-occupational
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Diflubenzuron is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to diflubenzuron through food and water, which has already been
addressed.
5. Aggregate cancer risk for U.S. population. Based on the
available evidence, which included adequate carcinogenicity studies in
rats and mice, and battery of negative mutagenicity studies,
diflubenzuron has been classified as ``Group E,'' evidence of non-
carcinogenicity for humans, by the Agency. As noted in Unit IV.B.1.iii.
of this document, the Agency has concluded that human exposure to PCA
and CPU (metabolites of diflubenzuron) will not be affected by the
proposed new uses. EPA has previously found aggregate exposure to these
compounds to be safe. (September 19, 2002, 67 FR 59006); at https://
www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm.
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 diflubenzuron residues.
V. Other Considerations
A. Analytical Enforcement Methodology
There are adequate enforcement methods, published in the Pesticide
Analytical Manual (PAM, Vol. II), for determining diflubenzuron
residues of concern. In addition, a new analytical methodology for
plant commodities was successfully validated by an independent
laboratory as well as by Agency chemists at the Analytical Chemistry
Branch (ACB)/Biological and Economics Analysis Division (BEAD) in
conjunction with an approved rice petition (PP 8F4925). The new methods
were forwarded to the Food and Drug Administration (FDA) for
publication in PAM Vol. II as Roman Numeral Methods. These methods can
separately determine residues of diflubenzuron by gas chromatography/
electron-capture detection (GC/ECD), CPU by GC/ECD, and PCA by GC/mass
spectrometry (MS).
B. International Residue Limits
There are no Codex maximum residue limits established for
diflubenzuron on alfalfa forage and hay.
VI. Conclusion
Therefore, time-limited tolerances are established for combined
residues of the insecticide diflubenzuron, (N-[[(4-
chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide and its metabolites
4-chlorophenylurea and 4-chloroaniline, in or on alfalfa, forage and
alfalfa, hay at 6 ppm. These tolerances expire and are revoked on
December 31, 2011.
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under sections 408(e) and
408(l)(6) of FFDCA in response to a petition submitted to the Agency.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this final
rule has been exempted from review under Executive Order 12866, this
final rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it
require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance
with sections 408(e) and 408(l)(6) of FFDCA, 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides
[[Page 72357]]
that before a rule may take effect, the agency promulgating the rule
must submit a rule report to each House of the Congress and to the
Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 7, 2008.
Deborah McCall,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.377(b), amend the table under the heading ``Expiration/
Revocation Date'' by replacing the phrase ``6/30/07'' to read ``12/31/
11'' for the entries ``Alfalfa, forage'' and ``Alfalfa, hay.''
[FR Doc. E8-28308 Filed 11-26-08; 8:45 am]
BILLING CODE 6560-50-S