1-Naphthaleneacetic Acid Ethyl Ester; Pesticide Tolerance for Emergency Exemptions, 40513-40518 [E9-19200]
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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).
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
XII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
Dated: July 31, 2009.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
Inert ingredients
*
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
1-Naphthaleneacetic Acid Ethyl Ester;
Pesticide Tolerance for Emergency
Exemptions
Environmental Protection
Agency (EPA).
AGENCY:
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Final rule.
SUMMARY: This regulation establishes a
time-limited tolerance for residues of 1naphthaleneacetic acid ethyl ester in or
on avocados. 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 avocado trees.
This regulation establishes a maximum
permissible level for residues of 1naphthaleneacetic acid ethyl ester in
this food commodity. The time-limited
tolerance expires and is revoked on
December 31, 2012.
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Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, the table is amended
by adding alphabetically the following
inert ingredient to read as follows:
■
Uses
DATES: This regulation is effective
August 12, 2009. Objections and
requests for hearings must be received
on or before October 13, 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.
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0373. 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
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Colorant.
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ADDRESSES:
[EPA–HQ–OPP–2009–0373; FRL–8428–3]
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1. The authority citation for part 180
continues to read as follows:
■
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For seed treatment use only
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[FR Doc. E9–19193 Filed 8–11–09; 8:45 am]
ACTION:
PART 180—[AMENDED]
Limits
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Carbon Black (CAS Reg. No. 1333–86–4) ............................
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Therefore, 40 CFR chapter I is
amended as follows:
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Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9367; e-mail address:
ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• 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
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Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations
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 cite at https://
www.gpoaccess.gov/ecfr
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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–2009–0373 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 October 13, 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–2009–0373, 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.
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• 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 a timelimited tolerance for residues of the
plant growth regulator 1naphthaleneacetic acid ethyl ester in or
on avocados at 0.05 parts per million
(ppm). This time-limited tolerance
expires and is revoked on December 31,
2012. 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
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
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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 1Naphthaleneacetic Acid Ethyl Ester on
Avocados and FFDCA Tolerances
Avocado growers in Southern
California are dealing with emergency
conditions in their orchards caused by
unique environmental factors including
a hard freeze, strong Santa Ana winds,
drought, and fires that burned through
orchards damaging or killing trees.
Trees adversely affected by these
conditions need to be ‘‘stumped’’ to be
brought back into production. The
processing of ‘‘stumping’’ entails cutting
the primary scaffolding limbs of the tree
back to stumps and painting them with
white latex paint to protect them from
sunburn and disease. The treatment of
the pruned branches and cut stumps
with naphthalene acetic acid ethyl ester
slows the re-growth of vegetative
sprouts by about 70%. This growth
inhibition results in several lateral
sprouts instead of literally hundreds of
sprouts growing at and below the
pruning cuts. This shortens the pruning
time per tree or stump and the
management of the re-growth can be
accomplished with only one pruning
per season. After having reviewed the
submission, EPA determined that
emergency conditions exist for this
State, and that the criteria for an
emergency exemption are met. EPA has
authorized under FIFRA section 18 the
use of 1-naphthaleneacetic acid ethyl
ester on avocado trees limbs that have
been pruned or cut back to a stump for
control of excess sprout growth in
California. As part of its evaluation of
the emergency exemption application,
EPA assessed the potential risks
presented by residues of 1naphthaleneacetic acid ethyl ester in or
on avocados. In doing so, EPA
considered the safety 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. Consistent
with the need to move quickly on the
emergency exemption in order to
address an urgent non-routine situation
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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 this time-limited tolerance
expires and is revoked on December 31,
2012, 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 avocados
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 this time-limited
tolerance at the time of that application.
EPA will take action to revoke this timelimited tolerance earlier if any
experience with, scientific data on, or
other relevant information on this
pesticide indicate that the residues are
not safe.
Because this time-limited tolerance is
being approved under emergency
conditions, EPA has not made any
decisions about whether 1naphthaleneacetic acid ethyl ester meets
FIFRA’s registration requirements for
use on avocados or whether a
permanent tolerance 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 1naphthaleneacetic acid ethyl ester 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 California to use
this pesticide on this crop under FIFRA
section 18 absent the issuance of an
emergency exemption applicable within
that State. For additional information
regarding the emergency exemption for
1-naphthaleneacetic acid ethyl ester,
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
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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 1-naphthalene acetic acid
ethyl ester on avocado at 0.05 ppm.
EPA’s assessment of exposures and risks
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
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-term, intermediate-term,
and chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the level of concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
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adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for 1-naphthaleneacetic acid
ethyl ester used for human risk
assessment can be found at https://
www.regulations.gov in document
Naphthalene Acetates HED Risk
Assessment for Section 18 Use of
Naphthalene Acetic Acid Ethyl Ester on
Avocado Trees, page 11 in docket ID
number EPA–HQ–OPP–2009–0373.
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to 1-naphthaleneacetic acid
ethyl ester, EPA considered exposure
under the time-limited tolerances
established by this action as well as all
existing naphthalene acetic acid
tolerances in 40 CFR 180.155(a),
naphthalene acetic acid ethyl ester
tolerances in 40 CFR 180.155(b), and anaphthaleneacetamide and its
metabolite a-naphthalene acetic acid
(calculated as a-naphthalene acetic
acid) tolerances in 40 CFR 180.309. For
commodities having tolerances for both
naphthalene acetic acid and the
acetamide of naphthalene acetic acid,
the total amount of residues calculated
as naphthalene acetic acid shall not
exceed the higher of the two tolerances
(40 CFR 180.3(d)(7)). Collectively, these
chemicals are referred to as the
naphthalene acetates. For the purpose of
the human health risk assessment, all
forms of the naphthalene acetates are
combined (1-Naphthaleneacetic acid
(NAA), its salts, ester, and acetamide)
because they are structurally related and
are metabolized to the acid form and
eliminated from the body as glycine and
glucuronic acid conjugates within 48
hours after exposure EPA assessed
dietary exposures from the naphthalene
acetates in food as follows:
i. Acute exposure. In estimating acute
dietary exposure, 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, the acute dietary
exposure/risk analyses for all supported
naphthalene acetates food uses were
conducted using conservative, Tier 1
exposure assessments. The Tier I
analyses assume tolerance level residues
for all registered uses, 100 PCT for all
commodities with existing tolerances,
and default processing factors.
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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, the
chronic dietary exposure/risk analyses
for all supported food uses for the
naphthalene acetates were conducted
using conservative, Tier 1 exposure
assessments. The Tier I analyses assume
tolerance level residues for all registered
uses, 100 PCT for all commodities with
existing tolerances, and default
processing factors.
iii. Cancer. Based on the results of
carcinogenicity studies in rats and mice,
EPA has classified the naphthalene
acetates as ‘‘not likely to be carcinogenic
to humans’’ therefore, a quantitative
cancer exposure assessment is
unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue and/or PCT
information in the dietary assessment
for the naphthalene acetates. Tolerance
level residues and/or 100 PCT were
assumed for all food commodities.
2. Dietary exposure from drinking
water.The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for the naphthalene acetates in drinking
water. These simulation models take
into account data on the physical,
chemical, and fate/transport
characteristics of the naphthalene
acetates. 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 First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
naphthalene acetates for acute
exposures are estimated to be 12.9 parts
per billion (ppb) for surface water and
0.0008 ppb for ground water and for
chronic exposures for non-cancer
assessments are estimated to be 0.71
ppb for surface water and 0.0008 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 12.9 ppb was
used to assess the contribution to
drinking water, and for chronic dietary
risk assessment, the water concentration
of value 0.71 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
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(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Although there are residential uses for
the naphthalene acetates, the uses are
for ornamentals only (i.e., not turf) and
post-application residential exposure is
expected to be negligible. Therefore, a
quantitative assessment is not required.
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 the naphthalene
acetates to share a common mechanism
of toxicity with any other substances,
and the naphthalene acetates do not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that the
naphthalene acetates do 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.
There is low concern (and no residual
uncertainty) for pre-natal and postnatal
toxicity resulting from exposure to the
naphthalene acetates. The available data
provided no indication of increased
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susceptibility (quantitative or
qualitative) in rats or rabbits to in utero
exposure to naphthalene acetates or to
pre-natal and post-natal exposure in rat
reproduction studies.
3. Conclusion. Therefore, the FQPA
safety factor is reduced to 1x for risk
assessment for this chemical. A
developmental neurotoxicity study is
not required since there was no
evidence of neurotoxicity or
neuropathology from the available
studies and there is no concern or
residual uncertainty for pre-natal or
post-natal toxicity.
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 the
naphthalene acetates is complete.
ii. There is no indication that the
naphthalene acetates are neurotoxic
chemicals and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that the
naphthalene acetates result in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to the
naphthalene acetates 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 the naphthalene acetates.
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
additional cancer cases given the
estimated aggregate exposure. Shorttern, intermediate-term, and chronicterm risks are evaluated by comparing
the estimated aggregate food, water, and
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Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations
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. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to the
naphthalene acetates will occupy 10%
of the aPAD for children 1–2 years old,
the population group receiving the
greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to the
naphthalene acetates from food and
water will utilize 8% of the cPAD for
children 1–2 years old, the population
group receiving the greatest exposure.
3. Short-term and intermediate-term
risk. Short-term and intermediate-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Although the naphthalene acetates are
registered for residential use, the uses
are for ornamentals only (i.e., not turf)
and post-application residential
exposure is expected to be negligible.
Therefore, the short-term and
intermediate-term aggregate risks
consist of the sum of the risk from
exposure to the naphthalene acetates
through food and water and will not be
greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S.
population. EPA has classified the
naphthalene acetates as ‘‘not likely to be
carcinogenic to humans.’’ The
naphthalene acetates are not expected to
pose a cancer risk
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children,
from aggregate exposure to naphthalene
acetic acid residues.
V. Other Considerations
jlentini on DSKJ8SOYB1PROD with RULES
A. Analytical Enforcement Methodology
An adequate enforcement
methodology is available to enforce the
tolerance expression of a-naphthalene
acetic acid and 1-naphthaleneacetamide
in or on plant commodities. 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.
VerDate Nov<24>2008
16:35 Aug 11, 2009
Jkt 217001
B. International Residue Limits
There are no CODEX MRLs for
residues of 1-naphthaleneacetic acid
ethyl ester on avocados.
VI. Conclusion
Therefore, a time-limited tolerance is
established for residues of 1naphthaleneacetic acid ethyl ester in or
on avocado at 0.05 ppm. This tolerance
expires and is revoked on December 31,
2012.
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
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
PO 00000
Frm 00047
Fmt 4700
Sfmt 4700
40517
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
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: July 31, 2009.
Lois Rossi,
Director, Registration Division,Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.155 is amended by
redesignating paragraphs (a) and (b) as
paragraphs (a)(1) and (a)(2) and adding
a heading to paragraph (a); by adding a
new paragraph (b); and by adding and
reserving paragraphs (c) and (d)to read
as follows:
■
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Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations
§ 180.155 1-Naphthaleneacetic acid;
tolerances for residues.
(a) General. (1) * * *
(2) * * *
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of the ethyl ester of 1naphthaleneacetic acid in or on the
following raw agricultural commodities
resulting from use of the pesticide
Commodity
Parts per million
avocado
jlentini on DSKJ8SOYB1PROD with RULES
Expiration/revocation date
0.05
December 31, 2012
• Mail: Christina Cosentini, Region 8,
Solid and Hazardous Waste Program,
U.S. EPA, Region 8, 1595 Wynkoop
Street, Denver, Colorado 80202–1129,
phone number: (303) 312–6231.
• Hand Delivery or Courier: Deliver
[FR Doc. E9–19200 Filed 8–11–09; 8:45 am]
your comments to Christina Cosentini,
BILLING CODE 6560–50–S
Region 8, Solid and Hazardous Waste
Program, Mailcode 8P–HW, U.S. EPA,
Region 8, 1595 Wynkoop Street, Denver,
ENVIRONMENTAL PROTECTION
Colorado 80202–1129, phone number:
AGENCY
(303) 312–6231.
Instructions: Direct your comments to
40 CFR Part 271
Docket ID No. EPA–R08–RCRA–2009–
[EPA–R08–RCRA–2009–0341; FRL–8941–1]
0341. EPA’s policy is that all comments
received will be included in the public
Colorado: Final Authorization of State
docket without change, including any
Hazardous Waste Management
personal information provided, unless
Program Revisions
the comment includes information
claimed to be Confidential Business
AGENCY: Environmental Protection
Information (CBI) or other information,
Agency (EPA).
disclosure of which is restricted by
ACTION: Immediate final rule.
statute. Do not submit information that
SUMMARY: The Solid Waste Disposal Act, you consider to be CBI or otherwise
as amended, commonly referred to as
protected from disclosure through
the Resource Conservation and
https://www.regulations.gov, or e-mail.
Recovery Act (RCRA), allows the
The federal Web site, https://
Environmental Protection Agency (EPA) www.regulations.gov, is an ‘‘anonymous
to authorize states to operate their
access’’ system, which means EPA will
hazardous waste management programs not know your identity or contact
in lieu of the federal program. Colorado
information unless you provide it in the
has applied to the EPA for final
body of your comment. If you send an
authorization of changes to its
e-mail comment directly to EPA without
hazardous waste program under RCRA.
going through https://
EPA has determined that these changes
www.regulations.gov, your e-mail
satisfy all requirements needed to
address will be automatically captured
qualify for final authorization, and is
and included as part of the comment
authorizing the state’s changes through
that is placed in the public docket and
this immediate final action.
made available on the Internet. If you
submit an electronic comment, EPA
DATES: This final authorization will
recommends that you include your
become effective on October 13, 2009
unless the EPA receives adverse written name and other contact information in
the body of your comment and with any
comments by September 11, 2009. If
adverse written comments are received, disk or CD–ROM you submit. If EPA
EPA will publish a timely withdrawal of cannot read your comment due to
technical difficulties and cannot contact
this immediate final rule in the Federal
you for clarification, EPA may not be
Register and inform the public that this
able to consider your comment.
authorization will not take effect.
Electronic files should avoid the use of
ADDRESSES: Submit your comments,
special characters, any form of
identified by Docket No. EPA–R08–
encryption, and be free of any defects or
RCRA–2009–0341, by any of the
viruses. For additional information
following methods:
• Federal eRulemaking Portal: https:// about EPA’s public docket, visit the EPA
www.regulations.gov. Follow the on-line Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
instructions for submitting comments.
Docket: All documents in the docket
• E-mail: cosentini.christina@epa.gov.
are listed in the https://
• Fax: (303) 312–6341.
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
*
*
*
*
*
VerDate Nov<24>2008
pursuant to FIFRA section 18
emergency exemptions. The tolerances
expire and are revoked on the date
specified in the following table.
16:35 Aug 11, 2009
Jkt 217001
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Fmt 4700
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www.regulations.gov.index. Although
listed in the index, some information
may not be publicly available, e.g., CBI
or other information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available either
electronically through https://
www.regulations.gov or in hard copy
from 9 a.m. to 4 p.m. at: EPA Region 8,
1595 Wynkoop Street, Denver,
Colorado, contact: Christina Cosentini,
phone number (303) 312–6231, or the
Colorado Department of Public Health
and Environment, 4300 Cherry Creek
Drive South, Denver, Colorado 80222–
1530, contact: Randy Perila, phone
number (303) 692–3364. The public is
advised to call in advance to verify
business hours.
FOR FURTHER INFORMATION CONTACT:
Christina Cosentini, (303) 312–6231,
cosentini.christina@epa.gov or Randy
Perila, (303) 692–3364,
randy.perila@state.co.us.
SUPPLEMENTARY INFORMATION:
A. Why Are Revisions to State
Programs Necessary?
States that have received final
authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must
maintain a hazardous waste program
that is equivalent to, consistent with,
and no less stringent than the Federal
program. As the Federal program
changes, states must change their
programs and ask the EPA to authorize
the changes. Changes to state programs
may be necessary when Federal or state
statutory or regulatory authority is
modified or when certain other changes
occur. Most commonly, states must
change their programs because of
changes to the EPA’s regulations in 40
Code of Federal Regulations (CFR) parts
124, 260 through 266, 268, 270, 273, and
279.
B. What Decisions Have We Made in
This Rule?
We conclude that Colorado’s
application to revise its authorized
program meets all of the statutory and
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]]>Agencies
[Federal Register Volume 74, Number 154 (Wednesday, August 12, 2009)]
[Rules and Regulations]
[Pages 40513-40518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19200]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0373; FRL-8428-3]
1-Naphthaleneacetic Acid Ethyl Ester; Pesticide Tolerance for
Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of 1-naphthaleneacetic acid ethyl ester in or on avocados.
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 avocado trees. This
regulation establishes a maximum permissible level for residues of 1-
naphthaleneacetic acid ethyl ester in this food commodity. The time-
limited tolerance expires and is revoked on December 31, 2012.
DATES: This regulation is effective August 12, 2009. Objections and
requests for hearings must be received on or before October 13, 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-2009-0373. 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: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
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
[[Page 40514]]
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 cite 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-
2009-0373 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 October 13, 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-2009-0373, 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 a
time-limited tolerance for residues of the plant growth regulator 1-
naphthaleneacetic acid ethyl ester in or on avocados at 0.05 parts per
million (ppm). This time-limited tolerance expires and is revoked on
December 31, 2012. 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 1-Naphthaleneacetic Acid Ethyl Ester on
Avocados and FFDCA Tolerances
Avocado growers in Southern California are dealing with emergency
conditions in their orchards caused by unique environmental factors
including a hard freeze, strong Santa Ana winds, drought, and fires
that burned through orchards damaging or killing trees. Trees adversely
affected by these conditions need to be ``stumped'' to be brought back
into production. The processing of ``stumping'' entails cutting the
primary scaffolding limbs of the tree back to stumps and painting them
with white latex paint to protect them from sunburn and disease. The
treatment of the pruned branches and cut stumps with naphthalene acetic
acid ethyl ester slows the re-growth of vegetative sprouts by about
70%. This growth inhibition results in several lateral sprouts instead
of literally hundreds of sprouts growing at and below the pruning cuts.
This shortens the pruning time per tree or stump and the management of
the re-growth can be accomplished with only one pruning per season.
After having reviewed the submission, EPA determined that emergency
conditions exist for this State, and that the criteria for an emergency
exemption are met. EPA has authorized under FIFRA section 18 the use of
1-naphthaleneacetic acid ethyl ester on avocado trees limbs that have
been pruned or cut back to a stump for control of excess sprout growth
in California. As part of its evaluation of the emergency exemption
application, EPA assessed the potential risks presented by residues of
1-naphthaleneacetic acid ethyl ester in or on avocados. In doing so,
EPA considered the safety 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. Consistent with the need to move quickly on the emergency
exemption in order to address an urgent non-routine situation
[[Page 40515]]
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 this time-
limited tolerance expires and is revoked on December 31, 2012, 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 avocados
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 this time-limited tolerance
at the time of that application. EPA will take action to revoke this
time-limited tolerance earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether 1-
naphthaleneacetic acid ethyl ester meets FIFRA's registration
requirements for use on avocados or whether a permanent tolerance 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 1-naphthaleneacetic acid ethyl ester 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 California to
use this pesticide on this crop under FIFRA section 18 absent the
issuance of an emergency exemption applicable within that State. For
additional information regarding the emergency exemption for 1-
naphthaleneacetic acid ethyl ester, 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 1-naphthalene acetic acid
ethyl ester on avocado at 0.05 ppm. EPA's assessment of exposures and
risks 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-term,
intermediate-term, 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 1-naphthaleneacetic
acid ethyl ester used for human risk assessment can be found at https://www.regulations.gov in document Naphthalene Acetates HED Risk
Assessment for Section 18 Use of Naphthalene Acetic Acid Ethyl Ester on
Avocado Trees, page 11 in docket ID number EPA-HQ-OPP-2009-0373.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 1-naphthaleneacetic acid ethyl ester, EPA considered
exposure under the time-limited tolerances established by this action
as well as all existing naphthalene acetic acid tolerances in 40 CFR
180.155(a), naphthalene acetic acid ethyl ester tolerances in 40 CFR
180.155(b), and [alpha]-naphthaleneacetamide and its metabolite
[alpha]-naphthalene acetic acid (calculated as [alpha]-naphthalene
acetic acid) tolerances in 40 CFR 180.309. For commodities having
tolerances for both naphthalene acetic acid and the acetamide of
naphthalene acetic acid, the total amount of residues calculated as
naphthalene acetic acid shall not exceed the higher of the two
tolerances (40 CFR 180.3(d)(7)). Collectively, these chemicals are
referred to as the naphthalene acetates. For the purpose of the human
health risk assessment, all forms of the naphthalene acetates are
combined (1-Naphthaleneacetic acid (NAA), its salts, ester, and
acetamide) because they are structurally related and are metabolized to
the acid form and eliminated from the body as glycine and glucuronic
acid conjugates within 48 hours after exposure EPA assessed dietary
exposures from the naphthalene acetates in food as follows:
i. Acute exposure. In estimating acute dietary exposure, 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, the
acute dietary exposure/risk analyses for all supported naphthalene
acetates food uses were conducted using conservative, Tier 1 exposure
assessments. The Tier I analyses assume tolerance level residues for
all registered uses, 100 PCT for all commodities with existing
tolerances, and default processing factors.
[[Page 40516]]
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, the chronic dietary
exposure/risk analyses for all supported food uses for the naphthalene
acetates were conducted using conservative, Tier 1 exposure
assessments. The Tier I analyses assume tolerance level residues for
all registered uses, 100 PCT for all commodities with existing
tolerances, and default processing factors.
iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA has classified the naphthalene acetates as ``not
likely to be carcinogenic to humans'' therefore, a quantitative cancer
exposure assessment is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for the naphthalene acetates. Tolerance level residues and/or 100 PCT
were assumed for all food commodities.
2. Dietary exposure from drinking water.The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for the naphthalene acetates in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of the naphthalene acetates. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of naphthalene acetates
for acute exposures are estimated to be 12.9 parts per billion (ppb)
for surface water and 0.0008 ppb for ground water and for chronic
exposures for non-cancer assessments are estimated to be 0.71 ppb for
surface water and 0.0008 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 12.9 ppb was used to
assess the contribution to drinking water, and for chronic dietary risk
assessment, the water concentration of value 0.71 ppb was used to
assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Although there are residential uses for the naphthalene acetates,
the uses are for ornamentals only (i.e., not turf) and post-application
residential exposure is expected to be negligible. Therefore, a
quantitative assessment is not required.
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 the naphthalene acetates to share a common
mechanism of toxicity with any other substances, and the naphthalene
acetates do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that the naphthalene acetates do 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. There is low concern (and no
residual uncertainty) for pre-natal and postnatal toxicity resulting
from exposure to the naphthalene acetates. The available data provided
no indication of increased susceptibility (quantitative or qualitative)
in rats or rabbits to in utero exposure to naphthalene acetates or to
pre-natal and post-natal exposure in rat reproduction studies.
3. Conclusion. Therefore, the FQPA safety factor is reduced to 1x
for risk assessment for this chemical. A developmental neurotoxicity
study is not required since there was no evidence of neurotoxicity or
neuropathology from the available studies and there is no concern or
residual uncertainty for pre-natal or post-natal toxicity.
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 the naphthalene acetates is complete.
ii. There is no indication that the naphthalene acetates are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that the naphthalene acetates result in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to the naphthalene acetates 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 the naphthalene acetates.
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 additional cancer cases given the
estimated aggregate exposure. Short-tern, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and
[[Page 40517]]
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to the naphthalene acetates will occupy 10% of the aPAD for children 1-
2 years old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
the naphthalene acetates from food and water will utilize 8% of the
cPAD for children 1-2 years old, the population group receiving the
greatest exposure.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Although the naphthalene acetates are registered for residential
use, the uses are for ornamentals only (i.e., not turf) and post-
application residential exposure is expected to be negligible.
Therefore, the short-term and intermediate-term aggregate risks consist
of the sum of the risk from exposure to the naphthalene acetates
through food and water and will not be greater than the chronic
aggregate risk.
4. Aggregate cancer risk for U.S. population. EPA has classified
the naphthalene acetates as ``not likely to be carcinogenic to
humans.'' The naphthalene acetates are not expected to pose a cancer
risk
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to naphthalene acetic acid residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology is available to enforce the
tolerance expression of [alpha]-naphthalene acetic acid and 1-
naphthaleneacetamide in or on plant commodities. 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; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX MRLs for residues of 1-naphthaleneacetic acid
ethyl ester on avocados.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
1-naphthaleneacetic acid ethyl ester in or on avocado at 0.05 ppm. This
tolerance expires and is revoked on December 31, 2012.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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 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: July 31, 2009.
Lois Rossi,
Director, Registration Division,Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.155 is amended by redesignating paragraphs (a) and (b)
as paragraphs (a)(1) and (a)(2) and adding a heading to paragraph (a);
by adding a new paragraph (b); and by adding and reserving paragraphs
(c) and (d)to read as follows:
[[Page 40518]]
Sec. 180.155 1-Naphthaleneacetic acid; tolerances for residues.
(a) General. (1) * * *
(2) * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
ethyl ester of 1-naphthaleneacetic acid in or on the following raw
agricultural commodities resulting from use of the pesticide pursuant
to FIFRA section 18 emergency exemptions. The tolerances expire and are
revoked on the date specified in the following table.
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
avocado 0.05 December 31, 2012
----------------------------------------------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
* * * * *
[FR Doc. E9-19200 Filed 8-11-09; 8:45 am]
BILLING CODE 6560-50-S
