1-Naphthaleneacetic acid; Pesticide Tolerances, 30213-30218 [2013-12207]
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Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations
In addition, this rule does not have
tribal implications as specified by
Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is
not approved to apply in Indian country
located in the state, and EPA notes that
it will not impose substantial direct
costs on tribal governments or preempt
tribal law.
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this action and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by July 22, 2013. Filing a petition
for reconsideration by the Administrator
of this final rule does not affect the
finality of this action for the purposes of
judicial review nor does it extend the
time within which a petition for judicial
review may be filed, and shall not
postpone the effectiveness of such rule
or action. This action may not be
challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Oxides of
nitrogen, Ozone, Reporting and
recordkeeping requirements, Volatile
organic compounds.
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Dated: February 4, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.
Part 52, chapter I, title 40 of the Code
of Federal Regulations are amended as
follows:
PART 52—[AMENDED]
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
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Subpart D—Arizona
2. Section 52.120 is amended by
adding paragraphs (c)(155), (c)(156), and
(c)(157) to read as follows:
■
§ 52.120
Identification of plan.
*
*
*
*
*
(c) * * *
(155) The following plan was
submitted on November 6, 2009 by the
Governor’s designee.
(i) Incorporation by reference.
(A) Arizona Department of
Environmental Quality.
(1) Affidavit by Efrem K. Sepulveda,
Law Librarian, Arizona State Library,
Archives and Public Records, certifying
authenticity of reproduction of A.R.S.
§ 49–542 (2008 edition) plus title page
to pocket part of Title 49 (2008 edition),
signed January 11, 2013.
(2) Arizona Revised Statutes
(Thomson West, 2008 Cumulative
Pocket Part): Title 49 (the environment),
section 49–542 (‘‘Emissions inspection
program; powers and duties of director;
administration; periodic inspection;
minimum standards and rules;
exceptions; definition’’).
(ii) Additional materials.
(A) Arizona Department of
Environmental Quality.
(1) Final Arizona State
Implementation Plan Revision,
Exemption of Motorcycles from Vehicle
Emissions Inspections and Maintenance
Program Requirements in Area A
(October 2009), adopted by the Arizona
Department of Environmental Quality
on November 6, 2009, excluding
appendices A and C.
(156) The following plan was
submitted on January 11, 2011 by the
Governor’s designee.
(i) [Reserved]
(ii) Additional materials.
(A) Arizona Department of
Environmental Quality.
(1) Final Addendum to the Arizona
State Implementation Plan Revision,
Exemption of Motorcycles from Vehicle
Emissions Inspections and Maintenance
Program Requirements in Area A,
October 2009 (December 2010), adopted
by the Arizona Department of
Environmental Quality on January 11,
2011.
(157) The following plan was
submitted on May 25, 2012 by the
Governor’s designee.
(i) Incorporation by reference.
(A) Arizona Department of
Environmental Quality.
(1) Affidavit by Barbara Howe, Law
Reference Librarian, Arizona State
Library, Archives and Public Records,
certifying authenticity of reproduction
of Arizona Revised Statutes § 49–451
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(sic) (corrected to § 49–541) (2001
pocket part), signed May 3, 2012.
(2) Arizona Revised Statutes (West
Group, 2001 Cumulative Pocket Part):
title 49 (the environment), section 49–
541 (‘‘Definitions’’), subsection 1
[Definition of Area A].
[FR Doc. 2013–12091 Filed 5–21–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0203; FRL–9386–1]
1-Naphthaleneacetic acid; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of 1naphthaleneacetic acid in or on
avocado; fruit, pome, group 11–10;
mango; sapote, mamey; and rambutan.
This regulation additionally deletes
certain tolerances, identified and
discussed later in this document.
Interregional Research Project Number 4
(IR–4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective May
22, 2013. Objections and requests for
hearings must be received on or before
July 22, 2013, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0203, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
ADDRESSES:
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Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7390; email address:
nollen.laura@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2012–0203, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
B. How can I get electronic access to
other related information?
II. Summary of Petitioned-For
Tolerance
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
In the Federal Register of May 2, 2012
(77 FR 25954) (FRL–9346–1), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 2E7991) by IR–4, 500
College Road East, Suite 201W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.155 be
amended by establishing tolerances for
residues of the plant growth regulator 1naphthaleneacetic acid and its
conjugates in or on rambutan at 3 parts
per million (ppm); avocado, mango, and
sapote, mamey at 0.05 ppm; and fruit,
pome, group 11–10 at 0.15 ppm. The
petition additionally requested to
amend the tolerances in 40 CFR 180.155
by removing the tolerance for fruit,
pome, group 11 at 0.15 ppm, as it will
be superseded by the tolerance on fruit,
pome, group 11–10 at 0.15 ppm. That
document referenced a summary of the
petition prepared on behalf of IR–4 by
Amvac Chemical Corporation, the
registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA has revised
the proposed tolerance on rambutan
from 3.0 ppm to 2.0 ppm. The Agency
has also revised the tolerance
expression for all established
commodities to be consistent with
current Agency policy. The reason for
these changes is explained in Unit IV.C.
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2012–0203 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before July 22, 2013. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
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III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
that section, EPA has reviewed the
available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure for
1-naphthaleneacetic acid, including
exposure resulting from the tolerances
established by this action. EPA’s
assessment of exposures and risks
associated with 1-naphthaleneacetic
acid follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
Based on structural activity
relationship and metabolism data, all
forms of 1-naphthaleneacetic acid, its
salts, ester, and acetamide which are
collectively referred to as naphthalene
acetates (NAA), are expected to exhibit
similar toxicological effects. In selecting
endpoints of toxicity for risk assessment
to exposures to the various NAA forms,
the most conservative endpoint was
selected from the studies that showed
the lowest NOAELs for assessing a
particular exposure. In addition, all
forms degrade to the acid fairly quickly
in the field and in biological systems.
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Therefore, EPA has concluded that
required toxicity testing on any form
should serve for all members of this
group of chemicals.
Repeated oral exposures to NAA in
rats and dogs resulted in decreased body
weights, and body weight gains
accompanied by decreased food
consumption. The major target organs
from subchronic and chronic oral
exposures were the liver, stomach, and
lung. Repeated oral exposures also
resulted in decreased hematocrit and
hemoglobin, along with reduced red
blood cell count in rats and dogs and
hypocellularity of the bone marrow in
dogs.
There was no developmental toxicity
at the highest dose of NAA (the acid)
tested in the rat or in the rabbit (orally
gavaged), but developmental toxicity
(decreased fetal weight and minor
skeletal changes) were seen in rats
orally gavaged with the sodium salt.
Reproductive effects of NAA sodium
salts were limited to reduced litter
survival and pup weight throughout
lactation in both generations of offspring
in a 2-generation reproduction study.
NAA and its acetamide and the ethyl
ester were tested for mutagenic effects
in a gene mutation bacterial assay,
mouse lymphoma assay, and mouse
erythrocyte micronucleus assay, mouse
lymphoma assay, and mouse
erythrocyte micronucleus assay and
were not found to be mutagenic.
Additionally, NAA was tested for
mitotic gene conversion and dominant
lethality in rats and found to be
negative. In a published carcinogenicity
study of NAA acetamide in mice and a
guideline chronic/oncogenicity study of
NAA sodium salt in rats and mice, NAA
compounds were not carcinogenic in
mice or rats.
Specific information on the studies
received and the nature of the adverse
effects caused by NAA as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov in document:
‘‘Naphthalene Acetates Human Health
Risk Assessment for a Proposed Use on
Avocado, Mango, Mamey Sapote,
Rambutan, and Updating Crop Group
Fruit, Pome, Group 11–10.’’ at pages 42–
50 in docket ID number EPA–HQ–OPP–
2012–0203.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern (LOC) to use in
evaluating the risk posed by human
30215
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors (U/SF) are used in
conjunction with the POD to calculate a
safe exposure level—generally referred
to as a population-adjusted dose (PAD)
or a reference dose (RfD)—and a safe
margin of exposure (MOE). For nonthreshold risks, the Agency assumes
that any amount of exposure will lead
to some degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for NAA used for human risk
assessment is shown in Table 1 of this
unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NAA FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure and uncertainty/safety factors
Exposure/scenario
Acute dietary (General population
including infants and children
and females 13–49 years of
age)
RfD, PAD, LOC for risk
assessment
Study and toxicological effects
An acute RfD for the general population or any population subgroups was not selected because no effect
attributable to a single exposure was observed in animal studies.
Chronic dietary (All populations) ....
NOAEL = 15 mg/kg/day ...............
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.15 mg/kg/day .....
cPAD = 0.15 mg/kg/day
Dermal short-term (1 to 30 days) ..
Dermal study ................................
NOAEL = 300 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
Oral study .....................................
NOAEL = 50 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 10x
LOC for MOE = 100 .....................
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Inhalation
days).
short-term
(1
to
30
Cancer (Oral, dermal, inhalation) ..
LOC for MOE = 1,000 ..................
Chronic Toxicity—Dog LOAEL =
75 mg/kg/day based on stomach lesions in 75% of the males
and
by
slight
sinusoidal
histiocytosis in the liver of 50%
of the males.
21-Day dermal: NAA Na salt
LOAEL = 1,000 mg/kg/day
based on reduced body weight
gain and food efficiency.
Developmental Rat: NAA LOAEL
= 150 mg/kg/day based on decreased body weight gain during gestation period.
Not likely to be carcinogenic to humans.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligrams/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to NAA, EPA considered
exposure under the petitioned-for
tolerances as well as all existing NAA
tolerances in 40 CFR 180.155. EPA
assessed dietary exposures from NAA in
food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure. No such effects were
identified in the toxicological studies
for NAA; therefore, a quantitative acute
dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used Dietary Exposure Evaluation
Model software with the Food
Commodity Intake Database (DEEM–
FCID) Version 3.16, which uses food
consumption data from the U.S.
Department of Agriculture’s National
Health and Nutrition Examination
Survey, What We Eat in America,
(NHANES/WWEIA), conducted from
2003–2008. As to residue levels in food,
EPA assumed 100 percent crop treated
(PCT) and tolerance-level residues for
all commodities. In addition, DEEM
version 7.81 default processing factors
were used, when appropriate.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that NAA does not pose a
cancer risk to humans. Therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue and/or PCT
information in the dietary assessment
for NAA. 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 NAA in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of NAA.
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
Concentration in Ground Water (SCI–
GROW) models, the estimated drinking
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water concentrations (EDWCs) of NAA
for chronic exposures for non-cancer
assessments are estimated to be 2.99
parts per billion (ppb) for surface water
and 0.0226 ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 3.0 ppb
was used to assess the contribution to
drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets). NAA is
currently registered for root dip and
sprout inhibition applications to
ornamentals, which could result in
residential exposures. There is a
potential for short-term dermal and
inhalation exposures to residential
handlers, resulting from loading and
applying NAA. There are no residential
uses for NAA that result in exposure to
children via incidental oral activities.
The rooting compounds are applied by
holding the plant and dipping the roots
into solution. Very little exposure is
expected from this use. Sprout
inhibitors are applied by spray or paint
brush/roller after pruning trees, or by
spraying near the base of the tree after
pruning root suckers. There is very little
potential for postapplication exposure
to NAA for adults or children based on
the residential use pattern; therefore,
residential postapplication exposure is
not expected, nor is intermediate- or
long-term exposure scenarios based on
the intermittent nature of applications
by homeowners.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found NAA to share a
common mechanism of toxicity with
any other substances, and NAA does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that NAA
does not have a common mechanism of
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toxicity with other substances. For
information regarding EPA’s efforts to
determine which chemicals have a
common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see EPA’s Web site at
https://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA SF. In applying this provision,
EPA either retains the default value of
10X, or uses a different additional safety
factor when reliable data available to
EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity.
There is low concern and no residual
uncertainty for pre- and/or postnatal
toxicity resulting from exposure to the
NAA group of chemicals. The available
data provided no indication of increased
quantitative or qualitative susceptibility
of rats or rabbits to in utero exposure to
NAA or to prenatal and postnatal
exposure in rat reproduction studies. In
the developmental toxicity study
conducted with NAA sodium salt in
rats, fetal toxicity (mainly decreased
fetal weights and minor skeletal
changes) was observed at a dose lower
than the maternally toxic dose.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
was reduced to 1X for the oral and
dermal routes of exposure and retained
at 10X for the inhalation route of
exposure. That decision is based on the
following findings:
i. The toxicity database for NAA is not
complete. EPA concluded that a 28-day
inhalation toxicity study is required for
NAA, based on a weight-of-evidence
approach. A 10X SF was retained for the
inhalation route of exposure due to the
lack of the required 28-day inhalation
study and given that the endpoint for
subchronic inhalation is based on a
developmental study (NOAEL = 50 mg/
kg/day) that noted decreased body
weight gains during gestation.
Additionally, recent changes to 40
CFR part 158 imposed new data
requirements for immunotoxicity testing
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(OCSPP Guideline 870.7800) for
pesticide registration. While an
immunotoxicity study is not available
for NAA, the toxicology database does
not show any evidence of treatmentrelated effects on the immune system
and the overall weight-of-evidence
suggests that this chemical does not
directly target the immune system.
Consequently, the Agency does not
believe that conducting a functional
immunotoxicity study will result in a
lower POD than that currently used for
overall risk assessment, and therefore,
an additional safety factor is not needed
to account for lack of this study.
Acute and subchronic neurotoxicity
studies are also required as a part of
new data requirements in 40 CFR part
158; however, EPA has waived the
requirement for these studies at the
present time. This decision is based on:
(1) The lack of neurotoxicity and
neuropathology in the available
toxicology studies for NAA; and (2)
liver, stomach, and lung were identified
as the target organs, with dogs being the
most sensitive species. Therefore,
neurotoxicity studies conducted in rats
would not provide a more sensitive
endpoint for risk assessment, and
studies would be unlikely to yield PODs
lower than the current PODs used for
overall risk assessment.
ii. There is no indication that NAA 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 NAA
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.
In the developmental toxicity study
conducted with NAA sodium salt in
rats, fetal toxicity was observed at a
dose lower than the maternally toxic
dose. However, there were clear
NOAELs in this developmental study
and the PODs used in the chronic
dietary assessment (15 mg/kg/day) are
protective of the fetal effects observed in
the study.
iv. There are no residual uncertainties
identified in the exposure databases.
The chronic dietary food exposure
assessment was performed based on 100
PCT and tolerance-level residues. EPA
made conservative (protective)
assumptions in the ground water and
surface water modeling used to assess
exposure to NAA in drinking water.
Based on the discussion in Unit III.C.3.,
regarding limited residential use
patterns, exposure to residential
handlers is very low and EPA does not
anticipate postapplication exposure to
children or incidental exposures to
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14:58 May 21, 2013
Jkt 229001
toddlers resulting from use of NAA in
residential settings. These assessments
will not underestimate the exposure and
risks posed by NAA.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, NAA 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 NAA from food
and water will utilize 2.0% of the cPAD
for children 1–2 years old, the
population group receiving the greatest
exposure. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of NAA is not expected.
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). Though there is
potential for short-term dermal and
inhalation exposures to adult handlers
resulting from residential applications
of NAA to ornamentals, aggregate risk
was not estimated for NAA because the
toxicity endpoints selected for the
chronic dietary route of exposure and
those selected for inhalation and dermal
routes of exposure are not based on
common effects i.e., the chronic dietary
endpoint is based on systemic effects
and the dermal and inhalation
endpoints are based on decreased body
weight gain. Exposure pathways and
routes are only aggregated when they
share a common toxic effect.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
30217
Because no intermediate-term adverse
effect was identified, NAA is not
expected to pose an intermediate-term
risk.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
NAA is not expected to pose a cancer
risk to humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to NAA
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement method, a
high performance liquid
chromatography (HPLC) method using
fluorescence detection (Method NAA–
AM–001) and a similar method (Method
NAA–AM–002), is available to enforce
the tolerance expression for NAA in
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.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for NAA.
C. Revisions to Petitioned-For
Tolerances
Based on the data supporting the
petition, EPA revised the proposed
tolerance on rambutan from 3.0 ppm to
E:\FR\FM\22MYR1.SGM
22MYR1
30218
Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations
2.0 ppm. The Agency revised this
tolerance level based on analysis of the
residue field trial data using the
Organization for Economic Cooperation
and Development (OECD) tolerance
calculation procedures.
Finally, the Agency has revised the
tolerance expression to clarify: (1) That,
as provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
degradates of NAA not specifically
mentioned; and (2) that compliance
with the specified tolerance levels is to
be determined by measuring only the
specific compounds mentioned in the
tolerance expression.
pmangrum on DSK3VPTVN1PROD with RULES
V. Conclusion
Therefore, tolerances are established
for residues of NAA, 1naphthaleneacetic acid, in or on
avocado at 0.05 ppm; fruit, pome, group
11–10 at 0.15 ppm; sapote, mamey at
0.05 ppm; mango at 0.05 ppm; and
rambutan at 2.0 ppm. This regulation
additionally removes the tolerance in or
on fruit, pome, group 11 at 0.15 ppm
and the time-limited tolerance in or on
avocado at 0.05 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
VerDate Mar<15>2010
14:58 May 21, 2013
Jkt 229001
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 14, 2013.
Daniel J. Rosenblatt,
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:
■
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.155 is revised to read
as follows:
■
§ 180.155 1-Naphthaleneacetic acid;
tolerances for residues.
(a) General. Tolerances are
established for the residues of 1naphthaleneacetic acid, including its
metabolites and degradates in or on the
commodities in the following table.
Compliance with the tolerance levels
specified is to be determined by
measuring only 1-naphthaleneacetic
acid and its conjugates, calculated as the
Stoichiometric equivalent of 1naphthaleneacetic acid, in or on the
commodity.
Commodity
Parts per
million
Avocado ................................
Cherry, sweet .......................
Fruit, pome, group 11–10 .....
Mango ...................................
Olive ......................................
Orange ..................................
Pineapple1 ............................
Potato ...................................
Rambutan .............................
Sapote, mamey ....................
Tangerine ..............................
1 There
0.05
0.1
0.15
0.05
0.7
0.1
0.05
0.01
2.0
0.05
0.1
are no U.S. registrations since 1988.
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 2013–12207 Filed 5–21–13; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 152
[CMS–9995–IFC3]
RIN 0938–AQ70
Pre-Existing Condition Insurance Plan
Program
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Interim final rule with comment
period.
AGENCY:
SUMMARY: This interim final rule with
comment period sets the payment rates
for covered services furnished to
individuals enrolled in the Pre-Existing
Condition Insurance Plan (PCIP)
program administered directly by HHS
beginning with covered services
furnished on June 15, 2013. This interim
E:\FR\FM\22MYR1.SGM
22MYR1
]]>Agencies
[Federal Register Volume 78, Number 99 (Wednesday, May 22, 2013)]
[Rules and Regulations]
[Pages 30213-30218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12207]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0203; FRL-9386-1]
1-Naphthaleneacetic acid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of 1-
naphthaleneacetic acid in or on avocado; fruit, pome, group 11-10;
mango; sapote, mamey; and rambutan. This regulation additionally
deletes certain tolerances, identified and discussed later in this
document. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May 22, 2013. Objections and
requests for hearings must be received on or before July 22, 2013, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0203, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200
[[Page 30214]]
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 305-7390; email address: nollen.laura@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0203 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 22, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0203, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of May 2, 2012 (77 FR 25954) (FRL-9346-1),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 2E7991)
by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.155 be amended by establishing
tolerances for residues of the plant growth regulator 1-
naphthaleneacetic acid and its conjugates in or on rambutan at 3 parts
per million (ppm); avocado, mango, and sapote, mamey at 0.05 ppm; and
fruit, pome, group 11-10 at 0.15 ppm. The petition additionally
requested to amend the tolerances in 40 CFR 180.155 by removing the
tolerance for fruit, pome, group 11 at 0.15 ppm, as it will be
superseded by the tolerance on fruit, pome, group 11-10 at 0.15 ppm.
That document referenced a summary of the petition prepared on behalf
of IR-4 by Amvac Chemical Corporation, the registrant, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance on rambutan from 3.0 ppm to 2.0 ppm. The
Agency has also revised the tolerance expression for all established
commodities to be consistent with current Agency policy. The reason for
these changes is explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in that section, EPA has reviewed the available scientific
data and other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for 1-naphthaleneacetic acid, including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with 1-naphthaleneacetic
acid follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Based on structural activity relationship and metabolism data, all
forms of 1-naphthaleneacetic acid, its salts, ester, and acetamide
which are collectively referred to as naphthalene acetates (NAA), are
expected to exhibit similar toxicological effects. In selecting
endpoints of toxicity for risk assessment to exposures to the various
NAA forms, the most conservative endpoint was selected from the studies
that showed the lowest NOAELs for assessing a particular exposure. In
addition, all forms degrade to the acid fairly quickly in the field and
in biological systems.
[[Page 30215]]
Therefore, EPA has concluded that required toxicity testing on any form
should serve for all members of this group of chemicals.
Repeated oral exposures to NAA in rats and dogs resulted in
decreased body weights, and body weight gains accompanied by decreased
food consumption. The major target organs from subchronic and chronic
oral exposures were the liver, stomach, and lung. Repeated oral
exposures also resulted in decreased hematocrit and hemoglobin, along
with reduced red blood cell count in rats and dogs and hypocellularity
of the bone marrow in dogs.
There was no developmental toxicity at the highest dose of NAA (the
acid) tested in the rat or in the rabbit (orally gavaged), but
developmental toxicity (decreased fetal weight and minor skeletal
changes) were seen in rats orally gavaged with the sodium salt.
Reproductive effects of NAA sodium salts were limited to reduced litter
survival and pup weight throughout lactation in both generations of
offspring in a 2-generation reproduction study.
NAA and its acetamide and the ethyl ester were tested for mutagenic
effects in a gene mutation bacterial assay, mouse lymphoma assay, and
mouse erythrocyte micronucleus assay, mouse lymphoma assay, and mouse
erythrocyte micronucleus assay and were not found to be mutagenic.
Additionally, NAA was tested for mitotic gene conversion and dominant
lethality in rats and found to be negative. In a published
carcinogenicity study of NAA acetamide in mice and a guideline chronic/
oncogenicity study of NAA sodium salt in rats and mice, NAA compounds
were not carcinogenic in mice or rats.
Specific information on the studies received and the nature of the
adverse effects caused by NAA as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document: ``Naphthalene Acetates Human Health
Risk Assessment for a Proposed Use on Avocado, Mango, Mamey Sapote,
Rambutan, and Updating Crop Group Fruit, Pome, Group 11-10.'' at pages
42-50 in docket ID number EPA-HQ-OPP-2012-0203.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOC) to use in evaluating the risk posed by human exposure to
the pesticide. For hazards that have a threshold below which there is
no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors (U/SF) are used in conjunction
with the POD to calculate a safe exposure level--generally referred to
as a population-adjusted dose (PAD) or a reference dose (RfD)--and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for NAA used for human
risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for NAA for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population An acute RfD for the general population or any population subgroups was
including infants and children and not selected because no effect attributable to a single exposure was
females 13-49 years of age) observed in animal studies.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations).... NOAEL = 15 mg/kg/day... Chronic RfD = 0.15 mg/ Chronic Toxicity--Dog
UFA = 10x.............. kg/day. LOAEL = 75 mg/kg/day
UFH = 10x.............. cPAD = 0.15 mg/kg/day.. based on stomach
FQPA SF = 1x........... lesions in 75% of the
males and by slight
sinusoidal
histiocytosis in the
liver of 50% of the
males.
Dermal short-term (1 to 30 days)..... Dermal study........... LOC for MOE = 100...... 21-Day dermal: NAA Na
NOAEL = 300 mg/kg/day.. salt LOAEL = 1,000 mg/
UFA = 10x.............. kg/day based on
UFH = 10x.............. reduced body weight
FQPA SF = 1x........... gain and food
efficiency.
Inhalation short-term (1 to 30 days). Oral study............. LOC for MOE = 1,000.... Developmental Rat: NAA
NOAEL = 50 mg/kg/day... LOAEL = 150 mg/kg/day
UFA = 10x.............. based on decreased
UFH = 10x.............. body weight gain
FQPA SF = 10x.......... during gestation
period.
��������������������������������������
Cancer (Oral, dermal, inhalation).... Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligrams/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
[[Page 30216]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to NAA, EPA considered exposure under the petitioned-for
tolerances as well as all existing NAA tolerances in 40 CFR 180.155.
EPA assessed dietary exposures from NAA in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for NAA; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID) Version 3.16, which uses
food consumption data from the U.S. Department of Agriculture's
National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA), conducted from 2003-2008. As to residue levels
in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level
residues for all commodities. In addition, DEEM version 7.81 default
processing factors were used, when appropriate.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that NAA does not pose a cancer risk to humans. Therefore, a
dietary exposure assessment for the purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for NAA. 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 NAA in drinking water. These simulation models take into
account data on the physical, chemical, and fate/transport
characteristics of NAA. 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
Concentration in Ground Water (SCI-GROW) models, the estimated drinking
water concentrations (EDWCs) of NAA for chronic exposures for non-
cancer assessments are estimated to be 2.99 parts per billion (ppb) for
surface water and 0.0226 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 3.0 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). NAA is currently
registered for root dip and sprout inhibition applications to
ornamentals, which could result in residential exposures. There is a
potential for short-term dermal and inhalation exposures to residential
handlers, resulting from loading and applying NAA. There are no
residential uses for NAA that result in exposure to children via
incidental oral activities. The rooting compounds are applied by
holding the plant and dipping the roots into solution. Very little
exposure is expected from this use. Sprout inhibitors are applied by
spray or paint brush/roller after pruning trees, or by spraying near
the base of the tree after pruning root suckers. There is very little
potential for postapplication exposure to NAA for adults or children
based on the residential use pattern; therefore, residential
postapplication exposure is not expected, nor is intermediate- or long-
term exposure scenarios based on the intermittent nature of
applications by homeowners.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found NAA to share a common mechanism of toxicity with
any other substances, and NAA does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that NAA does not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. There is low concern and no
residual uncertainty for pre- and/or postnatal toxicity resulting from
exposure to the NAA group of chemicals. The available data provided no
indication of increased quantitative or qualitative susceptibility of
rats or rabbits to in utero exposure to NAA or to prenatal and
postnatal exposure in rat reproduction studies. In the developmental
toxicity study conducted with NAA sodium salt in rats, fetal toxicity
(mainly decreased fetal weights and minor skeletal changes) was
observed at a dose lower than the maternally toxic dose.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF was reduced to 1X for the oral and dermal routes of exposure
and retained at 10X for the inhalation route of exposure. That decision
is based on the following findings:
i. The toxicity database for NAA is not complete. EPA concluded
that a 28-day inhalation toxicity study is required for NAA, based on a
weight-of-evidence approach. A 10X SF was retained for the inhalation
route of exposure due to the lack of the required 28-day inhalation
study and given that the endpoint for subchronic inhalation is based on
a developmental study (NOAEL = 50 mg/kg/day) that noted decreased body
weight gains during gestation.
Additionally, recent changes to 40 CFR part 158 imposed new data
requirements for immunotoxicity testing
[[Page 30217]]
(OCSPP Guideline 870.7800) for pesticide registration. While an
immunotoxicity study is not available for NAA, the toxicology database
does not show any evidence of treatment-related effects on the immune
system and the overall weight-of-evidence suggests that this chemical
does not directly target the immune system. Consequently, the Agency
does not believe that conducting a functional immunotoxicity study will
result in a lower POD than that currently used for overall risk
assessment, and therefore, an additional safety factor is not needed to
account for lack of this study.
Acute and subchronic neurotoxicity studies are also required as a
part of new data requirements in 40 CFR part 158; however, EPA has
waived the requirement for these studies at the present time. This
decision is based on: (1) The lack of neurotoxicity and neuropathology
in the available toxicology studies for NAA; and (2) liver, stomach,
and lung were identified as the target organs, with dogs being the most
sensitive species. Therefore, neurotoxicity studies conducted in rats
would not provide a more sensitive endpoint for risk assessment, and
studies would be unlikely to yield PODs lower than the current PODs
used for overall risk assessment.
ii. There is no indication that NAA 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 NAA 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. In the developmental toxicity study conducted with NAA sodium
salt in rats, fetal toxicity was observed at a dose lower than the
maternally toxic dose. However, there were clear NOAELs in this
developmental study and the PODs used in the chronic dietary assessment
(15 mg/kg/day) are protective of the fetal effects observed in the
study.
iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessment was performed
based on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to NAA in drinking water. Based on the
discussion in Unit III.C.3., regarding limited residential use
patterns, exposure to residential handlers is very low and EPA does not
anticipate postapplication exposure to children or incidental exposures
to toddlers resulting from use of NAA in residential settings. These
assessments will not underestimate the exposure and risks posed by NAA.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
NAA 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
NAA from food and water will utilize 2.0% of the cPAD for children 1-2
years old, the population group receiving the greatest exposure. Based
on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of NAA is not
expected.
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). Though there
is potential for short-term dermal and inhalation exposures to adult
handlers resulting from residential applications of NAA to ornamentals,
aggregate risk was not estimated for NAA because the toxicity endpoints
selected for the chronic dietary route of exposure and those selected
for inhalation and dermal routes of exposure are not based on common
effects i.e., the chronic dietary endpoint is based on systemic effects
and the dermal and inhalation endpoints are based on decreased body
weight gain. Exposure pathways and routes are only aggregated when they
share a common toxic effect.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term adverse effect was identified, NAA
is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, NAA is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to NAA residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement method, a high performance liquid
chromatography (HPLC) method using fluorescence detection (Method NAA-
AM-001) and a similar method (Method NAA-AM-002), is available to
enforce the tolerance expression for NAA in 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.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for NAA.
C. Revisions to Petitioned-For Tolerances
Based on the data supporting the petition, EPA revised the proposed
tolerance on rambutan from 3.0 ppm to
[[Page 30218]]
2.0 ppm. The Agency revised this tolerance level based on analysis of
the residue field trial data using the Organization for Economic
Cooperation and Development (OECD) tolerance calculation procedures.
Finally, the Agency has revised the tolerance expression to
clarify: (1) That, as provided in FFDCA section 408(a)(3), the
tolerance covers metabolites and degradates of NAA not specifically
mentioned; and (2) that compliance with the specified tolerance levels
is to be determined by measuring only the specific compounds mentioned
in the tolerance expression.
V. Conclusion
Therefore, tolerances are established for residues of NAA, 1-
naphthaleneacetic acid, in or on avocado at 0.05 ppm; fruit, pome,
group 11-10 at 0.15 ppm; sapote, mamey at 0.05 ppm; mango at 0.05 ppm;
and rambutan at 2.0 ppm. This regulation additionally removes the
tolerance in or on fruit, pome, group 11 at 0.15 ppm and the time-
limited tolerance in or on avocado at 0.05 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 14, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.155 is revised to read as follows:
Sec. 180.155 1-Naphthaleneacetic acid; tolerances for residues.
(a) General. Tolerances are established for the residues of 1-
naphthaleneacetic acid, including its metabolites and degradates in or
on the commodities in the following table. Compliance with the
tolerance levels specified is to be determined by measuring only 1-
naphthaleneacetic acid and its conjugates, calculated as the
Stoichiometric equivalent of 1-naphthaleneacetic acid, in or on the
commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Avocado.................................................. 0.05
Cherry, sweet............................................ 0.1
Fruit, pome, group 11-10................................. 0.15
Mango.................................................... 0.05
Olive.................................................... 0.7
Orange................................................... 0.1
Pineapple\1\............................................. 0.05
Potato................................................... 0.01
Rambutan................................................. 2.0
Sapote, mamey............................................ 0.05
Tangerine................................................ 0.1
------------------------------------------------------------------------
\1\ There are no U.S. registrations since 1988.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2013-12207 Filed 5-21-13; 8:45 am]
BILLING CODE 6560-50-P
