1-Naphthaleneacetic acid; Pesticide Tolerances, 26954-26959 [2012-11117]
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Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
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 those engaged in the
following activities:
• 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 to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
A. Does this action apply to me?
[EPA–HQ–OPP–2004–0144; FRL–9346–9]
RIN 2070–ZA16
1-Naphthaleneacetic acid; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of 1naphthaleneacetic acid, potassium and
sodium salts in or on potatoes. Stehekin,
LLC petitioned EPA for clearance of use
of this pesticide under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
8, 2012. Objections and requests for
hearings must be received on or before
July 9, 2012, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2004–0144. All documents in the
docket are listed in the docket index
available at 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: Rose
Mary Kearns, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703)–305–5611; email address:
kearns.rosemary@epa.gov.
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ADDRESSES:
SUPPLEMENTARY INFORMATION:
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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://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced
in this document electronically, please
go to https://www.epa.gov/ocspp and
select ‘‘Test Methods and Guidelines.’’
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–2004–0144 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 9, 2012. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2004–0144, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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. Summary of Petitioned-for Tolerance
In the Federal Register of September
8, 2010 (75 FR 54629) (FRL–8843–3),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C. 346a
(d)(3), announcing the filing of a
pesticide petition (PP 0F7687) by
Stehekin, LLC, 1012 Good Lander Drive,
Selah, Washington 98942. The petition
requested that a tolerance exemption be
established for residues of the fungicide
1-naphthaleneacetic acid (1naphthaleneacetamide), on potatoes.
That notice referenced a summary of the
petition prepared by Stehekin, LLC, 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 a revised petition which
requested a tolerance and review of the
data supporting the petition, EPA has
determined that it is appropriate to
establish a tolerance in association with
the use of 1-naphthaleneacetic acid (1naphthaleneacetamide) on potatoes.
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.’’
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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 section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for 1naphthalneactic acid, its salts, ester, and
acetamide which are collectively
referred to as naphthalene acetates
(NAA) including exposure resulting
from the tolerances established by this
action. EPA’s assessment of exposures
and risks associated with NAA 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 are expected
to exhibit similar toxicological effects.
Therefore the Agency concluded that
required toxicity testing on any form
should serve for all members of this
group of chemicals.
Naphthalene acetates have low acute
toxicity via the oral, inhalation and
dermal routes of exposure. 1Naphthaleneacetic acid is not a skin
irritant or a dermal sensitizer. The 1naphthaleneacetic acid and its sodium
salt were found to be irritating to the
eye. Repeated exposure oral toxicity
studies in rats and dogs resulted in
decreased body weights and body
weight gains accompanied by decreased
food consumption.
The major target organs of subchronic
and chronic oral exposure were the
liver, stomach and lung. Repeated oral
exposure also resulted in decreased
hematocrit and hemoglobin along with
reduced RBC count in rats and dogs and
hypocellularity of the bone marrow in
dogs.
There was no developmental toxicity
at the highest dose of 1naphthaleneacetic acid tested in the rat
or in the rabbit, but developmental
toxicity (decreased fetal weight and
minor skeletal changes) were seen in
rats orally gavaged with the sodium salt.
Reproductive effects of
naphthaleneacetic acid sodium salt
were limited to reduced litter survival
and pup weight throughout lactation in
both generations of offspring in a 2generation reproduction study.
Naphthaleneacetic acid and it’s
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 mutagenic. Additionally 1naphthaleneacetic acid was tested for
mitotic gene conversion and dominant
lethality in rats and found to be
negative.
Carcinogenicity studies of NAA in
mice and in rats for the 1naphthaleneacetic acid group showed
no evidence of carcinogenicity. Specific
information on the studies received and
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the nature of the adverse effects caused
by NAA as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can
be found at https://www.regulations.gov
in the document ‘‘Naphthalene Acetates
HED Risk Assessment for Section 3
Proposed New Use on Potato Seed
Pieces’’ at pages 10 through 14 in docket
ID number EPA–HQ–OPP–2004–0144.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for 1-naphthaleneaetic acid
used for human risk assessment is
shown in Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 1-NAPHTHALENEACETIC ACID FOR USE IN HUMAN
HEALTH RISK ASSESSMENT
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Exposure/scenario
Acute dietary (General
population including
infants and children).
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Point of departure and
uncertainty/safety
factors
RfD, PAD, LOC for
risk
assessment
Study and toxicological effects
An acute RfD for the general population subgroups was not selected because no effect attributable to a single (or few)
day(s) oral exposure was observed in animal studies.
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Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Rules and Regulations
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 1-NAPHTHALENEACETIC ACID FOR USE IN HUMAN
HEALTH RISK ASSESSMENT—Continued
Exposure/scenario
Point of departure and
uncertainty/safety
factors
RfD, PAD, LOC for
risk
assessment
Study and toxicological effects
Chronic dietary (All
populations).
NOAEL = 15 mg/kg/
day.
UFA = 10x
UFH = 10x
Chronic RfD = 0.15
mg/kg/day.
cPAD = 0.15 mg/kg/
day
Chronic Toxicity—Dog.
LOAEL = 75 mg/kg/day based on stomach lesions in 75% of the
males and by slight sinusoidal histocytosis in the liver of 50% of
the males.
Dermal short-term (1 to
30 days).
Dermal (or oral) study
NOAEL = 300 mg/
kg/day.
UFA = 10x
UFH = 10x
LOC for MOE = 100 ...
Dermal Toxicity Study-Rat.
LOAEL = 1000 mg/kg/day based on reduced body weight gain and
food efficiency.
Dermal intermediateterm (1 to 6 months).
Dermal (or oral) study
NOAEL = 300 mg/
kg/day.
UFA = 10x
UFH = 10x
LOC for MOE = 100 ...
Dermal Toxicity Study—Rat.
LOAEL = 1000 mg/kg/day based on reduced body weight gain and
food efficiency.
Inhalation short-term (1
to 30 days).
Inhalation (or oral)
study NOAEL= 50
mg/kg/day (inhalation absorption rate
= 100%).
UFA = 10x
UFH = 10x
LOC for MOE = 100 ...
Developmental Toxicity Study—Rat.
LOAEL = 250 mg/kg/day based on decreased body weight gain during the gestation period.
Inhalation (1 to 6
months).
Inhalation (or oral)
study NOAEL = 25
mg/kg/day (inhalation absorption rate
= 100%).
UFA = 10x
UFH = 10x
LOC for MOE = 100 ...
Subchronic Study—Dog.
LOAEL = for systemic toxicity = 150 mg/kg/day based on lesions of
the GI tract and hypocellularity of the bone marrow.
Cancer (all routes) .......
A ‘‘not likely’’ human carcinogen.
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LOAEL = lowest observed adverse effect level. LOC = level of concern. MOE = margin of exposure. N/A = not applicable. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c = chronic). POD = Point of Departure = A data or an estimated point
that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to NAA, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
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 the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
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assumed tolerance level residues for all
registered uses, 100% crop treated for
all commodities with existing
tolerances, and default processing
factors.
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 percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for 1-naphthaleneacetic. Tolerance level
residues and/or 100% CT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for NAA in drinking water. These
simulation models take into account
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data on the physical, chemical, and fate/
transport characteristics of 1naphthaleneacetic acid. 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, estimated drinking
water concentrations (EDWCs) of
naphthaleneacetic acetates for peak and
average concentrations of naphthalene
acetates in surface water are 0.02 ppm
and 0.003 ppm respectively. The
modeled peak and average EDWCs for
ground water is 0.00002 ppm.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model.
For chronic dietary risk assessment,
the water concentration of value .003
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ppm 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). There is
a potential for short-term residential
exposure to NAA from ornamental uses.
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 naphthalene
acetates 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 Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is low concern (and no residual
uncertainty) for prenatal and/or
postnasal toxicity resulting from
exposure to the NAA group of
chemicals. The available data provided
no indication of increased susceptibility
(quantitative or qualitative) to rats or
rabbits to in utero exposure to
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naphthalene acetates or to prenatal and
postnatal exposure in rat reproduction
studies.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. Acceptable developmental toxicity
studies in the rat and rabbit, and an
acceptable reproduction study in the rat
are available. Recent changes to 40 CFR
part 158 require acute and subchronic
neurotoxicity and immunotoxicity
studies. An immunotoxicity study is not
available. However, the toxicology data
base for NAA 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. The toxicity database
does not show any indications of
neurotoxicity or neuropathology (the
liver, stomach, lung, and hematological
parameters are the target organs based
on repeat toxicity studies in rats, mice
and dogs).
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.
iv. There are no residual uncertainties
identified in the exposure databases.
EPA made conservative (protective)
assumptions in dietary assessment and
in the ground and surface water
modeling used to assess exposure to
NAA in drinking water. EPA made
conservative (protective) assumptions in
the residential handler assessment. Postapplication exposure to residents is not
expected.
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
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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% of the
cPAD for children 1–2 years old, the
population group receiving the greatest
exposure.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
There is potential for short-term
residential exposure to NAA from
ornamental uses. Oral, dermal and
inhalation exposures cannot be
combined for short-term aggregate risk
assessment, however, because oral
exposure endpoints are not based on
common toxicological effects with
either dermal or inhalation endpoints.
Estimated dermal and inhalation MOEs
for residential exposure to naphthalene
acetates are 3,800 and 58,000
respectively. These estimated exposures
are greater than the target MOE of 100
and therefore not of concern. Although
a POD from an oral study was used to
assess residential handler inhalation
risks for NAA, the Agency does not
believe this assessment is underprotective of adult handlers. Inhalation
MOEs calculated for residential
handlers were all >58,000, thus
providing an ample margin of safety to
account for any uncertainties in routeto-route extrapolation.
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).
Intermediate-term exposure to NAA is
not expected based on residential use
patterns. Therefore, 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,
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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
methodology (HPLC methods (Method
NAA–AM 001 and Method NAA–AM–
002) for determination of NAA in plant
commodities have been submitted and
reviewed. These methods have been
subjected to successful independent
laboratory validations. Acceptable
recoveries were obtained from apples,
olives and olive oil fortified with NAA
at the method limit of quantitation
(LOQ; 0.01 ppm) and at 1.0 ppm.
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
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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 U.N.
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.
No Codex, Canadian, or Mexican
maximum residue limits (MRLs) have
been established for residues of
naphthalene acetates. Therefore, there
are no trade issues with this action.
C. Revisions to Petitioned-for Tolerances
The applicant’s petition requested an
exemption from the requirement of a
tolerance for this seed potato
application but upon review of
submitted information, the Agency
determined that a potato tolerance is
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16:28 May 07, 2012
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needed. In lieu of providing field trial
data, a theoretical calculation was
provided, to show that residues of 1naphthaleneacetic acid on potatoes will
be less than the analytical method’s
level of quantitation (0.01 ppm) when
using the label application rates on
potato seed pieces. The Agency
determined that a tolerance at the level
of quantitation is appropriate and that
an exemption is not appropriate because
some residues below the level of
quantitation may be present and there is
toxicological concern for NAA.
V. Conclusion
Therefore, tolerances are established
for residues of 1-naphthaleneacetic acid
and its conjugates calculated as 1naphthaleneacetic acid from the
application of 1-naphthaleneacetic acid,
its ammonium, sodium, or potassium
salts, ethyl ester, and acetamide in or on
food commodities as follows: in or on
potato at 0.01 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) 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 on the basis of a petition
under section 408(d) of FFDCA, 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,
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Fmt 4700
Sfmt 4700
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) (Pub. L. 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).
VII. 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: April 27, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
E:\FR\FM\08MYR1.SGM
08MYR1
Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Rules and Regulations
adopt or to show evidence of being
already in effect in order to qualify or
■ 1. The authority citation for part 180
remain qualified for participation in the
continues to read as follows:
National Flood Insurance Program
(NFIP).
Authority: 21 U.S.C. 321(q), 346a and 371.
DATES: The date of issuance of the Flood
■ 2. Section 180.155 is amended by
Insurance Rate Map (FIRM) showing
alphabetically adding the following
BFEs and modified BFEs for each
commodity to the table in paragraph (a)
community. This date may be obtained
to read as follows:
by contacting the office where the maps
§ 180.155 1–Naphthaleneacetic acid;
are available for inspection as indicated
tolerances for residues.
in the table below.
(a) * * *
ADDRESSES: The final BFEs for each
community are available for inspection
Parts per
Commodity
at the office of the Chief Executive
million
Officer of each community. The
respective addresses are listed in the
*
*
*
*
*
table below.
FOR FURTHER INFORMATION CONTACT: Luis
Potato .........................................
0.01 Rodriguez, Chief, Engineering
Management Branch, Federal Insurance
*
*
*
*
*
and Mitigation Administration, Federal
Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,
*
*
*
*
*
(202) 646–4064, or (email)
[FR Doc. 2012–11117 Filed 5–7–12; 8:45 am]
Luis.Rodriguez3@fema.dhs.gov.
BILLING CODE 6560–50–P
SUPPLEMENTARY INFORMATION: The
Federal Emergency Management Agency
(FEMA) makes the final determinations
DEPARTMENT OF HOMELAND
listed below for the modified BFEs for
SECURITY
each community listed. These modified
elevations have been published in
Federal Emergency Management
newspapers of local circulation and
Agency
ninety (90) days have elapsed since that
publication. The Deputy Federal
44 CFR Part 67
Insurance and Mitigation Administrator
[Docket ID FEMA–2012–0003]
has resolved any appeals resulting from
this notification.
Final Flood Elevation Determinations
This final rule is issued in accordance
AGENCY: Federal Emergency
with section 110 of the Flood Disaster
Management Agency, DHS.
Protection Act of 1973, 42 U.S.C. 4104,
and 44 CFR part 67. FEMA has
ACTION: Final rule.
developed criteria for floodplain
SUMMARY: Base (1% annual-chance)
management in floodprone areas in
Flood Elevations (BFEs) and modified
accordance with 44 CFR part 60.
BFEs are made final for the
Interested lessees and owners of real
communities listed below. The BFEs
property are encouraged to review the
and modified BFEs are the basis for the
proof Flood Insurance Study and FIRM
floodplain management measures that
available at the address cited below for
each community is required either to
each community.
PART 180—[AMENDED]
mstockstill on DSK4VPTVN1PROD with RULES
Flooding source(s)
The BFEs and modified BFEs are
made final in the communities listed
below. Elevations at selected locations
in each community are shown.
National Environmental Policy Act.
This final rule is categorically excluded
from the requirements of 44 CFR part
10, Environmental Consideration. An
environmental impact assessment has
not been prepared.
Regulatory Flexibility Act. As flood
elevation determinations are not within
the scope of the Regulatory Flexibility
Act, 5 U.S.C. 601–612, a regulatory
flexibility analysis is not required.
Regulatory Classification. This final
rule is not a significant regulatory action
under the criteria of section 3(f) of
Executive Order 12866 of September 30,
1993, Regulatory Planning and Review,
58 FR 51735.
Executive Order 13132, Federalism.
This final rule involves no policies that
have federalism implications under
Executive Order 13132.
Executive Order 12988, Civil Justice
Reform. This final rule meets the
applicable standards of Executive Order
12988.
List of Subjects in 44 CFR Part 67
Administrative practice and
procedure, Flood insurance, Reporting
and recordkeeping requirements.
Accordingly, 44 CFR part 67 is
amended as follows:
PART 67—[AMENDED]
1. The authority citation for part 67
continues to read as follows:
■
Authority: 42 U.S.C. 4001 et seq.;
Reorganization Plan No. 3 of 1978, 3 CFR,
1978 Comp., p. 329; E.O. 12127, 44 FR 19367,
3 CFR, 1979 Comp., p. 376.
§ 67.11
[Amended]
2. The tables published under the
authority of § 67.11 are amended as
follows:
■
* Elevation
in feet
(NGVD)
+ Elevation
in feet
(NAVD)
# Depth in
feet above
ground
∧ Elevation
in meters
(MSL)
Modified
Location of referenced elevation
Communities affected
Benton County, Arkansas, and Incorporated Areas
Docket No.: FEMA–B–1174
Blossom Way Creek ..................
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16:28 May 07, 2012
At the Osage/Turtle Creek confluence .......................................
Approximately 0.4 mile upstream of 1st Street ..........................
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26959
E:\FR\FM\08MYR1.SGM
+1204
+1346
08MYR1
City of Rogers.
]]>Agencies
[Federal Register Volume 77, Number 89 (Tuesday, May 8, 2012)]
[Rules and Regulations]
[Pages 26954-26959]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11117]
[[Page 26954]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2004-0144; FRL-9346-9]
RIN 2070-ZA16
1-Naphthaleneacetic acid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of 1-
naphthaleneacetic acid, potassium and sodium salts in or on potatoes.
Stehekin, LLC petitioned EPA for clearance of use of this pesticide
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 8, 2012. Objections and
requests for hearings must be received on or before July 9, 2012, 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-2004-0144. All documents in the
docket are listed in the docket index available at 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: Rose Mary Kearns, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703)-305-5611; email address:
kearns.rosemary@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 those
engaged in the following activities:
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 to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I 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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced in this document electronically,
please go to https://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''
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-2004-0144 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 9, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2004-0144, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online 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. Summary of Petitioned-for Tolerance
In the Federal Register of September 8, 2010 (75 FR 54629) (FRL-
8843-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a (d)(3), announcing the filing of a pesticide petition (PP
0F7687) by Stehekin, LLC, 1012 Good Lander Drive, Selah, Washington
98942. The petition requested that a tolerance exemption be established
for residues of the fungicide 1-naphthaleneacetic acid (1-
naphthaleneacetamide), on potatoes. That notice referenced a summary of
the petition prepared by Stehekin, LLC, 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 a revised petition which requested a tolerance and
review of the data supporting the petition, EPA has determined that it
is appropriate to establish a tolerance in association with the use of
1-naphthaleneacetic acid (1-naphthaleneacetamide) on potatoes.
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.''
[[Page 26955]]
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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for 1-naphthalneactic acid,
its salts, ester, and acetamide which are collectively referred to as
naphthalene acetates (NAA) including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with NAA 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 are
expected to exhibit similar toxicological effects. Therefore the Agency
concluded that required toxicity testing on any form should serve for
all members of this group of chemicals.
Naphthalene acetates have low acute toxicity via the oral,
inhalation and dermal routes of exposure. 1-Naphthaleneacetic acid is
not a skin irritant or a dermal sensitizer. The 1-naphthaleneacetic
acid and its sodium salt were found to be irritating to the eye.
Repeated exposure oral toxicity studies in rats and dogs resulted in
decreased body weights and body weight gains accompanied by decreased
food consumption.
The major target organs of subchronic and chronic oral exposure
were the liver, stomach and lung. Repeated oral exposure also resulted
in decreased hematocrit and hemoglobin along with reduced RBC count in
rats and dogs and hypocellularity of the bone marrow in dogs.
There was no developmental toxicity at the highest dose of 1-
naphthaleneacetic acid tested in the rat or in the rabbit, but
developmental toxicity (decreased fetal weight and minor skeletal
changes) were seen in rats orally gavaged with the sodium salt.
Reproductive effects of naphthaleneacetic acid sodium salt were
limited to reduced litter survival and pup weight throughout lactation
in both generations of offspring in a 2-generation reproduction study.
Naphthaleneacetic acid and it's 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
mutagenic. Additionally 1-naphthaleneacetic acid was tested for mitotic
gene conversion and dominant lethality in rats and found to be
negative.
Carcinogenicity studies of NAA in mice and in rats for the 1-
naphthaleneacetic acid group showed no evidence of carcinogenicity.
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 the document ``Naphthalene Acetates HED Risk
Assessment for Section 3 Proposed New Use on Potato Seed Pieces'' at
pages 10 through 14 in docket ID number EPA-HQ-OPP-2004-0144.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for 1-naphthaleneaetic
acid used for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for 1-Naphthaleneacetic Acid for Use in Human Health Risk
Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population An acute RfD for the general population subgroups was not selected because no
including infants and children). effect attributable to a single (or few) day(s) oral exposure was observed
in animal studies.
----------------------------------------------------------------------------------------------------------------
[[Page 26956]]
Chronic dietary (All populations) NOAEL = 15 mg/kg/day Chronic RfD = 0.15 Chronic Toxicity--Dog.
UFA = 10x........... mg/kg/day. LOAEL = 75 mg/kg/day based on
UFH = 10x........... cPAD = 0.15 mg/kg/ stomach lesions in 75% of the
day. males and by slight sinusoidal
histocytosis in the liver of 50%
of the males.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days). Dermal (or oral) LOC for MOE = 100.. Dermal Toxicity Study-Rat.
study NOAEL = 300 LOAEL = 1000 mg/kg/day based on
mg/kg/day. reduced body weight gain and food
UFA = 10x........... efficiency.
UFH = 10x...........
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term (1 to 6 Dermal (or oral) LOC for MOE = 100.. Dermal Toxicity Study--Rat.
months). study NOAEL = 300 LOAEL = 1000 mg/kg/day based on
mg/kg/day. reduced body weight gain and food
UFA = 10x........... efficiency.
UFH = 10x...........
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 100.. Developmental Toxicity Study--Rat.
days). study NOAEL= 50 mg/ LOAEL = 250 mg/kg/day based on
kg/day (inhalation decreased body weight gain during
absorption rate = the gestation period.
100%).
UFA = 10x...........
UFH = 10x...........
----------------------------------------------------------------------------------------------------------------
Inhalation (1 to 6 months)....... Inhalation (or oral) LOC for MOE = 100.. Subchronic Study--Dog.
study NOAEL = 25 mg/ LOAEL = for systemic toxicity =
kg/day (inhalation 150 mg/kg/day based on lesions of
absorption rate = the GI tract and hypocellularity
100%). of the bone marrow.
UFA = 10x...........
UFH = 10x...........
----------------------------------------------------------------------------------------------------------------
Cancer (all routes).............. A ``not likely'' human carcinogen.
----------------------------------------------------------------------------------------------------------------
LOAEL = lowest observed adverse effect level. LOC = level of concern. MOE = margin of exposure. N/A = not
applicable. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c = chronic).
POD = Point of Departure = A data or an estimated point that is derived from observed dose-response data and
used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant
human exposures. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
(interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to NAA, EPA considered exposure under the petitioned-for
tolerances as well as all existing 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 the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance
level residues for all registered uses, 100% crop treated for all
commodities with existing tolerances, and default processing factors.
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 percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for 1-naphthaleneacetic. Tolerance level residues
and/or 100% CT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for NAA in drinking water. These simulation models take into
account data on the physical, chemical, and fate/transport
characteristics of 1-naphthaleneacetic acid. 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, estimated
drinking water concentrations (EDWCs) of naphthaleneacetic acetates for
peak and average concentrations of naphthalene acetates in surface
water are 0.02 ppm and 0.003 ppm respectively. The modeled peak and
average EDWCs for ground water is 0.00002 ppm.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
For chronic dietary risk assessment, the water concentration of
value .003
[[Page 26957]]
ppm 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). There is a potential
for short-term residential exposure to NAA from ornamental uses.
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 naphthalene acetates 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 Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There is low concern (and no
residual uncertainty) for prenatal and/or postnasal toxicity resulting
from exposure to the NAA group of chemicals. The available data
provided no indication of increased susceptibility (quantitative or
qualitative) to rats or rabbits to in utero exposure to naphthalene
acetates or to prenatal and postnatal exposure in rat reproduction
studies.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. Acceptable developmental toxicity studies in the rat and rabbit,
and an acceptable reproduction study in the rat are available. Recent
changes to 40 CFR part 158 require acute and subchronic neurotoxicity
and immunotoxicity studies. An immunotoxicity study is not available.
However, the toxicology data base for NAA 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. The toxicity database does not show any indications of
neurotoxicity or neuropathology (the liver, stomach, lung, and
hematological parameters are the target organs based on repeat toxicity
studies in rats, mice and dogs).
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.
iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in dietary
assessment and in the ground and surface water modeling used to assess
exposure to NAA in drinking water. EPA made conservative (protective)
assumptions in the residential handler assessment. Post-application
exposure to residents is not expected.
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% of the cPAD for children 1-2
years old, the population group receiving the greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
There is potential for short-term residential exposure to NAA from
ornamental uses. Oral, dermal and inhalation exposures cannot be
combined for short-term aggregate risk assessment, however, because
oral exposure endpoints are not based on common toxicological effects
with either dermal or inhalation endpoints. Estimated dermal and
inhalation MOEs for residential exposure to naphthalene acetates are
3,800 and 58,000 respectively. These estimated exposures are greater
than the target MOE of 100 and therefore not of concern. Although a POD
from an oral study was used to assess residential handler inhalation
risks for NAA, the Agency does not believe this assessment is under-
protective of adult handlers. Inhalation MOEs calculated for
residential handlers were all >58,000, thus providing an ample margin
of safety to account for any uncertainties in route-to-route
extrapolation.
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).
Intermediate-term exposure to NAA is not expected based on
residential use patterns. Therefore, 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,
[[Page 26958]]
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 methodology (HPLC methods (Method NAA-AM
001 and Method NAA-AM-002) for determination of NAA in plant
commodities have been submitted and reviewed. These methods have been
subjected to successful independent laboratory validations. Acceptable
recoveries were obtained from apples, olives and olive oil fortified
with NAA at the method limit of quantitation (LOQ; 0.01 ppm) and at 1.0
ppm.
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 U.N. 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.
No Codex, Canadian, or Mexican maximum residue limits (MRLs) have
been established for residues of naphthalene acetates. Therefore, there
are no trade issues with this action.
C. Revisions to Petitioned-for Tolerances
The applicant's petition requested an exemption from the
requirement of a tolerance for this seed potato application but upon
review of submitted information, the Agency determined that a potato
tolerance is needed. In lieu of providing field trial data, a
theoretical calculation was provided, to show that residues of 1-
naphthaleneacetic acid on potatoes will be less than the analytical
method's level of quantitation (0.01 ppm) when using the label
application rates on potato seed pieces. The Agency determined that a
tolerance at the level of quantitation is appropriate and that an
exemption is not appropriate because some residues below the level of
quantitation may be present and there is toxicological concern for NAA.
V. Conclusion
Therefore, tolerances are established for residues of 1-
naphthaleneacetic acid and its conjugates calculated as 1-
naphthaleneacetic acid from the application of 1-naphthaleneacetic
acid, its ammonium, sodium, or potassium salts, ethyl ester, and
acetamide in or on food commodities as follows: in or on potato at 0.01
ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) 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 on the basis
of a petition under section 408(d) of FFDCA, 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 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) (Pub. L. 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).
VII. 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: April 27, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 26959]]
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 alphabetically adding the following
commodity to the table in paragraph (a) to read as follows:
Sec. 180.155 1-Naphthaleneacetic acid; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Potato...................................................... 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-11117 Filed 5-7-12; 8:45 am]
BILLING CODE 6560-50-P
