Imazapic; Pesticide Tolerances, 49927-49932 [2013-19867]
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remainder of the rule, EPA may adopt
as final those provisions of the rule that
are not the subject of an adverse
comment.
III. Statutory and Executive Order
Reviews
Under the Clean Air Act, the
Administrator is required to approve a
SIP submission that complies with the
provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP
submissions, EPA’s role is to approve
State choices, provided that they meet
the criteria of the Clean Air Act.
Accordingly, this action merely
approves State law as meeting Federal
requirements and does not impose
additional requirements beyond those
imposed by State law. For that reason,
this action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Order 12866 (58 FR 51735,
October 4, 1993);
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide EPA with the
discretionary authority to address
disproportionate human health or
environmental effects with practical,
appropriate, and legally permissible
methods under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, this rule does not have
tribal implications as specified by
Executive Order 13175 (65 FR 67249,
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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 Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by October 15, 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. Parties with
objections to this direct final rule are
encouraged to file a comment in
response to the parallel notice of
proposed rulemaking for this action
published in the Proposed Rules section
of today’s Federal Register, rather than
file an immediate petition for judicial
review of this direct final rule, so that
EPA can withdraw this direct final rule
and address the comment in the
proposed rulemaking. 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, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements, Volatile
organic compounds.
Dated: July 26, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.
Part 52, Chapter I, Title 40 of the Code
of Federal Regulations is amended as
follows:
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49927
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for Part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart F—California
2. Section 52.220, is amended by
adding paragraphs (c)(70)(i)(B)(1),
(c)(164)(i)(C)(5) and (c)(270)(i)(A)(2) to
read as follows:
■
§ 52.220
Identification of plan.
*
*
*
*
*
(c) * * *
(70) * * *
(i) * * *
(B) * * *
(1) Previously approved on September
2, 1981 in paragraph (c)(70)(i)(B) of this
section and now deleted without
replacement, for the Antelope Valley
area only, Antelope Valley Rule 1101,
previously South Coast Rule 1101.
South Coast Rule 1101 remains in effect
for the South Coast area.
*
*
*
*
*
(164) * * *
(i) * * *
(C) * * *
(5) Previously approved on April 17,
1987 in paragraph (c)(164)(i)(C)(1) of
this section and now deleted without
replacement, Ventura County Rule 67.
*
*
*
*
*
(270) * * *
(i) * * *
(A) * * *
(2) Previously approved on December
13, 1999 in paragraph (c)(270)(i)(A)(1) of
this section and now deleted without
replacement, Ventura County Rule 37.
*
*
*
*
*
[FR Doc. 2013–19872 Filed 8–15–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0384; FRL–9394–8]
Imazapic; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of imazapic in or
on sugarcane, cane. BASF Corporation
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective
August 16, 2013. Objections and
SUMMARY:
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requests for hearings must be received
on or before October 15, 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–2012–0384, 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: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@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).
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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://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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–2012–0384 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 October 15, 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–
2012–0384, 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 July 25,
2012 (77 FR 43562) (FRL–9353–6), 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 2E8021) by BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709. The petition
requested that 40 CFR 180.490 be
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amended by establishing tolerances for
residues of the herbicide imazapic 2[4,5-dihydro-4-methyl-4-(1methylethyl)-5-oxo-1H-imidazol-2-yl]-5methyl-3-pyridinecarboxylic acid in or
on sugarcane at 0.01 parts per million
(ppm). That document referenced a
summary of the petition prepared by
BASF 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 level and the
commodity definition. EPA is also
revising the tolerance expression to
clarify the chemical moieties that are
covered by the tolerances and specify
how compliance will be measured. The
reasons for these changes are 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
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for imazapic
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with imazapic follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
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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.
Imazapic is categorized as having low
acute toxicity by the oral, inhalation,
and dermal routes of exposure. It is
minimally irritating to the eye, nonirritating to the skin, and not a skin
sensitizer.
No evidence of subchronic toxicity
was observed to rodents via the oral or
dermal routes. In the chronic oral
toxicity study in dogs, minimal
degeneration and/or necrosis of the
skeletal muscle of the thigh and/or
abdomen was seen at the lowest dose
tested. At higher doses, additional
effects were seen in the liver (increased
absolute weights and changes in clinical
chemical parameters), kidney
(decreased urinary pH in females), and
erythropoietic system (changes in
hematological parameters, and
microscopic changes in the bone
marrow and spleen). At the high dose,
there was also inflammation in the
esophagus similar to that in skeletal
muscle as well as discoloration of the
lung in both sexes.
In the developmental toxicity study
with rats, no maternal or developmental
toxicity was seen at the limit dose. In
the developmental toxicity study in
rabbits, maternal effects of decreased
body-weight gain and food consumption
were observed at the dose level that did
not result in developmental effects. In
the 2-generation reproduction study in
rats, no parental or reproductive toxicity
was seen at the limit dose. In the battery
of mutagenicity studies, no evidence of
mutagenicity was observed.
Imazapic is classified as a ‘‘Group E’’
chemical (not likely to be a human
carcinogen) by any relevant route of
administration based on the absence of
carcinogenicity seen in rodents.
Since the last risk assessment in 2001,
acute neurotoxicity, subchronic
neurotoxicity, and immunotoxicity
studies were submitted in response to
the 40 CFR part 158 data requirements.
There was no evidence of
immunotoxicity or neurotoxicity
observed in the submitted studies.
In the 2001 risk assessment and in the
Federal Register of December 26, 2001
(66 FR 66325) (FRL–6816–2), a 28-day
inhalation toxicity study was required
due to the potential for repeated handler
inhalation exposure anticipated from
use on pastures and rangeland.
However, EPA concluded in the April
17, 2012 document ‘‘Imazapic:
Summary of Hazard and Science Policy
Council (HASPOC) Meeting of March
15, 2012: Recommendations on the
Requirement of a 28-day Inhalation
Study’’ that based on a weight-ofevidence approach, this study is not
required at this time.
Specific information on the studies
received and the nature of the adverse
effects caused by imazapic as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
‘‘Imazapic. Human-Health Risk
Assessment. Petition for Tolerances for
Use on Soybeans and Sugarcane
Without U.S. Registration,’’ pp. 14–17 in
49929
docket ID number EPA–HQ–OPP–2012–
0384.
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 imazapic used for human
risk assessment is shown in the Table of
this unit.
TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR IMAZAPIC FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure and
uncertainty/safety
factors
RfD, PAD, LOC for risk
assessment
Study and
toxicological
effects
Acute dietary (General population including infants and children; and Females 13–50
years of age).
None .......................................
None .......................................
Chronic dietary (All populations) ......................
LOAEL = 137 mg/kg/day ........
UFA = 10X
UFH = 10X
FQPA SF/UFL = 10X
Chronic RfD = 0.137 mg/kg/
day.
cPAD = 0.137 mg/kg/day .......
No acute dietary endpoint selected based on the absence of an appropriate
endpoint attributed to a single dose.
One-Year Dog Feeding Study
LOAEL = 137 mg/kg/day
based on increased incidence of minimal degeneration and/or necrosis of skeletal muscle.
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Exposure/scenario
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. 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). UFL = use of a LOAEL to extrapolate a NOAEL.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to imazapic, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
imazapic tolerances in 40 CFR 180.490.
EPA assessed dietary exposures from
imazapic 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 imazapic; 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’s 2003–2008 National
Health and Nutrition Examination
Survey, What We Eat in America
(NHANES/WWEIA). As to residue levels
in food, EPA incorporated tolerancelevel residues and 100 percent crop
treated (PCT) for all commodities.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that imazapic 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 imazapic. 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 imazapic in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of imazapic.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the FQPA Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCI–
GROW) models, the estimated drinking
water concentrations (EDWCs) of
imazapic for chronic exposures for noncancer assessments are estimated to be
1.46 ppb for surface water and 13.73
ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
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into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 13.73 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). Imazapic
is not registered for any specific use
patterns that would result in residential
exposure.
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 imazapic to share
a common mechanism of toxicity with
any other substances, and imazapic does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
imazapic 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 no evidence of increased preor postnatal susceptibility based on the
results of the rat and rabbit prenatal
developmental toxicity studies and the
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2-generation reproductive toxicity
study.
3. Conclusion. EPA is retaining the
default 10X FQPA safety factor for all
exposure scenarios due to the use of a
LOAEL to extrapolate a NOAEL for the
POD for the chronic dietary endpoint.
That decision is based on the following
findings:
i. Although all required toxicity
studies have been submitted for
imazapic, the chronic study used for
chronic dietary risk assessment did not
demonstrate a NOAEL, and a LOAEL
was used as an endpoint. Therefore,
EPA is retaining the 10X FQPA safety
factor for use of a LOAEL to extrapolate
a NOAEL.
ii. There is no indication that
imazapic 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 imazapic
results in increased susceptibility in in
utero rats or rabbits in the prenatal
developmental studies or in young rats
in the 2-generation reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The chronic dietary food exposure
assessments were performed based on
100 PCT and tolerance-level residues.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to imazapic in drinking water. These
assessments will not underestimate the
exposure and risks posed by imazapic.
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, imazapic 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 imazapic from
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food and water will utilize 4% of the
cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. There are no residential uses
for imazapic.
3. Short- and intermediate-term risks.
Short- and intermediate-term aggregate
exposure takes into account short- and
intermediate-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). Because there are no
currently registered residential uses, no
short- or intermediate-term aggregate
risk assessments were conducted for
imazapic.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
imazapic 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 imazapic
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(Method SOP–PA.0288, a liquid
chromatography with tandem mass
spectroscopy (LC–MS/MS)) is available
to enforce the tolerance expression. The
method may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address:
residuemethods@epa.gov.
tkelley on DSK3SPTVN1PROD with RULES
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
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EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for imazapic on sugarcane.
C. Revisions to Petitioned-For
Tolerances
EPA revised the proposed commodity
definition of ‘‘sugarcane’’ to reflect the
correct terminology of ‘‘sugarcane,
cane’’ and revised the proposed
tolerance of 0.01 ppm to 0.03 ppm. All
residues (parent plus metabolites) were
below the limit of quantification (LOQ).
The revised tolerance level is based
upon the sum of the LOQs (0.01 + 0.01
+ 0.01 = 0.03 ppm) for each of the three
compounds in the tolerance expression.
In accordance with Agency guidance on
tolerance expressions, the tolerance
expressions for imazapic are revised by
clarifying that the tolerances cover
‘‘residues of imazapic, including its
metabolites and degradates’’.
V. Conclusion
Therefore, tolerances are established
for residues of imazapic, 2-[4,5-dihydro4-methyl-4-(1-methylethyl)-5-oxo-1Himidazol-2-yl]-5-methyl-3pyridinecarboxylic acid and its
metabolites in or on sugarcane, cane at
0.03 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
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
PO 00000
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Fmt 4700
Sfmt 4700
49931
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: August 7, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
E:\FR\FM\16AUR1.SGM
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49932
Federal Register / Vol. 78, No. 159 / Friday, August 16, 2013 / Rules and Regulations
PART 180—[AMENDED]
ENVIRONMENTAL PROTECTION
AGENCY
1. The authority citation for part 180
continues to read as follows:
■
40 CFR Part 180
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Amend § 180.490 as follows:
a. Revise the section heading;
b. Revise the introductory text in
paragraph (a)(1) and add alphabetically
the following commodity to the table;
■ c. Revise the introductory text in
paragraph (a)(2); and
■ d. Revise the heading in paragraph (c).
The amendments read as follows:
tkelley on DSK3SPTVN1PROD with RULES
■
■
■
[EPA–HQ–OPP–2012–0405; FRL–9395–6]
Emamectin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of emamectin
benzoate in or on wine grapes. Syngenta
Crop Protection, LLC, requested this
§ 180.490 Imazapic; tolerances for
residues.
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA). This
(a) General. (1) Tolerances are
established for residues of the herbicide document also makes a technical
correction to the tolerance expression in
imazapic, including its metabolites and
the section.
degradates, in or on the commodities
listed in the following table.
DATES: This regulation is effective
Compliance with the tolerance levels
August 16, 2013. Objections and
specified is to be determined by
requests for hearings must be received
measuring the sum of imazapic (2-[4,5on or before October 15, 2013, and must
dihydro-4-methyl-4-(1-methylethyl)-5be filed in accordance with the
oxo-1H-imidazol-2-yl]-5-methyl-3instructions provided in 40 CFR part
pyridinecarboxylic acid) and its
178 (see also Unit I.C. of the
metabolites (±)-2-[4,5-dihydro-4-methyl- SUPPLEMENTARY INFORMATION).
4-(1-methylethyl)-5-oxo-1H-imidazol-2- ADDRESSES: The docket for this action,
yl]-5-hydroxymethyl-3identified by docket identification (ID)
pyridinecarboxylic acid and (±)-2-[4,5number EPA–HQ–OPP–2012–0405, is
dihydro-4-methyl-4-(1-methylethyl)-5available at https://www.regulations.gov
oxo-1H-imidazol-2-yl]-5-(b-Dor at the Office of Pesticide Programs
glucopyranosyloxy)methyl-3Regulatory Public Docket (OPP Docket)
pyridinecarboxylic acid, calculated as
in the Environmental Protection Agency
the stoichiometric equivalent of
Docket Center (EPA/DC), EPA West
imazapic.
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Parts per
Commodity
Public Reading Room is open from 8:30
million
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
*
*
*
*
*
telephone number for the Public
Sugarcane, cane ..................
0.03 Reading Room is (202) 566–1744, and
the telephone number for the OPP
(2) Tolerances are established for
Docket is (703) 305–5805. Please review
residues of the herbicide imazapic,
the visitor instructions and additional
including its metabolites and
information about the docket available
degradates, in or on the commodities
at https://www.epa.gov/dockets.
listed in the following table.
FOR FURTHER INFORMATION CONTACT: Lois
Compliance with the tolerance levels
Rossi, Registration Division, (7505P),
specified is to be determined by
Office of Pesticide Programs,
measuring the sum of imazapic (2-[4,5Environmental Protection Agency, 1200
dihydro-4-methyl-4-(1-methylethyl)-5Pennsylvania Ave. NW., Washington,
oxo-1H-imidazol-2-yl]-5-methyl-3DC 20460–0001; telephone number:
pyridinecarboxylic acid) and its
(703) 305–7090; email address:
metabolite (±)-2-[4,5-dihydro-4-methylRDFRNotices@epa.gov.
4-(1-methylethyl)-5-oxo-1H-imidazol-2SUPPLEMENTARY INFORMATION:
yl]-5-hydroxymethyl-3pyridinecarboxylic acid, calculated as
I. General Information
the stoichiometric equivalent of
A. Does this action apply to me?
imazapic.
*
*
*
*
*
You may be potentially affected by
(c) Tolerances with regional
this action if you are an agricultural
registrations. [Reserved]
producer, food manufacturer, or
*
*
*
*
*
pesticide manufacturer. The following
[FR Doc. 2013–19867 Filed 8–15–13; 8:45 am]
list of North American Industrial
BILLING CODE 6560–50–P
Classification System (NAICS) codes is
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17:24 Aug 15, 2013
Jkt 229001
SUMMARY:
PO 00000
Frm 00030
Fmt 4700
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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/textidx?&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–2012–0405 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 October 15, 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–
2012–0405, 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.
E:\FR\FM\16AUR1.SGM
16AUR1
]]>Agencies
[Federal Register Volume 78, Number 159 (Friday, August 16, 2013)]
[Rules and Regulations]
[Pages 49927-49932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19867]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0384; FRL-9394-8]
Imazapic; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
imazapic in or on sugarcane, cane. BASF Corporation requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 16, 2013. Objections and
[[Page 49928]]
requests for hearings must be received on or before October 15, 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-2012-0384, 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: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@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-2012-0384 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
October 15, 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-2012-0384, 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 July 25, 2012 (77 FR 43562) (FRL-9353-
6), 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
2E8021) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.490 be amended by
establishing tolerances for residues of the herbicide imazapic 2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-methyl-3-
pyridinecarboxylic acid in or on sugarcane at 0.01 parts per million
(ppm). That document referenced a summary of the petition prepared by
BASF 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 level and the commodity definition. EPA
is also revising the tolerance expression to clarify the chemical
moieties that are covered by the tolerances and specify how compliance
will be measured. The reasons for these changes are 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 FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for imazapic including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with imazapic follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as
[[Page 49929]]
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.
Imazapic is categorized as having low acute toxicity by the oral,
inhalation, and dermal routes of exposure. It is minimally irritating
to the eye, non-irritating to the skin, and not a skin sensitizer.
No evidence of subchronic toxicity was observed to rodents via the
oral or dermal routes. In the chronic oral toxicity study in dogs,
minimal degeneration and/or necrosis of the skeletal muscle of the
thigh and/or abdomen was seen at the lowest dose tested. At higher
doses, additional effects were seen in the liver (increased absolute
weights and changes in clinical chemical parameters), kidney (decreased
urinary pH in females), and erythropoietic system (changes in
hematological parameters, and microscopic changes in the bone marrow
and spleen). At the high dose, there was also inflammation in the
esophagus similar to that in skeletal muscle as well as discoloration
of the lung in both sexes.
In the developmental toxicity study with rats, no maternal or
developmental toxicity was seen at the limit dose. In the developmental
toxicity study in rabbits, maternal effects of decreased body-weight
gain and food consumption were observed at the dose level that did not
result in developmental effects. In the 2-generation reproduction study
in rats, no parental or reproductive toxicity was seen at the limit
dose. In the battery of mutagenicity studies, no evidence of
mutagenicity was observed.
Imazapic is classified as a ``Group E'' chemical (not likely to be
a human carcinogen) by any relevant route of administration based on
the absence of carcinogenicity seen in rodents.
Since the last risk assessment in 2001, acute neurotoxicity,
subchronic neurotoxicity, and immunotoxicity studies were submitted in
response to the 40 CFR part 158 data requirements. There was no
evidence of immunotoxicity or neurotoxicity observed in the submitted
studies.
In the 2001 risk assessment and in the Federal Register of December
26, 2001 (66 FR 66325) (FRL-6816-2), a 28-day inhalation toxicity study
was required due to the potential for repeated handler inhalation
exposure anticipated from use on pastures and rangeland. However, EPA
concluded in the April 17, 2012 document ``Imazapic: Summary of Hazard
and Science Policy Council (HASPOC) Meeting of March 15, 2012:
Recommendations on the Requirement of a 28-day Inhalation Study'' that
based on a weight-of-evidence approach, this study is not required at
this time.
Specific information on the studies received and the nature of the
adverse effects caused by imazapic 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 ``Imazapic. Human-Health Risk
Assessment. Petition for Tolerances for Use on Soybeans and Sugarcane
Without U.S. Registration,'' pp. 14-17 in docket ID number EPA-HQ-OPP-
2012-0384.
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 imazapic used for
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Imazapic for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and
factors assessment toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population None................... None................... No acute dietary
including infants and children; and endpoint selected
Females 13-50 years of age). based on the absence
of an appropriate
endpoint attributed to
a single dose.
Chronic dietary (All populations).... LOAEL = 137 mg/kg/day.. Chronic RfD = 0.137 mg/ One-Year Dog Feeding
UFA = 10X.............. kg/day. Study LOAEL = 137 mg/
UFH = 10X.............. cPAD = 0.137 mg/kg/day. kg/day based on
FQPA SF/UFL = 10X...... increased incidence of
minimal degeneration
and/or necrosis of
skeletal muscle.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. 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). UFL = use of a LOAEL to extrapolate a NOAEL.
[[Page 49930]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to imazapic, EPA considered exposure under the petitioned-for
tolerances as well as all existing imazapic tolerances in 40 CFR
180.490. EPA assessed dietary exposures from imazapic 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 imazapic; 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's 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA incorporated
tolerance-level residues and 100 percent crop treated (PCT) for all
commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that imazapic 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 imazapic. 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 imazapic in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of imazapic. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the FQPA Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of imazapic for chronic
exposures for non-cancer assessments are estimated to be 1.46 ppb for
surface water and 13.73 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 13.73 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). Imazapic is not
registered for any specific use patterns that would result in
residential exposure.
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 imazapic to share a common mechanism of toxicity
with any other substances, and imazapic does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that imazapic 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 no evidence of
increased pre- or postnatal susceptibility based on the results of the
rat and rabbit prenatal developmental toxicity studies and the 2-
generation reproductive toxicity study.
3. Conclusion. EPA is retaining the default 10X FQPA safety factor
for all exposure scenarios due to the use of a LOAEL to extrapolate a
NOAEL for the POD for the chronic dietary endpoint. That decision is
based on the following findings:
i. Although all required toxicity studies have been submitted for
imazapic, the chronic study used for chronic dietary risk assessment
did not demonstrate a NOAEL, and a LOAEL was used as an endpoint.
Therefore, EPA is retaining the 10X FQPA safety factor for use of a
LOAEL to extrapolate a NOAEL.
ii. There is no indication that imazapic 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 imazapic results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessments were performed
based on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to imazapic in drinking water. These assessments
will not underestimate the exposure and risks posed by imazapic.
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,
imazapic 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
imazapic from
[[Page 49931]]
food and water will utilize 4% of the cPAD for children 1-2 years old,
the population group receiving the greatest exposure. There are no
residential uses for imazapic.
3. Short- and intermediate-term risks. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Because there are no
currently registered residential uses, no short- or intermediate-term
aggregate risk assessments were conducted for imazapic.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, imazapic 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 imazapic residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Method SOP-PA.0288, a liquid
chromatography with tandem mass spectroscopy (LC-MS/MS)) is available
to enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
email address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). 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 imazapic on sugarcane.
C. Revisions to Petitioned-For Tolerances
EPA revised the proposed commodity definition of ``sugarcane'' to
reflect the correct terminology of ``sugarcane, cane'' and revised the
proposed tolerance of 0.01 ppm to 0.03 ppm. All residues (parent plus
metabolites) were below the limit of quantification (LOQ). The revised
tolerance level is based upon the sum of the LOQs (0.01 + 0.01 + 0.01 =
0.03 ppm) for each of the three compounds in the tolerance expression.
In accordance with Agency guidance on tolerance expressions, the
tolerance expressions for imazapic are revised by clarifying that the
tolerances cover ``residues of imazapic, including its metabolites and
degradates''.
V. Conclusion
Therefore, tolerances are established for residues of imazapic, 2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
methyl-3-pyridinecarboxylic acid and its metabolites in or on
sugarcane, cane at 0.03 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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: August 7, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 49932]]
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. Amend Sec. 180.490 as follows:
0
a. Revise the section heading;
0
b. Revise the introductory text in paragraph (a)(1) and add
alphabetically the following commodity to the table;
0
c. Revise the introductory text in paragraph (a)(2); and
0
d. Revise the heading in paragraph (c).
The amendments read as follows:
Sec. 180.490 Imazapic; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
herbicide imazapic, including its metabolites and degradates, in or on
the commodities listed in the following table. Compliance with the
tolerance levels specified is to be determined by measuring the sum of
imazapic (2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-
2-yl]-5-methyl-3-pyridinecarboxylic acid) and its metabolites ()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
yl]-5-hydroxymethyl-3-pyridinecarboxylic acid and ()-2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
([beta]-D-glucopyranosyloxy)methyl-3-pyridinecarboxylic acid,
calculated as the stoichiometric equivalent of imazapic.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Sugarcane, cane......................................... 0.03
------------------------------------------------------------------------
(2) Tolerances are established for residues of the herbicide
imazapic, including its metabolites and degradates, in or on the
commodities listed in the following table. Compliance with the
tolerance levels specified is to be determined by measuring the sum of
imazapic (2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-
2-yl]-5-methyl-3-pyridinecarboxylic acid) and its metabolite ()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
yl]-5-hydroxymethyl-3-pyridinecarboxylic acid, calculated as the
stoichiometric equivalent of imazapic.
* * * * *
(c) Tolerances with regional registrations. [Reserved]
* * * * *
[FR Doc. 2013-19867 Filed 8-15-13; 8:45 am]
BILLING CODE 6560-50-P
