[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15710]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Ethalfluralin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
ethalfluralin in or on rapeseed subgroup 20A and sunflower subgroup
20B. This regulation additionally removes the established tolerances in
or on mustard, seed; rapeseed, seed; safflower, seed; and sunflower,
seed, as they will be superseded by the tolerances established by this
final rule. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
DATES: This regulation is effective July 3, 2013. Objections and
requests for hearings must be received on or before September 3, 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-2012-0303, is available at http://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 http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; email address: [email protected].
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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://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-2012-0303 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
September 3, 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-2012-0303, by one of
the following methods:
Federal eRulemaking Portal: http://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
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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
2E8007) by IR-4, 500 College Rd. East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.416 be amended by
establishing tolerances for residues of the herbicide ethalfluralin, N-
(trifluoromethyl)benzenamine, in or on rapeseed subgroup 20A and
sunflower subgroup 20B at 0.05 parts per million (ppm). That document
referenced a summary of the petition prepared on behalf of IR-4 by Dow
AgroSciences, the registrant, which is available in the docket, http://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 tolerance expression for all established commodities to be
consistent with current Agency policy. The reason for this change is
explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in 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 ethalfluralin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with ethalfluralin
A. Reliance on Previous Rulemaking Safety Finding and Risk Assessment
In the Federal Register of December 5, 2007 (72 FR 68529) (FRL-
8342-2), EPA published a final rule (2007 rulemaking) establishing
tolerances for residues of the herbicide ethalfluralin, N-ethyl-N-(2-
methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)benzenamine, in or on
dry and fresh dill leaves, mustard seed, potato, and rapeseed, seed at
0.05 ppm, based on EPA's conclusion that aggregate exposure to
ethalfluralin is safe for the general population, including infants and
children. Since 2007, there have been no additional tolerance actions
for ethalfluralin. The toxicity profile of ethalfluralin has not
changed since the 2007 rulemaking.
Except as supplemented by the information described in this unit,
EPA is relying on the risk assessment underlying the 2007 rulemaking to
establish tolerances of ethalfluralin in or on rapeseed subgroup 20A
and sunflower subgroup 20B. Further information about EPA's risk
assessment and determination of safety supporting the 2007 rulemaking
can be found at http://www.regulations.gov in the document entitled:
``Ethalfluralin: Human Health Risk Assessment for (IR-4) Proposed Uses
on Dill and Potato,'' document ID number EPA-HQ-OPP-2005-0195-0003. The
final rule for the 2007 rulemaking can be found in document ID number
EPA-HQ-OPP-2005-0195-0002. Currently, there are tolerances established
for residues of ethalfluralin in or on the representative commodities
of crop subgroups 20A (rapeseed) and 20B (sunflower seed).
These tolerances were based on adequate residue field trial data.
The results of these residue data indicate that no ethalfluralin
residues were detected in or on rapeseed and sunflower; therefore,
tolerances were established at the limit of quantitation (LOQ) of 0.05
ppm for these commodities. Additionally, ethalfluralin tolerances are
established at the LOQ of 0.05 ppm for mustard seed (subgroup 20A) and
safflower seed (subgroup 20B). The ``no detected residues'' finding is
further supported by review of the Pesticide Database Program (PDP),
where no residues of ethalfluralin were found on any crop from 2007 to
2010. Since the proposed use rates for all commodities in crop subgroup
20A and 20B are the same as what is currently permitted for application
to rapeseed and sunflower seed under the existing registrations, the
Agency expects similar ethalfluralin residues to be present on other
commodities in subgroups 20A and 20B.
Moreover, rapeseed and sunflower seed, in addition to safflower
seed, are by far the most consumed commodities in crop subgroups 20A
and 20B; other commodities in crop subgroup 20A and 20B have low rates
of consumption, as
supported by the fact that all members of subgroups 20A and 20B except
sesame, safflower, and mustard are not included in the National Health
and Nutrition Examination Survey/``What We Eat in America'' (NHANES/
WWEIA) dietary survey. EPA does not expect that adding sesame exposures
to the ethalfluralin risk assessment to change the overall risk since
consumption of sesame and exposure to ethalfluralin residues on sesame
are expected to be so minor compared to all the representative crops.
As a result, EPA does not expect the establishment of tolerances for
the rapeseed subgroup 20A and the sunflower subgroup 20B to increase
food exposure from what was assessed in the 2007 risk assessment.
Further, residues from drinking water are not expected to change
from the 2007 risk assessment because the application rate for subgroup
20A and 20B will be the same as the currently registered application
rate for rapeseed and sunflower. As a result, the addition of the new
crops in subgroups 20A and 20B would not change the estimated drinking
water concentrations used in the 2007 risk assessment. In addition,
since the 2007 risk assessment relied on monitoring data for the cancer
assessment, EPA has reviewed the most recent water monitoring data to
ensure that the conclusions of 2007 risk assessment are still valid.
Data from the U.S. Department of Agriculture's (USDA) PDP and U.S.
Geological Survey, National Water-Quality Assessment Program (USGS/
NAWQA) still show that there have been no detectable or very limited
detectable residues of ethalfluralin in sampled drinking water and
surface/ground water. PDP sampled 3,515 samples of drinking water
between 2006 and 2011, and there were no detects at a limit of
detection (LOD) between 30 and 400 parts per trillion (ppt). Likewise,
there has been a very low detection frequency (0.8%) of ethalfluralin
in the USGS/NAWQA monitoring data in the last search. Therefore, the
assumptions in the 2007 risk assessment regarding drinking water are
Since the dietary risk depends on both consumption (which the
Agency does not expect to vary significantly from the 2007 risk
assessment) and residue levels (which the Agency expects to remain the
same as the 2007 risk assessment), the Agency does not expect the risk
from ethalfluralin to change from the 2007 risk assessment.
B. Safety Factor for Infants and Children
1. 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 Food Quality Ptotection Act
(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
2. In the preamble to the 2007 rulemaking, EPA explained the
decision to reduce the FQPA SF to 1X based on reliable data. For this
action, EPA is reducing the FQPA SF to 1X for the following reasons:
a. For the 2007 rulemaking, the toxicity database was considered
complete. However, changes to 40 CFR part 158 since the 2007 rulemaking
imposed new data requirements for immunotoxicity testing and acute and
subchronic neurotoxicity testing for pesticide registration. In 2012,
EPA determined that the acute and subchronic neurotoxicity studies are
not required for ethalfluralin based on a weight-of-evidence approach,
considering all of the available hazard and exposure information.
However, the immunotoxicity study remains a data requirement at this
Although an immunotoxicity study has not been received by the
Agency, there is relatively little concern as there are no indications
of immunotoxicity in the toxicology database; it does not appear that
ethalfluralin directly targets the immune system. Additionally,
ethalfluralin does not belong to a class of chemicals (e.g., the
organotins, heavy metals, halogenated aromatic hydrocarbons) that would
be expected to be immunotoxic. Therefore, the Agency does not believe
that conducting an immunotoxicity study will result in a lower point of
departure (POD) than that currently used for overall risk assessment,
and the 10X FQPA SF (in the form of a database uncertainty factor
(UFDB)) is not needed to account for the lack of the study.
b. EPA has fully evaluated the toxicity database of ethalfluralin
with respect to the potential for special sensitivity of infants and
children, and concludes that there is low concern for pre- and
postnatal susceptibility for infants and children. The FQPA SF has been
reduced to 1X because:
i. The toxicity database is adequate to characterize potential pre-
and postnatal risk for infants and children.
ii. No reproductive or developmental effects were observed in rats.
iii. Although there were slight developmental effects observed
(skeletal malformations) in rabbits (fetuses), they were seen in the
presence of maternal toxicity. Additionally, the dose chosen for acute
dietary risk assessment is protective of the slight developmental
effects observed in the rabbit developmental toxicity studies.
c. Based on the discussion in Unit III.A., EPA does not expect
dietary exposure to ethalfluralin or residues in drinking water to be
Based upon the findings supporting the 2007 rulemaking and the
information discussed in Unit III., EPA concludes that there is a
reasonable certainty that no harm will result to the general
population, and to infants and children, from aggregate exposures to
ethalfluralin residues as a result of establishing the tolerances for
rapeseed subgroup 20A and sunflower subgroup 20B. Refer to the 2007
rulemaking, available at http://www.regulations.gov, for a detailed
discussion of the aggregate risk assessments and determination of
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies, two gas chromatography with
electron capture detection (GC/ECD) methods, are available to enforce
the tolerance expression. These methods are available in the Pesticide
Analytical Manual Volume II, section 180.416.
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 ethalfluralin.
C. Revisions to Petitioned-For Tolerances
The Agency has revised the tolerance expression to clarify:
1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of ethalfluralin not specifically
2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
Therefore, tolerances are established for residues of the herbicide
(trifluoromethyl)-benzenamine, in or on rapeseed subgroup 20A at 0.05
ppm and sunflower subgroup 20B at 0.05 ppm. This regulation
additionally removes established tolerances in or on mustard, seed;
rapeseed, seed; safflower, seed; and sunflower, seed.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: June 21, 2013.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.416:
i. Revise the introductory text of paragraph (a).
ii. Remove the commodities, ``Mustard, seed;'' ``Rapeseed, seed;''
``Safflower, seed;'' and ``Sunflower, seed'' from the table in
iii. Add alphabetically the following commodities to the table in
The amendments read as follows:
Sec. 180.416 Ethalfluralin; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide ethalfluralin, including its metabolites and degradates, in
or on the commodities in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only the residues of ethalfluralin, N-ethyl-N-(2-methyl-2-
* * * * *
Rapeseed subgroup 20A................................... 0.05
* * * * *
Sunflower subgroup 20B.................................. 0.05
* * * * *
* * * * *
[FR Doc. 2013-15710 Filed 7-2-13; 8:45 am]
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