[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07006]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
S-metolachlor; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation amends tolerances for residues of S-
metolachlor in or on corn, field, forage; corn, field, stover; corn,
pop, stover; corn, sweet, forage; and corn, sweet, stover. Syngenta
Crop Protection, LLC, requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 28, 2014. Objections and
requests for hearings must be received on or before May 27, 2014, 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-2012-0926, 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)
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: 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.
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.
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-2012-0926 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
May 27, 2014. 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-2012-0926, 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 January 16, 2013 (78 FR 3377) (FRL-9375-
4), 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
2F8155) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.368 be amended by
revising previously established tolerances for residues of the
herbicide S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-
methoxy-1-methylethyl)acetamide, in or on corn, field, forage at 20
parts per million (ppm); corn, stover at 40 ppm; and corn, sweet,
forage at 40 ppm. These tolerances were proposed in order to amend
tolerances previously established on these commodities at 6.0 ppm. That
document referenced a summary of the petition prepared by Syngenta Crop
Protection, LLC, 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 proposed tolerance level for corn, field, forage and has
corrected the proposed commodity definition, corn stover, to the
following commodity designations: Corn, field, stover; corn, pop,
stover; and corn, sweet, stover. 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 S-metolachlor including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with S-metolachlor
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
The existing toxicological database is primarily comprised of
studies conducted with metolachlor. However, bridging studies indicate
that the metolachlor toxicology database can be used to assess toxicity
for S-metolachlor. In subchronic (metolachlor and S-metolachlor) and
chronic (metolachlor) toxicity studies in dogs and rats, decreased body
body weight gain were the most commonly observed effects. No systemic
toxicity was observed when metolachlor was administered dermally. There
was no evidence of neurotoxic effects in the available toxicity
studies, and there is no evidence of immunotoxicity in the submitted
rat immunotoxicity study. Prenatal developmental studies in the rat and
rabbit with both metolachlor and S-metolachlor revealed no evidence of
a qualitative or quantitative susceptibility in fetal animals. A 2-
generation reproduction study with metolachlor in rats showed no
evidence of parental or reproductive toxicity. There are no residual
uncertainties with regard to pre- and/or postnatal toxicity.
Metolachlor has been evaluated for carcinogenic effects in the
mouse and the rat. Metolachlor did not cause an increase in tumors of
any kind in mice. In rats, metolachlor caused an increase in benign
liver tumors in rats, but this increase was seen only at the highest
dose tested and was statistically significant compared to controls only
in females. There was no evidence of mutagenic or cytogenetic effects
in vivo or in vitro. Based on this evidence, EPA has concluded that
metolachlor does not have a common mechanism of carcinogenicity with
acetochlor and alachlor, compounds that are structurally similar to
metolachlor. Taking into account the qualitatively weak evidence on
carcinogenic effects and the fact that the increase in benign tumors in
female rats occurs at a dose 1,500 times the chronic reference dose
(cRfD), EPA has concluded that the cRfD is protective of any potential
Specific information on the studies received and the nature of the
adverse effects caused by S-metolachlor 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 http://www.regulations.gov in document: ``S-Metolachlor, PP2F8115.
Human Health Risk Assessment for the petition for higher tolerances on
Corn, field, forage; Corn, sweet, forage; and Corn stover'' at pp. 34-
46 in docket ID number EPA-HQ-OPP-2012-0926.
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for S-metolachlor used for human risk assessment is discussed
in Unit III. of the final rule published in the Federal Register of
September 17, 2010 (75 FR 56897, p. 56899) (FRL-8842-3).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to S-metolachlor, EPA considered exposure under the
petitioned-for tolerances as well as all existing S-metolachlor
tolerances in 40 CFR 180.368. Both the acute and chronic analyses
assume tolerance-level residues on all crops with established, pending,
or proposed tolerances for metolachlor and/or S-metolachlor. In cases
where separate tolerance listings occur for both metolachlor and S-
metolachlor on the same commodity, the higher value of the two is used
in the analyses. Therefore, EPA assessed dietary exposures from S-
metolachlor 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. Such effects were identified
for S-metolachlor. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture's (USDA) Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), 1994-1996 and 1998. As to residue levels in food,
EPA assumed tolerance-level residues for all uses, 100 percent crop
treated (PCT) for all commodities, and default processing factors.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's
Nationwide CSFII, 1994-1996 and 1998. As to residue levels in food, EPA
assumed tolerance-level residues for all uses, 100 PCT for all
commodities, and default processing factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a non-linear RfD approach is appropriate for assessing
cancer risk to S-metolachlor. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for S-metolachlor. 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 S-metolachlor in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of S-metolachlor. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST),
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), Screening Concentration in Ground Water (SCI-GROW) models, and
the USGA National Water-Quality Assessment (NAWQA) Program monitoring
data, the Agency calculated conservative estimated drinking water
concentrations (EDWCs) of S-metolachlor and metolachlor originating
from ground water and surface water sources. EDWCs for metolachlor and
S-metolachlor were calculated for both the parent compound, as well as
the ethanesulfonic acid (ESA) and oxanilic acid (OA) degradates.
For surface water, PRZM/EXAMS and FIRST Version1.1.1 models were
used for EDWCs for the parent S-metolachlor and the ESA and OA
degradates, respectively. The SCI-GROW model was used to predict the
maximum acute and chronic concentrations present in shallow
groundwater. Current NAWQA monitoring data were also used to determine
EDWCs. Based on monitoring and modeling data, total EDWCs for acute and
chronic exposures from surface water are 219 parts per billion
(ppb) and 119 ppb, respectively. Groundwater EDWCs are 126 ppb for
acute and chronic exposures for non-cancer assessments.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 219 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 126 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). S-metolachlor is
currently registered for the following uses that could result in
residential exposures: Residential lawns or turf by professional
applicators. S-metolachlor is labeled for use on commercial (sod farm)
and residential warm-season turf grasses and other non-crop land
including golf courses, sports fields, and ornamental gardens. Since S-
metolachlor is not registered for homeowner purchase or use, the only
potential short-term residential risk scenario anticipated is
postapplication hand-to-mouth exposure of children playing on treated
lawns. S-metolachlor incidental oral exposure is assumed to include
hand-to-mouth, object-to-mouth, and incidental soil ingestion
exposures. No intermediate-term risk scenarios are anticipated for the
existing and proposed uses of S-metolachlor.
Small children are the population group of concern. Although the
type of site that S-metolachlor may be used on varies from golf courses
to ornamental gardens, the scenario chosen for risk assessment
(residential turf use) represents what the Agency considers the likely
upper-end of possible exposure. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found S-
metolachlor to share a common mechanism of toxicity with any other
substances, and S-metolachlor does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that S-metolachlor 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 http://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 Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
SF when reliable data available to EPA support the choice of a
2. Prenatal and postnatal sensitivity. No increase in
susceptibility was seen in developmental toxicity studies in the rat
and rabbit or in the reproductive toxicity studies in the rat. Toxicity
to offspring was observed at dose levels the same or greater than those
causing maternal or parental toxicity. Based on the results of
developmental and reproductive toxicity studies, there is not a concern
for increased qualitative and/or quantitative susceptibility following
in utero exposure to metolachlor or S-metolachlor.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
i. The toxicity database for S-metolachlor is complete to evaluate
the safety of the tolerance.
The last rule for S-metolachlor, published in the Federal Register
of August 15, 2012 (77 FR 48902) (FRL-9356-9), noted that
immunotoxicity and acute and subchronic neurotoxicity studies were
required. However, since that time, EPA has reviewed the available
hazard and exposure information for S-metolachlor and metolachlor and
has determined that based on the weight of the evidence approach the
acute and subchronic neurotoxicity studies are no longer required.
Additionally, an immunotoxicity study has been submitted to EPA since
the last published rule. No signs of immunotoxicity were noted in this
study at any dose level.
ii. There is no indication that S-metolachlor is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors to account for neurotoxicity.
iii. There is no evidence that S-metolachlor results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to S-metolachlor in drinking water. EPA used
similarly conservative assumptions to assess postapplication incidental
oral exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by S-metolachlor.
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to S-metolachlor will occupy 1.5% of the aPAD for all infants less than
1 year old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
S-metolachlor from food and water will utilize 11.6% of the cPAD for
all infants less than 1 year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of S-metolachlor is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). S-metolachlor
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to S-metolachlor.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 680 for
children 1-2 years old. Because EPA's level of concern for S-
metolachlor is a MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however, S-
metolachlor is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for S-
5. Aggregate cancer risk for U.S. population. As explained in Unit
III.A., EPA has concluded that the cRfD is protective of cancer
effects. As previously discussed, the chronic risk assessment indicated
that aggregate exposure to S-metolachlor does not pose a risk of
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 S-metolachlor residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies are available to enforce the
tolerance expression, including: a gas chromatography with nitrogen
phosphorous detector (GC/NPD) method (Method I) for determining
residues in or on crop commodities; and a gas chromatography with mass
spectroscopy detector (GC/MSD) method (Method II) for determining
residues in livestock commodities.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
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 MRLs for S-metolachlor.
C. Revisions to Petitioned-For Tolerances
Based on the available forage residue data submitted with the
petition, EPA revised the proposed tolerance on corn, field, forage
from 20 ppm to 40 ppm. The available data indicate that 20 ppm would
not be sufficient to cover likely residues in corn, field, forage at
approved application rates; a tolerance at 40 ppm is supported by the
available residue data. Additionally, the proposed tolerance for corn
stover has been revised to the following commodity entries: Corn,
field, stover; corn, pop, stover; and corn, sweet, stover. This
revision was made in order to accurately capture the correct commodity
terminology for regulated corn stover commodities.
Therefore, tolerances are amended for residues of S-metolachlor, S-
methylethyl)acetamide, from 6.0 ppm to 40 ppm in or on the following
commodities: Corn, field, forage; corn, field, stover; corn, pop,
stover; corn, sweet, forage; and corn, sweet, stover.
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: March 21, 2014.
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. 180.368, revise the following entries in the table in
paragraph (a)(2) to read as follows:
Sec. 180.368 Metolachlor; tolerances for residues.
(a) * * *
(2) * * *
* * * * *
Corn, field, forage..................................... 40
Corn, field, stover..................................... 40
* * * * *
Corn, pop, stover....................................... 40
Corn, sweet, forage..................................... 40
* * * * *
Corn, sweet, stover..................................... 40
* * * * *
* * * * *
[FR Doc. 2014-07006 Filed 3-27-14; 8:45 am]
BILLING CODE 6560-50-P