80 FR 68261 - Nicosulfuron; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 213 (November 4, 2015)

Page Range		68261-68265
FR Document		2015-27887

This regulation establishes tolerances for residues of nicosulfuron in or on sorghum, grain, forage; sorghum, grain, grain; and sorghum, grain, stover. E.I. du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 80 Issue 213 (Wednesday, November 4, 2015)

[Federal Register Volume 80, Number 213 (Wednesday, November 4, 2015)]
[Rules and Regulations]
[Pages 68261-68265]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-27887]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0034; FRL-9912-40]

Nicosulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
nicosulfuron in or on sorghum, grain, forage; sorghum, grain, grain;
and sorghum, grain, stover. E.I. du Pont de Nemours and Company
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective November 4, 2015. Objections and
requests for hearings must be received on or before January 4, 2016,
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-2013-0034, 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), West William Jefferson Clinton 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: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected]

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 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-2013-0034 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
January 4, 2016. 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

[[Page 68262]]

notice. Submit the non-CBI copy of your objection or hearing request,
identified by docket ID number EPA-HQ-OPP-2013-0034, 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
20460-0001.
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 19, 2013 (78 FR 43117) (FRL-9392-
9), 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
2F8132) by E.I. du Pont de Nemours and Company, 1007 Market Street,
Wilmington, DE 19898. The petition requested that 40 CFR 180.454 be
amended by establishing tolerances for residues of the herbicide
nicosulfuron, 3-pyridinecarboxamide, 2-((((4,6-dimethoxypyrimidin-2-
yl)aminocarbonyl)aminosulfonyl))-N,N-dimethyl, in or on sorghum, forage
at 0.4 parts per million (ppm); sorghum, grain at 0.8 ppm; and sorghum,
stover at 0.05 ppm. That document referenced a summary of the petition
prepared by E.I. du Pont de Nemours and Company, 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 commodity definitions, revised the proposed
tolerance level for ``sorghum, grain, forage'', and corrected the
typographical error in the chemical name of nicosulfuron in the
tolerance expression. Also, EPA has removed the expired emergency
exemption tolerances for Bermuda grass, forage and Bermuda grass, hay.
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 nicosulfuron including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with nicosulfuron follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Nicosulfuron has low acute toxicity by oral, dermal, and inhalation
routes of exposure. It is moderately irritating to the eye, non-
irritating to the skin, and is not a skin sensitizer. In repeated dose
studies by the oral route, nicosulfuron is minimally toxic, and rodents
are particularly insensitive to its effects. Chronic dietary
administrations to rats and mice did not produce any adverse effects at
the highest dose tested (HDT). Chronic dietary administration to dogs
produced mild effects (increased relative liver and kidney weights of
males) at the HDT.
Nicosulfuron showed no developmental effects in rats, and no
adverse effects were observed in the rat reproductive study. In the
rabbit developmental study, abortions occurred at the doses that caused
other maternal toxicity effects. There are no indications of neurotoxic
or immunotoxic effects elicited by nicosulfuron in animal studies; this
includes recently submitted acute and subchronic neurotoxicity studies
and an immunotoxicity study. There is no evidence of mutagenicity.
Nicosulfuron is classified as ``Not Likely to be Carcinogenic to
Humans'' based on lack of evidence of carcinogenicity in rats and mice
studies and lack of mutagenic effects in the in vitro and in vivo
genotoxicity studies.
Specific information on the studies received and the nature of the
adverse effects caused by nicosulfuron 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 ``Nicosulfuron: Human Health Risk
Assessment for Proposed Use on ALS Inhibitor Tolerant Sorghum,'' pp.
24-27 in docket ID number EPA-HQ-OPP-2013-0034.

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://

[[Page 68263]]

www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for nicosulfuron used for
human risk assessment is shown in Table 1 of this unit.

Table 1--Summary of Toxicological Doses and Endpoints for Nicosulfuron for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 125 mg/kg/day Chronic RfD = 1.25 Chronic oral toxicity--Dog.
UFA = 10x........... mg/kg/day. LOAEL = 500 mg/kg/day based on
UFH = 10x........... cPAD = 1.25 mg/kg/ increased relative liver and
FQPA SF = 1x........ day. kidney weights in males.
Supported by rabbit developmental
toxicity study (NOAEL = 100 mg/kg/
day, LOAEL = 500 mg/kg/day).
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. cPAD = chronic population adjusted dose. RfD
= reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to nicosulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing nicosulfuron tolerances in 40
CFR 180.454. EPA assessed dietary exposures from nicosulfuron 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 nicosulfuron; 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 assumed that
nicosulfuron residues were present at tolerance levels in all
commodities for which tolerances have been established or proposed, and
that 100% of those crops were treated with nicosulfuron.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that nicosulfuron does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for nicosulfuron. 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 nicosulfuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of nicosulfuron. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM-
GW), the estimated drinking water concentrations (EDWCs) of
nicosulfuron for chronic exposures for non-cancer assessments are
estimated to be 2.8 ppb for surface water and 19.2 ppb for ground
water. Based on the Screening Concentration in Ground Water (SCI-GROW)
model, the EDWC of nicosulfuron for chronic exposures for non-cancer
assessments are estimated to be 1.42 ppb.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 19.2 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). Nicosulfuron 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 nicosulfuron to share a common mechanism of
toxicity with any other substances, and nicosulfuron does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
nicosulfuron 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 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. No evidence of increased
sensitivity or susceptibility in the developing or young animal was
observed in the current database. No treatment-related

[[Page 68264]]

effects were seen for maternal or developmental toxicity up to and
including the HDT in the rat prenatal developmental study, and no
adverse effects were noted in the rat reproductive study. Although
increases in abortions and post-implantation losses were observed in
the rabbit developmental study, those effects occurred at the same
doses as other maternal toxicity, indicating that they were a secondary
effect of maternal toxicity, rather than a developmental or
reproductive effect.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for nicosulfuron is complete.
ii. There is no indication that nicosulfuron 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 nicosulfuron 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 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 nicosulfuron in drinking water. These assessments
will not underestimate the exposure and risks posed by nicosulfuron.

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,
nicosulfuron 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
nicosulfuron from food and water will utilize <1% of the cPAD for the
general U.S. population and all population subgroups including infants
and children. There are no residential uses for nicosulfuron.
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
residential uses, no short- or intermediate-term aggregate risk
assessments were conducted.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, nicosulfuron is not expected to pose a cancer risk to humans.
5. 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 nicosulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (Method DuPont-32277, a high
performance liquid chromatography with tandem mass spectroscopy (HPLC/
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:
[email protected].

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 nicosulfuron.

C. Revisions to Petitioned-For Tolerances

The Agency is revising the proposed commodity definitions of
``sorghum, forage'' to ``sorghum, grain, forage''; ``sorghum, grain''
to ``sorghum, grain, grain''; and ``sorghum, stover'' to ``sorghum,
grain, stover'' for consistency with EPA's Food and Feed Commodity
Vocabulary. The proposed tolerance level of 0.4 ppm for ``sorghum,
forage'' is revised to 0.3 ppm for ``sorghum, grain, forage'' based on
analysis of the residue field trial data using the Organization for the
Economic Cooperation and Development's tolerance calculation procedure.
The tolerance expression is revised to correct the typographical error
in the chemical name for nicosulfuron.

V. Conclusion

Therefore, tolerances are established for residues of nicosulfuron,
2-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-
dimethyl-3-pyridinecarboxamide, including its metabolites and
degradates, in or on sorghum, grain, forage at 0.3 ppm; sorghum, grain,
grain at 0.8 ppm; and sorghum, grain, stover at 0.05 ppm.
In addition, as a housekeeping measure, the Agency is removing the
expired emergency exemption tolerances on ``Bermuda grass, forage'' and
``Bermuda grass, hay''. The tolerances expired on December 31, 2011.

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

[[Page 68265]]

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: October 21, 2015.
G. Jeffrey Herndon,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec. 180.454, revise paragraph (a) introductory text and add
alphabetically the following commodities to the table and revise
paragraph (b) to read as follows:

Sec. 180.454 Nicosulfuron; tolerances for residues.

(a) General. Tolerances are established for residues of the
herbicide nicosulfuron, 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 nicosulfuron, 2-[[[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]amino]sulfonyl]-N,N-dimethyl-3-
pyridinecarboxamide.

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------

* * * * *
Sorghum, grain, forage..................................... 0.3
Sorghum, grain, grain...................................... 0.8
Sorghum, grain, stover..................................... 0.05
------------------------------------------------------------------------

(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2015-27887 Filed 11-3-15; 8:45 am]
BILLING CODE 6560-50-P

Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 68261

tribes. Thus, the Agency has determined Parts per Environmental Protection Agency, 1200
Commodity
that Executive Order 13132, entitled million Pennsylvania Ave. NW., Washington,
‘‘Federalism’’ (64 FR 43255, August 10, DC 20460–0001; main telephone
1999) and Executive Order 13175, Banana * ............................... 0.10 number: (703) 305–7090; email address:
entitled ‘‘Consultation and Coordination * There is no U.S. registration for use on this RDFRNotices@epa.gov.
with Indian Tribal Governments’’ (65 FR commodity as of November 4, 2015. SUPPLEMENTARY INFORMATION:
67249, November 9, 2000) do not apply (b) Section 18 emergency exemptions. I. General Information
to this action. In addition, this action [Reserved]
does not impose any enforceable duty or (c) Tolerances with regional A. Does this action apply to me?
contain any unfunded mandate as registrations. [Reserved] You may be potentially affected by
described under Title II of the Unfunded (d) Indirect or inadvertent residues this action if you are an agricultural
Mandates Reform Act (UMRA) (2 U.S.C. [Reserved] producer, food manufacturer, or
1501 et seq.).
[FR Doc. 2015–27891 Filed 11–3–15; 8:45 am]
pesticide manufacturer. The following
This action does not involve any list of North American Industrial
BILLING CODE 6560–50–P
technical standards that would require Classification System (NAICS) codes is
Agency consideration of voluntary not intended to be exhaustive, but rather
consensus standards pursuant to section provides a guide to help readers
ENVIRONMENTAL PROTECTION
12(d) of the National Technology determine whether this document
AGENCY
Transfer and Advancement Act applies to them. Potentially affected
(NTTAA) (15 U.S.C. 272 note). 40 CFR Part 180 entities may include:
VII. Congressional Review Act • Crop production (NAICS code 111).
[EPA–HQ–OPP–2013–0034; FRL–9912–40] • Animal production (NAICS code
Pursuant to the Congressional Review 112).
Nicosulfuron; Pesticide Tolerances • Food manufacturing (NAICS code
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and AGENCY: Environmental Protection 311).
other required information to the U.S. Agency (EPA). • Pesticide manufacturing (NAICS
Senate, the U.S. House of ACTION: Final rule. code 32532).
Representatives, and the Comptroller B. How can I get electronic access to
General of the United States prior to SUMMARY: This regulation establishes other related information?
publication of the rule in the Federal tolerances for residues of nicosulfuron
Register. This action is not a ‘‘major in or on sorghum, grain, forage; You may access a frequently updated
rule’’ as defined by 5 U.S.C. 804(2). sorghum, grain, grain; and sorghum, electronic version of EPA’s tolerance
grain, stover. E.I. du Pont de Nemours regulations at 40 CFR part 180 through
List of Subjects in 40 CFR Part 180 and Company requested these the Government Printing Office’s e-CFR
tolerances under the Federal Food, site at http://www.ecfr.gov/cgi-bin/text-
Environmental protection,
Drug, and Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Administrative practice and procedure,
DATES: This regulation is effective
40tab_02.tpl.
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping November 4, 2015. Objections and C. How can I file an objection or hearing
requirements. requests for hearings must be received request?
on or before January 4, 2016, and must
Dated: October 21, 2015. Under FFDCA section 408(g), 21
be filed in accordance with the
Jack E. Housenger, U.S.C. 346a, any person may file an
instructions provided in 40 CFR part
Director, Office of Pesticide Programs. objection to any aspect of this regulation
178 (see also Unit I.C. of the
and may also request a hearing on those
SUPPLEMENTARY INFORMATION).
Therefore, 40 CFR chapter I is objections. You must file your objection
amended as follows: ADDRESSES: The docket for this action, or request a hearing on this regulation
identified by docket identification (ID) in accordance with the instructions
PART 180—[AMENDED] number EPA–HQ–OPP–2013–0034, is provided in 40 CFR part 178. To ensure
available at http://www.regulations.gov proper receipt by EPA, you must
■ 1. The authority citation for part 180 or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
continues to read as follows: Regulatory Public Docket (OPP Docket) OPP–2013–0034 in the subject line on
in the Environmental Protection Agency the first page of your submission. All
Authority: 21 U.S.C. 321(q), 346a and 371. Docket Center (EPA/DC), West William objections and requests for a hearing
■ 2. Add § 180.688 to subpart C to read Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
as follows: Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
20460–0001. The Public Reading Room before January 4, 2016. Addresses for
§ 180.688 Diethofencarb; tolerance for is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections
residue. Monday through Friday, excluding legal and hearing requests are provided in 40
(a) General. (1) Tolerances are holidays. The telephone number for the CFR 178.25(b).
established for residues of the fungicide Public Reading Room is (202) 566–1744, In addition to filing an objection or
diethofencarb, including its metabolites and the telephone number for the OPP hearing request with the Hearing Clerk
and degradates, in or on the Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
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commodities in the table below. the visitor instructions and additional submit a copy of the filing (excluding
Compliance with the tolerance levels information about the docket available any Confidential Business Information
specified below is to be determined by at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
measuring only diethofencarb (1- FOR FURTHER INFORMATION CONTACT: Information not marked confidential
methylethyl N-(3,4- Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be
diethoxyphenyl)carbamate). (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior

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Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 68265

Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major DEPARTMENT OF COMMERCE
April 23, 1997). This final rule does not rule’’ as defined by 5 U.S.C. 804(2).
contain any information collections National Oceanic and Atmospheric
subject to OMB approval under the List of Subjects in 40 CFR Part 180 Administration
Paperwork Reduction Act (PRA) (44 Environmental protection,
U.S.C. 3501 et seq.), nor does it require 50 CFR Part 635
Administrative practice and procedure,
any special considerations under Agricultural commodities, Pesticides [Docket No. 150121066–5717–02]
Executive Order 12898, entitled
and pests, Reporting and recordkeeping
‘‘Federal Actions to Address RIN 0648–XE242
requirements.
Environmental Justice in Minority
Populations and Low-Income Dated: October 21, 2015. Atlantic Highly Migratory Species;
Populations’’ (59 FR 7629, February 16, G. Jeffrey Herndon, Atlantic Bluefin Tuna Fisheries
1994). Director, Registration Division, Office of AGENCY: National Marine Fisheries
Since tolerances and exemptions that Pesticide Programs. Service (NMFS), National Oceanic and
are established on the basis of a petition Atmospheric Administration (NOAA),
under FFDCA section 408(d), such as Therefore, 40 CFR chapter I is
Commerce.
the tolerance in this final rule, do not amended as follows:
ACTION: Temporary rule; inseason quota
require the issuance of a proposed rule,
the requirements of the Regulatory PART 180—[AMENDED] transfer.
Flexibility Act (RFA) (5 U.S.C. 601 et SUMMARY: NMFS is transferring 35
seq.), do not apply. ■ 1. The authority citation for part 180 metric tons (mt) of Atlantic bluefin tuna
This final rule directly regulates continues to read as follows: (BFT) quota from the Harpoon category
growers, food processors, food handlers, Authority: 21 U.S.C. 321(q), 346a and 371. and 65 mt from the Reserve category to
and food retailers, not States or tribes, the General category for the remainder
nor does this action alter the ■ 2. In § 180.454, revise paragraph (a) of the 2015 fishing year. This transfer
relationships or distribution of power introductory text and add alphabetically results in adjusted quotas of 566.7 mt,
and responsibilities established by the following commodities to the table 43.6 mt and 82.1 mt for the General,
Congress in the preemption provisions and revise paragraph (b) to read as Harpoon, and Reserve categories,
of FFDCA section 408(n)(4). As such, follows: respectively. This action is based on
the Agency has determined that this consideration of the regulatory
action will not have a substantial direct § 180.454 Nicosulfuron; tolerances for determination criteria regarding
effect on States or tribal governments, residues.
inseason adjustments and applies to
on the relationship between the national (a) General. Tolerances are Atlantic tunas General category
government and the States or tribal established for residues of the herbicide (commercial) permitted vessels and
governments, or on the distribution of nicosulfuron, including its metabolites Highly Migratory Species (HMS)
power and responsibilities among the and degradates, in or on the Charter/Headboat category permitted
various levels of government or between vessels when fishing commercially for
commodities in the following table.
the Federal Government and Indian BFT.
Compliance with the tolerance levels
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled specified in the following table is to be DATES: Effective October 30, 2015
‘‘Federalism’’ (64 FR 43255, August 10, determined by measuring only through December 31, 2015.
1999) and Executive Order 13175, nicosulfuron, 2-[[[[(4,6-dimethoxy-2- FOR FURTHER INFORMATION CONTACT:
entitled ‘‘Consultation and Coordination pyrimidinyl)amino]carbonyl]amino] Sarah McLaughlin or Brad McHale,
with Indian Tribal Governments’’ (65 FR sulfonyl]-N,N-dimethyl-3-pyridine 978–281–9260.
67249, November 9, 2000) do not apply carboxamide. SUPPLEMENTARY INFORMATION:
to this final rule. In addition, this final Regulations implemented under the
rule does not impose any enforceable Parts per authority of the Atlantic Tunas
Commodity million
duty or contain any unfunded mandate Convention Act (ATCA; 16 U.S.C. 971 et
as described under Title II of the seq.) and the Magnuson-Stevens Fishery
Unfunded Mandates Reform Act of 1995 * * * * * Conservation and Management Act
(UMRA) (2 U.S.C. 1501 et seq.). Sorghum, grain, forage ............. 0.3 (Magnuson-Stevens Act; 16 U.S.C. 1801
This action does not involve any Sorghum, grain, grain ............... 0.8 et seq.) governing the harvest of BFT by
technical standards that would require Sorghum, grain, stover ............. 0.05 persons and vessels subject to U.S.
Agency consideration of voluntary jurisdiction are found at 50 CFR part
consensus standards pursuant to section 635. Section 635.27 subdivides the U.S.
(b) Section 18 emergency exemptions.
12(d) of the National Technology BFT quota recommended by the
[Reserved]
Transfer and Advancement Act of 1995 International Commission for the
(NTTAA) (15 U.S.C. 272 note). * * * * * Conservation of Atlantic Tunas (ICCAT)
[FR Doc. 2015–27887 Filed 11–3–15; 8:45 am] among the various domestic fishing
VII. Congressional Review Act BILLING CODE 6560–50–P categories, per the allocations
Pursuant to the Congressional Review established in the 2006 Consolidated
Act (5 U.S.C. 801 et seq.), EPA will Highly Migratory Species Fishery
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submit a report containing this rule and Management Plan (2006 Consolidated
other required information to the U.S. HMS FMP) (71 FR 58058, October 2,
Senate, the U.S. House of 2006), as amended by the recently
Representatives, and the Comptroller published Amendment 7 to the 2006
General of the United States prior to Consolidated HMS FMP (Amendment 7)
publication of the rule in the Federal (79 FR 71510, December 2, 2014). NMFS

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Document Created: 2018-03-01 11:27:49
Document Modified: 2018-03-01 11:27:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective November 4, 2015. Objections and requests for hearings must be received on or before January 4, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 68261
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements