Nicosulfuron; Pesticide Tolerances, 68261-68265 [2015-27887]
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Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations
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 action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (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
(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.
Jack E. Housenger,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.688 to subpart C to read
as follows:
■
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§ 180.688
residue.
Diethofencarb; tolerance for
(a) General. (1) Tolerances are
established for residues of the fungicide
diethofencarb, including its metabolites
and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only diethofencarb (1methylethyl N-(3,4diethoxyphenyl)carbamate).
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Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
Banana * ...............................
0.10 number: (703) 305–7090; email address:
* There is no U.S. registration for use on this RDFRNotices@epa.gov.
commodity as of November 4, 2015.
SUPPLEMENTARY INFORMATION:
(b) Section 18 emergency exemptions. I. General Information
[Reserved]
A. Does this action apply to me?
(c) Tolerances with regional
registrations. [Reserved]
You may be potentially affected by
(d) Indirect or inadvertent residues
this action if you are an agricultural
[Reserved]
producer, food manufacturer, or
pesticide manufacturer. The following
[FR Doc. 2015–27891 Filed 11–3–15; 8:45 am]
list of North American Industrial
BILLING CODE 6560–50–P
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
ENVIRONMENTAL PROTECTION
determine whether this document
AGENCY
applies to them. Potentially affected
entities may include:
40 CFR Part 180
• Crop production (NAICS code 111).
[EPA–HQ–OPP–2013–0034; FRL–9912–40]
• Animal production (NAICS code
112).
Nicosulfuron; Pesticide Tolerances
• Food manufacturing (NAICS code
311).
AGENCY: Environmental Protection
• Pesticide manufacturing (NAICS
Agency (EPA).
code 32532).
ACTION: Final rule.
Parts per
million
Commodity
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 https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
SUMMARY:
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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
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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: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
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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-2yl)aminocarbonyl)aminosulfonyl))-N,Ndimethyl, 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, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA has revised
the proposed 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.
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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.
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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-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
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 https://
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www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for nicosulfuron used for
68263
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
Exposure/scenario
Chronic dietary (All populations)
Point of departure
and
uncertainty/safety
factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
NOAEL= 125 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 1.25
mg/kg/day.
cPAD = 1.25 mg/kg/
day
Chronic oral toxicity—Dog.
LOAEL = 500 mg/kg/day based on increased relative liver and
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).
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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.
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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 https://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 nonoccupational, 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
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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 https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
No evidence of increased sensitivity or
susceptibility in the developing or
young animal was observed in the
current database. No treatment-related
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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
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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:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
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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-[[[[(4,6dimethoxy-2-pyrimidinyl)amino]
carbonyl]amino]sulfonyl]-N,N-dimethyl3-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
E:\FR\FM\04NOR1.SGM
04NOR1
Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations
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).
rmajette on DSK7SPTVN1PROD with RULES
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
VerDate Sep<11>2014
13:40 Nov 03, 2015
Jkt 238001
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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.454, revise paragraph (a)
introductory text and add alphabetically
the following commodities to the table
and revise paragraph (b) to read as
follows:
■
§ 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-2pyrimidinyl)amino]carbonyl]amino]
sulfonyl]-N,N-dimethyl-3-pyridine
carboxamide.
68265
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 635
[Docket No. 150121066–5717–02]
RIN 0648–XE242
Atlantic Highly Migratory Species;
Atlantic Bluefin Tuna Fisheries
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; inseason quota
transfer.
AGENCY:
NMFS is transferring 35
metric tons (mt) of Atlantic bluefin tuna
(BFT) quota from the Harpoon category
and 65 mt from the Reserve category to
the General category for the remainder
of the 2015 fishing year. This transfer
results in adjusted quotas of 566.7 mt,
43.6 mt and 82.1 mt for the General,
Harpoon, and Reserve categories,
respectively. This action is based on
consideration of the regulatory
determination criteria regarding
inseason adjustments and applies to
Atlantic tunas General category
(commercial) permitted vessels and
Highly Migratory Species (HMS)
Charter/Headboat category permitted
vessels when fishing commercially for
BFT.
SUMMARY:
Effective October 30, 2015
through December 31, 2015.
DATES:
FOR FURTHER INFORMATION CONTACT:
Sarah McLaughlin or Brad McHale,
978–281–9260.
SUPPLEMENTARY INFORMATION:
Regulations implemented under the
Parts per
authority of the Atlantic Tunas
Commodity
million
Convention Act (ATCA; 16 U.S.C. 971 et
seq.) and the Magnuson-Stevens Fishery
Conservation and Management Act
*
*
*
*
*
Sorghum, grain, forage .............
0.3 (Magnuson-Stevens Act; 16 U.S.C. 1801
Sorghum, grain, grain ...............
0.8 et seq.) governing the harvest of BFT by
Sorghum, grain, stover .............
0.05 persons and vessels subject to U.S.
jurisdiction are found at 50 CFR part
635. Section 635.27 subdivides the U.S.
(b) Section 18 emergency exemptions.
BFT quota recommended by the
[Reserved]
International Commission for the
*
*
*
*
*
Conservation of Atlantic Tunas (ICCAT)
[FR Doc. 2015–27887 Filed 11–3–15; 8:45 am]
among the various domestic fishing
BILLING CODE 6560–50–P
categories, per the allocations
established in the 2006 Consolidated
Highly Migratory Species Fishery
Management Plan (2006 Consolidated
HMS FMP) (71 FR 58058, October 2,
2006), as amended by the recently
published Amendment 7 to the 2006
Consolidated HMS FMP (Amendment 7)
(79 FR 71510, December 2, 2014). NMFS
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
E:\FR\FM\04NOR1.SGM
04NOR1
Agencies
[Federal Register Volume 80, Number 213 (Wednesday, November 4, 2015)]
[Rules and Regulations]
[Pages 68261-68265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27887]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), 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 https://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: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-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: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of July 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, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the proposed 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 https://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 https://
[[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 https://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 https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. 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:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established 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