80_FR_68474 80 FR 68261 - Nicosulfuron; Pesticide Tolerances

80 FR 68261 - Nicosulfuron; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

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

Page Range68261-68265
FR Document2015-27887

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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                                             68262            Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations

                                             notice. Submit the non-CBI copy of your                  III. Aggregate Risk Assessment and                       Nicosulfuron showed no
                                             objection or hearing request, identified                 Determination of Safety                               developmental effects in rats, and no
                                             by docket ID number EPA–HQ–OPP–                                                                                adverse effects were observed in the rat
                                             2013–0034, by one of the following                          Section 408(b)(2)(A)(i) of FFDCA                   reproductive study. In the rabbit
                                             methods:                                                 allows EPA to establish a tolerance (the              developmental study, abortions
                                                                                                      legal limit for a pesticide chemical                  occurred at the doses that caused other
                                               • Federal eRulemaking Portal: http://                  residue in or on a food) only if EPA
                                             www.regulations.gov. Follow the online                                                                         maternal toxicity effects. There are no
                                                                                                      determines that the tolerance is ‘‘safe.’’            indications of neurotoxic or
                                             instructions for submitting comments.                    Section 408(b)(2)(A)(ii) of FFDCA                     immunotoxic effects elicited by
                                             Do not submit electronically any                         defines ‘‘safe’’ to mean that ‘‘there is a            nicosulfuron in animal studies; this
                                             information you consider to be CBI or                    reasonable certainty that no harm will                includes recently submitted acute and
                                             other information whose disclosure is                    result from aggregate exposure to the                 subchronic neurotoxicity studies and an
                                             restricted by statute.                                   pesticide chemical residue, including                 immunotoxicity study. There is no
                                               • Mail: OPP Docket, Environmental                      all anticipated dietary exposures and all             evidence of mutagenicity.
                                             Protection Agency Docket Center (EPA/                    other exposures for which there is                       Nicosulfuron is classified as ‘‘Not
                                             DC), (28221T), 1200 Pennsylvania Ave.                    reliable information.’’ This includes                 Likely to be Carcinogenic to Humans’’
                                             NW., Washington, DC 20460–0001.                          exposure through drinking water and in                based on lack of evidence of
                                                                                                      residential settings, but does not include            carcinogenicity in rats and mice studies
                                               • Hand Delivery: To make special
                                                                                                      occupational exposure. Section                        and lack of mutagenic effects in the in
                                             arrangements for hand delivery or
                                                                                                      408(b)(2)(C) of FFDCA requires EPA to                 vitro and in vivo genotoxicity studies.
                                             delivery of boxed information, please
                                                                                                      give special consideration to exposure                   Specific information on the studies
                                             follow the instructions at http://
                                                                                                      of infants and children to the pesticide              received and the nature of the adverse
                                             www.epa.gov/dockets/contacts.html.
                                                                                                      chemical residue in establishing a                    effects caused by nicosulfuron as well as
                                               Additional instructions on                             tolerance and to ‘‘ensure that there is a             the no-observed-adverse-effect-level
                                             commenting or visiting the docket,                       reasonable certainty that no harm will                (NOAEL) and the lowest-observed-
                                             along with more information about                        result to infants and children from                   adverse-effect-level (LOAEL) from the
                                             dockets generally, is available at http://               aggregate exposure to the pesticide                   toxicity studies can be found at http://
                                             www.epa.gov/dockets.                                     chemical residue. . . .’’                             www.regulations.gov in document
                                                                                                         Consistent with FFDCA section                      ‘‘Nicosulfuron: Human Health Risk
                                             II. Summary of Petitioned-For
                                                                                                      408(b)(2)(D), and the factors specified in            Assessment for Proposed Use on ALS
                                             Tolerance
                                                                                                      FFDCA section 408(b)(2)(D), EPA has                   Inhibitor Tolerant Sorghum,’’ pp. 24–27
                                                In the Federal Register of July 19,                   reviewed the available scientific data                in docket ID number EPA–HQ–OPP–
                                             2013 (78 FR 43117) (FRL–9392–9), EPA                     and other relevant information in                     2013–0034.
                                             issued a document pursuant to FFDCA                      support of this action. EPA has                       B. Toxicological Points of Departure/
                                             section 408(d)(3), 21 U.S.C. 346a(d)(3),                 sufficient data to assess the hazards of              Levels of Concern
                                             announcing the filing of a pesticide                     and to make a determination on
                                                                                                                                                               Once a pesticide’s toxicological
                                             petition (PP 2F8132) by E.I. du Pont de                  aggregate exposure for nicosulfuron
                                                                                                                                                            profile is determined, EPA identifies
                                             Nemours and Company, 1007 Market                         including exposure resulting from the                 toxicological points of departure (POD)
                                             Street, Wilmington, DE 19898. The                        tolerances established by this action.                and levels of concern to use in
                                             petition requested that 40 CFR 180.454                   EPA’s assessment of exposures and risks               evaluating the risk posed by human
                                             be amended by establishing tolerances                    associated with nicosulfuron follows.                 exposure to the pesticide. For hazards
                                             for residues of the herbicide                                                                                  that have a threshold below which there
                                                                                                      A. Toxicological Profile
                                             nicosulfuron, 3-pyridinecarboxamide, 2-                                                                        is no appreciable risk, the toxicological
                                             ((((4,6-dimethoxypyrimidin-2-                               EPA has evaluated the available                    POD is used as the basis for derivation
                                             yl)aminocarbonyl)aminosulfonyl))-N,N-                    toxicity data and considered its validity,            of reference values for risk assessment.
                                             dimethyl, in or on sorghum, forage at                    completeness, and reliability as well as              PODs are developed based on a careful
                                             0.4 parts per million (ppm); sorghum,                    the relationship of the results of the                analysis of the doses in each
                                             grain at 0.8 ppm; and sorghum, stover                    studies to human risk. EPA has also                   toxicological study to determine the
                                             at 0.05 ppm. That document referenced                    considered available information                      dose at which no adverse effects are
                                             a summary of the petition prepared by                    concerning the variability of the                     observed (the NOAEL) and the lowest
                                             E.I. du Pont de Nemours and Company,                     sensitivities of major identifiable                   dose at which adverse effects of concern
                                             the registrant, which is available in the                subgroups of consumers, including                     are identified (the LOAEL). Uncertainty/
                                             docket, http://www.regulations.gov.                      infants and children.                                 safety factors are used in conjunction
                                             There were no comments received in                          Nicosulfuron has low acute toxicity                with the POD to calculate a safe
                                             response to the notice of filing.                        by oral, dermal, and inhalation routes of             exposure level—generally referred to as
                                                Based upon review of the data                         exposure. It is moderately irritating to              a population-adjusted dose (PAD) or a
                                             supporting the petition, EPA has revised                 the eye, non-irritating to the skin, and              reference dose (RfD)—and a safe margin
                                             the proposed commodity definitions,                      is not a skin sensitizer. In repeated dose            of exposure (MOE). For non-threshold
                                             revised the proposed tolerance level for                 studies by the oral route, nicosulfuron is            risks, the Agency assumes that any
                                             ‘‘sorghum, grain, forage’’, and corrected                minimally toxic, and rodents are                      amount of exposure will lead to some
                                             the typographical error in the chemical                  particularly insensitive to its effects.              degree of risk. Thus, the Agency
                                             name of nicosulfuron in the tolerance                    Chronic dietary administrations to rats               estimates risk in terms of the probability
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                                             expression. Also, EPA has removed the                    and mice did not produce any adverse                  of an occurrence of the adverse effect
                                             expired emergency exemption                              effects at the highest dose tested (HDT).             expected in a lifetime. For more
                                             tolerances for Bermuda grass, forage and                 Chronic dietary administration to dogs                information on the general principles
                                             Bermuda grass, hay. The reasons for                      produced mild effects (increased                      EPA uses in risk characterization and a
                                             these changes are explained in Unit                      relative liver and kidney weights of                  complete description of the risk
                                             IV.C.                                                    males) at the HDT.                                    assessment process, see http://


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                                                              Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations                                        68263

                                             www.epa.gov/pesticides/factsheets/                         A summary of the toxicological                      human risk assessment is shown in
                                             riskassess.htm.                                          endpoints for nicosulfuron used for                   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
                                                                                               and               RfD, PAD, LOC for
                                                    Exposure/scenario                                                                                       Study and toxicological effects
                                                                                       uncertainty/safety         risk assessment
                                                                                             factors

                                             Chronic dietary (All populations)       NOAEL= 125 mg/kg/          Chronic RfD = 1.25         Chronic oral toxicity—Dog.
                                                                                      day.                        mg/kg/day.               LOAEL = 500 mg/kg/day based on increased relative liver and
                                                                                     UFA = 10x                  cPAD = 1.25 mg/kg/           kidney weights in males.
                                                                                     UFH = 10x                    day                      Supported by rabbit developmental toxicity study (NOAEL =
                                                                                     FQPA SF = 1x                                            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 = ex-
                                             trapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).


                                             C. Exposure Assessment                                      2. Dietary exposure from drinking                  to establish, modify, or revoke a
                                                                                                      water. The Agency used screening-level                tolerance, the Agency consider
                                                1. Dietary exposure from food and
                                                                                                      water exposure models in the dietary                  ‘‘available information’’ concerning the
                                             feed uses. In evaluating dietary
                                                                                                      exposure analysis and risk assessment                 cumulative effects of a particular
                                             exposure to nicosulfuron, EPA
                                                                                                      for nicosulfuron in drinking water.                   pesticide’s residues and ‘‘other
                                             considered exposure under the
                                                                                                      These simulation models take into                     substances that have a common
                                             petitioned-for tolerances as well as all
                                                                                                      account data on the physical, chemical,               mechanism of toxicity.’’
                                             existing nicosulfuron tolerances in 40
                                                                                                      and fate/transport characteristics of                    EPA has not found nicosulfuron to
                                             CFR 180.454. EPA assessed dietary
                                                                                                      nicosulfuron. Further information                     share a common mechanism of toxicity
                                             exposures from nicosulfuron in food as
                                                                                                      regarding EPA drinking water models                   with any other substances, and
                                             follows:
                                                                                                      used in pesticide exposure assessment                 nicosulfuron does not appear to produce
                                                i. Acute exposure. Quantitative acute                 can be found at http://www.epa.gov/                   a toxic metabolite produced by other
                                             dietary exposure and risk assessments                    oppefed1/models/water/index.htm.                      substances. For the purposes of this
                                             are performed for a food-use pesticide,                     Based on the Pesticide Root Zone                   tolerance action, therefore, EPA has
                                             if a toxicological study has indicated the               Model/Exposure Analysis Modeling                      assumed that nicosulfuron does not
                                             possibility of an effect of concern                      System (PRZM/EXAMS) and Pesticide                     have a common mechanism of toxicity
                                             occurring as a result of a 1-day or single               Root Zone Model Ground Water                          with other substances. For information
                                             exposure. No such effects were                           (PRZM–GW), the estimated drinking                     regarding EPA’s efforts to determine
                                             identified in the toxicological studies                  water concentrations (EDWCs) of                       which chemicals have a common
                                             for nicosulfuron; therefore, a                           nicosulfuron for chronic exposures for                mechanism of toxicity and to evaluate
                                             quantitative acute dietary exposure                      non-cancer assessments are estimated to               the cumulative effects of such
                                             assessment is unnecessary.                               be 2.8 ppb for surface water and 19.2                 chemicals, see EPA’s Web site at http://
                                                ii. Chronic exposure. In conducting                   ppb for ground water. Based on the                    www.epa.gov/pesticides/cumulative.
                                             the chronic dietary exposure assessment                  Screening Concentration in Ground
                                             EPA used the food consumption data                                                                             D. Safety Factor for Infants and
                                                                                                      Water (SCI–GROW) model, the EDWC of
                                             from the USDA’s 2003–2008 National                                                                             Children
                                                                                                      nicosulfuron for chronic exposures for
                                             Health and Nutrition Examination                         non-cancer assessments are estimated to                 1. In general. Section 408(b)(2)(C) of
                                             Survey, What We Eat in America                           be 1.42 ppb.                                          FFDCA provides that EPA shall apply
                                             (NHANES/WWEIA). As to residue levels                        Modeled estimates of drinking water                an additional tenfold (10X) margin of
                                             in food, EPA assumed that nicosulfuron                   concentrations were directly entered                  safety for infants and children in the
                                             residues were present at tolerance levels                into the dietary exposure model. For                  case of threshold effects to account for
                                             in all commodities for which tolerances                  chronic dietary risk assessment, the                  prenatal and postnatal toxicity and the
                                             have been established or proposed, and                   water concentration value of 19.2 ppb                 completeness of the database on toxicity
                                             that 100% of those crops were treated                    was used to assess the contribution to                and exposure unless EPA determines
                                             with nicosulfuron.                                       drinking water.                                       based on reliable data that a different
                                                iii. Cancer. Based on the data                           3. From non-dietary exposure. The                  margin of safety will be safe for infants
                                             summarized in Unit III.A., EPA has                       term ‘‘residential exposure’’ is used in              and children. This additional margin of
                                             concluded that nicosulfuron does not                     this document to refer to non-                        safety is commonly referred to as the
                                             pose a cancer risk to humans. Therefore,                 occupational, non-dietary exposure                    FQPA Safety Factor (SF). In applying
                                             a dietary exposure assessment for the                    (e.g., for lawn and garden pest control,              this provision, EPA either retains the
                                             purpose of assessing cancer risk is                      indoor pest control, termiticides, and                default value of 10X, or uses a different
                                             unnecessary.                                             flea and tick control on pets).                       additional safety factor when reliable
                                                iv. Anticipated residue and percent                                                                         data available to EPA support the choice
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                                                                                                      Nicosulfuron is not registered for any
                                             crop treated (PCT) information. EPA did                  specific use patterns that would result               of a different factor.
                                             not use anticipated residue and/or PCT                   in residential exposure.                                2. Prenatal and postnatal sensitivity.
                                             information in the dietary assessment                       4. Cumulative effects from substances              No evidence of increased sensitivity or
                                             for nicosulfuron. Tolerance level                        with a common mechanism of toxicity.                  susceptibility in the developing or
                                             residues and/or 100 PCT were assumed                     Section 408(b)(2)(D)(v) of FFDCA                      young animal was observed in the
                                             for all food commodities.                                requires that, when considering whether               current database. No treatment-related


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                                             68264            Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations

                                             effects were seen for maternal or                        selected. Therefore, nicosulfuron is not              organization in trade agreements to
                                             developmental toxicity up to and                         expected to pose an acute risk.                       which the United States is a party. EPA
                                             including the HDT in the rat prenatal                      2. Chronic risk. Using the exposure                 may establish a tolerance that is
                                             developmental study, and no adverse                      assumptions described in this unit for                different from a Codex MRL; however,
                                             effects were noted in the rat                            chronic exposure, EPA has concluded                   FFDCA section 408(b)(4) requires that
                                             reproductive study. Although increases                   that chronic exposure to nicosulfuron                 EPA explain the reasons for departing
                                             in abortions and post-implantation                       from food and water will utilize <1% of               from the Codex level.
                                             losses were observed in the rabbit                       the cPAD for the general U.S.                            The Codex has not established MRLs
                                             developmental study, those effects                       population and all population                         for nicosulfuron.
                                             occurred at the same doses as other                      subgroups including infants and                       C. Revisions to Petitioned-For
                                             maternal toxicity, indicating that they                  children. There are no residential uses               Tolerances
                                             were a secondary effect of maternal                      for nicosulfuron.
                                             toxicity, rather than a developmental or                   3. Short- and intermediate-term risks.                 The Agency is revising the proposed
                                             reproductive effect.                                     Short- and intermediate-term aggregate                commodity definitions of ‘‘sorghum,
                                                3. Conclusion. EPA has determined                     exposure takes into account short- and                forage’’ to ‘‘sorghum, grain, forage’’;
                                             that reliable data show the safety of                    intermediate-term residential exposure                ‘‘sorghum, grain’’ to ‘‘sorghum, grain,
                                             infants and children would be                            plus chronic exposure to food and water               grain’’; and ‘‘sorghum, stover’’ to
                                             adequately protected if the FQPA SF                      (considered to be a background                        ‘‘sorghum, grain, stover’’ for consistency
                                             were reduced to 1x. That decision is                     exposure level). Because there are no                 with EPA’s Food and Feed Commodity
                                             based on the following findings:                         residential uses, no short- or                        Vocabulary. The proposed tolerance
                                                i. The toxicity database for                          intermediate-term aggregate risk                      level of 0.4 ppm for ‘‘sorghum, forage’’
                                             nicosulfuron is complete.                                assessments were conducted.                           is revised to 0.3 ppm for ‘‘sorghum,
                                                ii. There is no indication that                         4. Aggregate cancer risk for U.S.                   grain, forage’’ based on analysis of the
                                             nicosulfuron is a neurotoxic chemical                    population. Based on the lack of                      residue field trial data using the
                                             and there is no need for a                               evidence of carcinogenicity in two                    Organization for the Economic
                                             developmental neurotoxicity study or                     adequate rodent carcinogenicity studies,              Cooperation and Development’s
                                             additional UFs to account for                            nicosulfuron is not expected to pose a                tolerance calculation procedure. The
                                             neurotoxicity.                                           cancer risk to humans.                                tolerance expression is revised to
                                                iii. There is no evidence that                          5. Determination of safety. Based on                correct the typographical error in the
                                             nicosulfuron results in increased                        these risk assessments, EPA concludes                 chemical name for nicosulfuron.
                                             susceptibility in in utero rats or rabbits               that there is a reasonable certainty that
                                             in the prenatal developmental studies or                                                                       V. Conclusion
                                                                                                      no harm will result to the general
                                             in young rats in the 2-generation                        population, or to infants and children                  Therefore, tolerances are established
                                             reproduction study.                                      from aggregate exposure to nicosulfuron               for residues of nicosulfuron, 2-[[[[(4,6-
                                                iv. There are no residual uncertainties               residues.                                             dimethoxy-2-pyrimidinyl)amino]
                                             identified in the exposure databases.                                                                          carbonyl]amino]sulfonyl]-N,N-dimethyl-
                                             The dietary food exposure assessments                    IV. Other Considerations                              3-pyridinecarboxamide, including its
                                             were performed based on 100 PCT and                      A. Analytical Enforcement Methodology                 metabolites and degradates, in or on
                                             tolerance-level residues. EPA made                                                                             sorghum, grain, forage at 0.3 ppm;
                                             conservative (protective) assumptions in                   Adequate enforcement methodology                    sorghum, grain, grain at 0.8 ppm; and
                                             the ground and surface water modeling                    (Method DuPont-32277, a high                          sorghum, grain, stover at 0.05 ppm.
                                             used to assess exposure to nicosulfuron                  performance liquid chromatography                       In addition, as a housekeeping
                                             in drinking water. These assessments                     with tandem mass spectroscopy (HPLC/                  measure, the Agency is removing the
                                             will not underestimate the exposure and                  MS/MS)) is available to enforce the                   expired emergency exemption
                                             risks posed by nicosulfuron.                             tolerance expression. The method may                  tolerances on ‘‘Bermuda grass, forage’’
                                                                                                      be requested from: Chief, Analytical                  and ‘‘Bermuda grass, hay’’. The
                                             E. Aggregate Risks and Determination of                  Chemistry Branch, Environmental                       tolerances expired on December 31,
                                             Safety                                                   Science Center, 701 Mapes Rd., Ft.                    2011.
                                                EPA determines whether acute and                      Meade, MD 20755–5350; telephone
                                             chronic dietary pesticide exposures are                  number: (410) 305–2905; email address:                VI. Statutory and Executive Order
                                             safe by comparing aggregate exposure                     residuemethods@epa.gov.                               Reviews
                                             estimates to the acute PAD (aPAD) and                                                                            This final rule establishes tolerances
                                                                                                      B. International Residue Limits                       under FFDCA section 408(d) in
                                             chronic PAD (cPAD). For linear cancer
                                             risks, EPA calculates the lifetime                         In making its tolerance decisions, EPA              response to a petition submitted to the
                                             probability of acquiring cancer given the                seeks to harmonize U.S. tolerances with               Agency. The Office of Management and
                                             estimated aggregate exposure. Short-,                    international standards whenever                      Budget (OMB) has exempted these types
                                             intermediate-, and chronic-term risks                    possible, consistent with U.S. food                   of actions from review under Executive
                                             are evaluated by comparing the                           safety standards and agricultural                     Order 12866, entitled ‘‘Regulatory
                                             estimated aggregate food, water, and                     practices. EPA considers the                          Planning and Review’’ (58 FR 51735,
                                             residential exposure to the appropriate                  international maximum residue limits                  October 4, 1993). Because this final rule
                                             PODs to ensure that an adequate MOE                      (MRLs) established by the Codex                       has been exempted from review under
                                             exists.                                                  Alimentarius Commission (Codex), as                   Executive Order 12866, this final rule is
                                                1. Acute risk. An acute aggregate risk                required by FFDCA section 408(b)(4).                  not subject to Executive Order 13211,
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                                             assessment takes into account acute                      The Codex Alimentarius is a joint                     entitled ‘‘Actions Concerning
                                             exposure estimates from dietary                          United Nations Food and Agriculture                   Regulations That Significantly Affect
                                             consumption of food and drinking                         Organization/World Health                             Energy Supply, Distribution, or Use’’ (66
                                             water. No adverse effect resulting from                  Organization food standards program,                  FR 28355, May 22, 2001) or Executive
                                             a single oral exposure was identified                    and it is recognized as an international              Order 13045, entitled ‘‘Protection of
                                             and no acute dietary endpoint was                        food safety standards-setting                         Children from Environmental Health


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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
rmajette on DSK7SPTVN1PROD with RULES




                                             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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 68261 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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