80_FR_55948 80 FR 55768 - Halosulfuron-methyl; Pesticide Tolerances

80 FR 55768 - Halosulfuron-methyl; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 180 (September 17, 2015)

Page Range55768-55773
FR Document2015-23298

This regulation establishes a tolerance for residues of halosulfuron-methyl in or on the pome fruit group 11-10 and a tolerance with regional registration for residues of halosulfuron-methyl in or on the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 80 Issue 180 (Thursday, September 17, 2015)
[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 55768-55773]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23298]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0574; FRL-9933-00]


Halosulfuron-methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
halosulfuron-methyl in or on the pome fruit group 11-10 and a tolerance 
with regional registration for residues of halosulfuron-methyl in or on 
the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 17, 2015. Objections and 
requests for hearings must be received on or before November 16, 2015, 
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-2014-0574, 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

[[Page 55769]]

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-2014-0574 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 
November 16, 2015. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0574, 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 February 11, 2015 (80 FR 7559) (FRL-
9921-94), 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 
4E8297) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, Suite 201 W, 500 College Road East, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.479 be 
amended by establishing tolerances for residues of the herbicide 
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] 
carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, 
including its metabolites and degradates, in or on the raw agricultural 
commodities: Fruit, pome, group 11-10 at 0.05 parts per million (ppm), 
and fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F 
at 0.05 ppm (associated with a regional registration). That document 
referenced a summary of the petition prepared by the Canyon Group, c/o 
Gowan Company, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received on the notice of 
filing.
    Based upon available data, EPA is establishing tolerances as 
requested.

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 halosulfuron-methyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with halosulfuron-
methyl 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.
    With repeated dosing, the available data on halosulfuron-methyl did 
not demonstrate a target organ or tissue in any of the test animals. 
Reduction in body weight was seen in the 90-day and 1-year oral 
toxicity studies in dogs. Reduced body weights were also seen in

[[Page 55770]]

rat studies at higher dose levels than those seen in dogs. An effect on 
the hematological parameters was detected in the dog studies, but the 
magnitude of changes was slight and the effect was considered to be 
marginal. Thus, the slight hematological changes were not considered to 
be adverse.
    In the prenatal developmental toxicity study in rats, increases in 
resorptions, soft tissue (dilation of the lateral ventricles) and 
skeletal variations, and decreases in body weights were seen in the 
fetuses compared to clinical signs and decreases in body weights and 
food consumption in the maternal animals at a similar dose level. In 
the rabbit developmental toxicity study, increases in resorptions and 
post-implantation losses and decreases in mean litter size were 
observed in the presence of decreases in body weight and food 
consumption in maternal animals. The fetal effects seen in 
developmental toxicity studies in rats and rabbits represented a 
qualitative increase in susceptibility. However, a clear no-observed-
adverse-effect-level (NOAEL) for these effects was established in both 
rat and rabbit developmental toxicity studies. No quantitative 
susceptibility was found in studies following pre-and/or post-natal 
exposures. Halosulfuron-methyl did not produce any effects on 
reproductive parameters in the 2-generation reproduction study in rats. 
No neurotoxic effects were observed in the acute or subchronic 
neurotoxicity studies up to 2,000 mg/kg or 760 mg/kg/day, respectively. 
In addition, no adverse effect was found in a 21-day dermal toxicity 
study at doses up to the limit dose (1,000 mg/kg/day).
    Halosulfuron-methyl is negative for mutagenicity in a battery of 
genotoxicity studies and is classified as ``not likely to be 
carcinogenic to humans'' based on lack of evidence for carcinogenicity 
in mice and rats following long-term dietary administration.
    Specific information on the studies received and the nature of the 
adverse effects caused by halosulfuron-methyl as well as the NOAEL and 
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies can be found at http://www.regulations.gov in document 
``Halosulfuron-Methyl. Human Health Risk Assessment for a Proposed Use 
on Pome Fruit Crop Group 11-10 and Small Fruit Vine Climbing Subgroup, 
Except Fuzzy Kiwifruit, Subgroup 13-07F'' at page 28 in docket ID 
number EPA-HQ-OPP-2014-0574.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for halosulfuron used for 
human risk assessment is discussed in Unit III. B. of the final rule 
published in the Federal Register of December 3, 2012 (77 FR 71555) 
(FRL-9370-6). However, there is one change to the prior toxicity 
endpoint and point of departure selections for halosulfuron-methyl 
discussed in the 2012 document. The previous toxicity endpoint for 
dermal exposure assessments was based on the results of a 21-day dermal 
toxicity study, where the no observed effect level (NOEL) and lowest 
observed effect level (LOEL) were established at 100 and 1,000 mg/kg/
day, respectively. The LOEL was based on ``total body weight gains in 
males.'' However, following a reevaluation of this study according to 
the current evaluation standard, there was only 4% reduction in 
absolute body weight in the affected 1,000 mg/kg/day males. This 
reduction was not considered to be adverse and no other adverse effect 
was reported in this study. No LOAEL could be established, and the 
NOAEL was 1,000 mg/kg/day. Based on this re-evaluation, halosulfuron-
methyl did not cause adverse effects at the limit dose (1,000 mg/kg/
day), and no toxicity endpoint could be established for the dermal 
exposure scenario. In addition, no quantitative susceptibility was 
found in studies following pre-and/or post-natal exposures. Hence, no 
dermal exposure assessment was necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to halosulfuron-methyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing halosulfuron-methyl 
tolerances in 40 CFR 180.479. EPA assessed dietary exposures from 
halosulfuron-methyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for halosulfuron-methyl. Exposure and 
risk assessments were conducted using the Dietary Exposure Evaluation 
Model software with the Food Commodity Intake Database (DEEM-FCID). 
This software uses 2003-2008 food consumption data from the United 
States Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA assumed tolerance-level residues and 100 
percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level 
residues and 100 PCT for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that halosulfuron-methyl 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 PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
halosulfuron-methyl. Tolerance-level residues and 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 halosulfuron-methyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport

[[Page 55771]]

characteristics of halosulfuron-methyl. Further information regarding 
EPA drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of halosulfuron-methyl 
for acute exposures are estimated to be 59.2 parts per billion (ppb) 
for surface water and 0.065 ppb for ground water and for chronic 
exposures are estimated to be 59.2 ppb for surface water and 0.065 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 59.2 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 59.2 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).
    Halosulfuron-methyl is currently registered for use by residential 
handlers on residential turf. EPA re-assessed residential exposure for 
aggregate risk assessment reflecting the removal of the dermal POD. EPA 
assessed short-term (1-30 days) exposure to halosulfuron-methyl for 
residential handlers (inhalation exposure) and children 1 to < 2 years 
old (post-application incidental oral exposures).
    The residential exposure scenario used in the adult aggregate 
assessment reflects inhalation exposure from mixing/loading/applying 
halosulfuron-methyl via backpack sprayer or manually pressurized 
handwand to turf.
    The residential exposure scenario used in the children 1 to <2 
years old aggregate assessment reflects hand-to-mouth incidental oral 
exposures from post-application exposure to treated turf.
    Intermediate-term exposures are not likely because of the 
intermittent nature of applications by homeowners.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found halosulfuron-methyl to share a common mechanism 
of toxicity with any other substances, and halosulfuron-methyl does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
halosulfuron-methyl 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. There was no quantitative 
evidence of increased susceptibility following pre- and/or post-natal 
exposure to halosulfuron-methyl. Qualitative susceptibility was seen in 
the prenatal developmental toxicity study in rats and in rabbits; 
however, this qualitative susceptibility was of low concern because (1) 
in both studies, there were clear NOAELs/LOAELs for developmental and 
maternal toxicities; (2) the developmental effects were seen in the 
presence of maternal toxicity; and (3) the effects were only seen at 
the high dose levels. In rats, the developmental effects were seen at a 
dose (750 mg/kg/day) which was approaching the limit-dose (1,000 mg/kg/
day). Furthermore, the PODs for risk assessment are protective of the 
effects which occur at high doses.
    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 halosulfuron-methyl is considered 
complete.
    ii. There is no indication that halosulfuron-methyl is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There was no quantitative evidence of increased susceptibility 
following pre- and/or post-natal exposure and the qualitative 
susceptibility observed in the developmental toxicity studies in rats 
and rabbits was of low concern for the reasons outlined in section 
III.D.2.
    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 halosulfuron-methyl in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
halosulfuron-methyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to halosulfuron-methyl will occupy <1% of the aPAD for females 13-49 
years old, the only population group of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
halosulfuron-methyl from food and water will utilize

[[Page 55772]]

5.7% of the cPAD for children 1-2 years old, the population subgroup 
receiving the greatest exposure. Based on the explanation in Unit 
III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of halosulfuron-methyl is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Halosulfuron-methyl is currently registered for uses that could 
result in short-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term residential exposures to halosulfuron-
methyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 25,000 for adults 
and 1,800 for children 1 to < 2 years old. Because EPA's level of 
concern for halosulfuron-methyl is a MOE of 100 or below, these MOEs 
are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
halosulfuron-methyl is not registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for halosulfuron-methyl.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, halosulfuron-methyl is not expected to pose a cancer risk to 
humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to halosulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC) 
thermionic-specific detection (TSD, nitrogen specific)) 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 a MRL for halosulfuron-methyl for any 
of the crops covered by this Final Rule.

V. Conclusion

    Therefore, a tolerance is established for residues of halosulfuron-
methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] 
carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, 
including its metabolites and degradates, in or on the fruit, pome, 
group 11-10 at 0.05 ppm, and a tolerance with regional registration is 
established for fruit, small vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 0.05 ppm. In addition, the existing tolerance for 
the commodity ``Apple'' in paragraph (a)(2) of Sec.  180.479 is removed 
since it is covered by the newly established fruit, pome, group 11-10 
tolerance.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action 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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary

[[Page 55773]]

consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 4, 2015.
Susan Lewis,
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.  180.479:
0
a. Remove the entry for ``Apple'' from the table in paragraph (a)(2);
0
b. Add alphabetically the entry for ``Fruit, pome, group 11-10'' to the 
table in paragraph (a)(2), and
0
c. Revise paragraph (c).
    The additions and revision read as follows:


Sec.  180.479  Halosulfuron-methyl; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Fruit, pome, group 11-10...................................         0.05
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of the herbicide 
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino]carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, 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 halosulfuron-methyl.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Fruit, small vine climbing, except fuzzy kiwifruit,                 0.05
 subgroup 13-07F...........................................
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-23298 Filed 9-16-15; 8:45 am]
BILLING CODE 6560-50-P



                                            55768            Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations

                                            Documents submitted using that system                    regarding admissibility of evidence and               § 957.16   Official record.
                                            are considered filed as of the date and                  other evidentiary issues, he or she is not              The transcript of testimony together
                                            time (Eastern Time) reflected in the                     bound by those rules. The weight to be                with all pleadings, orders, exhibits,
                                            system. Orders issued by the Hearing                     attached to evidence presented in any                 briefs, and other documents filed in the
                                            Officer shall be considered received by                  particular form will be within the                    proceeding shall constitute the official
                                            the parties on the date posted to the                    discretion of the Hearing Officer, taking             record of the proceeding.
                                            electronic filing system.                                into consideration all the circumstances
                                                                                                     of the particular case. Stipulations of               § 957.17   Public information.
                                            § 957.7    Failure to appear at the hearing.             fact agreed upon by the parties may be                  The Postal Service shall maintain for
                                              If a party fails to appear at the                      accepted as evidence at the hearing. The              public inspection copies of all findings
                                            hearing, the Hearing Officer may                         parties may stipulate the testimony that              of fact issued under this Part, and make
                                            proceed with the hearing, receive                        would be given by a witness if the                    them available through the Postal
                                            evidence and issue findings of fact                      witness were present. The Hearing                     Service Web site. The Recorder
                                            without requirement of further notice to                 Officer may in any case require                       maintains the complete official record of
                                            the absent party.                                        evidence in addition to that offered by               every proceeding.
                                            § 957.8    Hearings.
                                                                                                     the parties. A party requiring the use of             § 957.18   Ex parte communications.
                                                                                                     a foreign language interpreter allowing
                                              Hearings ordinarily will be conducted                  testimony to be taken in English for                    The provisions of 5 U.S.C. 551(14),
                                            in the Judicial Officer Department                       itself or witnesses it proffers is                    556(d), and 557(d) prohibiting ex parte
                                            courtroom at 2101 Wilson Boulevard,                      responsible for making all necessary                  communications are made applicable to
                                            Suite 600, Arlington, VA 22201–3078.                     arrangements and paying all costs and                 proceedings under these rules of
                                            However, the Hearing Officer, in his or                  expenses associated with the use of an                practice.
                                            her discretion, may order the hearing to                 interpreter.                                          Stanley F. Mires,
                                            be conducted at another location, or by
                                                                                                                                                           Attorney, Federal Compliance.
                                            another means such as by video.                          § 957.11    Witness fees.
                                                                                                                                                           [FR Doc. 2015–23314 Filed 9–16–15; 8:45 am]
                                            § 957.9    Appearances.                                    Each party is responsible for the fees
                                                                                                                                                           BILLING CODE 7710–12–P
                                                                                                     and costs for its own witnesses.
                                               (a) An individual Respondent may
                                            appear in his or her own behalf, a                       § 957.12    Transcript.
                                            corporation may appear by an officer                       Testimony and argument at hearings                  ENVIRONMENTAL PROTECTION
                                            thereof, a partnership or joint venture                  shall be reported verbatim, unless the                AGENCY
                                            may appear by a member thereof, or any                   Hearing Officer otherwise orders.
                                            of these may appear by a licensed                        Transcripts of the proceedings will be                40 CFR Part 180
                                            attorney.                                                made available or provided to the                     [EPA–HQ–OPP–2014–0574; FRL–9933–00]
                                               (b) After a request for a hearing has                 parties.
                                            been filed pursuant to the rules in this                                                                       Halosulfuron-methyl; Pesticide
                                            part, the General Counsel shall                          § 957.13    Proposed findings of fact.                Tolerances
                                            designate a licensed attorney as counsel                    (a) The Hearing Officer may direct the
                                            assigned to handle the case.                                                                                   AGENCY:  Environmental Protection
                                                                                                     parties to submit proposed findings of
                                               (c) All counsel, or a self-represented                                                                      Agency (EPA).
                                                                                                     fact and supporting explanations within
                                            Respondent, shall register in the                        15 days after the delivery of the official            ACTION: Final rule.
                                            electronic filing system, and request to                 transcript to the Recorder who shall                  SUMMARY:   This regulation establishes a
                                            be added to the case. Counsel also                       notify both parties of the date of its                tolerance for residues of halosulfuron-
                                            promptly shall file notices of                           receipt. The filing date for proposed                 methyl in or on the pome fruit group
                                            appearance.                                              findings shall be the same for both                   11–10 and a tolerance with regional
                                               (d) An attorney for any party who has                 parties.                                              registration for residues of halosulfuron-
                                            filed a notice of appearance and who                        (b) Proposed findings of fact shall be             methyl in or on the small vine climbing
                                            wishes to withdraw must file a motion                    set forth in numbered paragraphs and                  fruit, except fuzzy kiwifruit, subgroup
                                            requesting withdrawal, explaining the                    shall state with particularity all                    13–07F. Interregional Research Project
                                            reasons supporting the motion, and                       evidentiary facts in the record with                  Number 4 (IR–4) requested these
                                            identifying the name, email address,                     appropriate citations to the transcript or            tolerances under the Federal Food,
                                            mailing address, telephone number, and                   exhibits supporting the proposed                      Drug, and Cosmetic Act (FFDCA).
                                            fax number of the person who will                        findings.
                                            assume responsibility for representation                                                                       DATES: This regulation is effective
                                            of the party in question.                                § 957.14    Findings of fact.                         September 17, 2015. Objections and
                                                                                                       The Hearing Officer shall issue                     requests for hearings must be received
                                            § 957.10    Conduct of the hearing.                      written findings of fact, and transmit                on or before November 16, 2015, and
                                              The Hearing Officer may approve or                     them to the Vice President. Copies will               must be filed in accordance with the
                                            disapprove witnesses in his or her                       be sent to the parties.                               instructions provided in 40 CFR part
                                            discretion. All testimony will be taken                                                                        178 (see also Unit I.C. of the
                                            under oath or affirmation, and subject to                § 957.15    Computation of time.                      SUPPLEMENTARY INFORMATION).
                                            cross-examination. The Hearing Officer                     A designated period of time under the               ADDRESSES: The docket for this action,
                                            may exclude evidence to avoid unfair                     rules in this part excludes the day the               identified by docket identification (ID)
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                                            prejudice, confusion of the issues,                      period begins, and includes the last day              number EPA–HQ–OPP–2014–0574, is
                                            undue delay, waste of time, or                           of the period unless the last day is a                available at http://www.regulations.gov
                                            presentation of irrelevant, immaterial, or               Saturday, Sunday, or legal holiday, in                or at the Office of Pesticide Programs
                                            cumulative evidence. Although the                        which event the period runs until the                 Regulatory Public Docket (OPP Docket)
                                            Hearing Officer will consider the                        close of business on the next business                in the Environmental Protection Agency
                                            Federal Rules of Evidence for guidance                   day.                                                  Docket Center (EPA/DC), West William


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                                                             Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations                                      55769

                                            Jefferson Clinton Bldg., Rm. 3334, 1301                  must be in writing, and must be                       the petition prepared by the Canyon
                                            Constitution Ave. NW., Washington, DC                    received by the Hearing Clerk on or                   Group, c/o Gowan Company, the
                                            20460–0001. The Public Reading Room                      before November 16, 2015. Addresses                   registrant, which is available in the
                                            is open from 8:30 a.m. to 4:30 p.m.,                     for mail and hand delivery of objections              docket, http://www.regulations.gov. No
                                            Monday through Friday, excluding legal                   and hearing requests are provided in 40               comments were received on the notice
                                            holidays. The telephone number for the                   CFR 178.25(b).                                        of filing.
                                            Public Reading Room is (202) 566–1744,                     In addition to filing an objection or                 Based upon available data, EPA is
                                            and the telephone number for the OPP                     hearing request with the Hearing Clerk                establishing tolerances as requested.
                                            Docket is (703) 305–5805. Please review                  as described in 40 CFR part 178, please
                                                                                                                                                           III. Aggregate Risk Assessment and
                                            the visitor instructions and additional                  submit a copy of the filing (excluding
                                                                                                                                                           Determination of Safety
                                            information about the docket available                   any Confidential Business Information
                                            at http://www.epa.gov/dockets.                           (CBI)) for inclusion in the public docket.               Section 408(b)(2)(A)(i) of FFDCA
                                                                                                     Information not marked confidential                   allows EPA to establish a tolerance (the
                                            FOR FURTHER INFORMATION CONTACT:
                                                                                                     pursuant to 40 CFR part 2 may be                      legal limit for a pesticide chemical
                                            Susan Lewis, Registration Division
                                                                                                     disclosed publicly by EPA without prior               residue in or on a food) only if EPA
                                            (7505P), Office of Pesticide Programs,
                                                                                                     notice. Submit the non-CBI copy of your               determines that the tolerance is ‘‘safe.’’
                                            Environmental Protection Agency, 1200                                                                          Section 408(b)(2)(A)(ii) of FFDCA
                                            Pennsylvania Ave. NW., Washington,                       objection or hearing request, identified
                                                                                                     by docket ID number EPA–HQ–OPP–                       defines ‘‘safe’’ to mean that ‘‘there is a
                                            DC 20460–0001; main telephone                                                                                  reasonable certainty that no harm will
                                            number: (703) 305–7090; email address:                   2014–0574, by one of the following
                                                                                                     methods:                                              result from aggregate exposure to the
                                            RDFRNotices@epa.gov.
                                                                                                       • Federal eRulemaking Portal: http://               pesticide chemical residue, including
                                            SUPPLEMENTARY INFORMATION:                               www.regulations.gov. Follow the online                all anticipated dietary exposures and all
                                            I. General Information                                   instructions for submitting comments.                 other exposures for which there is
                                                                                                     Do not submit electronically any                      reliable information.’’ This includes
                                            A. Does this action apply to me?                         information you consider to be CBI or                 exposure through drinking water and in
                                               You may be potentially affected by                    other information whose disclosure is                 residential settings, but does not include
                                            this action if you are an agricultural                   restricted by statute.                                occupational exposure. Section
                                            producer, food manufacturer, or                            • Mail: OPP Docket, Environmental                   408(b)(2)(C) of FFDCA requires EPA to
                                            pesticide manufacturer. The following                    Protection Agency Docket Center (EPA/                 give special consideration to exposure
                                            list of North American Industrial                        DC), (28221T), 1200 Pennsylvania Ave.                 of infants and children to the pesticide
                                            Classification System (NAICS) codes is                   NW., Washington, DC 20460–0001.                       chemical residue in establishing a
                                            not intended to be exhaustive, but rather                  • Hand Delivery: To make special                    tolerance and to ‘‘ensure that there is a
                                            provides a guide to help readers                         arrangements for hand delivery or                     reasonable certainty that no harm will
                                            determine whether this document                          delivery of boxed information, please                 result to infants and children from
                                            applies to them. Potentially affected                    follow the instructions at http://                    aggregate exposure to the pesticide
                                            entities may include:                                    www.epa.gov/dockets/contacts.html.                    chemical residue. . . .’’
                                               • Crop production (NAICS code 111).                   Additional instructions on commenting                    Consistent with FFDCA section
                                               • Animal production (NAICS code                       or visiting the docket, along with more               408(b)(2)(D), and the factors specified in
                                            112).                                                    information about dockets generally, is               FFDCA section 408(b)(2)(D), EPA has
                                               • Food manufacturing (NAICS code                      available at http://www.epa.gov/                      reviewed the available scientific data
                                            311).                                                    dockets.                                              and other relevant information in
                                               • Pesticide manufacturing (NAICS                      II. Summary of Petitioned-For                         support of this action. EPA has
                                            code 32532).                                             Tolerance                                             sufficient data to assess the hazards of
                                                                                                                                                           and to make a determination on
                                            B. How can I get electronic access to                       In the Federal Register of February                aggregate exposure for halosulfuron-
                                            other related information?                               11, 2015 (80 FR 7559) (FRL–9921–94),                  methyl including exposure resulting
                                               You may access a frequently updated                   EPA issued a document pursuant to                     from the tolerances established by this
                                            electronic version of EPA’s tolerance                    FFDCA section 408(d)(3), 21 U.S.C.                    action. EPA’s assessment of exposures
                                            regulations at 40 CFR part 180 through                   346a(d)(3), announcing the filing of a                and risks associated with halosulfuron-
                                            the Government Printing Office’s e-CFR                   pesticide petition (PP 4E8297) by IR–4,               methyl follows.
                                            site at http://www.ecfr.gov/cgi-bin/text-                IR–4 Project Headquarters, Rutgers, The
                                            idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                     State University of New Jersey, Suite                 A. Toxicological Profile
                                            40tab_02.tpl.                                            201 W, 500 College Road East,                           EPA has evaluated the available
                                                                                                     Princeton, NJ 08540. The petition                     toxicity data and considered its validity,
                                            C. How can I file an objection or hearing                requested that 40 CFR 180.479 be                      completeness, and reliability as well as
                                            request?                                                 amended by establishing tolerances for                the relationship of the results of the
                                              Under FFDCA section 408(g), 21                         residues of the herbicide halosulfuron-               studies to human risk. EPA has also
                                            U.S.C. 346a, any person may file an                      methyl, methyl 5-[(4,6-dimethoxy-2-                   considered available information
                                            objection to any aspect of this regulation               pyrimidiny)amino]                                     concerning the variability of the
                                            and may also request a hearing on those                  carbonylaminosulfonyl]-3-chloro-1-                    sensitivities of major identifiable
                                            objections. You must file your objection                 methyl-1H-pyrazole-4-carboxylate,                     subgroups of consumers, including
                                            or request a hearing on this regulation                  including its metabolites and                         infants and children.
                                            in accordance with the instructions                      degradates, in or on the raw agricultural               With repeated dosing, the available
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                                            provided in 40 CFR part 178. To ensure                   commodities: Fruit, pome, group 11–10                 data on halosulfuron-methyl did not
                                            proper receipt by EPA, you must                          at 0.05 parts per million (ppm), and                  demonstrate a target organ or tissue in
                                            identify docket ID number EPA–HQ–                        fruit, small vine climbing, except fuzzy              any of the test animals. Reduction in
                                            OPP–2014–0574 in the subject line on                     kiwifruit, subgroup 13–07F at 0.05 ppm                body weight was seen in the 90-day and
                                            the first page of your submission. All                   (associated with a regional registration).            1-year oral toxicity studies in dogs.
                                            objections and requests for a hearing                    That document referenced a summary of                 Reduced body weights were also seen in


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                                            55770            Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations

                                            rat studies at higher dose levels than                   B. Toxicological Points of Departure/                 mg/kg/day), and no toxicity endpoint
                                            those seen in dogs. An effect on the                     Levels of Concern                                     could be established for the dermal
                                            hematological parameters was detected                       Once a pesticide’s toxicological                   exposure scenario. In addition, no
                                            in the dog studies, but the magnitude of                 profile is determined, EPA identifies                 quantitative susceptibility was found in
                                            changes was slight and the effect was                    toxicological points of departure (POD)               studies following pre-and/or post-natal
                                            considered to be marginal. Thus, the                     and levels of concern to use in                       exposures. Hence, no dermal exposure
                                            slight hematological changes were not                    evaluating the risk posed by human                    assessment was necessary.
                                            considered to be adverse.                                exposure to the pesticide. For hazards                C. Exposure Assessment
                                               In the prenatal developmental toxicity                that have a threshold below which there
                                                                                                                                                              1. Dietary exposure from food and
                                            study in rats, increases in resorptions,                 is no appreciable risk, the toxicological             feed uses. In evaluating dietary
                                            soft tissue (dilation of the lateral                     POD is used as the basis for derivation               exposure to halosulfuron-methyl, EPA
                                            ventricles) and skeletal variations, and                 of reference values for risk assessment.              considered exposure under the
                                                                                                     PODs are developed based on a careful                 petitioned-for tolerances as well as all
                                            decreases in body weights were seen in
                                                                                                     analysis of the doses in each                         existing halosulfuron-methyl tolerances
                                            the fetuses compared to clinical signs
                                                                                                     toxicological study to determine the                  in 40 CFR 180.479. EPA assessed dietary
                                            and decreases in body weights and food                   dose at which no adverse effects are
                                            consumption in the maternal animals at                                                                         exposures from halosulfuron-methyl in
                                                                                                     observed (the NOAEL) and the lowest                   food as follows:
                                            a similar dose level. In the rabbit                      dose at which adverse effects of concern
                                            developmental toxicity study, increases                                                                           i. Acute exposure. Quantitative acute
                                                                                                     are identified (the LOAEL). Uncertainty/              dietary exposure and risk assessments
                                            in resorptions and post-implantation                     safety factors are used in conjunction
                                            losses and decreases in mean litter size                                                                       are performed for a food-use pesticide,
                                                                                                     with the POD to calculate a safe                      if a toxicological study has indicated the
                                            were observed in the presence of                         exposure level—generally referred to as               possibility of an effect of concern
                                            decreases in body weight and food                        a population-adjusted dose (PAD) or a                 occurring as a result of a 1-day or single
                                            consumption in maternal animals. The                     reference dose (RfD)—and a safe margin                exposure.
                                            fetal effects seen in developmental                      of exposure (MOE). For non-threshold                     Such effects were identified for
                                            toxicity studies in rats and rabbits                     risks, the Agency assumes that any                    halosulfuron-methyl. Exposure and risk
                                            represented a qualitative increase in                    amount of exposure will lead to some                  assessments were conducted using the
                                            susceptibility. However, a clear no-                     degree of risk. Thus, the Agency                      Dietary Exposure Evaluation Model
                                            observed-adverse-effect-level (NOAEL)                    estimates risk in terms of the probability            software with the Food Commodity
                                            for these effects was established in both                of an occurrence of the adverse effect                Intake Database (DEEM–FCID). This
                                            rat and rabbit developmental toxicity                    expected in a lifetime. For more                      software uses 2003–2008 food
                                            studies. No quantitative susceptibility                  information on the general principles                 consumption data from the United
                                            was found in studies following pre-and/                  EPA uses in risk characterization and a               States Department of Agriculture’s
                                            or post-natal exposures. Halosulfuron-                   complete description of the risk                      (USDA’s) National Health and Nutrition
                                            methyl did not produce any effects on                    assessment process, see http://                       Examination Survey, What We Eat in
                                            reproductive parameters in the 2-                        www.epa.gov/pesticides/factsheets/                    America (NHANES/WWEIA). As to
                                            generation reproduction study in rats.                   riskassess.htm.                                       residue levels in food, EPA assumed
                                                                                                        A summary of the toxicological                     tolerance-level residues and 100 percent
                                            No neurotoxic effects were observed in
                                                                                                     endpoints for halosulfuron used for                   crop treated (PCT) for all commodities.
                                            the acute or subchronic neurotoxicity                    human risk assessment is discussed in
                                            studies up to 2,000 mg/kg or 760 mg/kg/                                                                           ii. Chronic exposure. In conducting
                                                                                                     Unit III. B. of the final rule published in           the chronic dietary exposure assessment
                                            day, respectively. In addition, no                       the Federal Register of December 3,                   EPA used the food consumption data
                                            adverse effect was found in a 21-day                     2012 (77 FR 71555) (FRL–9370–6).                      from the USDA NHANES/WWEIA. As
                                            dermal toxicity study at doses up to the                 However, there is one change to the                   to residue levels in food, EPA assumed
                                            limit dose (1,000 mg/kg/day).                            prior toxicity endpoint and point of                  tolerance-level residues and 100 PCT for
                                               Halosulfuron-methyl is negative for                   departure selections for halosulfuron-                all commodities.
                                            mutagenicity in a battery of genotoxicity                methyl discussed in the 2012 document.                   iii. Cancer. Based on the data
                                            studies and is classified as ‘‘not likely                The previous toxicity endpoint for                    summarized in Unit III.A., EPA has
                                            to be carcinogenic to humans’’ based on                  dermal exposure assessments was based                 concluded that halosulfuron-methyl
                                            lack of evidence for carcinogenicity in                  on the results of a 21-day dermal                     does not pose a cancer risk to humans.
                                            mice and rats following long-term                        toxicity study, where the no observed                 Therefore, a dietary exposure
                                            dietary administration.                                  effect level (NOEL) and lowest observed               assessment for the purpose of assessing
                                                                                                     effect level (LOEL) were established at               cancer risk is unnecessary.
                                               Specific information on the studies                   100 and 1,000 mg/kg/day, respectively.                   iv. Anticipated residue and PCT
                                            received and the nature of the adverse                   The LOEL was based on ‘‘total body                    information. EPA did not use
                                            effects caused by halosulfuron-methyl                    weight gains in males.’’ However,                     anticipated residue or PCT information
                                            as well as the NOAEL and the lowest-                     following a reevaluation of this study                in the dietary assessment for
                                            observed-adverse-effect-level (LOAEL)                    according to the current evaluation                   halosulfuron-methyl. Tolerance-level
                                            from the toxicity studies can be found                   standard, there was only 4% reduction                 residues and 100 PCT were assumed for
                                            at http://www.regulations.gov in                         in absolute body weight in the affected               all food commodities.
                                            document ‘‘Halosulfuron-Methyl.                          1,000 mg/kg/day males. This reduction                    2. Dietary exposure from drinking
                                            Human Health Risk Assessment for a                       was not considered to be adverse and no               water. The Agency used screening level
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                                            Proposed Use on Pome Fruit Crop                          other adverse effect was reported in this             water exposure models in the dietary
                                            Group 11–10 and Small Fruit Vine                         study. No LOAEL could be established,                 exposure analysis and risk assessment
                                            Climbing Subgroup, Except Fuzzy                          and the NOAEL was 1,000 mg/kg/day.                    for halosulfuron-methyl in drinking
                                            Kiwifruit, Subgroup 13–07F’’ at page 28                  Based on this re-evaluation,                          water. These simulation models take
                                            in docket ID number EPA–HQ–OPP–                          halosulfuron-methyl did not cause                     into account data on the physical,
                                            2014–0574.                                               adverse effects at the limit dose (1,000              chemical, and fate/transport


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                                                             Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations                                      55771

                                            characteristics of halosulfuron-methyl.                  Section 408(b)(2)(D)(v) of FFDCA                      protective of the effects which occur at
                                            Further information regarding EPA                        requires that, when considering whether               high doses.
                                            drinking water models used in pesticide                  to establish, modify, or revoke a                        3. Conclusion. EPA has determined
                                            exposure assessment can be found at                      tolerance, the Agency consider                        that reliable data show the safety of
                                            http://www.epa.gov/oppefed1/models/                      ‘‘available information’’ concerning the              infants and children would be
                                            water/index.htm.                                         cumulative effects of a particular                    adequately protected if the FQPA SF
                                               Based on the First Index Reservoir                    pesticide’s residues and ‘‘other                      were reduced to 1x. That decision is
                                            Screening Tool (FIRST) and Screening                     substances that have a common                         based on the following findings:
                                            Concentration in Ground Water (SCI–                      mechanism of toxicity.’’                                 i. The toxicity database for
                                            GROW) models, the estimated drinking                        EPA has not found halosulfuron-                    halosulfuron-methyl is considered
                                            water concentrations (EDWCs) of                          methyl to share a common mechanism                    complete.
                                            halosulfuron-methyl for acute exposures                  of toxicity with any other substances,                   ii. There is no indication that
                                            are estimated to be 59.2 parts per billion               and halosulfuron-methyl does not                      halosulfuron-methyl is a neurotoxic
                                            (ppb) for surface water and 0.065 ppb                    appear to produce a toxic metabolite                  chemical and there is no need for a
                                            for ground water and for chronic                         produced by other substances. For the                 developmental neurotoxicity study or
                                            exposures are estimated to be 59.2 ppb                   purposes of this tolerance action,                    additional UFs to account for
                                            for surface water and 0.065 ppb for                      therefore, EPA has assumed that                       neurotoxicity.
                                            ground water.                                                                                                     iii. There was no quantitative
                                                                                                     halosulfuron-methyl does not have a
                                               Modeled estimates of drinking water                                                                         evidence of increased susceptibility
                                                                                                     common mechanism of toxicity with
                                            concentrations were directly entered                                                                           following pre- and/or post-natal
                                                                                                     other substances. For information
                                            into the dietary exposure model. For                                                                           exposure and the qualitative
                                                                                                     regarding EPA’s efforts to determine
                                            acute dietary risk assessment, the water                                                                       susceptibility observed in the
                                                                                                     which chemicals have a common
                                            concentration value of 59.2 ppb was                                                                            developmental toxicity studies in rats
                                                                                                     mechanism of toxicity and to evaluate
                                            used to assess the contribution to                                                                             and rabbits was of low concern for the
                                                                                                     the cumulative effects of such
                                            drinking water. For chronic dietary risk                                                                       reasons outlined in section III.D.2.
                                                                                                     chemicals, see EPA’s Web site at
                                            assessment, the water concentration of                                                                            iv. There are no residual uncertainties
                                                                                                     http://www.epa.gov/pesticides/
                                            value 59.2 ppb was used to assess the                                                                          identified in the exposure databases.
                                                                                                     cumulative.
                                            contribution to drinking water.                                                                                The dietary food exposure assessments
                                               3. From non-dietary exposure. The                     D. Safety Factor for Infants and                      were performed based on 100 PCT and
                                            term ‘‘residential exposure’’ is used in                 Children                                              tolerance-level residues. EPA made
                                            this document to refer to non-                                                                                 conservative (protective) assumptions in
                                                                                                        1. In general. Section 408(b)(2)(C) of
                                            occupational, non-dietary exposure                                                                             the ground and surface water modeling
                                                                                                     FFDCA provides that EPA shall apply
                                            (e.g., for lawn and garden pest control,                                                                       used to assess exposure to halosulfuron-
                                                                                                     an additional tenfold (10X) margin of
                                            indoor pest control, termiticides, and                                                                         methyl in drinking water. EPA used
                                                                                                     safety for infants and children in the
                                            flea and tick control on pets).                                                                                similarly conservative assumptions to
                                                                                                     case of threshold effects to account for
                                               Halosulfuron-methyl is currently                                                                            assess post-application exposure of
                                                                                                     prenatal and postnatal toxicity and the
                                            registered for use by residential                                                                              children as well as incidental oral
                                                                                                     completeness of the database on toxicity
                                            handlers on residential turf. EPA re-                                                                          exposure of toddlers. These assessments
                                                                                                     and exposure unless EPA determines
                                            assessed residential exposure for                                                                              will not underestimate the exposure and
                                                                                                     based on reliable data that a different
                                            aggregate risk assessment reflecting the                                                                       risks posed by halosulfuron-methyl.
                                                                                                     margin of safety will be safe for infants
                                            removal of the dermal POD. EPA                                                                                 E. Aggregate Risks and Determination of
                                                                                                     and children. This additional margin of
                                            assessed short-term (1–30 days)                                                                                Safety
                                                                                                     safety is commonly referred to as the
                                            exposure to halosulfuron-methyl for
                                                                                                     FQPA Safety Factor (SF). In applying                     EPA determines whether acute and
                                            residential handlers (inhalation
                                                                                                     this provision, EPA either retains the                chronic dietary pesticide exposures are
                                            exposure) and children 1 to < 2 years
                                                                                                     default value of 10X, or uses a different             safe by comparing aggregate exposure
                                            old (post-application incidental oral
                                                                                                     additional safety factor when reliable                estimates to the acute PAD (aPAD) and
                                            exposures).
                                               The residential exposure scenario                     data available to EPA support the choice              chronic PAD (cPAD). For linear cancer
                                            used in the adult aggregate assessment                   of a different factor.                                risks, EPA calculates the lifetime
                                            reflects inhalation exposure from                           2. Prenatal and postnatal sensitivity.             probability of acquiring cancer given the
                                            mixing/loading/applying halosulfuron-                    There was no quantitative evidence of                 estimated aggregate exposure. Short-,
                                            methyl via backpack sprayer or                           increased susceptibility following pre-               intermediate-, and chronic-term risks
                                            manually pressurized handwand to turf.                   and/or post-natal exposure to                         are evaluated by comparing the
                                               The residential exposure scenario                     halosulfuron-methyl. Qualitative                      estimated aggregate food, water, and
                                            used in the children 1 to <2 years old                   susceptibility was seen in the prenatal               residential exposure to the appropriate
                                            aggregate assessment reflects hand-to-                   developmental toxicity study in rats and              PODs to ensure that an adequate MOE
                                            mouth incidental oral exposures from                     in rabbits; however, this qualitative                 exists.
                                            post-application exposure to treated                     susceptibility was of low concern                        1. Acute risk. Using the exposure
                                            turf.                                                    because (1) in both studies, there were               assumptions discussed in this unit for
                                               Intermediate-term exposures are not                   clear NOAELs/LOAELs for                               acute exposure, the acute dietary
                                            likely because of the intermittent nature                developmental and maternal toxicities;                exposure from food and water to
                                            of applications by homeowners.                           (2) the developmental effects were seen               halosulfuron-methyl will occupy <1%
                                               Further information regarding EPA                     in the presence of maternal toxicity; and             of the aPAD for females 13–49 years old,
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                                            standard assumptions and generic                         (3) the effects were only seen at the high            the only population group of concern.
                                            inputs for residential exposures may be                  dose levels. In rats, the developmental                  2. Chronic risk. Using the exposure
                                            found at http://www.epa.gov/pesticides/                  effects were seen at a dose (750 mg/kg/               assumptions described in this unit for
                                            trac/science/trac6a05.pdf.                               day) which was approaching the limit-                 chronic exposure, EPA has concluded
                                               4. Cumulative effects from substances                 dose (1,000 mg/kg/day). Furthermore,                  that chronic exposure to halosulfuron-
                                            with a common mechanism of toxicity.                     the PODs for risk assessment are                      methyl from food and water will utilize


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                                            55772            Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations

                                            5.7% of the cPAD for children 1–2 years                  IV. Other Considerations                              Agency. The Office of Management and
                                            old, the population subgroup receiving                                                                         Budget (OMB) has exempted these types
                                                                                                     A. Analytical Enforcement Methodology
                                            the greatest exposure. Based on the                                                                            of actions from review under Executive
                                            explanation in Unit III.C.3., regarding                     Adequate enforcement methodology                   Order 12866, entitled ‘‘Regulatory
                                            residential use patterns, chronic                        (gas chromatography (GC) thermionic-                  Planning and Review’’ (58 FR 51735,
                                            residential exposure to residues of                      specific detection (TSD, nitrogen                     October 4, 1993). Because this action
                                            halosulfuron-methyl is not expected.                     specific)) is available to enforce the                has been exempted from review under
                                               3. Short-term risk. Short-term                        tolerance expression.                                 Executive Order 12866, this action is
                                            aggregate exposure takes into account                       The method may be requested from:                  not subject to Executive Order 13211,
                                            short-term residential exposure plus                     Chief, Analytical Chemistry Branch,                   entitled ‘‘Actions Concerning
                                            chronic exposure to food and water                       Environmental Science Center, 701                     Regulations That Significantly Affect
                                            (considered to be a background                           Mapes Rd., Ft. Meade, MD 20755–5350;                  Energy Supply, Distribution, or Use’’ (66
                                            exposure level).                                         telephone number: (410) 305–2905;                     FR 28355, May 22, 2001) or Executive
                                               Halosulfuron-methyl is currently                      email address: residuemethods@                        Order 13045, entitled ‘‘Protection of
                                            registered for uses that could result in                 epa.gov.                                              Children from Environmental Health
                                            short-term residential exposure, and the                                                                       Risks and Safety Risks’’ (62 FR 19885,
                                            Agency has determined that it is                         B. International Residue Limits
                                                                                                                                                           April 23, 1997). This action does not
                                            appropriate to aggregate chronic                           In making its tolerance decisions, EPA              contain any information collections
                                            exposure through food and water with                     seeks to harmonize U.S. tolerances with               subject to OMB approval under the
                                            short-term residential exposures to                      international standards whenever                      Paperwork Reduction Act (PRA) (44
                                            halosulfuron-methyl.                                     possible, consistent with U.S. food                   U.S.C. 3501 et seq.), nor does it require
                                               Using the exposure assumptions                        safety standards and agricultural                     any special considerations under
                                            described in this unit for short-term                    practices. EPA considers the                          Executive Order 12898, entitled
                                            exposures, EPA has concluded the                         international maximum residue limits                  ‘‘Federal Actions to Address
                                            combined short-term food, water, and                     (MRLs) established by the Codex                       Environmental Justice in Minority
                                            residential exposures result in aggregate                Alimentarius Commission (Codex), as                   Populations and Low-Income
                                            MOEs of 25,000 for adults and 1,800 for                  required by FFDCA section 408(b)(4).                  Populations’’ (59 FR 7629, February 16,
                                            children 1 to < 2 years old. Because                     The Codex Alimentarius is a joint                     1994).
                                            EPA’s level of concern for halosulfuron-                 United Nations Food and Agriculture                      Since tolerances and exemptions that
                                            methyl is a MOE of 100 or below, these                   Organization/World Health                             are established on the basis of a petition
                                            MOEs are not of concern.                                 Organization food standards program,                  under FFDCA section 408(d), such as
                                               4. Intermediate-term risk.                            and it is recognized as an international              the tolerance in this final rule, do not
                                            Intermediate-term aggregate exposure                     food safety standards-setting                         require the issuance of a proposed rule,
                                            takes into account intermediate-term                     organization in trade agreements to                   the requirements of the Regulatory
                                            residential exposure plus chronic                        which the United States is a party. EPA               Flexibility Act (RFA) (5 U.S.C. 601 et
                                            exposure to food and water (considered                   may establish a tolerance that is                     seq.), do not apply.
                                            to be a background exposure level).                      different from a Codex MRL; however,                     This action directly regulates growers,
                                               An intermediate-term adverse effect                   FFDCA section 408(b)(4) requires that                 food processors, food handlers, and food
                                            was identified; however, halosulfuron-                   EPA explain the reasons for departing                 retailers, not States or tribes, nor does
                                            methyl is not registered for any use                     from the Codex level.                                 this action alter the relationships or
                                            patterns that would result in                              The Codex has not established a MRL                 distribution of power and
                                            intermediate-term residential exposure.                  for halosulfuron-methyl for any of the                responsibilities established by Congress
                                            Intermediate-term risk is assessed based                 crops covered by this Final Rule.                     in the preemption provisions of FFDCA
                                            on intermediate-term residential                                                                               section 408(n)(4). As such, the Agency
                                            exposure plus chronic dietary exposure.                  V. Conclusion                                         has determined that this action will not
                                            Because there is no intermediate-term                       Therefore, a tolerance is established              have a substantial direct effect on States
                                            residential exposure and chronic dietary                 for residues of halosulfuron-methyl,                  or tribal governments, on the
                                            exposure has already been assessed                       methyl 5-[(4,6-dimethoxy-2-                           relationship between the national
                                            under the appropriately protective                       pyrimidiny)amino]                                     government and the States or tribal
                                            cPAD (which is at least as protective as                 carbonylaminosulfonyl]-3-chloro-1-                    governments, or on the distribution of
                                            the POD used to assess intermediate-                     methyl-1H-pyrazole-4-carboxylate,                     power and responsibilities among the
                                            term risk), no further assessment of                     including its metabolites and                         various levels of government or between
                                            intermediate-term risk is necessary, and                 degradates, in or on the fruit, pome,                 the Federal Government and Indian
                                            EPA relies on the chronic dietary risk                   group 11–10 at 0.05 ppm, and a                        tribes. Thus, the Agency has determined
                                            assessment for evaluating intermediate-                  tolerance with regional registration is               that Executive Order 13132, entitled
                                            term risk for halosulfuron-methyl.                       established for fruit, small vine                     ‘‘Federalism’’ (64 FR 43255, August 10,
                                               5. Aggregate cancer risk for U.S.                     climbing, except fuzzy kiwifruit,                     1999) and Executive Order 13175,
                                            population. Based on the lack of                         subgroup 13–07F at 0.05 ppm. In                       entitled ‘‘Consultation and Coordination
                                            evidence of carcinogenicity in two                       addition, the existing tolerance for the              with Indian Tribal Governments’’ (65 FR
                                            adequate rodent carcinogenicity studies,                 commodity ‘‘Apple’’ in paragraph (a)(2)               67249, November 9, 2000) do not apply
                                            halosulfuron-methyl is not expected to                   of § 180.479 is removed since it is                   to this action. In addition, this action
                                            pose a cancer risk to humans.                            covered by the newly established fruit,               does not impose any enforceable duty or
                                               6. Determination of safety. Based on                  pome, group 11–10 tolerance.                          contain any unfunded mandate as
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                                            these risk assessments, EPA concludes                                                                          described under Title II of the Unfunded
                                            that there is a reasonable certainty that                VI. Statutory and Executive Order                     Mandates Reform Act (UMRA) (2 U.S.C.
                                            no harm will result to the general                       Reviews                                               1501 et seq.).
                                            population, or to infants and children                     This action establishes tolerances                     This action does not involve any
                                            from aggregate exposure to                               under FFDCA section 408(d) in                         technical standards that would require
                                            halosulfuron-methyl residues.                            response to a petition submitted to the               Agency consideration of voluntary


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                                                             Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations                                    55773

                                            consensus standards pursuant to section                  degradates, in or on the commodities in               Administration, Federal Emergency
                                            12(d) of the National Technology                         the following table. Compliance with                  Management Agency, 500 C Street SW.,
                                            Transfer and Advancement Act                             the tolerance levels specified in the                 Washington, DC 20472, (202) 646–4133.
                                            (NTTAA) (15 U.S.C. 272 note).                            following table is to be determined by
                                                                                                                                                           SUPPLEMENTARY INFORMATION:      The NFIP
                                                                                                     measuring only halosulfuron-methyl.
                                            VII. Congressional Review Act                                                                                  enables property owners to purchase
                                               Pursuant to the Congressional Review                                                           Parts per    Federal flood insurance that is not
                                                                                                         Commodity                                         otherwise generally available from
                                            Act (5 U.S.C. 801 et seq.), EPA will                                                                million
                                            submit a report containing this rule and                                                                       private insurers. In return, communities
                                                                                              Fruit, small vine climbing, ex-                              agree to adopt and administer local
                                            other required information to the U.S.
                                                                                                 cept fuzzy kiwifruit, subgroup                            floodplain management measures aimed
                                            Senate, the U.S. House of                            13–07F ..................................            0.05 at protecting lives and new construction
                                            Representatives, and the Comptroller
                                            General of the United States prior to                                                                          from future flooding. Section 1315 of
                                                                                              *      *       *       *         *                           the National Flood Insurance Act of
                                            publication of the rule in the Federal            [FR Doc. 2015–23298 Filed 9–16–15; 8:45 am]
                                            Register. This action is not a ‘‘major                                                                         1968, as amended, 42 U.S.C. 4022,
                                                                                              BILLING CODE 6560–50–P
                                            rule’’ as defined by 5 U.S.C. 804(2).                                                                          prohibits the sale of NFIP flood
                                                                                                                                                           insurance unless an appropriate public
                                            List of Subjects in 40 CFR Part 180                                                                            body adopts adequate floodplain
                                                                                              DEPARTMENT OF HOMELAND                                       management measures with effective
                                               Environmental protection,
                                                                                              SECURITY                                                     enforcement measures. The
                                            Administrative practice and procedure,
                                            Agricultural commodities, Pesticides              Federal Emergency Management                                 communities listed in this document no
                                            and pests, Reporting and recordkeeping Agency                                                                  longer meet that statutory requirement
                                            requirements.                                                                                                  for compliance with program
                                               Dated: September 4, 2015.                      44 CFR Part 64                                               regulations, 44 CFR part 59.
                                            Susan Lewis,
                                                                                                                                                           Accordingly, the communities will be
                                                                                              [Docket ID FEMA–2015–0001: Internal                          suspended on the effective date in the
                                            Director, Registration Division, Office of        Agency Docket No. FEMA–8399]
                                            Pesticide Programs.                                                                                            third column. As of that date, flood
                                                                                              Suspension       of  Community               Eligibility     insurance will no longer be available in
                                               Therefore, 40 CFR chapter I is                                                                              the community. We recognize that some
                                            amended as follows:                               AGENCY: Federal Emergency                                    of these communities may adopt and
                                                                                              Management Agency, DHS.                                      submit the required documentation of
                                            PART 180—[AMENDED]
                                                                                              ACTION: Final rule.                                          legally enforceable floodplain
                                            ■ 1. The authority citation for part 180                                                                       management measures after this rule is
                                                                                              SUMMARY: This rule identifies                                published but prior to the actual
                                            continues to read as follows:
                                                                                              communities where the sale of flood                          suspension date. These communities
                                               Authority: 21 U.S.C. 321(q), 346a and 371.     insurance has been authorized under                          will not be suspended and will continue
                                            ■ 2. In § 180.479:
                                                                                              the National Flood Insurance Program                         to be eligible for the sale of NFIP flood
                                            ■ a. Remove the entry for ‘‘Apple’’ from
                                                                                              (NFIP) that are scheduled for                                insurance. A notice withdrawing the
                                            the table in paragraph (a)(2);                    suspension on the effective dates listed                     suspension of such communities will be
                                            ■ b. Add alphabetically the entry for
                                                                                              within this rule because of                                  published in the Federal Register.
                                            ‘‘Fruit, pome, group 11–10’’ to the table         noncompliance with the floodplain
                                                                                              management requirements of the                                  In addition, FEMA publishes a Flood
                                            in paragraph (a)(2), and                                                                                       Insurance Rate Map (FIRM) that
                                            ■ c. Revise paragraph (c).                        program.    If the   Federal        Emergency
                                                                                              Management Agency (FEMA) receives                            identifies the Special Flood Hazard
                                               The additions and revision read as                                                                          Areas (SFHAs) in these communities.
                                            follows:                                          documentation         that    the    community         has
                                                                                              adopted the required floodplain                              The date of the FIRM, if one has been
                                            § 180.479 Halosulfuron-methyl; tolerances management measures prior to the                                     published, is indicated in the fourth
                                            for residues.                                     effective suspension date given in this                      column of the table. No direct Federal
                                               (a) * * *                                      rule, the suspension will not occur and                      financial assistance (except assistance
                                               (2) * * *                                      a notice of this will be provided by                         pursuant to the Robert T. Stafford
                                                                                              publication in the Federal Register on a Disaster Relief and Emergency
                                                                                 Parts per    subsequent date. Also, information                           Assistance Act not in connection with a
                                                       Commodity                                                                                           flood) may be provided for construction
                                                                                   million    identifying the current participation
                                                                                              status of a community can be obtained                        or acquisition of buildings in identified
                                                                                              from   FEMA’s     Community              Status   Book       SFHAs for communities not
                                                *        *          *          *         *                                                                 participating in the NFIP and identified
                                                                                              (CSB).
                                            Fruit, pome, group 11–10 .........           0.05 DATES: The effective date of each                            for more than a year on FEMA’s initial
                                                                                                                                                           FIRM for the community as having
                                                                                              community’s scheduled suspension is                          flood-prone areas (section 202(a) of the
                                                *        *          *          *         *    the third date (‘‘Susp.’’) listed in the                     Flood Disaster Protection Act of 1973,
                                                                                              third column of the following tables.                        42 U.S.C. 4106(a), as amended). This
                                               (c) Tolerances with regional                   ADDRESSES: The CSB is available at                           prohibition against certain types of
                                            registrations. Tolerances with regional           http://www.fema.gov/fema/csb.shtm.                           Federal assistance becomes effective for
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                                            registrations are established for residues FOR FURTHER INFORMATION CONTACT: If                                 the communities listed on the date
                                            of the herbicide halosulfuron-methyl,             you want to determine whether a                              shown in the last column. The
                                            methyl 5-[(4,6-dimethoxy-2-pyrimidiny) particular community was suspended                                      Administrator finds that notice and
                                            amino]carbonylaminosulfonyl]-3-chloro on the suspension date or for further                                    public comment procedures under 5
                                            -1-methyl-1H-pyrazole-4-carboxylate,              information, contact Bret Gates, Federal U.S.C. 553(b), are impracticable and
                                            including its metabolites and                     Insurance and Mitigation                                     unnecessary because communities listed


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Document Created: 2015-12-15 09:34:12
Document Modified: 2015-12-15 09:34:12
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 September 17, 2015. Objections and requests for hearings must be received on or before November 16, 2015, 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 55768 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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