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

Documents submitted using that system 

are considered filed as of the date and 

time (Eastern Time) reflected in the 

system. Orders issued by the Hearing 

Officer shall be considered received by 

the parties on the date posted to the 

electronic filing system. 

§ 957.7 Failure to appear at the hearing. 

If a party fails to appear at the 

hearing, the Hearing Officer may 

proceed with the hearing, receive 

evidence and issue findings of fact 

without requirement of further notice to 

the absent party. 

§ 957.8 Hearings. 

Hearings ordinarily will be conducted 

in the Judicial Officer Department 

courtroom at 2101 Wilson Boulevard, 

Suite 600, Arlington, VA 22201–3078. 

However, the Hearing Officer, in his or 

her discretion, may order the hearing to 

be conducted at another location, or by 

another means such as by video. 

§ 957.9 Appearances. 

(a) An individual Respondent may 

appear in his or her own behalf, a 

corporation may appear by an officer 

thereof, a partnership or joint venture 

may appear by a member thereof, or any 

of these may appear by a licensed 

attorney. 

(b) After a request for a hearing has 

been filed pursuant to the rules in this 

part, the General Counsel shall 

designate a licensed attorney as counsel 

assigned to handle the case. 

(c) All counsel, or a self-represented 

Respondent, shall register in the 

electronic filing system, and request to 

be added to the case. Counsel also 

promptly shall file notices of 

appearance. 

(d) An attorney for any party who has 

filed a notice of appearance and who 

wishes to withdraw must file a motion 

requesting withdrawal, explaining the 

reasons supporting the motion, and 

identifying the name, email address, 

mailing address, telephone number, and 

fax number of the person who will 

assume responsibility for representation 

of the party in question. 

§ 957.10 Conduct of the hearing. 

The Hearing Officer may approve or 

disapprove witnesses in his or her 

discretion. All testimony will be taken 

under oath or affirmation, and subject to 

cross-examination. The Hearing Officer 

may exclude evidence to avoid unfair 

prejudice, confusion of the issues, 

undue delay, waste of time, or 

presentation of irrelevant, immaterial, or 

cumulative evidence. Although the 

Hearing Officer will consider the 

Federal Rules of Evidence for guidance 

regarding admissibility of evidence and 

other evidentiary issues, he or she is not 

bound by those rules. The weight to be 

attached to evidence presented in any 

particular form will be within the 

discretion of the Hearing Officer, taking 

into consideration all the circumstances 

of the particular case. Stipulations of 

fact agreed upon by the parties may be 

accepted as evidence at the hearing. The 

parties may stipulate the testimony that 

would be given by a witness if the 

witness were present. The Hearing 

Officer may in any case require 

evidence in addition to that offered by 

the parties. A party requiring the use of 

a foreign language interpreter allowing 

testimony to be taken in English for 

itself or witnesses it proffers is 

responsible for making all necessary 

arrangements and paying all costs and 

expenses associated with the use of an 

interpreter. 

§ 957.11 Witness fees. 

Each party is responsible for the fees 

and costs for its own witnesses. 

§ 957.12 Transcript. 

Testimony and argument at hearings 

shall be reported verbatim, unless the 

Hearing Officer otherwise orders. 

Transcripts of the proceedings will be 

made available or provided to the 

parties. 

§ 957.13 Proposed findings of fact. 

(a) The Hearing Officer may direct the 

parties to submit proposed findings of 

fact and supporting explanations within 

15 days after the delivery of the official 

transcript to the Recorder who shall 

notify both parties of the date of its 

receipt. The filing date for proposed 

findings shall be the same for both 

parties. 

(b) Proposed findings of fact shall be 

set forth in numbered paragraphs and 

shall state with particularity all 

evidentiary facts in the record with 

appropriate citations to the transcript or 

exhibits supporting the proposed 

findings. 

§ 957.14 Findings of fact. 

The Hearing Officer shall issue 

written findings of fact, and transmit 

them to the Vice President. Copies will 

be sent to the parties. 

§ 957.15 Computation of time. 

A designated period of time under the 

rules in this part excludes the day the 

period begins, and includes the last day 

of the period unless the last day is a 

Saturday, Sunday, or legal holiday, in 

which event the period runs until the 

close of business on the next business 

day. 

§ 957.16 Official record. 

The transcript of testimony together 

with all pleadings, orders, exhibits, 

briefs, and other documents filed in the 

proceeding shall constitute the official 

record of the proceeding. 

§ 957.17 Public information. 

The Postal Service shall maintain for 

public inspection copies of all findings 

of fact issued under this Part, and make 

them available through the Postal 

Service Web site. The Recorder 

maintains the complete official record of 

every proceeding. 

§ 957.18 Ex parte communications. 

The provisions of 5 U.S.C. 551(14), 

556(d), and 557(d) prohibiting ex parte 

communications are made applicable to 

proceedings under these rules of 

practice. 

Stanley F. Mires, 

Attorney, Federal Compliance. 

[FR Doc. 2015–23314 Filed 9–16–15; 8:45 am] 

BILLING CODE 7710–12–P 

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. 

SUMMARY: This regulation establishes a 

tolerance for residues of halosulfuronmethyl in or on the pome fruit group 

11–10 and a tolerance with regional 

registration for residues of halosulfuronmethyl 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations 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: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–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 halosulfuronmethyl, 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 halosulfuronmethyl including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with halosulfuronmethyl 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 


tkelley on DSK3SPTVN1PROD with RULES
55770 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations 

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 noobserved-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. Halosulfuronmethyl 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 lowestobserved-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 halosulfuronmethyl 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations 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 nonoccupational, 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 reassessed 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 halosulfuronmethyl 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-tomouth 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 halosulfuronmethyl 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 preand/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 limitdose (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 halosulfuronmethyl 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 halosulfuronmethyl from food and water will utilize 


tkelley on DSK3SPTVN1PROD with RULES
55772 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations 

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 halosulfuronmethyl 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, halosulfuronmethyl 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 intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm 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) thermionicspecific 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: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established 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 § 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations 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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.479: 

■ a. Remove the entry for ‘‘Apple’’ from 

the table in paragraph (a)(2); 

■ b. Add alphabetically the entry for 

‘‘Fruit, pome, group 11–10’’ to the table 

in paragraph (a)(2), and 

■ c. Revise paragraph (c). 

The additions and revision read as 

follows: 

§ 180.479 Halosulfuron-methyl; tolerances 

for residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

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. 

Commodity Parts per 

million 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 

13–07F .................................. 0.05 

* * * * * 

[FR Doc. 2015–23298 Filed 9–16–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2015–0001: Internal 

Agency Docket No. FEMA–8399] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). 

DATES: The effective date of each 

community’s scheduled suspension is 

the third date (‘‘Susp.’’) listed in the 

third column of the following tables. 

ADDRESSES: The CSB is available at 

http://www.fema.gov/fema/csb.shtm. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact Bret Gates, Federal 

Insurance and Mitigation 

Administration, Federal Emergency 

Management Agency, 500 C Street SW., 

Washington, DC 20472, (202) 646–4133. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

from future flooding. Section 1315 of 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits the sale of NFIP flood 

insurance unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed in this document no 

longer meet that statutory requirement 

for compliance with program 

regulations, 44 CFR part 59. 

Accordingly, the communities will be 

suspended on the effective date in the 

third column. As of that date, flood 

insurance will no longer be available in 

the community. We recognize that some 

of these communities may adopt and 

submit the required documentation of 

legally enforceable floodplain 

management measures after this rule is 

published but prior to the actual 

suspension date. These communities 

will not be suspended and will continue 

to be eligible for the sale of NFIP flood 

insurance. A notice withdrawing the 

suspension of such communities will be 

published in the Federal Register. 

In addition, FEMA publishes a Flood 

Insurance Rate Map (FIRM) that 

identifies the Special Flood Hazard 

Areas (SFHAs) in these communities. 

The date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may be provided for construction 

or acquisition of buildings in identified 

SFHAs for communities not 

participating in the NFIP and identified 

for more than a year on FEMA’s initial 

FIRM for the community as having 

flood-prone areas (section 202(a) of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 

shown in the last column. The 

Administrator finds that notice and 

public comment procedures under 5 

U.S.C. 553(b), are impracticable and 

unnecessary because communities listed 


tkelley on DSK3SPTVN1PROD with RULES