4624 Federal Register / Vol. 79, No. 19 / Wednesday, January 29, 2014 / Rules and Regulations 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2013–1036] 

Drawbridge Operation Regulation; 

Hillsborough River, Tampa, FL 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation. 

SUMMARY: The Coast Guard has issued a 

temporary deviation from the operating 

schedule that governs the Hillsborough 

Avenue Bridge across the Hillsborough 

River, mile 4.8, at Tampa, Florida, to 

facilitate repairs. The deviation is 

necessary to provide repair personnel 

the time needed to safely remove 

equipment on the bridge prior to 

opening. This deviation allows the 

bridge a limited opening providing 20 

feet of vertical clearance if four hours 

advanced notice is given. Special 

arrangements with the bridge owner can 

be made for full openings. 

DATES: This rule is effective without 

actual notice from January 29, 2014 

until 7 p.m. on May 30, 2014. For the 

purposes of enforcement, actual notice 

will be used from 7 a.m. on January 6, 

2014, until January 29, 2014. 

ADDRESSES: The docket for this 

deviation, [USCG–2013–1036] is 

available at http://www.regulations.gov. 

Type the docket number in the 

‘‘SEARCH’’ box and click ‘‘SEARCH.’’ 

Click on Open Docket Folder on the line 

associated with this deviation. You may 

also visit the Docket Management 

Facility in Room W12–140 on the 

ground floor of the Department of 

Transportation West Building, 1200 

New Jersey Avenue SE., Washington, 

DC 20590, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

deviation, call or email Mr. Michael 

Lieberum, Chief Operations Section, 

Seventh Coast Guard District, Bridge 

Branch; telephone 305–415–6744, email 

michael.b.lieberum@uscg.mil. If you 

have questions on viewing the docket, 

call Cheryl Collins, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: The 

Florida Department of Transportation 

(FDOT) requested that the Hillsborough 

Avenue Bridge across the Hillsborough 

River, Tampa, Florida regulation be 

temporarily changed during the repairs 

to this bridge. The vertical clearance of 

the bridge in the closed position is 10 

feet. per 33 CFR 117.291(a), ‘‘[t]he 

drawspans for the drawbridges at Platt 

Street, mile 0.0, Brorein Street, mile 

0.16, Kennedy Boulevard, mile 0.4, Cass 

Street, mile 0.7, Laurel Street, mile 1.0, 

West Columbus Drive, mile 2.3, and 

West Hillsborough Avenue, mile 4.8, 

must open on signal if at least two hours 

notice is given; except that, the 

drawspan must open on signal as soon 

as possible for public vessels of the 

United States.’’ 

An FDOT contractor originally 

requested to place the bridge on a four 

hour notice for a 20 foot vertical 

clearance opening from November 2013 

through August 2014. This request was 

contested by the local marine 

community; therefore, the Coast Guard 

sought measures to ensure the bridge 

work could be conducted safely without 

unreasonably obstructing navigation 

through this area. Based on 

documentation received and subsequent 

coordination with FDOT and local 

marine interests, the Coast Guard 

determined that the following 

restrictions to the Hillsborough Avenue 

Bridge do not unreasonably restrict 

navigation and provide for the safety of 

workers and the movable bridge 

structure. 

The Hillsborough Avenue Bridge will 

open to a height of 20 feet of vertical 

clearance with a four hour notice to the 

bridge tender. The normal vertical 

clearance of the bridge in the closed 

position of 10 feet will be reduced by 4 

feet to accommodate the painting tarps. 

Vessels requiring less than six feet of 

vertical clearance may pass at any time. 

Vessels requiring more than 20 feet of 

vertical clearance need to contact Mr. 

Jim Fitzer, the project manager, at 813– 

636–2451 to coordinate a scheduled 

opening. Additionally, approximately 

10 nighttime closures from 8:00 p.m. 

until 6:00 a.m. may be required to 

complete repairs to Hillsborough 

Avenue Bridge. Notice will be 

published when these nighttime 

closures are required. 

The Coast Guard will inform 

waterway users of the change in 

operating schedule for this bridge 

through the Local Notice to Mariners. 

Mariners are advised to use this 

information in order to arrange safe 

transit through this bridge and minimize 

any delay caused by this temporary 

deviation. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: January 3, 2014. 

B. Dragon, 

Director, Seventh Coast Guard District, Bridge 

Administration. 

[FR Doc. 2014–01600 Filed 1–28–14; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0014; FRL–9903–88] 

Indaziflam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of indaziflam in 

or on coffee, banana, and palm oil. 

Bayer Crop Science requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 29, 2014. Objections and 

requests for hearings must be received 

on or before March 31, 2014, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0014, 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), EPA West 

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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

703–305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 


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Federal Register / Vol. 79, No. 19 / Wednesday, January 29, 2014 / Rules and Regulations 4625 

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–2013–0014 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 March 31, 2014. 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– 

2013–0014, 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.htm. 

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 

15, 2013 (78 FR 32) (FRL–9378–4), 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 2E8125) by Bayer Crop 

Science, 2 T.W. Alexander Drive; P.O. 

Box 12014; Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.653 be amended by 

establishing tolerances for residues of 

the herbicide indaziflam, N-[(1R, 2S)- 

2,3-dihydro-2,6-dimethyl-1H-inden-1- 

yl-1,3,5-triazine-2,4-diamine]-6-(1- 

fluoroethyl) and its fluoroethylindaziflam metabolite, each expressed 

as the parent compound, in or on coffee 

at 0.01 part per million (ppm), banana 

at 0.01 ppm, and palm oil at 0.03 ppm. 

That document referenced a summary of 

the petition prepared by Bayer 

CropScience, the registrant, which is 

available in the docket, http://

www.regulations.gov. A comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for indaziflam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with indaziflam 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. 

The nervous system is the major target 

for indaziflam toxicity in rats and dogs, 

with the dog being the more sensitive 

species based on neuropathology 

(degenerative nerve fibers in the brain, 

spinal cord and sciatic nerve). Clinical 

signs of neurotoxicity were observed in 

the acute, subchronic, and 

developmental neurotoxicity studies 

and consisted primarily of tremors, 

changes in activity and reactivity, 

repetitive chewing, dilated pupils, and 

oral, perianal, and nasal staining. 

Similar clinical signs of neurotoxicity 

were observed in the 2-generation 

reproduction study, the rat chronic 

toxicity study, and the combined rat 

carcinogenicity/chronic toxicity study. 

Neuropathology findings were also 

observed in the rat manifested as focal/ 

multifocal vacuolation of the median 

eminence of the brain and the pituitary 

pars nervosa and degenerative nerve 

fibers in the gasserian ganglion, sciatic 

nerve, and tibial nerve. Evidence of 

neurotoxicity was not seen in the 

mouse. 

Other organs affected by indaziflam in 

mice and rats include the kidney, liver, 

thyroid, stomach, seminal vesicles, and 

ovaries. Effects on the kidney were 

observed following chronic exposure in 

rats and mice while effects on the liver 

were observed following chronic 

exposure in the rat. Effects on the 

thyroid were only observed in multiple 


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dose rat studies. Chronic exposures also 

lead to atrophied or small seminal 

vesicles in male and female mice. 

However, these effects occurred at 

higher doses than those at which 

neurotoxicity was observed in the dog. 

Decreased body weight gain was 

observed in most studies following 

exposure to indaziflam. There was no 

evidence of immunotoxicity in the 

available studies, which included a 

guideline immunotoxocity study in the 

rat. No systemic effects were observed 

in the rat following a 28-day dermal 

exposure period. 

No evidence of increased quantitative 

or qualitative susceptibility was seen in 

developmental toxicity studies in rats 

and rabbits or in a reproduction study 

in rats. In the rat developmental toxicity 

study, decreased fetal weight was 

observed in the presence of maternal 

effects that included decreased body 

weight gain and food consumption. No 

developmental effects were observed in 

rabbits up to maternally toxic dose 

levels. Decreased pup weight and delays 

in sexual maturation (preputial 

separation in males and vaginal patency 

in females) were observed in the rat 2- 

generation reproductive toxicity study, 

along with clinical signs of toxicity, at 

a dose causing parental toxicity that 

included coarse tremors, renal toxicity 

and decreased weight gain. In the 

developmental neurotoxicity study, 

transiently decreased motor activity 

(PND 21 only) in male offspring was 

observed and was considered a potential 

neurotoxic effect. It was observed at a 

dose that also caused clinical signs of 

neurotoxicity along with decreased 

body weight in maternal animals. 

Indaziflam showed no evidence of 

carcinogenicity in the 2-year dietary rat 

and mouse bioassays. All genotoxicity 

studies that were conducted on 

indaziflam were negative. 

Testing in acute lethality studies with 

indaziflam resulted in low toxicity via 

the oral, dermal, and inhalation routes 

of exposure. Indaziflam was not an 

irritant to eyes Category IV) or skin and 

was not a skin sensitizer. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by indaziflam as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Indaziflam. Human Health Risk 

Assessment to Support Proposed New 

Import Tolerances (Without a U.S. 

Registration) on Banana, Coffee, and 

Palm Oil at page 33 in docket ID number 

EPA–HQ–OPP–2013–0014. 

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 indaziflam used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR INDAZIFLAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment 

Study and toxicological 

effects 

Acute dietary (General population including infants and 

children).

NOAEL = 7.5 mg/kg/day ...

UFA = 10x 

UFH =10x 

FQPA SF = 1x 

Acute RfD = 0.075 mg/kg/

day.

aPAD = 0.075 mg/kg/day. 

Subchronic Gavage Toxicity Study in Dogs. 

LOAEL = 15 mg/kg/day 

based on axonal degenerative microscopic findings in the brain, spinal 

cord and sciatic nerve. 

Chronic dietary (All populations) ..................................... NOAEL= 2 mg/kg/day .......

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.02 mg/kg/

day.

cPAD = 0.02 mg/kg/day. 

Chronic Dietary Toxicity 

Study in Dogs. 

LOAEL = 6/7 mg/kg/day M/

F based on nerve fiber 

degenerative lesions in 

the brain, spinal cord 

and sciatic nerve. 

Incidental oral short-term (1 to 30 days) ......................... NOAEL= 7.5 mg/kg/day ....

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic Gavage Toxicity Study in Dogs. 

LOAEL = 15 mg/kg/day 

based on axonal degenerative microscopic findings in the brain, spinal 

cord and sciatic nerve. 

Incidental oral intermediate-term (1 to 6 months) ........... NOAEL= 7.5 mg/kg/day ....

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic Gavage Toxicity Study in Dogs. 

LOAEL = 15 mg/kg/day 

based on axonal degenerative microscopic findings in the brain, spinal 

cord and sciatic nerve. 


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Federal Register / Vol. 79, No. 19 / Wednesday, January 29, 2014 / Rules and Regulations 4627 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR INDAZIFLAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment 

Study and toxicological 

effects 

Dermal short-term (1 to 30 days) .................................... Dermal (or oral) study 

NOAEL = 7.5 mg/kg/day 

(dermal absorption factor) = 7.3%.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic Gavage Toxicity Study in Dogs. 

LOAEL = 15 mg/kg/day 

based on axonal degenerative microscopic findings in the brain, spinal 

cord and sciatic nerve. 

Dermal intermediate-term (1 to 6 months) ...................... Dermal (or oral) study 

NOAEL = 7.5 mg/kg/day 

(dermal absorption factor) = 7.3%.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic Gavage Toxicity Study in Dogs. 

LOAEL = 15 mg/kg/day 

based on axonal degenerative microscopic findings in the brain, spinal 

cord and sciatic nerve. 

Inhalation short-term (1 to 30 days) ................................ Inhalation (or oral) study 

NOAEL = 7.5 mg/kg/day 

(Inhalation toxicity considered equivalent to 

oral toxicity).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic Gavage Toxicity Study in Dogs. 

LOAEL = 15 mg/kg/day 

based on axonal degenerative microscopic findings in the brain, spinal 

cord and sciatic nerve. 

Inhalation (1 to 6 months) ............................................... Inhalation (or oral) study 

NOAEL = 7.5 mg/kg/day 

(Inhalation toxicity considered equivalent to 

oral toxicity).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic Gavage Toxicity Study in Dogs. 

LOAEL = 15 mg/kg/day 

based on axonal degenerative microscopic findings in the brain, spinal 

cord and sciatic nerve. 

Cancer (Oral, dermal, inhalation) .................................... No evidence of carcinogenicity. Classified as ‘‘Not Likely to be Carcinogenic to Humans.’’ 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligrams/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to indaziflam, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

indaziflam tolerances in 40 CFR 

180.653. EPA assessed dietary 

exposures from indaziflam 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 indaziflam. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA)’s 2003–2008 National Health 

and Nutrition Examination Survey, 

What We Eat in America (NHANES/

WWEIA). As to residue levels in food, 

the acute dietary assessment assumes 

100% crop treated (PCT) along with 

tolerance or maximum residue level 

estimates for indaziflam. It used DEEM– 

WWEIA analyses to estimate the dietary 

exposure of the U.S. population and 

various population subgroups. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s 2003–2008 NHANES/ 

WWEIA. As to residue levels in food, 

the chronic dietary assessment used the 

same residue levels, analysis and PCT 

assumptions used in the acute dietary 

assessment. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that indaziflam 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 and/or PCT 

information in the dietary assessment 

for indaziflam. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for indaziflam in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of indaziflam. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

indaziflam equivalents for acute 

exposures are estimated to be 84 parts 

per billion (ppb) for surface water and 

3.7 ppb for ground water. For chronic 

exposures for non-cancer assessments 


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the estimates are 26 ppb for surface 

water and 3.7 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 84 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 26 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). Indaziflam 

is currently registered for the following 

uses that could result in residential 

exposures: Home lawn/turf and 

gardens/tree uses. There are no new 

indaziflam residential uses associated 

with this regulatory action. A reevaluation of existing indaziflam 

residential uses was conducted to 

incorporate updated policies and 

guidance in place since previous risk 

assessments. Short-term dermal and 

inhalation handler exposures for 

residential are expected for those 

making applications at their homes and 

short-term dermal and incidental oral 

exposures are expected via contact with 

residues following applications in 

outdoor home environments. For adults, 

the highest exposure was from dermal 

post-application high-contact (playing) 

activities on treated turf during spray 

applications. The highest exposure 

scenarios for children 1<2 years old 

were from dermal post-application highcontact (playing) and incidental oral 

exposure from treated turf. These 

exposure scenarios were then combined 

to determine a total residential exposure 

and risk estimate for children to be used 

for the aggregate assessment. 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 indaziflam to 

share a common mechanism of toxicity 

with any other substances, and 

indaziflam does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that indaziflam 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. 

The toxicology database for indaziflam 

consists of developmental toxicity 

studies in rats and rabbits and a 

reproduction study in rats. No 

developmental effects were observed in 

rabbits up to maternally toxic dose 

levels. Offspring effects in the 

developmental toxicity study in rats, 

developmental neurotoxicity study in 

rats, and the multigeneration toxicity 

study in rats only occurred in the 

presence of maternal toxicity and were 

not considered more severe than the 

parental effects. EPA concluded that 

there is no evidence of increased 

quantitative or qualitative susceptibility 

to rat or rabbit fetuses exposed in utero 

and/or post-natally to indaziflam. 

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 indaziflam 

is complete. 

ii. The endpoints selected for risk 

assessment are based on and are 

protective of the neurotoxic effects seen 

in the guideline studies. 

iii. There is no evidence that 

indaziflam results in increased 

susceptibility in utero in rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on tolerance or 

maximum residue levels for residues of 

concern and assumed 100 PCT. EPA 

made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to indaziflam in drinking 

water. EPA used similarly conservative 

assumptions to assess dermal postapplication exposure as well as 

incidental oral exposure of children. 

These assessments will not 

underestimate the exposure and risks 

posed by indaziflam. 

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 

indaziflam will occupy 19% of the 

aPAD for infants <1 year old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to indaziflam 

from food and water will utilize 8% of 

the cPAD for infants <1 year old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of indaziflam is not expected. 

3. Short-and intermediate-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). 

Indaziflam 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 indaziflam. 


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Federal Register / Vol. 79, No. 19 / Wednesday, January 29, 2014 / Rules and Regulations 4629 

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 1,400 for adults (postapplication) and 560 for children (postapplication). Because EPA’s level of 

concern for indaziflam is a MOE of 100 

or below, these MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

indaziflam is not expected to pose a 

cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to indaziflam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography with tandem 

mass spectrometry detection [LC/MS/

MS] method (DH–003–P07–02) for fruit 

and nut tree matrices for indaziflam and 

FDAT) 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 indaziflam. 

C. Response to Comments 

EPA received a comment to the notice 

of filing which said that pesticide 

residues should not be increased. The 

Agency understands the commenter’s 

concerns and recognizes that some 

individuals believe that pesticides 

should be banned on agricultural crops. 

However, the existing legal framework 

provided by section 408 of the Federal 

Food, Drug, and Cosmetic Act (FFDCA) 

states that tolerances may be set when 

persons seeking such tolerances or 

exemptions have demonstrated that the 

pesticide meets the safety standard 

imposed by that statute. This citizen’s 

comment appears to be directed at the 

underlying statute and not EPA’s 

implementation of it; the citizen has 

made no contention that EPA has acted 

in violation of the statutory framework. 

V. Conclusion 

Therefore, tolerances are established 

for residues of indaziflam, N-[(1R, 2S)- 

2,3-dihydro-2,6-dimethyl-1H-inden-1- 

yl-1,3,5-triazine-2,4-diamine]-6-(1- 

fluoroethyl) and its fluoroethylindaziflam metabolite, each expressed 

as the parent compound, in or on coffee, 

green bean at 0.01 ppm, banana at 0.01 

ppm, and palm oil at 0.03 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 10, 2014. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 


tkelley on DSK3SPTVN1PROD with RULES
4630 Federal Register / Vol. 79, No. 19 / Wednesday, January 29, 2014 / Rules and Regulations 

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 § 180.653, alphabetically add the 

following commodities, redesignate 

footnote 1 as footnote 2, and add a new 

footnote 1 to the table in paragraph (a) 

to read as follows: 

§ 180.653 Indaziflam; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Banana 1 ................................... 0.01 

Coffee, green bean 1 ................. 0.01 

* * * * * 

Palm, oil 1 .................................. 0.03 

* * * * * 

1 No U.S. Registrations as of 12/02/2013. 

* * * * * 

[FR Doc. 2014–01363 Filed 1–28–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

GENERAL SERVICES 

ADMINISTRATION 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

48 CFR Part 52 

[FAC 2005–72; FAR Case 2010–010; 

Correction; Docket 2010–0010, Sequence 1] 

RIN 9000–AM06 

Federal Acquisition Regulation; 

Service Contracts Reporting 

Requirements; Correction 

AGENCY: Department of Defense (DoD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Final rule; correction. 

SUMMARY: DoD, GSA, and NASA are 

issuing a correction to FAR Case 2010– 

010; Service Contracts Reporting 

Requirements (Item I), which was 

published in the Federal Register at 78 

FR 80369, December 31, 2013. 

DATES: Effective: January 30, 2014. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Edward Loeb, Procurement Analyst, at 

202–501–0650, for clarification of 

content. For information pertaining to 

status or publication schedules, contact 

the Regulatory Secretariat at 202–501– 

4755. Please cite FAC 2005–72; FAR 

Case 2010–010; Correction. 

SUPPLEMENTARY INFORMATION: DoD, GSA, 

and NASA published a document in the 

Federal Register at 78 FR 80369, 

December 31, 2013, inadvertently 

section FAR 52.204–15, the clause 

heading date is incorrectly stated; and 

in section 52.212–5 the paragraphs have 

been incorrectly redesignated. 

Correction 

In rule FR Doc. 2013–31148 published 

in the Federal Register at 78 FR 80369, 

December 31, 2013, make the following 

corrections: 

1. On page 80375, in the third 

column, section 52.204–15, clause 

heading, correct ‘‘JANUARY 30, 2014’’ 

to read ‘‘JAN 2014’’. 

2. On page 80376, in the first column, 

section 52.212–5, under instruction 

number 10, paragraph b, correct 

‘‘(b)(51)’’ and ‘‘(b)(53)’’ to read as 

‘‘(b)(52)’’ and ‘‘(b)(54)’’ respectively. 

Authority: 40 U.S.C. 121(c); 10 U.S.C. 

chapter 137; and 51 U.S.C. 20113. 

Dated: January 23, 2014. 

William Clark, 

Acting Director, Office of Government-wide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Government-wide Policy. 

[FR Doc. 2014–01644 Filed 1–28–14; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF DEFENSE 

GENERAL SERVICES 

ADMINISTRATION 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

48 CFR Part 52 

[FAC 2005–72; FAR Case 2013–021; 

Correction; Docket No. 2013–0021; 

Sequence No. 1] 

Federal Acquisition Regulation; 

Technical Amendments 

AGENCY: Department of Defense (DoD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Final rule. 

SUMMARY: This document makes 

amendments to the Federal Acquisition 

Regulation (FAR) in order to make 

editorial changes. 

DATES: Effective: January 29, 2014. 

FOR FURTHER INFORMATION CONTACT: The 

Regulatory Secretariat Division (MVCB), 

1800 F Street NW., 2nd Floor, 

Washington, DC 20405, 202–501–4755, 

for information pertaining to status or 

publication schedules. Please cite FAC 

2005–72, Technical Amendments. 

SUPPLEMENTARY INFORMATION: In order to 

update certain elements in 48 CFR Part 

52, this document makes editorial 

changes to the FAR. 

List of Subject in 48 CFR Part 52 

Government procurement. 

Dated: January 23, 2014. 

William Clark, 

Acting Director, Office of Government-wide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Government-wide Policy. 

Therefore, DoD, GSA, and NASA 

amend 48 CFR part 52 as set forth 

below: 

PART 52—SOLICITATION PORVISIONS 

AND CONTRACT CLAUSES 

■ 1. The authority citation for 48 CFR 

part 52 continues to read as follows: 

Authority: 40 U.S.C. 121(c); 10 U.S.C. 

chapter 137; and 51 U.S.C. 20113. 

52.204–8 [Amended] 

■ 2. Remove from the clause heading 

‘‘(DEC 2013)’’ and add ‘‘(JAN 2014)’’ in 

its place. 

52.212–5 [Amended] 

■ 3. Remove from the clause heading 

‘‘(DEC 2013)’’ and add ‘‘(JAN 2014)’’ in 

its place; and remove from paragraph 

(b)(27) ‘‘(DEC 2013) ERT Abbreviated 

Month and Year of Publication in the 

Federal Register])’’ and add ‘‘(JAN 

2014)’’ in its place. 

52.213–4 [Amended] 

■ 4. Remove from the clause heading 

and paragraph (b)(1)(ii) ‘‘(DEC 2013)’’ 

and add ‘‘(JAN 2014)’’ in its place. 

52.222–19 [Amended] 

■ 5. Remove from the clause heading 

‘‘(DEC 2013)’’ and add ‘‘(JAN 2014)’’ in 

its place. 

[FR Doc. 2014–01643 Filed 1–28–14; 8:45 am] 

BILLING CODE 6820–EP–P 


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