Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 18899 

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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: March 24, 2011. 

Lois Rossi, 

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. Section 180.448 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(c), to read as follows: 

§ 180.448 Hexythiazox; tolerances for 

residues. 

* * * * * 

(c) * * * 

Commodity Parts per million 

Bean, dried, seed (EPA Regions 7–12 only) .............................................................................................................................. 0.4 

bean, succulent (EPA Regions 7–12 only) ................................................................................................................................. 0.3 

* * * * * * * 

Corn, sweet, kernel plus cob with husks removed (EPA Regions 7–12 only) ........................................................................... 0.1 

Corn, sweet, forage (EPA Regions 7–12 only) ........................................................................................................................... 4.0 

* * * * * * * 

* * * * * 

[FR Doc. 2011–8182 Filed 4–5–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0636; FRL–8864–3] 

Indaziflam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of indaziflam in 

or on multiple commodities which are 

identified and discussed later in this 

document. Bayer CropScience LP 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

6, 2011. Objections and requests for 

hearings must be received on or before 

June 6, 2011, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0636. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Bethany Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; e-mail address: 

benbow.bethany@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 


erowe on DSK5CLS3C1PROD with RULES
18900 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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.gpoaccess.gov/ecfr. 

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–2009–0636 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 June 6, 2011. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0636, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of January 6, 

2010 (75 FR 864) (FRL–8801–5), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of two 

pesticide petitions (PP 9F7589 and PP 

9E7588) by Bayer CropScience LP, 2 

T.W. Alexander Dr., Research Triangle 

Park, NC 27709. The petition requested 

that 40 CFR part 180 be amended by 

adding a section for the herbicide 

indaziflam and establishing tolerances 

therein for residues of indaziflam, N- 

[(1R,2S)-2,3-dihydro-2,6-dimethyl-1Hinden-1-yl]-6-(1-fluoroethyl)-1,3,5- 

triazine-2,4-diamine, in or on fruit, 

citrus, group 10; fruit, pome, group 11; 

fruit, stone, group 12; nut, tree, group 

14; pistachio; grape; and olive; each at 

0.01 parts per million (ppm) and 

almond, hulls at 0.20 ppm (PP 9F7589). 

Additionally, Bayer CropScience LP 

requested an import tolerance for 

sugarcane, sugar, refined at 0.01 ppm 

(PP 9E7588). That notice referenced a 

summary of the petitions prepared by 

Bayer CropScience LP, the registrant, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petitions, EPA has 

modified the petitioner’s request by 

lowering the proposed tolerance level 

for almond, hulls from 0.20 ppm to 0.15 

ppm. EPA is also revising the proposed 

commodity term, ‘‘Sugarcane, sugar, 

refined’’ to read ‘‘Sugarcane, refined 

sugar.’’ Additionally, EPA is revising the 

citrus and pome fruit crop group names 

and the requested tolerance expression. 

The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 toxicology database for 

indaziflam is complete and adequate for 

selecting toxicity endpoints for risk 

assessment. The scientific quality of the 

data is relatively high, and the toxicity 

is well-characterized for all types of 

effects, including potential 

developmental, reproductive, 

immunologic and neurologic toxicity. 

Indaziflam has low acute toxicity via 

the oral, dermal, and inhalation routes 

of exposure. It is not irritating to the eye 

or skin and is not a dermal sensitizer. 

The nervous system is a target for 

indaziflam in rats and dogs. In the dog 

degenerative neuropathology of the 

brain, spinal cord and sciatic nerve was 

reported in the dog following both 

subchronic and chronic oral exposure. 

Neuropathology in the dog was the most 

sensitive effect and was selected as the 

risk assessment endpoint for all 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 18901 

repeated exposure scenarios. In the rat, 

histopathology of the brain and pituitary 

pars nervosa was observed following 

chronic exposure. Clinical signs of 

neurotoxicity were observed in both 

species in several studies, including rat 

adult and developmental neurotoxicity 

studies. Decreased motor activity 

observed in the rat acute neurotoxicity 

study was selected as the appropriate 

endpoint for assessing acute oral 

exposures. 

In addition to the neurological 

system, chronic exposure was 

associated with degenerative renal 

effects in the rat and mouse, 

hypertrophy (considered adaptive), 

increased macrovacuolation and 

multinucleated hepatocytes in the rat 

liver, increased follicular cell 

hypertrophy and colloid alteration in 

the rat thyroid, degeneration in rat 

reproductive tissues including 

atrophied seminal vesicles (males), and 

in female mice, blood-filled ovarian 

cysts/follicles (females) and gastric 

lesions. Thyroid and gastric effects were 

also observed following subchronic 

exposure of the rat. Decreased body 

weight gains were generally observed in 

the available subchronic and chronic 

studies. No systemic toxicity was 

observed in a 28-day dermal toxicity 

study in the rat. 

Developmental effects in offspring 

were absent or limited to doses that also 

caused systemic toxicity in the adult. In 

the rat developmental toxicity study, 

decreased fetal weight was observed in 

the presence of maternal effects that 

included decreased body weight and 

clinical signs of toxicity. 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 clinical signs 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. 

There was no evidence of 

carcinogenicity observed in the 2-year 

dietary rat or mouse carcinogenicity 

bioassays and no evidence of 

genotoxicity in mutagenicity studies 

(reverse gene mutation in bacteria, 

forward gene mutation in mammalian 

cells) or in vitro and in vivo 

chromosomal aberration assays. Based 

on the lack of evidence of 

carcinogenicity or genotoxicity, the 

Agency classified indaziflam as ‘‘not 

likely to be carcinogenic to humans.’’ 

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 for use in citrus, stone, and 

pome fruits; grapes; tree nuts; 

pistachios; olives; and sugar cane 

(imported refined sugar),’’ p. 41 in 

docket ID number EPA–HQ–OPP–2009– 

0636. 

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 NOAEL are observed and 

the LOAEL which adverse effects of 

concern are identified. 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 the table below of this unit. 

TABLE—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 females 

13–49 years of age and 

infants and children).

NOAEL = 50 mg/kg/day ....

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.5 mg/kg/day 

aPAD = 0.5 mg/kg/day 

Acute oral neurotoxicity in the rat. LOAEL = 100 mg/ 

kg/day based on decreased motor and locomotor 

activity in females. 

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 oral (dietary) toxicity in the dog. 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) and intermediate-term (1 to 6 

months).

NOAEL= 7.5 mg/kg/day ....

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic oral (gavage) in the dog. LOAEL = 15 mg/ 

kg/day based on axonal degenerative microscopic 

findings in the brain, spinal cord and sciatic nerve. 


erowe on DSK5CLS3C1PROD with RULES
18902 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 

TABLE—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) and intermediate-term (1 to 6 

months).

Dermal (or oral) study 

NOAEL = 7.5 mg/kg/day 

(dermal absorption rate 

= 7.3%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic oral (gavage) in the dog. 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) and intermediate-term (1 to 6 

months).1

Inhalation (or oral) study 

NOAEL= 7.5 mg/kg/day 

(inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic oral (gavage) in the dog. LOAEL = 15 mg/ 

kg/day based on axonal degenerative microscopic 

findings in the brain, spinal cord and sciatic nerve. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not Likely to be Carcinogenic to Humans’’ based on the absence of significant tumor increases in 

the two-year dietary rat and mouse bioassays. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 1EPA selected a point of departure from an oral study to assess short-term residential handler inhalation risks for indaziflam. While it is possible that extrapolation of an inhalation endpoint from an oral study may sometimes underestimate inhalation risk, in this case the Agency believes the risk assessment is protective of adult handlers. MOEs calculated for residential handlers ranged from 3,000 to 510,000, thus providing 

an ample margin of safety to account for any uncertainties in route-to-route extrapolation. Further, the contribution of residential inhalation exposure to aggregate risk is small. 

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. There are no tolerances 

currently established for indaziflam. 

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) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed that residues are 

present in all commodities at the 

tolerance level and that 100% of 

commodities are treated with 

indaziflam. DEEM–FCID, Version 2.03 

default concentration factors were used 

to estimate residues of indaziflam in 

processed commodities with the 

exception of the empirically derived 

raisin processing factor of 2.8x. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed that residues are present in all 

commodities at the tolerance level and 

that 100% of commodities are treated 

with indaziflam. DEEM–FCID, Version 

2.03 default concentration factors were 

used to estimate residues of indaziflam 

in processed commodities with the 

exception of the empirically derived 

raisin processing factor of 2.8x. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified indaziflam as ‘‘Not Likely 

to be Carcinogenic to Humans’’ 

therefore, a dietary exposure assessment 

for the purpose of assessing cancer risk 

is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for indaziflam. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The residues of concern in 

drinking water include indaziflam and 

its degradates: Triazine indanone, 

indaziflam-carboxylic acid, indaziflamolefin, indaziflam-hydroxyethyl, 

fluoroethyl-diaminotriazine (FDAT), 

and dihydroaminotriazine (a degradate 

of FDAT). The Agency used screening 

level water exposure models in the 

dietary exposure analysis and risk 

assessment for indaziflam and its 

degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of indaziflam 

and its degradates. 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 and its degradates for acute 

exposures are estimated to be 84 parts 

per billion (ppb) for surface water and 

3.7 ppb for ground water. The chronic 

exposures for non-cancer assessments 

are estimated to be 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 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 18903 

is currently registered for the following 

uses that could result in residential 

exposures: Residential turfgrass and 

recreational areas. EPA assessed 

residential exposure using the following 

assumptions: There is a potential for 

short-term exposure of homeowners 

applying products containing 

indaziflam on home lawns. There is also 

a potential for short- and intermediateterm post-application exposure of adults 

and children entering lawn and 

recreation areas, including golf courses, 

which have been treated with 

indaziflam. Indaziflam post-application 

inhalation exposures are expected to be 

negligible due to its low vapor pressure, 

low application rates, and the types of 

application equipment used (i.e., handheld equipment that is not likely to 

generate a vapor). Therefore, a 

quantitative post-application inhalation 

exposure assessment was not 

considered necessary. EPA assessed the 

following residential exposure 

scenarios: 

i. Short-term dermal and inhalation 

exposures of residential handlers using 

various types of application equipment 

and formulation types on the proposed 

residential use sites; 

ii. Short-term post-application dermal 

exposures of adults and children 

entering treated turf areas; and 

iii. Short-term postapplication 

incidental oral exposures of children 

from contact with treated turfgrass. 

Since the doses and endpoints 

selected to assess short- and 

intermediate-term exposures are the 

same, a separate quantitative 

intermediate-term assessment was not 

completed; the short-term risk 

assessments are protective of 

intermediate-term risks. 

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. Indaziflam 

and its metabolite 

fluoroethyldiaminotriazine (FDAT) 

contain a triazine moiety within their 

chemical structures. Several triazine 

herbicides were determined by EPA to 

have a common mechanism of toxicity 

based on their ability to disrupt the 

hypothalamic-pituitary-gonadal axis 

(U.S. EPA, 2002). The triazine common 

mechanism group (TCMG) includes 

atrazine, simazine, propazine, and the 

metabolites desethyl-s-atrazine (DEA), 

deisopropyl-s-atrazine (DIA), and 

diaminochlorotriazine (DACT). 

Indaziflam and its metabolite FDAT 

were considered for incorporation into 

the TCMG by EPA based on structure; 

indaziflam, FDAT, and the TCMG 

members contain a common triazine 

moiety. However, EPA determined that 

it would not be appropriate to include 

indaziflam and FDAT in the TCMG for 

the following reasons: 

i. The structure of indaziflam and 

FDAT are unique in that they contain a 

fluoroethyl group at the 2-position of 

the triazine ring, whereas the TCMG 

members contain a chlorine substituent 

at the 2-position of the triazine ring and; 

ii. Indaziflam and FDAT do not elicit 

the same toxicological responses shared 

by the TCMG members. The TCMG 

members cause an increase in mammary 

gland tumors in rats and multiple 

developmental effects such as 

attenuation of the luteinizing hormone 

surge, altered pregnancy outcome, and 

delayed preputial separation. Although 

delayed sexual maturation was observed 

in the rat reproductive toxicity study, 

the effects occurred only at the highest 

dose. None of the other effects 

associated with the TCMG members 

were observed in the carcinogenicity, 

developmental, or reproductive 

guideline studies for indaziflam. In a 

non-guideline study, FDAT delayed 

vaginal patency in a dose-dependent 

manner. However, none of the other 

characteristic developmental effects of 

the TCMG members were observed, and 

this effect only occurred at higher doses 

compared to DACT. Therefore, unlike 

other pesticides for which EPA has 

followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA found that neither 

indaziflam nor its metabolite FDAT 

have 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 pre- and post-natal toxicity 

database for indaziflam includes 

guideline rat and rabbit developmental 

toxicity studies, a 2-generation 

reproduction toxicity study in rats and 

a developmental neurotoxicity study in 

rats. As discussed in Unit III.A., there 

was no evidence of increased pre- or 

post-natal susceptibility of fetuses or 

offspring in any of these studies. 

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 considered complete and includes 

acceptable developmental toxicity 

studies in rats and rabbits, a 

2-generation reproductive toxicity study 

in rats, a developmental neurotoxicity 

in rats, acute and subchronic 

neurotoxicity screening studies in rats, 

and an immunotoxicity study. 

ii. There is no evidence that 

indaziflam results in increased pre- or 

post-natal susceptibility of rats or 

rabbits in the prenatal developmental 

studies of rats in the 2-generation 

reproduction study, or of rats in the 

developmental neurotoxicity study. 

iii. There are no significant residual 

uncertainties in the exposure databases. 

The final report on the stability of 

indaziflam in frozen storage and 

processing data for citrus oil were only 

recently submitted by the petitioner and 

are currently undergoing full review at 

the Agency; however, based on a 

preliminary screening of the data, EPA 

does not expect these studies to have a 

measurable impact on exposure 

estimates for indaziflam. 

a. Storage stability. Preliminary 

information from the study indicates 

that indaziflam is stable in frozen 


erowe on DSK5CLS3C1PROD with RULES
18904 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 

storage over a 25–26 month period, well 

beyond the 17-month period that 

samples from the residue field trials 

were stored frozen prior to analysis. 

b. Citrus oil processing data. 

Although all citrus commodities from 

submitted field trials and a processing 

study have total residues below the 

method limit of quantitation (LOQ) at a 

5× exaggerated application rate, data 

were required for the processed 

commodity citrus oil due to the 

extremely high theoretical concentration 

factor (1000x). Citrus oil was not 

analyzed during the originally 

submitted processing study. Data from 

the recently submitted study indicate 

that indaziflam residues concentrate in 

citrus oil at approximately 11.7x 

compared to those in citrus raw 

agricultural commodities (RACs). Based 

on this preliminary concentration factor, 

the total residues in citrus oil are still 

estimated to be less than the LOQ. 

Therefore, EPA believes that the 

tolerance of 0.01 ppm (the LOQ) for 

citrus fruit is adequate to cover residues 

in citrus oil, as no finite residues would 

be expected in citrus oil even at 

exaggerated rates. 

The dietary food exposure 

assessments were performed assuming 

tolerance-level residues and 100 PCT for 

all commodities. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to indaziflam in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children 

including incidental oral exposure of 

toddlers. 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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to indaziflam will 

occupy 3% of the aPAD for infants, less 

than 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 10% of 

the cPAD for infants, less than 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-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. 

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 2,400 for adults and 1,300 for 

children. For adults, EPA aggregated 

short-term residential handler 

inhalation and dermal exposure with 

chronic dietary exposure from food and 

water. For children, EPA aggregated 

short-term dermal and incidental oral 

residential exposures plus chronic 

dietary exposure from food and water. 

Because EPA’s level of concern for 

indaziflam is for MOEs below 100, 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). 

Since the doses and endpoints selected 

to assess short- and intermediate-term 

exposures to indaziflam are the same, a 

separate quantitative intermediate-term 

assessment was not completed; the 

short-term risk assessments are 

protective of both short- and 

intermediate-term risks. 

5. 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. 

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 indaziflam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry (LC/ 

MS/MS) Method DH–003–P07–02) is 

available to enforce the tolerance 

expression. The method is able to 

determine, separately, residues of 

indaziflam and FDAT. 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; e-mail 

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 U.N. 

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 an 

MRL for indaziflam. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is lowering the almond, hulls 

tolerance proposed at 0.20 ppm to 0.15 

ppm based on analysis of the field trial 

data using the Agency’s NAFTAharmonized tolerance/MRL calculator in 

accordance with the Guidance for 

Setting Pesticide Tolerances Based on 

Field Trial Data. EPA is also revising the 

proposed commodity term, ‘‘Sugarcane, 

sugar, refined’’ to read ‘‘Sugarcane, 

refined sugar’’ to agree with the 

Agency’s Food and Feed Vocabulary. 

Additionally, EPA is revising the 

requested tolerance expression to clarify 

the chemical moieties that are covered 

by the tolerances and specify how 

compliance with the tolerances is to be 

measured. The revised tolerance 

expression makes clear that the 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 18905 

tolerances cover residues of the 

herbicide indaziflam, including its 

metabolites and degradates, but that 

compliance with the tolerance levels is 

to be determined by measuring only 

indaziflam, N-[(1R,2S)-2,3-dihydro-2,6- 

dimethyl-1H-inden-1-yl]-6-(1- 

fluoroethyl)-1,3,5-triazine-2,4-diamine, 

in or on the commodities. 

EPA was petitioned for tolerances on 

citrus fruit group 10 and pome fruit 

group 11. In the Federal Register of 

December 8, 2010 (75 FR 76284) (FRL– 

8853–8), EPA issued a final rule that 

revised the crop grouping regulations. 

As part of this action, EPA expanded 

and revised the existing citrus fruit 

group 10 and pome fruit group 11. 

Changes to crop group 10 included 

adding the specialty commodities 

Australian desert lime, Australian finger 

lime, Australian round lime, Brown 

River finger lime, Japanese summer 

grapefruit, Mediterranean mandarin, 

Mount White lime, New Guinea wild 

lime, Russell River lime, sweet lime, 

Tachibana orange, Tahiti lime, tangelo, 

tangor, trifoliate orange, and uniq fruit; 

creating subgroups; revising the 

representative commodities; and 

naming the new crop group citrus fruit 

group 10–10. Changes to crop group 11 

included adding the specialty 

commodities azarole, medlar, Asian 

pear, Chinese quince, Japanese quince, 

and tejocote; creating subgroups; 

revising the representative commodities; 

and naming the new crop group pome 

fruit group 11–10. EPA indicated in the 

December 8, 2010 final rule as well as 

the earlier January 6, 2010 proposed 

rule (75 FR 807) (FRL–8801–2) that, for 

existing petitions for which a Notice of 

Filing had been published, the Agency 

would attempt to conform these 

petitions to the rule. Therefore, 

consistent with this rule, EPA has 

assessed exposure to the herbicide, 

indaziflam, assuming use under the 

revised crop groups. Because revising 

the requested crop groups to the 

updated crop groups did not result in a 

risk of concern, EPA is proposing to 

establish tolerances for indaziflam 

residues on citrus fruit group 10–10 and 

pome fruit group 11–10. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the herbicide indaziflam, 

including its metabolites and 

degradates, in or on fruit, citrus, group 

10–10 at 0.01 ppm; fruit, pome, group 

11–10 at 0.01 ppm; fruit, stone, group 12 

at 0.01 ppm; nut, tree, group 14 at 0.01 

ppm; pistachio at 0.01 ppm; almond, 

hulls at 0.15 ppm; grape at 0.01 ppm; 

olive at 0.01 ppm; and sugarcane, 

refined sugar at 0.01 ppm. Compliance 

with the tolerance levels is to be 

determined by measuring only 

indaziflam, N-[(1R,2S)-2,3-dihydro-2,6- 

dimethyl-1H-inden-1-yl]-6-(1- 

fluoroethyl)-1,3,5-triazine-2,4-diamine, 

in or on the commodities. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: March 23, 2011. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.653 is added to read as 

follows: 

§ 180.653 Indaziflam; tolerances for 

residues: 

(a) General. Tolerances are 

established for residues of the herbicide 

indaziflam, N-[(1R,2S)-2,3-dihydro-2,6- 

dimethyl-1H-inden-1-yl]-6-(1- 

fluoroethyl)-1,3,5-triazine-2,4-diamine, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

table below is to be determined by 


erowe on DSK5CLS3C1PROD with RULES
18906 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 

measuring only indaziflam, in or on the 

commodity. 

Commodity Parts per 

million 

Almond, hulls ............................ 0.15 

Fruit, citrus, group 10–10 ......... 0.01 

Fruit, pome, group 11–10 ......... 0.01 

Fruit, stone, group 12 ............... 0.01 

Grape ........................................ 0.01 

Nut, tree, group 14 ................... 0.01 

Olive .......................................... 0.01 

Pistachio ................................... 0.01 

Sugarcane, refined sugar 1 ....... 0.01 

1Tolerance without a corresponding U.S. 

registration. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2011–7774 Filed 4–5–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0307; FRL–8864–1] 

Mancozeb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mancozeb in 

or on almonds, cabbage, lettuce, 

peppers, and broccoli. Dow 

AgroSciences LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

6, 2011. Objections and requests for 

hearings must be received on or before 

June 6, 2011, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2005–0307. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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.gpoaccess.gov/ecfr. 

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–2005–0307 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 June 6, 2011. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2005–0307, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of November 

30, 2005 (70 FR 71836) (FRL–7747–5), 

EPA issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PP 3E6536 for 

mandarin oranges/mandarins; PP 

4F4324 for almond nuts and almond 

hulls; PP 4F4333 for broccoli, cabbage, 

lettuce, and peppers) by Dow 

AgroSceinces LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268. The 

petitions requested that 40 CFR 180.176 

be amended by establishing tolerances 

for residues of the fungicide mancozeb, 

zinc manganese ethylenebis 

dithiocarbamate, in or on mandarin 


erowe on DSK5CLS3C1PROD with RULES