61592 Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 

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: September 26, 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 180.626 is amended by 

revising the table in paragraph (a)(1) to 

read as follows: 

§ 180.626 Prothioconazole; tolerances for 

residues. 

(a) * * * (1) * * * 

Commodity Parts per 

million 

Alfalfa, forage ........................... 0 .02 

Alfalfa, hay ................................ 0 .02 

Beet, sugar, roots ..................... 0 .25 

Corn, sweet kernel plus cob 

with husks removed .............. 0 .04 

Grain, aspirated grain fractions 11 

Grain, cereal, forage, fodder 

and straw, group 16, except 

sorghum, and rice; forage ..... 8 .0 

Grain, cereal, forage, fodder 

and straw, group 16, except 

sorghum, and rice; hay ......... 7 .0 

Grain, cereal, forage, fodder 

and straw, group 16, except 

sorghum, and rice; stover ..... 10 

Grain, cereal, forage, fodder 

and straw, group 16, except 

sorghum, straw ..................... 5 .0 

Grain, cereal, group 15, except 

sweet corn and sorghum ...... 0 .35 

Pea and bean, dried shelled, 

except soybean, subgroup 

6C .......................................... 0 .9 

Peanut ...................................... 0 .02 

Potato ....................................... 0 .02 

Rapeseed, seed ....................... 0 .15 

Rice, hulls ................................. 0 .90 

Soybean, forage ....................... 4 .5 

Soybean, hay ............................ 17 

Soybean, seed .......................... 0 .15 

* * * * * 

[FR Doc. 2011–25704 Filed 10–4–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0906; FRL–8874–6] 

Isopyrazam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of isopyrazam in 

or on banana. Syngenta Crop Protection, 

Inc., requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 5, 2011. Objections and 

requests for hearings must be received 

on or before December 5, 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–2009–0906. 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: 

Shaunta Hill, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8961; e-mail address: hill.

shaunta@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 


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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 61593 

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–2009–0906 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 December 5, 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–2009–0906, 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 February 4, 

2010 (75 FR 5790) (FRL–8807–5), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 9E7606) by 

Syngenta Crop Protection, Inc., P.O. Box 

18300, Greensboro, NC 27419–8300. 

The petition requested that 40 CFR part 

180 be amended by establishing a 

tolerance for residues of the fungicide 

isopyrazam, in or on banana at 0.05 

ppm parts per million (ppm). That 

notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, Inc., the registrant, which is 

available in the docket, http://www.

regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 isopyrazam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with isopyrazam 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. Isopyrazam is of 

low acute toxicity by the oral, dermal 

and inhalation routes, and is not a skin 

or eye irritant. The primary target organ 

for isopyrazam toxicity is the liver based 

on subchronic and chronic oral studies 

in the rat, mouse rabbit and dog. The 

principal effects observed in these 

studies are increased organ weight and 

centrilobular hepatocyte hypertrophy. 

Liver toxicity is usually accompanied by 

reductions in body weight and food 

consumption. Isopyrazam does not 

cause reproductive toxicity. 

Developmental effects (eye 

abnormalities) were observed in the 

absence of maternal toxicity in two 

range finding developmental toxicity 

studies in rabbits providing some 

evidence of sensitivity/susceptibility 

following pre- and/or postnatal 

exposure. Developmental studies in rats 

produced developmental effects but 

only at doses that were also maternally 

toxic. Acute and subchronic oral 

neurotoxicity studies in rats show no 

evidence of neurotoxicity. Effects 

characteristic of neurotoxicity (side-toside head wobble, ataxia, reduced 

stability) were observed on day 2 in one 

subchronic oral study in dogs and at 

week 4 in a second subchronic dog 

study. These effects were not observed 

in the chronic dog study. However, EPA 

concluded for the following reasons that 

it is unlikely that there was a neurotoxic 

basis for these effects. First, the effects 

were seen only in a study not 

specifically conducted to identify 

neurotoxic potential and where detailed 

clinical and histopathological analyses 

for neurotoxic effects were not 

performed whereas isopyrazam showed 

no evidence of neurotoxicity in the 

available acute and subchronic 

neurotoxicity studies. Second, 

isopyrazam is not structurally similar to 

known neurotoxicants or neurotoxic 

classes of chemicals. Finally, its 

pesticidal mode of action does not 

demonstrate potential for neurotoxicity. 

Based on these findings, a 

developmental neurotoxicity study for 

isopyrazam is not required. 

There is no evidence of 

immunotoxicity based on a 28-day 

dietary immunotoxicity study in rats. 

The lowest observed adverse effect level 


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61594 Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 

(LOAEL) for immunotoxicity was not 

identified and the no observed adverse 

effect level (NOAEL) for 

immunotoxicity is 1,356 milligrams/ 

kilograms (mg/kg). The study NOAEL 

was 127 mg/kg/day, based on transient 

body weight loss and high liver weights 

at both 608 and 1,356 mg/kg/day. The 

toxicology database for isopyrazam does 

not show any evidence of treatmentrelated effects on the immune system. 

The overall weight of evidence suggests 

that this chemical does not directly 

target the immune system. 

Isopyrazam is classified as ‘‘Likely to 

be Carcinogenic to Humans’’ based on 

tumors in male and female rats. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by isopyrazam as well as the NOAEL 

and the LOAEL from the toxicity studies 

can be found at http://www.regulations.

gov in document ‘‘Isopyrazam Human 

Health Risk Assessment for the 

Establishment of a Tolerance for 

isopyrazam (SYN52043) Fungicide in/ 

on Imported Banana,’’ on pp. 8–12 in 

docket ID number EPA–HQ–OPP–2009– 

0906. 

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 (LOC) 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. 

PODs for incidental oral, dermal and 

inhalation exposure are not needed to 

assess risk for the requested tolerance 

on bananas because use of isopyrazam 

will only lead to dietary exposure, and 

have therefore not been selected for this 

risk assessment. 

The acute POD of 30 mg/kg/day 

(NOAEL) was selected based on the 

NOAEL from a subchronic toxicity 

study in dogs. In that study, clinical 

signs of toxicity (side-to-side head 

wobble) were observed beginning on 

day 2 and continuing throughout the 

study in 1 of 4 male dogs at the LOAEL 

of 100 mg/kg/day. Transient clinical 

signs (side-to-side head wobble, ataxia, 

reduced stability) were also observed at 

300 mg/kg/day in 3 of 4 male dogs on 

days 2 and 3 only. An uncertainty factor 

of 100x (10x to account for interspecies 

extrapolation and 10x for intraspecies 

variation) was applied to the NOAEL to 

obtain an aRfD of 0.30 mg/kg/day. This 

endpoint is considered to occur 

following a single dose and is applicable 

to the population of concern (general 

population, including infants and 

children). It is considered to be a very 

conservative endpoint since it is based 

on observations in 1/4 dogs and these 

acute clinical signs were not reproduced 

in a second 90-day study in dogs or in 

the chronic dog study. This endpoint is 

also protective of the effects seen at the 

limit dose (2,000 mg/kg/day) in the 

acute neurotoxicity study in rats 

(decreased rearing and locomotor 

activity) and the developmental effect 

(bilateral microphthalmia) in the 

developmental rabbit studies (at doses 

≥400 mg/kg/day). Therefore, a separate 

acute dietary endpoint for females of 

reproductive age is not necessary. As 

discussed in this unit, EPA has reduced 

the Food Quality Protection Act (FQPA) 

Safety Factor (SF) to 1x, and thus the 

acute Population Adjusted Dose (aPAD) 

is equivalent to the acute Reference 

Dose (aRfD). 

The chronic POD of 5.5 mg/kg/day 

was selected based on the NOAEL in a 

chronic toxicity/carcinogenicity feeding 

study in rats. The LOAEL in that study 

was 27.6 mg/kg/day based on decreased 

body weight and body weight gain in 

females; increased incidences of 

hepatocellular hypertrophy, pigment in 

centrilobular hepatocytes, eosinophilic 

foci of altered hepatocytes, vacuolation 

of centrilobular hepatocytes, bile duct 

hyperplasia, and bile duct fibrosis in 

both sexes; and brown pigment in the 

kidney in females. An uncertainty factor 

of 100x (10x to account for interspecies 

extrapolation and 10x for intraspecies 

variation) was applied to the dose to 

obtain the chronic reference dose (cRfD) 

of 0.055 mg/kg/day. As discussed in this 

unit, EPA has reduced the FQPA SF to 

1x, and thus, the chronic population 

adjusted dose (cPAD) is equivalent to 

the cRfD. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to isopyrazam, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from isopyrazam 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. 

A conservative acute dietary (food 

only) exposure analysis was performed 

for the general U.S. population and 

various population subgroups. 

Tolerance level residues and 100 

percent crop treated (PCT) assumptions 

were used. Dietary Exposure Evaluation 

Model (DEEM) default processing 

factors were used for processed 

commodities, since separate tolerances 

are not considered necessary for 

processed banana commodities. 

ii. Chronic exposure. Conservative 

chronic and cancer dietary (food only) 

exposure analyses were performed for 

the general U.S. population and various 

population subgroups. Tolerance level 

residues and 100 PCT assumptions were 

used. DEEM default and empirical 

processing factors were used for banana 

processed commodities, since separate 

tolerances for these commodities were 

not considered necessary. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

non-linear approach is used and a 

cancer RfD is calculated based on an 

earlier noncancer key event. If 

carcinogenic mode of action data are not 

available, or if the mode of action data 

determines a mutagenic mode of action, 

a default linear cancer slope factor 

approach is utilized. Based on the data 

summarized in Unit III.A., EPA has 

concluded that isopyrazam should be 

classified as ‘‘Likely to be Carcinogenic 

to Humans’’. 

A linear quantification of 

carcinogenic potential was required for 

isopyrazam based on rat tumors. A 

cancer slope factor or Q1* of 0.00629 

(mg/kg/day) ¥1 was calculated based on 


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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 61595 

an increase in liver adenomas and/or 

carcinomas in female rats. The resulting 

cancer aggregate (food) exposure 

estimate was less than the level of 

concern. Cancer risk was 1.3 × 10¥7 for 

the general U.S. population. Cancer risk 

was quantified using the same estimates 

as discussed in Unit III.C.1.ii. 

2. Dietary exposure from drinking 

water. An assessment of residues in 

drinking water is not needed because 

there is no drinking water exposure 

associated with the establishment of a 

tolerance on imported crops. 

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). 

Isopyrazam is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found isopyrazam to 

share a common mechanism of toxicity 

with any other substances, and 

isopyrazam does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that isopyrazam 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 SF. In applying this provision, 

EPA either retains the default value of 

10x, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There is some evidence for increased 

susceptibility following pre- and or 

postnatal exposures based on effects 

seen in range finding developmental 

toxicity studies in rabbits. 

Developmental effects (eye 

abnormalities) were observed in two 

preliminary developmental studies in 

Himalayan rabbits in the absence of 

maternal toxicity. These effects occurred 

at relatively high doses (200–400 mg/kg/ 

day). There was no evidence of 

increased susceptibility in the main 

study in New Zealand white rabbits. In 

range finding and definitive 

developmental toxicity studies in rats, 

neither quantitative nor qualitative 

evidence of increased susceptibility of 

fetuses to in utero exposure to 

isopyrazam was observed. There was no 

evidence of increased susceptibility in a 

2-generation reproduction study 

following pre- or postnatal exposure to 

isopyrazam. There is no evidence of 

neuropathology or abnormalities in the 

development of the fetal nervous system 

from the available toxicity studies 

conducted with isopyrazam. Clear 

NOAELs/LOAELs were established for 

the developmental effects seen in rats 

and rabbits as well as for the offspring 

effects seen in the 2-generation 

reproduction study and a dose-response 

relationship for the effects of concern is 

well characterized. The dose used for 

the acute dietary risk assessment (30 

mg/kg/day), based on effects seen in the 

subchronic dog study, is protective of 

the developmental and offspring effects 

seen in rabbits at 200–400 mg/kg/day. 

Based on these considerations, there are 

no residual uncertainties for pre-and/or 

postnatal susceptibility. 

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 

isopyrazam is complete and adequate 

for assessing increased susceptibility 

under FQPA; 

ii. There is no indication of increased 

susceptibility of fetuses to in utero and/ 

or postnatal exposure in the 

developmental and reproductive 

toxicity studies in rats; 

There is some evidence for increased 

susceptibility following pre- and or 

postnatal exposures based on effects 

seen in range finding developmental 

toxicity studies in rabbits. However, 

based on the discussion above, EPA has 

concluded that there are no residual 

uncertainties for pre-and/or postnatal 

susceptibility. 

iii. The dietary risk assessment is 

based on parent plus metabolite 

residues in/on banana, and will not 

underestimate dietary exposure to 

isopyrazam. For the acute, chronic and 

cancer dietary analyses, tolerance level 

residues of parent plus metabolite and 

100 PCT assumptions were used for all 

treated commodities. There are no 

residual uncertainties identified in the 

exposure databases. 

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 margin 

of exposure (MOE) exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to isopyrazam will 

occupy less than 1% of the aPAD for all 

populations. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to isopyrazam 

from food will utilize less than 1% of 

the cPAD for all populations receiving 

the greatest exposure. There are no 

residential uses for isopyrazam. 

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). Isopyrazam is not 

registered in the U.S. Short-term risk is 

assessed based on short-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for 

isopyrazam. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 


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61596 Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 

exposure to food and water (considered 

to be a background exposure level). 

Isopyrazam is not registered in the U.S. 

Intermediate-term risk is assessed based 

on intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for isopyrazam. 

5. Aggregate cancer risk for U.S. 

population. The Cancer Assessment 

Review Committee (CARC) classified 

isopyrazam as Likely to be Carcinogenic 

to Humans. This classification was 

based on the presence of thyroid 

follicular cell tumors in male rats, and 

liver and uterine tumors in female rats 

at doses that were adequate to evaluate 

the carcinogenic potential of 

isopyrazam. No treatment-related 

tumors were seen in mice. There is no 

mutagenic concern for isopyrazam. 

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 isopyrazam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Method GRM006.01B) 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 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 a MRL 

for isopyrazam on banana. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of isopyrazam, in or on 

banana at 0.05 ppm. 

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: September 27, 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 180.654 is added to read as 

follows: 

§ 180.654 Isopyrazam; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

isopyrazam, including its metabolites 

and degradates, in or on the commodity 


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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 61597 

listed below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

isopyrazam, 3-difluoromethyl-1-methyl1H-pyrazole-4-carboxylic acid (9- 

isopropyl-1,2,3,4-tetrahydro-1,4- 

methano-naphthalen-5-yl)-amide, in or 

on the following commodity. 

Commodity Parts per 

million 

Banana1 .................................... 0.05 

1There is no U.S. registration for use of 

isopyrazam on banana. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2011–25707 Filed 10–4–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Parts 18 and 19 

RIN 2105–AD60 

Grants and Cooperative Agreements to 

State and Local Governments: DOT 

Amendments on Regulations on 

Uniform Administrative Requirements 

for Grants and Agreements With 

Institutions of Higher Education, 

Hospitals and Other Non-Profit 

Organizations 

AGENCY: Department of Transportation 

(DOT), Office of the Secretary (OST). 

ACTION: Final rule. 

SUMMARY: The Department of 

Transportation (DOT) is adopting a 

public proposal on Grants and 

Cooperative Agreements to State and 

Local Governments; Grants and 

Agreements with Institutions of Higher 

Education, Hospitals and Other NonProfit Organizations. The rule amends 

Department of Transportation 

regulations on uniform administrative 

requirements for grants and agreements 

with Institutions of Higher Education, 

Hospitals and other Non-profit 

Organizations. Specifically, the DOT is 

making requirements for these grants 

and agreements consistent with the 

uniform administrative requirements for 

grants and cooperative agreements to 

State and Local governments. In 

addition, this rule updates references to 

applicable cost principles for grants and 

cooperative agreements with State and 

Local Governments that appear in 

current Department of Transportation 

regulations. 

DATES: This rule is effective November 

4, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Shields, Office of the Senior 

Procurement Executive, Office of 

Administration (M–61), (202) 366– 

4268, 1200 New Jersey Avenue, SE., 

Washington, DC 20590–0001. Office 

hours are from 7:45 a.m. to 4:15 p.m. 

e.t., Monday through Friday, except 

Federal holidays. 

Background 

Regulations governing two types of 

U.S. Department of Transportation grant 

and cooperative agreements recipients 

are found in Parts 18 and 19 of Title 49 

of the Code of Federal Regulations: 

1. 49 CFR part 18: Uniform 

Administrative Requirements for Grants 

and Cooperative Agreements to State 

and Local Governments. 

2. 49 CFR part 19: Uniform 

Administrative Requirements for Grants 

and Agreements with Institutions of 

Higher Education, Hospitals, and Other 

Non-Profit Organizations. 

Both of these parts contain a 

provision that governs allowable costs. 

However, 49 CFR 18.22 imposes specific 

limitations on the use of grant funds 

while 49 CFR 19.27 merely lists cost 

principles applicable to each kind of 

grant and agreement recipient. 

Specifically, under 49 CFR 18.22(a), 

grant funds may only be used for: 

(1) The allowable costs of the 

grantees, subgrantees and cost-type 

contractors, including allowable costs in 

the form of payments to fixed-price 

contractors; and 

(2) Reasonable fees or profit to costtype contractors but not any fee or profit 

(or other increment above allowable 

costs) to the grantee or subgrantee. 

Public comments on this matter were 

solicited in a Federal Register notice 

dated May 2, 2008. Only one comment 

was received, from Robert Taylor, 

regarding the Office of Management and 

Budget (OMB) cost principle circulars as 

well as revisions prohibiting the 

payment of profit or fee to grantees and 

subgrantee covered by 49 CFR part 19. 

This comment did not pertain to the 

content of the proposed rule. Therefore, 

we are adopting the proposed rule 

without change. 

This rule imposes the same limitation 

on the use of funds used for Grants and 

Agreements with Institutions of Higher 

Education, Hospitals, and Other NonProfit Organizations as there are on the 

use of funds used for Uniform 

Administrative Requirements for Grants 

and Cooperative Agreements to State 

and Local Governments. 

In addition, this rule updates 

references to applicable cost principles 

for grants and cooperative agreements 

with State and Local Governments that 

appear in 49 CFR 18.22(b) and include 

comparable updates references in 49 

CFR 19.27(b). These updated references 

are necessary in light of the 

establishment of title 2 of the Code of 

Federal Regulations in 2004. Subtitle A 

of title 2 of the Code of Federal 

Regulations consists of governmentwide guidance from the Office of 

Management and Budget (OMB) to 

Federal agencies for grants and other 

financial assistance and 

nonprocurement agreements that 

previously had been contained in seven 

separate OMB circulars and other OMB 

policy documents. Currently, 49 CFR 

18.22(b) references three specific OMB 

circulars that are now codified in 

several Parts in chapter II, subtitle A of 

title 2 of the Code of Federal 

Regulations. This rule amends 49 CFR 

18.22(b) by replacing the citations to 

these former OMB circulars with the 

appropriate references in title 2 of the 

Code of Federal Regulations and would 

reflect these same changes in 49 CFR 

19.27(b). 

The rule also makes minor referencing 

revisions to the Office of Management 

and Budget (OMB) cost principle 

circulars and, consistent with OMB 

materials, revises prohibitions on 

payment of profit or fee to grantees and 

subgrantees covered by 49 CFR part 19. 

The revised referencing is needed as the 

OMB cost circulars have been published 

in Title II of the Code of Federal 

Regulations since August 2005. 

However, these OMB circulars are only 

published as guidance (see 2 CFR 

1.105(a)). Also, the OMB circular 

number has been retained in the title of 

each circular, for example, 2 CFR part 

225, Cost Principles for State and Local 

Governments (OMB Circular A–87). 

The title for the CFR part 19, which 

includes the OMB Circular number in 

the title, is included in the reference for 

all three cost principles. In addition, 

this makes the formatting of all titles in 

49 CFR sections 18.22 and 18.27 

consistent. 

Rulemaking Analyses and Notices 

Executive Order 12866 (Regulatory 

Planning and Review) and DOT 

Regulatory Policies and Procedures 

The DOT has determined that this 

document does not constitute a 

significant rule within the meaning of 

Executive Order 12866 or within the 

meaning of Department of 

Transportation regulatory policies and 

procedures. DOT anticipates that the 


jlentini on DSK4TPTVN1PROD with RULES