34252 Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations 

a. ‘‘Commercial Base Price,’’ 

‘‘Commercial Base Pricing,’’ or 

‘‘ComBasPrice.’’ 

b. ‘‘Commercial Plus Price,’’ 

‘‘Commercial Plus Pricing,’’ or 

‘‘ComPlsPrice.’’ 

* * * * * 

420 Priority Mail 

* * * * * 

425 Mail Preparation 

* * * * * 

2.0 Marking 

[Reorganize and revise section 2.0 as 

follows:] 

2.1 Product Marking 

The marking ‘‘Priority Mail’’ must be 

placed prominently on the address side 

of each piece of Priority Mail. 

2.2 Price Marking 

Except for pieces paid using permit 

imprint, Priority Mail pieces claiming 

the commercial base or commercial plus 

price must bear the appropriate price 

marking, printed on the piece or 

produced as part of the meter imprint or 

PC Postage indicia. Place the marking 

directly above, directly below, or to the 

left of the postage. Markings are as 

follows: 

a. ‘‘Commercial Base Price,’’ 

‘‘Commercial Base Pricing,’’ or 

‘‘ComBasPrice.’’ 

b. ‘‘Commercial Plus Price,’’ 

‘‘Commercial Plus Pricing,’’ or 

‘‘ComPlsPrice.’’ 

* * * * * 

Stanley F. Mires, 

Attorney, Legislative. 

[FR Doc. E9–16205 Filed 7–14–09; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0458; FRL–8423–8] 

Fenamidone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenamidone in 

or on cilantro, leaves; grape; okra; 

turnip, greens; and vegetable, root, 

except sugar beet, subgroup 1B, except 

radish; and combined residues of 

fenamidone and its metabolite RPA 

717879 in or on corn, field, forage; corn, 

field, grain; corn, field, stover; corn, 

sweet, forage; corn, sweet, kernel plus 

cob with husks removed; corn, sweet, 

stover; soybean, forage; soybean, hay; 

and soybean, seed. It also removes 

existing permanent and time-limited 

tolerances on carrot that are superseded 

by the new tolerance on vegetable, root, 

except sugar beet, subgroup 1B, except 

radish. The new tolerance on grape will 

be a tolerance with regional registration 

(East of the Rocky Mountains) and will 

replace the current tolerance which is 

restricted to imported grapes. 

Interregional Research Project Number 4 

(IR–4) and Bayer CropScience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

15, 2009. Objections and requests for 

hearings must be received on or before 

September 14, 2009, 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–2008–0458. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2008–0458 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before September 14, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations 34253 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0458, 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. Petition for Tolerance 

In the Federal Registers of June 13, 

2008 (73 FR 33814) (FRL–8367–3) and 

December 3, 2008 (73 FR 73644) (FRL 

8386–9), EPA issued notices pursuant to 

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

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

pesticide petition (PP 8E7350) by 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, Suite 

201W, Princeton, NJ 08540; and a 

pesticide petition (PP 8F7410) by Bayer 

CropScience, 2 T.W. Alexander Dr., 

Research Triangle Park, NC 27709. PP 

8E7350 requested that 40 CFR 180.579 

be amended by establishing tolerances 

for residues of the fungicide 

fenamidone, 4H-Imidazol-4-one, 3,5- 

dihydro-5-methyl-2-(methylthio)-5- 

phenyl-3-(phenylamino)-, (S)-, in or on 

vegetables, root, except sugar beet, 

subgroup 1B, except radish at 0.2 parts 

per million (ppm); turnip, leaves at 55 

ppm; coriander, leaves at 60 ppm; okra 

at 3.5 ppm; and a tolerance with 

regional registration for residues of 

fenamidone on grape at 1.0 ppm. The 

grape tolerance would replace an 

existing grape tolerance that was 

established only to address the 

importation of grapes containing 

fenamidone residues. PP 8F7410 

requested that 40 CFR 180.579 be 

amended by establishing tolerances for 

indirect or inadvertent residues of 

fenamidone and its metabolite RPA 

717879, 2,4-imidazolidinedione, 5- 

methyl-5-phenyl, in or on corn, field, 

forage at 0.50 ppm; corn, field grain at 

0.02 ppm; corn, stover at 0.35 ppm; 

corn, sweet, forage at 0.15 ppm; corn, 

sweet, kernel plus cob with husks 

removed at 0.02 ppm; soybean, forage at 

0.20 ppm; soybean, hay at 0.20 ppm; 

and soybean, seed at 0.02 ppm (all in PP 

8F7410). The notices referenced 

summaries of the petitions prepared by 

Bayer CropScience, the registrant, 

which are available to the public in 

docket ID numbers EPA–HQ–OPP– 

2008–0458 (PP 8E7350) and EPA–HQ– 

OPP–2006–0848 (PP 8F7410) at http:// 

www.regulations.gov. There were no 

comments received in response to the 

notices of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the commodity terms, and/or tolerance 

levels for several commodities. EPA also 

determined that separate tolerances 

should be established on stover from 

field and sweet corn. 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 the petitioned-for 

tolerances for residues of fenamidone on 

cilantro, leaves at 60 ppm; okra at 3.5 

ppm; turnip, greens at 55 ppm; and 

vegetable, root, except sugar beet, 

subgroup 1B, except radish at 0.15 ppm; 

a tolerance with regional registration in 

or on grape at 1.0 ppm; and tolerances 

for combined residues of fenamidone 

and its metabolite RPA 717879 in or on 

corn, field, forage at 0.25 ppm; corn, 

field, grain at 0.02 ppm; corn, field, 

stover at 0.40 ppm; corn, sweet, forage 

at 0.15 ppm; corn, sweet, kernel plus 

cob with husks removed at 0.02 ppm; 

corn, sweet, stover at 0.20 ppm; 

soybean, forage at 0.15 ppm; soybean, 

hay at 0.25 ppm; and soybean, seed at 

0.02 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing tolerances 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. 

Fenamidone has low acute toxicity 

via the oral, dermal and inhalation 

routes of exposure. It is a moderate eye 

irritant, but is not a dermal irritant or a 

dermal sensitizer. The liver is the target 

organ in chronic studies in the rat, 

mouse and dog. The thyroid is also a 

target organ in the rat. There is no 

evidence of immunotoxicity in the 

available toxicity studies with 

fenamidone and no indication of 

carcinogenicity in the carcinogenicity 

studies conducted in rats and mice. EPA 

has classified fenamidone as ‘‘not likely 

to be a human carcinogen’’ by all 

relevant routes of exposure. 

Fenamidone did not demonstrate any 

qualitative or quantitative increased 

susceptibility of fetuses or offspring in 

the rat and rabbit developmental 

toxicity studies or the 2–generation rat 

reproduction study. In the rat 

reproduction study (Sprague Dawley 

rat), decreased absolute brain weight 

and pup body weight occurred at the 

same dose levels as decreased absolute 

brain weight and parental body weight, 

food consumption and increased liver 

and spleen weight. Developmental 

toxicity (decreased fetal weights and 

incomplete ossification) was observed 

in the rat only at the limit dose. 

Fenamidone did not produce 

developmental toxicity in the rabbit or 

reproductive toxicity in the rat. 

No treatment-related effects were 

observed on motor activity or in the 

functional observation battery (FOB) 

parameters measured in the subchronic 

neurotoxicity study in rats. In this 

subchronic neurotoxicity study, 

marginal decreases in brain weights 

were observed only in high dose males. 

In the acute neurotoxicity study in rats, 

the most commonly observed clinical 

sign was staining/soiling of the 

anogenital region. Other day–1 FOB 

findings included mucous in the feces, 


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hunched posture and unsteady gait. In 

a developmental neurotoxicity study in 

Wistar rats, no neurobehavioral effects 

and no neuropathological changes were 

observed at any dose in the offspring, 

but decreased body weight was 

observed during pre- and post-weaning. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenamidone 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 the document 

Fenamidone. Human Health Risk 

Assessment to Support Section 3 

Proposals to Add New Uses on the Root 

Vegetable Subgroup 1B (except radish), 

Okra, Turnip Greens, Cilantro Leaves, 

Grapes Grown East of the Rock 

Mountains and Rotational Crop Uses for 

Field Corn, Sweet Corn and Soybeans, 

page 30 in docket ID number EPA–HQ– 

OPP–2008–0458. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 fenamidone used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document Fenamidone. Human Health 

Risk Assessment to Support Section 3 

Proposals to Add New Uses on the Root 

Vegetable Subgroup 1B (except radish), 

Okra, Turnip Greens, Cilantro Leaves, 

Grapes Grown East of the Rock 

Mountains and Rotational Crop Uses for 

Field Corn, Sweet Corn and Soybeans, 

page 12 in docket ID number EPA–HQ– 

OPP–2008–0458. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenamidone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fenamidone tolerances in 40 

CFR 180.579. EPA assessed dietary 

exposures from fenamidone 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. 

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 Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed that 100% of all 

crops with existing or proposed 

registrations are treated with 

fenamidone and that residues are 

present at maximum field trial levels. 

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 100% of all crops with 

existing or proposed registrations are 

treated with fenamidone and that 

residues are present at maximum field 

trial levels. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified fenamidone as ‘‘not 

likely to be carcinogenic to humans;’’ 

therefore, an exposure assessment for 

evaluating cancer risk is not needed for 

this chemical. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

EPA did not use PCT information in 

assessing dietary exposure to 

fenamidone. 

2. Dietary exposure from drinking 

water. The fenamidone residues of 

toxicological concern in drinking water 

include parent fenamidone and its 

degradation products, RPA 412636, RPA 

412108, RPA 411639, RPA 413255, RPA 

409446, and RPA 410995. The Agency 

used screening level water exposure 

models in the dietary exposure analysis 

and risk assessment for fenamidone and 

its degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fenamidone 

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 (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fenamidone and its degradates for acute 

exposures are estimated to be 47.88 

parts per billion (ppb) for surface water 

and 176 ppb for ground water. The 

EDWCs of fenamidone and its 

degradates for chronic exposures for 

non-cancer assessments are estimated to 

be 12.86 ppb for surface water and 176 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute and chronic dietary risk 

assessment, the water concentration 

value of 176 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 


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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). 

Fenamidone 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 fenamidone to 

share a common mechanism of toxicity 

with any other substances, and 

fenamidone does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fenamidone 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 website 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 postnatal toxicity database 

for fenamidone includes rat and rabbit 

developmental toxicity studies, a rat 

developmental neurotoxicity study 

(DNT) and a 2–generation reproduction 

toxicity study in rats. No evidence of 

increased quantitative or qualitative 

susceptibility of rat or rabbit fetuses to 

in utero exposure was observed in the 

developmental toxicity studies. There 

was no developmental toxicity in rabbit 

fetuses up to 100 milligrams/kilogram/ 

day (mg/kg/day), the highest dose tested 

(HDT); whereas an increase in absolute 

liver weight was observed in the does at 

30 and 100 mg/kg/day. Since the liver 

was identified as one of the principal 

target organs in rodents and dogs, the 

occurrence of this finding in rabbits at 

30 and 100 mg/kg/day was considered 

strong evidence of maternal toxicity. In 

the rat developmental study, 

developmental toxicity manifested as 

decreased fetal body weight and 

incomplete fetal ossification in the 

presence of maternal toxicity in the 

form of decreased body weight and food 

consumption at the limit dose (1,000 

mg/kg/day). The effects at the limit dose 

were comparable between fetuses and 

dams. No quantitative or qualitative 

evidence of increased susceptibility was 

observed in the 2–generation 

reproduction study in rats. In that study, 

both the parental and offspring LOAELs 

were based on decreased absolute brain 

weight in female F1 adults and female 

F2 offspring at 89.2 mg/kg/day. At 438.3 

mg/kg/day, parental effects consisted of 

decreased body weight and food 

consumption, and increased liver and 

spleen weight. Decreased pup body 

weight was also observed at the same 

dose level of 438.3 mg/kg/day. There 

were no effects on reproductive 

performance up to 438.3 mg/kg/day 

(HDT). 

The results of the DNT study 

indicated an increased susceptibility of 

offspring. There was no maternal 

toxicity at the HDT (429 mg/kg/day). 

Effects in the offspring included 

decreased body weight (9–11%) and 

body weight gain (8–20%) during preweaning and decreased body weight (4– 

6%) during post-weaning at 429 mg/kg/ 

day (LOAEL). There were no 

neurobehavioral effects and no 

neuropathological changes at any dose 

in the offspring. The concern for the 

increased susceptibility observed in the 

DNT is low because: 

i. Of the lack of neurobehavioral or 

neuropathological changes in the 

offspring at any dose; 

ii. A clear NOAEL for the adverse 

effects in the study was identified; 

iii. The endpoints used for the various 

risk assessment scenarios are much 

more sensitive than that of the 

decreased bodyweight of the offspring 

occurring at almost half the limit-dose 

(429 mg/kg/day); and 

iv. The NOAELs of 10.4, 5.4 and 2.83 

mg/kg/day used for short-term, 

intermediate-term and long-term risk 

assessments, respectively, are 

considerably (9–45 fold) lower than the 

offspring NOAEL of 92.3 mg/kg/day in 

the DNT. 

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 

fenamidone is adequate to assess the 

pre- and postnatal toxicity of 

fenamidone. In accordance with the 

revised 40 CFR part 158 Data 

Requirements for Pesticides, an 

immunotoxicity study (870.7800) is 

required for fenamidone. In the absence 

of specific immunotoxicity studies, EPA 

has evaluated the available fenamidone 

toxicity data to determine whether an 

additional database uncertainty factor is 

needed to account for potential 

immunotoxicity. There was no evidence 

of adverse effects on the organs of the 

immune system in any study with 

fenamidone, and fenamidone does not 

belong to a class of chemicals (e.g., the 

organotins, heavy metals, or 

halogenated aromatic hydrocarbons) 

that would be expected to be 

immunotoxic. Based on these 

considerations, EPA does not believe 

that conducting immunotoxicity testing 

will result in a point of departure lower 

than those already selected for 

fenamidone; therefore, an additional 

database uncertainty factor is not 

needed to account for potential 

immunotoxicity. 

ii. There was no evidence of 

neurotoxicity in the subchronic 

neurotoxicity study submitted for 

fenamidone. There was evidence of 

neurotoxicity (urination, staining/ 

soiling of the anogenital region, mucous 

in the feces and unsteady gait in 

females) in the acute neurotoxicity 

study, and EPA used the NOAEL from 

this study to assess acute dietary 

exposure. There was also evidence of 

neurotoxicity (decreased absolute brain 

weights) in the 2–generation rat 

reproduction study; however, there was 

no indication of increased susceptibility 

of offspring with regard to these effects. 

Finally, there was no evidence of 

neurotoxicity at any dose in the 

submitted DNT study. Based on the 

results of these studies, EPA concluded 

that there is no need for additional UFs 

to account for neurotoxicity. 

iii. There is no evidence that 

fenamidone results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in offspring in the 2–generation 

reproduction study. Although there is 

evidence of increased quantitative 

susceptibility in the DNT study, the 

degree of concern is low and the Agency 

did not identify any residual 

uncertainties after establishing toxicity 


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34256 Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations 

endpoints and traditional UFs to be 

used in the risk assessment of 

fenamidone. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on reliable data 

from residue field trials and assuming 

100 PCT. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fenamidone in 

drinking water. Residential exposure is 

not expected from the existing and new 

uses of fenamidone. These assessments 

will not underestimate the exposure and 

risks posed by fenamidone. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute 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 fenamidone will 

occupy 5% of the aPAD for children, 1 

to 2 years 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 fenamidone 

from food and water will utilize 88% of 

the cPAD for children, 1 to 2 years old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for fenamidone. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure take into account 

short-term or intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Fenamidone is not registered for any use 

patterns that would result in residential 

exposure. Therefore, the short-term or 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

fenamidone through food and water and 

will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Fenamidone is classified as 

‘‘not likely to be carcinogenic to 

humans’’ and is, therefore, not expected 

to pose a cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fenamidone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatographic method 

coupled with tandem mass spectrum 

detection (LC/MS/MS)) 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 

There are no Codex, Canadian or 

Mexican MRLs (maximum residue 

levels) for residues of fenamidone in or 

on any of the commodities requested in 

these petitions. 

C. Revisions to Petitioned-for Tolerances 

EPA has revised the commodity terms 

and/or tolerance levels for several 

commodities. EPA revised the 

commodity terms proposed by IR–4 as 

‘‘vegetables, root, except sugar beet, 

subgroup 1B, except radish’’; 

‘‘coriander, leaves’’; and ‘‘turnip, 

leaves’’ to read ‘‘vegetable, root, except 

sugar beet, subgroup 1B, except radish’’; 

‘‘cilantro, leaves’’; and ‘‘turnip, greens’’; 

and determined that separate tolerances 

were needed for stover from field and 

sweet corn (i.e., ‘‘corn, field, stover’’ and 

‘‘corn, sweet, stover’’) to agree with the 

Food and Feed Vocabulary. EPA revised 

the tolerance level for ‘‘vegetable, root, 

except sugar beet, subgroup 1B, except 

radish’’ from 0.2 ppm to 0.15 ppm to 

agree with the existing tolerance on 

carrot, the representative commodity on 

which the proposed tolerance was 

based. EPA revised the tolerances for 

‘‘corn, field, forage’’ from 0.50 ppm to 

0.25 ppm’’; ‘‘corn, field, stover’’ from 

0.35 ppm to 0.40 ppm; ‘‘corn, sweet, 

stover’’ from 0.35 ppm to 0.20 ppm; 

‘‘soybean, forage’’ from 0.20 ppm to 0.15 

ppm; and ‘‘soybean, hay’’ from 0.20 

ppm to 0.25 based on analyses of field 

trial data using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fenamidone, 

4H-Imidazol-4-one, 3,5-dihydro-5- 

methyl-2-(methylthio)-5-phenyl-3-

(phenylamino)-, (S)-, on cilantro, leaves 

at 60 ppm; okra at 3.5 ppm; turnip, 

greens at 55 ppm; and vegetable, root, 

except sugar beet, subgroup 1B, except 

radish at 0.15 ppm; a tolerance with 

regional registration is established for 

residues of fenamidone in or on grape 

at 1.0 ppm; and tolerances are 

established for combined residues of 

fenamidone and its metabolite RPA 

717879 in or on corn, field, forage at 

0.25 ppm; corn, field, grain at 0.02 ppm; 

corn, field, stover at 0.40 ppm; corn, 

sweet, forage at 0.15 ppm; corn, sweet, 

kernel plus cob with husks removed at 

0.02 ppm; corn, sweet, stover at 0.20 

ppm; soybean, forage at 0.15 ppm; 

soybean, hay at 0.25 ppm; and soybean, 

seed at 0.02 ppm. The existing 

permanent and time-limited tolerances 

on carrot are removed, since residues on 

carrots will be covered by the new 

tolerance on vegetable, root, except 

sugar beet, subgroup 1B, except radish. 

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). 


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Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations 34257 

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) (Public Law 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: July 1, 2009. 

G. Jeffery Herndon, 

Acting 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 180.579 paragraph (a)(1) 

table is amended by removing the 

commodities ‘‘carrot’’ and ‘‘grape 

(imported)’’ and adding the following 

commodities; by removing and 

reserving paragraph (b); by revising 

paragraph (c); and by adding the 

following commodities to the table in 

paragraph (d) to read as follows: 

§ 180.579 Fenamidone; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per million 

* * * * * 

Cilantro, leaves ............... 60 

* * * * * 

Okra ................................ 3.5 

* * * * * 

Turnip, greens ................ 55 

* * * * * 

Vegetable, root, except 

sugar beet, subgroup 

1B, except radish ........ 0.15 

* * * * * 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. A tolerance with regional 

registration as defined in §180.1(m) is 

established for residues of fenamidone, 

4H-Imidazol-4-one, 3,5-dihydro-5- 

methyl-2-(methylthio)-5-phenyl-3- 

(phenylamino)-, (S)-, in or on the 

following commodity: 

Commodity Parts per million 

Grape1 ............................ 1.0 

1Applicable to grapes grown East of the 

Rocky Mountains. 

(d) Indirect or inadvertent residues. * 

* * 

Commodity Parts per million 

Corn, field, forage ........... 0.25 

Corn, field, grain ............. 0.02 

Corn, field, stover ........... 0.40 

Corn, sweet, forage ........ 0.15 

Commodity Parts per million 

Corn, sweet, kernel plus 

cob with husks removed ......................... 0.02 

Corn, sweet, stover ........ 0.20 

Soybean, forage ............. 0.15 

Soybean, hay .................. 0.25 

Soybean, seed ................ 0.02 

* * * * * 

[FR Doc. E9–16817 Filed 7–14–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 745 

[EPA–HQ–OPPT–2005–0049; FRL–8422–7] 

RIN 2070–AJ48 

Lead; Minor Amendments to the 

Renovation, Repair, and Painting 

Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is issuing a final rule 

making two minor revisions to the final 

Lead Renovation, Repair, and Painting 

Program (RRP) rule that published in 

the Federal Register on April 22, 2008. 

First, this final rule requires accredited 

providers of renovator or dust sampling 

technician training to submit postcourse notifications, including digital 

photographs of each successful trainee, 

to EPA. The 2008 rule establishes 

accreditation, training, certification, and 

recordkeeping requirements as well as 

work practice standards on persons 

performing renovations for 

compensation in most pre-1978 housing 

and child-occupied facilities. The postcourse notification requirement, 

designed to supply important 

information for EPA’s compliance 

monitoring efforts, was inadvertently 

omitted from the final RRP rule’s 

regulatory text. In addition, this final 

rule removes the requirement for 

accredited lead-based paint activities 

training providers—those who provide 

inspector, risk assessor, project 

designer, and abatement supervisor and 

worker training—to submit to EPA a 

digital photograph of each successful 

trainee along with their post-course 

notifications. That requirement, 

inadvertently imposed as part of the 

final RRP rule, is unnecessary because 

EPA already receives photographs of 

these individuals through other means. 

DATES: This final rule is effective July 

15, 2009. 


srobinson on DSKHWCL6B1PROD with RULES