70890 Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Rules and Regulations 

not justify less than full SIP approval of 

the rule at this time. 

Comment #8: WD–40 commented that 

the SIP emission credits associated with 

this rule are based on outdated data and 

are significantly low if the rule covers 

more than just metal working facilities. 

Response #8: The rule specifically 

states that it covers all VOC containing 

fluids used for metalworking and for 

metal protection. The exact amount of 

emission credit associated with this rule 

is not relevant to the action on whether 

to approve the rule into the federallyenforceable SIP. 

Comment #9: WD–40 further stated 

that rule 1144 does not meet RACT 

because it: (a) does not exempt small 

containers; and (b) does not allow low 

vapor pressure VOCs as do other EPA 

and CARB regulations. 

Response #9: States are not limited to 

implementing RACT and may, 

particularly for extreme Ozone 

nonattainment areas like South Coast, 

need more stringent requirements to 

fulfill attainment and other 

requirements of CAA Sections 110 and 

part D. See also response to comments 

3, 4 and 5. 

III. EPA Action 

No comments were submitted that 

change our assessment that the 

submitted rules comply with the 

relevant CAA requirements. Therefore, 

as authorized in section 110(k)(3) of the 

Act, EPA is fully approving these rules 

into the California SIP. 

IV. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to approve a 

SIP submission that complies with the 

provisions of the Act and applicable 

Federal regulations. 42 U.S.C. 7410(k); 

40 CFR 52.02(a). Thus, in reviewing SIP 

submissions, EPA’s role is to approve 

State choices, provided that they meet 

the criteria of the Clean Air Act. 

Accordingly, this action merely 

approves State law as meeting Federal 

requirements and does not impose 

additional requirements beyond those 

imposed by State law. For that reason, 

this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act 

(5 U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address 

disproportionate human health or 

environmental effects with practical, 

appropriate, and legally permissible 

methods under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

Tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on Tribal governments or preempt 

Tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Reporting and recordkeeping 

requirements, Volatile organic 

compounds]. 

Dated: October 21, 2011. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, chapter I, title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraphs (c)(388)(i)(A) to read 

as follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(388) New and amended regulations 

for the following APCD were submitted 

on April 5, 2011 by the Governor’s 

Designee. 

(i) Incorporation by reference. 

(A) South Coast Air Quality 

Management District—SCAQMD) 

(1) Rule 1143, ‘‘Consumer Paint 

Thinners & Multi-purpose Solvents,’’ 

adopted on March 6, 2009 and amended 

December 3, 2010. 

(2) Rule 1144, ‘‘Metal Working Fluids 

and Direct-Contact Lubricants,’’ adopted 

on March 6, 2009, and amended July 9, 

2010. 

* * * * * 

[FR Doc. 2011–29459 Filed 11–15–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0866; FRL–9325–4] 

Fenamidone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for inadvertent residues of 

fenamidone in or on the cereal grains 

crop group 15, except rice and the 

forage, fodder, and straw of cereal grains 

crop group 16, except rice. Bayer Crop 

Science requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 16, 2011. Objections and 

requests for hearings must be received 

on or before January 17, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 


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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–2010–0866. 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: 

Rosemary Kearns, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5611; email address: 

kearns.rosemary@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://ecfr.gpoaccess.gov/cgi/t/

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0866 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 January 17, 2012. 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–2010–0866, 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 December 

15, 2010 (75 FR 78240) (FRL–8853–1), 

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 0F7764) by Bayer 

CropScience, 2 T.W. Alexander Dr., 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.547 

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 

grain, cereal, group 15 (except rice) at 

0.1 ppm; grain, forage, group 16 (except 

rice) at 0.3 ppm; and grain, stover, group 

16 (except rice) at 0.5 ppm. That notice 

referenced a summary of the petition 

prepared by Bayer CropScience, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

EPA has modified the commodity 

definitions for which tolerances are 

being established. The reason for these 

changes is 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 fenamidone 


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70892 Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Rules and Regulations 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenamidone 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. An acceptable 

guideline immunotoxicity study in rats 

has been reviewed. While the study 

showed a potential immunosuppression 

at the highest dose tested, the existing 

risk assessment points of departure are 

lower and are therefore protective of 

this potential effect. Fenamidone is not 

likely to be a human carcinogen based 

on the negative carcinogenic potential of 

fenamidone in rats and mice and studies 

indicate that there is no concern for 

mutagenicity for fenamidone. 

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 

Dawleyrat), 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, 

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 docket ID EPA– 

HQ–OPP–2010–0866 on pages 25–28 of 

the document titled ‘‘Fenamidone: 

Human Health Risk Assessment to 

Support the Label Amendment to 

Permit Rotation to All Cereal Grain, 

Except Rice and Establish Revised 

Tolerances for Inadvertent Residues.’’ 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for fenamidone used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENAMIDONE 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 (All populations).NOAEL = 125 milligrams/ 

kilograms/day (mg/kg/ 

day).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.25 mg/kg/ 

day.

aPAD = 1.25 mg/kg/day 

Acute Neurotoxicity in Rats: LOAEL = 500 mg/kg/day 

based on urination, staining/soiling of the anogenital 

region, mucous in the feces, and unsteady gait in 

the females. 

Chronic dietary (All populations).NOAEL= 2.83 mg/kg/day ..

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.0283 mg/ 

kg/day.

cPAD = 0.0283 mg/kg/day 

2 Year Chronic Toxicity/Carcinogenicity in Rats: 

LOAEL = 7.07/9.24 mg/kg/day (M/F) based on increase in severity of diffuse thyroid C-cell 

hyperplasia in both sexes. 

Cancer (Oral, dermal, inhalation).Based on the negative carcinogenic potential of fenamidone in rats and mice, EPA has classified fenamidone as 

‘‘not likely’’ to be a human carcinogen by all relevant routes of exposure. 

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. 


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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. 

Such effects were identified for 

fenamidone. 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 conducted a conservative 

acute dietary risk assessment which 

used maximum field trial residue values 

and assumed 100 percent crop treated 

for all commodities. 

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 

conducted a conservative acute dietary 

risk assessment which used maximum 

field trial residue values and assumed 

100 percent crop treated for all 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fenamidone does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue 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. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fenamidone in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fenamidone. 

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 

fenamidone for acute exposures are 

estimated to be 47.88 parts per billion 

(ppb) for surface water and 178 ppb for 

ground water. For chronic exposures for 

non-cancer assessments these levels are 

estimated to be 12.86 ppb for surface 

water and 178 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

both acute and chronic dietary risk 

assessments, the water concentration 

value of 178 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). 

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 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 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 dose 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 


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performance up to 438.3 mg/kg/day 

(highest dose tested; 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. There were no 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 NOAEL of 2.83 mg/kg/day 

used for the long-term risk assessment is 

33x 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 toxicology database for 

fenamidone is complete for purposes of 

the characterization of potential prenatal and/or post-natal risks to infants 

and children. 

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. No qualitative or quantitative 

increased susceptibility of rat or rabbit 

fetuses to in utero exposure in the 

developmental toxicity studies was 

observed. There was no qualitative or 

quantitative increased susceptibility in 

the two generation reproduction study 

(rat). There is low concern for residual 

uncertainties in the DNT study in the rat 

since there is a well established 

offspring NOAEL for the reasons noted 

in Unit III.D.2. 

iv. Residue values used in the dietary 

risk assessments are unlikely to 

underestimate risk. Dietary exposure 

assessments were conducted using 

maximum field trial residue values and 

assumed 100% crop treated. Therefore, 

the acute and chronic dietary, food only, 

exposure is considered an upper bound 

conservative estimate. The contribution 

from drinking water is minimal. EPA 

concludes that the acute and chronic 

exposure estimates in this analysis are 

unlikely to underestimate actual 

exposure. The drinking water 

component of the dietary assessment 

utilizes water concentration values 

generated by modeling parameters 

which are designed to provide 

conservative, health protective, highend estimates of water concentrations 

which will not likely be exceeded. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fenamidone will occupy 5% of the 

aPAD for children 1–2 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 90% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. There are no residential uses 

for fenamidone. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, fenamidone is not 

registered for any use patterns that 

would result in short- and/or 

intermediate-term residential exposure. 

Short- and/or intermediate-term risk is 

assessed based on short- and/or 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short- or 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 short-term risk), 

no further assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for fenamidone. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fenamidone is not expected to pose a 

cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 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 

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 


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Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Rules and Regulations 70895 

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. 

There are no Codex MRLs for 

fenamidone in cereal crops (crop group 

15 and 16, except rice). 

C. Revisions to Petitioned-For 

Tolerances 

EPA has modified the commodity 

definitions that were proposed in the 

Notice of Filing to (1) be consistent with 

Agency policy and nomenclature and 

(2) to have all of crop group 16 under 

a single tolerance instead of separated 

into separate ones as proposed. 

EPA is removing the tolerances for 

corn, field forage; corn, field, grain; 

corn, field, stover; corn, sweet, forage, 

corn, sweet, plus cob with husks 

removed; corn, sweet, stover; wheat, 

grain; wheat, hay; wheat, forage; and 

wheat, straw from paragraph (d) that are 

covered by the newly created crop 

group tolerances. 

Also, EPA has revised the tolerance 

expression to clarify (1) that, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of fenamidone not 

specifically mentioned; and (2) that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only the specific compounds mentioned 

in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for indirect or inadvertent residues of 

fenamidone (4–H-imidazol-4-one, 3,5- 

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

phenyl-3-(phenylamino, (S)-) and its 

metabolite RPA 717879 (2,4- 

imidazolidinedione, 5-methyl-5-phenyl) 

in or on grain, cereal, group 15, except 

rice at 0.1 ppm; and grain, cereal, forage, 

fodder and straw, group 16, except rice 

at 0.5 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: October 27, 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. In § 180.579, revise paragraphs 

(a)(1) introductory text, (a)(2) 

introductory text, (c) introductory text, 

and paragraph (d) to read as follows: 

§ 180.579 Fenamidone; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide, 

fenamidone, including its metabolites 

and degradates, in or on the following 

commodities. Compliance with the 

tolerance levels is to be determined by 

measuring only fenamidone (4HImidazol-4-one, 3,5-dihydro-5-methyl2-(methylthio)-5-phenyl-3 

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

commodities: 

* * * * * 

(2) Tolerances are established for 

residues of the fungicide fenamidone, 

including its metabolites and 

degradates, in or on the following 

commodities. Compliance with the 

tolerance levels is to be determined by 

measuring fenamidone (4H-Imidazol-4- 

one, 3,5-dihydro-5-methyl-2- 

(methylthio)-5-phenyl-3 

(phenylamino)-,(S)-), and its metabolite 

RPA 717879 (2,4-imidazolidinedione, 5- 

methyl-5-phenyl), in or on the 

commodities: 

* * * * * 

(c) Tolerances with regional 

registrations. A tolerance with regional 

registration as defined in § 180.1(l) is 

established for residues of the fungicide 

fenamidone, including its metabolites 

and degradates, in or on the following 

commodities. Compliance with the 


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70896 Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Rules and Regulations 

tolerance levels is to be determined by 

measuring only fenamidone (4HImidazol-4-one, 3,5-dihydro-5-methyl-2- 

(methylthio)-5-phenyl-3 (phenylamino)-,(S)-), in or on the commodity: 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for residues 

of the fungicide fenamidone, including 

its metabolites and degradates, in or on 

the following commodities. Compliance 

with the tolerance levels is to be 

determined by measuring fenamidone 

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

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

(phenylamino)-,(S)-), and its metabolite 

RPA 717879 (2,4-imidazolidinedione, 5- 

methyl-5-phenyl), in or on the following 

commodities when present therein as a 

result of application of fenamidone to 

the crops in paragraph (a)(1). 

Commodity Parts per 

million 

Grain, cereal, group 15, except rice .............................. 0 .1 

Grain, cereal, forage, fodder 

and straw, group 16, except 

rice ...................................... 0 .5 

Soybean, forage ..................... 0 .15 

Soybean, hay .......................... 0 .25 

Soybean, seed ........................ 0 .02 

Strawberry .............................. 0 .15 

[FR Doc. 2011–29618 Filed 11–15–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[[EPA–HQ–OPP–2011–0606; FRL–8892–1] 

Polyethylene Glycol; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of a-Hydro-whydroxypoly(oxyethylene), minimum 

number average molecular weight (in 

amu), 17,000; also known as 

polyethylene glycol, when used as an 

inert ingredient in a pesticide chemical 

formulation. Clariant Corporation 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of a-Hydro-whydroxypoly(oxyethylene), minimum 

number average molecular weight (in 

amu), 17,000 on food or feed 

commodities. 

DATES: This regulation is effective 

November 16, 2011. Objections and 

requests for hearings must be received 

on or before January 17, 2012, 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–2011–0606. 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: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; email address: 

fertich.elizabeth@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: 

• 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 provides 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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. 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–2011–0606 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 January 17, 2012. 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–2011–0606, 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 


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