28276 Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 

Commodity Parts per 

million 

Goat, meat ................................ 0 .01 

Goat, meat byproducts ............. 0 .03 

Grain, aspirated fractions ......... 20 .0 

Grain, cereal, group 15, (except 

corn, field, grain; except 

corn, pop, grain; except corn, 

kernels plus cobs with husks 

removed; except wheat) ....... 3 .0 

Grain, cereal, forage, fodder 

and straw, group 16 .............. 20 

Horse, fat .................................. 0 .05 

Horse, meat .............................. 0 .01 

Horse, meat byproducts ........... 0 .03 

Milk ........................................... 0 .005 

Oilseeds, group 20 ................... 0 .9 

Pea and bean, dried shelled 

except soybean, subgroup 

6C .......................................... 0 .4 

Pea and bean, succulent 

shelled, subgroup 6B ............ 0 .5 

Peanut ...................................... 0 .01 

Peanut, refined oil .................... 0 .02 

Plum, prune .............................. 3 .0 

Potato, wet peel ........................ 0 .1 

Rice, bran ................................. 4 .5 

Rice, hulls ................................. 8 .0 

Sheep, fat ................................. 0 .05 

Sheep, meat ............................. 0 .01 

Sheep, meat byproducts .......... 0 .03 

Soybean, hulls .......................... 0 .3 

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

Vegetable, foliage of legume, 

group 7 .................................. 30 

Vegetables, fruiting, group 8 .... 0 .7 

Vegetable, legume, edible podded, subgroup 6A ................. 2 .0 

Vegetable, tuberous and corm, 

subgroup 1C ......................... 0 .02 

Wheat, bran .............................. 0 .6 

Wheat, grain ............................. 0 .3 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–11602 Filed 5–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0425; FRL–9341–8] 

Penflufen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of penflufen in or 

on multiple commodities which are 

identified and discussed later in this 

document. Bayer CropScience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

14, 2012. Objections and requests for 

hearings must be received on or before 

July 13, 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–2010–0425. 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: 

Marianne Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8043; email address: 

lewis.marianne@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. To access the 

OCSPP test guidelines referenced in this 

document electronically, please go 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

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–2010–0425 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 July 13, 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–2010–0425, 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 


emcdonald on DSK29S0YB1PROD with RULES
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 28277 

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 September 

8, 2010 (75 FR 54631) (FRL–8843–3), 

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 0F7711) by Bayer 

CropScience, 2 T.W. Alexander Drive 

P.O. Box 12014, Research Triangle Park, 

NC 27709. The petition requested that 

40 CFR part 180 be amended by 

establishing tolerances for residues of 

the penflufen, N-[2-(1,3- 

dimethylbutyl)phenyl]-5-fluoro-1,3- 

dimethyl-1H-pyrazole-4-carboxamide, 

in or on alfalfa, forage; alfalfa, hay; 

vegetable, tuberous and corm, subgroup 

1C; vegetable, legume, group 6; 

vegetable, foliage of legume, group 7; 

grain, cereal, group 15, grain, cereal, 

forage, fodder and straw, group 16; 

oilseed, group 19; cotton, gin byproducts at 0.01 parts per million 

(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. 

Based upon review of the data 

supporting the petition, EPA has made 

some minor modifications to some 

commodity definitions for consistency 

with EPA naming-conventions for those 

commodities. The reason for these 

changes is explained in Unit IV.D. 

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 penflufen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with penflufen 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. Penflufen is an 

alkylamide fungicide belonging to the 

chemical class of carboxamides. The 

reported pesticidal mode of action is as 

an inhibitor of mitochondrial 

respiration by inhibiting succinate 

dehydrogenase, an enzyme in the 

electron transport system. 

The liver and thyroid are target organs 

for penflufen. Increased liver weight, 

alterations in clinical chemistry 

parameters relevant to effects on the 

liver, and an increase in the incidence 

of hepatocellular hypertrophy were 

consistent findings across species and 

duration of exposure (28-day, 90-day, 

and 1- to 2-year exposure periods). The 

hepatic total cytochrome P–450 content, 

and benzoxyresorufin (BROD) and 

pentoxyresorufin (PROD) enzyme 

activities, were shown to be increased in 

rats of both sexes following subchronic 

oral exposure. Additionally, increased 

incidence of thyroid follicular cell 

hypertrophy/hyperplasia was observed 

across studies and species (no data 

provided on thyroid hormone levels). 

The liver and thyroid findings were 

mostly reversible after a 3-month 

recovery period in the rat. In the rat and 

mouse, following 104 week/78 week 

exposure periods at dose levels up to 

and/or greater than the limit dose, there 

was no increase in the incidence of liver 

or thyroid tumors. 

Reproductive toxicity was observed in 

the 2-generation reproduction study in 

rats. Delayed sexual maturation was 

observed in females in both generations, 

and magnitude of the associated decline 

in body weight was not considered to be 

a factor in the delay in sexual 

maturation. Developmental toxicity was 

not observed in the rat or rabbit, 

although the dose levels in both studies 

were not considered adequate to assess 

developmental toxicity potential of 

penflufen. However, there is little 

concern that new studies would identify 

a developmental endpoint with a noobserved-adverse-effect-level (NOAEL) 

lower than the NOAEL selected for risk 

assessment. 

Decreased motor/locomotor activity 

was observed in both sexes of rats 

following acute and in female rats 

following subchronic oral exposure, 

although neuropathological lesions were 

not observed in either study. 

There are no mutagenicity concerns. 

Carcinogenicity studies with penflufen 

found a statistically significant increase 

in histiocytic sarcomas in male rats; a 

marginal increase in brain astrocytomas, 

a fatal tumor, in male rats at the high 

dose; and ovarian adenomas in female 

rats at the high dose. Although these 

three tumors were considered treatmentrelated, they provided weak evidence of 

carcinogenicity due to the marginal 

nature of the tumor responses. There 

was no evidence of carcinogenicity in 

male or female mice. Given the weak 

evidence indicating any potential for 

carcinogenicity, EPA has determined 

that quantification of risk using a nonlinear approach reference dose (i.e., 

RfD) will adequately account for all 

chronic toxicity, including 

carcinogenicity, which could result 

from exposure to penflufen. The NOAEL 

(38 milligram/kilogram/day (mg/kg/ 

day)) used for establishing the Chronic 

RfD is approximately 10-fold lower than 

the dose (approximately 300 mg/kg/day) 

that induced a marginal tumor response. 

The EPA has determined that the 

chronic population adjusted dose is 

protective of all long-term effects, 

including potential carcinogenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by penflufen as well as 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Penflufen. Human Health Risk 

Assessment to Support New Uses on 

Potato (Crop Subgroup 1C), Legume 

Vegetables (Crop Group 6 and Crop 

Group 7), Cereal Grains (Crop Group 15 

and Crop Group 16), Oilseeds (Crop 

Group 20), and Alfalfa’’ in docket ID 

number EPA–HQ–OPP–2010–0425. 


emcdonald on DSK29S0YB1PROD with RULES
28278 Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which 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 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 penflufen used for human 

risk assessment is shown in the Table of 

this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PENFLUFEN 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, including 

children and women 13–49 years of 

age).

NOAEL = 50 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.5 

mg/kg/day.

aPAD = 0.5 mg/kg/ 

day 

Acute neurotoxicity study in rats. 

LOAEL = 100 mg/kg/day based on decreased motor and 

locomotor activity (39–81% on day of treatment) in females. 

Chronic dietary (All populations) ............ NOAEL= 38 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.38 

mg/kg/day.

cPAD = 0.38 mg/ 

kg/day 

Chronic toxicity study in dogs. 

LOAEL = 357/425 mg/kg/day, based on decreased terminal body weight and body weight gain (females), increased prothrombin time (males), increased alkaline 

phosphate activity, decreased cholesterol, increased 

GGT levels, decreased albumin and albumin/globulin 

ratio, decreased calcium and phosphorus, increased 

liver weights, increased incidence of focal hepatocellular 

brown pigment and hepatocellular hypertrophy, and an 

increased incidence of thyroid follicular cell hypertrophy 

in both sexes, and in increased incidence of zona glomerulosa vacuolation of the adrenal gland in females. 

Cancer (Oral, dermal, inhalation) ........... Quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to penflufen. 

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

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose 

(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. Mg/kg/day = milligrams/kilograms/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to penflufen, EPA considered 

exposure under the petitioned-for 

tolerances. EPA assessed dietary 

exposures from penflufen 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 

penflufen. 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 used tolerance-level 

residues, default dietary exposure 

evaluation model (DEEM) processing 

factors for dried potatoes and assumed 

100 percent crop treated (PCT) for all 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EP used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance-level residues, default 

DEEM processing factors for dried 

potatoes and assumed 100 PCT 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 

used tolerance-level residues, default 

DEEM processing factors for dried 

potatoes and assumed 100 PCT for all 

commodities. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

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

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or non-linear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used based on an earlier non-cancer key 

event. If carcinogenic mode of action 

data are not available, or if the mode of 

action data determines a mutagenic 

mode of action, a default linear cancer 

slope factor approach is utilized. Based 

on the data summarized in Unit III.A., 

EPA has concluded that a non-linear 

RfD approach is appropriate for 

assessing cancer risk to penflufen. 

Cancer risk was assessed using the same 


emcdonald on DSK29S0YB1PROD with RULES
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 28279 

exposure estimates as discussed in Unit 

III.C.1.ii. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for penflufen. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for penflufen in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of penflufen. 

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 First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

penflufen for acute exposures are 

estimated to be 11.4 parts per billion 

(ppb) for surface water and 16.6 ppb for 

ground water. The EDWC of penflufen 

for chronic exposures for non-cancer 

assessments are estimated to be 1.8 ppb 

for surface water and 16.6 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 16.6 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 16.6 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). 

Penflufen 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 penflufen to share 

a common mechanism of toxicity with 

any other substances, and penflufen 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that penflufen 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. 

In the rat multi-generation reproduction 

study there was slight decrease in litter 

size, delayed sexual maturation, 

decreased body weight/gain, decreased 

brain, spleen, and thymus weights were 

noted in the offspring. At the same dose 

level the adults exhibited decreased 

body weight/gain, alteration in food 

consumption, decreased thymus weight, 

and decrease spleen weights. In the rat 

developmental toxicity study, the 

maternal findings (decreased body 

weight gain) at the highest dose tested 

(HDT) are considered minimal. No 

adverse effects were observed on the 

foetuses. In the rabbit developmental 

toxicity study, the maternal findings 

(decreased body weight gain) at the HDT 

are considered minimal. No adverse 

effects were observed at the HDT. 

3. Conclusion. The Agency 

recommends that the 10X FQPA safety 

factor for the protection of infants and 

children, be reduced to 1X. The risk 

assessments conducted for penflufen 

were based on the most sensitive 

endpoints in the toxicity database, and 

the NOAELs selected for risk assessment 

are considered protective of potential 

developmental, neurotoxic, and 

immunotoxic effects for infants and 

children. Highly conservative exposure 

estimates were incorporated into the 

risk assessment for penflufen. There are 

no residual uncertainties with regard to 

pre- and/or postnatal toxicity or 

neurotoxicity, and exposure; therefore, 

reduction of the 10X FQPA safety factor 

for penflufen to 1X is appropriate based 

on the following findings: 

i. The toxicity database for penflufen 

is complete for consideration of 

estimated risks for all populations of 

concern. 

ii. Although decreased motor activity 

was observed following acute oral 

exposure, no neuropathological lesions 

were observed and there is little concern 

for neurotoxicity. There is no need for 

a developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although there is some evidence 

of qualitative sensitivity of the young 

(delayed sexual maturation and 

decreased litter size), the effects are well 

characterized, and there is a clear 

NOAEL. The dose level where offspring 

effects were identified in the 

reproduction study is comparable to the 

high dose used in the rat developmental 

toxicity study where no effects were 

identified in either the maternal or fetal 

rat. Since minimal/no effects were 

observed in the developmental toxicity 

studies following exposure of the 

maternal animals to dose levels equal to 

and greater than those tested in the 

studies used for risk assessment, there is 

little concern that new studies would 

identify a developmental endpoint with 

a NOAEL lower than the NOAELs 

selected for risk assessment. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to penflufen in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by penflufen. 

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. 


emcdonald on DSK29S0YB1PROD with RULES
28280 Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. A highly conservative acute 

dietary exposure assessment 

demonstrated that penflufen does not 

pose an unacceptable aggregate risk. 

2. Chronic risk. There are no 

residential uses for penflufen; therefore, 

the chronic aggregate risk assessment 

includes exposures from dietary 

consumption of food and water only. A 

highly conservative chronic aggregate 

dietary exposure assessment 

demonstrated that penflufen does not 

pose an unacceptable aggregate chronic 

risk. 

3. Short-term risk. There are no 

residential uses of penflufen; therefore a 

short-term aggregate risk assessment 

was not conducted for this chemical. 

4. Intermediate-term risk. There are 

no residential uses of penflufen; 

therefore an intermediate-term aggregate 

risk assessment was not conducted for 

this chemical. 

5. Aggregate cancer risk for U.S. 

population. In a rat carcinogenicity 

study with penflufen a statistically 

significant increase in histiocytic 

sarcomas with a positive trend in male 

rats only (but in the absence of a dose 

response and lack of pre-neoplastic 

lesions) were seen. A marginal increase 

in brain astrocytomas was also observed 

in males at the high dose; however, this 

effect was not dose-related, did not 

reach statistical significance, and there 

was no overall trend. In addition, there 

were no pre-neoplastic lesions, such as 

glial proliferations, which are a good 

indicator of chemical tumor induction 

(i.e., there will be changes in the cells 

prior to transformation to a neoplasm). 

The ovarian adenomas observed at the 

high dose also showed no dose 

response, no pair-wise significance, no 

decrease in latency, and there were no 

pre-neoplastic lesions such as 

hyperplasia of the epithelial cells of the 

endometrium. Additionally, there was 

no evidence of carcinogenicity in male 

or female mice (at doses that were 

judged to be adequate to assess the 

carcinogenic potential), no concern for 

mutagenicity (in vivo or in vitro) for the 

parent molecule or the two metabolites, 

and there were no other lines of 

evidence (such as structure-activity 

relationship). Although these three 

tumors were considered treatmentrelated, they provided weak evidence of 

carcinogenicity due to the marginal 

nature of the tumor responses and the 

other factors mentioned in this unit. 

Given the weak evidence indicating any 

potential for carcinogenicity, EPA has 

determined that quantification of risk 

using a non-linear approach (i.e., RfD) 

will adequately account for all chronic 

toxicity, including carcinogenicity, 

which could result from exposure to 

penflufen. The NOAEL (38 mg/kg/day) 

used for establishing the chronic RfD is 

approximately 10-fold lower than the 

dose (approximately 300 mg/kg/day) 

that induced a marginal tumor response. 

The EPA has determined that the 

chronic population adjusted dose is 

protective of all long-term effects, 

including potential carcinogenicity. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to penflufen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. The method involves 

extraction of samples with acetonitrile/ 

water, cleanup using solid phase 

extraction, and analysis of penflufen by 

liquid chromatography/mass 

spectrometry (LC/MS/MS) (EL–002– 

P09–03). 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for penflufen. 

C. Revisions to Petitioned-For 

Tolerances 

Some minor modifications to 

commodity definitions initially 

submitted were made to be consistent 

with the updated EPA namingconventions for commodities. 

V. Conclusion 

Therefore, tolerances are established 

for residues of penflufen, in or on 

alfalfa, forage; alfalfa, hay; vegetable, 

tuberous and corm, subgroup 1C; 

vegetable, legume, group 6; vegetable, 

foliage of legume, group 7; grain, cereal, 

group 15, grain, cereal, forage, fodder 

and straw, group 16; oilseed, group 19; 

cotton, gin by-products at 0.01 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 


emcdonald on DSK29S0YB1PROD with RULES
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 28281 

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: May 3, 2012. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.664 is added to subpart 

C to read as follows: 

§ 180.664 Penflufen; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

penflufen, including its metabolites and 

degradates, in or on the following 

commodities listed in the table. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

penflufen N-[2-(1,3- 

dimethylbutyl)phenyl]-5-fluoro-1,3- 

dimethyl-1H-pyrazole-4-carboxamide, 

in or on the following commodities. 

Commodity Parts per 

million 

Alfalfa, forage ............................. 0.01 

Alfalfa, hay .................................. 0.01 

Cotton, gin by-products .............. 0.01 

Grain cereal, forage, fodder and 

straw, group 16 ....................... 0.01 

Grain, cereal, group 15 .............. 0.01 

Oilseed, group 20 ....................... 0.01 

Vegetable, foliage of legume, 

group 7 .................................... 0.01 

Vegetable, legume, group 6 ....... 0.01 

Vegetable, tuberous and corm 

subgroup 1C ........................... 0.01 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–11629 Filed 5–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 799 

[EPA–HQ–OPPT–2005–0033; FRL–9350–2] 

RIN 2070–AD16 

Withdrawal of Revocation of TSCA 

Section 4 Testing Requirements for 

One High Production Volume Chemical 

Substance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: In the Federal Register issue 

of March 16, 2012, EPA published a 

direct final rule revoking certain testing 

requirements promulgated under the 

Toxic Substances Control Act (TSCA) 

for 10 chemical substances, including 

benzenesulfonic acid, [[4-[[4- 

(phenylamino)phenyl][4-(phenylimino)- 

2,5-cyclohexadien-1- 

ylidene]methyl]phenyl]amino]- (CAS 

No. 1324–76–1), also known as C.I. 

Pigment Blue 61. EPA received an 

adverse comment regarding C.I. Pigment 

Blue 61. This document withdraws the 

revocation of testing requirements for 

C.I. Pigment Blue 61 as described in the 

March 16, 2012 direct final rule. In 

withdrawing the revocation, this 

document also restores the original 

testing requirements as currently shown 

in the Code of Federal Regulations 

(CFR). Elsewhere in today’s Federal 

Register, EPA is publishing a proposed 

rule revoking the same testing 

requirements for C.I. Pigment Blue 61 

that were published in the March 16, 

2012 direct final rule. 

DATES: This final rule is effective May 

15, 2012. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Catherine 

Roman, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8157; email address: 

roman.catherine@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI–Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

A list of potentially affected entities is 

provided in the Federal Register issue 

of March 16, 2012 (77 FR 15609) (FRL– 

9335–6). If you have questions regarding 

the applicability of this action to a 

particular entity, consult the technical 

person listed under FOR FURTHER

INFORMATION CONTACT. 

II. What rule is being withdrawn? 

In the March 16, 2012 Federal 

Register, EPA issued a revocation of 

some or all of the TSCA section 4 testing 

requirements for 10 chemical substances 

by direct final rule. In accordance with 

the procedures described in the March 

16, 2012 Federal Register document, 

EPA is withdrawing the revocation of 

certain testing requirements for C.I. 

Pigment Blue 61 and also restoring the 

original testing requirements found in 

the CFR, because the Agency received 

an adverse comment concerning this 

chemical substance. The final rule 

revoking testing requirements for the 

other 9 chemical substances described 

in the March 16, 2012 Federal Register 

document is otherwise unaffected by the 

withdrawal of the revocation for C.I. 

Pigment Blue 61. Elsewhere in today’s 

Federal Register, EPA is proposing a 

rule to revoke certain test rule 

requirements for C.I. Pigment Blue 61. 

The docket identification (ID) number 

for the test rule concerning this 

chemical substance was established at 

EPA–HQ–OPPT–2005–0033. That 

docket includes information considered 

by the Agency in developing those rules 

and the adverse comment. 


emcdonald on DSK29S0YB1PROD with RULES