76304 Federal Register / Vol. 76, No. 235 / Wednesday, December 7, 2011 / Rules and Regulations 

List of Subjects 

40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen oxides, Particulate matter, 

Sulfur dioxide. 

40 CFR Part 81 

Air pollution control, Environmental 

protection, National parks, Wilderness 

areas. 

Dated: November 22, 2011. 

Susan Hedman, 

Regional Administrator, Region 5. 

Parts 52 and 81, 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 P—Indiana 

■ 2. Section 52.776 is amended by 

adding paragraphs (v)(4) and (w)(4) to 

read as follows: 

§ 52.776 Control strategy: Particulate 

matter. 

* * * * * 

(v) * * * 

(4) The Chicago-Gary-Lake County, ILIN nonattainment area (Lake and Porter 

Counties), as submitted on April 3, 

2008, and supplemented on March 6, 

2009. The maintenance plan establishes 

2025 motor vehicle emissions budgets 

for Lake and Porter Counties of 2,915.19 

tons per year for NOX and 132.70 tons 

per year for primary PM2.5. 

(w) * * * 

(4) Indiana’s 2005 NOX, primary 

PM2.5, and SO2 emissions inventory 

satisfies the emission inventory 

requirements of section 172(c)(3) of the 

Clean Air Act for Lake and Porter 

Counties. 

PART 81—[AMENDED] 

■ 3. The authority citation for part 81 

continues to read as follow: 

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

■ 4. Section 81.315 is amended by 

revising the entry for Chicago-Gary-Lake 

County, IL-IN in the table entitled 

‘‘Indiana PM2.5 (Annual NAAQS)’’ to 

read as follows: 

§ 81.315 Indiana. 

* * * * * 

INDIANA—PM2.5

[Annual NAAQS] 

Designated area 

Designation 1

Date 2 Type 

*******

Chicago-Gary-Lake County, IL-IN: February 6, 2012 ...................................................................... Attainment. 

Lake County 

Porter County 

*******

1 Includes Indian Country located in each county or area, except as otherwise specified. 

2This date is 90 days after January 5, 2005, unless otherwise noted. 

* * * * * 

[FR Doc. 2011–31131 Filed 12–6–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–1026; FRL–9325–2] 

Saflufenacil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of saflufenacil in 

or on Banana; Coffee, green bean; and 

Mango. BASF Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 7, 2011. Objections and 

requests for hearings must be received 

on or before February 6, 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–2010–1026. 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: 

Kathryn Montague, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–1243; email address: 

montague.kathryn@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). 


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• 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–2010–1026 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 February 6, 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–2010–1026, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of February 4, 

2011 (76 FR 6465) (FRL–8858–7), 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 0E7806) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR 180.649 be amended by 

establishing tolerances for residues of 

the herbicide saflufenacil, including its 

metabolites and degradates, in or on 

Banana, whole fruit; Coffee, green bean; 

and Mango, fruit at 0.03 parts per 

million (ppm). Compliance with the 

tolerance levels is to be determined by 

measuring only the sum of saflufenacil, 

2-chloro-5-[3,6-dihydro-3-methyl-2,6-

dioxo-4-(trifluoromethyl)-1(2H)-

pyrimidinyl]-4-fluoro-N-[[methyl(1- 

methylethyl)amino]sulfonyl]benzamide, 

and its metabolites N-[2-chloro-5-(2,6-

dioxo-4-(trifluoromethyl)-3,6-dihydro-1

(2H)-pyrimidinyl)-4-fluorobenzoyl]-N’-

isopropylsulfamide and N-[4-chloro-2-

fluoro-5-({[(isopropylamino)

sulfonyl]amino}carbonyl)phenyl]urea, 

calculated as the stoichiometric 

equivalent of saflufenacil, in or on the 

commodities. That notice referenced a 

summary of the petition prepared by 

BASF Corporation, the registrant, which 

is available in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the commodity terms for 

Banana and Mango. The reason for this 

change 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 saflufenacil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with saflufenacil 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. 

Saflufenacil has low acute toxicity via 

the oral, dermal, and inhalation routes 

of exposure. It is slightly irritating to the 

eye but is neither a dermal irritant nor 

sensitizer. 

Short-term, subchronic, and chronic 

toxicity studies in rats, mice, and dogs 

identified the hematopoietic system as 

the target organ of saflufenacil. 

Protoporphyrinogen oxidase inhibition 

in the mammalian species may result in 

disruption of heme synthesis which in 

turn causes anemia. In these studies, 

decreased hematological parameters 

(red blood cells (RBC), hematocrit (Ht), 

mean corpuscular volume (MCV), mean 

corpuscular hemoglobin (MCH), and 

mean corpuscular hemoglobin 

concentration (MCHC)) were seen at 

about the same dose level across 

species, except in the case of the dog, 

where the effects were seen at a slightly 

higher dose. These effects occurred 

around the same dose level from the 


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short- through long-term exposures 

without increasing in severity. Effects 

were also seen in the liver (increased 

weight, centrilobular fatty change, and 

lymphoid infiltrate) in mice, the spleen 

(increased spleen weight and 

extramedullary hematopoiesis) in rats, 

and in both these organs (increased iron 

storage in the liver and extramedullary 

hematopoiesis in the spleen) in dogs. No 

dermal toxicity was seen at the limit 

dose in a 28-day dermal toxicity study 

in rats. 

Carcinogenicity studies in rats and 

mice showed no evidence of increased 

incidence of tumors at the tested doses. 

Saflufenacil is weakly clastogenic in the 

in vitro chromosomal aberration assay 

in V79 cells in the presence of S9 

activation; however, the response was 

not evident in the absence of S9 

activation. It is neither mutagenic in 

bacterial cells nor clastogenic in rodents 

in vivo. Saflufenacil is classified as ‘‘not 

likely to be carcinogenic to humans.’’ 

Increased fetal and offspring 

susceptibility to saflufenacil were 

observed in the developmental toxicity 

studies in the rat and rabbit and in the 

2-generation reproduction study in the 

rat. Developmental effects such as 

decreased fetal body weights and 

increased skeletal variations occurred at 

doses that were not maternally toxic in 

the developmental study in rats, 

indicating increased quantitative 

susceptibility. In rabbits, developmental 

effects such as increased liver 

porphyrins were observed at doses that 

were not maternally toxic, indicating 

increased quantitative susceptibility. In 

the 2-generation reproduction study in 

rats, offspring effects such as increased 

number of stillborn pups, decreased 

viability and lactation indices, 

decreased pre-weaning body weight 

and/or body-weight gain, and changes 

in hematological parameters were 

observed at a dose resulting in less 

severe maternal toxicity (decreased food 

intake, body weight/weight gain and 

changes in hematological parameters 

and organ weights indicative of anemia), 

indicating increased qualitative 

susceptibility. 

There was no evidence of 

neurotoxicity or neuropathology in the 

toxicity database for saflufenacil. In the 

acute neurotoxicity study, a decrease in 

motor activity was observed on the first 

day of dosing at the limit dose in males 

only. The finding was not accompanied 

by any other neuropathological changes 

and was considered a reflection of a 

mild and transient general systemic 

toxicity and not a substance-specific 

neurotoxic effect. In the subchronic 

neurotoxicity study, systemic toxicity 

(anemia), but no evidence of 

neurotoxicity, was seen in males and 

females. 

There is no evidence of immunotoxity 

in the saflufenacil database. The 

increase in spleen weight seen only in 

rats in the 90-day oral toxicity study is 

attributable to an increased clearance of 

defective RBCs (i.e., defective 

hemoglobin synthesis) and is thus an 

indication of toxicity to the 

hematopoietic system rather than to the 

immune system. In a 28-day 

immunotoxicity study in rats, 

saflufenacil failed to induce toxicity 

specific to the immune system at the 

highest dose tested, indicating that 

saflufenacil does not directly target the 

immune system at the dose levels being 

used for risk assessment. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by saflufenacil as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

Saflufenacil. Human-Health Risk 

Assessment for Proposed Tolerances for 

Residues in/on Imported Coffee, 

Banana, and Mango at page 19 in docket 

ID number EPA–HQ–OPP–2010–1026. 

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 (U/SF) 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 nonthreshold 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 saflufenacil used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of May 11, 2011 (76 

FR 27256) (FRL–8872–7). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to saflufenacil, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing saflufenacil tolerances in 40 

CFR 180.649. EPA assessed dietary 

exposures from saflufenacil 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 

saflufenacil. 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). The unrefined 

assessment assumed 100% crop treated 

(CT), Dietary Exposure Evaluation 

Model (DEEM)TM 7.81 default 

concentration factors, and tolerancelevel residues for all commodities, 

except cottonseed; sunflower subgroup 

20B; soybean, seed; vegetable, legume, 

subgroup 6C, pea and bean (except 

soybean); and rapeseed subgroup 20A, 

for which the tolerance levels were 

multiplied by a correction factor to 

account for a metabolite of concern 

which is not included in the tolerance 

expression. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. Chronic dietary exposure was 

assessed using the same food residue 

assumptions as in the acute dietary 

exposure assessment discussed in unit 

III.C.1.i. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that saflufenacil does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for saflufenacil in drinking water. These 


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simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of saflufenacil. 

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 Pesticide 

Root Zone Model/Ground Water 

(PRZM/GW) models, the estimated 

drinking water concentrations (EDWCs) 

of saflufenacil for acute exposures are 

estimated to be 37.3 parts per billion 

(ppb) for surface water and 180 ppb for 

ground water. EDWCs for chronic 

exposures for non-cancer assessments 

are estimated to be 23.8 ppb for surface 

water and 173 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 180 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 173 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). 

Saflufenacil 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 saflufenacil to 

share a common mechanism of toxicity 

with any other substances, and 

saflufenacil does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that saflufenacil 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 (10×) 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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10×, or uses a different 

additional SF 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 saflufenacil includes rat and rabbit 

developmental toxicity studies, a 2- 

generation reproduction toxicity study 

in rats, acute and subchronic 

neurotoxicity studies in rats, and a 28- 

day immunotoxicity study in rats. As 

discussed in Unit III.A. there was 

evidence of quantitative susceptibility 

of fetuses to saflufenacil exposure in the 

developmental toxicity studies in rats 

and rabbits and evidence of qualitative 

susceptibility of offspring in the rat 

reproduction study. 

An analysis was performed to 

determine the degree of concern for the 

effects observed in the developmental 

and reproduction toxicity studies when 

considered in the context of all available 

toxicity data, and to identify any 

residual uncertainties after establishing 

toxicity endpoints and traditional 

uncertainty factors (UFs) to be used in 

the risk assessment of saflufenacil. The 

degree of concern is low and there are 

no residual uncertainties for the 

increased susceptibility since: 

i. Clear NOAELs/LOAELs were 

established for the developmental 

effects seen in rats and rabbits as well 

as for the offspring effects seen in the 2- 

generation reproduction study; 

ii. Dose-response relationships for the 

effects of concern are well 

characterized; 

iii. None of the effects in the 

developmental or reproduction studies 

were attributable to a single exposure 

and, therefore, are not of concern for 

acute risk assessment; and 

iv. The dose used to evaluate chronic 

dietary risks is lower than the NOAELS 

for fetal/offspring effects in the 

developmental and reproduction studies 

and is, therefore, protective of the 

developmental and offspring effects 

observed in these studies. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database for 

saflufenacil is complete. 

ii. There is no indication that 

saflufenacil is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although there is evidence of 

increased quantitative and qualitative 

susceptibility of offspring in the 

developmental and reproduction studies 

for saflufenacil, the degree of concern is 

low and the Agency did not identify any 

residual uncertainties after establishing 

toxicity endpoints and traditional UFs 

to be used in the risk assessment of 

saflufenacil. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

saflufenacil in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by 

saflufenacil. 

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 

saflufenacil will occupy <1% of the 

aPAD for the general U.S. population 

and all population subgroups including 

infants and children. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to saflufenacil 

from food and water will utilize 31% of 

the cPAD for infants less than 1 year 


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old, the population group receiving the 

greatest exposure. There are no 

residential uses for saflufenacil. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

A short-term adverse effect was 

identified; however, saflufenacil is not 

registered for any use patterns that 

would result in short-term residential 

exposure. Short-term risk is assessed 

based on short-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for 

saflufenacil. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, saflufenacil is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

saflufenacil. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

saflufenacil is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to saflufenacil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectroscopy/mass spectroscopy (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 

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 saflufenacil. 

C. Response to Comments 

An anonymous citizen objected to the 

presence of any pesticide residues on 

food. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, the existing legal 

framework provided by section 408 of 

FFDCA contemplates that tolerances 

greater than zero may be set when 

persons seeking such tolerances or 

exemptions have demonstrated that the 

pesticide meets the safety standard 

imposed by that statute. This citizen’s 

comment appears to be directed at the 

underlying statute and not EPA’s 

implementation of it; the citizen has 

made no contention that EPA has acted 

in violation of the statutory framework. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has revised the proposed 

commodity terms as follows to agree 

with the Agency’s Food and Feed 

Commodity Vocabulary: ‘‘Banana, 

whole fruit’’ was changed to ‘‘Banana;’’ 

‘‘Mango, fruit’’ was changed to 

‘‘Mango’’. 

V. Conclusion 

Therefore, tolerances are established 

for residues of saflufenacil, including its 

metabolites and degradates, as set forth 

in the regulatory text. 

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, 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 76, No. 235 / Wednesday, December 7, 2011 / Rules and Regulations 76309 

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: November 21, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.649 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a)(1) to read as follows: 

§ 180.649 Saflufenacil; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Banana 1 ................................... 0.03 

Coffee, green bean 1 ................. 0.03 

* * * * * 

Mango 1 ..................................... 0.03 

* * * * * 

1 No U.S. registration as of December 7, 

2011. 

* * * * * 

[FR Doc. 2011–31394 Filed 12–6–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0845; FRL–8885–8] 

Isoxaflutole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of isoxaflutole in 

or on Soybean, seed and Grain, 

aspirated fractions. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

December 7, 2011. Objections and 

requests for hearings must be received 

on or before February 6, 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–2010–0845. 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: 

Kathryn V. Montague, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–1243; email address: 

montague.kathryn@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 

harmonized test guidelines referenced 

in this document electronically, please 

go to 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 


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