27256 Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0755; FRL–8872–7] 

Saflufenacil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation revises or 

removes certain established tolerances 

and establishes new tolerances for 

residues of saflufenacil in or on 

multiple commodities which are 

identified and discussed later in this 

document. BASF Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

11, 2011. Objections and requests for 

hearings must be received on or before 

July 11, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0755. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0755 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 11, 2011. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0755, 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 September 

23, 2010 (75 FR 57942) (FRL–8845–4), 

EPA issued a notice pursuant to section 

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

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

pesticide petitions (PP 0F7744 and PP 

0F7766) by BASF Corporation, 26 Davis 

Drive, P.O. Box 13528, Research 

Triangle Park, NC 27709–3528. The 

petitions requested that 40 CFR 180.649 

be amended by establishing tolerances 

for residues of the herbicide 

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

methyl-2,6-dioxo-4-(trifluoromethyl)-1(2 

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

methylethyl)amino]sulfonyl]benzamide, 

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

dioxo-4-(trifluoromethyl)-3,6-dihydro1(2 H)-pyrimidinyl)-4-fluorobenzoyl]- 

N-′isopropylsulfamide and N-[4-chloro2-fluoro-5-({[(isopropylamino)

sulfonyl]amino}carbonyl)phenyl]urea, 

calculated as the stoichiometric 

equivalent of saflufenacil, in or on 

oilseeds, cottonseed subgroup 20C, gin 

byproducts at 3.5 parts per million 

(ppm); oilseeds, cottonseed subgroup 

20C, undelinted seed at 0.2 ppm; 

oilseeds, sunflower subgroup 20B, seed 

at 1.0 ppm; pea, vines at 8.0 ppm; 

soybean, aspirated grain fractions at 

4.52 ppm; soybean, hulls at 0.42 ppm; 

soybean, seed at 0.1 ppm; vegetable, 

legume, subgroup 6C, beans, dry at 0.5 

ppm; and vegetable, legume, subgroup 

6C, peas, dry at 0.1 ppm (PP 0F7744); 

and in or on oilseeds, rapeseed 

subgroup 20A, seed at 0.8 ppm (PP 

0F7766). That notice referenced 


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Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 27257 

summaries of the petitions prepared by 

BASF Corporation, the registrant, which 

are 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 revised 

the proposed commodity terms and 

tolerance levels for several commodities 

and determined that established 

tolerances for certain livestock 

commodities should be increased. The 

reasons for these changes are explained 

in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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 

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 recently submitted 

28-day immunotoxicity study, 

saflufenacil failed to induce toxicity 

specific to the immune system at the 

highest dose tested (i.e., 52 milligrams/ 

kilogram/bodyweight/day (mg/kg bw/ 

day)), 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 Uses in/on 

Vegetable, Legume, Subgroup 6C, pea 

and bean (except soybean); Soybean; 

Rapeseed Subgroup 20A; Sunflower 

Subgroup 20B; and Cottonseed 

Subgroup 20C’’ at page 31 in docket ID 

number EPA–HQ–OPP–2010–0755. 

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 


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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 saflufenacil used for 

human risk assessment is shown in the 

following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SAFLUFENACIL 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 (General population including 

infants and children).

NOAEL = 500 mg/kg/ 

day.

UFA = 10x ..................

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 5.0 mg/ 

kg/day.

aPAD = 5.0 mg/kg/day 

Acute Neurotoxicity Study in the Rat. 

LOAEL = 2,000 mg/kg/day based on decreased motor activity representing mild 

and transient systemic toxicity in males. A 

LOAEL was not established for females. 

Chronic dietary (All populations) ..................... NOAEL= 4.6 mg/kg/ 

day.

UFA = 10x ..................

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.046 

mg/kg/day.

cPAD = 0.046 mg/kg/ 

day.

Chronic/Carcinogenicity in the Mouse. 

LOAEL = 13.8 mg/kg/day based on decreased red blood cells, hemoglobin, and 

Ht and porphyria observed in the satellite 

group. 

Cancer (Oral, dermal, inhalation) .................... Classification: Not likely carcinogenic to humans based on the lack of tumors in the mouse and 

rat carcinogenicity studies and lack of mutagenicity. 

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. LOC = level of concern. 

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 U.S. 

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), Dietrary Exposure Evaluation 

Model (DEEMTM 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. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for saflufenacil. Tolerance level residues 

(or, for some commodities, tolerancelevel residues adjusted to account for an 

additional metabolite of concern) and 

100% CT 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 saflufenacil in drinking water. These 

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), 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 


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Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 27259 

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 (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 prenatal and postnatal toxicity 

database for saflufenacil includes rat 

and rabbit developmental toxicity 

studies, a two-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 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- 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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to saflufenacil will 

occupy less than 1% of the aPAD for 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 30% of 

the cPAD for infants less than 1 year 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for saflufenacil. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure take into account short- or 

intermediate-term residential exposure 

plus chronic exposure from food and 

water (considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, saflufenacil is not 

registered for any use patterns that 

would result in short- or intermediateterm residential exposure. Short- and 

intermediate-term risks are assessed 

based on short- 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- and intermediate-term 

risk), no further assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 


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27260 Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 

assessment for evaluating short- and 

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) methods D0603/02 (plants) and 

L0073/01 (livestock)) is available to 

enforce the tolerance expression. The 

methods 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. 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: ‘‘oilseeds, 

cottonseed subgroup 20C, gin 

byproducts’’ was changed to ‘‘cotton, gin 

byproducts;’’ ‘‘oilseeds, cottonseed 

subgroup 20C, undelinted seed’’ was 

changed to ‘‘cottonseed subgroup 20C;’’ 

‘‘oilseeds, sunflower subgroup 20B, 

seed’’ was changed to ‘‘sunflower 

subgroup 20B;’’ ‘‘soybean, aspirated 

grain fractions’’ was changed to ‘‘grain, 

aspirated fractions;’’ ‘‘pea, vines’’ was 

changed to ‘‘pea, hay;’’ and ‘‘oilseeds, 

rapeseed subgroup 20A, seed’’ was 

changed to ‘‘rapeseed subgroup 20A.’’ 

EPA has also revised most of the 

proposed tolerance levels. Based on 

analysis of the field trial data using the 

Agency’s tolerance/MRL calculator in 

accordance with the Agency’s 

‘‘Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data,’’ 

proposed tolerances were revised for 

cotton, gin byproducts from 3.5 ppm to 

0.45 ppm; for pea, hay from 8.0 ppm to 

17 ppm; and for rapeseed subgroup 20A 

from 0.8 ppm to 0.45 ppm. Proposed 

tolerances for grain, aspirated fractions 

and soybean, seed were increased from 

4.52 ppm to 10 ppm and 0.42 ppm to 

0.50 ppm, respectively, based on 

processing factors (150x for aspirated 

grain fractions and 6x for soybean hulls) 

derived from a soybean processing 

study in conjunction with the highest 

average field trial (HAFT) residue of 

0.07 ppm from soybean residue studies. 

In addition, EPA determined that 

separate tolerances were not needed for 

dry peas and beans, proposed at 0.1 

ppm and 0.5 ppm, respectively. A single 

tolerance of 0.30 ppm on ‘‘pea and bean, 

dried shelled, except soybean, subgroup 

6C’’ was determined to be appropriate 

based on analysis of the dry bean field 

trial data using the Agency’s tolerance/ 

MRL calculator. Since residues were 

significantly lower in dried peas, they 

were not used in calculating the 

subgroup 6C tolerance. Finally, based 

on calculated livestock dietary burdens 

in light of the new tolerances and data 

from a cattle feeding study, EPA has 

determined that established tolerances 

for liver and meat byproducts, except 

liver, of cattle, goats, horses, and sheep 

should be increased from 0.80 ppm to 

2.5 ppm and 0.02 ppm to 0.05 ppm, 

respectively. 

In conjunction with establishing these 

tolerances, the existing tolerance for 

‘‘vegetable, foliage of legume, group 7’’ is 

being revised to read ‘‘vegetable, foliage 

of legume, group 7 (except pea, hay)’’; 

the existing tolerance for ‘‘vegetable, 

legume, group 6’’ at 0.03 ppm is being 

replaced with tolerances on ‘‘vegetable, 

legume, edible podded, subgroup 6A’’ 

and ‘‘pea and bean, succulent shelled, 

subgroup 6B’’ at the same level (0.03 

ppm); and the existing tolerances for 

‘‘sunflower, seed’’ and ‘‘cotton, 

undelinted seed,’’ which are superseded 

by tolerances on cottonseed subgroup 

20C and sunflower subgroup 20B, are 

being deleted. 

V. Conclusion 

Therefore, tolerances are established 

or revised for residues of saflufenacil, 

including its metabolites and 

degradates, in or on the commodities as 

codified in the regulatory text in 

§ 180.649(a)(1) and (a)(2). 

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, 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 tolerances 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, 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 27261 

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 (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, 

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, 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 as 

follows: 

■ a. Revise the table in paragraph (a)(1). 

■ b. In the table in paragraph (a)(2), 

revise the entries for cattle, liver; cattle, 

meat byproducts, except liver; goat, 

liver; goat, meat byproducts, except 

liver; horse, liver; horse, meat 

byproducts, except liver; sheep, liver; 

and sheep, meat byproducts, except 

liver. 

The revised texts read as follows: 

§ 180.649 Saflufenacil; tolerances for 

residues. 

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

Commodity Parts per 

million 

Almond, hulls ............................ 0 .10 

Cotton, gin byproducts ............. 0 .45 

Cottonseed subgroup 20C ....... 0 .20 

Fruit, citrus, group 10 ............... 0 .03 

Fruit, pome, group 11 ............... 0 .03 

Fruit, stone, group 12 ............... 0 .03 

Grain, aspirated fractions ......... 10 

Grain, cereal, forage, fodder 

and straw group 16 ............... 0 .10 

Grain, cereal, group 15 ............ 0 .03 

Grape ........................................ 0 .03 

Nut, tree, group 14 ................... 0 .03 

Pea and bean, dried shelled, 

except soybean, subgroup 

6C .......................................... 0 .30 

Pea and bean, succulent 

shelled, subgroup 6B ............ 0 .03 

Pea, hay ................................... 17 

Pistachio ................................... 0 .03 

Rapeseed subgroup 20A .......... 0 .45 

Sunflower subgroup 20B .......... 1 .0 

Soybean, hulls .......................... 0 .50 

Soybean, seed .......................... 0 .10 

Vegetable, foliage of legume, 

group 7 (except pea, hay) .... 0 .10 

Vegetable, legume, edible podded, subgroup 6A ................. 0 .03 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, liver ................................ 2 .5 

* * * * * 

Cattle, meat byproducts, except 

liver ........................................ 0 .05 

* * * * * 

Goat, liver ................................. 2 .5 

* * * * * 

Goat, meat byproducts, except 

liver ........................................ 0 .05 

* * * * * 

Horse, liver ............................... 2 .5 

* * * * * 

Horse, meat byproducts, except 

liver ........................................ 0 .05 

* * * * * 

Sheep, liver ............................... 2 .5 

* * * * * 

Sheep, meat byproducts, except liver ................................ 0 .05 

* * * * * 

* * * * * 

[FR Doc. 2011–11553 Filed 5–10–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–1009; FRL–8873–2] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of propiconazole 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project #4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). In 

addition, this action establishes a timelimited tolerance for residues of 

propiconazole in or on avocado, in 

response to the approval of a quarantine 

exemption under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) authorizing use to control 

the disease, laurel wilt (caused by 

Raffaelea lauricola) in the state of 

Florida. This regulation establishes a 

maximum permissible level of residues 

of propiconazole in this food 

commodity. The time-limited tolerance 

expires and is revoked on December 31, 

2013. 

DATES: This regulation is effective May 

11, 2011. Objections and requests for 

hearings must be received on or before 

July 11, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–1009. 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.), 


srobinson on DSKHWCL6B1PROD with RULES