Federal Register / Vol. 74, No. 175 / Friday, September 11, 2009 / Rules and Regulations 46683 

the current production year, the 

payment rate is 80 percent of the 

monthly payment rate calculated in 

paragraph (e) of this section. 

(g) The monthly feed cost for covered 

livestock equals the product obtained by 

multiplying: 

(1) 30 days; 

(2) A payment quantity equal to the 

amount referred to in paragraph (h) of 

this section as the ‘‘feed grain 

equivalent’’, as determined under 

paragraph (h) of this section; and 

(3) A payment rate equal to the corn 

price per pound, as determined in 

paragraph (i) of this section. 

(h) The feed grain equivalent equals, 

in the case of: 

(1) An adult beef cow, 15.7 pounds of 

corn per day or 

(2) In the case of any other type or 

weight of covered livestock, an amount 

determined by the Secretary that 

represents the average number of 

pounds of corn per day necessary to 

feed that specific type of livestock. 

(i) The corn price per pound equals 

the quotient obtained by dividing: 

(1) The higher of: 

(i) The national average corn price per 

bushel for the 12-month period 

immediately preceding March 1 of the 

calendar year for which LFP payment is 

calculated or 

(ii) The national average corn price 

per bushel for the 24-month period 

immediately preceding March 1 of the 

calendar year for which LFP payment is 

calculated 

(2) By 56. 

(j) The monthly feed cost using the 

normal carrying capacity of the eligible 

grazing land equals the product 

obtained by multiplying: 

(1) 30 days; 

(2) A payment quantity equal to the 

feed grain equivalent of 15.7 pounds of 

corn per day; 

(3) A payment rate equal to the corn 

price per pound, as determined in 

paragraph (i) of this section; and 

(4) The number of animal units the 

eligible livestock producer’s grazing 

land or pastureland can sustain during 

the normal grazing period in the county 

for the specific type of grazing land or 

pastureland, in the absence of a drought 

or fire, determined by dividing the: 

(i) Number of eligible grazing land or 

pastureland acres of the specific type of 

grazing land or pastureland by 

(ii) The normal carrying capacity of 

the specific type of eligible grazing land 

or pastureland as determined under this 

subpart. 

(k) An eligible livestock producer will 

be eligible to receive payments for 

grazing losses due to a fire as specified 

in § 760.305(c): 

(1) For the period, subject to 

paragraph (l)(2) of this section: 

(i) Beginning on the date on which the 

Federal Agency prohibits the eligible 

livestock producer from using the 

managed rangeland for grazing and 

(ii) Ending on the earlier of the last 

day of the Federal lease of the eligible 

livestock producer or the day that 

would make the period a 180 day period 

and 

(2) For grazing losses that occur on 

not more than 180 days per calendar 

year. 

(3) For 50 percent of the monthly feed 

cost, as determined under § 760.308(g), 

pro-rated to a daily rate, for the total 

number of livestock covered by the 

Federal lease of the eligible livestock 

producer. 

Signed in Washington, DC, September 4, 

2009. 

Jonathan W. Coppess, 

Administrator, Farm Service Agency. 

[FR Doc. E9–21906 Filed 9–9–09; 11:15 am] 

BILLING CODE 3410–05–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0352; FRL–8430–4] 

Saflufenacil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

saflufenacil and its metabolites and 

degradates in or on various plant and 

livestock commodities. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 11, 2009. Objections and 

requests for hearings must be received 

on or before November 10, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0352. 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; e-mail 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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 


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46684 Federal Register / Vol. 74, No. 175 / Friday, September 11, 2009 / Rules and Regulations 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0352 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before November 10, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0352, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of June 13, 

2008 (73 FR 33814) (FRL–8367–3), 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 8F7322) by BASF 

Corporation, 26 Davis Dr., P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR part 180 be amended by adding 

a section for the herbicide saflufenacil 

and establishing tolerances therein for 

combined residues of saflufenacil (aka 

BAS 800 H), N′-[2-chloro-4-fluoro-5-(3- 

methyl-2,6-dioxo-4-(trifluromethyl)-3,6- 

dihydro-1(2H)-pyrimidinyl)benzyl]-Nisopropyl-N-methylsulfamide plus its 

metabolite M800H11, N-[2-chloro-5-

(2,6-dioxo-4(trifluormethyl)-3,6- 

dihydro-1(2H)-pyrimidinyl)-4- 

fluorobenzoyl]-N′-isopropylsulfamide, 

and its metabolite M800H35, (N-[4- 

chloro-2-fluoro-5-

({[(isopropylamino)sulfonyl]amino}

carbonyl)phenyl]urea), in or on legume 

vegetables (group 06), citrus fruits 

(group 10), pome fruits (group 11), stone 

fruits (group 12), tree nuts (group 14), 

pistachio, cereal grains (group 15), 

undelinted cotton seed, cotton gin 

byproducts, and grape at 0.03 parts per 

million (ppm); foliage of legume 

vegetables (group 07); forage, fodder and 

straw of cereal grains (group 16); and 

sorghum stover at 0.1 ppm; almond 

hulls at 0.2 ppm; and sunflower seed at 

0.7 ppm. The petition also requested 

that tolerances be established for 

residues of saflufenacil, M800H11 and 

M800H35 on animal kidney at 0.02 ppm 

and animal liver at 0.8 ppm, although 

the proposed tolerance levels for kidney 

and liver were not specified in the 

company’s notice of filing. That notice 

referenced a summary of the petition 

prepared by BASF Corporation, the 

registrant, which is available to the 

public 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 revised 

the tolerance levels for almond hulls 

and sunflower seed; determined that a 

tolerance for sorghum stover is 

unnecessary; determined that tolerances 

are required for additional livestock 

commodities; and revised the tolerance 

expression for plant and livestock 

commodities. EPA also revised 

commodity terms, as necessary, to agree 

with the Agency’s Food and Feed 

Commodity Vocabulary. The reasons for 

these changes are 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 the petitioned-for 

tolerances for residues of saflufenacil, 

including its metabolites and 

degradates, on the plant commodities 

almond, hulls at 0.10 ppm; cotton, gin 

byproducts at 0.10 ppm; cotton, 

undelinted seed at 0.03 ppm; fruit, 

citrus, group 10 at 0.03 ppm; fruit, 

pome, group 11 at 0.03 ppm; fruit, 

stone, group 12 at 0.03 ppm; grain, 

cereal, forage, fodder and straw group 

16 at 0.10 ppm; grain, cereal, group 15 

at 0.03 ppm; grape at 0.03 ppm; nut, 

tree, group 14 at 0.03 ppm; pistachio at 

0.03 ppm; sunflower, seed at 1.0 ppm; 

vegetable, foliage of legume, group 7 at 

0.10 ppm; and vegetable, legume, group 

6 at 0.03 ppm; and on the livestock 

commodities cattle, fat at 0.01 ppm; 

cattle, liver at 0.80 ppm; cattle, meat at 

0.01 ppm; cattle, meat byproducts, 

except liver at 0.02 ppm; goat, fat at 0.01 

ppm; goat, liver at 0.80 ppm; goat, meat 

at 0.01 ppm; goat, meat byproducts, 

except liver at 0.02 ppm; hog, fat at 0.01 

ppm; hog, liver at 0.80 ppm; hog, meat 

at 0.01 ppm; hog, meat byproducts, 

except liver at 0.02 ppm; horse, fat at 

0.01 ppm; horse, liver at 0.80 ppm; 

horse, meat at 0.01 ppm; horse, meat 

byproducts, except liver at 0.02 ppm; 

milk at 0.01 ppm; sheep, fat at 0.01 

ppm; sheep, liver at 0.80 ppm; sheep, 

meat at 0.01 ppm; and sheep, meat 

byproducts, except liver at 0.02 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing tolerances 

follows. 


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Federal Register / Vol. 74, No. 175 / Friday, September 11, 2009 / Rules and Regulations 46685 

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-term 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. 

These effects also occurred around the 

same dose level from the short-term 

through long-term exposures without 

increasing in severity. 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. 

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. Revised Human-Health 

Risk Assessment for Proposed Uses in/ 

on Legume Vegetables (Crop Group 06), 

the Foliage of Legume Vegetables (Crop 

Group 07), Citrus Fruits (Crop Group 

10), Pome Fruits (Crop Group 11), Stone 

Fruits (Crop Group 12), Tree Nuts (Crop 

Group14), Cereal Grains (Crop Group 

15), Forage, Fodder and Straw of Cereal 

Grains (Crop Group 16), Grapes, Cotton, 

and Sunflower, page 45 in docket ID 

number EPA–HQ–OPP–2008–0352. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for saflufenacil used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document Saflufenacil. Revised HumanHealth Risk Assessment for Proposed 

Uses in/on Legume Vegetables (Crop 

Group 06), the Foliage of Legume 

Vegetables (Crop Group 07), Citrus 

Fruits (Crop Group 10), Pome Fruits 

(Crop Group 11), Stone Fruits (Crop 

Group 12), Tree Nuts (Crop Group14), 

Cereal Grains (Crop Group 15), Forage, 

Fodder and Straw of Cereal Grains 


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46686 Federal Register / Vol. 74, No. 175 / Friday, September 11, 2009 / Rules and Regulations 

(Crop Group 16), Grapes, Cotton, and 

Sunflower, page 27 in docket ID number 

EPA–HQ–OPP–2008–0352. 

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. No other 

tolerances have been established for 

saflufenacil. 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. 

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 Intakes by Individuals (CSFII). As 

to residue levels in food, EPA assumed 

that residues are present in all 

commodities at the tolerance level and 

that 100% of commodities are treated 

with saflufenacil. Dietary Exposure 

Evaluation Model (DEEM(TM)) 7.81 

default concentration factors were used 

to estimate residues of saflufenacil in 

processed 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 the same assumptions (tolerancelevel residues, 100% crop treated, and 

DEEM(TM) 7.81 default concentration 

factors) as in the acute exposure 

assessment. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified saflufenacil as ‘‘not likely 

to be carcinogenic to humans;’’ 

therefore, an exposure assessment to 

evaluate cancer risk is unnecessary for 

this chemical. 

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 

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) 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 website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicity 

database for saflufenacil includes rat 

and rabbit developmental toxicity 

studies and a two-generation 

reproduction toxicity 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. 

iv. The dose used to evaluate chronic 

dietary risks (4.6 milligrams/kilogram/ 

day (mg/kg/day)) is lower than the 

NOAELS for fetal/offspring effects in the 

developmental and reproduction studies 

(5 mg/kg/day in the rat developmental 

study, 50 mg/kg/day in the rabbit 

developmental study, and 15 mg/kg/day 

in the rat reproduction study) and is, 

therefore, protective of the 

developmental and offspring effects 

observed in these studies and 

v. Residential exposures are not 

expected, since there are no residential 

uses proposed for saflufenacil. 


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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 adequate to assess the 

prenatal and postnatal toxicity of 

saflufenacil. In accordance with 40 CFR 

part 158 Toxicology Data requirements, 

an immunotoxicity study (870.7800) is 

required for saflufenacil. In the absence 

of specific immunotoxicity studies, EPA 

has evaluated the available saflufenacil 

toxicity data to determine whether an 

additional database uncertainty factor is 

needed to account for potential 

immunotoxicity. An increase in spleen 

weight, an organ of the immune system, 

was seen in rats in the 90–day oral 

toxicity study. This effect 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. 

There were no other effects on immune 

system organs observed in toxicity 

studies with saflufenacil, and 

saflufenacil does not belong to a class of 

chemicals (e.g., the organotins, heavy 

metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxic. Based on these 

considerations, EPA does not believe 

that conducting immunotoxicity testing 

will result in a point of departure lower 

than those already selected for 

saflufenacil, and an additional database 

uncertainty factor is not needed to 

account for potential immunotoxicity. 

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. There is evidence of increased 

quantitative and qualitative 

susceptibility of offspring in the 

developmental and reproduction studies 

for saflufenacil; however, 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 groundwater and surface water 

modeling used to assess exposure to 

saflufenacil in drinking water. 

Residential exposure to saflufenacil is 

not expected. 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 pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

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

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to 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 28% 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-term/intermediate-term risk. 

Short-term and intermediate-term 

aggregate exposures take into account 

short-term or intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Saflufenacil is not registered for any use 

patterns that would result in residential 

exposure. Therefore, the short-term and 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

saflufenacil through food and water and 

will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Saflufenacil is classified as 

‘‘not likely to be carcinogenic to 

humans’’ and is, therefore, not expected 

to pose a cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to saflufenacil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry (LCMS/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 

There are no Codex, Canadian, or 

Mexican maximum residue limits 

(MRLs) established for residues of 

saflufenacil and its metabolites in crops 

or livestock commodities. The residue 

definition and tolerances being 

established by this rule are harmonized 

with MRLs being established 

concurrently by Canada and Australia. 

C. Response to Comments 

EPA received one comment in 

response to the petition notice of filing. 

The commenter, a private citizen, 

expressed strong objections to 

‘‘genetically engineered foods.’’ The 

commenter’s objections are not relevant 

to this petition, since the tolerances for 

saflufenacil do not involve genetically 

altered herbicide-tolerant crops. 

D. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerance levels for almond hulls 

and sunflower seed; determined that a 

tolerance for sorghum stover is 

unnecessary; determined that tolerances 

are required for additional livestock 

commodities; and revised the tolerance 

expression for plant and livestock 

commodities. EPA also revised 

commodity terms, as necessary, to agree 

with the Agency’s Food and Feed 

Commodity Vocabulary. 

EPA increased the tolerance on 

sunflower seed from 0.7 ppm to 1.0 ppm 

based on analysis of the field trial data 

using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

The tolerance on almond hulls was 

decreased from 0.2 ppm to 0.10 ppm, 

based on the results of field trials 

showing that all residues were less than 

the limit of quantitation (LOQ) (0.025 

ppm for each analyte) at the proposed 

preharvest interval (PHI) of 7 days. The 


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tolerance level was determined by 

adding the LOQs for saflufenacil and its 

two regulated analytes and rounding up 

to 0.10 ppm. EPA determined that a 

separate tolerance on sorghum stover is 

unnecessary, since sorghum stover is 

included in crop group 16 (grain, cereal, 

forage, fodder and straw group). 

The petitioner proposed tolerances for 

saflufenacil and its metabolites 

M800H11 and M800H35 on animal 

kidney at 0.02 ppm and on animal liver 

at 0.80 ppm. EPA determined that 

M800H11 and M800H35 should be 

excluded from the tolerance expression 

for livestock commodities based on the 

low potential for exposure to these 

metabolites from the proposed uses. 

Data from the cattle feeding study with 

saflufenacil indicate that tolerances are 

needed for residues of saflufenacil at 

0.80 ppm in liver and at 0.02 ppm in the 

meat byproducts, except liver, of cattle, 

goats, horses, hogs, and sheep. EPA is 

also establishing tolerances at the 

method LOQ (0.01 ppm) for fat, meat, 

and milk, because feeding levels in the 

cattle feeding study were not high 

enough (i.e., 10X) to demonstrate 

conclusively that detectable residues 

would not occur in these livestock 

commodities. 

Although the commodity terms 

proposed in the petition itself were 

largely in accordance with the Agency’s 

Food and Feed Commodity Vocabulary, 

many were incorrectly specified in the 

Notice of Filing: legume vegetables 

(group 06); citrus fruits (group 10); 

pome fruits (group 11); stone fruits 

(group 12); tree nuts (group 14); cereal 

grains (group 15); undelinted cotton 

seed; cotton gin byproducts; foliage of 

legume vegetables (group 07); forage, 

fodder and straw of cereal grains (group 

16); almond hulls; and sunflower seed. 

EPA has corrected these commodity 

terms to read: vegetable, legume, group 

6; fruit, citrus, group 10; fruit, pome, 

group 11; fruit, stone, group 12; nut, 

tree, group 14; grain, cereal, group 15; 

cotton, undelinted seed; cotton, gin 

byproducts; vegetable, foliage of legume, 

group 7; grain, cereal, forage, fodder and 

straw group 16; almond, hulls; and 

sunflower, seed. 

Finally, EPA is revising the tolerance 

expressions for plant and livestock 

commodities to clarify the chemical 

moieties that are covered by the 

tolerances and specify how compliance 

with the tolerances is to be measured. 

The revised tolerance expressions make 

clear that the tolerances cover ‘‘residues 

of saflufenacil, including its metabolites 

and degradates,’’ and that compliance 

with the tolerance levels will be 

determined, for livestock commodities, 

by measuring only saflufenacil; and for 

plant commodities, 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. 

V. Conclusion 

Therefore, tolerances are established 

for residues of saflufenacil, including its 

metabolites and degradates, on the plant 

commodities almond, hulls at 0.10 ppm; 

cotton, gin byproducts at 0.10 ppm; 

cotton, undelinted seed at 0.03 ppm; 

fruit, citrus, group 10 at 0.03 ppm; fruit, 

pome, group 11 at 0.03 ppm; fruit, 

stone, group 12 at 0.03 ppm; grain, 

cereal, forage, fodder and straw group 

16 at 0.10 ppm; grain, cereal, group 15 

at 0.03 ppm; grape at 0.03 ppm; nut, 

tree, group 14 at 0.03 ppm; pistachio at 

0.03 ppm; sunflower, seed at 1.0 ppm; 

vegetable, foliage of legume, group 7 at 

0.10 ppm; and vegetable, legume, group 

6 at 0.03 ppm; and on the livestock 

commodities cattle, fat at 0.01 ppm; 

cattle, liver at 0.80 ppm; cattle, meat at 

0.01 ppm; cattle, meat byproducts, 

except liver at 0.02 ppm; goat, fat at 0.01 

ppm; goat, liver at 0.80 ppm; goat, meat 

at 0.01 ppm; goat, meat byproducts, 

except liver at 0.02 ppm; hog, fat at 0.01 

ppm; hog, liver at 0.80 ppm; hog, meat 

at 0.01 ppm; hog, meat byproducts, 

except liver at 0.02 ppm; horse, fat at 

0.01 ppm; horse, liver at 0.80 ppm; 

horse, meat at 0.01 ppm; horse, meat 

byproducts, except liver at 0.02 ppm; 

milk at 0.01 ppm; sheep, fat at 0.01 

ppm; sheep, liver at 0.80 ppm; sheep, 

meat at 0.01 ppm; and sheep, meat 

byproducts, except liver at 0.02 ppm. 

Compliance with the tolerance levels for 

plant commodities will 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. Compliance 

with the tolerance levels for livestock 

commodities will be determined by 

measuring only saflufenacil. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 


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Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 2, 2009. 

Debra Edwards, 

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 180.649 is added to read as 

follows: 

§ 180.649 Saflufenacil; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of saflufenacil, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of saflufenacil, 2-chloro-5-[3,6-dihydro3-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 

fluoro-5-({[(isopropylamino)sulfonyl]

amino}carbonyl)phenyl]urea, calculated 

as the stoichiometric equivalent of 

saflufenacil, in or on the commodities. 

Commodity Parts per million 

Almond, hulls .................. 0.10 

Cotton, gin byproducts ... 0.10 

Cotton, undelinted seed 0.03 

Fruit, citrus, group 10 ..... 0.03 

Fruit, pome, group 11 ..... 0.03 

Fruit, stone, group 12 ..... 0.03 

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 

Pistachio ......................... 0.03 

Sunflower, seed .............. 1.0 

Vegetable, foliage of legume, group 7 ............... 0.10 

Vegetable, legume, 

group 6 ........................ 0.03 

(2) Tolerances are established for 

residues of saflufenacil, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only 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, in or on the 

commodities. 

Commodity Parts per million 

Cattle, fat ........................ 0.01 

Cattle, liver ...................... 0.80 

Cattle, meat .................... 0.01 

Cattle, meat byproducts, 

except liver .................. 0.02 

Goat, fat .......................... 0.01 

Goat, liver ....................... 0.80 

Goat, meat ...................... 0.01 

Goat, meat byproducts, 

except liver .................. 0.02 

Hog, fat ........................... 0.01 

Hog, liver ........................ 0.80 

Hog, meat ....................... 0.01 

Hog, meat byproducts, 

except liver .................. 0.02 

Horse, fat ........................ 0.01 

Horse, liver ..................... 0.80 

Horse, meat .................... 0.01 

Horse, meat byproducts, 

except liver .................. 0.02 

Milk ................................. 0.01 

Sheep, fat ....................... 0.01 

Sheep, liver ..................... 0.80 

Sheep, meat ................... 0.01 

Sheep, meat byproducts, 

except liver .................. 0.02 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E9–21826 Filed 9–10–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0834; FRL–8426–2] 

Azinphos-methyl, Disulfoton, 

Esfenvalerate, Ethylene oxide, 

Fenvalerate, et al.; Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking certain 

tolerances for the fungicides 

prothioconazole and thiabendazole; the 

herbicide primisulfuron-methyl; and the 

insecticides azinphos-methyl, 

disulfoton, esfenvalerate, fenvalerate, 

and phosalone; the plant growth 

regulator 1-naphthaleneacetic acid; and 

the antimicrobial/insecticidal agent 

ethylene oxide. Also, EPA is modifying 

certain tolerances for the insecticides 

disulfoton, esfenvalerate, and phosmet; 

and the plant growth regulator 1- 

naphthaleneacetic. In addition, EPA is 

establishing new tolerances for the 

insecticides disulfoton, esfenvalerate, 

and phosmet; and the antimicrobial/ 

insecticidal agent ethylene oxide and 

ethylene chlorohydrin (a reaction 

product formed during the fumigation/ 

sterilization process). The regulatory 

actions finalized in this document are in 

follow-up to the Agency’s reregistration 

program under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), and tolerance reassessment 

program under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), section 

408(q). 

DATES: This regulation is effective 

September 11, 2009. Objections and 

requests for hearings must be received 

on or before November 10, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0834. 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. 


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