23640 Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0275; FRL–8412–6] 

Iodosulfuron-methyl-sodium; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of iodosulfuronmethyl-sodium in or on wheat, forage; 

wheat, grain; wheat, hay; and wheat, 

straw. Bayer Cropscience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

20, 2009. Objections and requests for 

hearings must be received on or before 

July 20, 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–2009–0275. 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: 

Hope Johnson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5410; e-mail address: 

johnson.hope@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 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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–2009–0275 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 July 20, 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–2009–0275, 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 July 9, 2008 

(73 FR 39289) (FRL–8371–2), 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 1F6299) by Bayer 

Cropscience, 2 Alexander Drive, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.580 

be amended by establishing tolerances 

for residues of the herbicide 

iodosulfuron-methyl-sodium, methyl 4- 

iodo-2-[3-(4-methoxy-6-methyl-1,3,5 

triazin-2-yl) ureidosulfonyl] benzoate, 

sodium salt, in or on wheat, grain at 

0.02 parts per million (ppm); wheat, 

forage at 0.06 ppm; wheat, straw at 0.05 

ppm; and wheat, hay at 0.05 ppm. That 

notice referenced a summary of the 

petition prepared by Bayer Cropscience, 

the registrant, which is available to the 

public 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 

concluded that 40 CFR 180.580 can be 

amended by establishing tolerances for 

residues of the herbicide iodosulfuronmethyl sodium, methyl 4-iodo-2-[3-(4- 

methoxy-6-methyl-1,3,5 triazin-2-yl) 

ureidosulfonyl] benzoate, sodium salt, 

in or on wheat, grain at 0.02 ppm; 

wheat, straw at 0.05 ppm; wheat, hay at 

0.05ppm; and wheat, forage at 0.10 ppm 

Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 23641 

instead of the petitioned for 0.06 ppm 

for wheat, forage. The reason for this 

change is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of iodosulfuronmethyl-sodium on wheat, forage at 0.06 

ppm; wheat, grain at 0.02 ppm; wheat, 

hay at 0.05 ppm; and wheat, straw at 

0.05 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing tolerances 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by iodosulfuron-methyl-sodium 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 document 

Iodosulfuron-Methyl-Sodium; HumanHealth Risk Assessment for Proposed 

Section 3 New Use on Wheat, page 37 

in docket ID number EPA–HQ–OPP– 

2009–0275. 

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-, intermediate-, 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. 

Iodosulfuron-methyl-sodium was 

assessed in a complete battery of 

subchronic (mice and rats), chronic 

(mice, rats, and dogs), carcinogenicity 

(mice and rats), developmental (rat and 

rabbit) and reproductive (rat) toxicity 

studies. In general high doses typically 

in the range of greater than 300 mg/kg/ 

day were required to cause systemic 

toxicity characterized as decreases in 

body weight, body weight gain, 

hepatotoxicity in mice and/or dogs and 

gross and histopathological changes in 

the hematopoietic system in dogs. 

Developmental toxicity was seen only at 

the limit dose in the rats, no 

developmental toxicity was seen in the 

rabbit, and no reproductive toxicity was 

seen in the rat. 

Hematopoietic-related toxicity was 

only seen in female dogs in both the 

subchronic and chronic toxicity studies. 

The hematopoietic system involved in 

the production of blood includes 

primarily the bone marrow, spleen, and 

lymph nodes. In both the subchronic 

and chronic studies, microscopic 

pathology of the bone marrow and 

spleen were seen at approximately (50 

m/k/day; LOAEL). The NOAEL was 8 

mg/kg/day. 

The toxicity profile of iodosulfuronmethyl-sodium indicates that the dog to 

be the most sensitive species with the 

effects on the hematopoietic system 

being the most sensitive endpoint. The 

NOAEL (approximately 8 mg/kg/day) 

based on the most sensitive endpoint is 

used for assessing risk to intermediate 

(oral, dermal and inhalation routes) and 

chronic (oral, dermal and inhalation 

routes) durations resulting from 

exposure to iodosulfuron-methylsodium. 

A summary of the toxicological 

endpoints for iodosulfuron-methylsodium used for human risk assessment 

can be found at http:// 

www.regulations.gov in document 

Iodosulfuron-Methyl-Sodium; HumanHealth Risk Assessment for Proposed 

Section 3 New Use on Wheat, page 13 

in docket ID number EPA–HQ–OPP– 

2009–0275. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to iodosulfuron-methylsodium, EPA considered exposure 

under the petitioned-for tolerances as 

well as all existing iodosulfuron-methylsodium tolerances in (40 CFR 180.580). 

EPA assessed dietary exposures from 

iodosulfuron-methyl-sodium 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 United States 

Department of Agriculture (USDA), 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance level 

residues and 100% crop treated 

23642 Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 

information to complete the acute 

dietary exposure assessment. Drinking 

water values were incorporated directly 

into the assessment. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA, 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance level residues and 100% 

crop treated information to complete the 

chronic dietary exposure assessment. 

Drinking water values were 

incorporated directly into the 

assessment. 

iii. Cancer. The Agency determined 

that iodosulfuron-methyl-sodium was 

‘‘not likely to be a human carcinogen’’ 

with regards to its potential as a human 

carcinogen. This decision was based on 

the lack of evidence for carcinogenicity 

in mice and rats. Iodosulfuron-methylsodium was negative for mutagenicity in 

various assays. Furthermore, registered 

sulfonyl urea compounds (structurally 

similar compounds) have been found to 

be non-carcinogenic. Based on this 

weight-of-evidence, an exposure 

assessment to evaluate cancer risk for 

iodosulfuron-methyl-sodium was not 

necessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for iodosulfuron-methyl-sodium. 

Tolerance level residues and 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for iodosulfuron-methyl-sodium in 

drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of iodosulfuron-methylsodium. 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), Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) and 

Screening Concentration in Ground 

Water (SCI-GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of iodosulfuron-methylsodium for acute exposures are 

estimated to be 0.60 parts per billion 

(ppb) for surface water and 0.00004 ppb 

for ground water. For chronic exposures 

for non-cancer assessments are 

estimated to be 0.067 ppb for surface 

water and 0.00004 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 0.60 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 0.067 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). 

Iodosulfuron-methyl-sodium is 

currently registered for the following 

uses that could result in residential 

exposures: Ornamental turf. EPA 

assessed residential exposure using the 

following assumptions: As the 

ornamental turf use is labeled ‘‘intended 

for professional use,’’ and therefore is 

not available for direct residential use, 

a residential handler assessment was 

not conducted. All applications for the 

turf use are to be performed by 

professional (commercial) applicators. 

The ornamental turf product is intended 

for use on ornamental turfgrass on golf 

courses, sports fields, commercial 

lawns, cemeteries, parks, campsites, 

recreational areas, home lawns, 

roadsides, school grounds and sodfarms. 

Based on this use pattern, short and 

intermediate term risk was assessed. 

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 iodosulfuronmethyl-sodium to share a common 

mechanism of toxicity with any other 

substances, and iodosulfuron-methylsodium does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that iodosulfuron-methylsodium 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. 

There is qualitative evidence of 

increased susceptibility based on the rat 

developmental study where delayed 

ossification was observed in the fetuses 

of dams that exhibited minimal 

maternal toxicity (salivation). Similarly, 

there is qualitative and quantitative 

evidence of increased susceptibility 

based on the multi-generation rat 

reproduction study where no parental 

systemic effects were observed at the 

highest dose tested (HDT) and offspring 

toxicity was observed at a lower dose. 

Susceptibility was not observed in the 

developmental toxicity study in the 

rabbit. 

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 

iodosulfuron-methyl-sodium is 

complete, except for the requirements 

for an immunotoxicity, acute, and 

subchronic neurotoxicity studies. The 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios and for evaluation of the 

requirements under FQPA. EPA has 

determined that an additional 

uncertainty factor is not required to 

account for potential neurotoxicity or 

immunotoxicity. The reasons for this 

determination are described as follows: 

a. The toxicity database for 

iodosulfuron-methyl-sodium is 

complete, except for immunotoxicity 

testing. EPA began requiring functional 

immunotoxicity testing of all food and 

non-food use pesticides on December 

26, 2007. Since this requirement went 

into effect well after the tolerance 

petition was submitted, these studies 

are not yet available for iodosulfuronmethyl-sodium. 

Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 23643 

In the absence of specific 

immunotoxicity studies, EPA has 

evaluated the available iodosulfuronmethyl-sodium toxicity data to 

determine whether an additional 

database uncertainty factor is needed to 

account for potential immunotoxicity. 

In the case of iodosulfuron-methylsodium, the available data do not 

indicate a concern for potential 

immunotoxicity. No treatment-related 

changes were seen in hematology 

parameters, organ weights (thymus, 

spleen), gross necropsy (enlarged lymph 

nodes) or histopathology (spleen, 

thymus, lymph nodes) when tested up 

to and including the limit dose (1000 

mg/kg/day) in mice or rats. Marginal 

effects, manifested as histopathological 

changes in the bone marrow and spleen, 

were seen in female dogs. Minimal to 

moderate hyperplasia of the 

hematopoietic cells was seen in the one 

female. No treatment-related changes 

were seen in male dogs. The 

subcapsular congestion in the spleen is 

a common finding and is probably 

related to the means of euthanasia since 

barbiturates can cause the splenic 

musculature to relax and often leads to 

blood filled spleens. Therefore, the 

lesions of the spleen are not evidence of 

immunotoxicity. In the absence of 

corroborative changes in any 

hematology parameters, weights of 

thymus, spleen and lymph nodes, or 

histopathological changes in the thymus 

and lymph nodes in the dogs, the 

changes observed are considered 

hematopoietic, not immunotoxic. 

Therefore an additional uncertainty 

factor is not needed to account for 

potential immunotoxicity. 

b. Acute and subchronic neurotoxicity 

testing is also required as a result of 

changes made to pesticide data 

requirements in December 2007. 

Although acute and subchronic 

neurotoxicity testing has not yet been 

submitted, iodosulfuron-methyl-sodium 

does not belong to a class chemical that 

would be expected to be neurotoxic. 

There is no evidence of neurotoxicity in 

the data base in any species at any dose 

level. In the 90-day dietary studies with 

mice and rats, there were no signs 

indicative of neurotoxicity when tested 

at the limit dose (1000 mg/kg/day). In 

both species, the LOAEL was based on 

decreases in body weight and/or body 

weight gain. These findings indicate 

that the prospective neurotoxicity 

studies will have to be tested at the 

Limit Dose and even with the enhanced 

evaluation of neurotoxic parameters; 

these studies will not yield a lower dose 

for risk assessment. Therefore, a 

database uncertainty factor is not 

required. 

ii. While there is qualitative evidence 

of increased susceptibility based on the 

rat developmental study, the 

developmental toxicity manifested as 

delayed ossification (which are 

variations not malformations) were seen 

only at the limit dose in the presence of 

maternal toxicity, and with a clear 

NOAEL for the effect of concern. 

Susceptibility was not observed in the 

developmental toxicity study in the 

rabbit. Additionally no parental 

systemic effects were observed at the 

limit dose and offspring toxicity was 

observed at a lower dose (34.2 mg/kg/ 

day; manifested as decreased pup 

viability on post-natal day (PND) 0 and 

4) in the multi-generation rat 

reproduction study. In spite of the lack 

of parental toxicity, there was a well 

characterized NOAEL/LOAEL for 

offspring toxicity; the developmental 

NOAEL is used for the acute dietary risk 

assessment; and the NOAEL (7.3 mg/kg/ 

day) used for the chronic dietary risk 

assessment is approximately 47-fold 

lower than the offspring NOAEL (346 

mg/kg/day). Therefore, there is low 

concern for increased susceptibility for 

iodosulfuron-methyl-sodium and no 

additional uncertainty factor is needed. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to iodosulfuronmethyl-sodium in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by iodosulfuron-methylsodium. 

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. Short-, 

intermediate-, and chronic-term 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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

iodosulfuron-methyl-sodium will 

occupy <1.0 % of the aPAD for (all 

infants (<1 year old)) the population 

group receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to iodosulfuronmethyl-sodium from food and water 

will utilize 3.1% of the cPAD for 

(children 3–5 years old) the population 

group receiving the greatest exposure. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of iodosulfuron-methyl-sodium 

is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Iodosulfuron-methyl-sodium is 

currently registered for use that could 

result in short-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

iodosulfuron-methyl-sodium. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 110,000 for 

children 3–5 years old and 420,000 for 

adults 20–49 years old. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Iodosulfuron-methyl-sodium is 

currently registered for use that could 

result in intermediate-term residential 

exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure to 

iodosulfuron-methyl-sodium through 

food and water with intermediate-term 

exposures for iodosulfuron-methylsodium. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures 

aggregated result in aggregate MOEs of 

21,000 for children 3–5 years old, and 

84,000 for adults 20–49 years old. 

23644 Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence for carcinogenicity in mice 

and rats, iodosulfuron-methyl-sodium is 

not expected to pose a cancer risk. 

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 

iodosulfuron-methyl-sodium residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography using mass 

spectrometric detection (LC/MS/MS) 

and by high performance liquid 

chromatography with ultra violet 

detection (HPLC/UV)) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex MRLs for residues 

of iodosulfuron-methyl-sodium, and no 

Mexican MRLs have been established. 

Canadian MRLs have been established 

for certain residues of iodosulfuronmethyl-sodium; however, no MRLs have 

been established for wheat commodities 

at this time. 

C. Revisions to Petitioned-For 

Tolerances 

Review of available field trial data 

indicate that the proposed tolerance for 

wheat, forage (0.06 ppm) is too low; a 

tolerance of 0.10 ppm is appropriate 

based on the maximum residue limit 

(MRL) observed in/on forage. 

V. Conclusion 

Therefore, tolerances are established 

for residues of iodosulfuron-methylsodium, methyl 4-iodo-2-[3-(4-methoxy6-methyl-1,3,5 triazin-2-yl) 

ureidosulfonyl] benzoate, sodium salt, 

in or on wheat, forage at 0.10 ppm; 

wheat, grain at 0.02 parts per million 

(ppm); wheat, hay at 0.05 ppm; and 

wheat, straw at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (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: May 11, 2009. 

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 180.580 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.580 Iodosulfuron-methyl-sodium; 

tolerances for residues. 

(a) * * * 

Commodity Parts per million 

* * * * * * * 

Wheat, forage ................................................................................................................................................................................ 0.10 

Wheat, grain .................................................................................................................................................................................. 0.02 

Wheat, hay ..................................................................................................................................................................................... 0.05 

Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 23645 

Commodity Parts per million 

Wheat, straw ............................................................................................................ 0.05 

* * * * * 

[FR Doc. E9–11633 Filed 5–19–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R06–RCRA–2008–0757; FRL–8905–4] 

Louisiana: Final Authorization of State 

Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Immediate final rule. 

SUMMARY: Louisiana has applied to the 

EPA for final authorization of the 

changes to its hazardous waste program 

under the Resource Conservation and 

Recovery Act (RCRA). The EPA has 

determined that these changes satisfy all 

requirements needed to qualify for final 

authorization, and is authorizing the 

State’s changes through this immediate 

final action. The EPA is publishing this 

rule to authorize the changes without a 

prior proposal because we believe this 

action is not controversial and do not 

expect comments that oppose it. Unless 

we receive written comments which 

oppose this authorization during the 

comment period, the decision to 

authorize Louisiana’s changes to its 

hazardous waste program will take 

effect. If we receive comments that 

oppose this action, we will publish a 

document in the Federal Register 

withdrawing this rule before it takes 

effect, and a separate document in the 

proposed rules section of this Federal 

Register will serve as a proposal to 

authorize the changes. 

DATES: This final authorization will 

become effective on July 20, 2009 unless 

the EPA receives adverse written 

comment by June 19, 2009. If the EPA 

receives such comment, it will publish 

a timely withdrawal of this immediate 

final rule in the Federal Register and 

inform the public that this authorization 

will not take effect. 

ADDRESSES: Submit your comments by 

one of the following methods: 

1. Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

2. E-mail: patterson.alima@epa.gov. 

3. Mail: Alima Patterson, Region 6, 

Regional Authorization Coordinator, 

State/Tribal Oversight Section (6PD–O), 

Multimedia Planning and Permitting 

Division, EPA Region 6, 1445 Ross 

Avenue, Dallas, Texas 75202–2733. 

4. Hand Delivery or Courier: Deliver 

your comments to Alima Patterson, 

Region 6, Regional Authorization 

Coordinator, State/Tribal Oversight 

Section (6PD–O), Multimedia Planning 

and Permitting Division, EPA Region 6, 

1445 Ross Avenue, Dallas, Texas 75202– 

2733. 

Instructions: Do not submit 

information that you consider to be CBI 

or otherwise protected through 

regulations.gov, or e-mail. The Federal 

regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means the EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an e-mail 

comment directly to the EPA without 

going through regulations.gov, your email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, the EPA recommends that 

you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If the EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

the EPA may not be able to consider 

your comment. Electronic files should 

avoid the use of special characters, any 

form of encryption, and be free of any 

defects or viruses. You can view and 

copy Louisiana’s application and 

associated publicly available materials 

from 8:30 a.m. to 4 p.m. Monday 

through Friday at the following 

locations: Louisiana Department of 

Environmental Quality, 602 N. Fifth 

Street, Baton Rouge, Louisiana 70884– 

2178, phone number (225) 219–3559 

and EPA, Region 6, 1445 Ross Avenue, 

Dallas, Texas 75202–2733, phone 

number (214) 665–8533. Interested 

persons wanting to examine these 

documents should make an 

appointment with the office at least two 

weeks in advance. 

FOR FURTHER INFORMATION CONTACT: 

Alima Patterson, Region 6, Regional 

Authorization Coordinator, State/Tribal 

Oversight Section (6PD–O), Multimedia 

Planning and Permitting Division, EPA 

Region 1445 Ross Avenue, Dallas, Texas 

75202–2733, (214) 665–8533 and e-mail 

address patterson.alima@epa.gov. 

SUPPLEMENTARY INFORMATION: 

A. Why Are Revisions to State 

Programs Necessary? 

States which have received final 

authorization from the EPA under RCRA 

section 3006(b), 42 U.S.C. 6926(b), must 

maintain a hazardous waste program 

that is equivalent to, consistent with, 

and no less stringent than the Federal 

program. As the Federal program 

changes, States must change their 

programs and ask the EPA to authorize 

the changes. Changes to State programs 

may be necessary when Federal or State 

statutory or regulatory authority is 

modified or when certain other changes 

occur. 

Most commonly, States must change 

their programs because of changes to the 

EPA’s regulations in 40 Code of Federal 

Regulations (CFR) parts 124, 260 

through 268, 270, 273, and 279. 

B. What Decisions Have We Made in 

This Rule? 

We conclude that Louisiana’s 

application to revise its authorized 

program meets all of the statutory and 

regulatory requirements established by 

RCRA. Therefore, we grant Louisiana 

final authorization to operate its 

hazardous waste program with the 

changes described in the authorization 

application. Louisiana has 

responsibility for permitting treatment, 

storage, and disposal facilities within its 

borders (except in Indian Country) and 

for carrying out the aspects of the RCRA 

program described in its revised 

program application, subject to the 

limitations of the Hazardous and Solid 

Waste Amendments of 1984 (HSWA). 

New Federal requirements and 

prohibitions imposed by Federal 

regulations that the EPA promulgates 

under the authority of HSWA take effect 

in authorized States before they are 

authorized for the requirements. Thus, 

the EPA will implement those 

requirements and prohibitions in 

Louisiana including issuing permits, 

until the State is granted authorization 

to do so. 

C. What Is the Effect of Today’s 

Authorization Decision? 

The effect of this decision is that a 

facility in Louisiana subject to RCRA 

will now have to comply with the