44440 Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0419; FRL–9390–2] 

Imazosulfuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of imazosulfuron 

in or on the melon subgroup 9A and the 

tuberous and corm subgroup 1C. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective July 

24, 2013. Objections and requests for 

hearings must be received on or before 

September 23, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0419, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0419 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 23, 2013. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0419, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at 

http://www.epa.gov/dockets/ 

contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 22, 

2012 (77 FR 50661) (FRL–9358–9), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 2E8025) by Interregional 

Research Project Number 4 (IR–4), 500 

College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.651 be 

amended by establishing tolerances for 

residues of the herbicide imazosulfuron, 

(2-chloro-N-[[(4,6-dimethoxy-2- 

pyrimidinyl)amino]carbonyl] imidazo- 

[1,2-a]pyridine-3-sulfonamide), in or on 

tuberous and corm vegetables, crop 

subgroup 1C at 0.02 parts per million 

(ppm); and in melon, crop subgroup 9A 

at 0.02 ppm. That document referenced 

a summary of the petition prepared by 

Valent USA Corporation, the registrant, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the commodity definitions to 

be consistent with Agency policy. The 

reason for these changes 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 


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reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.* * *’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 imazosulfuron 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with imazosulfuron 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. 

The toxicology data for imazosulfuron 

suggest that this herbicide possesses 

relatively low toxicity. Many of the 

effects of single or repeated dosing were 

observed near or beyond the respective 

limit doses. 

The primary target organ of 

imazosulfuron in repeated-dose studies 

was the liver in all species tested. Mild 

to moderate thyroid effects were 

apparent only in the chronic toxicity 

study in dogs. Dramatic eye effects 

(retinal degeneration, lens 

vascularization, cataracts and corneal 

scarring) were observed in rats fed 

>1,000 mg/kg/day beginning at 3 

months in the chronic toxicity/ 

carcinogenicity study. Ocular effects 

(increased incidence of eye opacity, 

corneal edema, inflammation and 

neovascularization) were also observed 

in the high-dose males (4,577 mg/kg/ 

day) in the 90-day feeding toxicity study 

in rats. Decreased body weight and body 

weight gain compared to control were 

frequent findings throughout the 

toxicology database for imazosulfuron. 

Clinical signs (decreased motor 

activity, abnormal gait, upward 

curvature of the spine and piloerection) 

were observed in males at the limit dose 

of the acute neurotoxicity study; 

however, these effects can be attributed 

to generalized toxicity and were 

resolved by day 2 of the study. No 

neurotoxic effects were observed during 

the subchronic screening battery or 

noted as clinical signs in any other 

repeated-dose study. 

No developmental effects were 

observed at the highest dose tested 

(HDT) (125 mg/kg/day) in the rabbit 

developmental toxicity study. No 

developmental or reproductive toxicity 

was observed in the 1-generation rat 

study. Decreased pup viability was 

observed in the rat 2-generation 

reproduction study at a dose 

approaching the limit dose (LOAEL = 

892 mg/kg/day) in both the F1 and F2 

offspring generations. Mortality was also 

observed in the parental generation at 

this dose. No increased qualitative or 

quantitative offspring susceptibility was 

apparent in any of the submitted studies 

for imazosulfuron. 

There was no evidence of 

carcinogenicity in rats and mice up to 

the limit dose at 24 and 18 months, 

respectively. Imazosulfuron was 

determined to be non-mutagenic in 

bacteria and negative in an in vivo 

mammalian cytogenetics assay. Overall, 

there was no evidence that 

imazosulfuron was either mutagenic or 

clastogenic in either in vivo or in vitro 

assays. The cancer classification is ‘‘not 

likely to be carcinogenic to humans,’’ 

based on the absence of significant 

tumor increases in the carcinogenicity 

studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by imazosulfuron 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 

titled ‘‘Imazosulfuron: Human Health 

Risk Assessment for Proposed Uses on 

Melon (Crop Subgroup 9A) and 

Tuberous and Corm Vegetables (Crop 

Subgroup 1C),’’ pp. 29–33 in docket ID 

number EPA–HQ–OPP–2012–0419. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for imazosulfuron used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of December 29, 

2010 (75 FR 81878) (FRL–8857–4). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to imazosulfuron, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing imazosulfuron tolerances in 40 

CFR 180.651. EPA assessed dietary 

exposures from imazosulfuron in food 

as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

imazosulfuron. In estimating acute 

dietary exposure, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA assumed 

100 percent crop treated (PCT) and 

tolerance-level residues for all registered 

and proposed uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/ 

WWEIA. As to residue levels in food, 

EPA assumed 100 PCT and tolerancelevel residues for all registered and 

proposed uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that imazosulfuron does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 


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information in the dietary assessment 

for imazosulfuron. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for imazosulfuron in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

imazosulfuron. 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 Tier 1 Rice Model and 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of imazosulfuron for acute 

exposures are estimated to be 278.9 

parts per billion (ppb) for surface water 

and 4.8 ppb for ground water and for 

chronic exposures are estimated to be 

278.9 ppb for surface water and 4.8 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment, the water 

concentration value of 278.9 ppb was 

used to assess the contribution to 

drinking water. For the chronic dietary 

risk assessment, the water concentration 

of value 278.9 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). 

Imazosulfuron is currently registered for 

the following uses that could result in 

residential exposures: Residential 

turfgrass and recreational areas. EPA 

assessed residential exposure using the 

following assumptions: 

Residential handlers may receive 

short-term dermal and inhalation 

exposure to imazosulfuron when 

mixing, loading, and applying the 

pesticide on home lawns. Since a 

dermal endpoint of concern was not 

identified for imazosulfuron, only shortterm inhalation exposure of residential 

handlers was assessed. 

Post-application inhalation exposure 

is not expected due to the nature of 

pesticide applications to residential 

lawns. Based on climate effects (such as 

rain) and post-application activities 

(such as lawn mowing), inhalation 

exposure to imazosulfuron is expected 

to be negligible. Furthermore, 

imazosulfuron has low acute inhalation 

toxicity, low vapor pressure (<3.5 × 

10¥6 Pa) and a low proposed use rate 

(0.3 lb ai/A). Therefore, EPA assessed 

only short-term post-application 

incidental oral exposure of children 

(toddlers) based on the following 

scenarios: Incidental oral exposure from 

treated turf via hand-to-mouth activities; 

incidental oral exposure from treated 

turf via object-to-mouth activities; and 

incidental oral exposure from treated 

turf via soil ingestion. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

science/residential-exposure-sop.html. 

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 imazosulfuron to 

share a common mechanism of toxicity 

with any other substances, and 

imazosulfuron does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that imazosulfuron does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of increased 

susceptibility following in utero and/or 

postnatal exposure in the 

developmental toxicity studies in rats or 

rabbits, or in the 2-generation rat 

reproduction study. Neither the rat nor 

rabbit developmental studies identified 

developmental effects. The parental 

NOAEL is clearly defined, less than or 

equal to the offspring NOAEL and based 

on general systemic toxicity. At nearlimit dose, 20%–30% decreases in 

numbers of implants/dam, total pups/ 

dam and live pups/dam on post-natal 

day (PND) 0, and viability index were 

observed in F1 pups of the 2-generation 

reproductive study in rats. Similarly, 

decreased live pups/dam and live births 

and viability and lactation indices were 

noted for F2 pups at doses that induced 

parental mortality. The points of 

departure are protective of these effects. 

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 

imazosulfuron is complete. 

ii. There is no indication that 

imazosulfuron is a neurotoxic chemical 

based on clinical observations of 

neurotoxicity during the conduct of 

developmental or chronic studies. No 

adverse neurobehavioral signs were 

observed at doses approaching the limit 

dose in any of the short-term studies 

(subchronic oral, 21-day dermal). No 

neurotoxic effects were observed during 

the subchronic neurotoxicity screen in 

which adverse effects of decreased body 

weight, body weight gain and food 

efficiency were observed at 575 mg/kg/ 

day (LOAEL). The acute neurotoxicity 

screen (ACN) yielded a LOAEL at the 

limit dose for clinical signs, abnormal 

gait, decreased activity, piloerection and 

upward curvature of the spine and 

decreased motor activity in males, all of 

which were resolved by day 2. No 

treatment-related effects were observed 

in Functional Observational Battery 

(FOB) parameters, gross and 

neurohistopathology, motor activity or 

brain morphometrics of the ACN. The 

weight of evidence demonstrates that 

imazosulfuron is not a neurotoxic 

compound because the clinical findings 

in the ACN study occurred only at the 

limit dose and may be attributed to 

generalized toxicity. A developmental 

neurotoxicity study is not required at 

this time. 

iii. As discussed in Unit III.D.2., there 

is no concern for increased 

susceptibility to offspring following preand postnatal exposure to rats or in 

utero exposure in rabbits. 

iv. There are no residual uncertainties 

identified in the exposure databases. 


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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 

imazosulfuron 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 imazosulfuron. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

imazosulfuron will occupy 1.2% of the 

aPAD for all infants less than one 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 imazosulfuron 

from food and water will utilize 2% of 

the cPAD for all infants less than one 

year 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 

imazosulfuron 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). 

Imazosulfuron is currently registered 

for uses 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 imazosulfuron. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 33,000 for adults and 8,700 for 

children. Because EPA’s level of 

concern for imazosulfuron is a MOE of 

100 or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, imazosulfuron 

is not registered for any use patterns 

that would result in intermediate-term 

residential exposure. Because there is 

no intermediate-term residential 

exposure and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

imazosulfuron. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

imazosulfuron is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to 

imazosulfuron residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography method with tandem 

mass spectroscopy detection (LC/MS/ 

MS)) is available to enforce the 

tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established any 

MRLs for imazosulfuron. 

C. Revisions to Petitioned-For 

Tolerances 

The proposed commodity definitions 

are being modified from ‘‘Melon crop 

subgroup 9A’’ to ‘‘Melon subgroup 9A’’ 

and ‘‘Tuberous and corm vegetables 

crop subgroup 1C’’ to ‘‘Vegetable, 

tuberous and corm, subgroup 1C’’ to be 

in line with Agency terminology. 

V. Conclusion 

Therefore, tolerances are established 

for residues of imazosulfuron, (2-chloroN-[[(4,6-dimethoxy-2- 

pyrimidinyl)amino]carbonyl] imidazo- 

[1,2-a]pyridine-3-sulfonamide), in or on 

melon subgroup 9A at 0.02 ppm and 

vegetable, tuberous and corm, subgroup 

1C at 0.02 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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). 


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44444 Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: July 17, 2013. 

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. In § 180.651, in paragraph (a), add 

alphabetically the following 

commodities to the table to read as 

follows: 

§ 180.651 Imazosulfuron; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Melon subgroup 9A ...................... 0.02 

*****

Vegetable, tuberous and corm, 

subgroup 1C ............................. 0.02 

* * * * * 

[FR Doc. 2013–17823 Filed 7–23–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0628; FRL–9393–2] 

Mancozeb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mancozeb in 

or on walnuts and tangerines. United 

Phosphorus requested the tolerance for 

walnuts and Dow AgroSciences 

requested the tolerance for tangerines 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

24, 2013. Objections and requests for 

hearings must be received on or before 

September 23, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0628, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s eCFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 


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