Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Rules and Regulations 60969 

Commodity Parts per million 

Cattle, meat .................... 0.02 

Cattle, meat byproducts 0.02 

Goat, meat ...................... 0.02 

Goat, meat byproducts ... 0.02 

Horse, meat .................... 0.02 

Horse, meat byproducts 0.02 

Milk ................................. 0.02 

Sheep, meat ................... 0.02 

Sheep, meat byproducts 0.02 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

Tolerances are established for indirect 

or inadvertent combined residues of 

thiencarbazone-methyl and its 

metabolite BYH 18636-MMT-glucoside 

[2-hexopyranosyl-5-methoxy-4-methyl2,4-dihydro-3H-1,2,4-triazol-3-one], 

calculated as the parent compound, in 

or on the following food commodities: 

Commodity Parts per million 

Soybean, forage ............. 0.04 

Soybean, hay .................. 0.15 

[FR Doc. E8–24040 Filed 10–14–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0042; FRL–8377–4] 

Cyprosulfamide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the herbicide 

safener cyprosulfamide in or on corn, 

field, forage; corn, field, grain; corn, 

field, stover; corn, pop, grain; corn, pop, 

stover; corn, sweet, forage; corn, sweet, 

kernel plus cob with husks removed; 

and corn, sweet, stover; and for 

combined residues of cyprosulfamide 

and its metabolite 4-(aminosulfonyl)-Ncyclopropylbenzamide, calculated as 

cyprosulfamide, in or on cattle, meat 

byproducts; goat, meat byproducts; 

horse, meat byproducts and sheep, meat 

byproducts. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 15, 2008. Objections and 

requests for hearings must be received 

on or before December 15, 2008, 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–2008–0042. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket 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 pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2008–0042 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 December 15, 2008. 

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–2008–0042, 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. 


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• 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’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 7E7206) by Bayer 

CropScience, 2 TW Alexander Drive, 

P.O. Box 12014, Research Triangle Park, 

NC 27709. The petition requested that 

40 CFR part 180 be amended by adding 

a section for the herbicide safener 

cyprosulfamide and establishing 

tolerances therein for residues of 

cyprosulfamide (parent) in or on the raw 

agricultural commodities field corn 

grain at 0.01 parts per million (ppm); 

sweet corn kernels at 0.01 ppm; sweet 

corn (k+cwhr) at 0.01 ppm; pop corn 

grain at 0.01 ppm; milk at 0.01ppm; 

cattle, meat at 0.01 ppm; cattle, fat at 

0.01 ppm; cattle, liver at 0.02 ppm; 

cattle, kidney at 0.05 ppm; goat, meat at 

0.01 ppm; goat, fat at 0.01 ppm; goat, 

liver at 0.02 ppm; goat, kidney at 0.05 

ppm; hog, meat at 0.01 ppm; hog, fat at 

0.01 ppm; hog, liver at 0.02 ppm; hog, 

kidney at 0.05 ppm; horse, meat at 0.01 

ppm; horse, fat at 0.01 ppm; horse, liver 

at 0.02 ppm; horse, kidney at 0.05 ppm; 

sheep, meat at 0.01 ppm; sheep, fat at 

0.01 ppm; sheep, liver at 0.02 ppm; and 

sheep, kidney at 0.05 ppm; and for 

residues of parent cyprosulfamide and 

its metabolites AE 0001789- 

sulfonamide-alanine, AE 0001789- 

sulfonamide-lactate, and AE 0001789-Ncyclopropyl-4-sulfamoylbenzamide in 

or on the raw agricultural commodity 

field corn forage at 0.15 ppm, sweet 

corn forage at 0.40 ppm, field corn 

stover at 0.60 ppm, sweet corn stover at 

0.60 ppm, and pop corn stover at 0.60 

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 

modified the metabolites to be included 

in the tolerance expression for livestock, 

corn forage and corn stover 

commodities; modified tolerance levels 

for corn stover commodities and field 

corn forage; and revised the livestock 

commodities for which tolerances are 

needed as well as the livestock 

commodity tolerance levels. The 

reasons for these changes are explained 

in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of the herbicide 

safener cyprosulfamide in or on corn, 

field, forage at 0.20 ppm; corn, field, 

grain at 0.01 ppm; corn, field, stover at 

0.20 ppm; corn, pop, grain at 0.01 ppm; 

corn, pop, stover at 0.20 ppm; corn, 

sweet, forage at 0.40 ppm; corn, sweet, 

kernel plus cob with husks removed at 

0.01 ppm; and corn, sweet, stover at 

0.35 ppm; and for combined residues of 

cyprosulfamide and its metabolite 4- 

(aminosulfonyl)-Ncyclopropylbenzamide, calculated as 

cyprosulfamide, in or on cattle, meat 

byproducts at 0.02 ppm; goat, meat 

byproducts at 0.02 ppm; horse, meat 

byproducts at 0.02 ppm; and sheep, 

meat byproducts at 0.02 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. 

Cyprosulfamide has low toxicity in 

acute toxicity and irritation studies and 

is not a skin sensitizer. In subchronic 

and chronic oral toxicity studies, the 

critical target organ for cyprosulfamide 

is the urinary tract including the kidney, 

bladder and ureters. Toxic effects in 

these organs include inflammation and 

irritation resulting from the formation of 

calculi caused by deposition of the 

parent compound at high doses. 

In the rat chronic toxicity/ 

carcinogenicity study, at doses 

associated with mortality due to 

nephropathy, there were treatmentrelated transitional cell carcinomas in 

the kidney of one male and a 

transitional cell carcinoma in the 

urinary bladder of one female. In mice, 

at a dose where there was formation of 

calculi in the urothelial system, 

cyprosulfamide was associated with two 

incidents of transitional cell papilloma 

in the urinary bladder. Since the 

neoplasms occurred only at high doses 

that also demonstrated calculi 

formation, cyprosulfamide was 

classified as ‘‘Not likely to be a 

Carcinogen to Humans at doses that do 

not cause urothelial cytotoxicity.’’ None 

of the battery of mutagenicity or genetic 

toxicity studies indicated a positive 

result for cyprosulfamide. 

There is no evidence of 

developmental toxicity in the prenatal 

developmental toxicity studies in the rat 

and rabbit and no evidence of increased 

qualitative or quantitative susceptibility 

of fetuses in these studies or of offspring 

in the 2–generation reproduction study 

in rats. Specific neurotoxicity was not 

identified in the rat, mouse or dog 

subchronic or chronic studies or in the 

rat acute and subchronic neurotoxicity 

screen studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by cyprosulfamide as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

Cyprosulfamide: Human Health Risk 

Assessment for Proposed Uses on Corn 

(Field, Sweet, and Pop), Sorghum (Seed 

Treatment), Residential Turf and 


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Ornamentals, page 55 in docket ID 

number EPA–HQ–OPP–2008–0042. 

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 NOAEL in the toxicology study 

identified as appropriate for use in risk 

assessment. However, if a NOAEL 

cannot be determined, 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 cyprosulfamide used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document Cyprosulfamide: Human 

Health Risk Assessment for Proposed 

Uses on Corn (Field, Sweet, and Pop), 

Sorghum (Seed Treatment), Residential 

Turf and Ornamentals in docket ID 

number EPA–HQ–OPP–2008–0042. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to cyprosulfamide, EPA 

considered exposure under the 

petitioned-for tolerances. No other 

tolerances have been established for 

cyprosulfamide. EPA assessed dietary 

exposures from cyprosulfamide 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. No such effects were 

identified in the toxicological studies 

for cyprosulfamide; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Surveys of Food 

Intakes by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

that 100% of crops with requested uses 

of cyprosulfamide are treated and that 

all treated crops contain residues at the 

tolerance level. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified cyprosulfamide as ‘‘Not 

likely to be a Carcinogen to Humans at 

doses that do not cause urothelial 

cytotoxicity ’’; therefore, a cancer 

exposure assessment 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 cyprosulfamide. 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 cyprosulfamide in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

cyprosulfamide. 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 Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

cyprosulfamide for chronic exposures 

for non-cancer assessments are 

estimated to be 2.4 parts per billion 

(ppb) for surface water and 0.14 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 2.4 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). 

Cyprosulfamide is proposed for 

registration on the following use sites 

that could result in residential 

exposures: Residential turfgrass, 

ornamentals and recreational sites. EPA 

assessed residential exposure using the 

following assumptions: Homeowners 

who apply cyprosulfamide to 

ornamentals and turfgrass may be 

exposed for short-term durations via the 

dermal and inhalation routes. Shortterm dermal and inhalation exposures 

were assessed for residential handlers 

who mix, load and apply liquid 

cyprosulfamide products using lowpressure hand wands and garden hoseend sprayers. 

There is also potential for short-term 

postapplication dermal exposure of 

adults and children and incidental oral 

exposure of children following 

application of cyprosulfamide to turf 

(e.g. home lawns). EPA assessed adult 

and toddler postapplication dermal 

exposures as well as incidental oral 

exposure of toddlers from hand-tomouth, object-to-mouth and incidental 

soil ingestion activities. 

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.’’ 

Although cyprosulfamide has in 

common with other sulfonamide 

chemicals the ability to cause urinary 

tract calculi and in some cases tumors 

in the urinary tract at high doses, EPA 

has not made a common mechanism 

finding for cyprosulfamide such that 

cumulative risk assessment based on 

chemicals with a common mechanism is 

necessary for cyprosulfamide and other 

sulfonamides. With cyprosulfamide, the 

formation of calculi in the urinary tract 

results from the precipitation of 

cyprosulfamide once it reaches 

saturation in the animal’s system. 

Precipitation of cyprosulfamide is a 

physical/chemical process and not a 

mechanism of toxicity. Exposures to 

cyprosulfamide and other sulfonamides, 

such as thiencarbazone-methyl, are not 


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additive with regard to the formation of 

urinary tract calculi at anticipated 

exposure levels. At higher doses, each 

sulfonamide will form calculi 

independently of the other by a separate 

physical/chemical process. At lower 

doses, near the anticipated exposure 

levels, calculi will not form even if there 

is exposure to multiple sulfonamides 

because sulfonamides will not influence 

the formation of precipitates by each 

other. It would be appropriate to add 

exposures in assessing precipitate 

formation only if the sulfonamides 

interacted somehow during crystal 

formation. 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 the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

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 cyprosulfamide includes rat 

and rabbit developmental toxicity 

studies and a 2–generation reproduction 

toxicity study in rats. There was no 

evidence of increased susceptibility of 

in utero rats or rabbits in the prenatal 

developmental studies or of young rats 

in the 2–generation reproduction study. 

No fetal effects were seen in the rat 

developmental toxicity study at doses 

that produced maternal toxicity (weight 

gain effects and indications of kidney 

effects in one animal). There are two 

rabbit developmental studies available 

for cyprosulfamide. A second study was 

conducted due to excess maternal 

toxicity (including deaths) in the first 

study. As in the rat study, no fetal 

effects were seen in either rabbit study 

at doses that resulted in maternal 

toxicity (body weight decrease, reduced 

food consumption, and kidney effects in 

both studies; as well as deaths in the 

first study). 

In the rat reproduction study, effects 

in the pups occurred at doses that also 

resulted in maternal toxicity. Mid-dose 

effects included organ weight changes 

in the spleen and urinary tract in the 

dams and body weight changes in the 

pups. At the high dose, there was 

mortality among the dams associated 

with poor physical condition and severe 

renal lesion; effects in pups at the high 

dose included decreased pup weight, 

delayed vaginal opening (apparently 

related to the decreased pup weight), 

reduced viability (3 total litter loss in 

the F1 generation), reduced lactation 

index and clinical findings (paleness, 

cold to touch, missing milk spot and 

thin appearance). No increase in 

sensitivity of the pups was indicated. 

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 

cyprosulfamide is complete, except for 

immunotoxicity studies. EPA began 

requiring functional immunotoxicity 

testing of all food and non-food use 

pesticides on December 26, 2007. Since 

the requirement went into effect well 

after this tolerance petition was 

submitted, these studies are not yet 

available for cyprosulfamide. In the 

absence of specific immunotoxicity 

studies, EPA has evaluated the available 

toxicity data for cyprosulfamide and 

determined that an additional database 

uncertainty factor is not needed to 

account for potential immunotoxicity. 

EPA’s determination is based on the 

following considerations. 

a. There was some indication of 

possible immunotoxicity in the form of 

increased severity of lymphocytolysis in 

the subchronic mouse study in females, 

but only at a high dose of about 1,300 

mg/kg/day. Although minimal 

lymphocytolysis was seen in the control 

animals, lymphocytolysis to a slightly 

greater degree was observed in some of 

the high dose animals. This minor 

difference in severity is not of concern 

because: 

(1) The marginal change in severity 

between control and dosed animals was 

only noted at a very high dose and may 

not constitute an adverse effect. 

(2) No similar effect was seen in the 

carcinogenicity study in the mouse at 

about 600 mg/kg/day or in other species. 

b. EPA considered the entire toxicity 

database for cyprosulfamide for 

potential adverse effects on the thymus 

and spleen as indications of potential 

immunotoxicity. Although changes in 

thymus weight and shape and brown 

pigment in the spleen were noted, these 

were determined to be non-specific 

changes not indicative of 

immunotoxicity. 

c. Cyprosulfamide does not belong to 

a class of chemicals that would be 

expected to be immunotoxic. 

Therefore, based the considerations in 

this Unit, EPA does not believe that 

conducting immunotoxicity testing will 

result in a NOAEL less than the NOAEL 

of 39 mg/kg/day already established for 

cyprosulfamide, and an additional 

factor (UFDB) for database uncertainties 

is not needed to account for potential 

immunotoxicity. 

ii. There is no indication that 

cyprosulfamide is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

cyprosulfamide results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed assuming 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

cyprosulfamide 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 cyprosulfamide. 

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 


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Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Rules and Regulations 60973 

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. No adverse effect resulting from 

a single oral exposure was identified in 

the toxicology studies for 

cyprosulfamide and no acute dietary 

endpoint was selected. Therefore, 

cyprosulfamide is not expected to pose 

an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to cyprosulfamide 

from food and water will utilize less 

than 1% of the cPAD for the U.S. 

population and all population 

subgroups, including infants and 

children. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of cyprosulfamide is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure through food and 

water (considered to be a background 

exposure level). 

Cyprosulfamide 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 cyprosulfamide. 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 

6,900 for adults and 5,300 for children 

(toddlers). The aggregate MOE for adults 

is based on the residential turf scenario 

and includes combined food, drinking 

water, dermal and inhalation exposures 

for residential handlers as well as postapplication dermal exposures from 

activities on treated turf. The aggregate 

MOE for children includes food, 

drinking water and post-application 

dermal and incidental oral exposures 

(hand-to-mouth, object-to-mouth and 

soil ingestion) from activities on turf 

areas previously treated with 

cyprosulfamide. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure through food and water 

(considered to be a background 

exposure level). Cyprosulfamide is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Therefore, the 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

cyprosulfamide through food and water, 

which has already been addressed, and 

will not be greater than the chronic 

aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. EPA classified 

cyprosulfamide as ‘‘Not likely to be a 

Carcinogen to Humans at doses that do 

not cause urothelial cytotoxicity. ’’ 

Cyprosulfamide 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 

cyprosulfamide residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression in plants (High Pressure 

Liquid Chromatography/Mass 

Spectrometry/Mass Spectromety (HPLC/ 

MS/MS) Method UB–008–P06–01) and 

livestock commodities (HPLC/MS/MS 

Method UB–008–P06–01/02). 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 

cyprosulfamide in crop or livestock 

commodities. However, the U.S. is 

working with Canada and the United 

Kingdom to achieve MRL harmonization 

for corn grain. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA has 

modified the metabolites to be included 

in the tolerance expression for livestock, 

corn forage and corn stover 

commodities; modified tolerance levels 

for corn stover commodities and field 

corn forage; and revised the livestock 

commodities for which tolerances are 

needed as well as the livestock 

commodity tolerance levels. 

The petitioner proposed tolerances for 

residues of cyprosulfamide and three 

metabolites (AE 0001789-sulfonamidealanine, AE 0001789-sulfonamidelactate, and AE 0001789-N-cyclopropyl4-sulfamoylbenzamide) on corn forage 

and stover commodities as follows: 

Field corn forage at 0.15 ppm; field corn 

stover at 0.60 ppm; pop corn stover at 

0.60 ppm; sweet corn forage at 0.40 

ppm; and sweet corn stover at 0.60 ppm. 

Based on limited toxicity data for AE 

0001789-N-cyclopropyl-4- 

sulfamoylbenzamide, this metabolite 

cannot be excluded as a residue of 

concern based on hazard considerations. 

The other two metabolites (AE 0001789- 

sulfonamide-alanine, AE 0001789- 

sulfonamide-lactate) are expected to be 

less toxic than the parent compound 

based on structure activity relationship 

(SAR) analysis and can thus be 

excluded as residues of concern based 

on hazard considerations. In corn field 

trials, residues of all four compounds 

were low (most below the limit of 

quantitation of 0.01 ppm), with parent 

cyprosulfamide levels being the highest 

of the four. Based on the lack of hazard 

concern for two of the metabolites and 

the low levels of all three, EPA 

concluded that parent cyprosulfamide is 

the residue of concern to be included in 

the tolerance expression for corn 

commodities, including forage and 

stover. The results of the field trials 

support tolerances for residues of 

cyprosulfamide, per se, of 0.20 ppm in/ 

on field corn forage and stover; 0.20 

ppm in/on popcorn stover; 0.40 ppm in/ 

on sweet corn forage; and 0.35 ppm in/ 

on sweet corn stover. 

The petitioner proposed tolerances for 

residues of cyprosulfamide, per se, on 

meat (0.01 ppm), fat (0.01 ppm), liver 

(0.02 ppm) and kidney (0.05 ppm) of 

cattle, goat, hog, horse and sheep; and 

milk (0.01 ppm). As noted in this Unit, 

EPA concluded that the metabolite AE 

0001789-N-cyclopropyl-4- 

sulfamoylbenzamide (4- 

(aminosulfonyl)-Ncyclopropylbenzamide) cannot be 

excluded as a residue of concern based 

on hazard considerations. The data from 

the submitted cattle feeding study 

indicate that no quantifiable residues of 

cyprosulfamide or this metabolite are 

expected in milk, meat or fat. However, 

quantifiable residues of cyprosulfamide 

and its metabolite may occur in meat 

byproducts (kidney and liver) of cattle, 

goat, horse and sheep. Based on the 

calculated dietary burden of swine, 

there is no reasonable expectation of 

residues of cyprosulfamide or its 

metabolite in swine (hog) commodities. 

Therefore, EPA determined that 

tolerances are needed only for residues 

of cyprosulfamide and its metabolite (4- 

(aminosulfonyl)-Ncyclopropylbenzamide) in/on the meat 

byproducts of cattle, goat, horse and 

sheep. The submitted data and 

calculated dietary burden for ruminants 


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60974 Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Rules and Regulations 

indicate that a tolerance level of 0.02 

ppm in these commodities is 

appropriate. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the herbicide safener 

cyprosulfamide (N-[[4- 

[(cyclopropylamino)carbonyl] 

phenyl]sulfonyl]-2-methoxybenzamide) 

in or on corn, field, forage at 0.20 ppm; 

corn, field, grain at 0.01 ppm; corn, 

field, stover at 0.20 ppm; corn, pop, 

grain at 0.01 ppm; corn, pop, stover at 

0.20 ppm; corn, sweet, forage at 0.40 

ppm; corn, sweet, kernel plus cob with 

husks removed at 0.01 ppm; and corn, 

sweet, stover at 0.35 ppm; and for 

combined residues of cyprosulfamide 

and its metabolite, 4-(aminosulfonyl)-Ncyclopropylbenzamide, calculated as 

cyprosulfamide, in or on cattle, meat 

byproducts at 0.02 ppm; goat, meat 

byproducts at 0.02 ppm; horse, meat 

byproducts at 0.02 ppm; and sheep, 

meat byproducts at 0.02 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, 

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: September 29, 2008. 

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 180.644 is added to read as 

follows: 

§ 180.644 Cyprosulfamide; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the herbicide 

safener cyprosulfamide, N-[[4- 

[(cyclopropylamino)carbonyl] 

phenyl]sulfonyl]-2-methoxybenzamide, 

in or on the following raw agricultural 

commodities: 

Commodity Parts per million 

Corn, field, forage ........... 0.20 

Corn, field, grain ............. 0.01 

Corn, field, stover ........... 0.20 

Corn, pop, grain .............. 0.01 

Corn, pop, stover ............ 0.20 

Corn, sweet, forage ........ 0.40 

Corn, sweet, kernel plus 

cob with husks removed ......................... 0.01 

Corn, sweet, stover ........ 0.35 

(2) Tolerances are established for 

residues of the herbicide safener 

cyprosulfamide, N-[[4- 

[(cyclopropylamino)carbonyl] 

phenyl]sulfonyl]-2-methoxybenzamide, 

and its metabolite 4-(aminosulfonyl)-Ncyclopropylbenzamide, calculated as 

cyprosulfamide, in or on the following 

raw agricultural commodities: 

Commodity Parts per million 

Cattle, meat byproducts 0.02 

Goat, meat byproducts ... 0.02 

Horse, meat byproducts 0.02 

Sheep, meat byproducts 0.02 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertant residues. 

[Reserved] 

[FR Doc. E8–24034 Filed 10–14–08; 8:45 am] 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 08–2148; MB Docket No. 08–133; RM– 

11465] 

Television Broadcasting Services; 

Greenville, NC 

AGENCY: Federal Communications 

Commission. 


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