Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Rules and Regulations 60963 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by December 15, 2008. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: October 1, 2008. 

J.I. Palmer, Jr., 

Regional Administrator, Region 4. 

■ 40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart B—Alabama 

■ 2. Section 52.50(c) is amended by 

revising the entry for ‘‘Section 335–3– 

4.01’’ to read as follows: 

§ 52.50 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED ALABAMA REGULATIONS

State citation Title/subject State effective 

date EPA approval date Explanation 

* * * * * * * 

Chapter 335–3–4 Control of Particulate Emissions 

Section 335–3–4–.01 Visible Emissions ........................................... 9/30/2008 10/15/2008 [Insert citation 

of publication].

* * * * * * * 

* * * * * 

[FR Doc. E8–24031 Filed 10–14–08; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0132; FRL–8382–7] 

Thiencarbazone-methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

thiencarbazone-methyl [methyl 4-[[[(4,5- 

dihydro-3-methoxy-4-methyl-5-oxo-1H1,2,4-triazol-1-yl)- 

carbonyl]amino]sulfonyl]-5-methyl-3- 

thiophenecarboxylate], per se, in or on 

field corn, pop corn, sweet corn, and 

wheat; combined residues of 

thiencarbazone-methyl and its 

metabolite BYH 18636-MMT [5- 

methoxy-4-methyl-2,4-dihydro-3H1,2,4-triazol-3-one], calculated as the 

parent compound, in or on livestock 

commodities; and 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 soybeans. 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–2008–0132. 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 


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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: Jim 

Tompkins, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

703–305–5697; e-mail address: 

tompkins.jim@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 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, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0132 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–2008–0132, 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 April 16, 

2008 (73 FR 20633) (FRL–8359–1), 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 7F7208) by Bayer 

CropScience, 2 T.W. Alexander Drive, 

Research Triangle Park, NC 27709. The 

petition proposed tolerances be 

established for residues of the herbicide 

thiencarbazone-methyl, per se, in or 

corn, field, grain at 0.01 parts per 

million (ppm); corn, sweet, kernels at 

0.01 ppm; wheat, grain at 0.01 ppm; and 

soybean, seed at 0.01 ppm; 

thiencarbazone-methyl and its 

metabolites BYH 18636-MMT-glucoside 

and BYN 18636-N-desmethyl [methyl 4- 

(([(3-methoxy-5-oxo-4,5-dihydro-1H1,2,4-triazol-1- 

yl)carbonyl]amino)sulfonyl)-5- 

methylthiophene-3-carboxylate], 

calculated as the parent compound, in 

or on corn, field, forage at 0.03 ppm; 

corn, sweet, forage at 0.15 ppm; corn, 

field, stover at 0.04 ppm; corn, sweet 

stover at 0.04 ppm; corn, sweet, kernel 

plus cob with husks removed at 0.01 

ppm; wheat, hay at 0.02 ppm; wheat, 

straw at 0.02 ppm; wheat, forage at 0.09 

ppm; soybean, forage at 0.04 ppm; 

soybean, hay at 0.15 ppm, and cotton 

gin by-products at 0.15 ppm; and 

thiencarbazone-methyl and its 

metabolite BYH 18636-MMT, calculated 

as the parent compound, in or on milk 

at 0.01 ppm; cattle, meat at 0.01 ppm; 

cattle, fat at 0.01 ppm; cattle, liver at 

0.05 ppm; cattle, kidney at 0.02 ppm; 

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

ppm; goat, liver at 0.05 ppm; goat, 

kidney at 0.02 ppm; hog, meat at 0.01 

ppm; hog, fat at 0.01 ppm; hog, liver at 

0.05 ppm; hog, kidney at 0.02 ppm; 

horse, meat at 0.01 ppm; horse, liver at 

0.05 ppm; horse, kidney at 0.02 ppm; 

sheep, meat at 0.01 ppm; sheep, fat at 

0.01 ppm; sheep, liver at 0.05 ppm; and 

sheep, kidney at 0.02 ppm. There were 

no comments received in response to 

the notice of filing. 

Tolerance levels and commodity 

expressions have been revised for corn, 

field, forage; corn, field, stover; corn, 

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

forage; wheat, hay; wheat, straw; cotton 

gin byproducts; soybean, seed; and 

livestock commodities as a result of the 

review of the actual residue data and so 

that the listed commodities agree with 

current EPA commodity terms. 

Therefore, EPA is establishing 

tolerances for residues of 

thiencarbazone-methyl, per se, in or on 

corn, field, forage at 0.04 ppm; corn, 

field, grain at 0.01 ppm; corn, field, 

stover at 0.02 ppm; corn, pop, grain at 

0.01 ppm; corn, pop, stover at 0.01 ppm; 

corn, sweet, forage at 0.05 ppm; corn, 

sweet, kernel plus cob with husks 

removed at 0.01 ppm; corn, sweet, 

stover at 0.05 ppm; wheat, forage at 0.10 

ppm; wheat, grain at 0.01 ppm; wheat, 

hay at 0.01 ppm; and wheat, straw at 

0.01 ppm; combined residues of 

thiencarbazone-methyl and its 

metabolite BYH 18636-MMT, calculated 

as the parent compound, in or on cattle, 

meat at 0.02 ppm; cattle, meat 

byproducts at 0.02 ppm; goat, meat at 


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0.02 ppm; goat, meat byproducts at 0.02 

ppm; horse, meat at 0.02 ppm; horse, 

meat byproducts at 0.02 ppm; milk at 

0.02 ppm; sheep, meat at 0.02 ppm; and 

sheep, meat byproducts at 0.02 ppm; 

and indirect or inadvertent combined 

residues of thiencarbazone-methyl and 

its metabolite BYH 18636-MMTglucoside, calculated as the parent 

compound, in or on soybean, forage at 

0.04 ppm and soybean, hay at 0.15 ppm. 

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 

thiencarbazone-methyl, per se, in or on 

corn, field, forage at 0.04 ppm; corn, 

field, grain at 0.01 ppm; corn, field, 

stover at 0.02 ppm; corn, pop, grain at 

0.01 ppm; corn, pop, stover at 0.01 ppm; 

corn, sweet, forage at 0.05 ppm; corn, 

sweet, kernel plus cob with husks 

removed at 0.01 ppm; corn, sweet, 

stover at 0.05 ppm; wheat, forage at 0.10 

ppm; wheat, grain at 0.01 ppm; wheat, 

hay at 0.01 ppm; and wheat, straw at 

0.01 ppm; combined residues of 

thiencarbazone-methyl and its 

metabolite BYH 18636-MMT, calculated 

as the parent compound, in or on cattle, 

meat at 0.02 ppm; cattle, meat 

byproducts at 0.02 ppm; goat, meat at 

0.02 ppm; goat, meat byproducts at 0.02 

ppm; horse, meat at 0.02 ppm; horse, 

meat byproducts at 0.02 ppm; milk at 

0.02 ppm; sheep, meat at 0.02 ppm; and 

sheep, meat byproducts at 0.02 ppm; 

and indirect or inadvertent combined 

residues of thiencarbazone-methyl and 

its metabolite BYH 18636-MMTglucoside, calculated as the parent 

compound, in or on soybean, forage at 

0.04 ppm and soybean, hay at 0.15 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. 

Thiencarbazone-methyl has low 

toxicity in acute toxicity and irritation 

assessments and is not a skin sensitizer. 

In subchronic and chronic oral toxicity 

studies, the critical target organ for 

thiencarbazone-methyl is the urinary 

tract including the kidney, bladder and 

ureters. Toxicity in these structures 

from the formation of calculi that are 

formed by the deposition of the parent 

and are associated with the sulfonamide 

structure and these are evident in the 

dog, considered the most sensitive 

species at 179 milligrams/kilograms/day 

(mg/kg/day) in the chronic study. In 

mice, at 599 mg/kg/day in males and 

758 mg/kg/day in females, doses where 

there was formation of calculi in the 

urothelial system, thiencarbazonemethyl was associated with transitional 

cell epithelium tumors in the urinary 

bladder in one male and three females 

and in the prostatic urethra in one male. 

The battery of mutagenicity/genetic 

toxicity studies did not indicate a 

mutagenicity concern. Since the 

neoplasia occurred only in the high 

dose group, thiencarbazone-methyl was 

classified as ‘‘Not likely to be a 

carcinogen to humans at doses that do 

not cause urothelial cytotoxicity.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by thiencarbazone-methyl 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in 

document Human Health Risk 

Assessment at pages 56–59 in docket ID 

number EPA–HQ–OPP–2008–0132. 

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 thiencarbazone-methyl 

used for human risk assessment can be 

found at http://www.regulations.gov in 

document Human Health Risk 

Assessment at pages 25–26 in docket ID 

number EPA–HQ–OPP–2008–0132. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to thiencarbazone-methyl, 

EPA considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 


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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 thiencarbazonemethyl; therefore, a quantitative acute 

dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the dietary model Dietary 

Exposure Evaluation Model-Food 

Commodity Intake Database (DEEMFCID). The modeled exposure estimates 

for the chronic assessment are based on 

tolerance level residues, assuming 100% 

of the crops are treated, and include the 

highest modeled estimated drinking 

water concentrations (EDWCs). 

iii. Cancer. Thiencarbazone-methyl is 

not likely to be carcinogenic to humans 

at doses that do not cause urothelium 

cytotoxicity. The chronic reference dose 

(cRfD) of 117 mg/kg/day is adequately 

protective of any cancer or precancerous effects seen in 

carcinogenicity studies in rats and mice. 

The formation of the low incidence of 

the transitional cell tumors of the 

bladder in both sexes and urethra/ 

prostrate in males that develop at 599 

mg/kg/day in males and 758 mg/kg/day 

in females in mice is considered to be 

related to secondary effect of the 

urothelial toxicity (irritation) and 

regenerative proliferation associated 

with the formation of urinary tract 

crystals/calculi. This is commonly seen 

for bladder carcinogensis in rodents for 

non-genotoxic chemicals of the 

sulfonamide class. No tumors were seen 

in rats. 

iv. Anticipated residue and percent 

crop treated (PCT) information. 

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 thiencarbazone-methyl in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of thiencarbazonemethyl. 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 EDWCs of 

thiencarbazone-methyl for chronic 

exposures are estimated to be 0.36 parts 

per billion (ppb) for surface water and 

0.00079 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 0.36 

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). 

Thiencarbazone-methyl is currently 

pending registration for the following 

uses that could result in residential 

exposures: Application to residential 

turfgrass and recreational sites. EPA 

assessed residential exposure using the 

following assumptions: Residential 

handlers may receive short-term dermal 

and inhalation exposure when mixing, 

loading, and applying the herbicide. 

Residential post-application exposure 

via the inhalation route is expected to 

be negligible; however, dermal exposure 

is likely for adults and children entering 

treated lawns. Toddlers may also 

experience exposure via incidental nondietary ingestion during postapplication activities on treated turf. 

Residential short-term dermal, 

inhalation, and incidental oral 

exposures were assessed using the same 

NOAEL (159 mg/kg/day). One hundred 

percent absorption via the dermal and 

inhalation exposure routes was 

assumed, resulting in very conservative 

estimates of risk (MOEs). 

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 thiencarbazone-methyl 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 thiencarbazone-methyl such 

that cumulative risk assessment based 

on chemicals with a common 

mechanism is necessary for 

thiencarbazone-methyl and other 

sulfonamides. With thiencarbazonemethyl, the formation of calculi in the 

urinary tract results from the 

precipitation of thiencarbazone-methyl 

once it reaches saturation in the 

animal’s system. Precipitation of 

thiencarbazon-methyl is a physical/ 

chemical process and not a mechanism 

of toxicity. Exposures to 

thiencarbazone-methyl and other 

sulfonamides, are not 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. 

There is no indication of increased 

susceptibility of rat or rabbit offspring to 

thiencarbazone-methyl as indicated by 

the rat and rabbit developmental 

toxicity studies and the rat reproduction 

study. There is no concern for increased 

susceptibility to offspring. 

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 

thiencarbazone-methyl is complete, 

except for immunotoxicity studies. EPA 


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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 thiencarbazonemethyl. In the absence of specific 

immunotoxicity studies, EPA has 

evaluated the available toxicity data for 

thiencarbazone-methyl 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. EPA considered the entire toxicity 

database for thiencarbazone-methyl for 

adverse effects on the thymus and 

spleen for possible indications of 

immunotoxicity and determined that 

there were no changes in these 

structures indicative of immunotoxicity. 

There were also no changes in 

leucocytes or differential leucocyte 

counts to suggest an effect on the 

immune system. 

b. Thiencarbazone-methyl does not 

belong to a class of chemicals that 

would be expected to be immunotoxic. 

c. Therefore, based on the above 

considerations, EPA does not believe 

that conducting immunotoxicity testing 

will result in a NOAEL less than the 

NOAEL of 117 mg//kg/day already 

established for thiencarbazone-methyl, 

and an additional factor (UFDB) for 

database uncertainties is not needed to 

account for potential immunotoxicity. 

ii. There is no indication that 

thiencarbazone-methyl 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 

thiencarbazone-methyl 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 based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

thiencarbazone-methyl 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 thiencarbazone-methyl. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

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

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, thiencarbazonemethyl 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 

thiencarbazone-methyl from food and 

water will utilize 0.1% of the cPAD for 

children 1–2 yrs. and children 3–5 yrs. 

and <0.1% for all other population 

subgroups. 

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). 

Thiencarbazone-methyl is currently 

pending registration 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 

thiencarbazone-methyl. 

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 18,700 to adults 

and 13,500 to children. 

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). 

Although intermediate-term 

residential exposure could result from 

the use of thiencarbazone-methyl, no 

toxicological effects resulting from 

intermediate-term dosing were 

observed. Therefore, the aggregate risk is 

the sum of the risk from food and water 

and will not be greater than the chronic 

aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Thiencarbazone-methyl is 

not likely to be carcinogenic to humans. 

The cRfD of 117 mg/kg/day is 

adequately protective of any cancer or 

pre-cancerous effects seen in 

carcinogenicity studies in rats and mice 

and as the chronic risk assessment 

shows estimated exposure to 

thiencarbazone-methyl is well below the 

cRfD. 

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 

thiencarbazone-methyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

A high performance liquid 

chromotography/mass spectrometry/ 

mass spectrometry (HPLC/MS/MS) 

method was submitted for the 

determination of residues of 

thiencarbazone-methyl and two 

metabolites in/on samples of crop 

commodities. The validated limit of 

quantification (LOQ) is 0.01 ppm for 

each analyte in each matrix. A HPLC/ 

MS/MS method was submitted for the 

determination of residues of 

thiencarbazone-methyl in livestock 

commodities. The LOQ is 0.01 ppm. 

Adequate enforcement methodology 

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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

EPA established tolerances are 

harmonized with Maximum Residue 

Limits (MRLs) established in Canda, 

except for tolerances on livestock 

commodities, livestock feedstuffs, and 

soybeans (as a rotational crop). 

C. Revisions to Petitioned-For 

Tolerances 

Tolerance levels and commodity 

expressions have been revised for corn, 

field, forage; corn, field, stover; corn, 

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

forage; wheat, hay; wheat, straw; and 

livestock commodities as a result of the 


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60968 Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Rules and Regulations 

review of the actual residue data and so 

that the listed commodities agree with 

current EPA commodity terms. EPA 

concluded that there is no need to 

establish indirect or inadvertent 

tolerance levels in or on cotton gin 

byproducts or soybean, seed because the 

submitted field rotational crop data 

demonstrated that residues were not 

likely to be found on these commodities 

when the plant back intervals specified 

on the product labels are followed. EPA 

determined that the residue(s) of 

concern for both risk assessment and 

tolerance expression is thiencarbazonemethyl for corn and wheat commodities, 

thiencarbazone-methyl and BYH 18636- 

MMT-glucoside for soybean rotational 

crop commodities, and thiencarbazonemethyl and BYH 18636-MMT for 

livestock commodities. 

V. Conclusion 

Therefore EPA is establishing 

tolerances for residues of 

thiencarbazone-methyl, in or on corn, 

field, forage at 0.04 ppm; corn, field, 

grain at 0.01 ppm; corn, field, stover at 

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

corn, pop, stover at 0.01 ppm; corn, 

sweet, forage at 0.05 ppm; corn, sweet, 

kernel plus cob with husks removed at 

0.01 ppm; corn, sweet, stover at 0.05 

ppm; wheat, forage at 0.10 ppm; wheat, 

grain at 0.01 ppm; wheat, hay at 0.01 

ppm; and wheat, straw at 0.01 ppm; 

combined residues of thiencarbazonemethyl and its metabolite BYH 18636- 

MMT, calculated as the parent 

compound, in or on cattle, meat at 0.02 

ppm; cattle, meat byproducts at 0.02 

ppm; goat, meat at 0.02 ppm; goat, meat 

byproducts at 0.02 ppm; horse, meat at 

0.02 ppm; horse, meat byproducts at 

0.02 ppm; milk at 0.02 ppm; sheep, 

meat at 0.02 ppm; and sheep, meat 

byproducts at 0.02 ppm; and indirect or 

inadvertent combined residues of 

thiencarbazone-methyl and its 

metabolite BYH 18636-MMT-glucoside, 

calculated as the parent compound, in 

or on soybean, forage at 0.04 ppm and 

soybean, hay at 0.15 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: 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 180.645 is added to read as 

follows: 

§ 180.645 Thiencarbazone-methyl; 

tolerances for residues 

(a) General. (1) Tolerances are 

established for residues of 

thiencarbazone-methyl [methyl 4-[[[(4,5- 

dihydro-3-methoxy-4-methyl-5-oxo-1H1,2,4-triazol-1-yl)- 

carbonyl]amino]sulfonyl]-5-methyl-3- 

thiophenecarboxylate], per se, in or on 

the following food and feed 

commodities: 

Commodity Parts per million 

Corn, field, forage ........... 0.04 

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

Corn, field, stover ........... 0.02 

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

Corn, pop, stover ............ 0.01 

Corn, sweet, forage ........ 0.05 

Corn, sweet, kernel plus 

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

Corn, sweet, stover ........ 0.05 

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

Wheat, grain ................... 0.01 

Wheat, hay ..................... 0.01 

Wheat, straw ................... 0.01 

(2) Tolerances are established for 

combined residues of thiencarbazonemethyl and its metabolite BYH 18636- 

MMT [5-methoxy-4-methyl-2,4-dihydro3H-1,2,4-triazol-3-one], calculated as the 

parent compound, in or on the 

following food commodities of animal 

origin: 


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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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