19272 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

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 in accordance with 

sections 408(e) and 408(l)(6) 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). 

VIII. 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: April 1, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.614 is amended by 

revising paragraph (b) to read as follows: 

§ 180.614 Kasugamycin; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of kasugamycin, 3-O-[2-amino4-[(carboxyiminomethyl)amino]-2,3,4,6- 

tetradeoxy-a-D-arabino-hexopyranosyl]- 

D-chiro-inositol in or on the specified 

agricultural commodities, resulting from 

use of the pesticide pursuant to FFIFRA 

section 18 emergency exemptions. The 

tolerances expire and are revoked on the 

date specified in the table. 

Commodity Parts per million 

Expiration/ 

revocation 

date 

Apple 0.05 12/31/12 

* * * * * 

[FR Doc. 2010–8133 Filed 4–13–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0134; FRL–8818-9] 

Thifensulfuron methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of thifensulfuron 

methyl in or on safflower, seed. 

Interregional Research Project Number 4 

(IR-4) requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

14, 2010. Objections and requests for 

hearings must be received on or before 

June 14, 2010, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0134. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Barbara Madden, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6463; e-mail address: 

madden.barbara@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 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 19273 

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 Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0134 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 14, 2010. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009-0134, 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 8, 

2009 (74 FR 15971) (FRL– 8407–4), 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 9F7523) by IR-4, 

500 College Rd. East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.439 be 

amended by establishing a tolerance for 

residues of the herbicide thifensulfuron 

methyl, (methyl-3-[[[[(4-methoxy-6- 

methyl-1,3,5-triazin-2-yl) amino] 

carbonyl] amino] sulfonyl]-2- 

thiophenecarboxylate), in or on 

safflower, seed at 0.05 parts per million 

(ppm). That notice referenced a 

summary of the petition prepared on 

behalf of IR-4 by E.I. DuPont de 

Nemours, 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. 

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 

tolerance for residues of thifensulfuron 

methyl on safflower seed at 0.05ppm. 

EPA’s assessment of exposures and risks 

associated with thifensulfuron methyl 

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. 

Thifensulfuron methyl has mild to 

low acute toxicity when administered 

via the oral, inhalation and dermal 

routes of exposure. It has moderate to 

low toxicity with respect to eye and skin 

irritation and is not a dermal sensitizer. 

Most findings in the submitted studies 

related to decreases in body weights, 

body weight gains, or organ weights (a 

reflection of the lower body weights 

compared with control weights). There 

were increased liver weights in male 

dogs and increased thyroid/parathyroid 

weights in female dogs. There were no 

gross or histopathological changes 

reported in any of the studies. 

In the rat developmental study, there 

were no maternal effects at the highest 

dose tested (HDT). The rabbit 

developmental study showed a decrease 

in maternal body weights at the HDT. 

There were no developmental effects at 

the HDT. In the 2-generation rat 

reproduction study there were no 

parental, reproductive or offspring 

effects. There was an increase in 

quantitative susceptibility in the rat 

developmental study, based on 

decreased mean fetal body weights, and 

an increase in the incidence of small 

renal papillae (only at the highest dose 

level). 

Thifensulfuron methyl is classified as 

‘‘not likely to be carcinogenic to 

humans,’’ based on acceptable chronic/ 

carcinogenicity studies in rats and mice 

at doses that are considered to be 

adequate, and not excessive for the 

determination of carcinogenic potential. 

The available mutagenicity studies in 

vivo and in vitro show that 

thifensulfuron methyl is neither 

mutagenic nor clastogenic. 

Neurotoxicity was not observed in the 

submitted guideline studies. There were 


jlentini on DSKJ8SOYB1PROD with RULES
19274 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

no acute or subchronic neurotoxicity 

studies available for review. There were 

also no immunotoxicity studies 

submitted for review. Immunotoxicity 

was observed as a decrease in spleen 

weight in the subchronic rat study. 

However, this effect was only noted in 

males, and only at the mid-level dose of 

177 mg/kg. The lack of response at the 

high-level dose, the occurrence in a 

single sex, the availability of a clear 

NOAEL, and the absence of 

immunotoxic effects in the remainder of 

the database reduce EPA’s concern for 

immunotoxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by thifensulfuron 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 ‘‘Thifensulfuron Methyl. 

Human Health Risk Assessment for the 

Proposed Food/Feed Use of the 

Herbicide (Associated with Regional 

Section 3 Registration) on Safflower,’’ 

pp. 9-10 in docket ID number EPA–HQ– 

OPP–2009–0134. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level – generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD) – and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for thifensulfuron methyl 

used for human risk assessment is 

shown in the table of this unit. 

TABLE —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIFENSULFURON METHYL FOR USE IN HUMAN RISK

ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary 

(Females 13 - 50 years of 

age) 

NOAEL = 159 milligrams/kilograms/ 

day (mg/kg/day) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.59 mg/kg/day 

aPAD = 1.59 mg/kg/day 

Developmental Oral Toxicity-Rat. 

LOAEL = 725 mg/kg/day based on decreased mean body weight and increased incidence of small renal 

papillae 

Acute dietary 

(General population including 

infants and children) 

Not applicable. There were no single dose effects appropriate for acute exposure assessment for the general population. 

Chronic dietary 

(All populations) 

NOAEL= 4.3 mg/kg/day 

UFA =10x 

UFH = 10x 

FQPA SF 1x 

Chronic RfD = 0.043 mg/kg/ 

day 

cPAD = 0.043mg/kg/day 

Carcinogenicity oral toxicity in mice. 

LOAEL = 128 mg/kg/day based on decreased body weight and body 

weight gain. 

Cancer (Oral) Not likely to be a human carcinogen, based on the lack of evidence of carcinogenicity in rats and mice. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose 

(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to thifensulfuron methyl, EPA 

considered exposure under the 

petitioned-for tolerance as well as all 

existing thifensulfuron methyl 

tolerances in 40 CFR 180.439. EPA 

assessed dietary exposures from 

thifensulfuron methyl 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 effect was identified 

for thifensulfuron methyl for the general 

population. However, EPA identified 

potential acute effects (decreased mean 

body weight, and increased incidence of 

small renal papillae) from pre-natal 

exposure and thus is assessing exposure 

and risk for the population subgroup, 

females 13 – 49 years old. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance-level 

residues, DEEM default processing 

factors for all processed commodities 

and assumed 100 percent crop treated 

(PCT) for all commodities covered by 

existing or proposed tolerances. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance-level residues, DEEM 

default processing factors for all 

processed commodities and assumed 

100 PCT for all commodities covered by 

existing or proposed tolerances. 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 19275 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

classified thifensulfuron methyl as ‘‘not 

likely to be carcinogenic to humans’’. 

Therefore, a quantitative exposure 

assessment to evaluate cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

thifensulfuron methyl. 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 thifensulfuron methyl in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of thifensulfuron methyl. 

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 

thifensulfuron methyl for acute 

exposures are estimated to be 4.429 

parts per billion (ppb) for surface water 

and 0.0972 ppb for ground water and for 

chronic exposures for non-cancer 

assessments are estimated to be 1.5 ppb 

for surface water and .0972 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 4.429 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 1.5 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). 

Thifensulfuron methyl is not registered 

for any specific use patterns that would 

result in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found thifensulfuron 

methyl to share a common mechanism 

of toxicity with any other substances, 

and thifensulfuron methyl does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

thifensulfuron methyl does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database for thifensulfuron methyl 

includes rat and rabbit prenatal 

developmental toxicity studies and a 2– 

generation reproduction toxicity study 

in rats. There was evidence of increased 

quantitative susceptibility in the rat 

developmental toxicity study. At the 

HDT, decreased mean fetal weights, and 

an increase in incidence of small renal 

papillae were observed in the absence of 

maternal toxicity. There was no 

indication of pre- or post-natal 

susceptibility in the rabbit 

developmental or rat reproduction 

studies. 

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 

thifensulfuron methyl is complete 

except for immunotoxicity, acute 

neurotoxicity and subchronic 

neurotoxicity testing. Recent changes to 

40 CFR part 158 make acute and 

subchronic neurotoxicity testing 

(OPPTS Guideline 870.6200) and 

immunotoxicity testing (OPPTS 

Guideline 870.7800) required for 

pesticide registration; however, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. 

Neurotoxicity was not observed in 

any of the studies up to the HDT, nor 

is there any expectation of neurotoxicity 

based on the mechanism of action. 

Furthermore, the toxicity database for 

thifensulfuron methyl does not indicate 

that the immune system is the primary 

target organ. Immunotoxicity was 

observed as a decrease in spleen weight 

in the subchronic rat study. However, 

this effect was only noted in males, and 

only at the mid-level dose of 177 mg/kg. 

The lack of response in the high-level 

dose, the occurrence in a single sex, the 

availability of a clear NOAEL, and the 

absence of immunotoxic effects in the 

remainder of the database reduces EPA’s 

concern for immunotoxicity. The overall 

weight of evidence suggests that 

thifensulfuron methyl does not directly 

target the immune system, and this 

finding (decrease in spleen weight) may 

be due to secondary effects of a primary 

toxicity. Therefore, the Agency does not 

believe that conducting the acute and 

subchronic neurotoxicity, and the 

immunotoxicity studies will result in a 

lower point of departure than the 

currently selected endpoints for overall 

risk assessment, and therefore, a 

database uncertainty factor is not 

needed to account for the lack of these 

studies. 

ii. There is no indication that 

thifensulfuron 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 evidence that 

thifensulfuron methyl results in 

increased susceptibility in in utero rats 

in the prenatal developmental studies 

and in young rats in the 2–generation 

reproduction study; therefore, a degree 

of concern analysis was performed to 

determine the level of concern for the 

effects observed when considered in the 

context of all available toxicity data and 

to identify any residual concerns after 

establishing toxicity endpoints and 

traditional UF’s to be used in the 

thifensulfuron methyl risk assessment. 

In considering the overall toxicity 

profile and the endpoints and doses 

selected for the thifensulfuron methyl 

risk assessment, EPA characterized the 

degree of concern for the susceptibility 

observed in the rat developmental and 


jlentini on DSKJ8SOYB1PROD with RULES
19276 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

2-generation reproductive studies as low 

and determined that there are no 

residual uncertainties for prenatal and/ 

or postnatal toxicity because: 

a. The only missing toxicity data for 

thifensulfuron methyl are the newly 

required neurotoxicity and 

immunotoxicity studies; however, no 

additional UF is needed in the absence 

of these studies because there is no 

evidence to indicate that thifensulfuron 

methyl targets the nervous system or the 

immune system. Further, EPA has 

concluded a developmental 

neurotoxicity study is not required. 

b. There are clear NOAELs and 

LOAELs for the developmental and 

offspring effects noted in the rat 

developmental toxicity and in the 2– 

generation reproduction toxicity studies 

and the doses and endpoints have been 

selected from these studies for risk 

assessment for the relevant exposed 

populations, ie., pregnant females and 

children. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on conservative 

assumptions, including 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

thifensulfuron methyl in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by thifensulfuron methyl. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

thifensulfuron methyl will occupy less 

than 1% of the aPAD for females (ages 

13 – 49), the population subgroup 

receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to thifensulfuron 

methyl from food and water will utilize 

1% of the cPAD for children (ages 3 – 

5), the population subgroup receiving 

the greatest exposure. There are no 

residential uses for thifensulfuron 

methyl. 

3. Short and intermediate-term risk. 

Short and intermediate-term aggregate 

exposure takes into account residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). 

A short and intermediate-term 

adverse effect was identified; however, 

thifensulfuron methyl is not registered 

for any use patterns that would result in 

short or intermediate-term residential 

exposure. Short and intermediate-term 

risk is assessed based on short and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short or intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the point of departure used to assess 

short and intermediate-term risk), no 

further assessment of short or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short and 

intermediate-term risk for 

thifensulfuron methyl. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

thifensulfuron methyl is not expected to 

pose a cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

thifensulfuron methyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The following adequate enforcement 

methodology is available to enforce the 

tolerance expression: Two High 

Pressure Liquid Chromatography 

(HPLC) photo-conductivity detection 

methods. 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no CODEX, Canadian or 

Mexican maximum residue limits 

(MRLs) established for residues of 

thifensulfuron methyl on safflower. 

C. Revisions to Petitioned-For 

Tolerances 

EPA revised the tolerance expression 

in paragraph (a) to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

thifensulfuron methyl not specifically 

mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of thifensulfuron methyl 

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

triazin-2-yl) amino] carbonyl] amino] 

sulfonyl]-2-thiophenecarboxylate), in or 

on safflower, seed at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 19277 

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: April 1, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.439, revise paragraph (a) 

introductory text and paragraph (c) to 

read as follows: 

§ 180.439 Thifensulfuron methyl; 

tolerances for residues. 

(a) General. Tolerances are 

established for residues of 

thifensulfuron methyl, including its 

metabolites and degradates, in or on the 

commodities listed in the following 

table [below]. Compliance with the 

tolerance levels specified in the 

following table [below] is to be 

determined by measuring only 

thifensulfuron methyl (methyl 3-[[[[(4- 

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

yl)amino]carbonyl]amino] sulfonyl]-2- 

thiophenecarboxylate). 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances are established 

for residues of thifensulfuron methyl, 

including its metabolites and 

degradates, in or on the commodities 

listed in the following table [below]. 

Compliance with the tolerance levels 

specified in the following table [below] 

is to be determined by measuring only 

thifensulfuron methyl (methyl 3-[[[[(4- 

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

yl)amino]carbonyl]amino] sulfonyl]-2- 

thiophenecarboxylate). 

Commodity Parts per million 

Safflower, seed ............... 0.05 

* * * * * 

[FR Doc. 2010–8135 Filed 4–13–10; 8:45 am] 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 2, 90, and 95 

[WP Docket No. 07–100, FCC 10–36] 

PLMR Licensing; Frequency 

Coordination and Eligibility Issues 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) considers rule changes to 

certain of its rules that were addressed 

in a previous decision in this 

proceeding. In that decision, the 

Commission proposed various changes 

to its rules regarding PLMR licensing, 

including frequency coordination and 

eligibility issues. This proceeding is part 

of our continuing effort to provide clear 

and concise rules that facilitate new 

wireless technologies, devices and 

services, and are easy for the public to 

understand. 

DATES: Effective May 14, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Rodney P. Conway, at 

Rodney.Conway@FCC.gov, Wireless 

Telecommunications Bureau, (202) 418– 

2904, or TTY (202) 418–7233. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Second 

Report and Order (‘‘Second R&O’’) in 

WP Docket No. 07–100, FCC 10–36, 

adopted on March 3, 2010, and released 

March 10, 2010. In a Notice of Proposed 

Rulemaking and Order (NPRM and 

Order) published at 72 FR 32582, June 

13, 2007, in this proceeding, the 

Commission proposed various changes 

to its rules regarding PLMR licensing, 

including frequency coordination and 

eligibility issues. The full text of this 

document is available for inspection 

and copying during normal business 

hours in the FCC Reference Center, 445 

12th Street, SW., Washington, DC 

20554. The complete text may be 

purchased from the Commission’s copy 

contractor, Best Copy and Printing, Inc., 

445 12th Street, SW., Room CY–B402, 

Washington, DC 20554. The full text 

may also be downloaded at: http:// 

www.fcc.gov. Alternative formats are 

available to persons with disabilities by 

sending an e-mail to fcc504@fcc.gov or 

by calling the Consumer & 

Governmental Affairs Bureau at 202– 

418–0530 (voice), 202–418–0432 (tty). 

1. Part 90 contains the rules for both 

the Private Land Mobile Radio (PLMR) 

Services and certain Commercial Mobile 

Radio Services (CMRS). PLMR licensees 

generally do not provide for-profit 

communications services. Some 

examples of PLMR licensees are public 

safety agencies, businesses that use 

radio only for their internal operations, 

utilities, transportation entities, and 

medical service providers. CMRS 

licensees, by comparison, do provide 

for-profit communications services, 

such as paging and Specialized Mobile 

Radio services that offer customers 

communications that are interconnected 

to the public switched network. 

2. Frequency Coordination and 

Related Matters. Applications for new 

and modified part 90 stations generally 

require frequency coordination before 

the application is submitted to the 

Commission, but certain types of 

applications are exempt from the 

frequency coordination requirement 

because they do not ‘‘have an impact on 

near-term frequency selections.’’ The 

NPRM sought comment on whether to 

permit licensees to forgo frequency 


jlentini on DSKJ8SOYB1PROD with RULES