Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 13179 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

X. Congressional Review Act 

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 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: February 25, 2007. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention 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 180.1150 is revised to read 

as follows: 

§ 180.1150 6-Benzyladenine; exemption 

from the requirement of a tolerance. 

The biochemical plant regulator 6- 

benzyladenine (6–BA) is exempt from 

the requirement of a tolerance in or on 

apple and pear when applied at a rate 

of ≤182 grams of active ingredient per 

acre per season, and in or on pistachio 

when applied at a rate of ≤60 grams of 

active ingredient per acre per season. 

[FR Doc. 07–1386 Filed 3–20–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0208; FRL–8117–1] 

Thifensulfuron Methyl; Pesticide 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thifensulfuron 

methyl in or on rice, grain; rice, straw; 

sorghum, grain, forage; sorghum, grain, 

grain; and sorghum, grain, stover. E. I. 

DuPont de Nemours and Company 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

March 21, 2007. Objections and requests 

for hearings must be received on or 

before May 21, 2007, 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–2006–0208. 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: 

Vickie Walters, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5704; e-mail address: 

walters.vickie@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: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides 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 


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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 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2006–0208 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 

on or before May 21, 2007. 

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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0208, by one of 

the following methods: 

• Federal eRulemaking Porta: 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 Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of July 14, 

2006 (71 FR 40103) (FRL–8058–8), 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 4F6889) by E.I. 

Dupont de Nemours and Company, Inc., 

Laurel Run Plaza, P. O. Box 80038, 

Wilmington, DE 19880–0038. The 

petition requested that 40 CFR 

180.439(a) be amended by establishing 

tolerances 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 grain 

sorghum (forage, grain, stover) and rice 

(grain and straw) at 0.05 parts per 

million (ppm). That notice referenced a 

summary of the petition prepared by E.I. 

DuPont de Nemours and Company, Inc, 

the registrant, that has been included in 

the public docket. A comment was 

received in response to the notice of 

filing from B. Sachau, 15 Elm Street, 

Florham Park, NJ 07932. The comment 

and EPA’s response is discussed in Unit 

IV.C.4. 

During the course of the review the 

Agency decided to update the 

commodity listings to agree with current 

terminology. The commodities are listed 

as rice, grain; rice, straw; sorghum, 

grain, forage; sorghum, grain, grain; and 

sorghum, grain, stover. 

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....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for tolerances for residues of 

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

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

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

thiophenecarboxylate, on rice, grain at 

0.05 part per million (ppm); rice, straw 

at 0.05 ppm; sorghum, grain, forage at 

0.05 ppm; sorghum, grain, grain at 0.05 

ppm and sorghum, grain, stover at 0.05 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

the tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

thifensulfuron methyl as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found in Unit III.A. of the final 

rule published in the Federal Register 

of September 17, 2004 (69 FR 

55975)(FRL–7679–). 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 


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was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

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

pesticides/health/human.htm. 

A summary of the toxicological 

endpoints for thifensulfuron 

miethylused for human risk assessment 

is shown in Table 1 of this unit: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR THIFENSULFURON METHYL FOR USE IN HUMAN RISK

ASSESSMENT

Exposure/Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute dietary (Females 13–50 

years of age) 

NOAEL = 159 milligrams/kilograms/day (mg/kg/day).

UF = 100 ...............................

Acute RfD = 1.59 mg/kg/day 

Special FQPA SF = 1x ......

acute Population adjusted 

dose (aPAD) = acute 

Referenced dose (RfD).

Special FQPA SF = 1.59 

mg/kg/day.

Developmental oral toxicity study in rats. 

LOAEL = 725 mg/kg/day based on decreased 

mean body weight and increased incidence 

of small renal papillae 

Chronic dietary (All populations) NOAEL = 7 mg/kg/day ..........

UF = 100 Chronic RfD = 0.07 

mg/kg/day.

Special FQPA SF = 1x 

chronic Population adjusted dose (cPAD) = 

chronic RfD.

Special FQPA SF = 0.07 

mg/kg/day.

90 Day Oral Toxicity in Rat 

LOAEL = 177 mg/kg/day based on decreased 

body weight and body weight gain in both 

males and females, and increased spleen 

weights in males 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.439) for the 

residues of thifensulfuron methyl, in or 

on a variety of raw agricultural 

commodities. No tolerances for meat, 

milk, poultry and egg are established. 

Risk assessments were conducted by 

EPA to assess 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. 

The acute dietary analysis was 

performed for the population subgroup 

Females 13–49 only. This subgroup is 

the only one for which an acute dietary 

endpoint was identified. In conducting 

the acute dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intakes Database 

(DEEM-FCIDTM), which incorporates 

food consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII), and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the acute exposure assessments: 

Tolerance level residues and 100% crop 

treated (PCT). No empirical processing 

factors were used. A DEEM (Version 

7.81) default processing factor was used 

for corn syrup. Anticipated residues or 

estimates of PCT were not used. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM-FCIDTM, which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide CSFII, 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

Tolerance level residues and 100 PCT. 

No empirical processing factors were 

used. A DEEM (Version 7.81) default 

processing factor was used for corn 

syrup. Anticipated residues or estimates 

of PCT were not used. 

iii. Cancer. Thifensulfuron methyl is 

classified as ‘‘not likely to be 

carcinogenic to humans’’ based on 

acceptable chronic/carcinogenic studies 

in rats and mice. Therefore, a cancer 

exposure assessment was not 

performed. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

thifensulfuron methyl in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

thifensulfuron methyl. Further 

information regarding EPA drinking 

water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed/models/ 

water/index.htm. 

Based on the FQPA Index Reservior 

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 3.9 parts 

per billion (ppb) for surface water and 

0.27 ppb for ground water. The EDWCs 

for chronic exposures are estimated to 

be 1.5 ppb for surface water and 0.27 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model (DEEMFCID). For the acute dietary risk 

assessment the annual average 

concentration in surface water of 3.9 

ppb was used. For the chronic dietary 

risk assessment the annual average 

concentration in surface water of 1.5 

ppb was used. 

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, 


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indoor pest control, termiticides, and 

flea and tick control on pets). 

Thifensulfuron methyl is not 

registered for use on any sites that 

would result in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

thifensulfuron methyl and 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 not 

assumed that thifensulfuron methyl has 

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 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 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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 data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

There is no evidence in the 

developmental study in rabbits and two 

generation reproduction study in rats of 

increased quantitative or qualitative 

susceptibility of the offspring after in 

utero or post-natal exposure to 

thifensulfuron methyl. The acceptable 

developmental toxicity in rats revealed 

increased quantitative susceptibility of 

the fetus after in utero exposure. 

Nonetheless there are no residual 

uncertainties for pre and post natal 

toxicity because the fetal toxicity seen 

in the developmental rat study has been 

well-characterized and the NOAEL 

relied upon to calculate the chronic RfD 

is more than an order of magnitude 

lower than the NOAEL from the 

developmental rat study. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA safety factor to 1X. That 

decision is based on the following 

findings: 

i. The toxicity database for 

thifensulfuron methyl is complete. 

Although the impact of thifensulfuron 

methyl on the nervous system has not 

been specifically evaluated in 

neurotoxicity studies, available 

toxicology studies in four species (rat, 

mouse, dog, and rabbit) do not indicate 

a neurotoxic mode of action for this 

chemical and there are no concerns 

from potential developmental 

neurotoxicity. Therefore, a 

developmental neurotoxicity is not 

required for thifensulfuron methyl. 

ii. As discussed in above Unit III.D.2., 

there are no concerns or residual 

uncertainties for pre and/post natal 

toxicity. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food assessments were 

performed based on 100 PCT and 

tolerance level residues. Conservative 

ground water and surface water 

modeling estimates were used in the 

risk assessments. These assessments 

will not underestimate the exposure and 

risks posed by thifensulfuron methyl. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. The acute aggregate risk 

assessment is provided for females 13–

50 years old only. The existing data 

showed no indication that 

thifensulfuron methyl could cause 

adverse effects in the general population 

based upon a single dose. Thus there is 

no concern for acute dietary exposure to 

the general population. Using the 

exposure assumptions discussed in Unit 

III.C. for acute exposure, the acute 

dietary exposure from food and water to 

thifensulfuron methyl will occupy 

0.03% of the aPAD at the 95% 

percentile of exposure for females 13 

years and older. EPA does not expect 

the aggregate exposure to exceed 100% 

of the aPAD, 

2. Chronic risk. Using the exposure 

assumptions described in Unit III.C. for 

chronic exposure, EPA has concluded 

that exposure to thifensulfuron methyl 

from food and water will utilize <1 % 

of the cPAD for the U.S. population, 

<1% of the cPAD for all infants less than 

1 year old, and <1% of the cPAD for 

children 3-5 years old. There are no 

residential uses for thifensulfuron 

methyl that result in chronic residential 

exposure to thifensulfuron methyl. EPA 

does not expect the aggregate exposure 

to exceed 100% of the cPAD. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Thifensulfuron methyl is not 

registered for use on any sites that 

would result in residential exposure. 

Therefore, the aggregate risk is the sum 

of the risk from food and water, which 

does not exceed the Agency’s LOC. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Thifensulfuron methyl is not 

registered for use on any sites that 

would result in residential exposure. 

Therefore, the aggregate risk is the sum 

of the risk from food and water, which 

does not exceed the Agency’s LOC. 

5. Aggregate cancer risk for U.S. 

population. Thifensulfuron methyl is 

classified ‘‘as not likely to be a human 

carcinogen.’’ Therefore, EPA does not 

expect thifensulfuron methyl will pose 

a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population and to infants and children 

from aggregate exposure to 

thifensulfuron methyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(including high performance liquid 

chromatography (HPLC) with photoconductivity detection and liquid 

chromatography with detection via 

electrospray mass spectroscopy) are 

available to enforce the tolerance 


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expression. These 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 established or proposed 

Codex Maximum Residue Levels (MRLs) 

for residues of thifensulfuron methyl. 

Canadian and Mexican MRLs have been 

established for residues of 

thifensulfuron methyl for several crops. 

However no MRLs have been 

established for sorghum, grain, forage; 

sorghum, grain, grain; sorghum, grain, 

stover; rice, grain; or rice, straw. 

C. Response to Comments 

A comment for thifensulfuron methyl 

was received from Ms. B. Sachau, 15 

Elm Street, Florham Park, NJ 07932. Ms. 

Sachau stated that any residue of this 

product in food was dangerous and 

questioned the availability of testing for 

this chemical in combination with 

thousands of other chemicals used in 

America today. 

EPA generally does not require 

companies to conduct studies to 

evaluate the potential for synergistic 

effects from exposure to combinations of 

chemical exposure. Such testing rarely 

shows any kind of interaction 

(synergistic or antagonistic), and there 

are a nearly infinite number of possible 

combinations, making the cost of 

indiscriminate testing prohibitively 

high. 

Because synergism does not occur 

often, the scientific community believes 

that exposure to multiple chemicals is 

best assessed by looking at the effects 

caused by each chemical individually. 

The only exception to that is when 

people are exposed to multiple 

chemicals that share a common 

mechanism of toxicity. Then the effects 

of exposure to multiple chemicals are 

expected to be additive, adjusted for the 

relative toxicity of different chemicals. 

This is done through Agency 

cumulative risk assessments which are 

discussed in Unit III.C.4. of this 

document. Ms. Sachau did not submit 

any scientific evidence that supported a 

revision of Agency conclusions. 

Based on the Agency risk assessments 

discussed in Unit III.E. of this document 

the Agency has concluded that there is 

a reasonable certainty that no harm will 

result to the general population and to 

infants and children from aggregate 

exposure to thifensulfuron residues. Ms. 

Sachau did not submit any scientific 

evidence that supported a revision of 

Agency conclusions. 

V. Conclusion 

Therefore, the tolerances are 

established for residues of 

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

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

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

thiophenecarboxylate,on rice, grain at 

0.05 part per million (ppm); rice, straw 

at 0.05 ppm; sorghum, grain, forage at 

0.05 ppm; sorghum, grain, grain at 0.05 

ppm and sorghum, grain, stover at 0.05 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism(64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

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 


cprice-sewell on PROD1PC66 with RULES
13184 Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 

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 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: March 5, 2007. 

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 180.439 is amended by 

alphabetically adding commodities to 

the table in paragraph (a) to read as 

follows: 

§ 180.439 Thifensulfuron methyl; 

Tolerances for residues. 

(a) * * * 

Commodity Parts per million 

* * * * * 

Rice, grain ...................... 0.05 

Rice, straw ...................... 0.05 

Sorghum, grain, forage. .. 0.05 

Sorghum, grain, grain ..... 0.05 

Sorghum, grain, stover ... 0.05 

* * * * * 

* * * * * 

[FR Doc. E7–4762 Filed 3–20–07; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF THE INTERIOR 

Office of the Secretary 

43 CFR Part 10 

RIN 1024–AC84 

Native American Graves Protection 

and Repatriation Act Regulations—

Future Applicability 

AGENCY: Department of the Interior. 

ACTION: Final rule. 

SUMMARY: This final rule relates to one 

section of the regulations implementing 

the Native American Graves Protection 

and Repatriation Act of 1990 (‘‘the 

Act’’). This section outlines procedures 

for the future applicability of the Act to 

museums and Federal agencies. 

DATES: Effective Date: This rule is 

effective April 20, 2007. 

ADDRESSES: Mail inquires to Dr. Sherry 

Hutt, Manager, National NAGPRA 

Program, National Park Service, 1849 C 

Street, NW. (2253), Washington, DC 

20240–0001. Telephone: (202) 354–

1479. Fax: (202) 371–5197. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Case, Regulations Program Manager, 

National Park Service, 1849 C Street, 

NW., Room 7241, Washington, DC 

20240. Phone: (202) 208–4206. E-mail: 

jerry_case@nps.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On November 16, 1990, the Native 

American Graves Protection and 

Repatriation Act (25 U.S.C. 3001 et seq.) 

was signed into law. The Act addresses 

the rights of lineal descendants, Indian 

tribes, and Native Hawaiian 

organizations to certain Native 

American human remains, funerary 

objects, sacred objects, and objects of 

cultural patrimony with which they are 

affiliated. Section 13 of the Act requires 

the Secretary of the Interior to 

promulgate regulations to carry out 

provisions of the Act. 

Final regulations implementing the 

Act were published in the Federal 

Register on December 4, 1995, (60 FR 

62138), and codified as 43 CFR part 10. 

Five sections were reserved in the final 

regulations with the intention that they 

would be published in the future. One 

of the five reserved sections, designated 

§ 10.13, was set aside to clarify the 

applicability of the Act to museums and 

Federal agencies following the statutory 

deadlines for completion of summaries 

and inventories. 

The Act requires museums and 

Federal agencies, as defined by the Act, 

to provide summaries of their 

collections to any Indian tribe or Native 

Hawaiian organization that is, or is 

likely to be, culturally affiliated with the 

collection by November 16, 1993. The 

Act also requires museums and Federal 

agencies to prepare, in consultation 

with culturally affiliated Indian tribes 

and Native Hawaiian organizations, 

inventories of human remains and 

associated funerary objects by 

November 16, 1995. The Act also 

requires museums and Federal agencies 

to submit notices for publication in the 

Federal Register prior to repatriation. 

Four types of situations are 

anticipated where a museum or Federal 

agency may fall under the jurisdiction of 

the Act after the statutory deadlines: (1) 

The museum or Federal agency receives 

new collections; (2) a previously 

unrecognized Indian group is 

recognized as an Indian tribe; (3) an 

institution in possession or control of 

Native American human remains, 

funerary objects, sacred objects, or 

objects of cultural patrimony receives 

Federal funds for the first time; and (4) 

the museum or Federal agency revises a 

decision previously published in the 

Federal Register. In each case, this final 

rule establishes deadlines for the 

required summaries, inventories, or 

notices. 

This final rule provides museums and 

Federal agencies with a uniform set of 

procedures to ensure that lineal 

descendants, Indian tribes, and Native 

Hawaiian organizations know of the 

existence and location of cultural items 

with which they are affiliated and 

which they may be able to repatriate. 

These procedures facilitate the existing 

repatriation provisions of the Act, and 

are essential to the continued 

effectiveness of the Act. 

Preparation of the Rulemaking 

The proposed rule to clarify future 

applicability of the Act was published 

in the Federal Register on October 20, 

2004 (69 FR 61613). Public comment 

was invited for a 90-day period, ending 

on January 18, 2005. The proposed rule 

was also posted on the National 

NAGPRA Program Web site. The Native 

American Graves Protection and 

Repatriation Review Committee 

commented on the proposed rule at its 

November 2, 2004 teleconference. In 

addition, ten written comments were 

received during the comment period, 

representing three museums; three 

national scientific or museum 

organizations; two Federal agencies; one 

national Native American organization; 

and one non-Federally recognized 

Native American group. Comments 

addressed all sections of the proposed 

rule. All comments were fully 

considered when revising the proposed 

rule as a final rulemaking. 

Changes in Response to Public 

Comment 

Subsection 10.13(a) 

This subsection outlines the purpose 

of the proposed rule to clarify the 

applicability of the Act to museums and 

Federal agencies after expiration of the 

statutory deadlines for completion of 

summaries and inventories. 


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