Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Rules and Regulations 3621 

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) (Pub. L. 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: January 13, 2012. 

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 180.593 is amended in 

paragraph (a) by alphabetically adding 

the following commodities to the table 

to read as follows: 

§ 180.593 Etoxazole; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

*****

Corn, field, forage ................... 0 .80 

Corn, field, grain ..................... 0 .01 

Corn, field, refined oil ............. 0 .03 

Corn, field, stover ................... 4 .0 

Corn, pop, grain ...................... 0 .01 

Corn, pop, stover .................... 4 .0 

*****

* * * * * 

[FR Doc. 2012–1254 Filed 1–24–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–1017; FRL–9332–1] 

Rimsulfuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of rimsulfuron in 

or on the caneberry subgroup 13–07A 

and the bushberry subgroup 13–07B. 

Interregional Research Project No. 4 (IR– 

4) requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

January 25, 2012. Objections and 

requests for hearings must be received 

on or before March 26, 2012, 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–2010–1017. 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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 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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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


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3622 Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Rules and Regulations 

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–2010–1017 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 March 26, 2012. 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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–1017, 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. Summary of Petitioned-for Tolerance 

In the Federal Register of February 

25, 2011 (76 FR 10584) (FRL–8863–3), 

EPA issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 0E7809) by IR–4, 

Rutgers, The State University of New 

Jersey, 500 College Rd. East, Suite 

201W., Princeton, NJ 08540. The 

petition requested that 40 CFR 180.478 

be amended by establishing tolerances 

for residues of the herbicide 

rimsulfuron, N-((4,6- 

dimethoxypyrimidin-2- 

yl)aminocarbonyl)-3-(ethylsulfonyl)-2- 

pyridinesulfonamide, including its 

metabolites and degradates, in or on 

caneberry, subgroup 13–07A at 

0.01parts per million (ppm) and 

bushberry, subgroup 13–07B at 0.01 

ppm. That notice referenced a summary 

of the petition prepared by DuPont, the 

registrant, which is available 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 rimsulfuron 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with rimsulfuron 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. 

Rimsulfuron has low acute toxicity by 

oral, dermal, and inhalation routes of 

exposure. It is a moderate eye irritant 

and is not a dermal sensitizer. In 

subchronic and chronic toxicity studies 

in rats, toxic effects included decreased 

body weight, decreased body weight 

gain, increased relative liver and 

absolute kidney weights, and diuresis. 

In the subchronic study in mice, 

increased red blood cell (RBC) and 

hemoglobin, and decreased body weight 

gain and food efficiency were observed. 

In the chronic study in mice, decreased 

body weight, increased incidences of 

dilation and cysts in the glandular 

stomach, and degeneration of the 

testicular artery and tunica albuginea 

were observed. In the subchronic study 

in dogs, diuresis was indicated by 

urinary volume, platelet concentration 

and kidney weights accompanied by 

decreased urinary osmolality. In the 

chronic study in dogs, increased 

absolute liver and kidney weights, 

increased seminiferous tubule 

degeneration, and increased number of 

spermatid giant cells present in 

epididymides in males were observed. 

In the developmental toxicity study in 

rats, no toxicity was seen at the highest 

dose tested (HDT). In the developmental 

toxicity study in rabbits, and in the 2- 

generation reproduction toxicity study 

in rats, developmental/offspring toxicity 

was seen in the presence of maternal/ 

systemic toxicity and at similar dose 

levels. There is no quantitative or 

qualitative evidence of increased 

susceptibility following pre- and/or 

postnatal exposures, and there are no 

concerns or residual uncertainties. 

Rimsulfuron was classified by EPA as 

‘‘not likely to be carcinogenic to 

humans’’ based on the absence of 

tumors in carcinogenicity studies 

conducted in rats and mice. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by rimsulfuron as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Rimsulfuron. Human Health Risk 

Assessment for Proposed Section 3 Uses 

on Caneberry and Bushberry,’’ pp. 31– 

33 in docket ID number EPA–HQ–OPP– 

2010–1017. 

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 


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toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL are identified. 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 rimsulfuron used for 

human risk assessment is shown in the 

Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR RIMSULFURON FOR USE IN HUMAN HEALTH 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 and General population including infants and children).

No appropriate endpoint attributable to a single dose identified. 

Chronic dietary (All populations) .... NOAEL = 11.8 mg/kg/day ............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.118 mg/kg/day 

cPAD = 0.118 mg/kg/day 

Combined Chronic/Carcinogenicity-Rat LOAEL= 121 mg/ 

kg/day in males; 568mg/kg/day 

in females (NOAEL=163 mg/kg/ 

day), based on decreased body 

weight gains and liver effects. 

Cancer (Oral, dermal, inhalation) .. Rimsulfuron is considered ‘‘not likely to be carcinogenic to humans’’ due to the absence of tumors in rat 

and mouse carcinogenicity studies. 

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

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. Mg/kg/day = milligrams/kilograms/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to rimsulfuron, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing rimsulfuron tolerances in 40 

CFR 180.478. EPA assessed dietary 

exposures from rimsulfuron in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

No such effects were identified in the 

toxicological studies for rimsulfuron; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Continuing Surveys of Food by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed that rimsulfuron 

residues were present at tolerance levels 

in all commodities for which tolerances 

have been established, and that 100% of 

those crops were treated with 

rimsulfuron. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that rimsulfuron does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for rimsulfuron. 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 rimsulfuron in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of rimsulfuron. 

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 (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

rimsulfuron for acute exposures are 

estimated to be 5.596 parts per billion 

(ppb) for surface water and 0.016 ppb 

for ground water and for chronic 

exposures for non-cancer assessments 

are estimated to be 0.120 ppb for surface 

water and 0.016 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

chronic dietary risk assessment, the 

water concentration of value 0.120 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). 

Rimsulfuron 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 rimsulfuron to 

share a common mechanism of toxicity 

with any other substances, and 

rimsulfuron does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 


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tolerance action, therefore, EPA has 

assumed that rimsulfuron does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

In the developmental toxicity study in 

rats, no developmental toxicity was seen 

at the HDT. In the developmental 

toxicity study in rabbits and in the 2- 

generation study in rats, developmental 

and offspring toxicity were seen in the 

presence of maternal/systemic toxicity. 

Consequently, there is no evidence of 

quantitative or qualitative increased 

susceptibility following in utero or 

postnatal exposures. Therefore, there are 

no concerns, nor residual uncertainties 

for pre- and/or postnatal toxicity after 

exposure to rimsulfuron. 

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 

rimsulfuron is complete with the 

exception of the acute and subchronic 

neurotoxicity and the immunotoxicity 

studies which are required by the new 

part 158 guidelines. Despite the 

requirement for these studies, there is 

no evidence that rimsulfuron either 

causes neurotoxic effects or directly 

targets the immune system, and 

therefore an additional uncertainty 

factor is not needed to account for the 

lack of these studies. 

ii. A developmental neurotoxicity 

study is not required because neither 

the subchronic or chronic toxicity 

studies in rats and dogs, the 

developmental toxicity studies in rats 

and rabbits, nor the 2-generation 

reproduction study indicated that the 

nervous system was specifically affected 

by treatment with rimsulfuron. 

iii. There is no evidence that 

rimsulfuron 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 and surface water modeling 

used to assess exposure to rimsulfuron 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by rimsulfuron. 

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 aPAD and 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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from 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, rimsulfuron 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 rimsulfuron 

from food and water will utilize < 1% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for rimsulfuron. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Short- and intermediate-term adverse 

effects were identified; however, 

rimsulfuron is not registered for any use 

patterns that would result in short- and/ 

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- and/or intermediateterm residential exposure and chronic 

dietary exposure has already been 

assessed under the appropriately 

protective cPAD (which is at least as 

protective as the POD used to assess 

short- and intermediate-term risk), no 

further assessment of short- and 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for rimsulfuron. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

rimsulfuron 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 rimsulfuron 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography with tandem 

mass spectroscopy (LC/MS/MS)) is 

available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd. Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 


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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Rules and Regulations 3625 

The Codex has not established a MRL 

for rimsulfuron. 

V. Conclusion 

Therefore, tolerances are established 

for residues of rimsulfuron, N-((4,6- 

dimethoxypyrimidin-2- 

yl)aminocarbonyl)-3-(ethylsulfonyl)-2- 

pyridinesulfonamide, including its 

metabolites and degradates, in or on 

caneberry, subgroup 13–07A at 0.01 

ppm; and bushberry, subgroup 13–07B 

at 0.01 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) (Pub. L. 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: January 11, 2012. 

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 180.478 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.478 Rimsulfuron; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Bushberry, subgroup 13–07B ... 0.01 

Caneberry, subgroup 13–07A .. 0.01 

* * * * * 

* * * * * 

[FR Doc. 2012–1258 Filed 1–24–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2011–0002] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street SW., Washington, DC 20472, 

(202) 646–4064, or (email) 

luis.rodriguez1@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 


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