Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 59909 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Rita 

Kumar, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8291; e-mail address: 

kumar.rita@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

The Agency included in the final rule 

a list of those who may be potentially 

affected by this action. If you have 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

II. What does this technical amendment 

Do? 

This technical amendment adds 

Bushberry, subgroup 13–07B to the table 

in paragraph (a) to 40 CFR 180.628. On 

July 27, 2011 (76 FR 44815) (FRL–8875– 

5), the Registration Division issued in 

the Federal Register an amendment to 

40 CFR 180.628. In the preamble to the 

final rule RD discussed the addition of 

several commodities and tolerances, 

including a tolerance for Bushberry, 

subgroup 13–07B. However, the 

tolerance for Bushberry was 

inadvertently omitted from the 

regulatory amendment and the table in 

180.628. This technical amendment 

corrects that omission. 

III. Why is this correction issued as a 

final rule? 

Section 553 of the Administrative 

Procedure Act (APA), 5 U.S.C. 

553(b)(3)(B), provides that, when an 

Agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary or contrary to the public 

interest, the Agency may issue a final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making this technical amendment 

final without prior proposal and 

opportunity for comment, because this 

omission was a typographical error. The 

tolerance for Bushberry, subgroup 13– 

07B was included in the petitioned for 

tolerances, exposure and risk 

evaluation, determination of safety, and 

conclusion sections of the Final Rule, 

FR Doc. 2011–18708 published in the 

Federal Register of July 27, 2011 (76 FR 

44815–44821). EPA finds that this 

constitutes good cause under 5 U.S.C. 

553(b)(3)(B). 

IV. Do any of the statutory and 

Executive Order reviews apply to this 

action? 

This technical amendment adds a 

tolerance that was inadvertently omitted 

from a previously published final rule 

and does not otherwise change the 

original requirements of the final rule. 

Since this rule corrects an omission, this 

action is not subject to the statutory and 

Executive Order review requirements. 

For information about the statutory and 

Executive Order review requirements as 

they related to the final rule, see Unit 

VI. in the Federal Register of July 27, 

2011 (76 FR 44815–44821) (FRL–8875– 

5). 

V. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

Agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 15, 2011. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR part 180 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 § 180.628, in the table to 

paragraph (a), add the entry for 

bushberry, subgroup 13–07B to read as 

follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Bushberry, subgroup 13–07B ..... 2.5 

Commodity Parts per 

million 

* * * * * 

[FR Doc. 2011–24370 Filed 9–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0186; FRL–8885–3] 

Amisulbrom; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of amisulbrom in 

or on grapes and tomatoes. Nissan 

Chemical Industries, Inc., c/o Lewis & 

Harrison requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 28, 2011. Objections and 

requests for hearings must be received 

on or before November 28, 2011, 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–2010–0186. 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: Olga 

Odiott, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 


emcdonald on DSK5VPTVN1PROD with RULES
59910 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 

DC 20460–0001; telephone number: 

(703) 308–9369; e-mail address: 

odiott.olga@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 

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–2010–0186 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 November 28, 2011. 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–2010–0186, 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 May 19, 

2010 (75 FR 28009) (FRL–8823–2) and 

the Federal Register of February 25, 

2011 (76 FR 10584) (FRL–8863–3), EPA 

issued notices pursuant to section 

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

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

pesticide petitions (PP 9E7650 and PP 

0E7790) by Nissan Chemical Industries, 

Inc., c/o Lewis & Harrison, 122 C St., 

NW., Suite 740, Washington, DC 20001. 

The petitions requested that 40 CFR part 

180 be amended by establishing 

tolerances for residues of the fungicide 

amisulbrom, 3-[(3-bromo-6-fluoro-2- 

methyl-1H-indole-1-yl) sulfonyl]-N,Ndimethyl-1H-1,2,4-triazole-1- 

sulfonamide, in or on grapes at 0.4 parts 

per million (ppm), raisins at 1.0 ppm 

(PP 9E7650), tomato at 0.5 ppm, and 

tomato paste at 1.2 ppm (PP 0E7790). 

The notices referenced summaries of the 

petitions prepared by Nissan Chemical 

Industries, Inc., the registrant, which are 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notices 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 amisulbrom 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with amisulbrom 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. 

Amisulbrom is of low acute toxicity 

by the oral, dermal and inhalation 

routes and is not irritating to the eyes 

and skin. Rat, mouse, and rabbit studies 

indicate that amisulbrom systemic 

toxicity is primarily characterized by 

decreases in body weight and body 

weight gain, and reduced food 

consumption and/or efficiency. Based 

on the results of the acute and 

subchronic oral neurotoxicity studies in 

rats, as well as other subchronic and 

chronic studies, a developmental 

neurotoxicity (DNT) study is not needed 

for amisulbrom. None of these studies 

indicated specific neurotoxicity 

responses to amisulbrom. The T-cell 

dependent antibody response (TDAR) 

assay showed no evidence of treatmentrelated effects in rat and mouse 

immunotoxicity studies. The rat 


emcdonald on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 59911 

developmental toxicity study 

demonstrated cleft palate and other 

malformations only at the highest doses. 

There were no effects in the fetuses in 

the rabbit developmental toxicity study 

at the highest dose tested. 

In accordance with the EPA’s Final 

Guidelines for Carcinogen Risk 

Assessment (March 2005), amisulbrom 

is classified as ‘‘Suggestive Evidence of 

Carcinogenic Potential’’. This 

classification is based on: Liver tumors 

in male mice at both an adequate and 

excessive dose; liver tumors in both 

sexes of rats only at an excessive dose; 

and forestomach tumors in female rats 

also only at an excessive dose. 

In the case of amisulbrom, a cancer 

risk from dietary exposure is of low 

concern based on the following 

considerations: 

• The liver tumors seen in male mice 

only were benign with no progression to 

malignancy; 

• The liver tumors in rats seen only 

at excessive doses (i.e., greater than the 

Limit Dose of 1,000 milligrams/ 

kilogram/day (mg/kg/day)) were also 

benign with no progression to 

malignancy; 

• The forestomach tumors seen only 

in female rats occurred only at an 

excessive dose which was greater than 

the Limit-Dose; 

• None of these tumors resulted in 

reduced latency; and 

• There is no concern for 

mutagenicity/genotoxicity. 

In sum, the only evidence showing 

any concern for carcinogenicity is the 

occurrence of benign liver tumors in one 

sex and one species (i.e., male mice). 

Given the marginal evidence relating to 

potential carcinogenicity, the Agency 

has determined that the chronic 

population adjusted dose (PAD) will 

adequately account for all chronic 

effects, including carcinogenicity, likely 

to result from exposure to amisulbrom. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by amisulbrom 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 

‘‘Amisulbrom. Human-Health Risk 

Assessment for the Establishment of 

Tolerances for Amisulbrom Fungicide 

in/on Imported Grape and Tomato’’ at 

page 23 in docket ID number EPA–HQ– 

OPP–2010–0186. 

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 PAD or a reference dose (RfD)—and a 

safe margin of exposure (MOE). For nonthreshold 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 amisulbrom used for 

human risk assessment is shown in the 

following Table 1. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR AMISULBROM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, for risk 

assessment Study and toxicological effects 

Acute dietary (General population including infants 

and children) 

NOAEL = 200 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 2 mg/kg/day 

aPAD = 2 mg/kg/day 

Rat acute neurotoxicity screen study. 

LOAEL = 2,000 mg/kg/day based on 7% decrease in 

brain weight. 

Chronic dietary (All populations) NOAEL = 54 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.54 mg/kg/ 

day 

cPAD = 0.54 mg/kg/day 

Multiple studies: Combined chronic toxicity/carcinogenicity study in rats, multigenerational reproduction 

study in rats, mouse carcinogenicity, and subchronic 

and chronic dog studies. NOAEL = 54 mg/kg/day 

from the multigenerational study (parental systemic 

NOAEL). The LOAEL of 96 mg/kg/day is from the 

combined chronic toxicity/carcinogenicity study in 

rats and is based on decreased body weight, body 

weight gains in both sexes, and indications of 

hepatotoxicity and nephrotoxicity. The mouse (98 

mg/kg/day) and dog (100 mg/kg/day) LOAELs are 

similar. 

Cancer (Oral, dermal, inhalation) ‘‘Suggestive Evidence of Carcinogenic Potential’’. This classification is based on liver tumors in male mice at adequate and excessive doses and liver and stomach tumors in male and/or female rats at excessive doses. The 

chronic RfD is protective against potential carcinogenic effects. 

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. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to amisulbrom, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from amisulbrom in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 


emcdonald on DSK5VPTVN1PROD with RULES
59912 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 

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. Such effects were identified 

for amisulbrom. 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, default 

processing factors, and 100% crop 

treated assumptions to characterize the 

acute dietary exposure assessment. 

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, default 

processing factors, and 100% crop 

treated assumptions to characterize the 

chronic dietary exposure assessment. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier non-cancer key 

event. If carcinogenic mode of action 

data are not available, or if the mode of 

action data determines a mutagenic 

mode of action, a default linear cancer 

slope factor approach is utilized. Based 

on the data summarized in Unit III.A., 

EPA has concluded that a nonlinear RfD 

approach will be protective of any 

cancer risk posed by amisulbrom. 

Cancer risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii., chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for amisulbrom. Tolerance level 

residues and/or 100% CT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. Pesticide residues in drinking 

water are not expected. These tolerances 

are for residues of amisulbrom in/on 

imported grapes and tomatoes and there 

are no pesticide registrations in the 

United States associated with the 

tolerances. Therefore, the presence of 

amisulbrom in drinking water in this 

country resulting from the treatment of 

crops is not expected. 

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). 

Amisulbrom is not registered for use 

in the United States; therefore, 

residential exposures are not expected. 

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 amisulbrom to 

share a common mechanism of toxicity 

with any other substances, and 

amisulbrom does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that amisulbrom 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. 

There was an apparent indication of 

prenatal sensitivity in the rat 

developmental toxicity study. There 

were no effects in the dams at the 

highest dose tested (1,000 mg/kg/day). 

However, several of the rat fetuses in 

two litters were noted to have 

malformations and alterations including 

cleft palate, bent scapula, humerus ulna 

and/or radius, constricted spinal cord in 

the cervical region, cervical kyphosis, 

and medially thickened/kinked ribs 

with distorted ribcage. The NOAEL for 

the offspring in the rat developmental 

study was 300 mg/kg/day. There were 

no indications of increased postnatal 

offspring sensitivity in the rat 

reproduction study where the NOAEL 

(∼54 mg/kg/day) and LOAEL (∼274 mg/ 

kg/day) for the pups was the same as for 

the parents. There were no effects in the 

rabbit developmental toxicity study at 

the highest dose tested (300 mg/kg/day). 

Since effects in the rat pups in the 

developmental toxicity study occur at a 

dose (1,000 mg/kg/day) well above the 

NOAELs used for risk assessment (54 

and 200 mg/kg/day), no additional UF 

for sensitivity/susceptibility in the 

developing animal is needed because 

the application of the lower NOAEL will 

be protective against possible 

developmental effects in the offspring. 

Based on the available data and the 

selection of risk assessment endpoints 

that are protective of developmental 

effects, there are no residual 

uncertainties with regard to prenatal 

and/or postnatal toxicity. 

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 

amisulbrom is complete. 

ii. Neither the rat subchronic 

neurotoxicity screen studies or the rat 

multigenerational reproduction study or 

other subchronic or chronic studies 

indicated specific neurotoxicity 

responses to amisulbrom. Although the 

acute neurotoxicity study observed 

decreased brain weight, this effect 

occurred only at the very high limit 

dose for acute neurotoxicity testing, in 

only one sex, and a NOAEL was 

identified. Therefore, there is no need 

for a developmental neurotoxicity study 

or additional UFs to account for 

neurotoxicity. 

iii. Based on the developmental and 

reproductive toxicity studies discussed 

in Unit III.D.2., there are no residual 

uncertainties with regard to prenatal 

and/or postnatal toxicity. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

tolerance-level residues. Since there are 

no currently registered or proposed uses 

of amisulbrom in the United States and 

adequate food residue data are available, 

these assessments will not 

underestimate the exposure and risks 

posed by amisulbrom. 


emcdonald on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 59913 

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. Since the subject tolerances are 

for residues of amisulbrom in/on 

imported commodities a risk assessment 

was conducted for exposure to 

amisulbrom from food only, as there are 

no drinking water or residential 

exposures associated with imported 

grapes and tomatoes. The acute and the 

chronic dietary risk estimates from food 

are not of concern for the general 

population or any other population 

subgroup. Exposures were equivalent to 

< 1% aPAD and < 1% cPAD for all 

population subgroups. As discussed in 

Unit III.C.1.iii, EPA concluded that 

regulation based on the chronic 

reference dose will be protective for 

both chronic and carcinogenic risks. As 

noted in this unit there are no chronic 

risks of concern. 

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 

amisulbrom residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

A Liquid Chromatography-Mass 

Spectrometer/Mass Spectrometer (LC– 

MS/MS) method (NAS 490/042294) is 

available as an enforcement method for 

the determination of amisulbrom in 

plant commodities. The limit of 

quantitation (LOQ) of the method was 

0.01 ppm for amisulbrom. This method 

was adequately validated for data 

collection purposes and a successful 

independent laboratory validation study 

was conducted. Additionally, 

amisulbrom is amenable to analysis 

using FDA multi-residue methods C and 

E, which are also suitable confirmatory 

and/or enforcement methods. 

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. The 

Codex has not established a MRL for 

amisulbrom. 

V. Conclusion 

Therefore, tolerances are established 

for residues of amisulbrom, 3-[(3-bromo6-fluoro-2-methyl-1H-indole-1- 

yl)sulfonyl]-N,N-dimethyl-1H-1,2,4- 

triazole-1-sulfonamide, in or on grape at 

0.40 ppm; grape, raisin at 1.0 ppm; 

tomato at 0.50 ppm; and tomato, paste 

at 1.2 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 


emcdonald on DSK5VPTVN1PROD with RULES
59914 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 16, 2011. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.656 is added to read as 

follows: 

§ 180.656 Amisulbrom; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

amisulbrom, including its metabolites 

and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels is to be 

determined by measuring only 

amisulbrom, 3-[(3-bromo-6-fluoro-2- 

methyl-1H-indole-1-yl) sulfonyl]-N, Ndimethyl-1H-1, 2, 4-triazole-1- 

sulfonamide]. 

Commodity 1 Parts per 

million 

Grape ........................................ 0 .40 

Grape, raisin ............................. 1 .0 

Tomato ...................................... 0 .50 

Tomato, paste ........................... 1 .2 

1There is no U.S. registration for use of 

amisulbrom on grape or tomato. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2011–24685 Filed 9–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Parts 300–3, 301–30, 301–31, 

Appendix E to Chapter 301, 302–3, 

302–4, 302–6, and 303–70 

[FTR Amendment 2011–04; FTR Case 2010– 

303; Docket Number 2011–0019, Sequence 

1] 

RIN 3090–AJ06 

Federal Travel Regulation (FTR); 

Terms and Definitions for 

‘‘Dependent’’, ‘‘Domestic Partner’’, 

‘‘Domestic Partnership’’, and 

‘‘Immediate Family’’ 

AGENCY: Office of Governmentwide 

Policy, General Services Administration 

(GSA). 

ACTION: Final rule. 

SUMMARY: GSA has adopted as final, 

with two changes, an interim rule 

amending the Federal Travel Regulation 

(FTR) by adding terms and definitions 

for ‘‘Dependent’’, ‘‘Domestic partner’’, 

and ‘‘Domestic partnership’’, and by 

revising the definition of ‘‘Immediate 

family’’ to include ‘‘Domestic partner’’ 

and children, dependent parents, and 

dependent brothers and sisters of the 

Domestic partner as named members of 

the employee’s household. This final 

rule also adds references to domestic 

partners and domestic partnerships, 

where applicable, in the FTR. 

DATES: Effective date: September 28, 

2011. 

FOR FURTHER INFORMATION CONTACT: For 

clarification of content, contact Mr. Rick 

Miller, Office of Travel, Transportation, 

and Asset Management (MT), General 

Services Administration, at (202) 501– 

3822 or e-mail at rodney.miller@gsa.gov. 

Contact the Regulatory Secretariat 

(MVCB), 1275 First Street, NE., 

Washington, DC 20417, (202) 501–4755, 

for information pertaining to status or 

publication schedules. Please cite FTR 

Amendment 2011–04; FTR case 2010– 

303. 

SUPPLEMENTARY INFORMATION: 

A. Background 

On June 17, 2009, President Obama 

signed a Presidential Memorandum on 

Federal Benefits and NonDiscrimination stating that ‘‘[t]he heads 

of all other executive departments and 

agencies, in consultation with the Office 

of Personnel Management, shall conduct 

a review of the benefits provided by 

their respective departments and 

agencies to determine what authority 

they have to extend such benefits to 

same-sex domestic partners of Federal 

employees.’’ GSA conducted its review 

and, as part of that review, identified a 

number of changes to the FTR that 

could be made. Subsequently, on June 2, 

2010, President Obama signed a 

Presidential Memorandum, ‘‘Extension 

of Benefits to Same-Sex Domestic 

Partners of Federal Employees,’’ which 

directed agencies to immediately take 

actions, consistent with existing law, to 

extend certain benefits, including travel 

and relocation benefits, to same-sex 

domestic partners of Federal employees, 

and, where applicable, to the children of 

same-sex domestic partners of Federal 

employees. 

Pursuant to 5 U.S.C. 5707, the 

Administrator of General Services is 

authorized to prescribe necessary 

regulations to implement laws regarding 

Federal employees who are traveling 

while in the performance of official 

business away from their official 

stations. Similarly, 5 U.S.C. 5738 

mandates that the Administrator of 

General Services prescribe regulations 

relating to official relocation. The 

overall implementing authority is the 

FTR, codified in Title 41 of the Code of 

Federal Regulations, Chapters 300–304 

(41 CFR chapters 300–304). 

Pursuant to this authority, this final 

rule adds the same terms and 

definitions, based on a published Office 

of Personnel Management (OPM) 

memorandum to agencies, dated June 2, 

2010, ‘‘Implementation of the 

President’s Memorandum Regarding 

Extension of Benefits to Same-Sex 

Domestic Partners of Federal 

Employees,’’ and guidance from 5 CFR 

875, ‘‘Federal Long Term Care Insurance 

Program,’’ for ‘‘Domestic partner’’ and 

‘‘Domestic partnership’’, adds a 

definition for ‘‘Dependent’’, and revises 

the definition of ‘‘Immediate family’’ to 

include ‘‘Domestic partner’’ and 

children, dependent parents, and 

dependent brothers and sisters of the 

Domestic partner as named members of 

the employee’s household. This rule 

also adds references to ‘‘Domestic 

partners’’ and ‘‘domestic partnership,’’ 

where applicable, to travel and 

relocation allowances permitted under 

existing statutes. Due to current 

statutory restrictions, this final rule does 

not apply to house-hunting trip expense 

reimbursement, the relocation income 

tax allowance, the income tax 

reimbursement allowance, or nonFederal source travel. 

B. Summary of Comments Received 

GSA received 13 comments on the 

interim rule published in the Federal 

Register on November 3, 2010 (75 FR 

67629). 

• Three associations and three 

individuals supported the rule, four 


emcdonald on DSK5VPTVN1PROD with RULES