Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 12877 

§ 180.910 Inert ingredients used preharvest and post-harvest; exemptions from 

the requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Potassium benzoate (as 

No. 582–25–2).

none .... preservative 

* * * * * 

■ 3. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Potassium benzoate (as 

No. 582–25–2).

none .... preservative 

* * * * * 

[FR Doc. 2011–5051 Filed 3–8–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0122; FRL–8858–5] 

Fomesafen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fomesafen in 

or on pepper (bell and non-bell), potato, 

and tomato. Syngenta Crop Protection, 

Inc. requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

March 9, 2011. Objections and requests 

for hearings must be received on or 

before May 9, 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–2010–0122. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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–2010–0122 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 May 9, 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–2010–0122, 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 Registers of September 

4, 2009 (74 FR 45848) (FRL–8434–4) 

and March 19, 2010 (75 FR 13277) 

(FRL–8813–2), 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 9F7563 

and PP 9F7667) by Syngenta Crop 

Protection, Inc., PO Box 18300, 

Greensboro, NC 27419–8300. The 

petitions requested that 40 CFR 180.433 

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12878 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 

be amended by establishing tolerances 

for residues of the herbicide fomesafen, 

5-[2-cloro-4-(trifluoromethyl)phenoxy]- 

N-(methylsulfonyl)-2-nitrobenzamide, 

in or on potato and tomato (PP 9F7563); 

and pepper (PP 9F7667) at 0.025 parts 

per million (ppm). Those notices 

referenced summaries of the petitions 

prepared by Syngenta Crop Protection, 

Inc., the registrant, which are available 

in the dockets, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing of PP 9F7563. Comments 

were received on the notice of filing of 

PP 9F7667. EPA’s response to these 

comments is discussed in Unit IV.C. 

EPA has revised the proposed 

tolerance expression and the commodity 

terms for peppers in accordance with 

current Agency policy. These revisions 

are discussed in Unit IV.D. 

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 fomesafen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fomesafen 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. 

Fomesafen has a low order of acute 

toxicity by the oral route of exposure, is 

severely irritating to the eye, and is 

moderately irritating to the skin. In the 

subchronic and chronic toxicity studies 

in rats and mice, food consumption or 

food efficiency, body weight/body 

weight gain, and histopathological 

changes in the liver were the parameters 

that were most often affected. Dogs and 

mice also showed hematological 

changes (e.g., decreased erythrocyte 

count, hemoglobin, or hematocrit). 

There was no evidence of neurotoxicity 

or immunotoxicity in the toxicological 

studies with fomesafen. There was no 

evidence that fomesafen results in 

increased susceptibility of rat or rabbit 

fetuses in the prenatal developmental 

studies or in young rats in the 2- 

generation reproduction study. 

There was no evidence of 

carcinogenicity in the rat chronic 

toxicity/carcinogenicity study. Liver 

tumors were produced in the mouse 

carcinogenicity study; however, EPA 

classified fomesafen as ‘‘Not Likely to be 

Carcinogenic to Humans,’’ based on the 

weight-of-evidence supporting 

activation of peroxisome proliferatoractivated receptor alpha (PPARa) as the 

mode of action for fomesafen-induced 

hepatocarcinogenesis in mice. The data 

did not support either mutagenesis or 

cytotoxicity followed by regenerative 

proliferation as alternative modes of 

action. While the proposed mode of 

action for liver tumors in mice is 

theoretically plausible in humans, it is 

unlikely to take place in humans based 

on quantitative species differences in 

PPARa activation and toxicokinetics. 

Detailed information on the factors EPA 

considered in making this 

determination can be found at http:// 

www.regulations.gov in the document 

‘‘FOMESAFEN: Second Report of the 

Cancer Assessment Review Committee’’ 

in docket ID number EPA–HQ–OPP– 

2010–0122. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fomesafen 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 the document 

‘‘Fomesafen Sodium: Human Health 

Risk Assessment for the Establishment 

of Tolerances and Registration of New 

Uses of Fomesafen Sodium on Potatoes 

and Peppers,’’ p. 30 in docket ID number 

EPA–HQ–OPP–2010–0122. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for fomesafen used for human 

risk assessment is shown the Table of 

this unit. 

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Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 12879 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FOMESAFEN 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 (All population subgroups, including Females 13– 

49 years of age, infants and children).

No toxic effects attributable to a single dose of fomesafen were found in the database. 

Chronic dietary (All populations) .... NOAEL= 0.25 mg/kg/day UFA = 

10x.

UFH = 10x FQPA SF = 1x 

Chronic RfD = 0.0025 mg/kg/day Chronic toxicity—rat LOAEL = 5 

mg/kg/day based on hyalinization of the liver in males. 

cPAD = 0.0025 mg/kg/day. 

Cancer (Oral, dermal, inhalation) .. Fomesafen is classified as ‘‘Not Likely to be Carcinogenic to Humans.’’ 

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

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

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

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fomesafen, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fomesafen tolerances in 40 CFR 180.433. 

EPA assessed dietary exposures from 

fomesafen 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 fomesafen; 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 United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intakes by Individuals (CSFII). As 

to residue levels in food, EPA assumed 

that residues would be present in all 

commodities at the tolerance level and 

that 100% of all crops are treated with 

fomesafen. Dietary Exposure Evaluation 

Model/Food Commodity Intake 

Database (DEEM–FCIDTM), Version 2.03, 

default processing factors were used to 

determine residues in processed 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fomesafen 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 or PCT 

information in the dietary assessment 

for fomesafen. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used a screeninglevel water exposure model to estimate 

residues of fomesafen in surface water. 

This simulation model, the Pesticide 

Root Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS), 

takes into account data on the physical, 

chemical, and fate/transport 

characteristics of fomesafen. 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 model results, the 

estimated drinking water concentration 

(EDWC) of fomesafen for chronic 

exposures for non-cancer assessments is 

estimated to be 10.535 parts per billion 

(ppb) for surface water. 

The Agency estimated residues of 

fomesafen in ground water based on the 

results of a prospective ground water 

monitoring study, submitted by the 

registrant, Syngenta Crop Protection, 

Inc. The maximum residue found in the 

study, which was conducted on a 

vulnerable North Carolina soil using a 

soybean cropping system, was 1 ppb, an 

order of magnitude lower than the 

modeled estimate for surface water. 

The modeled estimate of fomesafen in 

surface water was used in the dietary 

exposure analysis and risk assessment 

for fomesafen in drinking water. For 

chronic dietary risk assessment, the 

water concentration of value 10.535 ppb 

was directly entered into the dietary 

exposure model 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). Fomesafen 

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.’’ 

Fomesafen is a member of the 

diphenyl ether chemical family. The 

common toxicity that these compounds 

share is induction of liver effects (liver 

hypertrophy, increase in liver weight, 

tumors). Members of this class have 

been shown to induce rodent liver 

effects/tumors through the activation of 

the peroxisome proliferator-activated 

receptor (PPARa). It should be noted 

that liver hypertrophy and increases in 

liver weight are part of the range of 

morphological changes that result from 

chemically-mediated effects on the 

PPARa receptor and 

hepatocarcinogenesis. Although PPARa 

agonists can induce liver rodent tumors, 

the potential for PPARa agonists to 

induce liver tumors in other species, 

including humans, appears to be 

unlikely. This is because evidence 

shows that these other species are 

quantitatively less sensitive to the 

effects of PPARa agonism due to 

toxicodynamic differences between the 

human and rodent nuclear PPARa 

receptor. Thus, while this mode of 

action for liver tumors in rodent is 

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12880 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 

qualitatively possible in humans, it is 

unlikely to take place in humans based 

on quantitative species differences in 

PPARa activation and toxicokinetics. 

Accordingly, although members of the 

diphenyl ether family, as well as other 

classes of compounds, may share a 

common hepatocarcinogenic mode of 

action, cumulative exposure to PPARa 

agonists is unlikely to induce liver 

carcinogenesis in humans. 

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. 

The pre- and postnatal database for 

fomesafen includes a prenatal 

developmental toxicity study in rabbits, 

two prenatal developmental toxicity 

studies in rats, and a 2-generation 

reproduction toxicity study in rats. The 

rabbit developmental study was 

classified as unacceptable because of 

bacterial infection in the colony; 

however, the study provided 

information to assess potential 

developmental toxicity in rabbits. There 

was no significant difference between 

the treated and control animals for 

developmental abnormalities in the 

rabbit study. In the two rat 

developmental studies (considered 

together), developmental effects 

(postimplantation loss) occurred at the 

same dose causing maternal toxicity 

(staining of the ventral fur and 

significantly decreased body weight 

gain (>10%)). In the rat reproduction 

study, offspring effects (increased 

incidence of liver hyalinization in 

males) occurred at the same dose 

causing parental effects (liver 

histopathology in males and females of 

both generations). 

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 fomesafen 

is largely complete, lacking only 

immunotoxicity and acute and 

subchronic neurotoxicity studies. EPA 

has evaluated the available toxicity data 

for fomesafen and determined that an 

additional database uncertainty factor is 

not needed to account for the lack of 

these studies. As stated in Unit III.A, 

fomesafen primarily impacts the 

parameters of food consumption or food 

efficiency, body weight/body weight 

gain, and histopathological changes in 

the liver. There is no evidence that 

fomesafen causes immunotoxic or 

neurotoxic effects in any of the available 

toxicity studies, and EPA does not 

believe that conducting immunotoxicity 

and acute/subchronic neurotoxicity 

testing will result in a NOAEL less than 

0.25 mg/kg/day, which is presently used 

as the point of departure for chronic risk 

assessment. 

ii. There is no indication that 

fomesafen is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

fomesafen 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 surface water modeling used to 

assess exposure to fomesafen in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by fomesafen. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. 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, fomesafen 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 fomesafen from 

food and water will utilize 32% of the 

cPAD for infants, less than 1 year old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for fomesafen. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- or 

intermediate-term residential exposure 

plus chronic exposure from food and 

water (considered to be a background 

exposure level). Short-/intermediateterm adverse effects (hyalinization of 

hepatocytes, increased eosinophilia, 

reduced granulation, increased liver 

weights in males and females, and 

increases in plasma alkaline 

phosphatase, alanine transminase and 

aspartate transaminase in males in the 

90-day rat feeding study) were 

identified; however, fomesafen is not 

registered for any use patterns that 

would result in short- or intermediateterm residential exposure. Short- and 

intermediate-term risks are assessed 

based on short- or intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there is no 

short- or intermediate-term residential 

exposure and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short- or intermediateterm risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for fomesafen. 

4. Aggregate cancer risk for U.S. 

population. As explained in Unit III.A, 

EPA has concluded that the mode of 

action for fomesafen-induced 

hepatocarcinogenesis in mice is 

unlikely to take place in humans; 

therefore, fomesafen 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 fomesafen 

residues. 

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Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 12881 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with tandem mass 

spectrometry detection (HPLC/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; e-mail 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 

fomesafen on pepper, potato, or tomato. 

C. Response to Comments 

An anonymous citizen objected to the 

presence of any pesticide residues on 

food. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, the existing legal 

framework provided by section 408 of 

the Federal Food, Drug and Cosmetic 

Act (FFDCA) contemplates that 

tolerances greater than zero may be set 

when persons seeking such tolerances 

or exemptions have demonstrated that 

the pesticide meets the safety standard 

imposed by that statute. This citizen’s 

comment appears to be directed at the 

underlying statute and not EPA’s 

implementation of it; the citizen has 

made no contention that EPA has acted 

in violation of the statutory framework. 

D. Revisions to Petitioned-for 

Tolerances 

In its petition PP 9F7667, the 

registrant proposed a tolerance of 0.025 

ppm for residues of fomesafen in or on 

the commodity ‘‘pepper.’’ Consistent 

with recommendations in the Agency’s 

Food and Feed Commodity Vocabulary, 

EPA is establishing separate tolerances 

for ‘‘pepper, bell’’ and ‘‘pepper, non-bell’’ 

at 0.025 ppm each. 

EPA is also revising the requested 

tolerance expression to clarify the 

chemical moieties that are covered by 

the tolerances and specify how 

compliance with the tolerances is to be 

measured. The revised tolerance 

expression makes clear that the 

tolerances cover residues of the 

herbicide fomesafen, including its 

metabolites and degradates, but that 

compliance with the tolerance levels is 

to be determined by measuring only 

fomesafen, 5-[2-chloro-4- 

(trifluoromethyl)phenoxy]-N- 

(methylsulfonyl)-2-nitrobenzamide. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fomesafen, including its 

metabolites and degradates, in or on 

pepper, bell; pepper, non-bell; potato; 

and tomato at 0.025 ppm. Compliance 

with the tolerance levels is to be 

determined by measuring only 

fomesafen, 5-[2-chloro-4- 

(trifluoromethyl)phenoxy]-N- 

(methylsulfonyl)-2-nitrobenzamide. 

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. 

mstockstill on DSKH9S0YB1PROD with RULES

12882 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 

Dated: February 28, 2011. 

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 180.433 is amended by 

revising the introductory text in 

paragraph (a) and alphabetically adding 

the following commodities to the table 

in paragraph (a) to read as follows: 

§ 180.433 Fomesafen; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

fomesafen, including its metabolites and 

degradates, in or on the following 

commodities. Compliance with the 

tolerance levels specified in the 

following table below is to be 

determined by measuring only 

fomesafen, 5-[2-chloro-4- 

(trifluoromethyl)phenoxy]-N- 

(methylsulfonyl)-2-nitrobenzamide, in 

or on the commodity. 

Commodity Parts per 

million 

* * * * 

Pepper, bell ................................ 0.025 

Pepper, non-bell ......................... 0.025 

Potato ......................................... 0.025 

* * * * 

Tomato ........................................ 0.025 

* * * * * 

[FR Doc. 2011–5070 Filed 3–8–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 040205043–4043–01] 

RIN 0648–XA229 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; SnapperGrouper Fishery of the South Atlantic; 

Closure 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS closes the commercial 

sector for golden tilefish in the 

exclusive economic zone (EEZ) of the 

South Atlantic. This closure is 

necessary to protect the golden tilefish 

resource. 

DATES: This rule is effective 12:01 a.m., 

local time, March 9, 2011, until 12:01 

a.m., local time, January 1, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Catherine Bruger, telephone: 727–824– 

5305, fax: 727–824–5308, e-mail: 

Catherine.Bruger@noaa.gov. 

SUPPLEMENTARY INFORMATION: The 

snapper-grouper fishery of the South 

Atlantic is managed under the Fishery 

Management Plan for the SnapperGrouper Fishery of the South Atlantic 

Region (FMP). The FMP was prepared 

by the South Atlantic Fishery 

Management Council and is 

implemented under the authority of the 

Magnuson-Stevens Fishery 

Conservation and Management Act by 

regulations at 50 CFR part 622. 

The commercial quota for golden 

tilefish in the South Atlantic is 282,819 

lb (128,284 kg) for the current fishing 

year, January 1 through December 31, 

2011, as specified in 50 CFR 

622.42(e)(2). 

Under 50 CFR 622.43(a), NMFS is 

required to close the commercial sector 

for golden tilefish when its quota has 

been reached, or is projected to be 

reached, by filing a notification to that 

effect with the Office of the Federal 

Register. NMFS has determined that the 

commercial quota for South Atlantic 

golden tilefish will have been reached 

by March 9, 2011. Accordingly, the 

commercial sector for South Atlantic 

golden tilefish is closed effective 12:01 

a.m., local time, March 9, 2011, until 

12:01 a.m., local time, January 1, 2012. 

The operator of a vessel with a valid 

commercial vessel permit for South 

Atlantic snapper-grouper having golden 

tilefish onboard must have landed and 

bartered, traded, or sold such golden 

tilefish prior to 12:01 a.m., local time, 

March 9, 2011. During the closure, the 

bag limit and possession limits specified 

in 50 CFR 622.39(d)(1)(ii) and (d)(2), 

respectively, apply to all harvest or 

possession of golden tilefish in or from 

the South Atlantic EEZ, and the sale or 

purchase of golden tilefish taken from 

the EEZ is prohibited. The prohibition 

on sale or purchase does not apply to 

the sale or purchase of golden tilefish 

that were harvested, landed ashore, and 

sold prior to 12:01 a.m., local time, 

March 9, 2011, and were held in cold 

storage by a dealer or processor. For a 

person on board a vessel for which a 

Federal commercial or charter vessel/ 

headboat permit for the South Atlantic 

snapper-grouper fishery has been 

issued, the sale and purchase provisions 

of the commercial closure for golden 

tilefish would apply regardless of 

whether the fish are harvested in State 

or Federal waters, as specified in 50 

CFR 622.43(a)(5)(ii). 

Classification 

This action responds to the best 

available information recently obtained 

from the fishery. The Assistant 

Administrator for Fisheries, NOAA, 

(AA), finds that the need to immediately 

implement this action to close the 

commercial sector for golden tilefish 

constitutes good cause to waive the 

requirements to provide prior notice 

and opportunity for public comment 

pursuant to the authority set forth in 5 

U.S.C. 553(b)(B), as such procedures 

would be unnecessary and contrary to 

the public interest. Such procedures 

would be unnecessary because the rule 

itself has been subject to notice and 

comment, and all that remains is to 

notify the public of the closure. 

Allowing prior notice and 

opportunity for public comment is 

contrary to the public interest because 

of the need to immediately implement 

this action to protect the fishery since 

the capacity of the fishing fleet allows 

for rapid harvest of the quota. Prior 

notice and opportunity for public 

comment would require time and would 

potentially result in a harvest well in 

excess of the established quota. 

For the aforementioned reasons, the 

AA also finds good cause to waive the 

30-day delay in the effectiveness of this 

action under 5 U.S.C. 553(d)(3). 

This action is taken under 50 CFR 

622.43(a) and is exempt from review 

under Executive Order 12866. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: March 4, 2011. 

Margo Schulze-Haugen, 

Acting Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service. 

[FR Doc. 2011–5360 Filed 3–4–11; 4:15 pm] 

BILLING CODE 3510–22–P 

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