Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 12873 

For each . . . Complying with the requirement to . . . You must demonstrate continuous compliance 

by . . . 

iv. Maintaining the 4-hour rolling averages 

within the operating limitations for the operating parameters established during the 

performance test. 

aAfter you have demonstrated compliance for two consecutive tests, you may reduce the frequency of subsequent performance tests to annually. If the results of any subsequent annual performance test indicate the stationary RICE is not in compliance with the CO or formaldehyde 

emission limitation, or you deviate from any of your operating limitations, you must resume semiannual performance tests. 

[FR Doc. 2011–5196 Filed 3–8–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0117; FRL–8863–2] 

Potassium Benzoate; Exemption From 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of potassium 

benzoate (Cas No. 582–25–2) under 40 

CFR 180.910 when used as an inert 

ingredient (preservative) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest, and under 40 CFR 180.930 

when used as an inert ingredient 

(preservative) in pesticide formulations 

applied to animals (used for food). 

Landis International, on behalf of 

Whitmire Micro-Gen submitted two 

petitions to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

potassium benzoate. 

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–2011–0117. 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: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; e-mail address: 

fertich.elizabeth@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• 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 provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

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 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–2011–0117 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–2011–0117, 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 

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12874 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Exemption 

In the Federal Register of February 6, 

2008 (73 FR 6964) (FRL–8350–9), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

7E7241) by Landis International, on 

behalf of Whitmire Micro-Gen, 3185 

Madison Highway, P.O. Box 5126, 

Valdosta, GA 31603–5126, under docket 

ID number EPA–HQ–OPP–2008–0040. 

The petition requested that 40 CFR 

180.910 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of potassium 

benzoate (Cas No. 582–25–2) when used 

as an inert ingredient (preservative) in 

pesticide formulations applied pre- and 

post-harvest. In the Federal Register of 

June 4, 2008 (73 FR 31862) (FRL–8365– 

3), EPA issued a notice pursuant to 

section 408 of FFDCA, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP 8E7333) by Landis 

International, on behalf of Whitmire 

Micro-Gen, 3185 Madison Highway, 

P.O. Box 5126, Valdosta, GA 31603– 

5126, under docket ID number EPA– 

HQ–OPP–2008–0059. The petition 

requested that 40 CFR 180.930 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of potassium benzoate (Cas No. 

582–25–2) when used as an inert 

ingredient (preservative) in pesticide 

formulations applied to animals. Both 

notices referenced a summary of the 

petition prepared by Landis 

International, on behalf of Whitmire 

Micro-Gen, the petitioner, which is 

available in the docket, http:// 

www.regulations.gov. Two comments 

were received in the docket for PP 

7E7241, however they are unrelated to 

potassium benzoate and the Agency 

believes they were placed in this docket 

in error by the commenters. There were 

no comments received in response to 

the notice of filing for PP 8E7333. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), 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 potassium 

benzoate including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with potassium 

benzoate follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

Potassium benzoate is an approved 

food preservative, similar in structure 

and reactivity to the more widely used 

sodium benzoate. Both are classified by 

the U.S. Food and Drug Administration 

(FDA) as Generally Recognized as Safe 

(GRAS). In conducting this assessment, 

toxicity data on potassium benzoate and 

the surrogate chemicals sodium 

benzoate and benzoic acid were used. 

Both potassium benzoate and sodium 

benzoate are salts of benzoic acid. 

Because all benzoates, in particular 

benzoic acid and sodium benzoate, react 

similarly to potassium benzoate, they 

were used as surrogates in the 

development of this profile. 

Available data show that the acute 

toxicity of potassium benzoate is 

negligible, having an oral median lethal 

dose (LD50) of >10,000 milligrams per 

kilogram body weight (mg/kg/bw). 

Acute dermal and inhalation toxicity is 

low as indicated by the >2,000 mg/kg/ 

bw LD50 and >12.2 milligrams per liter 

(mg/L) median lethal concentration 

(LC50) of benzoic acid. Sodium benzoate 

was not irritating to the skin and 

induced only slight eye irritation in 

rabbits. Sodium benzoate and benzoic 

acid were non-sensitizing in animal 

tests but showed a very low incidence 

of sensitization in humans patch tested. 

Both sodium benzoate and benzoic acid 

are known to induce non-immunogenic 

contact reactions, and that is the likely 

explanation for the low positive 

response. 

Subacute, subchronic and chronic 

toxicity data also indicate that 

potassium benzoate should be relatively 

nontoxic. Available oral and dermal 

studies had a no-observed-adverseeffect-level (NOAEL) ≥2,000 mg/kg/bw 

and the inhalation study had a NOAEL 

>25 milligrams per cubic meter (mg/ 

m3). Sodium benzoate was not 

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Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 12875 

carcinogenic in a lifetime mouse feeding 

study and there is no indication that 

potassium benzoate should be 

neurotoxic. Genotoxicity studies 

indicate the benzoates are not 

mutagenic; however chromosomal 

aberration studies gave ambiguous 

results. Benzoic acid did not induce 

reproductive toxicity in a 4-generation 

study. In the human body under normal 

physiological conditions, potassium 

benzoate changes from the ionized form 

to the undissociated benzoic acid. 

Benzoic acid and its salts are rapidly 

absorbed by mammals, conjugated with 

glycine, and rapidly excreted in the 

urine as hippuric acid. There is no 

reported accumulation of benzoate in 

the body. However, the ability to 

conjugate benzoic acid depends upon 

adequate liver function and nutritional 

supply of glycine. 

All data indicates that potassium 

benzoate is relatively non-toxic as are 

the other benzoates. No toxicity would 

be expected from potassium benzoate 

when used at low concentrations in 

pesticides. 

No developmental toxicity studies are 

available in the database. However, no 

systemic toxicity was observed at doses 

up to 750 mg/kg/day, the highest dose 

tested (HDT), in a 4-generation 

reproductive study with benzoic acid. In 

addition, no systemic toxicity was 

observed in the laboratory animals at 

high doses >2,000 mg/kg/day of 

potassium benzoate and benzoates 

indicating relatively low hazard 

potential. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by potassium benzoate as 

well as the NOAEL and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in the 

document ‘‘PC Code 709103: Potassium 

Benzoate (CAS Reg. No. 582–25–2); 

Human Health Risk Assessment and 

Ecological Effects Assessment to the 

Support Proposed Exemption from the 

Requirement of a Tolerance When Used 

as an Inert Ingredient in Pesticide 

Formulations,’’ page 7 docket ID number 

EPA–HQ–OPP–2011–0117. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Subacute, subchronic and chronic 

toxicity data indicate that potassium 

benzoate is relatively nontoxic. 

Available oral and dermal toxicity 

studies had a NOAEL greater than or 

equal to 2,000 mg/kg/day and the 

inhalation study had a NOAEL greater 

than 25 mg/m3. Sodium benzoate was 

not shown to be carcinogenic and there 

is no indication that potassium benzoate 

will be neurotoxic. Studies also indicate 

that benzoates are not mutagenic and 

benzoic acid did not induce 

reproductive toxicity in a 4-generation 

study. Since no toxicity was observed at 

high doses, quantitative risk assessment 

is deemed unnecessary. 

C. Exposure Assessment 

No hazard was identified for the acute 

and chronic dietary assessment (food 

and drinking water), or for the short, 

intermediate, and long term residential 

assessments, therefore no aggregate risk 

assessments were performed. Available 

toxicological studies indicate lack of 

systemic toxicity at doses up to 2,000 

mg/kg/day. Therefore, no quantitative 

dietary or occupational and residential 

risk assessment was conducted. 

1. Dietary exposure from food and 

feed uses and drinking water. In 

evaluating dietary exposure to 

potassium benzoate, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

Since toxicity was seen only at doses 

greater than 2,000 mg/kg/day for 

potassium benzoate, a quantitative 

exposure assessment for potassium 

benzoate was not conducted. Any 

possible dietary exposure to potassium 

benzoate from its use as an inert 

ingredient in pesticide products would 

be through consumption of food to 

which pesticide products containing it 

have been applied and possibly through 

drinking water (from runoff). 

Metabolism data indicates that 

potassium benzoate would be rapidly 

absorbed, metabolized, and excreted. 

2. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). Potassium benzoate is used in 

pharmaceuticals and cosmetics. It can 

also be used in nonfood use pesticide 

products. Considering the low toxicity 

of potassium benzoate, residues of 

concern are not anticipated from 

residential exposures (inhalation and 

dermal) and therefore a quantitative 

aggregate risk assessment was not 

performed. 

3. 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 potassium 

benzoate to share a common mechanism 

of toxicity with any other substances, 

and potassium benzoate does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that potassium benzoate 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 

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. 

No developmental toxicity studies are 

available in the database. However, no 

systemic toxicity was observed at doses 

up to 750 mg/kg/day in a 4-generation 

reproductive study with benzoic acid. In 

addition, no systemic toxicity was 

observed in the laboratory animals at 

high doses >2,000 mg/kg/day of 

potassium benzoate and benzoates 

indicating relatively low hazard 

potential. There was no evidence of 

clinical signs of neurotoxicity, therefore, 

a developmental neurotoxicity study is 

not required. In addition, no evidence of 

immunotoxicity is available in the 

database, therefore, an immunotoxicity 

study is not required. In terms of 

hazard, there are low concerns and low 

residual uncertainties regarding prenatal 

and/or postnatal toxicity. Based on this 

information, there is no concern at this 

time for increased sensitivity to infants 

and children to potassium benzoate 

when used as an inert ingredient in 

pesticide formulations and a safety 

factor analysis has not been used to 

assess risk. For the same reason, EPA 

has determined that an additional safety 

factor is not needed to protect the safety 

of infants and children. 

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12876 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Rules and Regulations 

E. Aggregate Risks and Determination of 

Safety 

Given the lack of concern for hazard 

posed by potassium benzoate, EPA 

concludes that there are no dietary or 

aggregate dietary/non-dietary risks of 

concern as a result of exposure to 

potassium benzoate in food and water or 

from residential exposure. Residues of 

concern are not anticipated for dietary 

exposure (food and drinking water) or 

for residential exposure (dermal and 

inhalation) from the use of potassium 

benzoate as an inert ingredient in 

pesticide products. As discussed in this 

unit, EPA expects aggregate exposure to 

potassium benzoate to pose no 

appreciable dietary risk given that the 

data show a lack of any systemic 

toxicity at doses up to 2,000 mg/kg/day 

and a lack of any apparent 

developmental effects. 

Taking into consideration all available 

information on potassium benzoate, 

EPA has determined that there is a 

reasonable certainty that no harm to any 

population subgroup, including infants 

and children, will result from aggregate 

exposure to potassium benzoate under 

reasonably foreseeable circumstances. 

Therefore, the establishment of an 

exemption from tolerance under 40 CFR 

180.910 for residues of potassium 

benzoate when used as an inert 

ingredient in pesticide formulations 

applied pre- and post-harvest and under 

40 CFR 180.930 for residues of 

potassium benzoate when used as an 

inert ingredient in pesticide 

formulations applied to animals, is safe 

under FFDCA section 408. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

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 potassium benzoate. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 and 40 CFR 

180.930 for potassium benzoate when 

used as an inert ingredient 

(preservative) in pesticide formulations 

applied pre- and post-harvest and 

applied to animals. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this 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). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 25, 2011. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

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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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