67038 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 

activities unless to do so would be 

inconsistent with applicable law or 

otherwise impractical. Voluntary 

consensus standards are technical 

standards (e.g., materials specifications, 

test methods, sampling procedures and 

business practices) that are developed or 

adopted by voluntary consensus 

standards bodies. The NTTAA directs 

the EPA to provide Congress, through 

the Office of Management and Budget, 

with explanations when the agency 

decides not to use available and 

applicable voluntary consensus 

standards. This action does not involve 

technical standards. Therefore, the EPA 

did not consider the use of any 

voluntary consensus standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order 12898 (59 FR 7629, 

Feb. 16, 1994) establishes federal 

executive policy on environmental 

justice. Its main provision directs 

federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies and activities on minority 

populations and low-income 

populations in the United States. 

The EPA has determined that this 

final rule will not have 

disproportionately high and adverse 

human health or environmental effects 

on minority or low-income populations 

because it does not affect the level of 

protection provided to human health or 

the environment. This good cause final 

action simply extends the date for the 

EPA to take action on a petition. 

K. Congressional Review Act 

The Congressional Review Act (CRA), 

5 U.S.C. 801 et seq., as added by the 

Small Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. Section 808 allows 

the issuing agency to make a rule 

effective sooner than otherwise 

provided by the CRA if the agency 

makes a good cause finding that notice 

and public procedure is impracticable, 

unnecessary or contrary to the public 

interest. This determination must be 

supported by a brief statement. 5 U.S.C. 

808(2). As stated previously, the EPA 

has made such a good cause finding, 

including the reasons therefore, and 

established an effective date of 

November 8, 2013.The 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 the rule in 

the Federal Register. This action is not 

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

804(2). 

IV. Statutory Authority 

The statutory authority for this action 

is provided by sections 110, 126 and 

307 of the Act as amended (42 U.S.C. 

7410, 7426 and 7607). 

V. Judicial Review 

Under section 307(b)(1) of the CAA, 

judicial review of this final rule is 

available only by the filing of a petition 

for review in the U.S. Court of Appeals 

for the for the appropriate circuit by 

January 7, 2014. Under section 307(b)(2) 

of the CAA, the requirements that are 

the subject of this final rule may not be 

challenged later in civil or criminal 

proceedings brought by us to enforce 

these requirements. 

List of Subjects in 40 CFR Part 52 

Environmental protection, 

Administrative practices and 

procedures, Air pollution control, 

Electric utilities, Incorporation by 

reference, Intergovernmental relations, 

Sulfur dioxide. 

Dated: October 30, 2013. 

Gina McCarthy, 

Administrator. 

[FR Doc. 2013–26642 Filed 11–7–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0003; FRL–9402–7] 

FD&C Green No. 3; 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 FD&C Green 

No. 3 (CAS Reg. No. 2353–45–9) when 

used as an inert ingredient (dye) in 

antimicrobial formulations, for use on 

food contact surfaces in public eating 

places, dairy processing equipment, and 

food processing equipment and utensils. 

The firm Exponent, on behalf of Ecolab 

submitted a petition 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 FD&C 

Green No. 3. FD&C Green No. 3 is also 

known as Fast Green FCF. 

DATES: This regulation is effective 

November 8, 2013. Objections and 

requests for hearings must be received 

on or before January 7, 2014, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0003, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 


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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.ecfr.gov/cgi-bin/textidx?&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–2013–0003 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 January 7, 2014. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0003, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa. 

gov/dockets. 

II. Petition for Exemption 

In the Federal Register of February 

15, 2013 (78 FR 11126) (FRL–9378–4), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10527) by Exponent 

(1150 Connecticut Ave. NW., Suite 

1100; Washington, DC 20036), on behalf 

of Ecolab, Inc., 370 N. Wabasha St., St. 

Paul, MN 55102. The petition requested 

that 40 CFR 180.940(a) be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of FD&C Green No. 3 (CAS Reg. No. 

2353–45–9) when used as an inert 

ingredient (dye) in antimicrobial 

formulations, for use on food contact 

surfaces in public eating places, dairy 

processing equipment, and food 

processing equipment and utensils. That 

document referenced a summary of the 

petition prepared by Exponent, on 

behalf of Ecolab, the petitioner, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 FFDCA section 

408(c)(2)(A), 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 FD&C Green No. 

3 including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with FD&C Green No. 3 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by FD&C Green No. 3 as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectVerDate Mar<15>2010 15:17 Nov 07, 2013 Jkt 232001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\FR\FM\08NOR1.SGM 08NOR1

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level (LOAEL) from the toxicity studies 

are discussed in this unit. 

FD&C Green No. 3 is not acutely toxic 

via the oral route in rats and dogs. In a 

long-term study in mice, there were no 

treatment-related effects on mortality. 

Histological examination of all animals 

did not reveal any treatment-related 

lesions. There was also no difference 

between control and treated animals in 

terms of the incidence of benign and 

malignant neoplasms. The NOAEL was 

5% in the diet (equivalent of 7,500 

milligrams/kilogram bodyweight/day 

(mg/kg bw/day), the highest dose tested 

(HDT). 

Multiple long-term studies in mice, 

dogs and rats fed diets containing FD&C 

Green No. 3 were conducted. 

Microscopic examination revealed no 

treatment-related lesions attributable to 

feeding of the color in any of the 

studies. There were also no treatmentrelated effects on growth or mortality. 

A carcinogenicity study with an in 

utero phase was conducted with 

Charles-River albino rats. Rats were fed 

diets containing 0, 1.25, 2.5 or 5.0% 

(equivalent to 0, 625, 1,250 and 2,500 

mg/kg bw/day) FD&C No. 3 for 2 months 

prior to mating and throughout gestation 

and lactation. The NOAEL for 

carcinogenicity was 5% in the diet 

(equivalent to 2,500 mg/kg bw/day; the 

HDT). No reproductive toxicity was 

observed at doses up to 5% in the diet 

(equivalent to 2,500 mg/kg bw/day). The 

NOAEL for systemic toxicity in parental 

animals was 2.5% in the diet 

(equivalent to 1,250 mg/kg bw/day). The 

NOAEL is based on decreases in food 

consumption and increases in thyroid 

and kidney weights seen at the LOAEL 

of 5% in the diet. The NOAEL for 

offspring toxicity was 2.5% in the diet 

(equivalent to 1,250 mg/kg bw/day) 

based on decreases in pup body weight 

and pup mortality seen at the LOAEL of 

5% in the diet (equivalent to 2,500 mg/ 

kg bw/day), the HDT. 

A 3-generation reproduction study 

was completed on FD&C Green No. 3 in 

Long-Evans rats at dose levels of 0, 10, 

100, 300 or 1,000 mg/kg bw/day. No 

treatment-related effects on food 

consumption, body weight, adult 

mortality, mating performance, 

pregnancy and fertility rates, gestation 

length, offspring survival, weights and 

sex, litter survival, resorption rates, or 

necropsy findings were observed in the 

study. There were also no macroscopic 

or microscopic tissue abnormalities 

attributable to treatment. The NOAEL 

was 1,000 mg/kg bw/day. 

FD&C Green No. 3 was determined to 

be non-mutagenic. The metabolism 

potential of FD&C Green No. 3 was 

tested in rats and dogs. Almost all of the 

color was excreted unchanged in the 

feces of the rats and no color was found 

in the urine. A smaller portion of the 

color, not exceeding 5% of the given 

dose, was found in the bile of the dogs. 

B. Toxicological Points of Departure/ 

Levels of Concern 

The available toxicity study indicates 

that FD&C Green No. 3 has a very low 

overall toxicity. The lowest NOAEL in 

the database is 1,000 mg/kg bw/day. In 

the carcinogenicity study with an in 

utero phase, the effects on the pups 

(decreased body weights and pup 

mortality) and kidney and thyroid 

toxicity in adults were observed at 5% 

in diet (equivalent to 2,500 mg/kg/day). 

Since these effects were observed at 2.5 

times the limit dose of 1,000 mg/kg/day, 

there are low concerns for the hazard. 

Since no endpoint of concern was 

identified for the acute and chronic 

dietary exposure assessments and shortand intermediate-term dermal and 

inhalation exposure assessments, a 

quantitative risk assessment for FD&C 

Green No. 3 is not necessary. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to FD&C Green No. 3, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from FD&C 

Green No. 3 in food as follows: Dietary 

exposure to FD&C Green No. 3 can 

occur from eating food that has come in 

contact with surfaces treated with 

pesticide formulations containing this 

inert ingredient. Dietary exposure to 

FD&C Green No. 3 can also occur from 

eating foods which contain FD&C Green 

No. 3 as an ingredient. However, since 

an endpoint of concern for risk 

assessment was not identified, a 

quantitative dietary exposure 

assessment for FD&C Green No. 3 was 

not conducted. 

2. Dietary exposure from drinking 

water. Dietary exposure from drinking 

water to FD&C Green No. 3 can occur by 

drinking water that has been 

contaminated by contact with run-off 

from pesticide treated areas, such as 

countertops. Since an endpoint for risk 

assessment was not identified, a 

quantitative dietary exposure 

assessment from drinking water for 

FD&C Green No. 3 was not conducted. 

3. From non-dietary exposure. From 

non-dietary exposure. The term 

‘‘residential exposure’’ is used in this 

document to refer to non-occupational, 

non-dietary exposure (e.g., for lawn and 

garden pest control, indoor pest control, 

termiticides, and flea and tick control 

on pets). The proposed use of FD&C 

Green No. 3 as a dye under 40 CFR 

180.940(a) is expected to result in 

residential exposure to this chemical. 

However, since there are no 

toxicological effects of concern 

identified in the available database, it is 

not necessary to conduct assessments of 

residential (non-occupational) 

exposures and risks. There are no 

dermal or inhalation toxicological 

endpoints of concern to the Agency; 

therefore, quantitative assessments have 

not been conducted. 

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 FD&C Green No. 

3 to share a common mechanism of 

toxicity with any other substances, and 

FD&C Green No. 3 does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that FD&C Green No. 3 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 

Food Quality Protection Act (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. 

In the carcinogenicity study with an 

in utero phase, the effects on the pups 

(decreased body weights and pup 

mortality) and kidney and thyroid 

toxicity in adults were observed at 5% 

in diet (equivalent to 2,500 mg/kg/day). 


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Since these effects were observed at 2.5 

times the limit dose of 1,000 mg/kg/day, 

there are low concerns for the hazard. 

Therefore, it is concluded that there is 

no evidence of qualitative or 

quantitative susceptibility of infants and 

children in the available database. 

The available toxicity studies suggest 

low toxicity of FD&C Green No. 3. The 

toxicity database for FD&C Green No. 3 

contains an acute oral toxicity study and 

chronic toxicity studies, including 

carcinogenicity, and reproductive 

toxicity studies. No reproductive or 

developmental toxicity was observed in 

the 3-generation reproduction study at 

the limit dose. The database also 

contains mutagenicity studies, and 

metabolism data. There is no indication, 

based upon the available data, that 

FD&C Green No. 3 is a neurotoxic or 

immunotoxic chemical. Due to the lack 

of toxicity of FD&C Green No. 3, the 

Agency determined that a quantitative 

risk assessment using safety factors was 

not necessary for assessing risk. For the 

same reason, no additional safety factor 

is needed for assessing risk to infants 

and children. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on FD&C Green No. 3, EPA 

has determined that there is a 

reasonable certainty that no harm to any 

population subgroup will result from 

aggregate exposure to FD&C Green No. 

3 under reasonable foreseeable 

circumstances. Therefore, the 

establishment of an exemption from the 

requirement of a tolerance under 40 CFR 

180.940(a) for residues of FD&C Green 

No. 3 when used as an inert ingredient 

(dye) in antimicrobial formulations, for 

use on food contact surfaces in public 

eating places, dairy processing 

equipment, and food processing 

equipment and utensils, 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 

United Nation Food and Agriculture 

Organization/World Health 

Organization (FAO/WHO) 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 FD&C Green No. 3. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180. 940(a) for FD&C 

Green No. 3 (CAS Reg. No. 2353–45–9) 

when used as an inert ingredient (dye) 

in antimicrobial formulations, for use on 

food contact surfaces in public eating 

places, dairy processing equipment, and 

food processing equipment and utensils. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 

1501 et seq.). 

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) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: October 30, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 


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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 § 180.940, in paragraph (a) 

alphabetically add the following inert 

ingredient to the table to read as 

follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

FD&C Green No. 3 ...................................................................... CAS Reg. No. 2353–45–9 .......................................................... None. 

* * * * * * * 

[FR Doc. 2013–26760 Filed 11–7–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0710; FRL–9401–5] 

Boscalid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of boscalid in or 

on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 8, 2013. Objections and 

requests for hearings must be received 

on or before January 7, 2014, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0710, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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.ecfr.gov/cgi-bin/textidx?&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–2012–0710, 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 January 7, 2014. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0710, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of January 16, 

2013 (78 FR 3377) (FRL–9375–4), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 2E8068) by BASF 


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