58886 Federal Register / Vol. 78, No. 186 / Wednesday, September 25, 2013 / Rules and Regulations 

(c) * * * 

TABLE 1—EPA-APPROVED KENTUCKY REGULATIONS

State citation Title/subject 

State 

effective 

date 

EPA approval date Explanation 

Chapter 59 New Source Standards 

*******

401 KAR 59:174 Stage II controls at gasoline 

dispensing facilities.

04/25/13 09/25/13 [Insert citation of publication].Exemption from Stage II vapor control requirements for 

rental fleet vehicle refueling at the Cincinnati/Northern 

Kentucky International Airport Enterprise Holdings, 

Inc., facility. 

*******

* * * * * 

[FR Doc. 2013–22973 Filed 9–24–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0568; FRL–9396–1] 

FD&C Blue No. 1; 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 Blue No. 

1 (CAS Reg. No. 3844–45–9) when used 

as an inert ingredient (dye) in pesticides 

formulation applied to growing crops 

(seed treatment). Exponent on behalf of 

Sensient Colors, LLC 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 

Blue No. 1. 

DATES: This regulation is effective 

September 25, 2013. Objections and 

requests for hearings must be received 

on or before November 25, 2013, 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–2012–0568, 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 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–2012–0568 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before November 25, 2013. 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– 

2012–0568, 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. 


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• 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. Petition for Exemption 

In the Federal Register of August 22, 

2012 (77 FR 50661) (FRL–9358–9), EPA 

issued a document pursuant to FFDCA 

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

the filing of a pesticide petition (PP 

2E8004) by Exponent (1150 Connecticut 

Ave. NW., Suite 1100, Washington, DC 

20036) on behalf of Sensient Colors, 

LLC (2515 N. Jefferson Ave., St. Louis, 

MO 63106). The petition requested that 

40 CFR 180.920 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of FD&C Blue No. 1 (CAS Reg. No. 

3844–45–9) when used as an inert 

ingredient (dye) in pesticide 

formulations applied to growing crops 

(seed treatment). That document 

referenced a summary of the petition 

prepared by Exponent on behalf of 

Sensient Colors, LLC, 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 Blue No. 1 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with FD&C Blue No. 1 

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 Blue No. 1 as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. The chemical 

is also referred to as Brilliant Blue FCF 

in this document, as this name is 

synonymous with FD&C Blue No. 1. 

FD&C Blue No. 1 is not acutely toxic 

via the oral route in rats and via 

subcutaneous injection in mice. Longterm studies of the effects of the color 

administered in the diet to dogs, rats 

and mice did not indicate any 

significant toxic effects. In a chronic dog 

study, treatment at doses up to 200 

milligrams/kilogram bodyweight/day 

(mg/kg bw/day) for a time period of 1 

year did not show any treatment related 

signs of toxicity or histological 

abnormalities. In a 2-year study, rats fed 

a diet containing up to 2,000 mg/kg bw/ 

day Brilliant Blue FCF showed no 

evidence of treatment related effects. In 

a second long term study in rats, 

Brilliant Blue FCF was fed as part of the 

diet for 75 weeks. No treatment related 

effects were found at 1,500 mg/kg bw/ 

day, the highest dose tested. 

Lifetime exposure of mice to Brilliant 

Blue FCF as part of the diet did not 

result in consistent biologically 

significant, compound related adverse 

effects on behavior, morbidity, 

mortality, hematology, general physical 

observations or tumor incidence. The 

NOAEL for this study was determined 

to be 7,354 mg/kg bw/day for male and 

8,966 mg/kg bw/day for female, the 

highest doses tested. 

Rats were treated with Brilliant Blue 

FCF in a chronic toxicity study coupled 

with a reproductive study. The NOAEL 

was 1,072 mg/kg bw/day for male rats 

and 631 mg/kg bw/day for females, 

based on a 15% decrease in terminal 

mean body weight and decreased 

survival in high dose females. In the 

reproductive portion of the study, there 

were no compound related effects on 

fertility, gestation, parturition, lactation, 

pup survival through weaning, or on 

number of live and stillborn pups. The 

NOAEL was 1,073 mg/kg bw/day male 

rats and 1,318 mg/kg bw/day for 

females. 

Brilliant Blue FCF was fed to three 

successive generations of male and 

female rats at dose levels up to 1,000 

mg/kg bw/day. There were no treatment 

related effects on adult mortality, 

mating, pregnancy and fertility rates, 

lengths of gestation period, offspring 

survival or sex, litter survival or 


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necropsy findings. The NOAEL for this 

study was 1,000 mg/kg bw/day, the 

highest dose tested. Two additional 

reproductive studies in rats and rabbits 

did not result fetal toxicity or anomalies 

at doses up to 2,000 mg/kg bw/day and 

200 mg/kg bw day, respectively. 

Based on the results of the available 

genotoxicity studies, it was concluded 

that Brilliant Blue FCF is not of concern 

with respect to genotoxicity. A 

developmental neurotoxicity study also 

indicates that there were no 

toxicological effects of concern. 

Immunotoxicity studies were not 

available for review. However, signs of 

immunotoxicity were not observed in 

any of the available studies conducted 

at doses above the limit dose of 1,000 

mg/kg/day. The metabolism of Brilliant 

Blue FCF was determined in multiple 

studies. In three studies with rats that 

were given Brilliant Blue FCF either via 

gavage or in the diet, the major route of 

excretion was through the feces with 

total recoveries at a minimum of 92% 

indicating very limited absorption via 

oral route of exposure. The lack of 

gastrointestinal absorption and 

metabolism was confirmed by studies in 

guinea pigs and mice. 

B. Toxicological Points of Departure/

Levels of Concern 

The available toxicity studies indicate 

that FD&C Blue No. 1 has a very low 

overall toxicity. A NOAEL of 1,072 mg/ 

kg bw/day for male rats and 631 mg/kg 

bw/day for females can be derived from 

a chronic toxicity study coupled with a 

reproductive study based on a 15% 

decrease in terminal mean body weight 

and decreased survival in high dose 

females. However, these results were 

not reproducible in several other 

chronic longer duration studies at 

higher doses. Several long-term studies 

indicate a higher NOAEL above the 

limit dose. Therefore, EPA concludes 

that the existing database does not show 

a toxic endpoint of concern for acute, 

chronic, and short- and intermediateterm risks, and, accordingly, a 

quantitative risk assessment for FD&C 

Blue No. 1 is not necessary. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to FD&C Blue No. 1, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from FD&C 

Blue No. 1 in food as follows: Dietary 

exposure to FD&C Blue No. 1 can occur 

from eating food treated with pesticide 

formulations containing this inert 

ingredient. Dietary exposure can also 

occur from eating foods which contain 

FD&C Blue No. 1 as an ingredient. It is 

widely used as an ingredient in food 

products such as ice cream, bottled food 

coloring, icings, ice pops, dairy 

products, sweets and drinks. However, 

since an endpoint of concern for risk 

assessment was not identified, a 

quantitative dietary exposure 

assessment for FD&C Blue No. 1 was not 

conducted. 

2. Dietary exposure from drinking 

water. Dietary exposure from drinking 

water to FD&C Blue No. 1 can occur by 

drinking water that has been 

contaminated by run-off from a 

pesticide treated area. Since an 

endpoint for risk assessment was not 

identified, a quantitative dietary 

exposure assessment from drinking 

water for FD&C Blue No. 1 was not 

conducted. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). The 

proposed use of FD&C Blue No. 1 as a 

seed treatment/dye under 40 CFR 

180.920 is not expected to result in 

residential exposure to this chemical. 

Residential exposure is possible based 

on other currently approved inert uses 

of this chemical. However, since there 

are no toxicological effects of concern 

identified, it is not necessary to conduct 

assessments of residential (nonoccupational) 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 Blue No. 1 

to share a common mechanism of 

toxicity with any other substances, and 

FD&C Blue No. 1 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 Blue No. 1 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. 

The available toxicity studies suggest 

low toxicity of FD&C Blue No. 1. The 

toxicity database for FD&C Blue No. 1 

contains an acute oral toxicity study, 

sub-chronic and chronic toxicity 

studies, including carcinogenicity, 

reproductive and developmental 

toxicity studies. No reproductive or 

developmental toxicity was observed in 

the modified reproduction study, 3- 

generation reproduction study and 

developmental toxicity studies in rats 

and rabbits. The database also contains 

mutagenicity studies, neurotoxicity data 

and metabolism data. There is no 

indication, based upon the available 

data, that FD&C Blue No. 1 is a 

neurotoxic or immunotoxic chemical or 

results in increased qualitative or 

quantitative susceptibility in infants or 

children. Based on this information, 

there is no concern, at this time, for 

increased sensitivity to infants and 

children to this chemical when used as 

inert ingredient in pesticides 

formulations. Due to the lack of toxicity 

of FD&C No. 1, EPA did not use safety 

factors in qualitatively assessing its risk, 

and, 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 Blue No. 1, EPA 

has determined that there is a 

reasonable certainty that no harm will 

result to the general population, or to 

infants and children, from aggregate 

exposure to FD&C Blue No. 1 residues 

under reasonably foreseeable 

circumstances. Therefore, the 

establishment of an exemption from 

tolerance under 40 CFR 180.920 for 

residues of FD&C Blue No. 1 when used 


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Federal Register / Vol. 78, No. 186 / Wednesday, September 25, 2013 / Rules and Regulations 58889 

as an inert ingredient (dye) in pesticide 

formulations applied to growing crops 

(seed treatment) 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 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 Blue No. 1. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for FD&C Blue 

No. 1 (CAS Reg. No. 3844–45–9) when 

used as an inert ingredient (dye) in 

pesticide formulations applied to 

growing crops (seed treatment). 

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: September 17, 2013. 

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. In § 180.920, alphabetically add the 

following inert ingredient to the table, 

after the entry for Europic chloride and 

before the entry for FD&C Blue No. 1, 

methyl-polyethylene glycol derivative 

(CAS Reg. No. 9079–34–9), to read as 

follows: 

§ 180.920 Inert ingredients used preharvest; exemption from the requirement of 

a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

FD&C Blue No. 1 (CAS Reg. No. 3844–45–9) ............... For seed treatment use only ............................................ Dye, coloring agent 

*******


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58890 Federal Register / Vol. 78, No. 186 / Wednesday, September 25, 2013 / Rules and Regulations 

[FR Doc. 2013–23371 Filed 9–24–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 271 and 272 

[EPA–R06–2013–0027; FRL–9819–8] 

Louisiana: Final Authorization of StateInitiated Changes and Incorporation by 

Reference of Approved State 

Hazardous Waste Management 

Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: During a review of 

Louisiana’s regulations, the EPA 

identified a variety of State-initiated 

changes to its hazardous waste program 

under the Resource Conservation and 

Recovery Act (RCRA). We have 

determined that these changes are minor 

and satisfy all requirements needed to 

qualify for Final authorization and are 

authorizing the State-initiated changes 

through this direct Final action. In 

addition, this document corrects 

technical errors made in the June 28, 

2012 Federal Register authorization 

document for Louisiana. 

The Solid Waste Disposal Act, as 

amended, commonly referred to as the 

Resource Conservation and Recovery 

Act (RCRA), allows the Environmental 

Protection Agency (EPA) to authorize 

States to operate their hazardous waste 

management programs in lieu of the 

Federal program. The EPA uses the 

regulations entitled ‘‘Approved State 

Hazardous Waste Management 

Programs’’ to provide notice of the 

authorization status of State programs 

and to incorporate by reference those 

provisions of the State statutes and 

regulations that will be subject to the 

EPA’s inspection and enforcement. The 

rule codifies in the regulations the prior 

approval of Louisiana’s hazardous waste 

management program and incorporates 

by reference authorized provisions of 

the State’s statutes and regulations. 

DATES: This regulation is effective 

November 25, 2013, unless the EPA 

receives adverse written comment on 

the codification of the Louisiana 

authorized program by the close of 

business October 25, 2013. If the EPA 

receives such comments, it will publish 

a timely withdrawal of this direct final 

rule in the Federal Register informing 

the public that this rule will not take 

effect. The incorporation by reference of 

authorized provisions in the Louisiana 

statutes and regulations contained in 

this rule is approved by the Director of 

the Federal Register as of November 25, 

2013 in accordance with 5 U.S.C. 552(a) 

and 1 CFR part 51. 

ADDRESSES: Submit your comments by 

one of the following methods: 

1. Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

2. Email: patterson.alima@epa.gov or 

banks.julia@epa.gov 

3. Mail: Alima Patterson, Region 6, 

Regional Authorization Coordinator, or 

Julia Banks, Codification Coordinator, 

State/Tribal Oversight Section (6PD–O), 

Multimedia Planning and Permitting 

Division, EPA Region 6, 1445 Ross 

Avenue, Dallas, Texas 75202–2733. 

4. Hand Delivery or Courier: Deliver 

your comments to Alima Patterson, 

Region 6, Regional Authorization 

Coordinator, or Julia Banks, Codification 

Coordinator, State/Tribal Oversight 

Section (6PD–O), Multimedia Planning 

and Permitting Division, EPA Region 6, 

1445 Ross Avenue, Dallas, Texas 75202– 

2733. 

Instructions: Do not submit 

information that you consider to be CBI 

or otherwise protected through 

regulations.gov, or email. The Federal 

regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means the EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to the EPA without 

going through regulations.gov, your 

email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, the EPA recommends that 

you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If the EPA cannot read your 

comment due to technical difficulties, 

and cannot contact you for clarification, 

the EPA may not be able to consider 

your comment. Electronic files should 

avoid the use of special characters, any 

form of encryption, and be free of any 

defects or viruses. (For additional 

information about the EPA’s public 

docket, visit the EPA Docket Center 

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

epahome/dockets.htm). 

You can view and copy the 

documents that form the basis for this 

codification and associated publicly 

available materials from 8:30 a.m. to 

4:00 p.m. Monday through Friday at the 

following location: EPA Region 6, 1445 

Ross Avenue, Dallas, Texas, 75202– 

2733, phone number (214) 665–8533 or 

(214) 665–8178. Interested persons 

wanting to examine these documents 

should make an appointment with the 

office at least two weeks in advance. 

FOR FURTHER INFORMATION CONTACT: 

Alima Patterson, Region 6 Regional 

Authorization Coordinator, or Julia 

Banks, Codification Coordinator, State/

Tribal Oversight Section (6PD–O), 

Multimedia Planning and Permitting 

Division, EPA Region 6, 1445 Ross 

Avenue, Dallas, Texas 75202–2733, 

Phone numbers: (214) 665–8533 or (214) 

665–8178, and Email address 

patterson.alima@epa.gov or 

banks.julia@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Authorization of State-Initiated 

Changes 

A. Why are revisions to State programs 

necessary? 

States which have received Final 

authorization from the EPA under RCRA 

section 3006(b), 42 U.S.C. 6926(b), must 

maintain a hazardous waste program 

that is equivalent to, consistent with, 

and no less stringent than the Federal 

hazardous waste program. As the 

Federal program changes, the States 

must change their programs and ask the 

EPA to authorize the changes. Changes 

to State hazardous waste programs may 

be necessary when Federal or State 

statutory or regulatory authority is 

modified or when certain other changes 

occur. Most commonly, States must 

change their programs because of 

changes to the EPA’s regulations in 40 

Code of Federal Regulations (CFR) parts 

124, 260 through 268, 270, 273 and 279. 

States can also initiate their own 

changes to their hazardous waste 

program and these changes must then be 

authorized. 

B. What decisions have we made in this 

rule? 

We conclude that Louisiana’s 

revisions to its authorized program meet 

all of the statutory and regulatory 

requirements established by RCRA. We 

found that the State-initiated changes 

make Louisiana’s rules more clear or 

conform more closely to the Federal 

equivalents and are so minor in nature 

that a formal application is unnecessary. 

Therefore, we grant Louisiana final 

authorization to operate its hazardous 

waste program with the changes 

described in the table at Section G 

below. Louisiana has responsibility for 

permitting Treatment, Storage, and 

Disposal Facilities (TSDFs) within its 

borders (except in Indian Country) and 

for carrying out all authorized aspects of 

the RCRA program, subject to the 


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