Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Rules and Regulations 59265 

PART 55—OUTER CONTINENTAL 

SHELF AIR REGULATIONS 

■ 1. The authority citation for part 55 

continues to read as follows: 

Authority: Section 328 of the Clean Air 

Act (42 U.S.C. 7401 et seq.) as amended by 

Public Law 101–549. 

■ 2. Section 55.14 is amended by 

revising paragraph (e)(3)(ii)(F) to read as 

follows: 

§ 55.14 Requirements that apply to OCS 

sources located within 25 miles of states 

seaward boundaries, by state. 

* * * * * 

(e) * * * 

(3) * * * 

(ii) * * * 

(F) Santa Barbara County Air 

Pollution Control District Requirements 

Applicable to OCS Sources, May 2013. 

* * * * * 

■ 3. Appendix A to CFR part 55 is 

amended by revising paragraph (b)(6) 

under the heading ‘‘California’’ to read 

as follows: 

Appendix A to Part 55—Listing of State 

and Local Requirements Incorporated 

by Reference Into Part 55, by State. 

* * * * * 

California 

* * * * * 

(b) * * * 

(6) The following requirements are 

contained in Santa Barbara County Air 

Pollution Control District Requirements 

Applicable to OCS Sources: 

Rule 102 Definitions (Adopted 06/21/12) 

Rule 103 Severability (Adopted 10/23/78) 

Rule 106 Notice to Comply for Minor 

Violations (Repealed 01/01/2001) 

Rule 107 Emergencies (Adopted 04/19/01) 

Rule 201 Permits Required (Adopted 06/19/ 

08) 

Rule 202 Exemptions to Rule 201 (Adopted 

06/21/12) 

Rule 203 Transfer (Adopted 04/17/97) 

Rule 204 Applications (Adopted 04/17/97) 

Rule 205 Standards for Granting Permits 

(Adopted 04/17/97) 

Rule 206 Conditional Approval of 

Authority to Construct or Permit to Operate 

(Adopted 10/15/91) 

Rule 207 Denial of Application (Adopted 

10/23/78) 

Rule 210 Fees (Adopted 03/17/05) 

Rule 212 Emission Statements (Adopted 10/ 

20/92) 

Rule 301 Circumvention (Adopted 10/23/ 

78) 

Rule 302 Visible Emissions (Adopted 10/ 

23/78) 

Rule 304 Particulate Matter-Northern Zone 

(Adopted 10/23/78) 

Rule 305 Particulate Matter ConcentrationSouthern Zone (Adopted 10/23/78) 

Rule 306 Dust and Fumes-Northern Zone 

(Adopted 10/23/78) 

Rule 307 Particulate Matter Emission 

Weight Rate-Southern Zone (Adopted 10/ 

23/78) 

Rule 308 Incinerator Burning (Adopted 10/ 

23/78) 

Rule 309 Specific Contaminants (Adopted 

10/23/78) 

Rule 310 Odorous Organic Sulfides 

(Adopted 10/23/78) 

Rule 311 Sulfur Content of Fuels (Adopted 

10/23/78) 

Rule 312 Open Fires (Adopted 10/02/90) 

Rule 316 Storage and Transfer of Gasoline 

(Adopted 01/15/09) 

Rule 317 Organic Solvents (Adopted 10/23/ 

78) 

Rule 318 Vacuum Producing Devices or 

Systems-Southern Zone (Adopted 10/23/ 

78) 

Rule 321 Solvent Cleaning Operations 

(Adopted 06/21/12) 

Rule 322 Metal Surface Coating Thinner 

and Reducer (Adopted 10/23/78) 

Rule 323 Architectural Coatings (Adopted 

11/15/01) 

Rule 324 Disposal and Evaporation of 

Solvents (Adopted 10/23/78) 

Rule 325 Crude Oil Production and 

Separation (Adopted 07/19/01) 

Rule 326 Storage of Reactive Organic 

Compound Liquids (Adopted 01/18/01) 

Rule 327 Organic Liquid Cargo Tank Vessel 

Loading (Adopted 12/16/85) 

Rule 328 Continuous Emission Monitoring 

(Adopted 10/23/78) 

Rule 330 Surface Coating of Metal Parts and 

Products (Adopted 06/21/12) 

Rule 331 Fugitive Emissions Inspection and 

Maintenance (Adopted 12/10/91) 

Rule 332 Petroleum Refinery Vacuum 

Producing Systems, Wastewater Separators 

and Process Turnarounds (Adopted 06/11/ 

79) 

Rule 333 Control of Emissions from 

Reciprocating Internal Combustion Engines 

(Adopted 06/19/08) 

Rule 342 Control of Oxides of Nitrogen 

(NOX) from Boilers, Steam Generators and 

Process Heaters) (Adopted 04/17/97) 

Rule 343 Petroleum Storage Tank Degassing 

(Adopted 12/14/93) 

Rule 344 Petroleum Sumps, Pits, and Well 

Cellars (Adopted 11/10/94) 

Rule 346 Loading of Organic Liquid Cargo 

Vessels (Adopted 01/18/01) 

Rule 349 Polyester Resin Operations 

(Adopted 06/21/12) 

Rule 352 Natural Gas-Fired Fan-Type 

Central Furnaces and Residential Water 

Heaters (Adopted 10/20/11) 

Rule 353 Adhesives and Sealants (Adopted 

06/21/12) 

Rule 359 Flares and Thermal Oxidizers 

(Adopted 06/28/94) 

Rule 360 Emissions of Oxides of Nitrogen 

from Large Water Heaters and Small 

Boilers (Adopted 10/17/02) 

Rule 361 Small Boilers, Steam Generators, 

and Process Heaters (Adopted 01/17/08) 

Rule 370 Potential to Emit—Limitations for 

Part 70 Sources (Adopted 01/20/11) 

Rule 505 Breakdown Conditions Sections 

A.,B.1,. and D. only (Adopted 10/23/78) 

Rule 603 Emergency Episode Plans 

(Adopted 06/15/81) 

Rule 702 General Conformity (Adopted 10/ 

20/94) 

Rule 801 New Source Review (Adopted 04/ 

17/97) 

Rule 802 Nonattainment Review (Adopted 

04/17/97) 

Rule 803 Prevention of Significant 

Deterioration (Adopted 04/17/97) 

Rule 804 Emission Offsets (Adopted 04/17/ 

97) 

Rule 805 Air Quality Impact Analysis and 

Modeling (Adopted 04/17/97) 

Rule 808 New Source Review for Major 

Sources of Hazardous Air Pollutants 

(Adopted 05/20/99) 

Rule 810 Federal Prevention of Significant 

Deterioration (PSD) (Adopted 01/20/11) 

Rule 1301 Part 70 Operating Permits— 

General Information (Adopted 01/20/11) 

Rule 1302 Part 70 Operating Permits— 

Permit Application (Adopted 11/09/93) 

Rule 1303 Part 70 Operating Permits— 

Permits (Adopted 11/09/93) 

Rule 1304 Part 70 Operating Permits— 

Issuance, Renewal, Modification and 

Reopening (Adopted 11/09/93) 

Rule 1305 Part 70 Operating Permits— 

Enforcement (Adopted 11/09/93) 

* * * * * 

[FR Doc. 2013–23377 Filed 9–25–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0945; FRL–9400–6] 

FD&C Yellow No. 5; 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 Yellow 

No. 5 (CAS Reg. No. 1934–21–0) when 

used as an inert ingredient (dye) in 

antimicrobial pesticide formulations 

applied to food-contact surfaces in 

public eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils. Exponent, Inc. 

on behalf of Ecolab, Inc., 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. These regulations eliminate 

the need to establish a maximum 

permissible level for residues of FD&C 

Yellow No. 5. 

DATES: This regulation is effective 

September 26, 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) 

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59266 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Rules and Regulations 

number EPA–HQ–OPP–2012–0945, 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/text-idx?&c=ecfr&tpl=/

ecfrbrowse/Title40/40tab_02.tpl. To 

access the OCSPP test guidelines 

referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2012–0945 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– 

2012–0945, 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. Petition for Exemption 

In the Federal Register of January 16, 

2013 (78 FR 3377) (FRL–9375–4), EPA 

issued a document pursuant to FFDCA 

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

the filing of a pesticide petition (PP IN– 

10528) by Exponent, Inc. on behalf of 

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

Paul, MN 55102. The petition requested 

an exemption from the requirement of a 

tolerance be established for residues of 

FD&C Yellow No. 5 (CAS Reg. No. 

1934–21–0) when used as an inert 

ingredient under 40 CFR 180.940(a) for 

use in antimicrobial pesticide 

formulations applied to food-contact 

surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils at an 

end-use concentration not to exceed 

1,000 parts per million (ppm). That 

document referenced a summary of the 

petition submitted by Ecolab, Inc., 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 

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Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Rules and Regulations 59267 

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 Yellow No. 

5 including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with FD&C Yellow No. 5 

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 Yellow No. 5 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. 

FD&C Yellow No. 5 is a FDA 

permanently listed color additive used 

in food, drugs and cosmetics, including 

drugs and cosmetics for the eye area. 

FDA’s color additive evaluation 

included the consideration of an 

extensive set of toxicological data on 

FD&C Yellow No. 5. FDA concluded 

that this colorant was safe and 

established a maximum acceptable daily 

intake for FD&C Yellow No. 5. 

Similarly, the Joint Expert Committee 

on Food Additives of the Food and 

Agriculture Organization/World Health 

Organization (JECFA) as well as the 

European Union Scientific Committee 

for Food (SCF) has evaluated FD&C 

Yellow No. 5 for the purpose of 

establishing estimates of acceptable 

daily intake (ADI) as a food additive. In 

2004, EPA conducted a tolerance 

reassessment of the tolerance 

exemptions for FD&C Yellow No. 5 (also 

referred to as tartrazine) under 40 CFR 

180.910, 180.930, 180.940(b), and 

180.940(c) which included a summary 

of the FDA and JECFA evaluations of 

FD&C Yellow No. 5. 

The FDA and JECFA evaluations of 

FD&C Yellow No. 5 included reviews of 

an extensive set of toxicological data 

including genotoxicity, chronic toxicity/ 

carcinogenicity and reproductive and 

developmental toxicity. Both 

evaluations concluded that the available 

data demonstrated that no adverse 

effects were seen in studies at limit dose 

levels. The FDA evaluation resulted in 

the establishment of an ADI of 5.0 

milligrams/kilogram/day (mg/kg/day) 

based on a chronic oral toxicity study in 

dogs in which the no-observed adverse 

effect level (NOAEL) was 500 mg/kg/day 

(highest dose tested) with a safety factor 

of 100. The JECFA and SCF evaluations 

of FD&C Yellow No. 5 established ADIs 

of 7.5 mg/kg/day based upon a chronic 

dietary toxicity study in rats in which 

the no-observed adverse effect level 

(NOAEL) was 750 mg/kg/day (highest 

dose tested) with a safety factor of 100. 

More recently, the European Food 

Safety Authority has reevaluated FD&C 

Yellow No. 5 and concluded that the 

present database does not give reason to 

revise the ADI of 7.5 mg/kg bw/day. 

As a result of these extensive 

evaluations of FD&C Yellow No. 5, in 

which either no adverse effects were 

noted, or the effects of single or repeated 

dosing were observed only at levels 

beyond the respective limit doses, EPA 

has utilized a qualitative approach to 

assessing human health risks from 

exposure to FD&C Yellow No. 5. No 

hazard endpoint of concern was 

identified for the acute and chronic 

dietary assessment (food and drinking 

water), or for the short-, intermediate-, 

and long-term residential assessments 

(via all exposure routes), therefore, 

acute and chronic dietary and short-, 

intermediate-, and long-term residential 

exposure assessments were not 

performed. 

B. Toxicological Points of Departure/

Levels of Concern 

There were no adverse effects in 

repeat dose toxicity, reproductive, and 

developmental studies with FD&C 

Yellow No. 5 at or above limit dose 

levels to either parental animals or their 

offspring. Based on the available 

mutagenicity studies, EPA concluded 

that FD&C Yellow No. 5 is not likely to 

be genotoxic. There was no evidence of 

carcinogenicity in rats and mice up to 

the limit dose at 24 and 18 months, 

respectively. Thus, due to its low 

potential hazard and lack of hazard 

endpoint, the Agency has determined 

that a quantitative risk assessment using 

safety factors applied to a point of 

departure protective of an identified 

hazard endpoint is not appropriate for 

FD&C Yellow No. 5. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to FD&C Yellow No. 5, EPA 

considered exposure under the 

proposed exemptions from the 

requirement of a tolerance. Dietary 

exposure to FD&C Yellow No. 5 can 

occur when eating food treated with 

pesticide formulation containing this 

inert ingredient. In addition, dietary 

exposure to FD&C Yellow No. 5 could 

occur via residues from treated food 

contact surfaces; and from food that 

contains FD&C Yellow No. 5, as a color 

additive. Since an endpoint for risk 

assessment was not identified, a 

quantitative dietary exposure 

assessment for FD&C Yellow No. 5 was 

not conducted. 

2. Dietary exposure from drinking 

water. Dietary exposure from drinking 

water to FD&C Yellow No. 5 can occur 

by drinking water that has been 

contaminated by run-off from a 

pesticide treated area and from 

antimicrobial formulations used in foodcontact surface sanitizing solutions. 

Since an endpoint for risk assessment 

was not identified, a quantitative dietary 

exposure assessment from drinking 

water for FD&C Yellow No. 5 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., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Residential (oral, dermal and 

inhalation) exposure to FD&C Yellow 

No. 5 from its use as an inert ingredient 

in food-contact surface sanitizing 

solutions for public eating places, dairyprocessing equipment, food-processing 

equipment and utensils is possible. 

Residential exposure to, FD&C Yellow 

No. 5 as a result of its use as a color 

additive in foods, drugs and cosmetics 

is also possible. Since an endpoint for 

risk assessment was not identified, a 

quantitative residential exposure 

assessment for FD&C Yellow No. 5 was 

not conducted. 

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59268 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Rules and Regulations 

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 Yellow No. 

5 to share a common mechanism of 

toxicity with any other substances, and 

FD&C Yellow No. 5 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 Yellow No. 5 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 

The toxicity database for FD&C 

Yellow No. 5 contains several acute, 

subchronic, long-term, developmental, 

reproductive and carcinogenic studies, 

as well as mutagenicity studies. No 

adverse effects were identified in those 

studies. There were no clinical signs of 

neurotoxicity or systemic toxicity 

observed with FD&C Yellow No. 5 in the 

available database up to the limit dose. 

No developmental or reproductive 

effects were seen in the available 

developmental and reproductive 

toxicity studies at doses of FD&C Yellow 

No. 5 up to the limit dose, 1,064 mg/kg/ 

day. Thus, there is no residual 

uncertainty regarding prenatal and/or 

postnatal toxicity of FD&C Yellow No. 5. 

Due to the lack of toxicity of FD&C 

Yellow No. 5, 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 Yellow No. 5, 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 FD&C Yellow No. 5 under 

reasonable foreseeable circumstances. 

Therefore, the establishment of 

exemptions from tolerance under 

180.940(a) for residues of FD&C Yellow 

No. 5 when used as an inert ingredient 

in food-contact surface sanitizing 

solutions for public eating places, dairyprocessing equipment, 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 exemptions 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 Yellow No. 

5. 

VI. Conclusions 

Therefore, exemptions from the 

requirement of a tolerance are 

established for residues of FD&C Yellow 

No. 5 (CAS Reg. No. 1934–21–0) under 

180.940(a) when used as an inert 

ingredient (dye) in food-contact surface 

sanitizing solutions for public eating 

places, dairy-processing equipment, 

food-processing equipment and utensils. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes exemptions 

from the requirement of 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 exemptions 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 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Rules and Regulations 59269 

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 § 180.940, alphabetically add the 

following inert ingredient to the table in 

paragraph (a) 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 Yellow No. 5 .................................... 1934–21–0 When ready for use, the end-use concentration is not to exceed 1000 ppm. 

*******

* * * * * 

[FR Doc. 2013–23391 Filed 9–25–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R4–ES–2012–0004; 

4500030113] 

1018–AY06 

Endangered and Threatened Wildlife 

and Plants; Endangered Species 

Status for the Fluted Kidneyshell and 

Slabside Pearlymussel 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Final rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), determine 

endangered species status under the 

Endangered Species Act of 1973 (Act), 

as amended, for the fluted kidneyshell 

(Ptychobranchus subtentum) and 

slabside pearlymussel (Pleuronaia 

dolabelloides). These two species are 

endemic to portions of the Cumberland 

and Tennessee River systems of 

Alabama, Kentucky, Mississippi, 

Tennessee, and Virginia. The effect of 

this regulation is to add these species to 

the List of Endangered and Threatened 

Wildlife and to implement the Federal 

protections provided by the Act for 

these species. 

DATES: This rule is effective on October 

28, 2013. 

ADDRESSES: This final rule is available 

on the Internet at http://

www.regulations.gov and at http://

www.fws.gov/cookeville. Comments and 

materials we received, as well as 

supporting documentation we used in 

preparing this rule, are available for 

public inspection at http://

www.regulations.gov. All of the 

comments, materials, and 

documentation that we considered in 

this rulemaking are available by 

appointment, during normal business 

hours, at: U.S. Fish and Wildlife 

Service, Tennessee Ecological Services 

Field Office, 446 Neal Street, 

Cookeville, TN 38501; telephone 931– 

528–6481; facsimile 931–528–7075. 

FOR FURTHER INFORMATION CONTACT: 

Mary Jennings, Field Supervisor, U.S. 

Fish and Wildlife Service, Tennessee 

Ecological Services Field Office, 446 

Neal Street, Cookeville, TN 38501; 

telephone 931–528–6481; facsimile 

931–528–7075. If you use a 

telecommunications device for the deaf 

(TDD), call the Federal Information 

Relay Service (FIRS) at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Why we need to publish a rule. Under 

the Endangered Species Act, a species 

warrants protection through listing if it 

is endangered or threatened throughout 

all or a significant portion of its range. 

Listing a species as an endangered or 

threatened species can only be 

completed by issuing a rule. Elsewhere 

in today’s Federal Register, we 

designate critical habitat for the fluted 

kidneyshell and slabside pearlymussel. 

This rule lists the fluted kidneyshell 

and slabside pearlymussel as 

endangered species. 

The basis for our action. Under the 

Act, we may determine that a species is 

endangered or threatened based on any 

of five factors: (A) The present or 

threatened destruction, modification, or 

curtailment of its habitat or range; (B) 

overutilization for commercial, 

recreational, scientific, or educational 

purposes; (C) disease or predation; (D) 

the inadequacy of existing regulatory 

mechanisms; or (E) other natural or 

manmade factors affecting its continued 

existence. We have determined these 

two mussel species are facing threats 

based on three of these five factors (A, 

D, and E). Both species have been 

eliminated from more than 50 percent of 

the streams from which they were 

historically known, and from more than 

1,000 river miles (in the Cumberland 

and Tennessee mainstem rivers alone) 

from which they were historically 

known due to a variety of threats, 

including impoundments, mining, poor 

water quality, excessive sedimentation, 

and environmental contaminants. 

Peer review and public comment. We 

sought comments from independent 

specialists to ensure that our 

determination is based on scientifically 

sound data, assumptions, and analyses. 

We invited these peer reviewers to 

comment on our listing proposal. We 

also considered all comments and 

information we received during the 

comment period. 

Previous Federal Actions 

We proposed listing the fluted 

kidneyshell and slabside pearlymussel 

as endangered under the Act with 

critical habitat on October 4, 2012 (77 

FR 60804). For a complete history of all 

Federal actions related to these species, 

please refer to the October 4, 2012, 

proposed listing and critical habitat 

rule. Elsewhere in today’s Federal 

Register, we designate critical habitat 

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