15702 Federal Register / Vol. 79, No. 55 / Friday, March 21, 2014 / Rules and Regulations 

Lead, Pb, Particulate matter, Reporting 

and recordkeeping requirements. 

Dated: February 28, 2014. 

Jared Blumenfeld, 

Regional Administrator, Region 9. 

Therefore, 40 CFR Chapter I is 

amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart DD—Nevada 

■ 2. In § 52.1470, in paragraph (e), the 

table is amended by adding entries for: 

■ a. ‘‘Nevada’s Clean Air Act § 110(a)(1) 

and (2) State Implementation Plan for 

the 2008 Lead NAAQS, excluding 

appendices A–G for NDEP; and 

excluding the Washoe County District 

Board of Health Agenda, Minutes, 

Certificate of Adoption, Cover Letter to 

NDEP, and Proof of Publication’’; and 

■ b. ‘‘Clark County Portion of Nevada’s 

Clean Air Act § 110(a)(1) and (2) State 

Implementation Plan for the 2008 Lead 

NAAQS, excluding Cover Letter to 

NDEP and Clark County Air Quality 

Regulations’’ after the entry for ‘‘Section 

12—Resources’’. 

The additions as follows: 

§ 52.1470 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED NEVADA NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES

Name of SIP provision Applicable geographic or nonattainment area 

State submittal 

date EPA approval date Explanation 

Air Quality Implementation Plan for the State of Nevada 

*******

Nevada’s Clean Air Act 

§ 110(a)(1) and (2) State 

Implementation Plan for the 

2008 Lead NAAQS, excluding appendices A–G for 

NDEP; and excluding the 

Washoe County District 

Board of Health Agenda, 

Minutes, Certificate of Adoption, Cover Letter to NDEP, 

and Proof of Publication.

State-wide, within NDEP jurisdiction and Washoe County.10/12/2011 [Insert Federal Register 

page number where the 

document begins] 03/21/

2014.

‘‘Infrastructure’’ SIP for NDEP 

and Washoe County for the 

2008 Pb standard. 

Clark County Portion of Nevada’s Clean Air Act 

§ 110(a)(1) and (2) State 

Implementation Plan for the 

2008 Lead NAAQS, excluding Cover Letter to NDEP 

and Clark County Air Quality Regulations.

Clark County .......................... 7/23/2012 [Insert Federal Register 

page number where the 

document begins] 03/21/

2014.

‘‘Infrastructure’’ SIP for Clark 

County for the 2008 Pb 

standard. 

* * * * * * * 

■ 3. Section 52.1472 is amended by 

adding paragraph (g) to read as follows: 

§ 52.1472 Approval status. 

* * * * * 

(g) 2008 Pb NAAQS: The SIPs 

submitted on October 12, 2011, July 23, 

2012, and August 30, 2012 are partially 

disapproved for Clean Air Act (CAA) 

elements 110(a)(2)(C), (D)(i)(II), and (J) 

for the Nevada Division of 

Environmental Quality (NDEP), Clark 

County, and Washoe County portions of 

the Nevada SIP; for CAA element (D)(ii) 

for the NDEP and Washoe County 

portions of the Nevada SIP; and for CAA 

element 110(a)(2)(F)(iii) for the Clark 

County portion of the Nevada SIP. 

[FR Doc. 2014–06053 Filed 3–20–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0012; FRL–9907–41] 

Heat-killed Burkholderia spp. Strain 

A396 Cells and Spent Fermentation 

Media; 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 heat-killed 

Burkholderia spp. strain A396 cells and 

spent fermentation media in or on all 

food commodities when applied as a 

biological insecticide to agricultural 

crops and used in accordance with label 

directions and good agricultural 

practices. Marrone Bio Innovations, Inc., 

submitted a petition to the EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) requesting an exemption 

from the requirement of a tolerance. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of heat-killed Burkholderia 

spp. strain A396 cells and spent 

fermentation media under FFDCA. 

DATES: This regulation is effective 

March 21, 2014. Objections and requests 

for hearings must be received on or 

before May 20, 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–2011–0012, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

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Federal Register / Vol. 79, No. 55 / Friday, March 21, 2014 / Rules and Regulations 15703 

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: 

Michael Glikes, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6231; email address: 

glikes.michael@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(g), 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 the EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0012 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before May 20, 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– 

2011–0012, 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. Background 

In the Federal Register of February 

25, 2011 (76 FR 10587) (FRL–8863–4), 

EPA issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

tolerance petition (PP 0F7778) by 

Marrone Bio Innovations, Inc. 2121 

Second Street, Suite B–107, Davis, CA 

95618. The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of Burkholderia spp. strain A396. 

Subsequently, the applicant modified its 

manufacturing process and changed the 

active ingredient from a live microbe to 

one that is inactivated by applying high 

temperatures during the production of 

the manufacturing product. Hence, the 

active ingredient in the end-use product 

applied to crops is ‘‘heat-killed.’’ The 

notice referenced a summary of the 

petition prepared by the petitioner, 

Marrone Bio Innovations Inc., which is 

available in the docket via http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Final Rule 

A The EPA’s Safety Determination 

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 exemption is ‘‘safe.’’ 

Section 408(c)(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.’’ Pursuant to 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance exemption 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. . . .’’ Additionally, 

FFDCA section 408(b)(2)(D) requires 

that EPA consider ‘‘available 

information concerning the cumulative 

effects of [a particular pesticide’s] . . . 

residues and other substances that have 

a common mechanism of toxicity.’’ 

EPA evaluated the available toxicity 

and exposure data on heat-killed 

Burkholderia spp. strain A396 cells and 

spent fermentation media and 

considered its validity, completeness, 

and reliability, as well as the 

relationship of this information to 

human risk. Based upon that evaluation, 

EPA concludes that there is a reasonable 

certainty that no harm will result to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of heat-killed Burkholderia 

spp. strain A396 cells and spent 

fermentation media. Therefore, an 

exemption from the requirement of a 

tolerance is established for residues of 

heat-killed Burkholderia spp. strain 

A396 cells and spent fermentation 

media in or on all food commodities 

when applied to elicit induced systemic 

resistance in plants and used in 

accordance with label directions and 

good agricultural practices. A full 

explanation of the data upon which EPA 

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15704 Federal Register / Vol. 79, No. 55 / Friday, March 21, 2014 / Rules and Regulations 

relied and its risk assessment based on 

that data can be found within the 

February 28, 2014 document entitled 

‘‘Federal Food, Drug, and Cosmetic Act 

(FFDCA) Considerations for Heat-killed 

Burkholderia spp. strain A396 cells and 

spent fermentation media.’’ This 

document, as well as other relevant 

information, is available in the docket 

for this action as described under 

ADDRESSES. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons stated above and in the 

aforementioned February 28, 2014 

document, and because EPA is 

establishing an exemption from the 

requirement of a tolerance without any 

numerical limitation. 

C. 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. In this context, 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 Nations 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 heat-killed Burkholderia spp. strain 

A396 cells and spent fermentation 

media. 

IV. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

exemption under FFDCA section 408(d) 

in response to a petition submitted to 

EPA. 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 exemption 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. 

As a result, this action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

EPA 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, EPA 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 

EPA 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). 

V. 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: February 28, 2014. 

Steve Bradbury, 

Director, 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. Add § 180.1325 to subpart D to read 

as follows: 

§ 180.1325 Heat-killed Burkholderia spp. 

strain A396 cells and spent fermentation 

media exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of heat-killed Burkholderia spp. strain 

A396 cells and spent fermentation 

media in or on all food commodities 

when applied as a biological insecticide 

to agricultural crops and used in 

accordance with label directions and 

good agricultural practices. 

[FR Doc. 2014–06228 Filed 3–20–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 1 

[Docket No. DOT–OST–2012–0123] 

RIN 2105–AE28 

Organization and Delegation of Powers 

and Duties 

AGENCY: Office of the Secretary of 

Transportation (OST), U.S. Department 

of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: The Secretary of 

Transportation is authorized to delegate 

functions, powers, and duties as the 

Secretary deems appropriate. This rule 

amends the existing delegations of 

authority by relocating the delegations 

to the Inspector General currently found 

in the Department’s regulations on the 

Freedom of Information Act and 

updates the delegation of authority to 

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