60748 Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Rules and Regulations 

Coast Guard commissioned, warrant or 

petty officer who has been designated 

by the COTP to act on the COTP’s 

behalf. The on-scene representative may 

be on a Coast Guard vessel; Maine State 

Police, Maine Marine Patrol or other 

designated craft; or may be on shore and 

communicating with vessels via VHF– 

FM radio or loudhailer. Members of the 

Coast Guard Auxiliary may be present to 

inform vessel operators of this 

regulation. 

(6) All other relevant regulations, 

including but not limited to the Rules of 

the Road (33 CFR chapter I, subchapter 

E) remain in effect within the regulated 

area and must be strictly followed at all 

times. 

(c) Effective and enforcement period. 

This regulation is effective and 

enforceable 24 hours a day from 12:01 

a.m. on September 19, 2014, until 11:59 

p.m. on April 30, 2017. 

(1) Prior to commencing or 

suspending enforcement of this 

regulation, the COTP will give notice by 

appropriate means to inform the 

affected segments of the public, to 

include dates and times. Such means of 

notification will include, but are not 

limited to, Broadcast Notice to Mariners, 

Local Notice to Mariners, and other 

means described in 33 CFR 165.7. 

(2) Violations of this RNA may be 

reported to the COTP at (207) 767–0303 

or on VHF-Channel 16. 

Dated: September 19, 2014. 

V.B. Gifford, 

Captain, U.S. Coast Guard, Acting 

Commander, First Coast Guard District. 

[FR Doc. 2014–24080 Filed 10–7–14; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0569; FRL–9916–13] 

Pseudomonas Fluorescens Strain D7; 

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 Pseudomonas 

fluorescens strain D7 in or on all food 

commodities when used in accordance 

with label directions and good 

agricultural practices. Ag-Chem 

Consulting, agent for Northwest 

Agricultural Products submitted a 

petition to 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 Pseudomonas 

fluorescens strain D7 under FFDCA. 

DATES: This regulation is effective 

October 8, 2014. Objections and 

requests for hearings must be received 

on or before December 8, 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–2013–0569, 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), West William 

Jefferson Clinton 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: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

BPPDFRNotices@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 EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0569 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 December 8, 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– 

2013–0569, 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. 


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Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Rules and Regulations 60749 

II. Background and Statutory Findings 

In the Federal Register of September 

12, 2013 (78 FR 56185) (FRL–9399–7), 

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 2F8103) by 

Northwest Agricultural Products, 821 

South Chestnut Ave., Pasco, WA 99301. 

The petition requested that 40 CFR part 

180 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of Pseudomonas 

fluorescens strain D7 in or on growing 

crops and rangeland. That notice 

referenced a summary of the petition 

prepared by the petitioner Ag-Chem 

Consulting as agent for Northwest 

Agricultural Products, which is 

available in the docket via http://

www.regulations.gov. No relevant 

comments were 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.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. 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 or 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 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.’’ 

The EPA evaluated the available 

toxicity and exposure data on 

Pseudomonas fluorescens strain D7 and 

considered its validity, completeness, 

and reliability, as well as the 

relationship of this information to 

human risk. A full explanation of the 

data upon which the EPA relied and its 

risk assessment based on that data can 

be found within the August 22, 2014 

document entitled, ‘‘Federal Food, Drug, 

and Cosmetic Act (FFDCA) 

Considerations for Pseudomonas 

fluorescens strain D7.’’ This document, 

as well as other relevant information, is 

available in the docket for this action as 

described under ADDRESSES. 

Based upon that evaluation, the 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 Pseudomonas fluorescens 

strain D7. Therefore, an exemption from 

the requirement of a tolerance is 

established for residues of Pseudomonas 

fluorescens strain D7 in or on all food 

commodities when used in accordance 

with label directions and good 

agricultural practices. 

EPA notes that although the petitioner 

requested an exemption from the 

requirement of a tolerance for residues 

of Pseudomonas fluorescens strain D7 

in or on ‘‘growing crops and rangeland,’’ 

neither of those terms is a recognized 

food commodity term used by the 

Agency in the establishment of 

tolerances. Nevertheless, the Agency 

considers the term ‘‘growing crops’’ to 

be quite broad, without limitations to 

the types of food commodities that it 

might cover and thus, is establishing a 

tolerance using the commodity 

terminology of ‘‘all food commodities’’ 

instead. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons contained in the document 

entitled, ‘‘Federal Food, Drug, and 

Cosmetic Act (FFDCA) Considerations 

for Pseudomonas fluorescens strain 

D7,’’ and because the 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. 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 Pseudomonas fluorescens strain D7. 

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 

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 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, 

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 


asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER
60750 Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Rules and Regulations 

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). 

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: August 29, 2014. 

Marty Monell, 

Acting 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 § 180.1326 to subpart D to read 

as follows: 

§ 180.1326 Pseudomonas fluorescens 

strain D7; exemption from the requirement 

of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Pseudomonas fluorescens strain D7 

in or on all food commodities when 

used in accordance with label directions 

and good agricultural practices. 

[FR Doc. 2014–24028 Filed 10–7–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 194 

[EPA–HQ–OAR–2013–0684; FRL–9917–57– 

OAR] 

RIN 2060–AR60 

Criteria for the Certification and 

Recertification of the Waste Isolation 

Pilot Plant’s Compliance With the 

Disposal Regulations; Panel Closure 

Redesign 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: With this document, the U.S. 

Environmental Protection Agency (EPA, 

or the Agency) approves the U.S. 

Department of Energy’s (DOE, or the 

Department) planned change request to 

implement the Run-of-Mine Panel 

Closure System (ROMPCS) at the Waste 

Isolation Pilot Plant (WIPP) and amends 

the WIPP Compliance Criteria to allow 

an EPA-approved panel closure other 

than the currently-required Option D 

design. Technical analyses demonstrate 

that, with the modified panel closure 

design, WIPP remains in compliance 

with the 10,000 year release limits set 

by the ‘‘Environmental Standards for the 

Management and Disposal of Spent 

Nuclear Fuel, High-Level and 

Transuranic (TRU) Radioactive Waste.’’ 

The changes do not lessen the 

requirements for complying with the 

Compliance Criteria, nor do these 

changes impact the technical approach 

that the EPA will employ when 

considering any future planned changes 

to the panel closure system. Compliance 

with environmental or public health 

regulations other than the EPA’s longterm radioactive waste disposal 

regulations and WIPP Compliance 

Criteria is not addressed by today’s 

action. 

DATES: Effective October 8, 2014. 

ADDRESSES: Docket: All documents in 

the docket are listed in the 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. The EPA has established a docket 

for this action under Docket ID No. 

[EPA–HQ–OAR–2013–0684; FRL–9917– 

57–OAR]. Publicly available docket 

materials related to this action (e.g., the 

Technical Support document [TSD]) are 

available either electronically through 

www.regulations.gov, on the Agency’s 

WIPP Web site (http://www.epa.gov/

radiation/wipp) or in hard copy at the 

Air and Radiation Docket in the EPA 

Docket Center, (EPA/DC) EPA West, 

Room 3334, 1301 Constitution Ave. 

NW., Washington, DC 20004. The EPA 

Docket Center 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 Air 

and Radiation Docket is (202) 566–1742. 

In accordance with the EPA’s 

regulations at 40 CFR part 2 and in 

accordance with normal EPA docket 

procedures, if copies of any docket 

materials are requested, a reasonable fee 

may be charged for photocopying. 

FOR FURTHER INFORMATION CONTACT: Ray 

Lee or Jonathan Walsh, Radiation 

Protection Division, Mail Code 6608J, 

U.S. Environmental Protection Agency, 

1200 Pennsylvania Avenue, 

Washington, DC, 20460; telephone 

number: 202–343–9463 or 202–343– 

9238; fax number: 202–343–2305; email 

address: lee.raymond@epa.gov or 

walsh.jonathan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Preamble Acronyms and Abbreviations 

Several acronyms and terms used to 

describe components of the WIPP 

disposal system and performance 

assessment computer models are 

included in this preamble. To ease the 

reading of this preamble and for 

reference purposes, the following terms 

are defined here: 

BRAGFLO Computer model used to 

simulate brine and gas flow 

CBFO Carlsbad Field Office 

CCA Compliance Certification Application 

CCDF Complementary Cumulative 

Distribution Function 

CFR Code of Federal Regulations 

DBR Direct Brine Release 

DOE U.S. Department of Energy 

DRZ Disturbed Rock Zone 

EPA U.S. Environmental Protection Agency 

FEPs Features, Events and Processes 

LWA Land Withdrawal Act 

MSHA Mine Safety and Health 

Administration 

NMED New Mexico Environment 

Department 

OPC Ordinary Portland Cement 

PA Performance Assessment 

PABC Performance Assessment Baseline 

Calculation 

PAVT Performance Assessment Verification 

Test 

PCS Panel Closure System 

PCS–2012 Panel Closure System 2012 

Performance Assessment 

PCR Planned Change Request 

PC3R Panel Closure Redesign and 

Repository Reconfiguration Performance 

Assessment 

PMR Permit Modification Request 


asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER