Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Rules and Regulations 35147 

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 

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: June 3, 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 § 180.910, add to the table, after 

the entry ‘‘Propane,’’ the following inert 

ingredient to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

1,3-Propanediol (CAS Reg. No. 504–63–2) ................................... ................ Solvent, co-solvent, diluent, or freeze-point depressant. 

* * * * * * * 

■ 3. In § 180.940, add to the table in 

paragraph (a), after the entry ‘‘potassium 

iodide,’’ the following inert ingredient 

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 

* * * * * * * 

1,3-Propanediol ............................................................................................................ 504–63–2 None. 

* * * * * * * 

* * * * * 

[FR Doc. 2013–13823 Filed 6–11–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0264; FRL–9389–2] 

Bacillus pumilus Strain BU F–33; 

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 Bacillus 

pumilus strain BU F–33 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. Becker Underwood, 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 Bacillus pumilus strain 

BU F–33 under the FFDCA. 

DATES: This regulation is effective June 

12, 2013. Objections and requests for 

hearings must be received on or before 

August 12, 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–2012–0264, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 


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35148 Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Rules and Regulations 

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: 

Jeannine Kausch, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8920; email address: 

kausch.jeannine@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–2012–0264 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 August 12, 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 the EPA without 

prior notice. Submit the non-CBI copy 

of your objection or hearing request, 

identified by docket ID number EPA– 

HQ–OPP–2012–0264, 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 September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

the 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 2F7978) 

by Becker Underwood, Inc., 801 Dayton 

Ave., P.O. Box 667, Ames, IA 50010. 

The petition requested that 40 CFR part 

180 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of Bacillus 

pumilus strain BU F–33. The notice 

referenced a summary of the petition 

prepared by the petitioner, Becker 

Underwood, 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 the 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 the 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, the EPA must take into 

account the factors set forth in FFDCA 

section 408(b)(2)(C), which require the 

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 the 

EPA 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 Bacillus 

pumilus strain BU F–33 and considered 

its validity, completeness, and 

reliability, as well as the relationship of 

this information to human risk. 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 Bacillus pumilus strain BU 

F–33. Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of Bacillus pumilus strain 

BU F–33 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 the 

EPA relied and its risk assessment based 

on that data can be found within the 

May 22, 2013 document entitled 

‘‘Federal Food, Drug, and Cosmetic Act 

(FFDCA) Considerations for Bacillus 

pumilus strain BU F–33.’’ This 

document, as well as other relevant 

information, is available in the docket 


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Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Rules and Regulations 35149 

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 

document entitled ‘‘Federal Food, Drug, 

and Cosmetic Act (FFDCA) 

Considerations for Bacillus pumilus 

strain BU F–33,’’ 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, the 

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, the 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. The 

EPA may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

the EPA explain the reasons for 

departing from the Codex level. 

The Codex has not established a MRL 

for Bacillus pumilus strain BU F–33. 

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 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, 

the 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, the 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 

the EPA’s 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.), the EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 31, 2013. 

Steven 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 § 180.1322 to subpart D to read 

as follows: 

§ 180.1322 Bacillus pumilus strain BU 

F–33; exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Bacillus pumilus strain BU F–33 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. 

[FR Doc. 2013–13821 Filed 6–11–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Parts 2, 10, 13, 15, 21, 29, 80, 

84, 85, and 100 

[Docket No. FWS–HQ–BPHR–2012–0089; 

FXGO16600954000–134–FF09B30000] 

RIN 1018–AY13 

Addresses of Regional Offices 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Final rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), are updating 

the names and addresses of our regional 

offices in our regulations at title 50 of 

the Code of Federal Regulations. We are 

also making other revisions to our 

regulations, such as updating the names 

and phone numbers of certain other 

Service offices. We are taking these 

actions to ensure regulated entities and 

the general public have accurate contact 

information for the Service’s offices. 

DATES: This rule is effective June 12, 

2013. 

ADDRESSES: This final rule is available 

on the Internet at http:// 

www.regulations.gov under Docket No. 

FWS–HQ–BPHR–2012–0089. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Brown, 703–358–2179. 


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