Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 9215 

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). 

VII. 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 10, 2015. 

Susan Lewis, 

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 § 180.464, add alphabetically the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.464 Dimethenamid; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Cotton, gin byproducts ......... 1.5 

Cottonseed subgroup 20C ... 0.01 

* * * * * 

* * * * * 

[FR Doc. 2015–03458 Filed 2–19–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0574; FRL–9920–62] 

Bacillus Subtilis Strain IAB/BS03; 

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 the fungicide 

Bacillus subtilis strain IAB/BS03 in or 

on all food commodities when used in 

accordance with label directions and 

good agricultural practices. 

Investigaciones y Aplicaciones 

Biotechnologicas (IAB, S.L.) 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 Bacillus subtilis strain 

IAB/BS03. 

DATES: This regulation is effective 

February 20, 2015. Objections and 

requests for hearings must be received 

on or before April 21, 2015, 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–2013–0574 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 Publishing 

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–2013–0574 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 April 21, 2015. 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 


Rmajette on DSK2VPTVN1PROD with RULES
9216 Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0574, 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. Background and Statutory Findings 

In the Federal Register of September 

12, 2013 (78 FR 56185) (FRL–9399–7), 

EPA issued a document pursuant to 

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

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 3F8177) 

by IAB, S.L. (Investigaciones y 

Aplicaciones Biotecnologicas S.L.), 

Avda, Paret del Patriarca 11–B, Ap. 30, 

46113 Moncada (Valencia) Spain. The 

petition requested that 40 CFR part 180 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of Bacillus subtilis 

strain IAB/BS03. That document 

referenced a summary of the petition 

prepared by the petitioner IAB, S.L., at 

http://www.regulations.gov which was 

not available in the docket due to an 

administrative error. 

In the Federal Register of December 3, 

2014 (79 FR 71713) (FRL–9919–58), 

EPA reopened the comment period on 

this petition (PP 3F8177) for 30 days to 

allow comments on the petition. Two 

comments received in response to the 

notice of filing. EPA’s response is 

located in Unit III. D. 

III. Final Rule 

A. 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.’’ 

Consistent with FFDCA section 

408(b)(2)(D), 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 to 

Bacillus subtilis strain IAB/BS03. EPA 

has evaluated the available toxicity data 

and considered its 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. A full explanation 

of the data upon which EPA relied and 

a summary of its risk assessment based 

on that data can be found within 

October 15, 2014 document entitled 

‘‘Federal Food, Drug, and Cosmetic Act 

(FFDCA) Considerations for Bacillus 

subtilis strain IAB/BS03.’’ This 

document, as well as other relevant 

information, is available in the docket 

for this action as described under 

ADDRESSES. 

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 Bacillus subtilis strain IAB/ 

BS03. Therefore, EPA is establishing an 

exemption from the requirement of a 

tolerance for residues of Bacillus subtilis 

strain IAB/BS03 in or on all food 

commodities when used in accordance 

with label directions and good 

agricultural practices. 

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 Bacillus subtilis strain IAB/BS03’’ 

and because the Agency 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), 

which is a joint United Nations Food 

and Agriculture Organization/World 

Health Organization food standards 

program, and it is recognized as an 

international food safety standardssetting organization in trade agreements 

to which the United States is a party. 

The Codex has not established a MRL 

for Bacillus subtilis strain IAB/BS03. 

D. Response to Comments 

Two general comments were filed 

opposing the establishment of any 

tolerance or exemption. The Agency 

recognizes that some individuals believe 

that no residue of pesticides should be 

allowed on foods; however, under the 

existing legal framework provided by 

section 408 of the Federal Food, Drug 

and Cosmetic Act (FFDCA), EPA is 

authorized to establish pesticide 

tolerances or exemptions where persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

the statute. Based on the available 

information, EPA has determined that 

the use of Bacillus subtilis strain IAB/

BS03 is safe. 

IV. Statutory and Executive Order 

Reviews 

This action 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 action has been exempted from 

review under Executive Order 12866, 

this action is not subject to Executive 


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Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 9217 

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 action 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 action 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 action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (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 

(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 4, 2015. 

Jack E. Housenger, 

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 § 180.1329 to subpart D to read 

as follows: 

§ 180.1329 Bacillus subtilis strain IAB/

BS03, exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Bacillus subtilis strain IAB/BS03 in or 

on all food commodities when used in 

accordance with label directions and 

good agricultural practices. 

[FR Doc. 2015–03465 Filed 2–19–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Pipeline and Hazardous Materials 

Safety Administration 

49 CFR Parts 171, 172, 173, and 175 

[Docket No. PHMSA–2009–0095 (HM–224F)] 

RIN 2137–AE44 

Hazardous Materials: Transportation of 

Lithium Batteries 

AGENCY: Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA), DOT. 

ACTION: Final rule; extension of 

compliance date. 

SUMMARY: PHMSA is extending for 

modes of transportation other than air 

the mandatory compliance date of a 

final rule published on August 6, 2014, 

under Docket No. HM–224F from 

February 6, 2015, until August 7, 2015. 

This extension is made in response to 

formal comments received from 

multiple stakeholders outlining 

challenges faced by the regulated 

community in fully implementing the 

provisions of the final rule by the 

February 6, 2015 mandatory compliance 

date. 

DATES: The compliance date for the final 

rule published August 6, 2014, at 79 FR 

46012, is extended until August 7, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Vincent Babich or Steven Webb 

Standards and Rulemaking Division, 

Pipeline and Hazardous Materials Safety 

Administration, telephone (202) 366– 

8553. 

SUPPLEMENTARY INFORMATION: On August 

6, 2014 [79 FR 46012], PHMSA in 

consultation with the Federal Aviation 

Administration (FAA) published a final 

rule under Docket No. PHMSA–2009– 

0095 (HM–224F) modifying 

requirements governing the 

transportation of lithium cells and 

batteries. The final rule revised hazard 

communication and packaging 

provisions for lithium batteries to 

harmonize the Hazardous Materials 

Regulations (HMR; CFR parts 171–180) 

with applicable provisions of the United 

Nations (UN) Model Regulations, the 

International Civil Aviation 

Organization’s Technical Instructions 

for the Safe Transport of Dangerous 

Goods by Air (ICAO Technical 

Instructions) and the International 

Maritime Dangerous Goods (IMDG) 

Code. In the August 6, 2014 final rule, 

PHMSA authorized a mandatory 

compliance date of February 6, 2015 (six 

months after publication in the Federal 

Register) for shippers to incorporate the 

new requirements into standard 

operating procedures and complete 

training of affected personnel. 

The Retail Industry Leaders 

Association, the Food Marketing 

Institute, the National Retail Federation, 

and the Rechargeable Battery 

Association submitted a joint request for 

an extension of six months to the 

current mandatory compliance date. 

These groups contend that the six 

month transitional period adopted in 

the final rule did not provide sufficient 

time to comply with the new 

requirements and has proven extremely 

challenging for the retail industry to 

implement in particular for surface 

transportation. The request notes that 

‘‘generally, the new regulations require 

that domestic ground shipments of 

products with lithium batteries adhere 

to shipping standards previously only 

required for international air and sea 

transportation’’. The groups further note 

that the detailed information necessary 

for compliance, such as the specific 


Rmajette on DSK2VPTVN1PROD with RULES