75754 Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Rules and Regulations 

action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898 (59 FR 7629, 

February 16, 1994). 

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 168 

Environmental protection, 

Administrative practice and procedure, 

Advertising, Exports, Labeling, 

Pesticides and pests, Reporting and 

recordkeeping requirements. 

Dated: December 12, 2014. 

James Jones, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 168—[AMENDED] 

■ 1. The authority citation for part 168 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y. 

■ 2. Revise the heading for subpart D to 

part 168 to read as follows: 

Subpart D—Procedures for Exporting 

Pesticides 

■ 3. Add § 168.65 to subpart D to read 

as follows: 

§ 168.65 Applicability. 

(a) This subpart describes the labeling 

requirements applicable to pesticide 

products and devices that are intended 

solely for export from the United States 

under the provisions of FIFRA section 

17(a). 

(b) This subpart applies to all export 

pesticide products and export pesticide 

devices that are exported for any 

purpose, including research. 

(c) Export pesticide products and 

export pesticide devices are also subject 

to requirements for pesticide production 

reporting, recordkeeping and 

inspection, and purchaser 

acknowledgement provisions that can 

be found in the following parts: 

(1) Pesticide production reporting 

requirements under FIFRA section 7 are 

located in part 167 of this chapter (as 

referenced in § 168.85(b)). 

(2) Recordkeeping and inspection 

requirements under FIFRA section 8 are 

located in part 169 of this chapter (as 

referenced in § 168.85(a)). 

(3) Purchaser acknowledgement 

statement provisions under FIFRA 

section 17(a) are located in § 168.75. 

■ 4. Revise § 168.66 to read as follows: 

§ 168.66 Labeling of pesticide products 

and devices for export. 

Any label and labeling information 

requirements in §§ 168.69, 168.70, and 

168.71 that are not met fully on the 

product label attached to the immediate 

product container may be met by 

collateral labeling that is either: 

(a) Attached to the immediate product 

(container label); or 

(b) Attached to or accompanies the 

shipping container of the export 

pesticide or export device at all times 

when it is shipped or held for shipment 

in the United States. 

§ 168.68 [Removed and Reserved] 

■ 5. Remove and reserve § 168.68. 

■ 6. In § 168.69, revise paragraph (a) to 

read as follows: 

§ 168.69 Registered export pesticide 

products. 

(a) Each export pesticide product that 

is registered under FIFRA section 3 or 

FIFRA section 24(c) must bear labeling 

approved by EPA for its registration or 

collateral labeling in compliance with 

§ 168.66. 

* * * * * 

■ 7. In § 168.70, revise the introductory 

text of paragraph (b) to read as follows: 

§ 168.70 Unregistered export pesticide 

products. 

* * * * * 

(b) Each unregistered export pesticide 

product must bear labeling that 

complies with all requirements of this 

section or collateral labeling in 

compliance with § 168.66. 

* * * * * 

■ 8. In § 168.71, revise paragraph (a) to 

read as follows: 

§ 168.71 Export pesticide devices. 

(a) Each export pesticide device sold 

or distributed anywhere in the United 

States must bear labeling that complies 

with all requirements of this section or 

collateral labeling in compliance with 

§ 168.66. 

* * * * * 

[FR Doc. 2014–29787 Filed 12–18–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0761; FRL–9919–26] 

Tobacco Mild Green Mosaic 

Tobamovirus Strain U2; Amendment to 

an Exemption From the Requirement 

of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing temporary tolerance exemption 

for Tobacco mild green mosaic 

tobamovirus by establishing a 

permanent exemption from the 

requirement of a tolerance for residues 

of Tobacco mild green mosaic 

tobamovirus strain U2 in or on all 

commodities of crop groups 17 and 18 

when applied as a post-emergent 

herbicide and used in accordance with 

label directions and good agricultural 

practices. Interregional Research Project 

Number 4 (IR–4) 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 

Tobacco mild green mosaic tobamovirus 

strain U2 under FFDCA. 

DATES: This regulation is effective 

December 19, 2014. Objections and 

requests for hearings must be received 

on or before February 17, 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–2013–0761, 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), 


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Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Rules and Regulations 75755 

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–2013–0761 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 February 17, 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 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0761, 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 

In the Federal Register of February 

21, 2014 (79 FR 9870) (FRL–9904–98), 

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 3E8181) 

by IR–4, 500 College Rd. East, Suite 

201W, Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Tobacco mild green mosaic 

tobamovirus strain U2. That document 

referenced a summary of the petition 

prepared by the petitioner IR–4, 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. 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 requires 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 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 Tobacco mild 

green mosaic tobamovirus strain U2 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 EPA relied and its risk 

assessment based on those data can be 

found within the October 30, 2014, 

document entitled ‘‘Federal Food, Drug, 

and Cosmetic Act (FFDCA) 

Considerations for Tobacco mild green 

mosaic tobamovirus strain U2.’’ This 

document, as well as other relevant 

information, is available in the docket 

for this action as described under 

ADDRESSES. Based upon its 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 Tobacco mild green mosaic 

tobamovirus strain U2. Therefore, the 

existing temporary tolerance exemption 

for Tobacco mild green mosaic 

tobamovirus is amended by establishing 

a permanent exemption from the 

requirement of a tolerance for residues 

of Tobacco mild green mosaic 

tobamovirus strain U2 in or on all 

commodities of crop groups 17 and 18 

when applied as a post-emergent 

herbicide and 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 October 30, 

2014, document entitled ‘‘Federal Food, 

Drug, and Cosmetic Act (FFDCA) 

Considerations for Tobacco mild green 

mosaic tobamovirus strain U2’’ and 

because EPA is establishing an 

exemption from the requirement of a 


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75756 Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Rules and Regulations 

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 Tobacco mild green mosaic 

tobamovirus strain U2. 

D. Revisions to Petitioned-for Tolerance 

Exemption 

In the Federal Register document of 

February 21, 2014, EPA announced IR– 

4’s filing of a pesticide petition that 

proposed establishing an exemption 

from the requirement of a tolerance for 

residues of Tobacco mild green mosaic 

tobamovirus strain U2. In 2009, EPA 

established a temporary tolerance 

exemption for Tobacco mild green 

mosaic tobamovirus (40 CFR 180.1276). 

The active ingredient described in this 

provision is the same active ingredient 

that is before EPA currently for a 

decision on a tolerance exemption 

petition, although, in accordance with 

40 CFR 158.2100(c)(2), the petitioner 

has now added a unique identifier/

strain designation after the microbe’s 

taxonomic name. Since a temporary 

tolerance exemption for Tobacco mild 

green mosaic tobamovirus already exists 

at 40 CFR 180.1276, EPA has decided to 

amend this particular section instead of 

establishing a new tolerance exemption 

section in 40 CFR part 180. With the 

presence of only one section in 40 CFR 

part 180 dedicated to tolerance 

exemptions associated with this 

microbial active ingredient and the 

replacement of a dated temporary 

tolerance exemption with a permanent 

tolerance exemption, EPA believes this 

action will, in the future, help avoid the 

potential for confusion amongst the 

regulated community and any other 

individuals interested in this action. 

IV. Statutory and Executive Order 

Reviews 

This action amends 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 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 amended on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance exemption in this action, 

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. 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 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, EPA 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 

EPA’s 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: December 11, 2014. 

Jack 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. Section 180.1276 is revised to read 

as follows: 

§ 180.1276 Tobacco mild green mosaic 

tobamovirus strain U2; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Tobacco mild green mosaic 

tobamovirus strain U2 in or on all 

commodities of crop groups 17 and 18 

when applied as a post-emergent 

herbicide and used in accordance with 

label directions and good agricultural 

practices. 

[FR Doc. 2014–29789 Filed 12–18–14; 8:45 am] 

BILLING CODE 6560–50–P 


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