Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 32155 

that some individuals believe that no 

residue of pesticides should be allowed. 

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. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for guar 

hydroxypropyltrimethylammonium 

chloride (CAS No. 71329–50–5) when 

used as an inert ingredient (thickener/ 

drift reduction agent) in pesticide 

formulations applied to growing crops. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 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: May 20, 2013. 

Lois Rossi, 

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. In § 180.920, the table is amended 

by alphabetically adding the following 

inert ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Guar hydroxypropyltrimethylammonium chloride (CAS Reg. No. 71329–50–5) ..... ............. Thickener/drift reduction agent. 

*******

[FR Doc. 2013–12782 Filed 5–28–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0441; FRL–9386–5] 

Difenzoquat; Order Revoking 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Order of revocation. 

SUMMARY: EPA is revoking all the 

tolerances for the pesticide difenzoquat. 

EPA previously required that data be 

submitted to support these tolerances 

and that notice of intent to submit that 

data be submitted to the Agency by 

March 19, 2013. No notice of intent to 

provide the required data was 

submitted. 


tkelley on DSK3SPTVN1PROD with RULES
32156 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 

DATES: This order of revocation is 

effective May 29, 2013. Objections and 

requests for hearings must be received 

on or before July 29, 2013, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.B. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0441, 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), 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: 

Joseph Nevola, Pesticide Re-Evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8037; email address: 

nevola.joseph@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 file an objection or hearing 

request? 

Under the Federal Food, Drug, and 

Cosmetic Act (FFDCA) section 408(g), 

21 U.S.C. 346a, any person may file an 

objection to any aspect of this order and 

may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this order 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–2012- 0441 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 July 29, 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 EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0441, 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. EPA’s Order to Revoke Tolerances 

A. What action is the Agency taking? 

Pursuant to FFDCA section 408(f), 

EPA determined that additional data are 

reasonably required to support the 

continuation of the tolerances for 

difenzoquat which are codified at 40 

CFR 180.369. In the Federal Register of 

December 19, 2012 (77 FR 75037) (FRL– 

9372–9), EPA issued a final data call-in 

order in follow-up to a proposed order 

which published in the Federal Register 

on July 6, 2012 (77 FR 39962) (FRL– 

9352–9). In the final data call-in order 

of December 19, 2012, EPA required the 

submission of various data to support 

the continuation of the tolerances for 

the pesticide difenzoquat. Because there 

are currently no domestic registrations 

for difenzoquat, these tolerances are 

referred to as ‘‘import tolerances.’’ 

According to the terms of the order, if 

the Agency did not receive a section 

408(f) Response Form identifying a 

person who agrees to submit the 

required data within 90 days after 

publication of the final order (March 19, 

2013), EPA would proceed to revoke the 

difenzoquat tolerances at 40 CFR 

180.369. 

Subsequent to the final data call-in 

order of December 19, 2012, EPA 

received no submissions of the ‘‘section 

408(f) Order Response’’ form within the 

required 90-day period. Therefore, in 

this order, EPA is revoking all the 

tolerances for the pesticide difenzoquat 

in 40 CFR 180.369, which includes 

tolerances for the following 

commodities: Barley, bran; barley, grain; 

barley, straw; cattle, fat; cattle, meat; 

cattle, meat byproducts; goat, fat; goat, 

meat; goat, meat byproducts; hog, fat; 

hog, meat; hog, meat byproducts; horse, 

fat; horse, meat; horse, meat byproducts; 

poultry, fat; poultry, meat; poultry, meat 

byproducts; sheep, fat; sheep, meat; 

sheep, meat byproducts; wheat, bran; 

wheat, grain; wheat, shorts; and wheat, 

straw. 

This tolerance revocation order for 

difenzoquat is subject to the objection 

and hearing procedure in FFDCA 

section 408(g)(2) but the only material 

issue in such a procedure is whether a 

submission required by the order was 

made in a timely fashion. 

B. What is the Agency’s authority for 

taking this action? 

Under FFDCA section 408(f)(2), if a 

submission required by an order issued 

pursuant to section 408(f)(1) is not 

received by the date specified in that 

order, EPA may by order published in 

the Federal Register revoke the 

tolerance that is the subject of that 

order. 

C. When do these actions become 

effective? 

As stated in the DATES section, this 

order is effective on the date of 

publication in the Federal Register. An 

order issued under FFDCA section 

408(f)(2) shall take effect upon 

publication unless the regulation or 

order specifies otherwise. However, the 

Agency may stay the effectiveness of the 

regulation or order if, after issuance of 

such regulation or order, objections are 

filed with respect to such regulation or 

order pursuant to FFDCA section 

408(g)(2). (21 U.S.C. 346a(g)(1)). 

Any commodities listed in the 

regulatory text of this document that are 

treated with the pesticides subject to 

this order, and that are in the channels 


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Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 32157 

of trade following the tolerance 

revocations, shall be subject to FFDCA 

section 408(1)(5), as established by the 

Food Quality Protection Act (FQPA). 

Under this unit, any residues of the 

pesticide in or on such food shall not 

render the food adulterated so long as it 

is shown to the satisfaction of the Food 

and Drug Administration that: 

1. The residue is present as the result 

of an application or use of the pesticide 

at a time and in a manner that was 

lawful under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA). 

2. The residue does not exceed the 

level that was authorized at the time of 

the application or use to be present on 

the food under a tolerance or exemption 

from tolerance. Evidence to show that 

food was lawfully treated may include 

records that verify the dates that the 

pesticide was applied to such food. 

III. Statutory and Executive Order 

Reviews 

This action, which revokes tolerances 

due to a failure to comply with a data 

call-in order, is in the form of an order 

and not a rule. (21 U.S.C. 346a(f)(1)(C)). 

Under the Administrative Procedure Act 

(APA), orders are expressly excluded 

from the definition of a rule. (5 U.S.C. 

551(4)). Accordingly, the regulatory 

assessment requirements imposed on a 

rulemaking do not apply to this action, 

as explained further in the following 

discussion. 

A. Executive Order 12866 and Executive 

Order 13563 

Because this order is not a ‘‘regulatory 

action’’ as that term is defined in 

Executive Order 12866, entitled 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993), this action 

is not subject to review by the Office of 

Management and Budget (OMB) under 

Executive Orders 12866 and 13563, 

entitled ‘‘Improving Regulation and 

Regulatory Review’’ (76 FR 3821, 

January 21, 2011). 

B. Paperwork Reduction Act 

This action does not impose 

additional burdens that require approval 

by OMB under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501 et 

seq.). The information collection 

activities associated with the prior order 

requesting data from any party 

interested in supporting the tolerances 

being revoked today were approved by 

OMB under OMB Control No. 2070– 

0174, and are identified by EPA ICR No. 

2288.01. Burden is defined at 5 CFR 

1320.3(b). Under the PRA, an Agency 

may not conduct or sponsor, and a 

person is not required to respond to a 

collection of information that requires 

OMB approval under PRA, unless it has 

been approved by OMB and displays a 

currently valid OMB control number. 

The OMB control numbers for EPA’s 

regulations in title 40 of the CFR, after 

appearing in the Federal Register, are 

listed in 40 CFR part 9, and included on 

the related collection instrument, or 

form, if applicable. 

C. Regulatory Flexibility Act 

Since this order is not a rule under 

the APA (5 U.S.C. 551(4)), and does 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. 

D. Unfunded Mandates Reform Act; and 

Executive Orders 13132 and 13175 

This order 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 section 

408(n)(4) of FFDCA. 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 order. In 

addition, this order 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. 1531– 

1538). 

E. Executive Orders 13045, 13211, and 

12898 

As indicated previously, this action is 

not a ‘‘regulatory action’’ as defined by 

Executive Order 12866. As a result, this 

action is not subject to Executive Order 

13045, entitled ‘‘Protection of Children 

from Environmental Health Risks and 

Safety Risks’’ (62 FR 19885, April 23, 

1997), and Executive Order 13211 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001). In addition, 

this order also does not 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). 

F. National Technology Transfer and 

Advancement Act 

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). 

IV. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., does not apply 

because this action is not a rule as that 

term is defined in 5 U.S.C. 804(3). 

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 7, 2013. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

§ 180.369 [Removed] 

■ 2. Remove § 180.369. 

[FR Doc. 2013–12595 Filed 5–28–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0461; FRL–9385–9] 

Methyl 5-(dimethylamino)-2-methyl-5- 

oxopentanoate; 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 methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate (1174627–68–9) when 

used as an inert ingredient solvent in 


tkelley on DSK3SPTVN1PROD with RULES