Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Rules and Regulations 75037 

AIR POLLUTION CONTROL REGULATIONS FOR SOUTH CAROLINA—Continued 

State citation Title/subject State 

effective date 

EPA 

approval date 

Federal Register notice 

Section 8–13–730 ........................................... Membership on or employment by regulatory 

agency of person associated with regulated business.

1/1/1992 8/1/2012 77 FR 45492 

* * * * * 

[FR Doc. 2012–30437 Filed 12–18–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0441; FRL–9372–9] 

Difenzoquat; Data Call-in Order for 

Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final order. 

SUMMARY: This order requires the 

submission of various data to support 

the continuation of the tolerances for 

the pesticide, difenzoquat. Pesticide 

tolerances are established under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). Following publication of this 

order, persons who are interested in the 

continuation of the difenzoquat 

tolerances must notify the Agency by 

completing and submitting the required 

section 408(f) Order Response Form 

(available in the docket) within 90 days. 

If the Agency does not receive within 90 

days after publication of the final order 

a section 408(f) Response Form 

identifying a person who agrees to 

submit the required data, EPA will 

revoke the difenzoquat tolerances. 

DATES: This final order is effective 

December 19, 2012. A section 408(f) 

Order Response Form must be received 

on or before March 19, 2013. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2012–0441. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public 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. 

Submit your section 408(f) Order 

Response Form, identified by docket 

identification (ID) number EPA–HQ– 

OPP–2012–0441, by one of the 

following methods: 

• Federal eRulemaking Portal: Follow 

the on-line instructions for submitting 

comments. 

• 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. 

FOR FURTHER INFORMATION CONTACT: 

Christina Scheltema, Pesticide Reevaluation Division (7508P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 308–2201; 

email address: 

scheltema.christina@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. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the harmonized 

test guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines,’’ which 

is listed under ‘‘Documents related to 

our mission.’’ 

II. Background 

A. What action is the agency taking? 

In this document EPA is issuing an 

order requiring the submission of 

various data to support the continuation 

of the difenzoquat tolerances at 40 CFR 

180.369, under section 408 of FFDCA, 

21 U.S.C. 346a. Difenzoquat is not 

currently registered under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), 7 U.S.C. 136 et seq. The 

last FIFRA registration for difenzoquat 

was canceled in 2010. However, 25 

FFDCA tolerances remain for residues of 

difenzoquat on the following 

commodities: Barley, cattle, goat, hog, 

horse, poultry, sheep, and wheat (40 

CFR 180.369). Because there are 

currently no domestic registrations for 

difenzoquat, these tolerances are 

referred to as ‘‘import tolerances.’’ It is 

these tolerances that are addressed by 

the Data Call-In order. 


wreier-aviles on DSK5TPTVN1PROD with 
75038 Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Rules and Regulations 

B. What is the agency’s authority for 

taking this action? 

Under section 408(f) of the FFDCA, 

EPA is authorized to require, by order, 

submission of data ‘‘reasonably required 

to support the continuation of a 

tolerance’’ when such data cannot be 

obtained under the Data Call-In 

authority of FIFRA section 3(c)(2)(B), or 

section 4 of the Toxic Substances 

Control Act (‘‘TSCA’’), 15 U.S.C. 2603. 

A FFDCA section 408 Data Call-In order 

may only be issued following 

publication of notice of the order and a 

60-day public comment provision. 

A section 408(f) Data Call-In order 

must contain the following elements: 

1. A requirement that one or more 

persons submit to EPA a notice 

identifying the person(s) who commit to 

submit the data required in the order. 

2. A description of the required data 

and the required reports connected to 

such data; 

3. An explanation of why the required 

data could not be obtained under 

section 3(c)(2)(B) of FIFRA or section 4 

of TSCA. 

4. The required submission date for 

the notice identifying one or more 

interested persons who commit to 

submit the required data and the 

required submission dates for all the 

data and reports required in the order 

(21 U.S.C. 346a(f)(1)(C)). 

EPA may by order modify or revoke 

the affected tolerances if any one of the 

following submissions is not made in a 

timely manner: 

1. A notice identifying the one or 

more interested persons who commit to 

submit the data. 

2. The data itself. 

3. The reports required under a 

section 408(f) order are not submitted by 

the date specified in the order (21 U.S.C. 

346a(f)(2)). 

C. What preliminary steps were taken by 

EPA prior to issuing this final order? 

On July 6, 2012 (77 FR 44181) (FRL– 

9352–9), EPA issued a proposed Data 

Call-In order for the pesticide 

difenzoquat in connection with 

tolerances for that pesticide under 

section 408 of the Federal Food, Drug, 

and Cosmetic Act (FFDCA), 21 U.S.C. 

346a. The proposed Data Call-In order 

included the following studies: 

• Neurotoxicity Screening Battery 

(870.6200). 

• Immunotoxicity Study (870.7800). 

• Crop Field Trials (860.1500)— 

(wheat hay, wheat forage, and barley 

hay). 

III. Summary of Public Comments 

Received and Agency Response to 

Comments 

EPA received no comments in 

response to the July 6, 2012, Federal 

Register notice announcing the 

Agency’s proposed Data Call-In order 

for difenzoquat. In addition, the Agency 

has not received any of the data 

identified in the proposed order as 

needed to support the difenzoquat 

tolerances. 

IV. Final Data Call-in Order 

Because no comments were submitted 

on the proposal and the data 

deficiencies identified in the proposed 

order remain, EPA is issuing this final 

Data Call-In order under FFDCA section 

408(f)(1)(C) for difenzoquat in the same 

form as the proposed order and for the 

reasons set forth in that proposed order. 

Specifically, this order: 

1. Requires notice of intent to submit 

data. A notice identifying the person or 

persons who commit to submit the data 

and reports in accordance with Unit 

IV.2. must be submitted to EPA if any 

person wishes to support the 

difenzoquat tolerances. The notice must 

be submitted on a section 408(f) Order 

Response Form which is available in the 

electronic docket, http:// 

www.regulations.gov, under docket ID 

number EPA–HQ–OPP–2012–0441. 

2. Establishes a deadline for 

submission of notice identifying data 

submitters. The notice described in Unit 

IV.1., identifying data submitters, must 

be submitted to and received by EPA on 

or before March 19, 2013. Instructions 

on methods for responding to this order 

(referred to in this order as a ‘‘section 

408(f) Order Response Form’’) are set 

out under the ADDRESSES section above. 

3. Describes data and reports required 

to support continuation of the 

difenzoquat tolerances, requires 

submission of those data and reports, 

and establishes deadlines for 

submission. The table in this Unit 

describes the data and reports required 

to be submitted on difenzoquat under 

this order and the deadlines for the 

submission of each study and report. 

The required submission date is 

calculated from March 19, 2013. Thus, 

for example, if EPA generally allows 12 

months to complete a study, the 

required submission date for such a 

study under this order would be 15 

months from the date of publication of 

the order in the Federal Register. 

Studies, study protocols, and reports 

should be submitted to the person listed 

under FOR FURTHER INFORMATION

CONTACT. 

TABLE—DATA AND REPORTS REQUIRED TO BE SUBMITTED ON DIFENZOQUAT

OCSPP 

harmonized guideline No. Study title Timeframe for protocol report submission 

Timeframe for data 

submission 

870.6200 ............................... Neurotoxicity Screening Battery ........................................ Not Required ....................... March 19, 2015. 

870.7800 ............................... Immunotoxicity Study ......................................................... 6 months .............................. March 19, 2014. 

860.1500 ............................... Crop Field Trials (wheat hay, wheat forage, and barley 

hay).

Not Required ....................... March 19, 2015. 

EPA provided a description of why 

the required data could not be obtained 

under section 3(c)(2)(B) of FIFRA or 

section 4 of TSCA in the proposed order 

and relies on that description in this 

final order. 

V. Failure to Submit Notice of Intent to 

Submit Data or Data and Reports 

If, by March 19, 2013 the Agency does 

not receive a section 408(f) Order 

Response Form identifying a person 

who agrees to submit the required data, 

EPA will revoke the difenzoquat 

tolerances at 40 CFR 180.369. Such 

revocation 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. 

Additional events that may be the 

basis for modification or revocation of 

difenzoquat tolerances include, but are 

not limited to the following: 

1. No person submits on the required 

schedule an acceptable protocol report 

when such report is required to be 

submitted to the Agency for review. 

2. No person submits on the required 

schedule acceptable data as required by 

the final order. 


wreier-aviles on DSK5TPTVN1PROD with 
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Rules and Regulations 75039 

VI. Statutory and Executive Order 

Reviews 

This action, which requires the 

submission of data in support of 

tolerances in accordance with FFDCA 

section 408, is in the form of an order 

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

Under the Administrative Procedures 

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: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

Because this order is not a ‘‘regulatory 

action’’ as that term is defined in 

Executive Order 12866 (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 (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 order 

requesting data from any party 

interested in supporting certain 

tolerances are already 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; 

Executive Order 13132: Federalism; and 

Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This order requests data from any 

party interested in supporting certain 

tolerances and does not impose 

obligations on any person or entity 

including 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 (64 FR 

43255, August 10, 1999) and Executive 

Order 13175 (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: Protection of 

Children From Environmental Health 

Risks and Safety Risks; Executive Order 

13211: Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use, and Executive 

Order 12898: Federal Actions To 

Address Environmental Justice in 

Minority Populations and Low Income 

Populations 

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 (62 FR 19885, April 23, 1997) and 

Executive Order 13211 (66 FR 28355, 

May 22, 2001). In addition, this order 

also does not require any special 

considerations under Executive Order 

12898 (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). 

VII. 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, Difenzoquat, 

Pesticides and pests, Reporting and 

recordkeeping requirements. 

Dated: December 12, 2012. 

Richard P. Keigwin, Jr., 

Director, Pesticide Re-evaluation Division, 

Office of Pesticide Programs. 

[FR Doc. 2012–30617 Filed 12–18–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0772; FRL–9369–5] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of propiconazole 

in or on sugarcane, cane. Syngenta Crop 

Protection, LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 19, 2012. Objections and 

requests for hearings must be received 

on or before February 19, 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–2011–0772, 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: Erin 

Malone, Registration Division (7505P), 


wreier-aviles on DSK5TPTVN1PROD with