Federal Register / Vol. 79, No. 190 / Wednesday, October 1, 2014 / Rules and Regulations 59119 

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). 

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: September 24, 2014. 

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 § 180.609, add alphabetically 

‘‘melon subgroup 9A’’; ‘‘sorghum, grain, 

forage’’; ‘‘sorghum, grain, grain’’; and 

‘‘sorghum, grain, stover’’ to the table in 

paragraph (a)(1) as follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Melon subgroup 9A .................. 1.5 

* * * * * 

Sorghum, grain, forage ............. 5.0 

Sorghum, grain, grain ............... 1.5 

Sorghum, grain, stover ............. 5.0 

* * * * * 

* * * * * 

[FR Doc. 2014–23398 Filed 9–30–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0277; FRL–9916–44] 

Tetraacetylethylenediamine and Its 

Metabolite, Diacetylethylenediamine; 

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 

tetraacetylethylenediamine (TAED), and 

its metabolite, diacetylethylenediamine 

(DAED), when used as a fungicide and 

a bactericide on rice and strawberries. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of TAED and DAED under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

October 1, 2014. Objections and 

requests for hearings must be received 

on or before December 1, 2014, 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–2013–0277, 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 Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 


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59120 Federal Register / Vol. 79, No. 190 / Wednesday, October 1, 2014 / Rules and Regulations 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, 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–2013–0277 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 December 1, 2014. 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– 

2013–0277, 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 October 25, 

2013 (78 FR 63938) (FRL–9901–96), 

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 3F8148) 

by Technology Sciences Group, Inc. 

(TSG) (the Petitioner), on behalf of AgriNeo, Inc., 3485 Ashby Saint-Laurent 

(Quebec), H4R 2K3, Canada. The 

petition requested that 40 CFR part 180 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of TAED and its 

metabolite, DAED in or on all food 

commodities. That document referenced 

a summary of the petition prepared by 

the Petitioner, TSG, which is available 

in the docket, http://

www.regulations.gov. There were no 

comments received on the notice of 

filing. 

Based upon the review of the data 

supporting the petition, EPA is 

establishing a tolerance exemption on 

rice and strawberries rather than all 

food commodities as requested. 

III. Final Rule 

A. The 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.’’ 

The EPA evaluated the available 

toxicity and exposure data on TAED and 

its metabolite, DAED 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 the 

EPA relied and its risk assessment based 

on that data can be found within the 

August 29, 2014 document entitled 

‘‘Federal Food, Drug, and Cosmetic Act 

(FFDCA) Considerations for 

Tetraacetylethylenediamine (TAED) and 

its metabolite Diacetylethylenediamine 

(DAED).’’ This document, as well as 

other relevant information, is available 

in the docket for this action as described 

under ADDRESSES. 

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 TAED and its metabolite, 

DAED. Therefore, an exemption from 

the requirement of a tolerance is 

established for residues of TAED and its 

metabolite, DAED when used as a 

fungicide and a bactericide on rice and 

strawberries. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. The 

Agency believes that an analytical 

enforcement method is not required for 

a tolerance exemption on rice and 

strawberries and there are no risk 

concerns for these crops. Further, 

residues are not expected on any other 

crops because rice is typically grown in 

areas that are not near or next to other 

crops. Additionally, the early planting 

of strawberries versus other like crops 

and the use of buffers limits the 

potential for residues of the pesticide on 

crops that may be near. 

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), as 

required by FFDCA section 408(b)(4). 

The Codex 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 TAED and its metabolite, DAED. 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 79, No. 190 / Wednesday, October 1, 2014 / Rules and Regulations 59121 

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 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 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, 

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). 

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: September 17, 2014. 

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 § 180.1327 to subpart D to read 

as follows: 

§ 180.1327 Tetraacetylethylenediamine 

(TAED) and its metabolite 

Diacetylethylenediamine (DAED); 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the pesticide, 

tetraacetylethylenediamine (TAED), and 

its metabolite diacetylethylenediamine 

(DAED), in or on rice and strawberries, 

when used as a fungicide and 

bactericide in accordance with label 

directions and good agricultural 

practices. 

[FR Doc. 2014–23112 Filed 9–30–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 412 

[CMS–1608–CN] 

RIN 0938–AS09 

Medicare Program; Inpatient 

Rehabilitation Facility Prospective 

Payment System for Federal Fiscal 

Year 2015; Correction 

ACTION: Final rule; Correction. 

SUMMARY: This document corrects 

technical errors that appeared in the 

final rule with comment period 

published in the Federal Register on 

August 6, 2014 entitled ‘‘Medicare 

Program; Inpatient Rehabilitation 

Facility Prospective Payment System for 

Federal Fiscal Year 2015’’ (79 FR 

45872). 

DATES: The corrections are effective 

October 1, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Gwendolyn Johnson, (410) 786–6954, 

for general information. 

Charles Padgett, (410) 786–2811, for 

information about the quality reporting 

program. 

Kadie Thomas, (410) 786–0468, or 

Susanne Seagrave, (410) 786–0044, for 

information about the payment policies 

and the proposed payment rates. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2014–18447 of August 6, 

2014 (79 FR 45872), there were a 

number of technical errors, which are 

identified and corrected in the 

‘‘Summary of Errors’’ and ‘‘Correction of 

Errors’’ sections of this correction 

document. The provisions of this 

correction document are effective as if 

they had been included in the document 

published on August 6, 2014. 

Accordingly, the corrections are 

effective October 1, 2014. 

II. Summary of Errors 

On page 45910, in Table 8: Quality 

Measures Finalized in the FY 2014 IRF 

PPS Final Rule Affecting the FY 2016 

and 2017 Adjustments to the IRF 

Annual Increase Factors and 

Subsequent Year Increase Factors, we 

inadvertently omitted the fiscal years 

affected by each of the listed quality 

measures, and therefore, are correcting 

the table. 

On page 45911, in our discussion of 

the FY 2014 IRF PPS final rule, we 

made a typographical error in 


wreier-aviles on DSK5TPTVN1PROD with RULES