59906 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 

when applied as an insecticide or 

miticide and used in accordance with 

good agricultural practices. 

[FR Doc. 2011–24990 Filed 9–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0849; FRL–8889–1] 

Fluazifop-P-butyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

and increases tolerances for residues of 

fluazifop-P-butyl in or on cotton, gin 

byproducts; cotton, refined oil; and 

cotton, undelinted seed. Syngenta Crop 

Protection requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 28, 2011. Objections and 

requests for hearings must be received 

on or before November 28, 2011, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0849. 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 Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn V. Montague, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–1243; e-mail 

address: montague.kathryn@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 those engaged in the 

following activities: 

• 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 to provide 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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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, 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–2010–0849 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 November 28, 2011. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0849, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of December 

15, 2010 (75 FR 78240) (FRL–8853–1), 

EPA issued a notice pursuant to section 

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

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

pesticide petition (PP 0F7768) by 

Syngenta Crop Protection, P.O. Box 

18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.411 

be amended by establishing tolerances 

for residues of the herbicide, fluazifopP-butyl, butyl(R)-2-[4-[[5- 

(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoate, and 

the free and conjugated forms of the 

resolved isomer of fluazifop, (R)-2-[4- 

[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoic acid, 

expressed as fluazifop, in or on cotton, 

undelinted seed at 0.9 ppm; and cotton, 

gin byproducts at 0.8 ppm. That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition EPA has made 

changes to the requested tolerances. 

First, EPA is raising the proposed 

cotton, gin byproducts tolerance from 

0.8 ppm to 1.5 ppm; second, raising the 

established cotton, refined oil tolerance 

from 0.2 ppm to 1.3 ppm; and finally, 


emcdonald on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 59907 

raising the proposed cotton, undelinted 

seed tolerance from 0.9 ppm to 1.0 ppm. 

EPA also retains the current tolerance 

expression for fluazifop-P-butyl that was 

established in 40 CFR 180.411 

paragraph (a) in the Federal Register of 

February 2, 2011 (76 FR 5696) (FRL– 

8861–1). The reason for these changes 

are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(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. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance 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. * * *’’ 

In the Federal Register of February 2, 

2011 EPA issued a final rule 

establishing a tolerance for residues of 

fluazifop-P-butyl in or on banana; beet, 

sugar; citrus, fruit, group 10; grape and 

potato. EPA has determined that 

establishing revised tolerances for 

cotton commodities will not 

significantly change the risk 

assessments the Agency relied on to 

support the February 2, 2011, tolerance 

action, as explained in this unit. 

Cotton commodities (undelinted seed, 

gin byproducts, meal, and hulls) may be 

used as roughage or protein concentrate 

feedstuffs in the diets of livestock. 

When the Agency conducted the risk 

assessment in support of the February 2, 

2011 tolerance action, it considered 

secondary residues of fluazifop-P-butyl 

in livestock commodities from 

consumption of fluazifop-P-butyl 

treated feed. In calculating livestock 

dietary burdens for fluazifop-P-butyl, 

EPA assumed that 100% of feed items 

consumed by livestock are treated with 

fluazifop-P-butyl. EPA also assumed 

residues were present in the roughage 

and protein concentrate components of 

livestock diets at the tolerance level for 

soybean feedstuffs of 2.5 parts per 

million (ppm) which is greater than the 

tolerances being established for cotton 

feedstuffs. Therefore, the Agency has 

determined that the establishment of a 

tolerance on the feed commodity cotton, 

gin byproducts at 1.5 ppm and raising 

the cotton, undelinted seed tolerance 

from 0.1 ppm to 1.0 ppm will not 

increase residues of fluazifop-P-butyl in 

livestock feed commodities above those 

calculated in the previous risk 

assessment conducted for the February 

2, 2011 tolerance action. 

The only human food item affected by 

this action is cotton, refined oil. This 

commodity was included in the most 

recent acute and chronic dietary 

exposure assessment for the February 2, 

2011 tolerance action at the level of 0.2 

ppm using the food consumption data 

from the USDA 1994–1996 and 1998 

Continuing Surveys of Food Intake by 

Individuals (CSFII). EPA conducted 

additional calculations using the 

increased level of 1.3 ppm for cotton, 

refined oil to determine if any increase 

in dietary exposure results. For both 

acute and chronic analyses, identical 

results were obtained to three 

significant figures. EPA typically reports 

dietary exposures as a percentage of the 

population adjusted dose (PAD) to just 

two significant figures. Therefore, EPA 

concludes that no significant increase in 

human dietary exposure resulting from 

the establishment of the revised cotton 

tolerances. 

Based on these considerations, EPA 

has determined that establishing the 

tolerance for fluazifop-P-butyl in cotton, 

gin byproducts at 1.5 ppm, raising the 

established cotton, refined oil from 0.2 

ppm to 1.3 ppm and raising the cotton, 

undelinted seed tolerance from 0.1 ppm 

to 1.0 ppm will not affect the estimated 

livestock dietary burden and will not 

change the estimated aggregate risks 

resulting from use of fluazifop-P-butyl, 

as discussed in the February 2, 2011 

Federal Register. Refer to the Federal 

Register document, available at http:// 

www.regulations.gov, for a detailed 

discussion of the aggregate risk 

assessment and determination of safety. 

Therefore, based on this information 

and the findings in the final rule 

published in the Federal Register of 

February 2, 2011, EPA concludes that 

there is a reasonable certainty that no 

harm will result to the general 

population, or to infants and children 

from aggregate exposure to fluazifop-Pbutyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(High Performance Liquid 

Chromatography/Ultra-Violet 

Spectrometry (HPLC/UV)) is available to 

enforce the tolerance expression. The 

method is available in Pesticide 

Analytical Methods (PAM), Volume II or 

may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

e-mail address: 

residuemethods@epa.gov. 

B. 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 Alimentarius is a joint U.N. 

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 fluazifop-P-butyl. 

C. Revisions to Petitioned-for Tolerances 

EPA has revised the proposed 

tolerances levels. Based on the 

submitted cotton undelinted seed and 

gin byproducts data, EPA calculated 

that the cotton, gin byproducts tolerance 

should be 1.5 ppm; cotton, refined oil 

tolerance should be 1.3 ppm, and 

cotton, undelinted seed tolerance 

should be 1.0 ppm. 

Also, EPA is retaining the current 

tolerance expression for fluazifop-Pbutyl. The current tolerance expression 

makes clear that the tolerances cover 

residues of the herbicide fluazifop-Pbutyl, including its metabolites and 

degradates, but that compliance with 

the tolerance levels is to be determined 

by measuring only the sum of fluazifopP-butyl, butyl(R)-2-[4-[[5- 

(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoate, and 

the free and conjugated forms of the 

resolved isomer of fluazifop, (R)-2-[4- 

[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoic acid, 

calculated as the stoichiometric 

equivalent of fluazifop, in or on the 

commodity. 


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59908 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluazifop-P-butyl, 

butyl(R)-2-[4-[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoate, and 

the free and conjugated forms of the 

resolved isomer of fluazifop, (R)-2-[4- 

[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoic acid, 

expressed as fluazifop, in or on cotton, 

gin byproducts; cotton, refined oil; and 

cotton, undelinted seed at 1.5 ppm, 1.3 

ppm and 1.0 ppm, respectively. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 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 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) (Pub. L. 104–4). 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), 

Public Law 104–113, section 12(d) (15 

U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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 15, 2011. 

Daniel J. Rosenblatt, 

Acting 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. Section 180.411, paragraph (a), the 

table is amended by: 

■ i. Revising the entries for ‘‘cotton, 

refined oil’’ and ‘‘cotton, undelinted 

seed’’; and 

■ ii. Adding the entry for ‘‘cotton, gin 

byproducts’’ to the table in paragraph (a) 

■ iii. The amendments read as follows: 

§ 180.411 Fluazifop-P-butyl; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

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

Cotton, refined oil ..................... 1.3 

Cotton, undelinted seed ........... 1.0 

* * * * * 

* * * * * 

[FR Doc. 2011–24517 Filed 9–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0888; FRL–8888–3] 

Chlorantraniliprole; Pesticide 

Tolerances; Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; correction 

amendment. 

SUMMARY: EPA issued a final rule in the 

Federal Register of July 27, 2011, 

concerning the regulation to establish 

pesticide tolerances for residues of 

chlorantraniliprole in or on multiple 

commodities. This document is being 

issued to correct an omission of the 

tolerance for Bushberry, subgroup 13– 

07B. 

DATES: This final rule is effective 

September 28, 2011. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0888. All documents in the 

docket are listed in the docket index 

available in 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 Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 


emcdonald on DSK5VPTVN1PROD with RULES