Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Rules and Regulations 66649 

55221), which were to become effective 

on November 12, 2013, are withdrawn. 

[FR Doc. 2013–26494 Filed 11–5–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0107; FRL–9399–4] 

Spirotetramat; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spirotetramat 

in or on corn, sweet, kernel plus cob 

with husks removed and persimmon 

and revises established tolerances in or 

on feijoa, papaya, and Spanish lime, 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 6, 2013. Objections and 

requests for hearings must be received 

on or before January 6, 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–2012–0107, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFNotices@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 EPA’s tolerance 

regulations at 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, 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–2012–0107 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 January 6, 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– 

2012–0107, 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. 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. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for spirotetramat 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with spirotetramat follows. 

In the Federal Register of July 17, 

2013 (78 FR 42736) (FRL–9391–6), the 

EPA proposed, on its own initiative 

under FFDCA section 408(e), 21 U.S.C. 

346a(e), to establish a tolerance for 

residues of the insecticide spirotetramat 

in or on corn, sweet kernel plus cob 

with husks removed at 1.5 parts per 

million (ppm) and persimmon at 2.5 

ppm. Additionally, EPA proposed to 

revise 40 CFR 180.641 by amending 

established tolerances in or on feijoa 

from 0.30 ppm to 2.5 ppm, papaya from 


pmangrum on DSK3VPTVN1PROD with RULES
66650 Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Rules and Regulations 

2.5 ppm to 0.40 ppm, and Spanish lime 

from 0.60 ppm to 13 ppm. The proposed 

rule referenced a recently published 

spirotetramat final rule printed in the 

Federal Register of May 15, 2013 (78 FR 

28507) (FRL–9382–8); in the risk 

assessments associated with that final 

rule, the EPA also considered these 

proposed uses. Since that time, the 

toxicity profile of spirotetramat has not 

changed, and the risk assessments that 

supported the establishment of those 

spirotetramat tolerances published in 

the May 15, 2013 Federal Register final 

rule remain valid. For a detailed 

discussion of the aggregate risk 

assessments and determination of safety 

that support these new and revised uses, 

please refer to the May 15, 2013 Federal 

Register final rule and its supporting 

documents, available at http://

www.regulations.gov. 

Therefore, EPA concludes that there is 

a reasonable certainty that no harm will 

result to the general population and to 

infants and children from aggregate 

exposure to spirotetramat residues. EPA 

relies upon the findings made in the 

May 15, 2013 Federal Register final rule 

and the underlying risk assessments in 

order to establish the new and revised 

tolerances as detailed in the July 17, 

2013 Federal Register proposed rule. 

III. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a high-performance liquid 

chromatography with tandem mass 

spectrometry (HPLC–MS/MS), is 

available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email 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 

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 established a MRL for 

spirotetramat in or on papaya at 0.4 

milligram/kilogram (mg/kg). This MRL 

is the same as the tolerance established 

for spirotetramat in or on papaya at 0.40 

ppm in the United States. There are no 

Codex MRLs established for the other 

commodities associated with this final 

rule. 

C. Response to Comments 

The EPA received one comment to the 

proposed rule which stated that no 

tolerances should be allowed for 

spirotetramat. The commenter 

expressed a general opposition to the 

use of ‘‘toxic chemicals’’ on food and 

faulted EPA for not conducting toxicity 

testing that combined spirotetramat 

with the ‘‘thousands’’ of other approved 

pesticides. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

certain pesticide chemicals should not 

be permitted in our food. However, the 

existing legal framework provided by 

FFDCA section 408 states that 

tolerances may be set when the 

pesticide meets the safety standard 

imposed by that statute. The Agency is 

required by FFDCA section 408 to 

estimate the risk of the potential 

exposure to these residues. EPA has 

concluded that there is a reasonable 

certainty that no harm will result from 

aggregate human exposure to 

spirotetramat residues from these uses. 

As far as the toxicity testing relied upon 

by EPA, testing requirements for 

pesticide tolerances have been specified 

by rulemaking after allowing for notice 

and comment by the public and peer 

review by appropriate scientific bodies. 

See 40 CFR part 158. Toxicity testing of 

a pesticide in combination with all 

other approved pesticides is neither 

required by the testing regulations nor 

practical. 

IV. Conclusion 

Therefore, tolerances are established 

for residues of spirotetramat, (cis-3-(2,5- 

dimethlyphenyl)-8-methoxy-2-oxo-1- 

azaspiro[4.5]dec-3-en-4-yl-ethyl 

carbonate) and its metabolites, cis-3- 

(2,5-dimethylphenyl)-4-hydroxy-8- 

methoxy-1-azaspiro[4.5]dec-3-en-2-one, 

cis-3-(2,5-dimethylphenyl)-3-hydroxy-8- 

methoxy-1-azaspiro[4.5]decane-2,4- 

dione, cis-3-(2,5-dimethylphenyl)-8- 

methoxy-2-oxo-1-azaspiro[4.5]dec-3-en4-yl beta-D-glucopyranoside-, and cis-3- 

(2,5-dimethylphenyl)-4-hydroxy-8- 

methoxy-1-azaspiro[4.5]decan-2-one, 

calculated as the stoichiometric 

equivalent of spirotetramat, in or on 

corn, sweet, kernel plus cob with husks 

removed at 1.5 ppm; and persimmon at 

2.5 ppm. Additionally, the regulation 

amends established tolerances in or on 

feijoa from 0.30 ppm to 2.5 ppm, papaya 

from 2.5 ppm to 0.40 ppm, and Spanish 

lime from 0.60 ppm to 13 ppm. 

V. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d). 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). 

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 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Rules and Regulations 66651 

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). 

VI. 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: October 25, 2013. 

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 § 180.641, in the table in 

paragraph (a)(1): 

■ a. Add alphabetically ‘‘corn, sweet, 

kernel plus cob with husks removed’’ 

and ‘‘persimmon’’; and 

■ b. Revise the entries for ‘‘feijoa,’’ 

‘‘papaya,’’ and ‘‘Spanish lime’’. 

The additions and revisions read as 

follows: 

§ 180.641 Spirotetramat; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Corn, sweet, kernel plus cob 

with husks removed ............ 1 .5 

* * * * * 

Feijoa ...................................... 2 .5 

* * * * * 

Papaya .................................... 0 .40 

Commodity Parts per 

million 

* * * * * 

Persimmon .............................. 2 .5 

* * * * * 

Spanish lime ........................... 13 

* * * * * 

* * * * * 

[FR Doc. 2013–26643 Filed 11–5–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0583; FRL–9401–9] 

Imazapyr; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of imazapyr in or 

on lentil at 0.2 parts per million (ppm); 

and rapeseed subgroup 20A and 

sunflower subgroup 20B at 0.05 ppm. 

BASF Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 6, 2013. Objections and 

requests for hearings must be received 

on or before January 6, 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–2012–0583, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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 EPA’s tolerance 

regulations at 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, 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–2012–0583 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 January 6, 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 


pmangrum on DSK3VPTVN1PROD with RULES