Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 66721 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0455; FRL–9364–8] 

Metconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

tolerance for residues of metconazole in 

or on corn, sweet, stover. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 7, 2012. Objections and 

requests for hearings must be received 

on or before January 7, 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–2012–0455, 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: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; email address: 

gibson.tamue@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://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–2012–0455 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 7, 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– 

2012–0455, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 22, 

2012 (77 FR 50661) (FRL–9358–9), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1F7937) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

the tolerance in the 40 CFR 180.617 be 

amended by increasing the established 

tolerance for residues of the fungicide 

metconazole, 5-[(4-chlorophenyl)- 

methyl]-2, 2-dimethyl-1-(1H-1, 2, 4- 

triazol-1-ylmethyl) cyclopentanol, 

measured as the sum of cis- and transisomers, in or on corn, sweet, stover 

from 4.5 parts per million (ppm) to 25.0 

ppm. That document referenced a 

summary of the petition prepared by 

BASF Corporation, 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 

modified the proposed tolerance level 

by increasing the tolerance for residues 

of corn, sweet, stover to 30 ppm. The 

reason for this change is 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 


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66722 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 

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 metconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with metconazole follows. 

EPA’s analysis of the impact of the 

proposed increase of the corn stover 

tolerance will have a minimal impact on 

exposure of livestock to metconazole 

and will not change the safety 

determination EPA made for 

metconazole in tolerance rulemaking 

published in the Federal Register of 

August 17, 2011 (76 FR 50898) (FRL– 

8882–7) and the initial establishment of 

the corn stover tolerance published in 

the Federal Register of May 7, 2009, 74 

FR 21260, FRL–8408–6. In the aggregate 

risk assessment supporting those 

actions, EPA included exposure from 

previously established tolerances for 

corn and corn by-products, including 

corn stover (See Metconazole: Human 

Health Assessment for Proposed Uses 

on Tuberous and Corm Vegetables 

Subgroup 1C and Bushberry Subgroup 

13–07B, EPA Docket Number EPA–HQ– 

OPP–2010–0621). In that risk 

assessment, metconazole exposure to 

humans due to the presence of 

metconazole in animal livestock feed 

items was calculated based on the 

tolerance levels in livestock 

commodities consumed by humans 

(e.g., meat and milk). Tolerance levels in 

livestock commodities are driven by the 

tolerance levels in livestock feed items, 

taking into account the makeup of the 

livestock diet. EPA’s analysis of the 

impact of raising the corn stover 

tolerance shows that there will be no 

increase in the maximum reasonably 

balanced dietary burden for beef cattle, 

swine, or poultry but a small increase 

for diary cattle. There is no increase for 

beef cattle, swine, or poultry because 

sweet corn stover is only a significant 

feed item in dairy cattle. Although there 

is an increase in the estimated dietary 

burden of metaconazole for dairy cattle 

associated with the proposed increase in 

the corn stover tolerance, the increase is 

relatively small (less than 15 percent) 

and, based on data from a cattle feeding 

study with metaconazole, EPA has 

determined that the small increase in 

dietary burden to dairy cattle will not 

result in metaconazole residues in food 

commodities from dairy cattle that 

exceed existing tolerances. Thus, 

despite the increase in the corn stover 

tolerance, the aggregate risk assessment 

underlying the 2009 and 2011 

metconazole rulemakings, which 

assumed residue levels in food 

commodities from dairy cattle at 

existing tolerances levels, remains an 

accurate estimate of metconazole risk. 

In the August 17, 2011 and May 7, 

2009 Federal Register actions, EPA 

concluded that there is reasonably 

certainty that no harm will result to the 

general population and to infants and 

children from aggregate exposure to 

metconazole residues. That conclusion 

was based on the findings that 

metconazole did not pose either an 

acute or cancer risk and that chronic 

exposure to metconazole from food and 

water falls well below the safe exposure 

level for all population groups, 

including children 1 to 2 years old, the 

population group receiving the greatest 

exposure. Refer to the August 17, 2011 

(76 FR 50898) (FRL–8882–7), Federal 

Register document, available at http:// 

www.regulations.gov, for a detailed 

discussion of the aggregate risk 

assessments and determination of 

safety. EPA relies upon those risk 

assessments and the findings made in 

the Federal Register documents in 

support of this action. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate high performance liquid 

chromatography with tandem mass 

spectrometry (Method D0604, entitled 

‘‘The Determination of Residues of BAS 

555 F and its Metabolites in Corn and 

Cotton Matrices Using LC/MS/MS’’), 

with the German multi-residue method 

DFG S19 as a confirmatory method, is 

adequate as an enforcement method. 

Method D0604 determines metconazole 

(cis—and transisomers), 1,2,4-triazole 

(T), triazolyalanine (TA), and 

triazolylacetic acid (TAA). DFG S19 

uses gas chromatography/nitrogen 

phosphorus detection (GC/NPD) or gas 

chromatography/mass spectrometric 

detection (GC/MS). The methods 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 not established a MRL 

for metconazole on corn, sweet, stover. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the analysis of the residue 

field trial data on field corn stover and 

using the Organization for Economic 

Cooperation and Development (OECD) 

tolerance calculation procedures, the 

tolerance for sweet corn stover was 

increased. 

V. Conclusion 

Therefore, tolerances are established 

for residues of metconazole, 5-[(4- 

chlorophenyl)-methyl]-2, 2-dimethyl-1- 

(1H-1, 2, 4-triazol-1-ylmethyl) 

cyclopentanol, measured as the sum of 

cis- and transisomers, in or on corn, 

sweet, stover at 30.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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 


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Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 66723 

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). 

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: October 26, 2012. 

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. In § 180.617, revise the following 

entry in the table in paragraph (a) to 

read as follows: 

§ 180.617 Metconazole; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Corn, sweet, stover ..................... 30.0 

* * * * * 

* * * * * 

[FR Doc. 2012–27191 Filed 11–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0009; FRL–9366–6] 

Fluazinam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluazinam in 

or on melon subgroup 9A and pepper/ 

eggplant subgroup 8–10B, associated 

with pesticide petition (PP) 1E7959; and 

soybean, seed and soybean, hulls, 

associated with PP 2F7977. 

Interregional Research Project Number 4 

(IR–4) and ISK Biosciences Corporation 

requested the tolerances associated with 

PPs 1E7959 and 2F7977, respectively, 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 7, 2012. Objections and 

requests for hearings must be received 

on or before January 7, 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–2012–0009, 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

Nollen.Laura@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://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 


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