41346 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Proposed Rules 

costs on Tribal governments or preempt 

Tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Intergovernmental 

relations, and Reporting and 

recordkeeping requirements. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: July 3, 2012. 

James B. Martin, 

Regional Administrator, Region 8. 

[FR Doc. 2012–17141 Filed 7–12–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0524; FRL–9353–9] 

Trinexapac-ethyl; Proposed Pesticide 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: This document proposes to 

amend the existing trinexapac-ethyl 

tolerance levels for wheat, forage and 

wheat, middlings as well as change the 

commodity definition for hog, kidney. 

Additionally the EPA proposes to 

establish tolerances for residues of 

trinexapac-ethyl in or on barley, bran; 

sugarcane, molasses; and wheat, bran 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: Comments must be received on 

or before September 11, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0524 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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. 

FOR FURTHER INFORMATION CONTACT: 

Bethany Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; email address: 

benbow.bethany@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. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. This Proposal 

EPA on its own initiative, under 

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

346a(e), is proposing to amend the 

existing trinexapac-ethyl tolerances for 

wheat, forage from 1.5 to 1.0 parts per 

million (ppm) and wheat, middlings 

from 6.5 to 10.5 ppm, as well as change 

the existing commodity definition for 

‘‘hog, kidney’’ to ‘‘hog, meat byproducts’’ as these changes are needed 

to correct inadvertent typographical 

errors listed in the final rule tolerance 

table for trinexapac-ethyl that was 

published in the Federal Register on 

March 2, 2012 (77 FR 12740) (FRL– 

9337–9). 

Additionally, the Agency is proposing 

to establish tolerances for residues of 

trinexapac-ethyl in or on barley, bran at 

2.5 ppm; sugarcane, molasses at 2.5 

ppm; and wheat, bran at 6.0 ppm based 

on the following: 

The final rule for trinexapac-ethyl that 

was published in the Federal Register of 

March 2, 2012, established tolerances 

for trinexapac-ethyl residues on the raw 

agricultural commodities of barley, 

sugarcane and wheat; however, 

tolerances for certain processed 

commodities (barley, bran; sugarcane, 

molasses; and wheat, bran) were not 

established in that final rule. Though 

these processed commodity tolerances 

were not proposed in the petition 

submitted to the Agency by the 

registrant, Syngenta Crop Protection, 

Inc., EPA determined they were needed 

in conjunction with establishing the raw 

agricultural commodity tolerances on 

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Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Proposed Rules 41347 

barley, sugarcane, and wheat. The data 

submitted by Syngenta do support these 

tolerances and the tolerances were 

included in the Agency’s last dietary 

and aggregate risk assessments. EPA 

intended to establish these processed 

tolerances as part of the March 2, 2012, 

rulemaking but they were inadvertently 

left out. Accordingly, EPA is now 

proposing these tolerances on its own 

initiative. 

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. * * *’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of FFDCA section 408 and 

a complete description of the risk 

assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

Consistent with 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, 

consistent with FFDCA section 

408(b)(2), for these proposed tolerances 

for residues of trinexapac-ethyl. EPA’s 

assessment of exposures and risks 

associated with establishing these 

tolerances is as follows. 

In connection with the March 2, 2012 

final rule for trinexapac-ethyl that 

established tolerances for trinexapacethyl residues on the raw agricultural 

commodities of barley, sugarcane and 

wheat, EPA assessed not only tolerances 

for these raw commodities but 

tolerances for the following associated 

processed commodities: Trinexapacethyl on barley, bran at 2.5 ppm; 

sugarcane, molasses at 2.5 ppm; and 

wheat, bran at 6.0 ppm in the dietary 

risk assessment. ‘‘Trinexapac-ethyl: 

Acute and Chronic Dietary Exposure 

and Risk Assessment for the Proposed 

Uses on Cereal Grains, Sugarcane and 

Grasses Grown for Seed’’ (September 13, 

2011), this and other supporting 

documents for this proposal can be 

accessed at www.regulations.gov under 

docket ID number EPA–HQ–OPP–2010– 

0524. In addition, EPA assessed the risk 

of trinexapac-ethyl tolerances for wheat, 

forage and wheat, middlings at the 

levels of 1.0 ppm and 10.5 ppm, 

respectively, rather than at 1.5 ppm and 

6.5 ppm as reported in the March 2, 

2012 final rule. Despite how the risk 

assessment was conducted, EPA 

inadvertently left the barley bran, 

sugarcane molasses, and wheat bran out 

of the final rule and, by mistake, 

established the wheat forage and wheat 

middlings tolerances at the incorrect 

level. EPA also inadvertently 

established a tolerance for ‘‘hog, 

kidney’’ instead of using the standard 

Agency commodity term of ‘‘hog, meat 

by-products.’’ EPA is proposing to 

correct these errors. 

In March 2, 2012 rule and the risk 

assessment underlying the rule, EPA 

concluded that all risk estimates were 

below EPA’s level of concern. The acute 

dietary exposure estimate for females 13 

to 49 years old will only utilize 2% of 

the acute population adjusted dose 

(aPAD), which is well below the 

Agency’s level of concern (100% of the 

aPAD). Chronic exposure to trinexapacethyl from food and water will utilize 

6% of the chronic population adjusted 

dose (cPAD) for children 1 to 2 years 

old, the population group receiving the 

greatest exposure. Further, trinexapacethyl is currently registered for uses that 

could result in short- and intermediateterm residential exposures for adults, 

and the Agency has determined the 

combined food, water, and adult postapplication dermal exposures result in 

aggregate MOEs of 761 for liquid 

products and 601 for granular products. 

These MOEs are above the EPA’s level 

of concern for trinexapac-ethyl, a MOE 

of 100 or below. Finally, based on the 

lack of evidence of carcinogenicity in 

two adequate rodent carcinogenicity 

studies, trinexapac-ethyl is not expected 

to pose a cancer risk to humans. 

Therefore, since aggregate risk and 

exposure estimates do not change as a 

result of these tolerance proposals, 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 

trinexapac-ethyl residues. Refer to the 

March 2, 2012 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 document in 

support of this action. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Method GRM020.01A, which utilizes 

high performance liquid 

chromatography with triple-quadruple 

mass spectrometry) 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 not established MRLs 

for trinexapac-ethyl in or on 

commodities associated with this 

action. 

V. Conclusion 

Tolerances are proposed for residues 

of trinexapac-ethyl in or on barley, bran 

at 2.5 ppm; sugarcane, molasses at 2.5 

ppm; and wheat, bran at 6.0 ppm. The 

EPA is also proposing to amend the 

existing trinexapac-ethyl tolerances for 

wheat, forage from 1.5 to 1.0 ppm and 

wheat, middlings from 6.5 to 10.5 ppm, 

as well as change the existing 

commodity definition for ‘‘hog, kidney’’ 

to ‘‘hog, meat by-products’’. 

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41348 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Proposed Rules 

VI. Statutory and Executive Order 

Reviews 

This proposed rule establishes a 

tolerance 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 proposed rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this proposed 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). This proposed rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled ‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997). 

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). Pursuant to 

the Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that these proposed tolerances 

will not have significant negative 

economic impact on a substantial 

number of small entities. Establishing 

an a pesticide tolerance or an exemption 

from the requirement of a pesticide 

tolerance is, in effect, the removal of a 

regulatory restriction on pesticide 

residues in food and thus such an action 

will not have any negative economic 

impact on any entities, including small 

entities. In addition, the Agency has 

determined that this action will not 

have a substantial direct effect on States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This proposed 

rule directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of FFDCA section 408(n)(4). 

For these same reasons, the Agency has 

determined that this proposed rule does 

not have any ‘‘tribal implications’’ as 

described in Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

proposed rule will not have substantial 

direct effects on tribal governments, on 

the relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this proposed rule. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 5, 2012. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, it is proposed that 40 CFR 

chapter I be 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 180.662 the table in 

paragraph (a) is amended by: 

i. Revising the entry for ‘‘Hog, 

Kidney’’ to read ‘‘Hog, meatbyproducts’’, 

ii. Revising the tolerance levels for 

‘‘Wheat, forage’’ and ‘‘Wheat, 

middlings’’, and 

iii. Alphabetically adding ‘‘Barley, 

bran’’; ‘‘Sugarcane, molasses’’; and 

‘‘Wheat, bran process’’. 

The amendments read as follows: 

§ 180.662 Trinexapac-ethyl; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Barley, bran .............................. 2 .5 

* * * * * 

Hog, meat by-products ............. 0 .03 

* * * * * 

Sugarcane, molasses ............... 2 .5 

Wheat, bran process ................ 6 .0 

Wheat, forage ........................... 1 .0 

* * * * * 

Wheat, middlings ...................... 10 .5 

* * * * * 

* * * * * 

[FR Doc. 2012–17143 Filed 7–12–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 271 and 272 

[EPA–R06–RCRA–2012–0411; FRL–9694–6] 

Louisiana: Final Authorization of StateInitiated Changes and Incorporation by 

Reference of State Hazardous Waste 

Management Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: During a review of 

Louisiana’s regulations, EPA identified 

a variety of State-initiated changes to 

Louisiana’s hazardous waste program 

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