50926 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

VIII. Conclusion 

Therefore, a temporary exemption is 

established for residues of PDJ when 

used on red apple varieties pre-harvest 

and in accordance with good 

agricultural practices. 

IX. References 

1. Creelman, R.A. and J.E. Mullet 

(1995) Jasmonic acid distribution and 

action in plants: Regulation during 

development and response to biotic and 

abiotic stress. Proceedings of the 

National Academies of Science, 92: 

4114-4119. 

2. EPA (2010) Environmental 

Protection Agency (EPA) Risk 

Assessment: Application for 

Experimental-Use Permit and 

Temporary Tolerance Exemption for 

FAL 1800 (Prohydrojasmon). May 18, 

2010. 

3. Mason, H.S., DeWald, D.B., 

Creelman, R.A., Mullet J.E. (1992) 

Coregulation of Soybean and Vegetative 

Storage Protein Gene Expression by 

Methyl Jasmonate and Soluble Sugars. 

Plant Physiology, 98: 859-867. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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) (Public Law 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). 

XI. 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: August 6, 2010. 

Steven Bradbury, 

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. Section 180.1299 is added to 

subpart D to read as follows: 

§ 180.1299 Prohydrojasmon; temporary 

exemption from the requirement of a 

tolerance. 

A temporary exemption from the 

requirement of a tolerance is established 

for residues of prohydrojasmon, propyl3-oxo-2-pentylcyclo-pentylacetate, 

when used on red apples varieties preharvest and when used in accordance 

with good agricultural practices and 

will expire on August 1, 2012. 

[FR Doc. 2010–20177 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0272; FRL–8837–5] 

2-propenoic acid, 2-methyl-, C12-16- 

alkyl esters, telomers with 1- 

dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated; Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 2-propenoic 

acid, 2-methyl-, C12-16-alkyl esters, 

telomers with 1-dodecanethiol, 

polyethylene-polypropylene glycol 

ether with propylene glycol 

monomethacrylate (1:1), and styrene 

2,2’-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated, number 

average molecular weight (in AMU) 

4000; when used as an inert ingredient 

in a pesticide chemical formulation 40 

CFR 180.960. Clariant Corporation 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of 2-propenoic acid, 2- 

methyl-, C12-16-alkyl esters, telomers 

with 1-dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated on food or feed commodities. 


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Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 50927 

DATES: This regulation is effective 

August 18, 2010. Objections and 

requests for hearings must be received 

on or before October 18, 2010, 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–2010–0272. 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: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; e-mail address: 

fertich.elizabeth@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. 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.gpoaccess.gov/ecfr. 

C. 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–2010–0272 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 October 18, 2010. 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–2010–0272, 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. Background and Statutory Findings 

In the Federal Register of June 8, 

2010, (75 FR 32463) (FRL–8827–5), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the receipt of a pesticide petition (PP 

0E7702) filed by Clariant Corporation, 

P.O. Box 866, 625 East Catawba Avenue, 

Mount Holly, NC 28120. The petition 

requested that 40 CFR 180.960 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of 2-propenoic acid, 2-methyl- 

, C12-16-alkyl esters, telomers with 1- 

dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated, number average molecular 

weight (in AMU) 4,000; CAS No. 

950207–35–9. That notice included a 

summary of the petition prepared by the 

petitioner and solicited comments on 

the petitioner’s request. The Agency did 

not receive any comments in response 

to this notice. 

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 

use 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 an 

exemption from the requirement of 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. . . .’’ and specifies 

factors EPA is to consider in 

establishing an exemption. 

III. Risk Assessment and Statutory 

Findings 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be shown that the 

risks from aggregate exposure to 

pesticide chemical residues under 


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50928 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

reasonably foreseeable circumstances 

will pose no appreciable risks to human 

health. In order to determine the risks 

from aggregate exposure to pesticide 

inert ingredients, the Agency considers 

the toxicity of the inert in conjunction 

with possible exposure to residues of 

the inert ingredient through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. If 

EPA is able to determine that a finite 

tolerance is not necessary to ensure that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to the inert ingredient, an 

exemption from the requirement of a 

tolerance may be established. 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. In the 

case of certain chemical substances that 

are defined as polymers, the Agency has 

established a set of criteria to identify 

categories of polymers expected to 

present minimal or no risk. The 

definition of a polymer is given in 40 

CFR 723.250(b) and the exclusion 

criteria for identifying these low-risk 

polymers are described in 40 CFR 

723.250(d). 2-propenoic acid, 2- 

methyl-, C12-16-alkyl esters, telomers 

with 1-dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated conforms to the definition of a 

polymer given in 40 CFR 723.250(b) and 

meets the following criteria that are 

used to identify low-risk polymers. 

1. The polymer is not a cationic 

polymer nor is it reasonably anticipated 

to become a cationic polymer in a 

natural aquatic environment. 

2. The polymer does contain as an 

integral part of its composition the 

atomic elements carbon, hydrogen, and 

oxygen. 

3. The polymer does not contain as an 

integral part of its composition, except 

as impurities, any element other than 

those listed in 40 CFR 723.250(d)(2)(ii). 

4. The polymer is neither designed 

nor can it be reasonably anticipated to 

substantially degrade, decompose, or 

depolymerize. 

5. The polymer is manufactured or 

imported from monomers and/or 

reactants that are already included on 

the TSCA Chemical Substance 

Inventory or manufactured under an 

applicable TSCA section 5 exemption. 

6. The polymer is not a water 

absorbing polymer with a number 

average molecular weight (MW) greater 

than or equal to 10,000 daltons. 

Additionally, the polymer also meets 

as required the following exemption 

criteria specified in 40 CFR 723.250(e). 

7. The polymer’s number average MW 

of 4,000 is greater than 1,000 and less 

than 10,000 daltons. The polymer 

contains less than 10% oligomeric 

material below MW 500 and less than 

25% oligomeric material below MW 

1,000, and the polymer does not contain 

any reactive functional groups. 

Thus, 2-propenoic acid, 2-methyl-, 

C12-16-alkyl esters, telomers with 1- 

dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated meets the criteria for a polymer 

to be considered low risk under 40 CFR 

723.250. Based on its conformance to 

the criteria in this unit, no mammalian 

toxicity is anticipated from dietary, 

inhalation, or dermal exposure to 2- 

propenoic acid, 2-methyl-, C12-16-alkyl 

esters, telomers with 1-dodecanethiol, 

polyethylene-polypropylene glycol 

ether with propylene glycol 

monomethacrylate (1:1), and styrene 

2,2’-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated. 

IV. Aggregate Exposures 

For the purposes of assessing 

potential exposure under this 

exemption, EPA considered that 2- 

propenoic acid, 2-methyl-, C12-16-alkyl 

esters, telomers with 1-dodecanethiol, 

polyethylene-polypropylene glycol 

ether with propylene glycol 

monomethacrylate (1:1), and styrene 

2,2’-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated, could be 

present in all raw and processed 

agricultural commodities and drinking 

water, and that non-occupational nondietary exposure was possible. The 

number average MW of 2-propenoic 

acid, 2-methyl-, C12-16-alkyl esters, 

telomers with 1-dodecanethiol, 

polyethylene-polypropylene glycol 

ether with propylene glycol 

monomethacrylate (1:1), and styrene 

2,2’-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated is 4,000 

daltons. Generally, a polymer of this 

size would be poorly absorbed through 

the intact gastrointestinal tract or 

through intact human skin. Since 2- 

propenoic acid, 2-methyl-, C12-16-alkyl 

esters, telomers with 1-dodecanethiol, 

polyethylene-polypropylene glycol 

ether with propylene glycol 

monomethacrylate (1:1), and styrene 

2,2’-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated conform 

to the criteria that identify a low-risk 

polymer, there are no concerns for risks 

associated with any potential exposure 

scenarios that are reasonably 

foreseeable. The Agency has determined 

that a tolerance is not necessary to 

protect the public health. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, 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.’’ 

EPA has not found 2-propenoic acid, 

2-methyl-, C12-16-alkyl esters, telomers 

with 1-dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated, to share a common mechanism 

of toxicity with any other substances, 

and 2-propenoic acid, 2-methyl-, C12- 

16-alkyl esters, telomers with 1- 

dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated, does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that 2-propenoic acid, 2- 

methyl-, C12-16-alkyl esters, telomers 

with 1-dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated, does not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Additional Safety Factor for the 

Protection of Infants and Children 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base unless 


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Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 50929 

EPA concludes that a different margin of 

safety will be safe for infants and 

children. Due to the expected low 

toxicity of 2-propenoic acid, 2-methyl-, 

C12-16-alkyl esters, telomers with 1- 

dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated, EPA has not used a safety 

factor analysis to assess the risk. For the 

same reasons the additional tenfold 

safety factor is unnecessary. 

VII. Determination of Safety 

Based on the conformance to the 

criteria used to identify a low-risk 

polymer, EPA concludes that there is a 

reasonable certainty of no harm to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of 2-propenoic acid, 2-methyl- 

, C12-16-alkyl esters, telomers with 1- 

dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated. 

VIII. Other Considerations 

A. 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. 

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 2-propenoic acid, 2-methyl-, C12-16- 

alkyl esters, telomers with 1- 

dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated. 

IX. Conclusion 

Accordingly, EPA finds that 

exempting residues of 2-propenoic acid, 

2-methyl-, C12-16-alkyl esters, telomers 

with 1-dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated, number average molecular 

weight (in AMU) 4,000 from the 

requirement of a tolerance will be safe. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 rules 

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 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). 

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, or otherwise have any unique 

impacts on local governments. 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) (Public 

Law 104–4). 

Although this action does not 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), EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low-income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. As such, to the 

extent that information is publicly 

available or was submitted in comments 

to EPA, the Agency considered whether 

groups or segments of the population, as 

a result of their location, cultural 

practices, or other factors, may have 

atypical or disproportionately high and 

adverse human health impacts or 

environmental effects from exposure to 

the pesticide discussed in this 

document, compared to the general 

population. If you received specific 

comments - consider addressing them 

here. 

XI. 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 rule in the Federal 

Register. This rule is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). 


erowe on DSK5CLS3C1PROD with RULES
50930 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 9, 2010. 

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 §180.960, the table is amended 

by adding alphabetically the following 

polymers to read as follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

*******

[2-propenoic acid, 2-methyl-, C12-16-alkyl esters, telomers with 1-dodecanethiol, poly 

ethylene-polypropylene glycol ether with propylene glycol monomethacrylate (1:1), and styrene 2,2’-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated, minimum number average 

molecular weight (in amu), 4,000 950207–35–9 

*******

[FR Doc. 2010–20297 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 258 

[EPA–R08–RCRA–2009–0621; FRL–9149–7] 

Final Determination To Approve 

Alternative Final Cover Request for the 

Lake County, Montana Landfill 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency Region VIII is making a final 

determination to approve an alternative 

final cover for the Lake County landfill, 

a municipal solid waste landfill 

(MSWLF) owned and operated by Lake 

County, Montana on the Confederated 

Salish and Kootenai Tribes’ Flathead 

Reservation in Montana. EPA is 

promulgating a site-specific rule 

proposed on February 10, 2010, that 

approves an alternative final cover for 

the Lake County, Montana landfill. 

DATES: This final rule is effective on 

August 18, 2010. The incorporation by 

reference of certain publications listed 

in this rule has been approved by the 

Director of the Federal Register on 

August 18, 2010. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–R08–RCRA–2009–0621. All 

documents in the docket are listed on 

the http://www.regulations.gov Web 

site. Although listed in the index, some 

information may not be publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically at http:// 

www.regulations.gov or in hard copy at 

the Environmental Protection Agency 

Region VIII, Montana Office, 10 West 

15th Street, Suite 3200, Helena, 

Montana. The Environmental Protection 

Agency Region VIII Montana Office is 

open from 8 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays, and is located in a secure 

building. To review docket materials at 

this location, it is recommended that the 

public make an appointment by calling 

(406) 457–5000 during normal business 

hours. 

FOR FURTHER INFORMATION CONTACT: 

Susanna Trujillo, Solid and Hazardous 

Waste Program, 8P–HW, Environmental 

Protection Agency, 1595 Wynkoop St., 

Denver, CO 80202; telephone number: 

(303) 312–7008; fax number: (303) 312– 

6341; e-mail address: 

trujillo.susanna@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. What did EPA propose? 

After completing a review of Lake 

County’s final site-specific flexibility 

application request, dated July 11, 2007, 

and March 17, 2008, and the 

amendments to that application, dated 

January 22, 2009, EPA proposed to 

approve in the Federal Register on 

February 10, 2010, (75 FR 6597) Lake 

County’s site-specific flexibility request 

to install an alternative final cover that 

varies from the final closure 

requirements of 40 Code of Federal 

Regulations (CFR) 258.60(a), but meets 

the criteria at 40 CFR 258.60(b). This 

approval would apply to the 15.4 acres 

of the landfill that have not been 

previously closed. 

B. What is a site-specific flexibility 

request? 

Under Sections 1008, 2002, 4004, and 

4010 of the Resource Conservation and 

Recovery Act of 1976 (RCRA) as 

amended by the Hazardous and Solid 

Waste Amendments of 1984 (HSWA), 

EPA established revised minimum 

Federal criteria for MSWLFs, including 

landfill location restrictions, operating 

standards, design standards and 

requirements for ground water 

monitoring, corrective action, closure 

and post-closure care, and financial 

assurance. Under RCRA Section 4005(c), 

States are required to develop permit 

programs for facilities that may receive 

household hazardous waste or waste 

from conditionally exempt small 

quantity generators, and EPA 

determines whether the program is 

adequate to ensure that facilities will 

comply with the revised criteria. 

The MSWLF criteria are at 40 CFR 

part 258. These regulations are selfimplementing and apply directly to 

owners and operators of MSWLFs. For 

many of these criteria, 40 CFR part 258 

includes a flexible performance 

standard as an alternative to the selfimplementing regulation. The flexible 

standard is not self-implementing, and 

use of the alternative standard requires 

approval by the Director of a State with 

an EPA-approved program. 

Because EPA’s approval of a State 

program does not extend to Indian 

country, owners and operators of 

MSWLF units located in Indian country 

cannot take advantage of the flexibilities 

available to those facilities subject to an 

approved State program. However, the 

EPA has the authority under Sections 

2002, 4004, and 4010 of RCRA to 

promulgate site-specific rules that may 

provide for use of alternative standards 

in Indian country. See Yankton Sioux 


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