Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 32157 

of trade following the tolerance 

revocations, shall be subject to FFDCA 

section 408(1)(5), as established by the 

Food Quality Protection Act (FQPA). 

Under this unit, any residues of the 

pesticide in or on such food shall not 

render the food adulterated so long as it 

is shown to the satisfaction of the Food 

and Drug Administration that: 

1. The residue is present as the result 

of an application or use of the pesticide 

at a time and in a manner that was 

lawful under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA). 

2. The residue does not exceed the 

level that was authorized at the time of 

the application or use to be present on 

the food under a tolerance or exemption 

from tolerance. Evidence to show that 

food was lawfully treated may include 

records that verify the dates that the 

pesticide was applied to such food. 

III. Statutory and Executive Order 

Reviews 

This action, which revokes tolerances 

due to a failure to comply with a data 

call-in order, is in the form of an order 

and not a rule. (21 U.S.C. 346a(f)(1)(C)). 

Under the Administrative Procedure Act 

(APA), orders are expressly excluded 

from the definition of a rule. (5 U.S.C. 

551(4)). Accordingly, the regulatory 

assessment requirements imposed on a 

rulemaking do not apply to this action, 

as explained further in the following 

discussion. 

A. Executive Order 12866 and Executive 

Order 13563 

Because this order is not a ‘‘regulatory 

action’’ as that term is defined in 

Executive Order 12866, entitled 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993), this action 

is not subject to review by the Office of 

Management and Budget (OMB) under 

Executive Orders 12866 and 13563, 

entitled ‘‘Improving Regulation and 

Regulatory Review’’ (76 FR 3821, 

January 21, 2011). 

B. Paperwork Reduction Act 

This action does not impose 

additional burdens that require approval 

by OMB under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501 et 

seq.). The information collection 

activities associated with the prior order 

requesting data from any party 

interested in supporting the tolerances 

being revoked today were approved by 

OMB under OMB Control No. 2070– 

0174, and are identified by EPA ICR No. 

2288.01. Burden is defined at 5 CFR 

1320.3(b). Under the PRA, an Agency 

may not conduct or sponsor, and a 

person is not required to respond to a 

collection of information that requires 

OMB approval under PRA, unless it has 

been approved by OMB and displays a 

currently valid OMB control number. 

The OMB control numbers for EPA’s 

regulations in title 40 of the CFR, after 

appearing in the Federal Register, are 

listed in 40 CFR part 9, and included on 

the related collection instrument, or 

form, if applicable. 

C. Regulatory Flexibility Act 

Since this order is not a rule under 

the APA (5 U.S.C. 551(4)), and does 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. 

D. Unfunded Mandates Reform Act; and 

Executive Orders 13132 and 13175 

This order 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 order. In 

addition, this order does not impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1531– 

1538). 

E. Executive Orders 13045, 13211, and 

12898 

As indicated previously, this action is 

not a ‘‘regulatory action’’ as defined by 

Executive Order 12866. As a result, this 

action is not subject to Executive Order 

13045, entitled ‘‘Protection of Children 

from Environmental Health Risks and 

Safety Risks’’ (62 FR 19885, April 23, 

1997), and Executive Order 13211 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001). In addition, 

this order also 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). 

F. National Technology Transfer and 

Advancement Act 

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 

(NTTAA), (15 U.S.C. 272 note). 

IV. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., does not apply 

because this action is not a rule as that 

term is defined in 5 U.S.C. 804(3). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 7, 2013. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

§ 180.369 [Removed] 

■ 2. Remove § 180.369. 

[FR Doc. 2013–12595 Filed 5–28–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0461; FRL–9385–9] 

Methyl 5-(dimethylamino)-2-methyl-5- 

oxopentanoate; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate (1174627–68–9) when 

used as an inert ingredient solvent in 


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32158 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest. SciReg, Inc. 

(12733 Director’s Loop, Woodbridge, VA 

22192), on behalf of Rhodia Inc. (CN 

7500, 8 Cedar Brook Drive, Cranbury, NJ 

08512–7500) submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate. 

DATES: This regulation is effective May 

29, 2013. Objections and requests for 

hearings must be received on or before 

July 29, 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–2012–0461. All 

documents in the docket are 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: 

Mark Dow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5533; email address: 

dow.mark@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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/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–2012–0461 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 July 29, 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– 

2012–0461, 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. Petition for Exemption 

In the Federal Register of August 22, 

2012 (77 FR 50661) (FRL–9358–9), EPA 

issued a document pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

2E8010) by SciReg, Inc. (12733 

Director’s Loop, Woodbridge, VA 

22192), on behalf of Rhodia Inc. (CN 

7500, 8 Cedar Brook Drive, Cranbury, NJ 

08512–7500). The petition requested 

that 40 CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of methyl 5-(dimethylamino)-2-methyl5-oxopentanoate (1174627–68–9) when 

used as an inert ingredient (solvent) in 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest (40 CFR 

180.910). That document referenced a 

summary of the petition prepared by 

SciReg, Inc. (12733 Director’s Loop, 

Woodbridge, VA 22192), on behalf of 

Rhodia Inc. (CN 7500, 8 Cedar Brook 

Drive, Cranbury, NJ 08512–7500), the 

petitioner, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols, and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers, and fatty 

acids; carriers such as clay, and 

diatomaceous earth; thickeners such as 

carrageenan, and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents, 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity, the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 


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Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 32159 

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 establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under 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(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), 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 methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate, including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by methyl 5-(dimethylamino)-2-methyl5-oxopentanoate as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

Methyl 5-(dimethylamino)-2-methyl5-oxopentanoate is not acutely toxic via 

the oral or dermal routes of exposure. It 

is not a primary eye irritant, a primary 

skin irritant, or a dermal sensitizer. A 

repeat dose reproduction/ 

developmental toxicity study showed 

no treatment-related effects on mating or 

fertility. There were no treatmentrelated effects on gestation, litter size, 

litter growth, and development as 

compared to controls. There was no 

evidence of any toxicity in the 

parameters evaluated in this study. The 

NOAEL for systemic toxicity was 

considered to be 1,000 milligram/ 

kilograms body weight/day (mg/kg bw/ 

day), the highest dose tested; a LOAEL 

was not observed in this study. A 

Bacterial Reverse Mutation Assay with 

Salmonella typhimurium concluded 

methyl 5-(dimethylamino)-2-methyl-5- 

oxopentanoate did not induce 

mutagenic activity. A Gene Mutation 

Assay with Chinese hamster cells 

showed no reproducible dosedependent increase in gene mutation 

frequency. A Chromosome Aberration 

Test with Human Lymphocytes in vitro 

showed no signs of cells carrying 

structural chromosomal aberrations. 

There was no evidence of an increase in 

polyploidy metaphases after treatment 

with methyl 5-(dimethylamino)-2- 

methyl-5-oxopentanoate. A Mammalian 

Erythrocyte Micronucleus Test with 

mice revealed no statistically significant 

decreases in the PCE/NCE ratio 

therefore, methyl 5-(dimethylamino)-2- 

methyl-5-oxopentanoate, is considered 

to be negative for genotoxicity. Methyl 

5-(dimethylamino)-2-methyl-5- 

oxopentanoate, is considered nonmutagenic, there are no known data that 

directly suggest that methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate is carcinogenic. Based on 

the absence any toxicity at the limit 

dose, lack of mutagenicity concerns, and 

lack of carcinogenicity triggers in the 

Derek analysis, EPA concluded that 

methyl 5-(dimethylamino)-2-methyl-5- 

oxopentanoate is unlikely to pose a 

cancer risk at anticipated human 

exposures. Neurotoxicity was not 

observed in a reproduction/ 

developmental toxicity screening study 

in rats, where neurotoxic parameters 

were evaluated. Immunotoxicity studies 

were not available for review. However, 

signs of immunotoxicity were not 

observed in any of the submitted 

studies. 

B. Toxicological Points of Departure/ 

Levels of Concern 

The available toxicity studies indicate 

that methyl 5-(dimethylamino)-2- 

methyl-5-oxopentanoate has a very low 

overall toxicity. The NOAEL is 1,000 

mg/kg bw/day (limit dose). Since signs 

of toxicity were not observed at the limit 

dose, an endpoint of concern for risk 

assessment purposes was not identified. 

Therefore, since no endpoint of concern 

was identified for the acute, and chronic 

dietary exposure assessments, and 

short-, and intermediate-term dermal, 

and inhalation exposure assessments, a 

quantitative risk assessment for methyl 

5-(dimethylamino)-2-methyl-5- 

oxopentanoate is not necessary. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to methyl 5-(dimethylamino)- 

2-methyl-5-oxopentanoate, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from methyl 

5-(dimethylamino)-2-methyl-5- 

oxopentanoate in food as follows: 

Dietary exposure to methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate can occur from eating 

food treated with pesticide formulations 

containing this inert ingredient. In 

addition, food can pick up residues of 

methyl 5-(dimethylamino)-2-methyl-5- 

oxopentanoate that has been used in 

pesticide formulations applied to treat 

food contact surfaces, thus resulting in 

indirect exposure. However, since an 

endpoint of concern for risk assessment 

was not identified, a quantitative dietary 

exposure assessment for methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate was not conducted. 

2. Dietary exposure from drinking 

water. Dietary exposure from drinking 

water to methyl 5-(dimethylamino)-2- 

methyl-5-oxopentanoate can occur by 

drinking water that has been 

contaminated by run-off from a 

pesticide treated area, and from 

antimicrobial formulations used in foodcontact surface sanitizing solutions. 

Since an endpoint for risk assessment 

was not identified, a quantitative dietary 

exposure assessment from drinking 


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32160 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 

water for methyl 5-(dimethylamino)-2- 

methyl-5-oxopentanoate was not 

conducted. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Methyl 5-(dimethylamino)-2-methyl5-oxopentanoate may be used in inert 

ingredients in pesticide products that 

are registered for specific uses that may 

result in both indoor and outdoor 

residential exposures. However, since 

there are no toxicological effects of 

concern occurring below the limit dose 

of 1,000 mg/kg bw/day, it is not 

necessary to conduct quantitative 

assessments of residential (nonoccupational) exposures and risks. 

There are no dermal or inhalation 

toxicological endpoints of concern to 

the Agency, therefore, quantitative 

assessments have not been conducted. 

4. 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 methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate to share a common 

mechanism of toxicity with any other 

substances, and methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate 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 Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(c) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) 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 database on toxicity 

and exposure, unless EPA determines, 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (FQPA) 

safety factor. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of qualitative or 

quantitative susceptibility of infants and 

children in the available database. 

3. Conclusion. As part of its 

qualitative assessment, the Agency did 

not use safety factors for assessing risk, 

and no additional safety factor is needed 

for assessing risk to infants and 

children. The available toxicity studies 

suggest low toxicity of methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate. The toxicity database for 

methyl 5-(dimethylamino)-2-methyl-5- 

oxopentanoate contains acute oral, 

dermal and inhalation toxicity studies; 

skin, eye, and sensitization studies; 

mutagenicity studies (gene mutation, 

chromosomal aberrations assay), 

including in vivo micronucleus assay; 

and reproduction/developmental 

toxicity screening study in the rat. There 

is no indication based upon the 

available data that methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate is a neurotoxic or 

immunotoxic chemical, or results in 

increased qualitative or quantitative 

susceptibility in infants or children. 

Based on this information, there is no 

concern, at this time, for increased 

sensitivity to infants and children to 

this chemical when used as inert 

ingredient in pesticides formulations. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate, EPA has determined 

that there is a reasonable certainty that 

no harm to any population subgroup 

will result from aggregate exposure to 

methyl 5-(dimethylamino)-2-methyl-5- 

oxopentanoate under reasonably 

foreseeable circumstances. Therefore, 

the establishment of an exemption from 

tolerance under 40 CFR 180.910 for 

residues of methyl 5-(dimethylamino)-2- 

methyl-5-oxopentanoate when used as 

an inert ingredient, specifically as a 

solvent, in pesticide formulations 

applied to growing crops and to raw 

agricultural commodities after harvest, 

is safe under FFDCA section 408. 

1. Aggregate cancer risk for U.S. 

population. For the reasons stated in 

Unit IV.A. methyl 5-(dimethylamino)-2- 

methyl-5-oxopentanoate is not expected 

to pose a cancer risk to humans. 

2. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate residues when used as 

an inert ingredient in pesticide 

formulations under 40 CFR 180.910. 

V. 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 

United Nation 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 Methyl 5-(dimethylamino)-2-methyl5-oxopentanoate. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for methyl 5- 

(dimethylamino)-2-methyl-5- 

oxopentanoate. (1174627–68–9) when 

used as an inert ingredient (solvent) in 

pesticide formulations applied to 

growing crops and to raw agricultural 

commodities after harvest. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance under FFDCA section 408(d) 

in response to a petition submitted to 


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Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 32161 

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 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). 

VIII. 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: May 20, 2013 

Lois A. 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 § 180.910, alphabetically add the 

following inert ingredient to the table to 

read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate (1174627–68–9) ............................................................ ........................... Solvent 

* * * * * * * 

[FR Doc. 2013–12457 Filed 5–28–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R06–RCRA–2012–0821; 9817–6] 

Oklahoma: Final Authorization of State 

Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Immediate direct rule. 

SUMMARY: Oklahoma has applied to the 

EPA for Final authorization of the 

changes to its hazardous waste program 

under the Resource Conservation and 

Recovery Act (RCRA). EPA has 

determined that these changes satisfy all 

requirements needed to qualify for Final 

authorization, and is authorizing the 

State’s changes through this immediate 

final action. The EPA is publishing this 

rule to authorize the changes without a 

prior proposal because we believe this 

action is not controversial and do not 

expect comments that oppose it. Unless 

we receive written comments which 

oppose this authorization during the 

comment period, the decision to 

authorize Oklahoma’s changes to its 

hazardous waste program will take 

effect. If we receive comments that 

oppose this action, we will publish a 

document in the Federal Register 

withdrawing this rule before it takes 

effect, and a separate document in the 

proposed rules section of this Federal 

Register will serve as a proposal to 

authorize the changes. 

DATES: This final authorization will 

become effective on July 29, 2013 unless 

the EPA receives adverse written 

comment by June 28, 2013. If the EPA 

receives such comment, it will publish 

a timely withdrawal of this immediate 

final rule in the Federal Register and 

inform the public that this authorization 

will not take effect. 

ADDRESSES: Submit your comments by 

one of the following methods: 

1. Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

2. Email: patterson.alima@epa.gov. 


tkelley on DSK3SPTVN1PROD with RULES