Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 57285 

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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 9, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

§ 180.628 [Amended] 

■ 2. Section 180.628, the table in 

paragraph (a), is amended as follows: 

■ i. Remove the following commodities: 

‘‘Cattle, liver’’; ‘‘Cattle, meat 

byproducts, except liver’’; ‘‘Corn, field 

forage’’; ‘‘Corn, field, stover’’; ‘‘Corn, 

pop, forage’’; ‘‘Corn, pop, stover’’; 

‘‘Corn, sweet, forage’’; ‘‘Corn, sweet, 

stover’’; ‘‘Fruit, citrus group 10’’; ‘‘Fruit, 

pome group 11, except mayhaw’’; ‘‘Goat, 

liver’’; ‘‘Goat, meat byproducts, except 

liver’’; ‘‘Horse, liver’’; ‘‘Horse, meat 

byproducts, except liver’’; ‘‘Mayhaw’’; 

‘‘Sheep, liver’’; and ‘‘Sheep, meat 

byproducts, except liver.’’ 

■ ii. Revise the following commodities: 

‘‘Egg’’; ‘‘Hog, fat’’; ‘‘Hog, meat 

byproducts’’; ‘‘Milk’’; ‘‘Poultry, fat’’; and 

‘‘Poultry, meat byproducts.’’ 

■ iii. Add alphabetically the 

commodities: ‘‘Cattle, meat 

byproducts’’; ‘‘Fruit, citrus, group 10– 

10’’; ‘‘Fruit, pome, group 11–10’’; ‘‘Goat, 

meat byproducts’’; ‘‘Grain, cereal, 

except rice and corn, group 15’’; ‘‘Grain, 

cereal, forage, fodder and straw, group 

16’’; ‘‘Hog, meat’’; ‘‘Horse, meat 

byproducts’’; Poultry, meat’’; and 

‘‘Sheep, meat byproducts.’’ 

■ 3. Section 180.628, the table in 

paragraph (d) is amended by removing 

the entry ‘‘Grain, cereal, forage, fodder 

and straw, group 16.’’ 

The additions and revisions read as 

follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, meat byproducts ........... 0.5 

* * * * * 

Fruit, citrus, group 10–10 ......... 1.4 

Fruit, pome, group 11–10 ......... 1.2 

* * * * * 

Goat, meat byproducts ............. 0.5 

* * * * * 

Grain, cereal, except rice and 

corn, group 15 ....................... 6.0 

Commodity Parts per 

million 

Grain, cereal, forage, fodder 

and straw, group 16 .............. 40 

* * * * * 

Hog, fat ..................................... 0.05 

Hog, meat ................................. 0.02 

Hog, meat byproducts .............. 0.05 

* * * * * 

Horse, meat byproducts ........... 0.5 

* * * * * 

Milk ........................................... 0.1 

* * * * * 

Poultry, fat ................................ 0.2 

Poultry, meat ............................ 0.05 

Poultry, meat byproducts .......... 0.2 

* * * * * 

Sheep meat byproducts ........... 0.5 

* * * * * 

* * * * * 

[FR Doc. 2013–22593 Filed 9–17–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0383; FRL–9398–4] 

2,5-Furandione, Polymer With 

Ethenylbenzene, Hydrolyzed, 3- 

(Dimethylamino)propyl Imide, Imide 

With Polyethylene-Polypropylene 

Glycol 2-Aminopropyl Me Ether, 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 2,5-furandione, 

polymer with ethenylbenzene, 

hydrolyzed, 3-(dimethylamino)propyl 

imide, imide with polyethylenepolypropylene glycol 2-aminopropyl me 

ether, 2,2′-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated (CAS Reg. 

No. 1062609–13–5) when used as an 

inert ingredient in a pesticide 

formulation. Evonik Goldschmidt 

Corporation (Evonik) 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 2,5-furandione, polymer 

with ethenylbenzene, hydrolyzed, 3- 


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57286 Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 2,2′-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated on food or feed commodities. 

DATES: This regulation is effective 

September 18, 2013. Objections and 

requests for hearings must be received 

on or before November 18, 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–2013–0383, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090 email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 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. 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–2013–0383 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 November 18, 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– 

2013–0383, 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. Background and Statutory Findings 

In the Federal Register of July 19, 

2013 (78 FR 43115) (FRL–9392–9), EPA 

issued a document pursuant to FFDCA 

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

the receipt of a pesticide petition (IN– 

10559) filed by Evonik Goldschmidt 

Corporation, P.O. Box 1299, 914 East 

Randolph Rd. Hopewell, VA 23860. The 

petition requested that 40 CFR 180.960 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of 2,5-furandione, 

polymer with ethenylbenzene, 

hydrolyzed, 3-(dimethylamino)propyl 

imide, imide with polyethylenepolypropylene glycol 2-aminopropyl me 

ether, 2,2′-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated; CAS Reg. 

No. 1062609–13–5. That document 

included a summary of the petition 

prepared by the petitioner and solicited 

comments on the petitioner’s request. 

The Agency received one comment. 

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 

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 


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Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 57287 

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) for 2,5-furandione, polymer 

with ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 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. 

7. The polymer does not contain 

certain perfluoroalkyl moieties 

consisting of a CF3- or longer chain 

length as specified in 40 CFR 

723.250(d)(6). 

Additionally, the polymer also meets 

as required the following exemption 

criteria specified in 40 CFR 723.250(e). 

8. The polymer’s number average MW 

of 5,816 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, 2,5-furandione, polymer with 

ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 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 2,5- 

furandione, polymer with 

ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 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 2,5- 

furandione, polymer with 

ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 2,2′-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated could be present in all raw and 

processed agricultural commodities and 

drinking water, and that nonoccupational non-dietary exposure was 

possible. The number average MW of 

2,5-furandione, polymer with 

ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 2,2′-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated is 5,816 daltons. Generally, a 

polymer of this size would be poorly 

absorbed through the intact 

gastrointestinal tract or through intact 

human skin. Since 2,5-furandione, 

polymer with ethenylbenzene, 

hydrolyzed, 3-(dimethylamino)propyl 

imide, imide with polyethylenepolypropylene glycol 2-aminopropyl me 

ether, 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 2,5-furandione, 

polymer with ethenylbenzene, 

hydrolyzed, 3-(dimethylamino)propyl 

imide, imide with polyethylenepolypropylene glycol 2-aminopropyl me 

ether, 2,2′-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated to share a 

common mechanism of toxicity with 

any other substances, and 2,5- 

furandione, polymer with 

ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl iide, imide with 

polyethylene-polypropylene glycol 2- 

aminopropyl me ether, 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 2,5-furandione, polymer 

with ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 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 Web site 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 

EPA concludes that a different margin of 

safety will be safe for infants and 

children. Due to the expected low 

toxicity of 2,5-furandione, polymer with 

ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 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. 


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57288 Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 

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 2,5-furandione, polymer 

with ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 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 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for 2,5-furandione, polymer with 

ethenylbenzene, hydrolyzed, 3- 

(dimethylamino)propyl imide, imide 

with polyethylene-polypropylene glycol 

2-aminopropyl me ether, 2,2′-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated. 

C. Response to Comments 

The one comment received was an 

anonymous public comment regarding 

the acceptability of the polymer under 

40 CFR 180.960 and whether it met the 

40 CFR 723.250 low risk polymer 

exemption. The comment stated, ‘‘When 

DMAPA (dimentylaminopropyl amine) 

is reacted into the polymer to form the 

imide, that leaves a tertiary amine 

(dimethylpropyl amine) that can be 

protonated to become cationic when 

dispersed in water. If there are more 

than one of these DMAPAs per polymer 

molecule the equivalent weight will be 

below the 5,000 amu required to meet 

40 CFR 723.250 low risk polymer 

exemption from both TSCA and to get 

approval on 40 CFR 180.960.’’ While 

this polymer does contain a tertiary 

amine functional group, the functional 

group equivalent weight is greater than 

5,000 daltons. Therefore, this polymer is 

a cationic polymer of low cationic 

density and not excluded from the 

polymer exemption criteria given at 40 

CFR 723.250(d). 

IX. Conclusion 

Accordingly, EPA finds that 

exempting residues of 2,5-furandione, 

polymer with ethenylbenzene, 

hydrolyzed, 3-(dimethylamino)propyl 

imide, imide with polyethylenepolypropylene glycol 2-aminopropyl me 

ether, 2,2′-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated from the 

requirement of a tolerance will be safe. 

X. Statutory and Executive Order 

Reviews 

This final 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 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) (15 U.S.C. 272 

note). 

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, 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) (2 U.S.C. 1501 et seq.). 

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 lowincome 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. 

XI. 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 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 57289 

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: September 9, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.960, alphabetically add the 

following polymer to the table to read as 

follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

*******

2,5-Furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2′-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated, minimum number average molecular weight (in amu), 5,816 ...................................................................................................................................... 1062609–13–5 

*******

[FR Doc. 2013–22601 Filed 9–17–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0441; FRL–9396–7] 

Difenzoquat; Denial of Objections 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Order. 

SUMMARY: In this Denial of Objections 

Order, EPA is denying the objections 

submitted by Amvac Chemical 

Corporation (AMVAC) to a Revocation 

Order EPA issued in May 2013 under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) revoking all tolerances for 

the pesticide difenzoquat. EPA revoked 

the tolerances, consistent with the terms 

of a previously issued Data Call-In 

Order, because no notices of intent to 

submit the required data were 

submitted, as directed by that Data CallIn Order. In its objections, AMVAC 

requested that EPA delay the effective 

date for revoking the difenzoquat 

tolerances for 41⁄2 years to allow for 

importation of food commodities that 

will be treated with the pesticide in 

Canada over the next 2 years. EPA 

denies AMVAC’s objections because 

AMVAC has not filed a proper objection 

to the Revocation Order. 

DATES: This order is effective September 

18, 2013. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0441, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Nevola, Pesticide Re-Evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8037; email address: 

nevola.joseph@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. 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). 

II. Introduction 

A. What action is the agency taking? 

In this Denial of Objections Order, 

EPA is denying the objections submitted 

by AMVAC to a Revocation Order 

issued by EPA in the Federal Register 

of May 29, 2013 (Ref. 1), in which EPA 

ordered the revocation of all tolerances 

for the pesticide difenzoquat under 

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

EPA revoked the tolerances, consistent 

with the terms of a previously issued 

Data Call-In Order (Ref. 2), because no 

notices of intent to submit the required 

data were received by EPA as directed 

by that Data Call-In Order. In its 

objections (Ref. 3), AMVAC requested 

that EPA delay the effective date for the 

revocation of the difenzoquat tolerances 

for 41⁄2 years to allow for importation of 

food commodities that will be treated 

with the pesticide in Canada over the 

next 2 years. EPA denies AMVAC’s 

objections because AMVAC has not 

filed a proper objection to the 

Revocation Order. The AMVAC 

objections are discussed in Unit IV., and 

EPA’s denial is discussed in Unit V. 

B. What is the agency’s authority for 

taking this action? 

The procedure for filing objections to 

tolerance actions and EPA’s authority 

for acting on such objections is 

contained in FFDCA section 408(g), 21 

U.S.C. 346a(g), and 40 CFR part 178. For 

orders issued under FFDCA section 

408(f)(2), the only material issue for 

consideration is whether a submission 

required under a FFDCA section 

408(f)(1)(C) order was made by the time 

specified in that FFDCA section 

408(f)(1)(C) order. 21 U.S.C. 346a(f)(2). 


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