Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 46279 

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: July 25, 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. Section 180.659 is amend by: 

■ i. Adding alphabetically the following 

commodities to the table in paragraph 

(a)(1); 

■ ii. Adding alphabetically the 

following commodities to the table in 

paragraph (a)(2); and 

■ iii. Adding paragraph (a)(4). 

The additions read as follows: 

§ 180.659 Pyroxasulfone; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Cotton, undelinted seed ............. 0.04 

Wheat, grain ............................... 0.03 

(2) * * * 

Commodity Parts per 

million 

Cotton, gin byproducts ............. 0 .20 

* * * * * 

Wheat, forage ........................... 6 .0 

Wheat, hay ............................... 1 .0 

Wheat, straw ............................. 0 .60 

* * * * * 

(4) Tolerances are established for 

residues of the herbicide pyroxasulfone, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only the sum of 

pyroxasulfone [3-[[[5-(difluoromethoxy)- 

1-methyl-3-(trifluoromethyl)-1Hpyrazol-4-yl]methyl]sulfonyl]-4,5- 

dihydro-5,5-dimethylisoxazole] and its 

metabolites [5-(difluoromethoxy)-1- 

methyl-3-(trifluoromethyl)-1H-pyrazol4-yl]methanesulfonic acid (M–1) and 5- 

(difluoromethoxy)-1-methyl-3- 

(trifluoromethyl)-1H-pyrazol-4- 

carboxylic acid (M–3), calculated as the 

stoichiometric equivalent of 

pyroxasulfone, in or on the commodity. 

Commodity Parts per 

million 

Milk ............................................. 0.003 

* * * * * 

[FR Doc. 2013–18412 Filed 7–30–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0010; FRL–9391–9] 

Forchlorfenuron; Temporary Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

temporary tolerances for residues of 

forchlorfenuron in or on multiple 

commodities which are identified and 

discussed later in this document. KIM– 

C1, LLC requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA) for uses 

associated with an experimental use 

permit. The tolerances expire on 

December 31, 2015. 

DATES: This regulation is effective July 

31, 2013. Objections and requests for 

hearings must be received on or before 

September 30, 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–2013–0010, 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: 

Marcel Howard, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6784; email address: 

howard.marcel@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://

www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&

tpl=/ecfrbrowse/Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 


ehiers on DSK2VPTVN1PROD with RULES
46280 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 

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–2013–0010 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 September 30, 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– 

2013–0010, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center, (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerances 

In the Federal Register of February 

15, 2013 (78 FR 11126) (FRL–9378–4), 

EPA issued a document pursuant to 

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

346a(d)(3), announcing the filing of a 

pesticide petition (PP 2F8055) by KIM– 

C1, LLC, 2547 West Shaw Avenue, Suite 

116, Fresno, CA 93711. The petition 

requested that 40 CFR 180.569 be 

amended by establishing temporary 

tolerances for residues of the plant 

growth regulator forchlorfenuron, (N-(2- 

chloro-4-pyridinyl)-N′-phenylurea), in 

or on almond; cherry, sweet; fig; pear; 

pistachio; and plum, prune, fresh at 0.01 

parts per million (ppm) and almond, 

hulls at 0.15 ppm. That document 

referenced a summary of the petition 

prepared by KIM–C1, LLC, the 

permittee, which is available to the 

public in the docket, http:// 

www.regulations.gov. A comment was 

received on the notice of filing. EPA’s 

response to that comment is discussed 

in Unit IV.C. These tolerances expire on 

December 31, 2015. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for forchlorfenuron 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with forchlorfenuron follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its 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. 

Forchlofenuron is not acutely toxic 

via the oral, dermal, and inhalation 

routes. Dose-related effects noted in the 

dog following subchronic and chronic 

exposure were generally limited to 

decreased body weight and body-weight 

gain. In the rat, the only organ that 

appeared to be affected was the kidney, 

which showed suppurative 

inflammation, suppurative 

pyelonephritis, non-suppurative 

interstitial nephritis, and cortical cysts 

following chronic exposure. 

Developmental toxicity (decreased fetal 

body weight and increased pup 

mortality) was observed in the rat only 

at a maternally-toxic dose. The 

developmental toxicity studies in rats 

and rabbits, as well as the reproductive 

toxicity study in rats, did not 

demonstrate any increased pre- or 

postnatal sensitivity. There was no 

evidence of neurotoxicity in any of the 

submitted studies. Forchlorfenuron is 

classified as not likely to be a human 

carcinogen and there is no concern for 

mutagenicity. There was no evidence of 

endocrine disruption in the 

forchlorfenuron database. 

Specific information on the studies 

received and the nature of the toxic 

effects caused by forchlorfenuron as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled Forchlorfenuron: Human Health 

Risk Assessment for Proposed Uses on 

the Bushberry Subgroup 13B and to 

Support a Requested Experimental Use 

Permit on Almonds, Sweet Cherries, 

Figs, Pears, Pistachios, and Plums/ 

Prunes in docket ID number EPA–HQ– 

OPP–2007–1065. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 46281 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for forchlorfenuron used for 

human risk assessment is discussed in 

Unit II. of the final rule published in the 

Federal Register of August 15, 2008 (73 

FR 47843) (FRL–8375–4). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to forchlorfenuron, EPA 

considered exposure from the 

petitioned-for tolerances as well as all 

existing forchlorfenuron tolerances in 

40 CFR 180.569. EPA assessed dietary 

exposures from forchlorfenuron in food 

as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

No such effects were identified in the 

toxicological studies for 

forchlorfenuron; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed tolerance-level residues and 

100% crop treated. Dietary Exposure 

Evaluation Model (DEEM version 7.81) 

default processing factors were used for 

apple juice, dried apples, dried pears, 

prune juice, cranberry juice, and grape 

juice. A processing factor was not used 

for raisins because a separate tolerance 

(resulting from an empirical processing 

study) has been established for this 

commodity. Additionally, the default 

processing factor was not used for 

prunes (dried plums) since data 

indicated that residues in prunes would 

not exceed the recommended plum 

tolerance. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that forchlorfenuron does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for forchlorfenuron. Tolerance level 

residues and/or 100% CT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for forchlorfenuron in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

forchlorfenuron. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

The conclusions of the Agency in the 

2008 human health risk assessment 

remain unchanged with respect to 

dietary exposure and risks. The Agency 

has verified that the previous estimated 

drinking water concentrations are also 

appropriate for use with this 

experimental use permit (EUP) request. 

Forchlorfenuron is persistent and 

moderately mobile in soils. 

Forchlorfenuron is also a substituted 

urea plant growth regulator that is 

essentially stable to all routes of 

dissipation except sensitized 

photodegradation in water. Based on the 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/ 

EXAMS) and Screening Concentration 

in Ground Water (SCI–GROW) models, 

the estimated drinking water 

concentrations (EDWCs) of 

forchlorfenuron from the proposed uses 

on almonds, sweet cherries, figs, pears, 

plums, and pistachios under the EUP 

will not exceed the EECs from the grape 

and kiwi uses previously assessed by 

the Agency in the document titled 

Drinking Water Assessment for 

Forchlorfenuron for Grape and Kiwi 

Uses. Therefore, the Agency has 

incorporated the drinking water EEC 

from the grape and kiwi analysis 

directly into this dietary assessment. 

For chronic exposures for non-cancer 

assessments are estimated to be 0.32 

parts per billion (ppb) for surface water 

and 0.003 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For chronic dietary risk assessment, 

the water concentration of value 0.32 

ppb was used to assess the contribution 

to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Forchlorfenuron is not registered for 

any specific use patterns that would 

result in residential exposure. 

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 forchlorfenuron to 

share a common mechanism of toxicity 

with any other substances, and 

forchlorfenuron does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that forchlorfenuron 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 

FQPA Safety Factor (SF). 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. 

The developmental and reproductive 

toxicity studies showed no evidence of 

increased sensitivity or susceptibility of 

young rats or rabbits following prenatal 

or postnatal exposure to 

forchlorfenuron. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

forchlorfenuron is complete. 


ehiers on DSK2VPTVN1PROD with RULES
46282 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 

ii. There is no indication that 

forchlorfenuron is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

forchlorfenuron results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

forchlorfenuron in drinking water. EPA 

used similarly conservative assumptions 

to assess exposure and risks posed by 

forchlorfenuron. These assessments will 

not underestimate the exposure and 

risks posed by forchlorfenuron. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, forchlorfenuron is 

not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 

forchlorfenuron from food and water 

will utilize < 1% of the cPAD. There are 

no residential uses for forchlorfenuron. 

3. Short-term risk and intermediateterm risk. Short-term and intermediateterm aggregate exposure takes into 

account short-term and intermediateterm residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Forchlorfenuron is currently not 

registered for any use patterns that 

would result in short-term and 

intermediate-term residential exposure. 

Because there is no short- or 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short- or intermediate-term risk), 

no further assessment of short- or 

intermediate-term risk is necessary. EPA 

relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for 

forchlorfenuron. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

forchlorfenuron is not expected to pose 

a cancer risk to humans. 

5. 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 

forchlorfenuron residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(HPLC/UV method (method # CCRL– 

MTH–029)) is available to enforce 

tolerances of forchlorfenuron in/on 

members of the Bushberry Subgroup 

13–07B and the commodities that are 

the subject of the proposed EUP. 

Residues are determined by HPLC/UV 

using external standards and residues 

are confirmed by liquid chromatography 

(LC) mass spectrometry (MS/MS) 

analysis. The validated limit of 

quantitation (LOQ) is 0.01 ppm for fruit 

and nut crops. 

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 forchlorfenuron. 

C. Response to Comment 

One comment was received in 

response to the notice of receipt of the 

EUP’s application. The commenter 

objected to the increase of chemical 

residues and expressed concerns about 

the effects of chemicals in general on 

humans and the environment. The 

Agency understands the commenter’s 

concerns regarding toxic chemicals and 

their potential effects on humans and 

the environment. Pursuant to its 

authority under the FFDCA, and as 

discussed further in this preamble, EPA 

conducted a comprehensive assessment 

of forchlorfenuron. Based on its 

assessment of the available data, the 

Agency has concluded that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

residues of forchlorfenuron, including 

those associated with the EUP. 

V. Conclusion 

Therefore, temporary tolerances are 

established for residues of 

forchlorfenuron, (N-(2-chloro-4- 

pyridinyl)-N′-phenylurea), including its 

metabolites and degradates in or on 

almond; cherry, sweet; fig; pear; 

pistachio; and plum, prune, fresh at 0.01 

ppm and in or on almond, hulls at 0.15 

ppm. An expiration date of December 

31, 2015, is established for these uses, 

which are associated with the EUP 

(71049–EUP–5) the Agency issued to 

KIM–C1, LLC for plant growth regulator 

forchlorfenuron. 

In addition, consistent with EPA’s 

policy for clarifying its tolerance 

expressions, EPA is revising the 

tolerance expression for forchlorfenuron 

to clarify that the tolerance includes 

metabolites and degradates of 

forchlorfenuron and that compliance 

with the tolerance levels specified in the 

table is to be determined by measuring 

only the sum of forchlorfenuron, (N-(2- 

chloro-4-pyridinyl)-N′-phenylurea). 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes temporary 

tolerances under FFDCA section 408(r) 

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 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 46283 

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 

submitted under FFDCA section 408(d), 

such as the tolerance in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 22, 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 § 180.569, revise paragraphs 

(a)(1) introductory text and (a)(2) to read 

as follows: 

§ 180.569 Forchlorfenuron; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of 

forchlorfenuron, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only forchlorfenuron (N-(2- 

chloro-4-pyridinyl)-N′-phenylurea). 

* * * * * 

(2) Temporary tolerances are 

established for residues of 

forchlorfenuron, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring on forchlorfenuron (N-(2- 

chloro-4-pyridinyl)-N′-phenylurea). 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Almond ..................................................................................................................................................................... 0.01 12/31/15 

Almond, hulls ........................................................................................................................................................... 0.15 12/31/15 

Cherry, sweet ........................................................................................................................................................... 0.01 12/31/15 

Fig ............................................................................................................................................................................ 0.01 12/31/15 

Pear ......................................................................................................................................................................... 0.01 12/31/15 

Pistachio .................................................................................................................................................................. 0.01 12/31/15 

Plum, prune, fresh ................................................................................................................................................... 0.01 12/31/15 

* * * * * 

[FR Doc. 2013–18182 Filed 7–30–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2012–0864; FRL–9392–4] 

RIN 2070–AB27 

Modification of Significant New Uses 

of Ethaneperoxoic Acid, 1,1- 

Dimethylpropyl Ester 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: Under the Toxic Substances 

Control Act (TSCA), EPA is finalizing an 

amendment to the significant new use 

rule (SNUR) for the chemical substance 

identified as ethaneperoxoic acid, 1,1- 

dimethylpropyl ester, which was the 

subject of premanufacture notice (PMN) 

P–85–680. This action requires persons 

who intend to manufacture or process 

the chemical substance for a use that is 

designated as a significant new use by 

this final rule to notify EPA at least 90 

days before commencing that activity. 

EPA believes that this action is 

necessary because new uses of the 


ehiers on DSK2VPTVN1PROD with RULES