Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Rules and Regulations 20461 

(ii) Enforcement date and time. 

Friday, Saturday, and Sunday of the 

third weekend in June; 10 a.m. to 7 p.m. 

each day. 

(70) Olde Ellison Bay Days Fireworks 

Display, Ellison Bay, Wisconsin—(i) 

Location. All waters of Lake Michigan, 

in the vicinity of Ellison Bay Wisconsin, 

within a 400 foot radius from the 

fireworks launch site located on a barge 

in position 45°15′36′′ N, 087°05′03′′ W 

(NAD 83). 

(ii) Enforcement date and time. The 

fourth Saturday of June; 9 p.m. to 10 

p.m. 

(71) Town of Porter Fireworks Display, 

Porter Indiana—(i) Location. All waters 

of Lake Michigan within the arc of a 

circle with a 1,000 foot radius from the 

fireworks launch site located in position 

41°39′56′′ N, 087°03′57′′ W (NAD 83). 

(ii) Enforcement date and time. The 

first Saturday of July; 8:45 p.m. to 9:30 

p.m. 

(72) City of Menasha 4th of July 

Fireworks, Lake Winnebago, Menasha, 

Wisconsin—(i) Location. All U.S. 

navigable waters of Lake Michigan and 

the Fox River within the arc of a circle 

with an 800 foot radius from the 

fireworks launch site at position 

41°39′56′′ N, 087°03′57′′ W (NAD 83). 

(ii) Enforcement date and time. July 4; 

9 p.m. to 10:30 p.m. 

(73) ISAF Nations Cup Grand Final 

Fireworks Display, Sheboygan, 

Wisconsin—(i) Location. All waters of 

Lake Michigan and Sheboygan Harbor, 

in the vicinity of the south pier in 

Sheboygan Wisconsin, within a 500 foot 

radius from the fireworks launch site 

located on land in position 43°44′55′′ N, 

087°41′51′′ W (NAD 83). 

(ii) Enforcement date and time. 

September 13; 7:45 p.m. to 8:45 p.m. 

(74) Magnificent Mile Fireworks 

Display, Chicago, Illinois—(i) Location. 

All waters and adjacent shoreline of the 

Chicago River bounded by the arc of the 

circle with a 210 foot radius from the 

fireworks launch site with its center in 

approximate position of 41°53′21′′ N, 

087°37′24′′ W (NAD 83). 

(ii) Enforcement date and time. The 

third weekend in November; sunset to 

termination of display. 

(75) Lubbers Cup Regatta; Spring 

Lake, MI—(i) Location. All waters of 

Spring Lake in Spring Lake, Michigan 

within a rectangle that is approximately 

6,300 by 300 feet. The rectangle will be 

bounded by the points beginning at 

43°04′55′′ N, 086°12′32′′ W; then east to 

43°04′57′′ N, 086°11′6′′ W; then south to 

43°04′54′′ N, 086°11′5′′ W; then west to 

43°04′52′′ N, 086°12′32′′ W; then north 

back to the point of origin [NAD 83]. 

(ii) Enforcement date and time. April 

12 from 3:00 p.m. until 7:00 p.m., and 

April 13 from 8:00 a.m. until 3:00 p.m. 

(76) Chicago Match Cup Race; 

Chicago, IL—(i) Location. All waters of 

Chicago Harbor in the vicinity of Navy 

Pier and the Chicago Harbor break wall 

bounded by coordinates beginning at 

41°53′37′′ N, 087°35′26′′ W; then south 

to 41°53′24′′ N, 087°35′26′′ W; then west 

to 41°53′24′′ N, 087°35′55′′ W; then 

north to 41°53′37′′ N, 087°35′55′′ W; 

then back to point of origin [NAD 83]. 

(ii) Enforcement date and time. This 

event has historically occurred during 

the month of August. The Captain of the 

Port, Sector Lake Michigan, will 

establish enforcement dates that will be 

announced with a Notice of 

Enforcement and marine information 

broadcasts. 

(77) Chicago to Mackinac Race; 

Chicago, IL—(i) Location. All waters of 

Lake Michigan in the vicinity of the 

Navy Pier at Chicago IL, within a 

rectangle that is approximately 1500 by 

900 yards. The rectangle is bounded by 

the coordinates beginning at 41°53′15.1′′ 

N, 087°35′25.8′′ W; then south to 

41°52′48.7′′ N, 087°35′25.8′′ W; then east 

to 41°52′49.0′′ N, 087°34′26.0′′ W; then 

north to 41°53′15′′ N, 087°34′26′′ W; 

then west, back to point of origin [NAD 

83]. 

(ii) Enforcement date and time. This 

event has historically occurred in the 

month of July. The Captain of the Port, 

Sector Lake Michigan, will establish 

enforcement dates that will be 

announced with a Notice of 

Enforcement and marine information 

broadcasts. 

(b) Definitions. The following 

definitions apply to this section: 

(1) Designated representative means 

any Coast Guard commissioned, 

warrant, or petty officer designated by 

the Captain of the Port, Sector Lake 

Michigan, to monitor a safety zone, 

permit entry into a zone, give legally 

enforceable orders to persons or vessels 

within a safety zone, and take other 

actions authorized by the Captain of the 

Port, Sector Lake Michigan. 

(2) Public vessel means a vessel that 

is owned, chartered, or operated by the 

United States, or by a State or political 

subdivision thereof. 

(c) Regulations. (1) The general 

regulations in 33 CFR 165.23 apply. 

(2) All persons and vessels must 

comply with the instructions of the 

Captain of the Port, Sector Lake 

Michigan, or his or her designated 

representative. Upon being hailed by the 

U.S. Coast Guard by siren, radio, 

flashing light or other means, the 

operator of a vessel shall proceed as 

directed. 

(3) All vessels must obtain permission 

from the Captain of the Port, Sector Lake 

Michigan, or his or her designated 

representative to enter, move within or 

exit a safety zone established in this 

section when the safety zone is 

enforced. Vessels and persons granted 

permission to enter one of the safety 

zones listed in this section shall obey all 

lawful orders or directions of the 

Captain of the Port, Sector Lake 

Michigan, or his or her designated 

representative. While within a safety 

zone, all vessels shall operate at the 

minimum speed necessary to maintain a 

safe course. 

(d) Suspension of enforcement. If the 

Captain of the Port, Sector Lake 

Michigan, suspends enforcement of any 

of these zones earlier than listed in this 

section, the Captain of the Port, Sector 

Lake Michigan, or his or her designated 

representative will notify the public by 

suspending the respective Broadcast 

Notice to Mariners. 

(e) Exemption. Public vessels, as 

defined in paragraph (b) of this section, 

are exempt from the requirements in 

this section. 

(f) Waiver. For any vessel, the Captain 

of the Port, Sector Lake Michigan, or his 

or her designated representative may 

waive any of the requirements of this 

section, upon finding that operational 

conditions or other circumstances are 

such that application of this section is 

unnecessary or impractical for the 

purposes of safety or environmental 

safety. 

Dated: March 22, 2013. 

M.W. Sibley, 

Captain, U.S. Coast Guard, Captain of the 

Port, Sector Lake Michigan. 

[FR Doc. 2013–07911 Filed 4–4–13; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0139; FRL–9381–7] 

Flumioxazin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flumioxazin in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

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20462 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Rules and Regulations 

DATES: This regulation is effective April 

5, 2013. Objections and requests for 

hearings must be received on or before 

June 4, 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–2012–0139, 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/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 

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–2012–0139 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 June 4, 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– 

2012–0139, 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 

Tolerance 

In the Federal Register of May 2, 2012 

(77 FR 25954) (FRL–9346–1), 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 2E7982) by IR–4, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.568 be 

amended by establishing tolerances for 

residues of the herbicide flumioxazin, 2- 

[7-fluoro-3,4-dihydro-3-oxo-4-(2- 

propynyl)-2H-1,4-benzoxazin-6-yl]- 

4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)- 

dione, in or on artichoke at 0.02 parts 

per million (ppm); cabbage and Chinese 

cabbage (tight-headed varieties only) at 

0.02 ppm; olives, and olive oil at 0.02 

ppm; pomegranate at 0.02 ppm; cactus 

fruit at 0.1 ppm, and cactus pads at 0.05 

ppm. That document referenced a 

summary of the petition prepared by 

Valent U.S.A. Corporation, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which tolerances 

are being established for some 

commodities. The reason for these 

changes is explained in Unit IV.C. 

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 flumioxazin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flumioxazin follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

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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. 

In general, flumioxazin has mild or 

low acute toxicity. Also, the subchronic 

and chronic toxicity studies 

demonstrated that toxic effects 

associated with flumioxazin include 

anemia as well as effects on the liver 

and the cardiovascular system. 

Developmental effects were observed in 

developmental rat studies but not in 

developmental rabbit studies. 

Hematologic (hematopoietic) effects of 

anemia were noted in rats, consisting of 

alterations in hemoglobin parameters. 

Increased renal toxicity in male rats was 

also reported following chronic 

exposure. There is no evidence of 

neurotoxicity or immunotoxicity in the 

recently submitted guideline studies. 

Increased quantitative susceptibility 

was seen in the rat developmental 

toxicity studies. Fetal effects were 

observed in the absence of maternal 

toxicity. In addition, both increased 

qualitative and quantitative 

susceptibility were observed in the rat 

reproduction study. Severe fetal effects 

were observed at lower doses than 

milder parental effects. In most of the 

available mutagenicity studies, 

flumioxazin was negative for 

mutagenicity; however, aberrations were 

seen in a chromosomal aberration assay 

(CHO cells). Based on the lack of 

evidence of carcinogenicity in mice and 

rats, flumioxazin is classified as ‘‘not 

likely to be carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flumioxazin as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2012–0139 on 

pages 43–48 of the document titled 

‘‘Flumioxazin. Human Health Risk 

Assessment for the Proposed Uses on 

Artichoke, Cabbage, Olive, Pomegranate, 

and Prickly Pear Cactus’’. 

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 

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 flumioxazin used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of September 21, 

2012 (77 FR 58493) (FRL–9358–3). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flumioxazin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing flumioxazin tolerances in 40 

CFR 180.568. EPA assessed dietary 

exposures from flumioxazin 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. 

Such effects were identified for 

flumioxazin. In estimating acute dietary 

exposure, EPA used food consumption 

information from the U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA) 

from 2003–2008. As to residue levels in 

food, EPA assumed tolerance level 

residues and 100 percent crop treated 

(PCT) for all proposed and registered 

commodities. In addition, EPA used 

default concentration factors to estimate 

residues of flumioxazin in processed 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WWEIA from 

2003–2008. As to residue levels in food, 

EPA assumed tolerance level residues 

and 100 PCT for all proposed and 

registered commodities. In addition, 

EPA used default concentration factors 

to estimate residues of flumioxazin in 

processed commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that flumioxazin 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 PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for flumioxazin. Tolerance level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. In the environment flumioxazin 

photodegrades very rapidly in water and 

on soil. Concentrations of flumioxazin 

and its major degradates (482–HA, APF, 

and THPA) are expected to be found in 

water; however, flumioxazin and the 

metabolites 482–HA and APF have been 

identified as the residues of concern in 

drinking water. 

To estimate concentrations of 

flumioxazin including its major 

degradates of concern (482–HA and 

APF) in ground water, the Agency used 

a screening level water exposure model 

in the dietary exposure analysis and risk 

assessment. This simulation model took 

into account data on the physical, 

chemical, and fate/transport 

characteristics of flumioxazin. Since 

this chemical is currently registered for 

direct applications to water, surface 

water estimates are based on the use of 

flumioxazin as an aquatic herbicide 

where a maximum 400 parts per billion 

(ppb) concentration is maintained. 

Hydrolysis is considered the major route 

of dissipation for flumioxazin in the 

environment and the levels of 

degradates (482–HA and APF) increase 

continuously with time. 

Based on the Screening Concentration 

in Ground Water (SCI–GROW) model 

the estimated drinking water 

concentrations (EDWCs) for both acute 

and chronic exposures of 482–HA and 

APF are estimated to be 45.27 ppb and 

2.66 ppb, respectively, in ground water. 

EDWCs of parent flumioxazin are 

estimated to be negligible in ground 

water for both acute and chronic 

exposures. For surface water, the 

EDWCs for flumioxazin are estimated to 

be 400 ppb for acute exposures and no 

482–HA and APF is expected to be 

present. For chronic exposures, EDWCs 

of flumioxazin and its major degradates 

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20464 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Rules and Regulations 

(482–HA and APF) are estimated to be 

9.4, 21.6, and 110.1 ppb, respectively, 

for surface water resulting in an EDWC 

of 142 ppb (total). 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 400 ppb was 

used to assess the contribution to 

drinking water of flumioxazin. For 

chronic dietary risk assessment, the 

water concentration of value 142 ppb 

(the total EDWC for flumioxazin, 482– 

HA and APF in surface water) was used 

to assess the contribution to drinking 

water of flumioxazin and its major 

degradates (482–HA and APF). 

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. 

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). 

Flumioxazin is currently registered 

for uses that could result in residential 

exposures, including aquatic areas, 

ornamental gardens, ornamental trees, 

turf, and golf courses. EPA assessed 

residential exposure with the 

assumption that homeowner handlers 

wear shorts, short-sleeved shirts, socks, 

and shoes, and that they complete all 

tasks associated with the use of a 

pesticide product including mixing/ 

loading, if needed, as well as the 

application. Residential handler 

exposure scenarios for both dermal and 

inhalation are considered to be shortterm only, due to the infrequent use 

patterns associated with homeowner 

products. 

EPA uses the term ‘‘postapplication’’ 

to describe exposure to individuals that 

occur as a result of being in an 

environment that has been previously 

treated with a pesticide. Flumioxazin is 

registered for use in many areas that can 

be frequented by the general population 

including residential areas, golf courses, 

lakes, and ponds. As a result, 

individuals can be exposed by entering 

these areas if they have been previously 

treated. Therefore, short-term and 

intermediate dermal postapplication 

exposures and risks were assessed for 

adults and children. In addition, oral 

post-application exposures and risks 

were assessed for children to be 

protective of possible hand-to-mouth, 

object-to-mouth, and soil ingestion 

activities that may occur on treated turf 

areas. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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 flumioxazin to 

share a common mechanism of toxicity 

with any other substances, and 

flumioxazin does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that flumioxazin 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. 

Evidence of increased susceptibility to 

fetuses was observed in the oral and 

dermal developmental rat studies i.e. 

cardiovascular anomalies (ventricular 

septal defect) that occurred in the 

absence of maternal toxicity. 

Additionally, the rat reproduction study 

demonstrated evidence of qualitative 

and quantitative post-natal 

susceptibility because reproductive 

effects in offspring were observed at 

doses lower than those that caused 

parental/systemic toxicity, and because 

the reproductive effects in offspring 

were considered to be more severe than 

the parental/systemic effects. 

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 for oral and dermal 

exposures, but be retained at 10X for 

inhalation exposures. That decision is 

based on the following findings: 

i. The toxicity database for 

flumioxazin is largely complete with the 

exception of an inhalation 

developmental study, which was 

recently determined necessary, in order 

to better assess route-specific inhalation 

risks. In the absence of this study, a 10X 

FQPA safety factor to account for 

database uncertainty is needed to 

protect the safety of infants and children 

to assess risks for all inhalation 

exposure scenarios. The toxicity profile 

can be characterized for all effects, 

including potential developmental and 

reproductive toxicity, immunotoxicity 

and neurotoxicity with the current 

database. 

ii. There is no indication that 

flumioxazin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although increased susceptibility 

was seen in the rat developmental and 

reproductive studies, EPA’s concern for 

these effects is low, and there are no 

residual uncertainties for pre- and/or 

postnatal toxicity because: 

a. The developmental toxicity 

NOAELs/LOAELs are well characterized 

after oral and dermal exposure; 

b. The offspring toxicity NOAEL and 

LOAEL are well characterized in the 

reproduction study and 

c. The points of departure for 

assessing risk to developing fetuses, 

infants, and children have been selected 

either from the developmental and 

reproductive toxicity studies from the 

chronic study which established a lower 

point of departure for chronic effects 

than the studies in pre- and postnatal 

animals. Thus, the regulatory endpoints 

for flumioxazin are protective of the 

increased susceptibility seen in the 

developmental and reproduction 

studies, and there are no residual 

concerns for these effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute and chronic dietary analyses 

were based on tolerance-level residues 

and 100 PCT assumptions for all 

commodities. The dietary drinking 

water assessment utilized water 

concentration values generated by 

model and associated modeling 

parameters which are designed to 

provide conservative, health protective, 

high-end estimates of water 

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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Rules and Regulations 20465 

concentrations. The residential 

exposure assessment incorporates 

similarly conservative assumptions in 

the assessment of post-application 

exposure to children and in the 

incidental oral exposure assessment for 

children. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

flumioxazin will occupy 75% of the 

aPAD for females 13–49 years old, the 

only population group of concern for 

acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to flumioxazin 

from food and water will utilize 44% of 

the cPAD for all infants less than 1 year 

old, the population subgroup receiving 

the greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

flumioxazin is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Flumioxazin is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to flumioxazin. 

Different methodologies were used for 

the presentation of short-term aggregate 

risk for adults and children. An 

aggregate risk estimate (ARI) approach 

was required to estimate short-term 

adult aggregate risk because there are 

different levels of concern (LOCs) for 

adult dermal and inhalation exposures, 

100 and 1,000, respectively. For shortterm child aggregate risk, the combined 

MOE approach was used because the 

endpoint of concern (decreased pup 

weight) and the LOC are the same. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

ARI of 1.12 for adults and aggregate 

MOE of 182 for children. Because EPA’s 

level of concern for flumioxazin is an 

ARI of 1 or below and a MOE of 100 or 

below, these aggregate risk estimates are 

not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Since the short- and intermediate-term 

toxicological endpoints for flumioxazin 

are the same for each route of exposure, 

only short-term exposures were 

assessed. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flumioxazin is not expected to pose a 

cancer risk to humans. 

6. 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 flumioxazin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography/nitrogenphosphorus detection (GC/NPD) 

method, Valent Method RM30–A–1) is 

available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established MRLs 

for flumioxazin for any of the 

commodities covered by this document. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency has revised the levels for 

prickly pear cactus fruit and pads from 

0.1 and 0.05 to 0.07 and 0.06, 

respectively. The modifications were 

due to the Agency’s use of the 

Organization for Economic Co-operation 

and Development (OECD) calculation 

procedures to determine the appropriate 

tolerance levels. 

Additionally, the petition proposed a 

tolerance for olive oil at 0.02 ppm. The 

Agency reviewed an olive oil processing 

study and found that the residue levels 

found in olive oil were the same as 

those found in olives. As such, the 

Agency has determined that a tolerance 

for olive is appropriate, and a separate 

tolerance on olive oil is not necessary. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flumioxazin, 2-[7-fluoro3,4-dihydro-3-oxo-4-(2-propynyl)-2H1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro1H-isoindole-1,3(2H)-dione, in or on 

artichoke, globe at 0.02 ppm; cabbage at 

0.02 ppm; cabbage, Chinese, napa at 

0.02 ppm; olive at 0.02 ppm; 

pomegranate at 0.02 ppm; prickly pear, 

fruit at 0.07 ppm; and prickly pear, pads 

at 0.06 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this 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 

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20466 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Rules and Regulations 

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). 

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: March 28, 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 § 180.568, add alphabetically the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.568 Flumioxazin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Artichoke, globe ........................ 0.02 

* * * * * 

Cabbage ................................... 0.02 

Cabbage, Chinese, napa .......... 0.02 

* * * * * 

Olive .......................................... 0.02 

* * * * * 

Pomegranate ............................ 0.02 

Prickly pear, fruit ....................... 0.07 

Prickly pear, pads ..................... 0.06 

* * * * * 

* * * * * 

[FR Doc. 2013–07980 Filed 4–4–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 68 

[Docket No. NIH–2008–0003] 

RIN 0905–AA43 

National Institutes of Health Loan 

Repayment Programs 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Final rule. 

SUMMARY: As a part of the Department 

of Health and Human Services (HHS)’s 

ongoing retrospective review initiative, 

the National Institutes of Health (NIH) is 

rescinding the existing regulations for 

two of its eight loan repayment 

programs and issuing in their place a 

new consolidated set of regulations 

governing all of the NIH Loan 

Repayment Programs (LRPs). There are 

currently eight programs, including 

three for researchers employed by the 

NIH (Intramural LRPs) and five for nonNIH scientists (Extramural LRPs). The 

Intramural LRPs include the Loan 

Repayment Program for Research with 

Respect to Acquired Immune Deficiency 

Syndrome (or AIDS Research LRP); 

Loan Repayment Program for General 

Research (or General Research LRP), 

which includes a program for the 

Accreditation Council for Graduate 

Medical Education (ACGME) Fellows; 

and Loan Repayment Program for 

Clinical Researchers from 

Disadvantaged Backgrounds (or Clinical 

Research LRP for Individuals from 

Disadvantaged Backgrounds). The 

Extramural LRPs include the Loan 

Repayment Program for Contraception 

and Infertility Research (or 

Contraception and Infertility Research 

LRP); Loan Repayment Program for 

Clinical Researchers from 

Disadvantaged Backgrounds (or Clinical 

Research LRP for Individuals from 

Disadvantaged Backgrounds); Loan 

Repayment Program for Clinical 

Research (or Clinical Research LRP); 

Loan Repayment Program for Pediatric 

Research (or Pediatric Research LRP); 

and Loan Repayment Program for 

Health Disparities Research (or Health 

Disparities Research LRP). 

DATES: This final rule is effective May 6, 

2013. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Moore, NIH Regulations Officer, Office 

of Management Assessment, NIH, 6011 

Executive Boulevard, Room 601, MSC 

7669, Rockville, MD 20892; by email at 

MooreJ@mail.nih.gov; by fax on 301– 

402–0169 (not a toll-free number); or by 

telephone 301–496–4607 (not a toll-free 

number) for information about the 

rulemaking process. For program 

information, contact: NIH Division of 

Loan Repayment by email lrp@nih.gov 

or telephone 866–849–4047. For 

information regarding the requirements, 

the application deadline dates, and an 

online application for the NIH Loan 

Repayment Programs, refer to the NIH 

Loan Repayment Program Web site, 

www.lrp.nih.gov. 

SUPPLEMENTARY INFORMATION: On 

November 4, 1988, Congress enacted the 

Health Omnibus Programs Extension of 

1988, (Pub. L. 100–607). Title VI of this 

law amended the Public Health Service 

(PHS) Act by adding section 487A (42 

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