3328 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 

environmental analysis checklist 

supporting this determination and a 

Categorical Exclusion Determination are 

available in the docket where indicated 

under ADDRESSES. We seek any 

comments or information that may lead 

to the discovery of a significant 

environmental impact from this rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.T05–1092, to read as 

follows: 

§ 165.T05–1092 Safety Zone Within the 

Lower Portion of Anchorage #9, Mantua 

Creek Anchorage; Paulsboro, NJ. 

Location: The southern one-third of 

the Anchorage #9 (Mantua Creek 

Anchorage), below position 39° 51.573 

N—075° 13.557 W. 

(a) Enforcement period: This rule will 

be enforced from December 20, 2012 

until January 31, 2013, unless cancelled 

earlier by the Captain of the Port. 

(b) Regulations: All persons are 

required to comply with the general 

regulations governing safety zones in 33 

CFR 165.23 of this part. 

(1) All persons and vessels utilizing 

the southern one-third portion of the 

anchorage must be authorized by the 

Captain of the Port or her representative. 

(2) All persons or vessels wishing to 

anchor within the safety zone must 

request authorization to do so from the 

Captain of the Port or her representative 

24 hours prior to the intended time of 

transit. 

(3) Vessels granted permission to 

anchor must do so in accordance with 

the directions provided by the Captain 

of the Port or her representative to the 

vessel. 

(4) To seek permission to anchor in 

the safety zone, the Captain of the Port 

or her representative can be contacted 

via Sector Delaware Bay Command 

Center (215) 271–4940. 

(5) This section applies to all vessels 

wishing to anchor in the safety zone 

within Mantua Creek Anchorage except 

vessels that are engaged in the following 

operations: 

(i) Enforcing laws; 

(ii) Servicing aids to navigation, and 

(iii) Emergency response vessels. 

(6) No person may enter a safety zone 

unless authorized by the COTP or the 

District Commander; 

(7) No person may bring or cause to 

be brought into a safety zone any 

vehicle, vessel, or object unless 

authorized by the COTP or the District 

Commander; 

(8) No person may remain in a safety 

zone or allow any vehicle, vessel, or 

object to remain in a safety zone unless 

authorized by the COTP or the District 

Commander; and 

(9) Each person in a safety zone who 

has notice of a lawful order or direction 

shall obey the order or direction of the 

COTP or District Commander issued to 

carry out the purposes of this subpart. 

(c) Definitions. 

(1) The Captain of the Port means the 

Commanding Officer of Sector Delaware 

Bay or any Coast Guard commissioned, 

warrant, or petty officer who has been 

authorized by the Captain of the Port to 

act on her behalf. 

(2) [Reserved] 

(d) Enforcement. The U.S. Coast 

Guard may be assisted in the patrol and 

enforcement of the Safety Zone by 

Federal, State, and local agencies. 

Dated: December 20, 2012. 

T.C. Wiemers, 

Captain, U.S. Coast Guard, Alternate Captain 

of the Port Delaware Bay. 

[FR Doc. 2013–00845 Filed 1–15–13; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0962; FRL–9371–1] 

Fluroxypyr; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluroxypyr in 

or on rice bran and rice grain. Dow 

AgroSciences LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 16, 2013. Objections and 

requests for hearings must be received 

on or before March 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–2011–0962, 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: 

Bethany Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; email address: 

benbow.bethany@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://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 3329 

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–2011–0962 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 March 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– 

2011–0962, 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 

Confidential Business Information (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 December 

30, 2011 (76 FR 82238) (FRL–9331–1), 

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 1F7928) by Dow 

AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268. The 

petition requested that 40 CFR 180.535 

be amended by establishing tolerances 

for residues of the herbicide, fluroxypyr 

1–MHE and its acid metabolite, 

fluroxypyr, in or on rice at 1.5 parts per 

million (ppm) and rice bran at 3.0 ppm. 

That document referenced a summary of 

the petition prepared by Dow 

AgroSciences LLC, the registrant, which 

is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 fluroxypyr 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluroxypyr 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. 

The active ingredient used in 

formulating end-use herbicide products 

is fluroxypyr 1-methylheptyl ester. 

However, since the ester form has been 

shown to rapidly hydrolyze to the acid 

form, the residues of fluroxypyr 1- 

methylheptyl ester along with its 

fluroxypyr acid metabolite (free and 

conjugated), are collectively expressed 

as ‘‘fluroxypyr’’ and are therefore 

regulated together for tolerance 

enforcement. In terms of toxicity, the 

ester and acid forms are considered the 

same. 

Fluroxypyr has low acute toxicity by 

the oral and dermal routes of exposure 

and moderate to mild acute toxicity by 

the inhalation route of exposure, based 

on lethality studies. Fluroxypyr is not a 

dermal sensitizer, nor is it irritating to 

the skin; however, it is a mild eye 

irritant. 

The kidney is the target organ for 

fluroxypyr following oral exposure to 

rats, mice, and dogs. In the rat, 

increased kidney weight, 

nephrotoxicity, and death were 

observed in both sexes in the 90-day 

feeding study, and increased kidney 

weight and microscopic kidney lesions 

were observed in both sexes in the 

chronic study. Increased kidney weight 

was also observed in maternal rats in 

the developmental toxicity study, and 

kidney effects (deaths due to renal 

failure; increased kidney weight, and 

microscopic kidney lesions) were 

observed in both sexes in the 2- 

generation reproduction study in rats. 

Although microscopic kidney lesions 

were observed in dogs in the 28-day 

feeding study, no kidney effects or other 

treatment related toxicity were seen in 

the chronic feeding study in dogs at the 

same doses used in the 28-day study. 

Microscopic kidney lesions were 

observed in mice following long-term 

exposure. 

There was no evidence of increased 

susceptibility (quantitative/qualitative) 

following in utero exposure in rats and 

rabbits, or following pre and/or 

postnatal exposure in rats. Neither 

developmental toxicity nor reproductive 

toxicity was observed in rats. In rabbits, 

developmental toxicity was not 

observed following exposure to dose 

levels that resulted in maternal death; 

however, abortions were observed in 

rabbits following exposure to fluroxypyr 

at the limit dose. There was no evidence 

of neurotoxicity or neuropathology in 

any of the studies. An immunotoxicity 

study in rats found no indication of 

immunotoxicity. Fluroxypyr is 

classified ‘‘not likely to be carcinogenic 

to humans’’ due to lack of evidence to 

suggest carcinogenicity in the database, 

and there is no concern for its 

mutagenicity potential. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluroxypyr 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 document 

‘‘Fluroxypyr. Human Health Risk 

Assessment to Support Proposed New 


srobinson on DSK4SPTVN1PROD with 
3330 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 

Use on Rice,’’ p. 15 in docket ID number 

EPA–HQ–OPP–2011–0962. 

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 fluroxypyr used for 

human risk assessment is shown in the 

Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUROXYPYR FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (All populations) .. No adverse effects were identified following a single oral dose and there are no developmental concerns noted 

in the database. 

Chronic dietary (All populations) NOAEL = 100 mg/ 

kg/day.

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

Chronic RfD = 1 mg/ 

kg/day.

cPAD = 1 mg/kg/day 

Chronic/Carcinogenicity-Rat LOAEL = 500 mg/kg/day, based 

on kidney effects (increased kidney weights, alterations in 

clinical chemistry parameters indicative of impaired renal 

functions, and increase in severity of chronic progressive 

glomerulonephropathy in both sexes). 

Incidental oral (Short- and Intermediate term).NOAEL = 100 mg/ 

kg/day.

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

LOC for MOE = 100 Chronic/Carcinogenicity-Rat LOAEL = 500 mg/kg/day, based 

on kidney effects (increased kidney weights, alterations in 

clinical chemistry parameters indicative of impaired renal 

functions, and increase in severity of chronic progressive 

glomerulonephropathy in both sexes). 

Inhalation (all durations) ........... Inhalation (or oral) 

study NOAEL = 

100 mg/kg/day (inhalation and oral 

toxicity assumed 

to be equivalent).

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

LOC for MOE = 100 Chronic/Carcinogenicity-Rat LOAEL = 500 mg/kg/day, based 

on kidney effects (increased kidney weights, alterations in 

clinical chemistry parameters indicative of impaired renal 

functions, and increase in severity of chronic progressive 

glomerulonephropathy in both sexes). 

Cancer (Oral) ............................ Classified as a ‘‘Not Likely’’ human carcinogen. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluroxypyr, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fluroxypyr tolerances in 40 CFR 

180.535. EPA assessed dietary 

exposures from fluroxypyr 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 fluroxypyr; 

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 U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, ‘‘What 

We Eat in America’’ (NHANES/WWEIA) 

dietary survey conducted in 2003–2008. 

As to residue levels in food, EPA 

assumed tolerance-level residues with 

100 percent crop treated (PCT) for all 

existing and proposed crop uses and 

default processing factors for processed 

commodities. 

iii. Cancer. EPA has concluded that 

fluroxypyr 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 fluroxypyr. Tolerance level residues 

and 100 PCT 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 fluroxypyr in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fluroxypyr. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 3331 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Tier 1 Rice Model and 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of fluroxypyr for acute and 

chronic exposures are both estimated to 

be 540 parts per billion (ppb) for surface 

water and 0.055 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute and chronic dietary risk 

assessment, the water concentration 

value of 540 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). 

Fluroxypyr is currently registered for 

the following uses that could result in 

residential exposures: Residential 

turfgrass, golf courses, parks and sports 

fields. EPA assessed residential 

exposure using the following 

assumptions: Residential handler 

exposure is expected to be short-term. 

Intermediate-term exposures are not 

likely because of the intermittent nature 

of applications by homeowners. Since 

there are no toxicity findings for the 

short-term dermal route of exposure up 

to the limit dose, only inhalation 

exposure was assessed for residential 

handlers of fluroxypyr. The following 

exposure scenarios were assessed for 

residential handlers: Loading and 

applying liquids with manually 

pressurized hand-wands, hose-end 

sprayers, and backpack applicators. 

For residential post-application 

exposure and risk estimates, EPA 

assumed that young children 1 to <2 

years old may receive incidental oral 

post-application exposure to fluroxypyr 

from treated turf. 

A residential bystander postapplication inhalation exposure 

assessment was not performed for 

fluroxypyr at this time because the 

chemical has low vapor pressure, is 

applied at a low rate, and is not applied 

via airblast. Although a quantitative 

residential post-application inhalation 

exposure assessment was not performed 

as a result of pesticide drift from 

neighboring treated agricultural fields, 

an inhalation exposure assessment was 

performed for flaggers. This exposure 

scenario, for which no risks of concern 

were identified, is representative of a 

worse case inhalation (drift) exposure 

and may be considered protective of 

most outdoor agricultural and 

commercial post-application inhalation 

exposure scenarios. 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 fluroxypyr to share a common 

mechanism of toxicity with any other 

substances, and fluroxypyr does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

fluroxypyr 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. 

There is no evidence of increased 

qualitative or quantitative susceptibility 

following in utero exposure in rats and 

rabbits or following pre and/or postnatal 

exposure in rats. 

Fluroxypyr is neither a developmental 

nor a reproductive toxicant in rats. 

Fluroxypyr has been evaluated for 

potential developmental effects in the 

rat and rabbit (gavage administration). 

Maternal toxicity included death in rats 

and rabbits. There were no 

developmental effects in the rat, and 

while abortions were observed in the 

rabbit, they occurred only at the limit 

dose. 

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 fluroxypyr 

is complete. 

ii. There is no indication that 

fluroxypyr 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 

fluroxypyr 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 chronic dietary food exposure 

assessment utilizes tolerance level 

residue estimates and assumes 100 PCT 

for all commodities. This assessment 

will not underestimate exposure/risk. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to fluroxypyr in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by fluroxypyr. 

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, fluroxypyr 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 fluroxypyr 


srobinson on DSK4SPTVN1PROD with 
3332 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 

from food and water will utilize 3.5% of 

the cPAD for all infants (<1 year old), 

the population group receiving the 

greatest exposure. 

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). Fluroxypyr 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 

fluroxypyr. 

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 

MOEs of 2,500 for adult handlers using 

a backpack sprayer, and 2,400 for 

children’s postapplication oral 

exposure. Because EPA’s level of 

concern for fluroxypyr is a MOE of 100 

or below, these MOEs 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). An 

intermediate-term adverse effect was 

identified; however, fluroxypyr is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

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 intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

fluroxypyr. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fluroxypyr 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 fluroxypyr 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography/electron capture 

detection (GC/ECD methods GRM 96.02 

and 96.03)) are available to enforce the 

tolerance expression. Fluroxypyr was 

previously tested through FDA’s 

Multiresidue Methodology, Protocols C, 

D, and E and was found to be recovered. 

The results have been published in the 

FDA Pesticide Analytical Manual, 

Volume I. The GRM 96.02 and 96.03 

methods 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. 

There are no Maximum Residue 

Limits (MRLs) established by Codex, 

Canada, or Mexico for any of the 

proposed commodities for fluroxypyr. 

V. Conclusion 

Therefore, tolerances are established 

for the combined residues of fluroxypyr 

1–MHE and its acid metabolite 

fluroxypyr, in or on rice at 1.5 ppm and 

rice bran at 3.0 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 

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). 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 3333 

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: January 7, 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 § 180.535, in paragraph (a), 

revise the introductory text and add 

alphabetically the following 

commodities to the table to read as 

follows: 

§ 180.535 Fluroxypyr 1-methylheptyl ester; 

tolerances for residues. 

(a) General. Tolerances are 

established for combined residues of 

fluroxypyr 1-methylheptyl ester [1- 

methylheptyl ((4-amino-3,5-dichloro-6- 

fluoro-2-pyridinyl)oxy)acetate] and its 

metabolite fluroxypyr [((4-amino-3,5- 

dichloro-6-fluoro-2-pyridinyl)oxy)acetic 

acid] in or on the following raw 

agricultural commodities. Compliance 

with the established tolerance levels is 

determined by measuring only the sum 

of fluroxypyr 1-methylheptyl ester [1- 

methylheptyl ((4-amino-3, 5-dichloro-6- 

fluoro-2-pyridinyl)oxy)acetate] and its 

metabolite fluroxypyr [((4-amino-3,5- 

dichloro-6-fluoro-2-pyridinyl)oxy)acetic 

acid] calculated as the stoichiometric 

equivalent of fluroxypyr. 

Commodity Parts per 

million 

* * * * * 

Rice, bran ..................................... 3.0 

Rice, grain .................................... 1.5 

* * * * * 

* * * * * 

[FR Doc. 2013–00562 Filed 1–15–13; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0038; FRL–9374–3] 

Spiromesifen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spiromesifen 

in or on tea, dried. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

January 16, 2013. Objections and 

requests for hearings must be received 

on or before March 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–2012–0038, 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: 

Jennifer Gaines, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5967; email address: 

Gaines.Jennifer@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–2012–0038 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 March 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– 

2012–0038, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 


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