12396 Federal Register / Vol. 79, No. 43 / Wednesday, March 5, 2014 / Rules and Regulations 

Dated: February 13, 2014. 

Mike Brinks, 

Acting Regional Administrator, Region 7. 

Chapter I, title 40 of the Code of 

Federal Regulations is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart AA—Missouri 

■ 2. In § 52.1320 the table in paragraph 

(c), under Chapter 6 is amended by 

revising the entry for ‘‘10–6.050’’ to read 

as follows: 

§ 52.1320 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED MISSOURI REGULATIONS

Missouri 

citation Title State effective date EPA approval date Explanation 

Missouri Department of Natural Resources 

* * * * * * * 

Chapter 6—Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control Regulations for the State of 

Missouri 

* * ** * * *

10–6.050 ......... Start-up, Shutdown, and Malfunction Conditions.07/30/10 03/05/14 [insert Federal Register page 

number where the document begins].

* * ** * * *

[FR Doc. 2014–04779 Filed 3–4–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0941; FRL–9906–19] 

Fluopicolide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for indirect or inadvertent 

residues of fluopicolide in or on corn, 

field, forage; corn, field, grain; corn, 

field, stover. Valent U.S.A. Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

March 5, 2014. Objections and requests 

for hearings must be received on or 

before May 5, 2014, 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–2012–0941, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 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 

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–2012–0941 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 May 5, 2014. 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 


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objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0941, 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 January 16, 

2013 (78 FR 3377) (FRL–9375–4), 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 (2F8099) by Valent U.S.A. 

Corporation, 1600 Riviera Avenue, Suite 

200; Walnut Creek, CA 94596. The 

petition requested that 40 CFR 180.627 

be amended by establishing tolerances 

for indirect or inadvertent residues of 

the fungicide fluopicolide, 2,6-dichloroN-[3-chloro-5-(trifluoromethyl)-2- 

pyridylmethyl]-benzamide, and its 

metabolite, 2,6-dichlorobenzamide, in 

or on corn, field, forage at 0.09 parts per 

million (ppm); corn, field, grain at 0.01 

ppm; and corn, field, stover at 0.3 ppm. 

These tolerances are being requested for 

fluopicolide residues that are likely to 

be found in or on corn when corn is 

planted as a rotational crop into a field 

that has previously been treated with 

fluopicolide, not for residues that result 

from direct application of fluopicolide 

to corn. That document referenced a 

summary of the petition prepared by 

Valent U.S.A. Corporation, the 

registrant, which EPA failed to make 

available through http://

www.regulations.gov. Subsequently, 

EPA posted the summary to the docket 

via http://www.regulations.gov and 

republished notice of the availability of 

Valent’s summary of its petition in the 

docket on September 12, 2013 (78 FR 

56185) (FRL–9399–7). There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerances for corn, field, 

forage from 0.09 ppm to 0.08 ppm; and 

for corn, field, stover from 0.3 ppm to 

0.20 ppm. The reasons for these changes 

are explained in Unit IV.D. 

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 fluopicolide 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluopicolide 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 toxicological database indicates 

that fluopicolide has relatively low 

acute toxicity. Fluopicolide is not a 

dermal sensitizer, primary eye irritant, 

or primary skin irritant. The subchronic 

and chronic toxicity studies showed 

that the primary effects of fluopicolide 

are in the liver. Kidney and thyroid 

toxicity were observed in rats only. 

Fluopicolide is not neurotoxic, 

carcinogenic, nor mutagenic. 

Developmental toxicity in the rabbit 

occurred only at doses that caused 

severe maternal toxicity (including 

death). In the rat, developmental effects 

were seen only at high dose levels (700 

milligrams/kilogram/day (mg/kg/day)) 

in the presence of maternal toxicity. 

Similarly, offspring effects (decreased 

body weight and body weight gain) 

occurred only at levels causing 

significant toxicity in parents of the 

multi-generation reproductive toxicity 

study. There is no evidence of increased 

quantitative susceptibility of rat or 

rabbit fetuses to in utero or postnatal 

exposure to fluopicolide. No toxic 

effects were observed in studies in 

which fluopicolide was administered by 

the dermal routes of exposure. The 

toxicological profile for fluopicolide 

suggests that increased durations of 

exposure do not significantly increase 

the severity of observed effects. The 

rabbit developmental and rat chronic/

cancer studies were therefore 

considered as potential studies for 

deriving risk assessment endpoints for 

all durations of exposure. Fluopicolide 

is classified as ‘‘not likely to be 

carcinogenic to humans’’, thus no 

quantification of cancer risks is 

required. 

Fluopicolide shares a metabolite, 2,6- 

dichlorobenzamide (BAM), with another 

active ingredient, dichlobenil. Residues 

of BAM are considered to be of 

regulatory concern, and separate 

toxicity data and endpoints for risk 

assessment have been selected for BAM. 

Since the toxicity profile for BAM has 

not changed since the last assessment 

EPA conducted for BAM, an analysis of 

the toxicology profile of BAM can be 

found in ‘‘Fluopicolide and its 

Metabolite, 2,6-Dichlorobenzamide 

(BAM). Amended Human Health Risk 

Assessment to Support New Section 3 

Uses on Brassica Leafy Greens Subgroup 

5B, Potatoes, Sugar Beets, Carrots and to 

Allow Rotation to Wheat,’’ dated 

November 21, 2007 (‘‘2007 BAM Risk 

Assessment’’) in docket ID number 

EPA–HQ–OPP–2006–0481). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluopicolide 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 

‘‘Fluopicolide. Human Health Risk 

Assessment of the new section 3 

tolerance on Rotational Corn’’ in docket 

ID number EPA–HQ–OPP–2012–0941. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 


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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 fluopicolide and BAM 

used for human risk assessment is 

discussed in Unit III.B. of the final rule 

published in the Federal Register of 

April 20, 2011 (76 FR 22045) (FRL– 

8859–9). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluopicolide, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fluopicolide tolerances in 40 

CFR 180.627. EPA did not consider 

additional exposures from BAM since 

the proposed change in use pattern does 

not add significantly to the BAM dietary 

exposure, and residues of BAM due to 

fluopicolide applications are 

significantly lower than those from 

dichlobenil applications. EPA is relying 

on conclusions from the 2007 BAM Risk 

Assessment. These conclusions remain 

unchanged and a revised quantitative 

BAM risk assessment was not 

conducted to support the proposed 

tolerances. EPA assessed dietary 

exposures from fluopicolide 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 fluopicolide; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

Acute effects were identified for 

BAM, and a conservative acute dietary 

exposure assessment for BAM was 

conducted. Maximum residues of BAM 

from fluopicolide field trials on 

tuberous and corm vegetables, leafy 

vegetables (except brassica), fruiting 

vegetables, cucurbit vegetables, grapes 

(domestic and imported), (except 

potato), and from dichlobenil field trials 

on food commodities with established/ 

pending tolerances (40 CFR 180.231) 

were included in the assessments. The 

assessments used 100 percent crop 

treated (PCT) except for apples, 

blueberries, cherries, cranberries, 

peaches, pears, and raspberries. 

ii. Chronic exposure. A chronic 

aggregate dietary (food and drinking 

water) exposure and risk assessment 

was conducted for fluopicolide using 

the Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM–FCID) Version 

3.16. This software uses 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA assumed 100 

PCT and tolerance-level residues. 

A conservative chronic dietary 

exposure assessment for BAM was 

conducted as described in Unit III.C.1.i. 

for the acute assessment. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluopicolide does not 

pose a cancer risk to humans. Therefore, 

a quantitative dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

The carcinogenic potential of BAM 

has been evaluated in only one species, 

the rat. That study showed an increased 

incidence of hepatocellular adenomas in 

high-dose females that was marginally 

statistically significant. In its previous 

BAM assessment, EPA assumed that 

BAM’s potential for carcinogenicity is 

similar to the parent having the greatest 

carcinogenic potential, specifically, 

dichlobenil, which has been classified 

as ‘‘Group C, possible human 

carcinogen’’ and for which EPA used a 

reference dose (RfD) approach for 

quantification of human cancer risk. 

Accordingly, EPA has assessed BAM’s 

cancer risk by using an RfD approach. 

For this assessment, EPA relied on BAM 

chronic exposure assessment as 

described in Unit III.C.1.ii. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for fluopicolide. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

EPA used anticipated residues and 

PCT information for the acute and 

chronic dietary risk assessments for 

BAM. For further analysis and EPA’s 

findings under section 408(b)(2)(E) of 

the FFDCA, see Unit III.C.1.iv. of the 

preamble to the fluopicolide final rule 

published in the Federal Register of 

April 20, 2011 (76 FR 22045, 22050) 

(FRL–8859–9). 

2. Dietary exposure from drinking 

water. A new drinking water assessment 

was not necessary for the establishment 

of tolerances resulting from inadvertent 

residues of fluopicolide on rotational 

corn. Previously, the Agency used 

screening level water exposure models 

in the dietary exposure analysis and risk 

assessment for fluopicolide in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of fluopicolide. 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. 

Based on the surface water 

concentrations estimated using the 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/

EXAMS); and Screening Concentrations 

in Ground Water (SCI–GROW) models, 

the estimated environmental 

concentrations (EECs) of fluopicolide for 

chronic exposures (non-cancer) 

assessments are estimated to be 24.14 

ppb for surface water and 0.5 ppb for 

ground water. Acute and cancer dietary 

risks were not quantified, as previously 

discussed. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

chronic dietary risk assessment, the 

water concentration of value 24.14 ppb 

was used to assess the contribution to 

drinking water. 

Considering residues of BAM in 

drinking water from uses of dichlobenil 

and fluopicolide, the uses on 

dichlobenil will result in the highest 

residues in drinking water. Therefore, 

the results from dichlobenil (from the 

use of nutsedge at 10 lb dichlobenil 

active ingredient/Acre (ai)/(A)) were 

used in the 2007 BAM Risk Assessment, 

i.e., 56.2 ppb was used as the value of 

BAM residues in drinking water in the 

dietary assessment for both the acute 

and chronic assessment. 


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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). 

Fluopicolide is currently registered for 

the following uses that could result in 

short-term residential exposures: 

Residential turf grass, recreational sites 

and ornamental plants. EPA assessed 

residential exposure using the following 

assumptions: Residential handlers may 

receive short-term dermal and 

inhalation exposure to fluopicolide 

when mixing, loading, and applying the 

formulations. Residential postapplication exposure via the dermal 

route is likely for adults and children 

entering treated lawns or treated 

gardens and during mowing and golfing 

activities. Children may also experience 

exposure via incidental non-dietary 

ingestion (i.e., hand-to-mouth, object-tomouth (turfgrass), and soil ingestion) 

during post-application activities on 

treated turf. 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. 

BAM is a metabolite/degradate which 

forms slowly; therefore, the scenarios 

were assessed in the previous 

assessment assuming that BAM is 

present at levels which reflect high end 

measurements observed in the longerterm metabolism studies in order to 

provide a protective assessment. The 

short-/intermediate-term dermal MOEs 

for adults and children are 10,000 and 

6,000, respectively, and the combined 

incidental oral MOE for toddlers is 

62,000. These MOEs are greater than the 

LOC of 100 for dermal exposure and 

1,000 for incidental oral exposure, on 

the day of application, and therefore, are 

not of concern. See 2007 BAM Risk 

Assessment. 

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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

fluopicolide and any other substances. 

Although fluopicolide shares a common 

metabolite, BAM, with dichlobenil, 

quantification of risks for residues of 

BAM resulting from fluopicolide was 

not done as part of this assessment 

because they contribute an insignificant 

amount to the total BAM exposure. 

Furthermore, aggregate risks to BAM are 

not of concern. For the purposes of this 

tolerance action, EPA has not assumed 

that fluopicolide has 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 the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

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. 

For fluopicolide, there is no evidence of 

quantitative susceptibility following in 

utero and/or postnatal exposure in the 

rabbit and rat developmental toxicity 

studies or in the 2-generation rat 

reproduction study. Qualitative 

susceptibility was observed in the rat 

developmental toxicity study. Fetal 

effects (reduced growth and skeletal 

defects) and late-term abortions were 

observed at doses at which only 

decreased body weight gain were 

observed in maternal animals. There is 

low concern for this qualitative 

susceptibility, because the fetal effects 

and late-term abortions have been well 

characterized and only occurred at a 

dose level near the limit dose. 

Protection of the maternal effects also 

protects for any effects that may occur 

during development. There are no 

residual uncertainties concerning 

prenatal and postnatal toxicity for 

fluopicolide. 

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 

fluopicolide is complete. 

ii. There is no indication that 

fluopicolide is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. As discussed in Unit III.D.2. in 

this document, the degree of concern for 

the prenatal and/or postnatal toxicity is 

low; thus, there is no need for the 10X 

FQPA safety factor to account for 

potential prenatal or post-natal toxicity. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary food exposure 

assessments were performed based on 

100 PCT and tolerance-level residues. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to fluopicolide in drinking water. 

Although EPA has required additional 

data on transferable residues from 

treated turf for fluopicolide, EPA is 

confident that it has not underestimated 

turf exposure due to the 

conservativeness of the default turf 

transfer value and conservative 

assumptions in the short-term turf 

assessment procedures (e.g., assuming 

residues do not degrade over the thirty 

day assessment period and assuming 

high-end activities on turf for every day 

of the assessment period). 

For reasons explained in III.D. of the 

preamble to the fluopicolide final rule 

published in the Federal Register of 

April 20, 2011 (76 FR 22045) (FRL– 

8859–9), EPA reduced the FQPA safety 

factor for BAM to 1X for inhalation and 

dermal exposure scenarios and retained 

the 10X FQPA safety factor for all other 

BAM exposure scenarios. EPA is relying 

on the findings in the preamble of the 

April 20, 2011 final rule and the 2007 

BAM Risk Assessment for the BAM 

FQPA safety factor determinations for 

this action. 

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-, 


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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, fluopicolide is not 

expected to pose an acute risk. 

The acute dietary exposure estimates 

for BAM at the 99.9th percentile of the 

exposure distribution are 11% of the 

aPAD for the general U.S. population 

and 28% aPAD for all infants 1 year old, 

the most highly exposed group. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluopicolide 

from food and water will utilize 12% of 

the cPAD for children 1–2 years of age, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

fluopicolide is not expected. 

The chronic dietary exposure 

estimates for BAM are 29% of the 

chronic cPAD for the general U.S. 

population and 93% cPAD for all 

infants (< 1 year old), the most highly 

exposed group, which is not of concern 

to the Agency. 

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). Fluopicolide 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 fluopicolide. 

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 110 for adult males and 

females and 183 for children 6–11 years 

of age. Because EPA’s level of concern 

for fluopicolide is a MOE of 100 or 

below, these MOEs are not of concern. 

Short-term exposures for 

fluopicolide’s metabolite BAM, may 

occur as a result of activities on treated 

turf. Incidental oral exposures related to 

turf activities have been combined with 

chronic dietary exposure estimates to 

assess short-term aggregate exposure for 

BAM. Since aggregate MOEs for BAM 

are greater than the LOC, they represent 

risk estimates that are below the 

Agency’s level 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). 

Intermediate-term exposures are not 

likely because of the intermittent nature 

of applications by homeowners. 

5. Aggregate cancer risk for U.S. 

population. As noted in Unit III.A., EPA 

has determined that fluopicolide is ‘‘not 

likely to be carcinogenic to humans.’’ As 

discussed in Unit III.C., EPA assessed 

the BAM cancer risk using an RfD 

approach. Relying on the BAM chronic 

risk assessment, EPA determines that 

BAM does not pose a cancer risk. 

Therefore, fluopicolide is not expected 

to pose a cancer risk. 

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 fluopicolide 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Liquid Chromatography/Tandum Mass 

Spectrometry (LC/MS/MS) method) 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 fluopicolide on corn, field, forage; 

corn, field, grain or corn, field, stover. 

C. Revisions to Petitioned-For 

Tolerances 

The established tolerance levels for 

field corn forage and field corn stover 

differ from the petition. The petitioner’s 

calculations were based on the sum of 

fluopicolide and BAM. Since the 

tolerance expression includes 

monitoring of residues of fluopicolide 

only for rotational crops for both food 

and feed commodities, it is not 

appropriate to consider residues of BAM 

in tolerance calculations. Therefore, 

EPA is establishing tolerances based on 

field trial data for fluopicolide only and 

using the Organization of Economic 

Cooperation and Development (OECD) 

calculation procedure. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluopicolide, 2,6- 

dichloro-N-[3-chloro-5- 

(trifluoromethyl)-2-pyridylmethyl]- 

benzamide, in or on corn, field, forage 

at 0.08 ppm; corn, field, grain at 0.01 

ppm; and corn, field, stover at 0.20 

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 


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Federal Register / Vol. 79, No. 43 / Wednesday, March 5, 2014 / Rules and Regulations 12401 

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: February 26, 2014. 

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 § 180.627, in paragraph (d), add 

alphabetically the following 

commodities to the table to read as 

follows: 

§ 180.627 Fluopicolide; tolerances for 

residues. 

* * * * * 

(d) * * * 

Commodity Parts per 

million 

Corn, field, forage ................. 0.08 

Corn, field, grain ................... 0.01 

Corn, field, stover ................. 0.20 

* * * * * 

[FR Doc. 2014–04832 Filed 3–4–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0949; FRL–9906–47] 

Triflumizole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of triflumizole 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). 

DATES: This regulation is effective 

March 5, 2014. Objections and requests 

for hearings must be received on or 

before May 5, 2014, 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–2012–0949, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 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 

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–2012–0949 in the subject line on 


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