45688 Federal Register / Vol. 79, No. 151 / Wednesday, August 6, 2014 / Rules and Regulations 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places, or vessels. 

7. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

8. Taking of Private Property 

This rule will not cause a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

9. Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

10. Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not create an environmental risk to 

health or risk to safety that may 

disproportionately affect children. 

11. Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

12. Energy Effects 

This action is not a ‘‘significant 

energy action’’ under Executive Order 

13211, Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use. 

13. Technical Standards 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

14. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have determined that this action is one 

of a category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves the 

establishment of a safety zone and, 

therefore it is categorically excluded 

from further review under paragraph 

34(g) of Figure 2–1 of the Commandant 

Instruction. An 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. 

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

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.T09–0635 to read as 

follows: 

§ 165.T09–0635 Safety Zone; Gay Games 9 

Open Swim, Lake Erie, Cleveland, OH. 

(a) Location. This safety zone will 

encompass all waters of Lake Erie near 

the shore of Edgewater Park in 

Cleveland, OH within a 1000-yard 

radius centered around 41°29′40′′ N and 

081°44′24′′ W (NAD 83). 

(b) Effective and enforcement period. 

This section is effective and will be 

enforced on August 10, 2014, from 8 

a.m. until 1 p.m. 

(c) Regulations. (1) In accordance with 

the general regulations in § 165.23, entry 

into, transiting, or anchoring within this 

safety zone is prohibited unless 

authorized by the Captain of the Port 

Buffalo or his designated on-scene 

representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the Captain of the Port 

Buffalo or his designated on-scene 

representative. 

(3) The ‘‘on-scene representative’’ of 

the Captain of the Port Buffalo is any 

Coast Guard commissioned, warrant or 

petty officer who has been designated 

by the Captain of the Port Buffalo to act 

on his behalf. 

(4) Vessel operators desiring to enter 

or operate within the safety zone shall 

contact the Captain of the Port Buffalo 

or his on-scene representative to obtain 

permission to do so. The Captain of the 

Port Buffalo or his on-scene 

representative may be contacted via 

VHF Channel 16. Vessel operators given 

permission to enter or operate in the 

safety zone must comply with all 

directions given to them by the Captain 

of the Port Buffalo, or his on-scene 

representative. 

Dated: July 25, 2014. 

B.W. Roche, 

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

Port Buffalo. 

[FR Doc. 2014–18605 Filed 8–5–14; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0225; FRL–9914–37] 

Fluopicolide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of fluopicolide in 

or on potato, processed potato waste; 

and vegetable, tuberous and corm, 

subgroup 1C. Valent U.S.A. Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 6, 2014. Objections and requests 

for hearings must be received on or 

before October 6, 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–2014–0225, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 151 / Wednesday, August 6, 2014 / Rules and Regulations 45689 

Docket Center (EPA/DC), West William 

Jefferson Clinton 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; main 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–2014–0225 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 October 6, 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 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0225, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of May 23, 

2014 (79 FR 29729) (FRL–9910–29), 

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 3F8191) 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 residues of 

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

pyridinyl]methyl]benzamide, in or on 

potato, processed waste at 0.3 parts per 

million (ppm); and vegetable, tuberous 

and corm, subgroup 1C at 0.3 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. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance in or on potato, 

processed waste from 0.3 ppm to 1.0 

ppm, and has revised the commodity 

terminology. 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. 

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 identified for 


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BAM. However, since increased 

tolerances on the commodities affected 

by this action do not add significantly 

to the BAM dietary exposure, the 

conclusions from the most recently 

conducted BAM human health risk 

assessment remain unchanged. 

The subchronic and chronic toxicity 

studies for fluopicolide showed that the 

primary effects following exposure 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, in the presence of 

maternal toxicity. Similarly, offspring 

effects (decreased body weight and body 

weight gain) in the multi-generation 

reproductive toxicity study occurred 

only at levels causing significant 

toxicity in parents. 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. Toxic 

effects observed in the rabbit 

developmental and rat chronic/cancer 

studies were selected as risk assessment 

endpoints for all durations of exposure. 

Fluopicolide is classified as not likely to 

be carcinogenic to humans and no 

quantification of cancer risks is 

required. 

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 ‘‘2,6-Dichlorobenzamide (BAM). 2,6- 

Dichlorobenzamide (BAM) as a 

Metabolite/Degradate of Fluopicolide 

and Dichlobenil. Human Health Risk 

Assessment for Proposed Uses of 

Rhubarb, Dichlobenil on Caneberries 

(Subgroup 13–07A), and Bushberries 

(Subgroup 13–07B).’’ dated June 19, 

2008, in docket ID number EPA–HQ– 

OPP–2007–0604. 

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:// 

w www.regulations.gov in document: 

‘‘Fluopicolide and its Metabolite, 2,6- 

Dichlorobenzamide (BAEM). Human 

Health Risk Assessment to Support a 

Petition for an Increased Tolerance on 

Tuberous and Corm Subgroup 1C 

Vegetables,’’ pp. 31–35 in docket ID 

number EPA–HQ–OPP–2014–0225. 

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 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 

The fluopicolide exposure assessment 

considers exposure from fluopicolide 

only. EPA did not reassess 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 2008 BAM 

Human Health Risk Assessment, which 

remain unchanged. A discussion of how 

BAM exposures were assessed can be 

found in Unit III.C. of the final rule 

published in the Federal Register of 

August 27, 2008 (73 FR 50563) (FRL– 

8377–7). 

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 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. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with 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 

percent crop treated (PCT) and 

tolerance-level residues. 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. 

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. 

2. Dietary exposure from drinking 

water. 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 exposure (non-cancer) 

assessments are estimated to be 24.14 


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ppb for surface water and 0.5 ppb for 

ground water. Acute and cancer dietary 

risks were not quantified, as previously 

discussed. 

3. From non-dietary exposure. i. 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). 

ii. Fluopicolide is currently registered 

for the use on residential turf grass, 

recreational sites, and ornamental plants 

that could result in short-term 

residential exposures. EPA assessed 

residential exposure using the following 

assumptions: 

a. Residential handler short-term 

dermal and inhalation exposures to 

fluopicolide when mixing, loading, and 

applying the formulations. 

b. Residential post-application 

exposures via the dermal route for 

adults and children entering treated 

lawns or treated gardens and during 

mowing and golfing activities. and 

c. Incidental non-dietary ingestion 

(i.e., hand-to-mouth, object-to-mouth, 

and soil ingestion) by children 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. 

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. 

There is no evidence of quantitative 

susceptibility following in utero and/or 

postnatal fluopicolide 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. In this 

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 for 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 regarding fluopicolide. 

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. There is no evidence that 

fluopicolide results in increased 

susceptibility in in utero rabbits in the 

prenatal developmental studies or in 

young rats in the 2-generation 

reproduction study. Although there was 

some evidence of qualitative 

susceptibility in the rat developmental 

toxicity study, as discussed in Unit 

III.D.2., 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 postnatal 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 thirtyday assessment period and assuming 

high-end activities on turf for every day 

of the assessment period). Therefore, 

EPA is confident that it has not 

underestimated postapplication 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by fluopicolide. 

4. Conclusion regarding BAM. For 

reasons explained in the Unit III.D.3.ii. 

of the preamble to the final rule 

published in the Federal Register of 

August 27, 2008, 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 August 27, 2008 

final rule and the 2008 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 


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45692 Federal Register / Vol. 79, No. 151 / Wednesday, August 6, 2014 / Rules and Regulations 

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, fluopicolide 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 fluopicolide 

from food and water will utilize 13% of 

the cPAD for children 1–2 years old, 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. 

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 average 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 adults and 180 for 

children aged 6 to less than 11 years 

old. Because EPA’s level of concern for 

fluopicolide 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, fluopicolide 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 average 

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 

fluopicolide. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fluopicolide is not expected to pose a 

cancer risk to humans. 

6. BAM. As noted in Unit III.C., EPA 

does not expect the increased tolerances 

in this action to increase BAM exposure 

above what was assessed in the June 19, 

2008 BAM risk assessment. None of the 

results of this BAM risk assessment 

indicated a risk from aggregate BAM 

exposures, including for acute and 

chronic risks. Similarly, since short- and 

intermediate-term aggregate MOEs for 

BAM are greater than the LOC, they 

represent risk estimates that are below 

the Agency’s level of concern. Finally, 

EPA has determined that BAM does not 

pose an aggregate cancer risk for the 

U.S. population. EPA has relied upon 

the conclusions from the June 19, 2008 

BAM Risk Assessment in order to make 

these determinations. 

7. 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/tandem mass 

spectrometry (LC/MS/MS), 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 an 

MRL for fluopicolide on the subject 

commodities. 

C. Response to Comments 

EPA received one comment to the 

Notice of Filing that made a request to 

reconsider ‘‘loosening tolerances’’ for 

several pesticide petitions, including for 

fluopicolide. The commenter 

additionally noted that, ‘‘It is an issue 

of environmental justice that our 

youngest citizens—our children—are 

disproportionately exposed to health 

risks.’’ The commenter points to an 

American Academy of Pediatrics Policy 

statement regarding pesticide exposure 

in children, a Centers for Disease 

Control and Prevention report on 

human exposure to environmental 

chemicals, and a President’s Cancer 

Panel regarding reducing environmental 

cancer risks in supporting the request to 

reconsider the tolerance amendments 

proposed for fluopicolide. 

The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

certain pesticide chemicals should not 

be permitted in our food, or that 

pesticide tolerances should be 

‘‘significantly tightened’’ as the 

commenter notes. However, the existing 

legal framework provided by section 

408 of the FFDCA states that tolerances 

may be set when EPA determines that 

aggregate exposure to that pesticide is 

safe, i.e., that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to the pesticide 

chemical residue. When making this 

determination, EPA considers the 

toxicity, including any potential 

carcinogenicity, of the pesticide and all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. EPA also gives 

special consideration to the potential 

susceptibility and exposures of infants 

and children to the pesticide chemical 

residue when making this 

determination. For fluopicolide, the 

Agency has considered all the available 

data, including all available data 

concerning the potential for 

carcinogenicity of fluopicolide and its 

metabolites, and concluded after 

conducting a risk assessment, that there 

is a reasonable certainty that no harm 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 151 / Wednesday, August 6, 2014 / Rules and Regulations 45693 

will result from aggregate human 

exposure to fluopicolide and that, 

accordingly, the amended fluopicolide 

tolerances on potato, processed potato 

waste and vegetable, tuberous and corm, 

subgroup 1C, are safe. 

D. Revisions to Petitioned-For 

Tolerances 

Based on the data supporting the 

petition, EPA has determined that the 

proposed tolerance in or on potato, 

processed waste at 0.3 ppm should be 

established at 1.0 ppm. That 

determination was based on the 

following: Processing data previously 

provided for the use of fluopicolide on 

potato indicate that residues of 

fluopicolide concentrate in wet peels. 

Residues of fluopicolide found in or on 

potatoes are estimated to be in the range 

of 0.2 ppm to 0.25 ppm following 

directed soil application. Using the 

highest estimated value of residues 

found in or on potato and the theoretical 

concentration factor of 4.0X for potato 

processed waste (in accordance with 

EPA’s Residue Chemistry Test 

Guidelines), EPA has determined that a 

tolerance of 1.0 ppm is appropriate for 

residues on potato, processed waste. 

Additionally, EPA has revised the 

commodity terminology to potato, 

processed potato waste in order to 

reflect the preferred designation. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluopicolide, 2,6- 

dichloro-N-[[3-chloro-5- 

(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide, in or on 

potato, processed potato waste at 1.0 

ppm; and vegetable, tuberous and corm, 

subgroup 1C at 0.3 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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 29, 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, revise the following 

entries in the table in paragraph (a) to 

read as follows: 

§ 180.627 Fluopicolide; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

***

* *

Potato, processed potato waste 1.0 

***

* *

Vegetable, tuberous and corm, 

subgroup 1C ......................... 0.3 

* * * * * 

[FR Doc. 2014–18458 Filed 8–5–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0904; FRL–9912–92] 

Bifenazate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of bifenazate in 

or on multiple commodities which are 

identified and discussed later in this 

document including tolerances with 

regional restrictions for timothy hay and 

timothy forage. In addition, this 

regulation removes existing tolerances 

on ‘‘fruit, pome, group 11’’ ‘‘vegetable, 

fruiting, group 8’’ and existing timelimited tolerances for ‘‘timothy, forage’’ 

and ‘‘timothy, hay’’ that are superseded 


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