Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Rules and Regulations 22045 

FOR FURTHER INFORMATION CONTACT: 

Kathryn Boyle, Field and External 

Affairs Division, (7506P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington DC 20460–0001; 

telephone number: (703) 305–6304; email address: boyle.kathryn@epa.gov, or 

contact Scott Drewes, same address; 

telephone number (703) 347–0107; email address: drewes.scott@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

This action is directed to the public 

in general. It simply announces the 

submission of a draft final rule to the 

U.S. Department of Agriculture (USDA) 

and the Department of Health and 

Human Services (HHS) and does not 

otherwise affect any specific entities. 

This action may, however, be of 

particular interest if you are a producer 

of pesticide products (NAICS 32532), 

antifoulants (NAICS 32551), 

antimicrobial pesticides (NAICS 32561), 

wood preservatives (NAICS 32519), 

importers of such products, or any 

person or company who seeks to register 

an antimicrobial, antifoulant coating, 

ballast water treatment, wood 

preservative pesticide, or to obtain a 

tolerance for such a pesticide. Since 

other entities may also be interested, the 

Agency has not attempted to describe all 

the specific entities that may be 

interested in this action. If you have any 

questions regarding this action, consult 

one of the persons listed under FOR

FURTHER INFORMATION CONTACT. 

II. What action is EPA taking? 

Section 25(a)(2) of FIFRA requires the 

Administrator to provide the Secretary 

of Agriculture with a copy of any final 

regulation at least 30 days before signing 

it for publication in the Federal 

Register. Similarly, section 21(b) of 

FIFRA provides that the Administrator 

must provide the Secretary of Health 

and Human Services with a copy of any 

draft final rule pertaining to a public 

health pesticide at least 30 days before 

signing it for publication in the Federal 

Register. The draft final rule is not 

available to the public until after it has 

been signed by EPA. If either Secretary 

comments in writing regarding the draft 

final rule within 15 days after receiving 

it, the Administrator shall include the 

comments of the Secretary, if requested 

by the Secretary, and the 

Administrator’s response to those 

comments in the final rule when 

published in the Federal Register. If the 

Secretary does not comment in writing 

within 15 days after receiving the draft 

final rule, the Administrator may sign 

the final rule for publication in the 

Federal Register anytime after the 15– 

day period. 

III. Do any statutory and executive 

order reviews apply to this notification? 

No. This document is not a rule; it is 

merely a notification of submission to 

the Secretaries of Agriculture and 

Health and Human Services. As such, 

none of the regulatory assessment 

requirements apply to this document. 

IV. Will this Notification be Subject to 

the Congressional Review Act? 

No. This action is not a rule for 

purposes of the Congressional Review 

Act (CRA), 5 U.S.C. 804(3), and will not 

be submitted to Congress and the 

Comptroller General. EPA will submit 

the final rule to Congress and the 

Comptroller General as required by the 

CRA. 

List of Subjects 

40 CFR Part 158 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

40 CFR Part 161 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 7, 2011. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

[FR Doc. 2011–9292 Filed 4–19–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0481; FRL–8859–9] 

Fluopicolide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the fungicide, 

fluopicolide [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide], including 

its metabolites and degradates. 

Compliance with the tolerance levels 

specified is to be determined by 

measuring only fluopicolide in or on the 

commodity. The fluopicolide 

metabolite, 2,6-dichlorobenzamide 

(BAM), is regulated with its own set of 

tolerances. This regulation establishes 

tolerances for residues of fluopicolide 

and its metabolites in or on multiple 

commodities which are identified and 

discussed later in this document. Valent 

U.S.A. Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

20, 2011. Objections and requests for 

hearings must be received on or before 

June 20, 2011, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2006–0481. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Janet Whitehurst, Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–6129; e-mail address: 

whitehurst.janet@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 


jlentini on DSKJ8SOYB1PROD with RULES
22046 Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Rules and Regulations 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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.gpoaccess.gov/ecfr. 

To access the harmonized test 

guidelines referenced in this document 

electronically, please go http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2006–0481 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 20, 2011. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2006–0481, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of February 4, 

2010 (75 FR 5790) (FRL–8807–5), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 9F7617 and 

9F7568 by Valent U.S.A, 1600 Riviera 

Ave., Walnut Creek, CA 94596–8025). 

The petitions requested that 40 CFR 

180.627 be amended by establishing 

tolerances for residues of the fungicide, 

fluopicolide, and its metabolites, in or 

on Brassica, leafy greens, subgroup 5B 

at 20 parts per million (ppm) (9F7617). 

Additionally, Valent U.S.A. has 

proposed establishing tolerances for 

residues of the fluopicolide metabolite, 

BAM on cattle, goat, horse and sheep 

meat at 0.02 ppm; cattle, goat, horse and 

sheep fat at 0.05 ppm; cattle, goat, horse 

and sheep meat byproducts at 0.05 ppm; 

and milk at 0.01 ppm (9F7568). These 

notices referenced a summary of the 

petitions prepared by Valent U.S.A., the 

registrant, which is available in the 

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

Valent U.S.A. previously submitted 

petition 5F7016 to the Agency for 

consideration of uses on tuberous and 

corm vegetables and tolerance for 

indirect or inadvertent tolerances 

resulting from rotation to wheat. The 

Interregional Research Project No 4 (IR– 

4) submitted petition 7E7172 which 

included uses on root and tuber 

vegetables. In the Federal Register of 

May 28, 2008 (73 FR 30492) (FRL–8363– 

7), and the Federal Register of June 27, 

2007 (72 FR 35237) (FRL–8133–4), EPA 

issued notices pursuant to section 

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

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

these petitions. The Agency reviewed 

the submitted petitions and concluded 

that due to data deficiencies, 

commodities that had associated animal 

feed items were not, at that time, 

supported by adequate data. Therefore, 

while the Agency approved the majority 

of new uses requested in the petition 

5F7016, the Agency did act on the 

request for uses on potato, sugar beets 

and carrots, and on the request to allow 

rotation to wheat. 

Valent U.S.A. subsequently submitted 

additional data to address deficiencies 

cited in the Agency reviews for the 

petition 5F7016, including supporting 

data for the animal metabolism study, a 

BAM feeding study, confirmatory 

analytical method and documentation 

that a BAM reference standard is 

available; and requests that 40 CFR 

180.627 be amended by establishing 

tolerances for residues of the fungicide 

fluopicolide in or on vegetable, tuberous 

and corm subgroup 1C at 0.02 ppm; 

potato, processed potato waste at 0.05 

ppm; vegetable root, subgroup 1A at 

0.15 ppm. The petitioner also requested 

the establishment of tolerances for 

indirect or inadvertent residues of 

fluopicolide in or on wheat, forage at 

0.20 ppm; wheat, grain at 0.02 ppm; 

wheat, hay at 0.50 ppm; wheat, milled 

byproducts at 0.07 ppm; wheat, straw at 

0.50 ppm; wheat, aspirated grain 

fractions at 0.07 ppm. Concurrently 

with establishing the crop subgroup 1A 

tolerance, the petitioner proposed to 

delete the current tolerance on the 

‘‘vegetable root, subgroup 1A, except 

sugar beet and carrot’’ since the new 1A 

unrestricted tolerance will cover the 

existing commodity tolerances as well 

as tolerances needed for the new uses 

on sugar beets and carrots. Additionally, 

concurrently with establishing the crop 

supgroup 1C ‘‘vegetable, tuberous and 

corm subgroup,’’ the petitioner proposed 

to delete the current tolerance on 

‘‘vegetable, tuberous and corm (except 

potato) subgroup 1D tolerance, since the 

new 1C subgroup tolerance will cover 

the existing commodity tolerances listed 

under 1C as well as the tolerance 

needed for the new use on potatoes. 

There were no comments received in 

response to these notices of filings. 

Based upon review of the data 

supporting the petition, EPA has 

modified the tolerances proposed for 

vegetable, brassica (cole) leafy subgroup 

5B. The appropriate tolerance for 

vegetable brassica (cole) leafy subgroup 

5B is 18 ppm. The reason for this 

change is explained in Unit IV.D. EPA 

has not established the requested BAM 

tolerances because the relevant data 

showed that no new tolerances for BAM 

are required for animal commodities. 

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.’’ 


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Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Rules and Regulations 22047 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 and 

separately for the fluopicolide 

metabolite, BAM, including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

fluopicolide and separately, the 

fluopicolide metabolite BAM follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data for fluopicolide 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 technical grade 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 (body weight, kidney) 

occurred only at levels causing 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 for all exposure scenarios. 

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 observed 

adverse effect level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Fluopicolide and its Metabolite, 2,6– 

Dichlorobenzamide (BAM). 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 

in the docket ID number EPA–HQ–OPP– 

2006–0481. 

BAM (AE C653711) is a common 

metabolite and/or environmental 

degradate of fluopicolide as well as the 

herbicide dichlobenil. Because the 

toxicological endpoints for BAM and 

fluopicolide are different, a separate 

human health risk assessment is 

required which addresses risks from 

exposure to BAM residues. The BAM 

risk assessment considers residues 

resulting from both fluopicolide and 

dichlobenil uses. However, BAM 

residues generated from fluopicolide 

uses are expected to be significantly 

lower than BAM residues from 

dichlobenil uses. 

EPA has evaluated the available 

toxicity data for BAM 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 BAM toxicity database indicates 

that BAM has moderate acute toxicity 

via the oral route of exposure. In 

subchronic and chronic toxicity studies, 

the primary oral effects seen in the rat 

and dog were body weight changes. 

Adverse liver effects were also observed. 

There is no evidence that BAM is either 

mutagenic or clastogenic nor is there 

evidence of endocrine mediated 

toxicity. BAM is considered to be 

neurotoxic. In the absence of 

carcinogenicity study data for a second 

species, the Agency has assumed that 

BAM’s carcinogenic potential is similar 

to that of dichlobenil, the parent 

compound having the greatest 

carcinogenicity potential. Dichlobenil is 

classified as ‘‘Group C, possible human 

carcinogen.’’ Quantification of cancer 

risk for BAM is based on the reference 

dose (RfD) approach which requires 

comparison of the chronic exposure to 

the RfD. Using this methodology will 

adequately account for all chronic toxic 

effects, including carcinogenicity, likely 

to result from exposure to BAM. 

Specific information regarding the 

metabolite of fluopicolide can be found 

in the document entitled 2,6- 

Dichlorobenzamide (BAM) as a 

Metabolite/Degradate of Fluopicolide 

and Dichlobenil. Human Health Risk 

Assessment for Proposed Uses of 

Fluopicolide on Tuberous and Corm 

Vegetables, Leafy Vegetables (except 

brassica), Fruiting Vegetables, Cucurbit 

Vegetables, Grapes, Turf, and 

Ornamentals, and for Indirect or 

Inadvertent Residues on the Rotational 

Crop Wheat (PC Codes: 027402 BAM 

and 027412 (fluopicolide), Petition No: 

5F7016 at regulations.gov). Both 

referenced documents are available in 

the docket established for this action, 

which is described under ADDRESSES, 

and is identified as docket ID number 

EPA–HQ–OPP–2006–0481. A 

quantitative reassessment of the BAM 

risk for the new uses associated with the 

petitions 9F7617 and 9F7568 was not 

conducted because the new uses do not 

add significantly to the BAM dietary 

exposure; therefore, the conclusions 

from the most recently conducted BAM 

human health risk assessment remain 

unchanged. 

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 


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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. 

The selected toxicological endpoints 

used for fluopicolide are presented 

below. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOPICOLIDE FOR USE IN DIETARY AND

OCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS

Exposure/scenario Point of departure Uncertainty/ 

FQPA safety factors 

RfD, PAD, level of 

concern for risk 

assessment 

Study and toxicological effects 

Acute Dietary (all populations) An endpoint attributable to a single dose was not identified from the available data. 

Chronic Dietary (all populations) Maternal NOAEL = 

20 mg/kg/day. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1X 

Chronic RfD = 

0.2 mg/kg/day 

cPAD = 0.2 mg/kg/ 

day. 

Developmental Toxicity Study in Rabbits 

LOAEL (maternal) = 60 mg/kg/day 

based on death, abortions/premature 

deliveries, decreased food consumption and body weight gain. 

Co-critical: Chronic/Oncogenicity Study 

in Rats 

NOAEL = 31.5 mg/kg/day. 

LOAEL = 109.4 mg/kg/day based on decreased body weight gain and increased thyroid weight and increased 

incidence of thyroid lesions. 

Incidental Oral Intermediate-Term 

(1–6 months) 

Maternal NOAEL = 

20 mg/kg/day. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1X 

MOE = 100 (occupational). 

MOE = 100 (residential). 

Developmental Toxicity Study in Rabbits 

LOAEL (maternal) = 60 mg/kg/day 

based on death, abortions/premature 

deliveries, decreased food consumption and body weight gain 

Dermal Short-, Intermediate- and 

Long-Term (1–30 days, 1–6 

months, and > 6 months) 

Maternal NOAEL = 

20 mg/kg/day. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1X 

37% dermal absorption. 

MOE = 100 (occupational). 

MOE = 100 (residential). 

Developmental Toxicity Study in Rabbits 

LOAEL (maternal) = 60 mg/kg/day 

based on death, abortions/premature 

deliveries, decreased food consumption and body weight gain. 

Co-critical: Chronic/Oncogenicity Study 

in Rats 

NOAEL = 31.5 mg/kg/day. 

LOAEL = 109.4 mg/kg/day based on decreased body weight gain and increased thyroid weight and increased 

incidence of thyroid lesions. 

Inhalation Short-, Intermediateand Long-term (1–30 days, 1–6 

months, and > 6 months) 

Maternal NOAEL = 

20 mg/kg/day. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1X 

(inhalation and oral 

toxicity are assumed to be 

equivalent). 

MOE = 100 (occupational). 

MOE = 100 (residential). 

Developmental Toxicity Study in Rabbits 

LOAEL (maternal) = 60 mg/kg/day 

based on death, abortions/premature 

deliveries, decreased food consumption and body weight gain. 

Co-critical: Chronic/Oncogenicity Study 

in Rats 

NOAEL = 31.5 mg/kg/day. 

LOAEL = 109.4 mg/kg/day based on decreased body weight gain and increased thyroid weight and increased 

incidence of thyroid lesions. 

Cancer (oral, dermal, inhalation) Classification: ‘‘Not Likely to be Carcinogenic to Humans.’’ 

FQPA SF = FQPA Safety Factor. 

LOC = level of concern. 

LOAEL = lowest observed adverse effect level. 

MOE = margin of exposure. 

N/A = not applicable. 

NOAEL = no observed adverse effect level. 

PAD = population adjusted dose (a = acute, c = chronic). 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. 

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). 


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Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Rules and Regulations 22049 

A summary of the toxicological 

endpoints for BAM used for human risk 

assessment can be found at 

regulations.gov in the document entitled 

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 in docket ID number 

EPA–HQ–OPP–2006–0481. 

The selected toxicological endpoints 

used for BAM are presented below. 

TABLE 2—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 2,6–DICHLOROBENZAMIDE (BAM) FOR USE IN

DIETARY, RESIDENTIAL, AND OCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS

Exposure scenario Point of departure Uncertainty/ 

FQPA safety factors 

RfD, PAD, level of 

concern for risk 

assessment 

Study and toxicological effects 

Acute Dietary (General population, including infants and 

children) 

LOAEL = 100 mg/kg/ 

day. 

UFA = 10X 

UFH = 10X 

FQPA SF4 5 = 10X (includes UFL and 

UFDB). 

aRfD = aPAD = 0.1 

mg/kg/day. 

Dose-range finding assay for in vivo mouse 

erythrocyte micronucleus assay. 

LOAEL = 100 mg/kg/day based on lethargy 

after a single oral dose. 

Acute Dietary (Females 13–49 years 

of age) 

NOAEL = 30 mg/kg/ 

day. 

UFA = 10X 

UFH = 10X 

FQPA SF 4 = 10X 

(includes UFDB). 

aRfD = aPAD = 0.03 

mg/kg/day. 

Developmental toxicity (rabbit) 

Offspring LOAEL = 90 mg/kg/day based on 

increased incidences of late abortion and 

skeletal (bipartite interparietal bone) and 

visceral (postcaval lung lobe agenesis) 

anomalies 

Chronic Dietary (All 

populations) 

NOAEL = 4.5 

mg/kg/day. 

UFA = 10X 

UFH = 10X 

FQPA SF 4 = 10X 

(includes UFDB). 

cRfD = cPAD = 

0.0045 mg/kg/day. 

Chronic toxicity (dog) 

LOAEL = 12.5 mg/kg/day based on decreased body weight and body weight 

gain. 

Incidental Oral 

Short- and Intermediate-Term (1–30 

days and 1–6 

months) 

NOAEL = 14 

mg/kg/day. 

UFA = 10X 

UFH = 10X 

FQPA SF4 = 10X 

(includes UFDB). 

Residential LOC for 

MOE = 1000. 

90-day oral (rat) 

LOAEL = 49 mg/kg/day based on decreased 

body weight gain (M) and reduced skeletal 

muscle tone (day 4 only in males; days 91 

and 92 only in females). 

Dermal 

Short-, Intermediate-, 

and Long-Term 

(1–30 days, 1–6 

months, and > 6 

months) 

NOAEL = 25 

mg/kg/day. 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X (residential uses only). 

Residential and Occupational LOC for 

MOE = 100. 

5-day dermal using dichlobenil 6 (mouse; literature study 1). 

LOAEL = 50 mg/kg/day based on olfactory 

epithelial damage. 

Inhalation 

Short-, Intermediate-, 

and Long-Term 

(1–30 days, 1–6 

months, and > 6 

months) 

NOAEL = 3.1 

mg/kg/day 2

UFA = 10X 

UFH = 10X 

FQPA SF = 1X (residential uses only). 

Residential and Occupational LOC for 

MOE = 100. 

28-day inhalation using dichlobenil 6 (rat) 

LOAEL = 5.5 mg/kg/day 3 based on nasal 

degeneration. 

Cancer Classification: Formally unclassified; parent herbicide dichlobenil classified as ‘‘Group C, possible human carcinogen’’ 

with RfD approach utilized for quantification of human risk. 

FQPA SF = FQPA Safety Factor. 

LOAEL = lowest observed adverse effect level. 

LOC = level of concern. 

NOAEL = no observed adverse effect level. 

MOE = margin of exposure. 

N/A = Not Applicable. 

PAD = population adjusted dose. 

RfD = reference dose (a = acute, c = chronic). 

UF = uncertainty factor. 

UFA = extrapolation from animal to human (interspecies). 

UFDB = to account for the absence of key data. 

UFH = potential variation in sensitivity among members of the human population (intraspecies). 

UFL = use of a LOAEL to extrapolate a NOAEL. 1 Deamer NJ, O’Callaghan JP, Genter MB. (1994). Olfactory toxicity resulting from dermal application of 2,6-dichlorobenzonitrile (dichlobenil) in 

the C57Bl mouse. Neurotoxicology 15(2):287–93. 2 Calculated as follows: (NOAEL) × (m3/1000 L) × (10.26 L/hr) × 6 hr/day × (1/0.236 kg), where NOAEL = 12 mg/m3 from 28-day inhalation toxicity study (Sprague Dawley rat). 3 Calculated as follows: (LOAEL) × (m3/1000 L) × (10.26 L/hr) × 6 hr/day × (1/0.236 kg), where LOAEL = 21 mg/m3 from 28-day inhalation toxicity study (Sprague Dawley rat). 4The FQPA SF has been retained in the form of a UFDB for the lack of neurotoxicity data, including olfactory toxicity data. 5The FQPA SF has been retained in the form of a UFL and UFDB for the use of a LOAEL to extrapolate a NOAEL and for the lack of olfactory 

toxicity data. 6 In the absence of route-specific data, endpoints for all dermal and inhalation exposure scenarios were identical to those for dichlobenil (parent), since olfactory toxicity has been observed following i.p. administration of BAM in mice [Brittebo EB, Eriksson C, Feil V, Bakke J, Brandt I. 

(1991). Toxicity of 2,6-dichlorothiobenzamide (chlorthiamid) and 2,6-dichlorobenzamide in the olfactory nasal mucosa of mice. Fundam Appl 

Toxicol 17(1):92–102]. 


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22050 Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Rules and Regulations 

A summary of the toxicological 

endpoints for BAM used for human risk 

assessment can be found at 

regulations.gov in the document entitled 

2,6-Dichlorobenzamide BAM as a 

Metabolite/Degradate of Fluopicolide 

and Dichlobenil. Human Health Risk 

Assessment for Proposed Uses of 

Fluopicolide on Tuberous and Corm 

Vegetables, Leafy Vegetables (except 

brassica), Fruiting Vegetables, Cucurbit 

Vegetables, Grapes, Turf, and 

Ornamentals, and for Indirect or 

Inadvertent Residues on the Rotational 

Crop Wheat (PC Codes: 027402 BAM 

and 027412 Fluopicolide, Petition No: 

5F7016 (71 FR 34345) (FRL–8071–4) in 

docket ID number EPA–HQ–OPP–2006– 

0481). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluopicolide and its 

metabolites, EPA considered exposure 

under the petitioned-for tolerances as 

well as all existing fluopicolide 

tolerances in 40 CFR 180.40. EPA 

assessed dietary exposures from 

fluopicolide and separately, its 

metabolite, BAM 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. 

A conservative acute dietary exposure 

assessment for the metabolite of 

fluopicolide, 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. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the U.S. 

Department of Agriculture 1994–1996 

and 1998 Continuing Survey of Food 

Intake by Individuals. As to residue 

levels in food, two chronic assessments 

were conducted: One assessment for 

parent fluopicolide (including residues 

of concern other than the metabolite 

BAM) and one assessment for BAM. As 

to residue levels in food, EPA assumed 

for the parent fluopicolide assessment 

that all foods for which there are 

tolerances were treated and contain 

tolerance-level residues. A conservative 

chronic dietary exposure assessment for 

the metabolite of fluopicolide, BAM, 

was conducted as described in Unit 

III.C.1.i. for the acute assessment. 

iii. Cancer. Fluopicolide is not likely 

to be carcinogenic to humans; therefore, 

a cancer risk assessment was not 

conducted for the parent fluopicolide. 

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. To be 

conservative, EPA has assumed that 

BAM’s potential for carcinogenicity is 

similar to the parent having the greatest 

carcinogenic potential. As noted, 

fluopicolide has been classified as not 

likely to be carcinogenic to humans; 

dichlobenil is classified as ‘‘Group C, 

possible human carcinogen’’ with the 

reference dose (RfD) approach utilized 

for quantification of human risk. 

Accordingly, EPA has assessed BAM’s 

cancer risk by comparing BAM exposure 

to the dichlobenil RfD. 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 or maximum field trial residues 

and 100% CT were assumed for all food 

commodities. 

EPA used anticipated residues and 

PCT information for the acute and 

chronic dietary risk assessments for 

BAM. Section 408(b)(2)(E) of FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such Data CallIns (DCIs) as are required by FFDCA 

section 408(b)(2)(E) and authorized 

under FFDCA section 408(f)(1). Data 

will be required to be submitted no later 

than 5 years from the date of issuance 

of these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which may be applied in a particular 

area. 

The assessments assumed 100 PCT for 

fluopicolide and dichlobenil, except for 

the following dichlobenil-treated crops: 

a. For the acute assessment: Apples 

(2.5%), blueberries (2.5%), cherries 

(2.5%), peaches (2.5%), pears (2.5%), 

and raspberries (5%). 

b. For the chronic assessment: Apples 

(1%), blueberries (1%), cherries (1%), 

cranberries (45%), peaches (1%), pears 

(1%), and raspberries (5%). 

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 


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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 

acute exposures are estimated to be 

25.50 parts per billion (ppb) for surface 

water and 0.5 ppb for ground water. 

The EECs for chronic exposures (noncancer) assessments are estimated to be 

24.14 ppb for surface water and 0.5 ppb 

for ground water. 

The EECs for chronic exposures 

(cancer) assessments are estimated to be 

22.36 ppb for surface water. The EECs 

for acute and chronic assessments are 

estimated to be 0.5 ppb in ground water. 

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 access 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)) are used 

in this 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. 

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 

residential exposures: Residential turf 

grass 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. Toddlers may 

also experience exposure via incidental 

non-dietary ingestion (i.e., hand-tomouth, object-to-mouth (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. 

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 fluopicolide or the 

fluopicolide metabolite, BAM to share a 

common mechanism of toxicity with 

any other substances. For the purposes 

of this tolerance action, therefore, EPA 

has assumed that fluopicolide and BAM 

do not have a common mechanism of 

toxicity with other substances. Residues 

of BAM resulting from both the use of 

fluopicolide as well as from dichlobenil 

were evaluated to support the requested 

new uses. 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 posnatal 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. 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. 

For BAM, there is no evidence of 

quantitative susceptibility following in 

utero and/or postnatal expsoure in the 

rabbit developmental toxicity study or 

in the 3-generation rat reproduction 

study. Qualitative susceptibility was not 

observed in the 3-generation 

reproduction study. Qualitative 

susceptibility was observed in the rabbit 

developmental toxicity study. Fetal 

effects (skeletal and visceral anomalies) 

and late-term abortions were observed. 

There is low concern for this qualitative 

susceptibility, because the fetal effects 

and late-term abortions have been wellcharacterized and occurred at dose 

levels where significant maternal 

toxicity (severe body weight gain 

decrements and decreased food 

consumption) was observed. 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 BAM. 

3. Conclusion. As to fluopicolide, EPA 

has determined that reliable data show 

that it would be safe for infants and 

children to reduce the FQPA SF to 1X. 

That decision is based on the following 

findings: 

i. The toxicity database for 

fluopicolide is largely complete, lacking 

only an immunotoxicity study. EPA has 

evaluated the available toxicity data for 

fluopicolide and determined that an 

additional database uncertainty factor is 

not needed to account for potential 

immunotoxicity. The most sensitive 

endpoint in the database was decreased 

food consumption, decreased body 

weight gain, abortions/premature 

deliveries, and death. No definitive 

cross-species target organ was identified 

for fluopicolide; however, liver toxicity, 

kidney toxicity, and thyroid toxicity 

were observed in the database. No 

treatment-related changes indicative of 

potential immunotoxicity were seen in 

hematology parameters, organ weights 

(thymus, spleen), gross necropsy 

(enlarged lymph nodes), or 

histopathology (spleen, thymus, lymph 

nodes) when tested up to the limit dose 

in mice and rats. Therefore, EPA does 

not believe that conducting a special 

harmonized test guideline series 

870.7800 immunotoxicity study will 

result in a NOAEL less than 20 mg/kg/ 

day, which is presently used as the 


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22052 Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Rules and Regulations 

point of departure for chronic risk 

assessment. 

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. The degree of concern for prenatal 

and/or postnatal toxicity is low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. Conservative 

ground water and surface water 

modeling estimates were used. Similarly 

conservative residential SOPs were used 

to assess post-application exposure to 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by fluopicolide. 

EPA has retained the 10X FQPA SF 

for BAM for those exposure scenarios 

that do not rely on dichlobenil toxicity 

data. These scenarios are acute dietary 

for the general population (including 

infants and children) and females 13–49 

years of age; chronic dietary; and 

incidental oral non-dietary. Although 

EPA has developmental, reproduction, 

and subchronic and chronic toxicity 

studies for the metabolite BAM, and a 

structure activity analysis indicates EPA 

has identified its principal toxicological 

effects and level of toxicity, EPA is 

retaining the FQPA 10X SF due to 

remaining questions regarding the 

systemic neurotoxic potential of BAM, 

including olfactory toxicity via the oral 

route of exposure and the use of a 

LOAEL in assessing acute dietary risk 

for the general population. For the 

dermal and inhalation routes of 

exposures, for which the Agency is 

relying on dichlobenil toxicity data, 

EPA has reduced the FQPA SF for BAM 

toxicity to 1X, based on a comparison of 

toxicity via the intraperitoneal route of 

exposure showing that higher doses of 

BAM are needed to induce levels of 

olfactory toxicity that are similar to 

those caused by dichlobenil. Olfactory 

toxicity, the most sensitive endpoint, 

was the endpoint chosen for these 

exposure scenarios. Other factors EPA 

considered in the FQPA SF decisions 

for BAM include the following: 

a. To compensate for deficiencies in 

the toxicology database for BAM, EPA 

performed a comparative analysis of the 

toxicity of BAM and the parent 

compounds, dichlobenil and 

fluopicolide, using the available animal 

data and DEREK analysis (Deductive 

Estimation of Risk from Existing 

Knowledge). DEREK is a toxicology 

application that uses structure-activity 

relationships to predict a broad range of 

toxicological properties based on a 

comprehensive analysis of a 

compound’s molecular structure. Based 

on the available animal data and DEREK 

analyses, BAM does not appear to cause 

different organ-specific toxicities 

compared to fluopicolide and 

dichlobenil. The kidney and liver 

toxicities are common to all three 

compounds. With respect to relative 

toxicity, conclusions from the 

evaluation of the animal studies appear 

to confirm that both fluopicolide and 

dichlobenil appear to be more or equally 

toxic compared to BAM. A full 

discussion of EPA’s comparative 

toxicity analysis of BAM, dichlobenil 

and fluopicolide can be found at 

http://www.regulations.gov in the 

document Comparative Toxicity Using 

Derek Analysis for Dichlobenil, 

Fluopicolide and BAM in docket ID 

number EPA–HQ–OPP–2007–0604. 

Based on the results of the available 

animal data and the DEREK analysis, 

EPA concludes that the safety factors 

discussed in the previous paragraph are 

adequate. 

b. There is no evidence that BAM 

results in increased susceptibility of in 

utero rabbits in the prenatal 

developmental toxicity study. 

c. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were refined using reliable PCT 

information and anticipated residue 

values calculated from residue field trial 

results. EPA made conservative 

(protective) assumptions in the ground 

water and surface water modeling used 

to assess exposure to BAM 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 BAM. 

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, 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 13% 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 

proposed for registration for use(s) that 

could result in short-term residential 

exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for fluopicolide. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that 

food, water, and residential exposures 

result in aggregate MOEs greater than 

the LOC of 100 for all population 

groups, and the aggregate short-term risk 

estimates for fluopicolide are below the 

Agency’s level 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 


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to be a background exposure level). 

Fluopicolide is proposed for registration 

for use(s) that could result in 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic food 

and water and intermediate-term 

exposures for fluopicolide. The 

intermediate-term aggregate risk for 

fluopicolide and BAM is the same as 

calculated above for the short-term 

aggregate risk. 

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. The chronic risk 

assessment for BAM is protective of any 

potential cancer risk. Fluopicolide has 

been classified as ‘‘not likely to be 

carcinogenic 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 fluopicolide 

and its metabolite, BAM 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 U.N. 

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. 

A Codex tolerance for fluopicolide 

has been established at 0.2 ppm for the 

straw and fodder (dry) of cereal grains. 

However, this level is lower than 

residues values seen in wheat straw in 

U.S. field trials. Since the Codex MRL 

would not cover residues of fluopicolide 

in wheat straw resulting from the 

allowed use pattern in the U.S., the 

Agency has used the NAFTA MRL 

calculator to determine an appropriate 

tolerance level. There are no other 

Codex, Canadian, or Mexican MRLs 

which have been established for the 

other uses which are the subject of this 

action. 

C. Revisions to Petitioned-for Tolerances 

The proposed tolerance for vegetable, 

brassica (cole) leafy subgroup 5B should 

be changed from 20 ppb to 18 ppb. This 

tolerance was determined considering 

residue/processing data and, as 

applicable, recent agency guidance 

(‘‘NAFTA Guidance Document for 

Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data,’’ 

Regulatory Proposal PRO2005–04, U.S. 

EPA and Health Canada, Pest 

Management Regulatory Agency, 2005. 

The Agency has considered the 

submitted BAM animal feeding study, 

has calculated maximum reasonably 

balanced diets for livestock 

commodities based on existing and new 

uses of fluopicolide and concludes that 

BAM tolerances are not required to 

support the requested new uses. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluopicolide, in or on 

vegetable, tuberous and corm subgroup 

1C at 0.02 ppm; potato, processed potato 

waste at 0.05 ppm; vegetable root, 

subgroup 1A at 0.15 ppm; vegetable, 

brassica leafy greens subgroup 5B at 18 

ppm; wheat, forage at 0.20 ppm; wheat, 

grain at 0.02 ppm; wheat, hay at 0.50 

ppm; wheat, milled byproducts at 0.07 

ppm; wheat, straw at 0.50 ppm; wheat, 

aspirated grain fractions at 0.07 ppm. 

Since the established tolerances for 

subgroup ‘‘1A, except sugar beets and 

carrots,’’ and crop subgroup 1D 

(vegetable, tuberous and corm, except 

potato) are subsumed by the new 

unrestricted crop subgroup 1A tolerance 

and the subgroup 1C (vegetable, 

tuberous and corm) tolerance, the 

Agency will delete these tolerances 

concurrently with establishing the 

tolerances above. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 

104–4). 

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 


jlentini on DSKJ8SOYB1PROD with RULES
22054 Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Rules and Regulations 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: April 8, 2011. 

G. Jeffrey Herndon, 

Acting Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.627 is amended by: 

■ i. Removing the entries ‘‘Vegetable 

root, subgroup 1A, except sugar beet 

and carrot’’ and ‘‘Vegetable, tuberous 

and corm (except potato) subgroup 1D’’ 

from the table in paragraph (a). 

■ ii. Revising (a) introductory text. 

■ iii. Adding alphabetically 

commodities to the table in paragraph 

(a). 

■ iv. Revising paragraph (d) to read as 

follows: 

§ 180.627 Fluopicolide; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

fluopicolide [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide], including 

its metabolites and degradates, in or on 

the commodities in the table in this 

paragraph. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

fluopicolide [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide] in or on 

the commodity. 

Commodity Parts per 

million 

* * * * * 

Potato, processed waste .......... 0 .05 

* * * * * 

Vegetable, brassica (cole) leafy 

subgroup 5B .......................... 18 

* * * * * 

Vegetable root, subgroup 1A ... 0 .15 

Vegetable, tuberous and corm 

subgroup 1C ......................... 0 .02 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for residues 

of the fungicide fluopicolide [2,6- 

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

(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide], including 

its metabolites and degradates, in or on 

the commodities in the table in this 

paragraph. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

fluopicolide [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide] in or on 

the commodity. 

Commodity Parts per 

million 

Wheat, aspirated grain fractions 0.07 

Wheat, forage ............................. 0.20 

Wheat, grain ............................... 0.02 

Wheat, hay ................................. 0.50 

Wheat, milled byproducts ........... 0.07 

Wheat, straw ............................... 0.50 

[FR Doc. 2011–9435 Filed 4–19–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 65 

[Docket ID FEMA–2011–0002] 

Changes in Flood Elevation 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Modified Base (1% annualchance) Flood Elevations (BFEs) are 

finalized for the communities listed 

below. These modified BFEs will be 

used to calculate flood insurance 

premium rates for new buildings and 

their contents. 

DATES: The effective dates for these 

modified BFEs are indicated on the 

following table and revise the Flood 

Insurance Rate Maps (FIRMs) in effect 

for the listed communities prior to this 

date. 

ADDRESSES: The modified BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–4064, or (e-mail) 

luis.rodriguez1@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below of the modified BFEs for 

each community listed. These modified 

BFEs have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Federal 

Insurance and Mitigation Administrator 

has resolved any appeals resulting from 

this notification. 

The modified BFEs are not listed for 

each community in this notice. 

However, this final rule includes the 

address of the Chief Executive Officer of 

the community where the modified BFE 

determinations are available for 

inspection. 

The modified BFEs are made pursuant 

to section 206 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4105, 

and are in accordance with the National 

Flood Insurance Act of 1968, 42 U.S.C. 

4001 et seq., and with 44 CFR part 65. 

For rating purposes, the currently 

effective community number is shown 

and must be used for all new policies 

and renewals. 

The modified BFEs are the basis for 

the floodplain management measures 

that the community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

to remain qualified for participation in 

the National Flood Insurance Program 

(NFIP). 

These modified BFEs, together with 

the floodplain management criteria 

required by 44 CFR 60.3, are the 

minimum that are required. They 

should not be construed to mean that 

the community must change any 

existing ordinances that are more 

stringent in their floodplain 

management requirements. The 

community may at any time enact 

stricter requirements of its own or 

pursuant to policies established by other 

Federal, State, or regional entities. 


jlentini on DSKJ8SOYB1PROD with RULES