Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 66723 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 26, 2012. 

Daniel J. Rosenblatt, 

Acting 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 § 180.617, revise the following 

entry in the table in paragraph (a) to 

read as follows: 

§ 180.617 Metconazole; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Corn, sweet, stover ..................... 30.0 

* * * * * 

* * * * * 

[FR Doc. 2012–27191 Filed 11–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0009; FRL–9366–6] 

Fluazinam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluazinam in 

or on melon subgroup 9A and pepper/ 

eggplant subgroup 8–10B, associated 

with pesticide petition (PP) 1E7959; and 

soybean, seed and soybean, hulls, 

associated with PP 2F7977. 

Interregional Research Project Number 4 

(IR–4) and ISK Biosciences Corporation 

requested the tolerances associated with 

PPs 1E7959 and 2F7977, respectively, 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 7, 2012. Objections and 

requests for hearings must be received 

on or before January 7, 2013, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0009, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

Nollen.Laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 


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66724 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0009 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 January 7, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0009, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-ForTolerance 

In the Federal Register of March 14, 

2012 (77 FR 15012) (FRL–9335–9), 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 1E7959) by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.574 be 

amended by establishing tolerances for 

residues of the fungicide fluazinam, (3- 

chloro-N-[3-chloro-2,6-dinitro-4- 

(trifluoromethyl)phenyl]-5- 

(trifluoromethyl)-2-pyridinamine), in or 

on fruiting vegetables group, pepper/ 

eggplant subgroup 8–10B at 0.10 parts 

per million (ppm); and cucurbit 

vegetables, melon subgroup 9A at 0.08 

ppm. That document referenced a 

summary of the petition prepared on 

behalf of IR–4 by ISK Biosciences 

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. 

Additionally, in the Federal Register 

of July 25, 2012 (77 FR 43562) (FRL– 

9353–6), EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of a PP 2F7977 by ISK Biosciences 

Corporation, 7470 Auburn Road, Suite 

A, Concord, OH 44077. The petition 

requested that 40 CFR 180.574 be 

amended by establishing tolerances for 

residues of the fungicide fluazinam in or 

on soybean, seed at 0.01 ppm; and 

soybean, hulls at 0.02 ppm. That 

document referenced a summary of the 

petition prepared by ISK Biosciences 

Corporation, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petitions, EPA has 

revised the tolerances for several 

commodities. The reason for these 

changes is 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 fluazinam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluazinam 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. 

Following subchronic and chronic 

exposure to fluazinam, the liver 

appeared to be a primary target organ in 

rats, dogs, and mice. Signs of liver 

toxicity included changes in clinical 

chemistry (increased serum alkaline 

phosphatase and aspartate 

aminotransferase), increased absolute 

and/or relative liver weights, increased 

incidences of gross lesions (pale, 

enlarged, pitted, mottled, accentuated 

markings), and a variety of 

histopathological lesions. Treatmentrelated effects were also observed in 

other organs following subchronic and 

chronic exposure to fluazinam, but 

these effects were not consistently noted 

in all three species or in all studies in 

a given species. In a subchronic 

inhalation toxicity study in rats, 

pulmonary effects were observed at the 

mid and high doses. These effects 

included dose-related increases in lung/ 

bronchial weights and increased 

incidences of alveolar macrophages and 

peribronchiolar proliferation in both 

sexes. 

In the developmental toxicity study in 

rabbits, treatment-related maternal 

effects (decreased food consumption 

and increased liver histopathology) 

were noted in the absence of fetal 

effects. In the 2-generation rat 

reproduction study, decreased pup 

weight gain was seen at the highest dose 

tested, in the presence of decreased food 

consumption and liver histopathology 

in parental animals. In a developmental 

toxicity study in rats, fetal effects 

included decreases in body and 

placental weights, increased incidences 

of facial/palate clefts, diaphragmatic 

hernias, delayed ossification in several 

bone types, increases in late resorptions, 

as well as evidence of a greenish 

amniotic fluid and post-implantation 

loss. Maternal effects, including 

decreases in body weight gain/food 

consumption and increases in water 


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Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 66725 

consumption and urogenital staining, 

were observed at the same dose level. In 

the rat developmental neurotoxicity 

(DNT) study, effects in pups (including 

decreases in body weight/body weight 

gain and delayed preputial separation) 

were noted in the absence of maternal 

toxicity. 

In an acute neurotoxicity study in 

rats, effects included decreases in motor 

activity and soft stools; these effects 

were considered to be due to systemic 

toxicity and not a result of frank 

neurotoxicity. No signs of neurotoxicity 

were observed in two subchronic 

neurotoxicity studies in rat up to the 

highest dose tested. A neurotoxic lesion 

described as vacuolation of the white 

matter of the central nervous system 

was observed in subchronic and chronic 

studies in mice and dogs; however, this 

lesion was found to be reversible and is 

attributed to an impurity. Based on the 

level of this impurity in technical grade 

fluazinam, the risk assessment for the 

parent compound is considered 

protective of the effects noted. In an 

immunotoxicity study in mice, 

significant suppressions of anti-sheep 

red blood cell antibody-forming cell 

assay response were demonstrated at the 

highest dose tested. 

In a rat carcinogenicity study, there 

was some evidence that fluazinam 

induced an increase in thyroid gland 

follicular cell tumors in male rats. There 

were statistically significant positive 

trends for thyroid gland follicular cell 

adenocarcinomas and combined 

follicular cell adenomas/ 

adenocarcinomas. The incidences of 

thyroid gland adenomas seen at 100 

ppm (3.8 mg/kg/day) and 

adenocarcinomas at 1,000 ppm were 

slightly outside their respective ranges 

for the historical controls. However, this 

increased incidence of thyroid tumors at 

100 ppm was not observed in male rats 

in another chronic study. Further in the 

rat carcinogenicity study where these 

effects were seen, the animals in the 

lower dose groups were only 

microscopically examined for thyroid 

lesions if abnormalities were observed 

in that organ at gross necropsy and 

therefore, the incidences of thyroid 

tumors in the lower dose groups may 

have been somewhat misleading (too 

high). In one mouse carcinogenicity 

study, clear evidence of a treatmentrelated increase of hepatocellular 

tumors was observed in male mice; in 

another mouse carcinogenicity study, 

there was equivocal evidence that 

fluazinam may have induced an 

increase in hepatocellular tumors in 

male mice. There was no evidence of 

statistically significant tumor increases 

in female mice or rats in any study and 

no evidence of mutagenic activity in the 

submitted mutagenicity studies for 

fluazinam. EPA has classified fluazinam 

as having suggestive evidence of 

carcinogenicity. Due to the equivocal 

and inconsistent nature of the cancer 

response in the rat and mouse studies, 

the Agency determined that 

quantification of risk using a non-linear 

approach (i.e., RfD) will adequately 

account for all chronic toxicity, 

including carcinogenicity, that could 

result from exposure to fluazinam. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluazinam as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Fluazinam. Human Health Risk 

Assessment to Support New Uses on 

Soybeans, the Melon Subgroup (9–A), 

and the Pepper/Eggplant Subgroup (8– 

10B), and to Support Registration 

Review’’ at pages 43–49 in docket ID 

number EPA–HQ–OPP–2012–0009. 

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 fluazinam used for human 

risk assessment is shown in Table 1 of 

this unit. To assess short-term dermal 

exposure, the dermal toxicity and 

dermal absorption studies were used to 

determine a refined dermal equivalent 

dose (RDD). To calculate a RDD, in vitro 

results using rat skin are corrected for 

any differences between in vitro and in 

vivo absorption rates and species 

differences between rats and humans. 

This refinement in dermal absorption is 

important because absorption by human 

skin is usually lower than that by rat 

skin. Accordingly, the combined use of 

the data from three dermal absorption 

studies and two testing systems offers 

greater precision in estimating human 

dermal absorption, which strengthens 

the reliability of the dermal risk 

assessment. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUAZINAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (Females 13–50 years of age) ... NOAEL = 7 milligrams/kilogram/day (mg/kg/day).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.07 mg/kg/day ..

aPAD = 0.07 mg/kg/day 

Developmental Toxicity 

Study—Rabbits 

LOAEL = 12 mg/kg/day based 

on increased incidence of 

total litter resorptions and 

possible increased incidence of fetal skeletal abnormalities. 


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66726 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUAZINAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/Scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (General population including infants and children).NOAEL = 50 mg/kg/day .........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.5 mg/kg/day ....

aPAD = 0.5 mg/kg/day 

Acute Neurotoxicity—Rats 

LOAEL = 1000 mg/kg/day 

based on decreased motor 

activity and soft stools on 

day of dosing. 

Chronic dietary (All populations) ...................... NOAEL = 1.1 mg/kg/day ........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.011 mg/kg/ 

day.

cPAD = 0.011 mg/kg/day 

Co-critical: 

Carcinogenicity—Mice 

LOAEL = 10.7 mg/kg/day 

based on liver 

histopathology and increased liver weight 

Chronic Dog 

LOAEL = 10 mg/kg/day based 

on marginal increases in 

the incidence of nasal dryness in females and the incidence/severity of gastric 

lymphoid hyperplasia in 

both sexes. 

Dermal short-term (1 to 30 days) ..................... Dermal study NOAEL= 10 mg/ 

kg/day.

Refined Dermal absorption 

rate = 2.44% 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

RDD*= 24.4 mg/kg/day ..........

LOC for MOE = 100 

21-Day Dermal Toxicity—Rats 

LOAEL= 100 mg/kg/day 

based on liver effects (increased AST and cholesterol levels). 

Cancer (Oral, dermal, inhalation) ..................... Non-linear RfD approach was used to assess cancer risk. 

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

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

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

sensitivity among members of the human population (intraspecies). * A Refined Dermal Equivalent Dose (RDD) of 24.4 mg/kg/day was calculated 

using the dermal POD and dermal absorption data. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluazinam, EPA considered 

exposure under the petitioned-fortolerances as well as all existing 

fluazinam tolerances in 40 CFR 180.574. 

EPA assessed dietary exposures from 

fluazinam in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

fluazinam. In estimating acute dietary 

exposure, EPA used food consumption 

information from the 2003–2008 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). As to 

residue levels in food, EPA utilized 

tolerance-level residues, 100 percent 

crop treated (PCT) for all commodities, 

and used DEEM default processing 

factors, when appropriate. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 2003– 

2008 NHANES/WWEIA. As to residue 

levels in food, EPA utilized tolerancelevel residues for all commodities 

except apple (for which the average 

field trial residue value was used), 

assumed 100 PCT for all commodities, 

and used DEEM default processing 

factors, when appropriate. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or non-linear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to fluazinam. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii. 

iv. Anticipated residue information. 

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 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. 

2. Dietary exposure from drinking 

water. The residues of concern in 


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drinking water for risk assessment are 

parent fluazinam and its degradates, 

including DCPA, CAPA, DAPA, HYPA, 

and AMPA. The Agency used screening 

level water exposure models in the 

dietary exposure analysis and risk 

assessment for fluazinam and its 

degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fluazinam 

and its degradates. 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 First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fluazinam and its degradates for surface 

water are estimated to be 226 parts per 

billion (ppb) for acute exposures and 

37.8 ppb for chronic exposures. For 

ground water, the EDWCs are estimated 

to be 0.404 ppb for both acute and 

chronic exposures. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

water concentration values of 226 ppb 

and 37.8 ppb were used to assess the 

contribution to drinking water in the 

acute and chronic dietary risk 

assessments, respectively. 

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). Fluazinam 

is currently registered for following use 

that could result in residential 

exposures: On turf at golf courses only. 

EPA assessed potential residential shortterm post-application dermal exposure 

from individuals, including adults, 

youth (11 to <16 years old), and 

children (6 to <11 years old), playing 

golf on treated turf. The short- and 

intermediate-term toxicological 

endpoints for fluazinam are the same for 

the dermal route of exposure. As a 

result, only the short-term dermal 

exposure was assessed. The resulting 

short-term risk estimates are considered 

to be protective of intermediate-term 

exposure and risk. 

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 fluazinam to share a common 

mechanism of toxicity with any other 

substances, and fluazinam does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

fluazinam does not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database for fluazinam includes rat and 

rabbit developmental toxicity studies, a 

2-generation reproductive toxicity study 

in rats, and a DNT study in the rat. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

in the rabbit developmental toxicity 

study or the rat 2-generation 

reproductive toxicity study; however, 

evidence of increased qualitative 

susceptibility of fetuses was observed in 

the rat developmental toxicity study and 

evidence of increased quantitative 

susceptibility of fetuses was observed in 

the rat DNT study. 

In the developmental toxicity study in 

rats, fetal effects (increased incidences 

of facial/palate clefts and other rare 

deformities in the fetuses) were 

observed in the presence of minimal 

maternal toxicity (decreased body 

weight gain and food consumption, and 

increased water consumption and 

urogenital staining). In the rat DNT 

study, decreases in body weight/body 

weight gain and a delay in completion 

of balano-preputial separation were 

observed in pups in the absence of 

maternal effects, suggesting increased 

quantitative susceptibility of the 

offspring. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for fluazinam 

is complete. 

ii. There is no evidence that 

fluazinam results in increased 

susceptibility in in utero rabbits in the 

prenatal developmental studies or in 

young rats in the 2-generation 

reproduction study; however, increased 

qualitative susceptibility was noted in 

the rat developmental toxicity study. 

The degree of concern for the observed 

effects is low because fetal effects were 

observed only at the highest dose tested 

in the presence of maternal toxicity, and 

there is a clear NOAEL for the fetal 

effects seen. Additionally, the NOAEL 

(50 mg/kg/day) identified in the 

developmental toxicity study in rats is 

significantly higher than the NOAEL 

used (7 mg/kg/day) to establish the aRfD 

for females 13–49. Therefore, the aRfD 

is protective of any potential 

developmental effects and there are no 

residual uncertainties for prenatal and/ 

or postnatal toxicity. 

Additionally, while a DNT study in 

rat did not show evidence of 

neurotoxicity, the study showed 

evidence of increased quantitative 

susceptibility of offspring. Although the 

NOAEL for this study (2 mg/kg/day) is 

lower than that used for the aRfD for 

females 13–49 (7 mg/kg/day), the effects 

noted in the DNT study are considered 

to be postnatal effects attributable to 

multiple doses; therefore, the study 

endpoint is not appropriate for acute 

dietary exposures. The cRfD (0.011 mg/ 

kg/day) is based on a lower NOAEL (1.1 

mg/kg/day), and is considered to be 

protective of potential developmental 

effects. Therefore, the degree of concern 

is low for the observed effects and there 

are no residual uncertainties with regard 

to prenatal and/or postnatal 

neurotoxicity. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The acute and chronic dietary food 

exposure assessments were performed 

based on 100 PCT for all commodities. 

Additionally, the acute assessment is 

based on tolerance-level residues for all 

commodities, and the chronic 

assessment is based on tolerance-level 


srobinson on DSK4SPTVN1PROD with 
66728 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 

residues for all commodities except 

apple (for which the average field trial 

value was used). These assumptions 

result in high-end estimates of dietary 

exposure. EPA made conservative 

(protective) assumptions in the ground 

water and surface water modeling used 

to assess exposure to fluazinam in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children. 

Incidental oral exposure of toddlers is 

not expected from any use pattern for 

fluazinam. These assessments will not 

underestimate the exposure and risks 

posed by fluazinam. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fluazinam will occupy 28% of the aPAD 

for females 13–49 years old; and 21% of 

the aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure for the general population, 

including infants and children. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluazinam from 

food and water will utilize 51% 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 fluazinam 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). Fluazinam is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

fluazinam. 

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 730 for children 6–<11 years 

old, 880 for youth 11–<16 years old, and 

970 for adults. Because EPA’s level of 

concern for fluazinam 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). 

Based on the discussion in Unit III.C.3., 

short-term risk estimates are considered 

to be protective of intermediate-term 

exposure and risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A., EPA has concluded that the 

cPAD is protective of possible cancer 

effects. 

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 fluazinam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate gas chromatography with 

electron capture detection (GC/ECD) 

method (6148–94–0170–MD–001) is 

available to enforce fluazinam 

tolerances on plant commodities. An 

adequate enforcement method for the 

determination of AMGT is also 

available. The method is a high 

performance liquid chromatography 

with ultraviolet detection (HPLC/UV) 

enforcement method entitled ‘‘Method 

Evaluation for the Analysis of AMGT in 

Grapes.’’ 

The methods may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for fluazinam on the commodities 

associated with this action. 

C. Response to Comments 

EPA received several comments to the 

docket, EPA–HQ–OPP–2012–0009; 

however, only one of these public 

submissions was in response to the 

Notice of Filing for PP 1E7959, while 

the remaining comments pertained to 

unrelated petitions in the Federal 

Register notice. For PP 1E7959, the 

commenter stated that no residue 

should be allowed for fluazinam and 

that they do not support manufacture or 

use of this product. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that pesticides should be banned 

on agricultural crops. However, the 

existing legal framework provided by 

section 408 of the Federal Food, Drug, 

and Cosmetic Act (FFDCA) states that 

tolerances may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. This citizen’s comment 

appears to be directed at the underlying 

statute and not EPA’s implementation of 

it; the citizen has made no contention 

that EPA has acted in violation of the 

statutory framework. In addition, the 

commenter included several adverse 

effects they believed were seen in 

animal toxicology studies for fluazinam. 

EPA has found that there is a reasonable 

certainty of no harm to humans after 

considering the toxicological studies 

and the exposure levels of humans to 

fluazinam. 

D. Revisions to Petitioned-ForTolerances 

Based on the data supporting the 

petitions, EPA revised the proposed 

tolerances on melon subgroup 9A from 

0.08 ppm to 0.07 ppm; pepper/eggplant 

subgroup 8–10B from 0.10 ppm to 0.09 

ppm; and soybean, hulls from 0.02 ppm 

to 0.05 ppm. The Agency revised these 

tolerance levels based on analysis of the 

residue field trial data using the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Rules and Regulations 66729 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluazinam, (3-chloro-N- 

[3-chloro-2,6-dinitro-4- 

(trifluoromethyl)phenyl]-5- 

(trifluoromethyl)-2-pyridinamine), in or 

on melon subgroup 9A at 0.07 ppm; 

pepper/eggplant subgroup 8–10B at 0.09 

ppm; soybean, seed at 0.01 ppm; and 

soybean, hulls at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations that Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

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: October 26, 2012. 

Daniel J. Rosenblatt, 

Acting 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 § 180.574, alphabetically add the 

following commodities to the table in 

paragraph (a)(1) to read as follows: 

§ 180.574 Fluazinam; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

*****

Melon subgroup 9A .................. 0.07 

*****

Pepper/eggplant subgroup 8– 

10B ........................................ 0.09 

*****

Soybean, seed .......................... 0.01 

Soybean, hulls .......................... 0.05 

*****

* * * * * 

[FR Doc. 2012–27198 Filed 11–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–2012–0738; FRL–9713–1] 

RIN 2050–AG73 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; Revision To Increase Public 

Availability of the Administrative 

Record File 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action to amend the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP), to 

acknowledge advancements in 

technologies used to manage and 

convey information to the public. 

Specifically, this revision will add 

language to EPA regulations to broaden 

the technology, to include computer 

telecommunications or other electronic 

means, that the lead agency is permitted 

to use to make the administrative record 

file available to the public. By updating 

the language used to describe permitted 

technology, the lead agency will be able 

to serve the information needs of a 

broader population, while maintaining 

the ability to provide traditional means 


srobinson on DSK4SPTVN1PROD with