Federal Register / Vol. 77, No. 220 / Wednesday, November 14, 2012 / Rules and Regulations 67771 

State and local officials early in the 

process of developing the proposed 

regulation. EPA also may not issue a 

regulation that has federalism 

implications and that preempts State 

law unless the Agency consults with 

State and local officials early in the 

process of developing the proposed 

regulation. 

This rule will not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, because it 

merely approves a State rule 

implementing a Federal standard, and 

does not alter the relationship or the 

distribution of power and 

responsibilities established in the CAA. 

Thus, the requirements of section 6 of 

the Executive Order do not apply to this 

rule. 

F. Executive Order 13175, Coordination 

With Indian Tribal Governments 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), requires EPA 

to develop an accountable process to 

ensure ‘‘meaningful and timely input by 

tribal officials in the development of 

regulatory policies that have tribal 

implications.’’ This final rule does not 

have tribal implications, as specified in 

Executive Order 13175. It will not have 

substantial direct effects on tribal 

governments, on the relationship 

between the Federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal government and Indian tribes. 

Thus, Executive Order 13175 does not 

apply to this rule. 

G. Executive Order 13045, Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets Executive Order 13045 

(62 FR 19885, April 23, 1997) as 

applying only to those regulatory 

actions that concern health or safety 

risks, such that the analysis required 

under section 5–501 of the Executive 

Order has the potential to influence the 

regulation. This rule is not subject to 

Executive Order 13045, because it 

approves a State rule implementing a 

Federal standard. 

H. Executive Order 13211, Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rule is not subject to Executive 

Order 13211, ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) because it is 

not a significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

Section 12 of the National Technology 

Transfer and Advancement Act 

(NTTAA) of 1995 requires Federal 

agencies to evaluate existing technical 

standards when developing a new 

regulation. To comply with NTTAA, 

EPA must consider and use ‘‘voluntary 

consensus standards’’ (VCS) if available 

and applicable when developing 

programs and policies unless doing so 

would be inconsistent with applicable 

law or otherwise impractical. 

The EPA believes that VCS are 

inapplicable to this action. Today’s 

action does not require the public to 

perform activities conducive to the use 

of VCS. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Population 

Executive Order (EO) 12898 (59 FR 

7629 (Feb. 16, 1994)) establishes federal 

executive policy on environmental 

justice. Its main provision directs 

federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA lacks the discretionary authority 

to address environmental justice in this 

rulemaking. 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. section 801 et seq., as added by 

the Small Business Regulatory 

Enforcement Fairness Act of 1996, 

generally provides that before a rule 

may take effect, the agency 

promulgating the rule must submit a 

rule report, which includes a copy of 

the rule, to each House of the Congress 

and to the Comptroller General of the 

United States. Section 804, however, 

exempts from section 801 the following 

types of rules: rules of particular 

applicability; rules relating to agency 

management or personnel; and rules of 

agency organization, procedure, or 

practice that do not substantially affect 

the rights or obligations of non-agency 

parties. 5 U.S.C. 804(3). Because this is 

a rule of particular applicability, EPA is 

not required to submit a rule report 

regarding this action under section 801. 

L. Petitions for Judicial Review 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by January 14, 2013. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this rule for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements (see section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Particulate matter, Reporting and 

recordkeeping requirements. 

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

Dated: November 1, 2012. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

[FR Doc. 2012–27564 Filed 11–13–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0985; FRL–9368–7] 

Flonicamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flonicamid in 

or on Berry, low growing, subgroup 13– 

07G; Rapeseed subgroup 20A, and 

cucumber. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 14, 2012. Objections and 

requests for hearings must be received 

on or before January 14, 2013, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0985, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 


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67772 Federal Register / Vol. 77, No. 220 / Wednesday, November 14, 2012 / Rules and Regulations 

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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; email address: 

jackson.sidney@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0985 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 14, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2011–0985, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

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

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of Wednesday, 

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 1E7842) by 

IR–4, IR–4 Project Headquarters, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.613 be 

amended by establishing tolerances for 

combined residues of the insecticide, 

flonicamid, N-(cyanomethyl)-4- 

(trifluoromethyl)-3- 

pyridinecarboxamide and its 

metabolites TFNA, 4- 

trifluoromethylnicotinic acid, TFNAAM, 4-trifluoromethylnicotinamide, 

TFNG, N-(4- 

trifluoromethylnicotinoyl)glycine, in or 

on cucumber at 1.3 parts per million 

(ppm), Berry, low growing subgroup 13– 

07G at 1.4 and Rapeseed subgroup 20A 

at 1.5 ppm. That document referenced a 

summary of the petition prepared by 

ISK Biosciences, 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 petition and/or current 

Agency policies, EPA has revised/ 

modified the petitioned-for flonicamid 

residue tolerance level in certain 

commodities and revised the tolerance 

expression for flonicamid residues. EPA 

is also revising the existing crop group 

tolerance on ‘‘Vegetable, cucurbit, group 

9’’ to exclude cucumbers. The reasons 

for these changes are explained in Unit 

IV.C. 

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 flonicamid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flonicamid follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 


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considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Flonicamid has low acute toxicity via 

the oral, inhalation and dermal routes of 

exposure. Flonicamid is nonirritating to 

the eye and skin and is not a dermal 

sensitizer. Its metabolites, TFNA, 

TFNA–AM, TFNG, TFNG–AM, and 

TFNA–OH, also demonstrated low 

toxicity in acute oral toxicity studies. In 

the 28-day dermal study with 

flonicamid technical no dermal or 

systemic toxicity was seen at the limit 

dose. In oral studies using rats and dogs, 

the kidney and liver are the target 

organs for flonicamid toxicity. Increased 

kidney weight and hyaline droplet 

deposition were observed as well as 

liver centrilobular hypertrophy in the 

rat 28-day oral range-finding, 90-day 

oral, developmental, and reproductive 

studies. The 90-day dog study showed 

kidney tubular vacuolation as well as 

increased adrenal weights, increased 

reticulocytes and decreased thymus 

weights. Increased reticulocyte count 

was noted in both the subchronic and 

chronic dog studies. 

In rats, developmental effects 

including increased incidence of 

cervical ribs were observed at 

maternally toxic (liver and kidney gross 

and histopathological effects) dose 

levels. In rabbits, developmental effects 

were not observed at any dose level 

including maternally toxic doses. 

Offspring effects (decreased body weight 

and delayed sexual maturation) in the 

multi-generation study were seen only 

in the presence of parental toxicity 

(kidney effects in males, blood effects in 

females). Thus, there is no evidence that 

flonicamid results in increased 

susceptibility (qualitative or 

quantitative) in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

There are no concerns for flonicamid 

neurotoxicity. Although clinical signs 

suggesting potential neurotoxic effects 

(e.g., decreased motor activity, tremors) 

were seen in the acute and subchronic 

neurotoxicity studies; other effects in 

these studies (e.g., increased mortality, 

and significant decreases in food 

consumption and body weight) 

indicated that the clinical signs were a 

result of the animals being in an 

extreme condition or otherwise 

compromised and in a state of general 

malaise. Also, these types of effects 

were not observed in the other 

subchronic or chronic studies in mice, 

rats or dogs. Thus, there is not clear 

evidence of neurotoxicity. Lastly, clear 

no-observed-adverse-effect-levels 

(NOAELs) and lowest-observed-adverseeffect-levels (LOAELs) were defined for 

the clinical signs, which are above the 

levels currently used for risk assessment 

purposes. Preliminary results of a 28- 

day oral (dietary) immunotoxicity study 

of technical flonicamid in female CD–1 

mice suggest that flonicamid is not an 

immuno-suppressant, either structurally 

or functionally up to and including dose 

levels exceeding the Limit Dose. 

Although there is some limited 

evidence suggesting that flonicamid has 

a potential for carcinogenic effects, EPA 

determined that quantification of risk 

using a non-linear approach (i.e., using 

a chronic reference dose (cRfD)) 

adequately accounts for all chronic 

toxicity, including carcinogenicity that 

could result from exposure to 

flonicamid. The following 

considerations support that 

determination. First, mutagenicity 

studies were negative for the parent 

chemical, flonicamid, and its 

metabolites, TFNA, TFNA–AM, TFNG, 

TFNG–AM, and TFNA–OH. Second, 

although flonicamid is carcinogenic in 

CD–1 mice, based on increased 

incidences of lung tumors associated 

with Clara cell activation, this tumor 

type is associated with species and 

strain sensitivity and is not directly 

correlated with cancer risks in humans. 

Third, nasal cavity tumors seen in male 

Wistar rats were linked to incisor 

inflammation and not considered to be 

treatment related. These tumor findings 

were confounded by the lack of a doseresponse and the biological significance 

is questionable. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flonicamid as well as 

the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Flonicamid: Human Health Risk 

Assessment for the Proposed Use on 

Low Growing Berry, Rapeseed, and 

Greenhouse Grown Cucumbers’’ at page 

29 in docket ID number EPA–HQ–OPP– 

2011–0985. 

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 flonicamid used for 

human risk assessment is shown in 

Table 1 of this unit. 

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

ASSESSMENT

Exposure/scenario POD and uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and 

children).

None/NA ............................... None/NA ............... No toxicological effects seen in a single dose study. 

Chronic dietary (All populations).NOAEL= 3.7 mg/kg/day .......

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

cRfD = 0.04 mg/kg/ 

day.

cPAD = 0.04 mg/ 

kg/day 

2-Generation reproduction rat study. 

Parental LOAEL = 22 mg/kg/day based on increased kidney weights, kidney hyaline deposition, increased blood 

serum LH (F1 females). 


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

ASSESSMENT—Continued 

Exposure/scenario POD and uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer .................................... A nonlinear 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. POD = Point of Departure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

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

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flonicamid, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

flonicamid tolerances in 40 CFR 

180.613. EPA assessed dietary 

exposures from flonicamid 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 flonicamid; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of Agriculture 

(USDA) 1994–1996 and 1998 

Continuing Service of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used an unrefined chronic 

dietary assessment conducted assuming 

100 percent crop treated (PCT) 

estimates, tolerance-level residues for 

all commodities, and empirical or 

Dietary Exposure Evaluation Model– 

Food Commodity Intake Database 

(DEEM–FCIDTM) default processing 

factors. 

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 nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or nonlinear 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 determine 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 flonicamid. Cancer risk 

was assessed using the same exposure 

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

chronic exposure. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for flonicamid. Tolerance-level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for flonicamid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of flonicamid. 

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. 

The drinking water assessment was 

conducted using a parent only and total 

toxic residues of flonicamid (flonicamid 

TTR) approach. Total toxic residues 

include TFNA, TFNA–AM, TFNA–OH, 

TFNG, and TFNG–AM. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of total 

toxic residues of flonicamid for chronic 

exposures for non-cancer assessments 

are estimated to be 1.9 parts per billion 

(ppb) for surface water and 0.00132 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 1.9 ppb 

was used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Flonicamid is currently registered for 

the following uses that could result in 

non-occupational exposures: 

Commercial ornamentals, 

interiorscapes, and nurseries. However, 

these product labels do not allow use in 

home gardens and greenhouses or in 

any residential settings. Therefore, 

residential handler scenarios are not 

expected and need not be assessed. 

Additionally, because no dermal 

toxicity endpoint was identified for 

flonicamid, a post-application 

residential exposure/risk assessment is 

not necessary. Post-application 

inhalation exposures are expected to be 

negligible. Therefore, no residential 

exposure is expected. 

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 flonicamid to 

share a common mechanism of toxicity 

with any other substances, and 

flonicamid does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that flonicamid 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 


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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 toxicity 

database for flonicamid includes 

prenatal developmental toxicity studies 

in rats and rabbits and a multigeneration reproduction toxicity study 

in rats. There is no evidence that 

flonicamid results in increased 

susceptibility (qualitative or 

quantitative) in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the multi-generation 

reproduction study. No developmental 

effects were seen in rabbits. In the 

multi-generation reproduction study, 

developmental delays in the offspring 

(decreased body weights, delayed sexual 

maturation) were seen only in the 

presence of parental toxicity (kidney 

and blood effects). Also, there are clear 

NOAELs and LOAELs for all effects. The 

degree of concern for prenatal and/or 

post-natal susceptibility is, therefore, 

low due to the lack of evidence of 

qualitative and quantitative 

susceptibility. 

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 for chronic dietary 

and other exposures, except as noted 

below. That decision is based on the 

following findings: 

i. The toxicity database for flonicamid 

is complete except for an 

immunotoxicity study and a subchronic 

inhalation study. Existing data are 

sufficient for endpoint selection for 

exposure/risk assessment scenarios, and 

for evaluation of the requirements under 

the FQPA. Except for decreased thymus 

weights in the subchronic dog study, 

there are no other indications in the 

available studies that organs associated 

with immune function are affected by 

flonicamid, and preliminary results of 

the above-mentioned immunotoxicity 

study suggested that flonicamid is not 

an immunosuppressant. EPA does not 

believe that the final results of the 

immunotoxicity study will result in a 

dose less than the point of departure 

already used in this risk assessment and 

an additional database uncertainty 

factor for potential immunotoxicity does 

not need to be applied. 

A subchronic 28-day inhalation study 

is required and is outstanding at this 

time. In the absence of a route specific 

inhalation study, EPA has retained a 

10X FQPA SF to assess risks for 

inhalation exposure scenarios. However, 

residential inhalation exposures are not 

expected. 

ii. The available data base includes 

acute and subchronic neurotoxicity 

studies. As discussed in Unit III.A., EPA 

has concluded that the clinical signs 

observed in those studies were not the 

result of a neurotoxic mechanism and 

that therefore a developmental 

neurotoxicity study is not required. 

iii. There was no evidence for 

quantitative or qualitative susceptibility 

following oral exposures to rats in utero 

or oral exposure to rabbits in utero. 

iv. There are no residual uncertainties 

identified in the exposure databases. An 

unrefined conservative chronic dietary 

exposure assessment for food and 

drinking water was conducted, 

assuming tolerance level residues for all 

existing and proposed commodities and 

100 PCT of registered and proposed 

crops treated. The drinking water 

assessment utilized water concentration 

values generated by models and 

associated modeling parameters which 

are designed to produce conservative, 

health protective, high-end estimates of 

water concentrations which are not 

likely to be exceeded. The dietary (food 

and drinking water) exposure 

assessment does not underestimate the 

potential exposure for infants, children, 

or women of child bearing age. 

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. An endpoint attributable to a 

single oral dose was not identified in 

the toxicity database; therefore, 

flonicamid is not expected to pose an 

acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to flonicamid 

from food and water will utilize 11% of 

the cPAD for the general U.S. 

population and 28% of the cPAD for 

children 1 to 2 years old, the population 

group receiving the greatest exposure. 

There are no expected long-term 

residential exposures. Because drinking 

water estimates have been combined 

with dietary exposures, the dietary 

assessment discussed in Unit III.C.3., 

serves as the aggregate exposure and 

risk assessment for flonicamid. 

3. Short-term and Intermediate-term 

risk. Short- and intermediate-term 

aggregate exposures take into account 

short- and intermediate-term residential 

exposures plus chronic exposure to food 

and water (considered to be a 

background exposure level). Short- and 

intermediate-term aggregate risk 

assessments were not conducted 

because residential exposure is not 

expected from the use pattern proposed 

in this registration request, or from any 

registered uses. 

4. 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. 

5. 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 flonicamid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methods are 

available to enforce the tolerances for 

flonicamid and the major metabolites in 

plants and livestock. The proposed 

method for plants uses Liquid 

Chromatography with Tandem Mass 

Spectrometry (LC/MS/MS) (FMC No. P– 

3561M) to determine the residues of 

flonicamid and its major metabolites, 

TFNA–AM, TFNA, and TFNG. 

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 


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possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There are no Codex MRLs established 

on the proposed crops. 

C. Revisions to Petitioned-For 

Tolerances 

Based on results from the 

Organization for Economic Cooperation 

and Development (OECD) spreadsheet 

tolerance calculation procedures, EPA 

modified certain IR–4 proposed 

tolerances for flonicamid residues. EPA 

increased the proposed tolerance from 

1.4 to 1.5 ppm for Berry, low growing, 

subgroup 13–07G and from 1.3 to 1.5 

ppm for cucumber. Because there is an 

existing crop group tolerance for 

‘‘Vegetable, cucurbit, group 9’’ that 

applies to cucumbers, EPA, for the sake 

of clarity, is revising that existing crop 

group tolerance to exclude cucumbers. 

Finally, EPA has revised the tolerance 

expression to clarify (1) that, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of flonicamid not specifically 

mentioned; and (2) that compliance 

with the specified tolerance levels is to 

be determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for the residues of flonicamid, N- 

(cyanomethyl)-4-(trifluoromethyl)-3- 

pyridinecarboxamide, and its 

metabolites TFNA (4- 

trifluoromethylnicotinic acid, TFNA– 

AM (4-trifluoromethylnicotinamide) 

and TFNG, N-(4- 

trifluoromethylnicotinoyl)glycine, in or 

on cucumber at 1.5 ppm; Berry, low 

growing, subgroup 13–07G at 1.5 ppm; 

and Rapeseed subgroup 20A at 1.5 ppm. 

Additionally, the tolerance entry for 

Vegetable, cucurbit group 9, is revised 

to exclude cucumber. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: November 1, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Amend § 180.613 as follows: 

■ i. Revise the introductory text of 

paragraph (a)(1). 

■ ii. Remove the entry ‘‘Vegetable, 

cucurbit, group 9’’ from the table in 

paragraph (a)(1), and add alphabetically 

four new entries. 

■ iii. Revise the introductory text of 

paragraph (a)(2). 

The added and revised text read as 

follows: 

§ 180.613 Flonicamid; tolerances for 

residues. 

(a) * * * (1) Tolerances are 

established for the residues of the 

insecticide flonicamid, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of flonicamid, 

N-(cyanomethyl)-4-(trifluoromethyl)-3- 

pyridinecarboxamide, and its 

metabolites, TFNA (4- 

trifluoromethylnicotinic acid), TFNA– 

AM (4-trifluoromethylnicotinamide), 


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Federal Register / Vol. 77, No. 220 / Wednesday, November 14, 2012 / Rules and Regulations 67777 

and TFNG, N-(4- 

trifluoromethylnicotinoyl)glycine, 

calculated as the stoichiometric 

equivalent of flonicamid, in or on the 

following commodities. 

Commodity Parts per 

million 

Berry, low growing, subgroup 

13–07G ............................. 1.5 

* * * * * 

Cucumber ............................. 1.5 

* * * * * 

Rapeseed subgroup 20A ...... 1.5 

* * * * * 

Vegetable, cucurbit, group 9, 

except cucumber ............... 0.4 

* * * * * 

(2) Tolerances are established for the 

residues of the insecticide flonicamid, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of flonicamid, N-(cyanomethyl)-4- 

(trifluoromethyl)-3- 

pyridinecarboxamide, and its 

metabolites, TFNA (4- 

trifluoromethylnicotinic acid), and 

TFNA–AM (4- 

trifluoromethylnicotinamide), 

calculated as the Stoichiometric 

equivalent of flonicamid, in or on the 

following commodities. 

* * * * * 

[FR Doc. 2012–27702 Filed 11–13–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1986–0005; FRL 9751–2] 

National Oil and Hazardous Substance 

Pollution Contingency Plan; National 

Priorities List Deletion of the Waste 

Management of Michigan-Holland 

Lagoons Superfund Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct Final Rule. 

SUMMARY: The U.S. Environmental 

Protection Agency (EPA) Region 5 is 

publishing a direct final Notice of 

Deletion of the Waste Management of 

Michigan-Holland Lagoons Superfund 

Site (Site), located in Ottawa County, 

Michigan from the National Priorities 

List (NPL). The NPL, promulgated 

pursuant to Section 105 of the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

an appendix to the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This direct 

final deletion is being published by EPA 

with the concurrence of the State of 

Michigan, through the Michigan 

Department of Environmental Quality 

(MDEQ), because EPA has determined 

that all appropriate response actions 

under CERCLA have been completed. 

However, this deletion does not 

preclude future actions under 

Superfund. 

DATES: This direct final rule is effective 

January 14, 2013 unless EPA receives 

adverse comments by December 14, 

2012. If adverse comments are received, 

EPA will publish a timely withdrawal of 

the direct final deletion in the Federal 

Register informing the public that the 

deletion will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–HQ– 

SFUND–1986–0005, by one of the 

following methods: 

• http://www.regulations.gov: Follow 

on-line instructions for submitting 

comments. 

• Email: Gladys Beard, NPL Deletion 

Process Manager, at 

beard.gladys@epa.gov or Dave Novak, 

Community Involvement Coordinator, at 

novak.dave@epa.gov. 

• Fax: Gladys Beard, NPL Deletion 

Process Manager, at (312) 697–2077. 

• Mail: Gladys Beard, NPL Deletion 

Process Manager, U.S. Environmental 

Protection Agency (SR–6J), 77 West 

Jackson Boulevard, Chicago, IL 60604, 

(312) 886–7253; or Dave Novak, 

Community Involvement Coordinator, 

U.S. Environmental Protection Agency 

(SI–7J), 77 West Jackson Boulevard, 

Chicago, IL 60604, (312) 886–7478 or 

(800) 621–8431. 

• Hand delivery: Dave Novak, 

Community Involvement Coordinator, 

U.S. Environmental Protection Agency 

(SI–7J), 77 West Jackson Boulevard, 

Chicago, IL 60604. Such deliveries are 

only accepted during the docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. The 

normal business hours are Monday 

through Friday, 8:30 a.m. to 4:30 p.m. 

CST, excluding federal holidays. 

Instructions: Direct your comments to 

Docket ID no. EPA–HQ–SFUND–1986– 

0005. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or email. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through http:// 

www.regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index. Although 

listed in the index, some information 

may not be publicly available, e.g., CBI 

or other information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in the 

hard copy. Publicly available docket 

materials are available either 

electronically at http:// 

www.regulations.gov or in hard copy at: 

• U.S. Environmental Protection 

Agency-Region 5, 77 West Jackson 

Boulevard, Chicago, IL 60604, Phone: 

(312) 353–1063. Hours: Monday through 

Friday, 8:30 a.m. to 4:30 p.m. CST, 

excluding Federal holidays. 

• Herrick District Library, 303 South 

River Avenue, Holland, MI 49423, 

Phone: (616) 355–3100. Hours: Monday 

through Tuesday, 9:00 a.m. to 9:00 p.m. 

EST; Wednesday through Friday, 9:00 

a.m. to 6:00 p.m. EST. 

FOR FURTHER INFORMATION CONTACT: 

Gladys Beard, NPL Deletion Process 

Manager, U.S. Environmental Protection 

Agency (SR–6J), 77 West Jackson 


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