26954 Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2004–0144; FRL–9346–9] 

RIN 2070–ZA16 

1-Naphthaleneacetic acid; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of 1- 

naphthaleneacetic acid, potassium and 

sodium salts in or on potatoes. Stehekin, 

LLC petitioned EPA for clearance of use 

of this pesticide under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

8, 2012. Objections and requests for 

hearings must be received on or before 

July 9, 2012, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2004–0144. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Rose 

Mary Kearns, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703)–305–5611; email address: 

kearns.rosemary@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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

Title40/40tab_02.tpl. To access the 

harmonized test guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/ocspp and 

select ‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2004–0144 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 July 9, 2012. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2004–0144, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of September 

8, 2010 (75 FR 54629) (FRL–8843–3), 

EPA issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 346a 

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

pesticide petition (PP 0F7687) by 

Stehekin, LLC, 1012 Good Lander Drive, 

Selah, Washington 98942. The petition 

requested that a tolerance exemption be 

established for residues of the fungicide 

1-naphthaleneacetic acid (1- 

naphthaleneacetamide), on potatoes. 

That notice referenced a summary of the 

petition prepared by Stehekin, LLC, 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 a revised petition which 

requested a tolerance and review of the 

data supporting the petition, EPA has 

determined that it is appropriate to 

establish a tolerance in association with 

the use of 1-naphthaleneacetic acid (1- 

naphthaleneacetamide) on potatoes. 

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.’’ 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Rules and Regulations 26955 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 1- 

naphthalneactic acid, its salts, ester, and 

acetamide which are collectively 

referred to as naphthalene acetates 

(NAA) including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with NAA 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. 

Based on structural activity 

relationship and metabolism data, all 

forms of 1-naphthaleneacetic acid, its 

salts, ester, and acetamide are expected 

to exhibit similar toxicological effects. 

Therefore the Agency concluded that 

required toxicity testing on any form 

should serve for all members of this 

group of chemicals. 

Naphthalene acetates have low acute 

toxicity via the oral, inhalation and 

dermal routes of exposure. 1- 

Naphthaleneacetic acid is not a skin 

irritant or a dermal sensitizer. The 1- 

naphthaleneacetic acid and its sodium 

salt were found to be irritating to the 

eye. Repeated exposure oral toxicity 

studies in rats and dogs resulted in 

decreased body weights and body 

weight gains accompanied by decreased 

food consumption. 

The major target organs of subchronic 

and chronic oral exposure were the 

liver, stomach and lung. Repeated oral 

exposure also resulted in decreased 

hematocrit and hemoglobin along with 

reduced RBC count in rats and dogs and 

hypocellularity of the bone marrow in 

dogs. 

There was no developmental toxicity 

at the highest dose of 1- 

naphthaleneacetic acid tested in the rat 

or in the rabbit, but developmental 

toxicity (decreased fetal weight and 

minor skeletal changes) were seen in 

rats orally gavaged with the sodium salt. 

Reproductive effects of 

naphthaleneacetic acid sodium salt 

were limited to reduced litter survival 

and pup weight throughout lactation in 

both generations of offspring in a 2- 

generation reproduction study. 

Naphthaleneacetic acid and it’s 

acetamide and the ethyl ester were 

tested for mutagenic effects in a gene 

mutation bacterial assay, mouse 

lymphoma assay, and mouse 

erythrocyte micronucleus assay, mouse 

lymphoma assay, and mouse 

erythrocyte micronucleus assay and 

were not mutagenic. Additionally 1- 

naphthaleneacetic acid was tested for 

mitotic gene conversion and dominant 

lethality in rats and found to be 

negative. 

Carcinogenicity studies of NAA in 

mice and in rats for the 1- 

naphthaleneacetic acid group showed 

no evidence of carcinogenicity. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by NAA as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies can 

be found at http://www.regulations.gov 

in the document ‘‘Naphthalene Acetates 

HED Risk Assessment for Section 3 

Proposed New Use on Potato Seed 

Pieces’’ at pages 10 through 14 in docket 

ID number EPA–HQ–OPP–2004–0144. 

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 1-naphthaleneaetic acid 

used for human risk assessment is 

shown in Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 1-NAPHTHALENEACETIC ACID 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 (General 

population including 

infants and children).

An acute RfD for the general population subgroups was not selected because no effect attributable to a single (or few) 

day(s) oral exposure was observed in animal studies. 

mstockstill on DSK4VPTVN1PROD with RULES

26956 Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 1-NAPHTHALENEACETIC ACID 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 

Chronic dietary (All 

populations).

NOAEL = 15 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

Chronic RfD = 0.15 

mg/kg/day.

cPAD = 0.15 mg/kg/ 

day 

Chronic Toxicity—Dog. 

LOAEL = 75 mg/kg/day based on stomach lesions in 75% of the 

males and by slight sinusoidal histocytosis in the liver of 50% of 

the males. 

Dermal short-term (1 to 

30 days).

Dermal (or oral) study 

NOAEL = 300 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 ... Dermal Toxicity Study-Rat. 

LOAEL = 1000 mg/kg/day based on reduced body weight gain and 

food efficiency. 

Dermal intermediateterm (1 to 6 months).Dermal (or oral) study 

NOAEL = 300 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 ... Dermal Toxicity Study—Rat. 

LOAEL = 1000 mg/kg/day based on reduced body weight gain and 

food efficiency. 

Inhalation short-term (1 

to 30 days).

Inhalation (or oral) 

study NOAEL= 50 

mg/kg/day (inhalation absorption rate 

= 100%).

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 ... Developmental Toxicity Study—Rat. 

LOAEL = 250 mg/kg/day based on decreased body weight gain during the gestation period. 

Inhalation (1 to 6 

months).

Inhalation (or oral) 

study NOAEL = 25 

mg/kg/day (inhalation absorption rate 

= 100%).

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 ... Subchronic Study—Dog. 

LOAEL = for systemic toxicity = 150 mg/kg/day based on lesions of 

the GI tract and hypocellularity of the bone marrow. 

Cancer (all routes) ....... A ‘‘not likely’’ human carcinogen. 

LOAEL = lowest observed adverse effect level. LOC = level of concern. MOE = margin of exposure. N/A = not applicable. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c = chronic). POD = Point of Departure = A data or an estimated point 

that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). 

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

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to NAA, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

tolerances in 40 CFR 180.155. EPA 

assessed dietary exposures from NAA 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 NAA; 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 USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed tolerance level residues for all 

registered uses, 100% crop treated for 

all commodities with existing 

tolerances, and default processing 

factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that NAA does not pose a 

cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for 1-naphthaleneacetic. Tolerance level 

residues and/or 100% CT 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 NAA in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of 1- 

naphthaleneacetic acid. 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, estimated drinking 

water concentrations (EDWCs) of 

naphthaleneacetic acetates for peak and 

average concentrations of naphthalene 

acetates in surface water are 0.02 ppm 

and 0.003 ppm respectively. The 

modeled peak and average EDWCs for 

ground water is 0.00002 ppm. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For chronic dietary risk assessment, 

the water concentration of value .003 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Rules and Regulations 26957 

ppm 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). There is 

a potential for short-term residential 

exposure to NAA from ornamental uses. 

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 naphthalene 

acetates to share a common mechanism 

of toxicity with any other substances, 

and NAA does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that NAA 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. 

There is low concern (and no residual 

uncertainty) for prenatal and/or 

postnasal toxicity resulting from 

exposure to the NAA group of 

chemicals. The available data provided 

no indication of increased susceptibility 

(quantitative or qualitative) to rats or 

rabbits to in utero exposure to 

naphthalene acetates or to prenatal and 

postnatal exposure in rat reproduction 

studies. 

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. Acceptable developmental toxicity 

studies in the rat and rabbit, and an 

acceptable reproduction study in the rat 

are available. Recent changes to 40 CFR 

part 158 require acute and subchronic 

neurotoxicity and immunotoxicity 

studies. An immunotoxicity study is not 

available. However, the toxicology data 

base for NAA does not show any 

evidence of treatment-related effects on 

the immune system and the overall 

weight of evidence suggests that this 

chemical does not directly target the 

immune system. Consequently, the 

Agency does not believe that conducting 

a functional immunotoxicity study will 

result in a lower POD than that 

currently used for overall risk 

assessment, and therefore, an additional 

safety factor is not needed to account for 

lack of this study. The toxicity database 

does not show any indications of 

neurotoxicity or neuropathology (the 

liver, stomach, lung, and hematological 

parameters are the target organs based 

on repeat toxicity studies in rats, mice 

and dogs). 

ii. There is no indication that NAA is 

a neurotoxic chemical and there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that NAA 

results in increased susceptibility in in 

utero rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

EPA made conservative (protective) 

assumptions in dietary assessment and 

in the ground and surface water 

modeling used to assess exposure to 

NAA in drinking water. EPA made 

conservative (protective) assumptions in 

the residential handler assessment. Postapplication exposure to residents is not 

expected. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, NAA 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 NAA, from 

food and water will utilize 2% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

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). 

There is potential for short-term 

residential exposure to NAA from 

ornamental uses. Oral, dermal and 

inhalation exposures cannot be 

combined for short-term aggregate risk 

assessment, however, because oral 

exposure endpoints are not based on 

common toxicological effects with 

either dermal or inhalation endpoints. 

Estimated dermal and inhalation MOEs 

for residential exposure to naphthalene 

acetates are 3,800 and 58,000 

respectively. These estimated exposures 

are greater than the target MOE of 100 

and therefore not of concern. Although 

a POD from an oral study was used to 

assess residential handler inhalation 

risks for NAA, the Agency does not 

believe this assessment is underprotective of adult handlers. Inhalation 

MOEs calculated for residential 

handlers were all >58,000, thus 

providing an ample margin of safety to 

account for any uncertainties in routeto-route extrapolation. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Intermediate-term exposure to NAA is 

not expected based on residential use 

patterns. Therefore, NAA is not 

expected to pose an intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

mstockstill on DSK4VPTVN1PROD with RULES

26958 Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Rules and Regulations 

NAA is not expected to pose a cancer 

risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to NAA 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology (HPLC methods (Method 

NAA–AM 001 and Method NAA–AM– 

002) for determination of NAA in plant 

commodities have been submitted and 

reviewed. These methods have been 

subjected to successful independent 

laboratory validations. Acceptable 

recoveries were obtained from apples, 

olives and olive oil fortified with NAA 

at the method limit of quantitation 

(LOQ; 0.01 ppm) and at 1.0 ppm. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

No Codex, Canadian, or Mexican 

maximum residue limits (MRLs) have 

been established for residues of 

naphthalene acetates. Therefore, there 

are no trade issues with this action. 

C. Revisions to Petitioned-for Tolerances 

The applicant’s petition requested an 

exemption from the requirement of a 

tolerance for this seed potato 

application but upon review of 

submitted information, the Agency 

determined that a potato tolerance is 

needed. In lieu of providing field trial 

data, a theoretical calculation was 

provided, to show that residues of 1- 

naphthaleneacetic acid on potatoes will 

be less than the analytical method’s 

level of quantitation (0.01 ppm) when 

using the label application rates on 

potato seed pieces. The Agency 

determined that a tolerance at the level 

of quantitation is appropriate and that 

an exemption is not appropriate because 

some residues below the level of 

quantitation may be present and there is 

toxicological concern for NAA. 

V. Conclusion 

Therefore, tolerances are established 

for residues of 1-naphthaleneacetic acid 

and its conjugates calculated as 1- 

naphthaleneacetic acid from the 

application of 1-naphthaleneacetic acid, 

its ammonium, sodium, or potassium 

salts, ethyl ester, and acetamide in or on 

food commodities as follows: in or on 

potato at 0.01 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions To 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

With Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 27, 2012. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Rules and Regulations 26959 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.155 is amended by 

alphabetically adding the following 

commodity to the table in paragraph (a) 

to read as follows: 

§ 180.155 1–Naphthaleneacetic acid; 

tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

*****

Potato ......................................... 0.01 

*****

* * * * * 

[FR Doc. 2012–11117 Filed 5–7–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2012–0003] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street SW., Washington, DC 20472, 

(202) 646–4064, or (email) 

Luis.Rodriguez3@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Federal 

Insurance and Mitigation Administrator 

has resolved any appeals resulting from 

this notification. 

This final rule is issued in accordance 

with section 110 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4104, 

and 44 CFR part 67. FEMA has 

developed criteria for floodplain 

management in floodprone areas in 

accordance with 44 CFR part 60. 

Interested lessees and owners of real 

property are encouraged to review the 

proof Flood Insurance Study and FIRM 

available at the address cited below for 

each community. 

The BFEs and modified BFEs are 

made final in the communities listed 

below. Elevations at selected locations 

in each community are shown. 

National Environmental Policy Act. 

This final rule is categorically excluded 

from the requirements of 44 CFR part 

10, Environmental Consideration. An 

environmental impact assessment has 

not been prepared. 

Regulatory Flexibility Act. As flood 

elevation determinations are not within 

the scope of the Regulatory Flexibility 

Act, 5 U.S.C. 601–612, a regulatory 

flexibility analysis is not required. 

Regulatory Classification. This final 

rule is not a significant regulatory action 

under the criteria of section 3(f) of 

Executive Order 12866 of September 30, 

1993, Regulatory Planning and Review, 

58 FR 51735. 

Executive Order 13132, Federalism. 

This final rule involves no policies that 

have federalism implications under 

Executive Order 13132. 

Executive Order 12988, Civil Justice 

Reform. This final rule meets the 

applicable standards of Executive Order 

12988. 

List of Subjects in 44 CFR Part 67 

Administrative practice and 

procedure, Flood insurance, Reporting 

and recordkeeping requirements. 

Accordingly, 44 CFR part 67 is 

amended as follows: 

PART 67—[AMENDED] 

■ 1. The authority citation for part 67 

continues to read as follows: 

Authority: 42 U.S.C. 4001 et seq.; 

Reorganization Plan No. 3 of 1978, 3 CFR, 

1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 

3 CFR, 1979 Comp., p. 376. 

§ 67.11 [Amended] 

■ 2. The tables published under the 

authority of § 67.11 are amended as 

follows: 

Flooding source(s) Location of referenced elevation 

* Elevation 

in feet 

(NGVD) 

+ Elevation 

in feet 

(NAVD) 

# Depth in 

feet above 

ground 

∧Elevation 

in meters 

(MSL) 

Modified 

Communities affected 

Benton County, Arkansas, and Incorporated Areas 

Docket No.: FEMA–B–1174 

Blossom Way Creek .................. At the Osage/Turtle Creek confluence ....................................... +1204 City of Rogers. 

Approximately 0.4 mile upstream of 1st Street .......................... +1346 

mstockstill on DSK4VPTVN1PROD with RULES