Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 30213 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

The Congressional Review Act, 5 

U.S.C. 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. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by July 22, 2013. Filing a petition 

for reconsideration by the Administrator 

of this final rule does not affect the 

finality of this action 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, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Oxides of 

nitrogen, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Dated: February 4, 2013. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, chapter I, title 40 of the Code 

of Federal Regulations are amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart D—Arizona 

■ 2. Section 52.120 is amended by 

adding paragraphs (c)(155), (c)(156), and 

(c)(157) to read as follows: 

§ 52.120 Identification of plan. 

* * * * * 

(c) * * * 

(155) The following plan was 

submitted on November 6, 2009 by the 

Governor’s designee. 

(i) Incorporation by reference. 

(A) Arizona Department of 

Environmental Quality. 

(1) Affidavit by Efrem K. Sepulveda, 

Law Librarian, Arizona State Library, 

Archives and Public Records, certifying 

authenticity of reproduction of A.R.S. 

§ 49–542 (2008 edition) plus title page 

to pocket part of Title 49 (2008 edition), 

signed January 11, 2013. 

(2) Arizona Revised Statutes 

(Thomson West, 2008 Cumulative 

Pocket Part): Title 49 (the environment), 

section 49–542 (‘‘Emissions inspection 

program; powers and duties of director; 

administration; periodic inspection; 

minimum standards and rules; 

exceptions; definition’’). 

(ii) Additional materials. 

(A) Arizona Department of 

Environmental Quality. 

(1) Final Arizona State 

Implementation Plan Revision, 

Exemption of Motorcycles from Vehicle 

Emissions Inspections and Maintenance 

Program Requirements in Area A 

(October 2009), adopted by the Arizona 

Department of Environmental Quality 

on November 6, 2009, excluding 

appendices A and C. 

(156) The following plan was 

submitted on January 11, 2011 by the 

Governor’s designee. 

(i) [Reserved] 

(ii) Additional materials. 

(A) Arizona Department of 

Environmental Quality. 

(1) Final Addendum to the Arizona 

State Implementation Plan Revision, 

Exemption of Motorcycles from Vehicle 

Emissions Inspections and Maintenance 

Program Requirements in Area A, 

October 2009 (December 2010), adopted 

by the Arizona Department of 

Environmental Quality on January 11, 

2011. 

(157) The following plan was 

submitted on May 25, 2012 by the 

Governor’s designee. 

(i) Incorporation by reference. 

(A) Arizona Department of 

Environmental Quality. 

(1) Affidavit by Barbara Howe, Law 

Reference Librarian, Arizona State 

Library, Archives and Public Records, 

certifying authenticity of reproduction 

of Arizona Revised Statutes § 49–451 

(sic) (corrected to § 49–541) (2001 

pocket part), signed May 3, 2012. 

(2) Arizona Revised Statutes (West 

Group, 2001 Cumulative Pocket Part): 

title 49 (the environment), section 49– 

541 (‘‘Definitions’’), subsection 1 

[Definition of Area A]. 

[FR Doc. 2013–12091 Filed 5–21–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0203; FRL–9386–1] 

1-Naphthaleneacetic acid; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 1- 

naphthaleneacetic acid in or on 

avocado; fruit, pome, group 11–10; 

mango; sapote, mamey; and rambutan. 

This regulation additionally deletes 

certain tolerances, identified and 

discussed later in this document. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective May 

22, 2013. Objections and requests for 

hearings must be received on or before 

July 22, 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–2012–0203, 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 


pmangrum on DSK3VPTVN1PROD with RULES
30214 Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 

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://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0203 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 22, 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– 

2012–0203, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.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 May 2, 2012 

(77 FR 25954) (FRL–9346–1), 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 2E7991) by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.155 be 

amended by establishing tolerances for 

residues of the plant growth regulator 1- 

naphthaleneacetic acid and its 

conjugates in or on rambutan at 3 parts 

per million (ppm); avocado, mango, and 

sapote, mamey at 0.05 ppm; and fruit, 

pome, group 11–10 at 0.15 ppm. The 

petition additionally requested to 

amend the tolerances in 40 CFR 180.155 

by removing the tolerance for fruit, 

pome, group 11 at 0.15 ppm, as it will 

be superseded by the tolerance on fruit, 

pome, group 11–10 at 0.15 ppm. That 

document referenced a summary of the 

petition prepared on behalf of IR–4 by 

Amvac Chemical 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 petition, EPA has revised 

the proposed tolerance on rambutan 

from 3.0 ppm to 2.0 ppm. The Agency 

has also revised the tolerance 

expression for all established 

commodities to be consistent with 

current Agency policy. The reason for 

these changes is 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 

that section, 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-naphthaleneacetic acid, including 

exposure resulting from the tolerances 

established by this action. EPA’s 

assessment of exposures and risks 

associated with 1-naphthaleneacetic 

acid 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 which are 

collectively referred to as naphthalene 

acetates (NAA), are expected to exhibit 

similar toxicological effects. In selecting 

endpoints of toxicity for risk assessment 

to exposures to the various NAA forms, 

the most conservative endpoint was 

selected from the studies that showed 

the lowest NOAELs for assessing a 

particular exposure. In addition, all 

forms degrade to the acid fairly quickly 

in the field and in biological systems. 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 30215 

Therefore, EPA has concluded that 

required toxicity testing on any form 

should serve for all members of this 

group of chemicals. 

Repeated oral exposures to NAA in 

rats and dogs resulted in decreased body 

weights, and body weight gains 

accompanied by decreased food 

consumption. The major target organs 

from subchronic and chronic oral 

exposures were the liver, stomach, and 

lung. Repeated oral exposures also 

resulted in decreased hematocrit and 

hemoglobin, along with reduced red 

blood cell count in rats and dogs and 

hypocellularity of the bone marrow in 

dogs. 

There was no developmental toxicity 

at the highest dose of NAA (the acid) 

tested in the rat or in the rabbit (orally 

gavaged), but developmental toxicity 

(decreased fetal weight and minor 

skeletal changes) were seen in rats 

orally gavaged with the sodium salt. 

Reproductive effects of NAA sodium 

salts were limited to reduced litter 

survival and pup weight throughout 

lactation in both generations of offspring 

in a 2-generation reproduction study. 

NAA and its 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 found to be mutagenic. 

Additionally, NAA was tested for 

mitotic gene conversion and dominant 

lethality in rats and found to be 

negative. In a published carcinogenicity 

study of NAA acetamide in mice and a 

guideline chronic/oncogenicity study of 

NAA sodium salt in rats and mice, NAA 

compounds were not carcinogenic in 

mice or rats. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by NAA as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in document: 

‘‘Naphthalene Acetates Human Health 

Risk Assessment for a Proposed Use on 

Avocado, Mango, Mamey Sapote, 

Rambutan, and Updating Crop Group 

Fruit, Pome, Group 11–10.’’ at pages 42– 

50 in docket ID number EPA–HQ–OPP– 

2012–0203. 

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 (LOC) 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 (U/SF) 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 nonthreshold 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 NAA used for human risk 

assessment is shown in Table 1 of this 

unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NAA 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 

and females 13–49 years of 

age) 

An acute RfD for the general population or any population subgroups was not selected because no effect 

attributable to a single exposure was observed in animal studies. 

Chronic dietary (All populations) .... NOAEL = 15 mg/kg/day ...............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

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 

histiocytosis in the liver of 50% 

of the males. 

Dermal short-term (1 to 30 days) .. Dermal study ................................

NOAEL = 300 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... 21-Day dermal: NAA Na salt 

LOAEL = 1,000 mg/kg/day 

based on reduced body weight 

gain and food efficiency. 

Inhalation short-term (1 to 30 

days).

Oral study .....................................

NOAEL = 50 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 10x 

LOC for MOE = 1,000 .................. Developmental Rat: NAA LOAEL 

= 150 mg/kg/day based on decreased body weight gain during gestation period. 

Cancer (Oral, dermal, inhalation) .. Not likely to be carcinogenic to humans. 

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

milligrams/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). 


pmangrum on DSK3VPTVN1PROD with RULES
30216 Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 

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 NAA 

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 Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCID) Version 3.16, which uses food 

consumption data from the U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America, 

(NHANES/WWEIA), conducted from 

2003–2008. As to residue levels in food, 

EPA assumed 100 percent crop treated 

(PCT) and tolerance-level residues for 

all commodities. In addition, DEEM 

version 7.81 default processing factors 

were used, when appropriate. 

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 PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for NAA. Tolerance level residues and/ 

or 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for NAA in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of NAA. 

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 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of NAA 

for chronic exposures for non-cancer 

assessments are estimated to be 2.99 

parts per billion (ppb) for surface water 

and 0.0226 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 3.0 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). NAA is 

currently registered for root dip and 

sprout inhibition applications to 

ornamentals, which could result in 

residential exposures. There is a 

potential for short-term dermal and 

inhalation exposures to residential 

handlers, resulting from loading and 

applying NAA. There are no residential 

uses for NAA that result in exposure to 

children via incidental oral activities. 

The rooting compounds are applied by 

holding the plant and dipping the roots 

into solution. Very little exposure is 

expected from this use. Sprout 

inhibitors are applied by spray or paint 

brush/roller after pruning trees, or by 

spraying near the base of the tree after 

pruning root suckers. There is very little 

potential for postapplication exposure 

to NAA for adults or children based on 

the residential use pattern; therefore, 

residential postapplication exposure is 

not expected, nor is intermediate- or 

long-term exposure scenarios based on 

the intermittent nature of applications 

by homeowners. 

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 NAA 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 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 pre- and/or postnatal 

toxicity resulting from exposure to the 

NAA group of chemicals. The available 

data provided no indication of increased 

quantitative or qualitative susceptibility 

of rats or rabbits to in utero exposure to 

NAA or to prenatal and postnatal 

exposure in rat reproduction studies. In 

the developmental toxicity study 

conducted with NAA sodium salt in 

rats, fetal toxicity (mainly decreased 

fetal weights and minor skeletal 

changes) was observed at a dose lower 

than the maternally toxic dose. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

was reduced to 1X for the oral and 

dermal routes of exposure and retained 

at 10X for the inhalation route of 

exposure. That decision is based on the 

following findings: 

i. The toxicity database for NAA is not 

complete. EPA concluded that a 28-day 

inhalation toxicity study is required for 

NAA, based on a weight-of-evidence 

approach. A 10X SF was retained for the 

inhalation route of exposure due to the 

lack of the required 28-day inhalation 

study and given that the endpoint for 

subchronic inhalation is based on a 

developmental study (NOAEL = 50 mg/ 

kg/day) that noted decreased body 

weight gains during gestation. 

Additionally, recent changes to 40 

CFR part 158 imposed new data 

requirements for immunotoxicity testing 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 30217 

(OCSPP Guideline 870.7800) for 

pesticide registration. While an 

immunotoxicity study is not available 

for NAA, the toxicology database does 

not show any evidence of treatmentrelated 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. 

Acute and subchronic neurotoxicity 

studies are also required as a part of 

new data requirements in 40 CFR part 

158; however, EPA has waived the 

requirement for these studies at the 

present time. This decision is based on: 

(1) The lack of neurotoxicity and 

neuropathology in the available 

toxicology studies for NAA; and (2) 

liver, stomach, and lung were identified 

as the target organs, with dogs being the 

most sensitive species. Therefore, 

neurotoxicity studies conducted in rats 

would not provide a more sensitive 

endpoint for risk assessment, and 

studies would be unlikely to yield PODs 

lower than the current PODs used for 

overall risk assessment. 

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. 

In the developmental toxicity study 

conducted with NAA sodium salt in 

rats, fetal toxicity was observed at a 

dose lower than the maternally toxic 

dose. However, there were clear 

NOAELs in this developmental study 

and the PODs used in the chronic 

dietary assessment (15 mg/kg/day) are 

protective of the fetal effects observed in 

the study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary food exposure 

assessment was performed based on 100 

PCT and tolerance-level residues. EPA 

made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to NAA in drinking water. 

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

regarding limited residential use 

patterns, exposure to residential 

handlers is very low and EPA does not 

anticipate postapplication exposure to 

children or incidental exposures to 

toddlers resulting from use of NAA in 

residential settings. These assessments 

will not underestimate the exposure and 

risks posed by NAA. 

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 2.0% 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 NAA 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). Though there is 

potential for short-term dermal and 

inhalation exposures to adult handlers 

resulting from residential applications 

of NAA to ornamentals, aggregate risk 

was not estimated for NAA because the 

toxicity endpoints selected for the 

chronic dietary route of exposure and 

those selected for inhalation and dermal 

routes of exposure are not based on 

common effects i.e., the chronic dietary 

endpoint is based on systemic effects 

and the dermal and inhalation 

endpoints are based on decreased body 

weight gain. Exposure pathways and 

routes are only aggregated when they 

share a common toxic effect. 

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). 

Because no intermediate-term adverse 

effect was identified, 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, 

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 method, a 

high performance liquid 

chromatography (HPLC) method using 

fluorescence detection (Method NAA– 

AM–001) and a similar method (Method 

NAA–AM–002), is available to enforce 

the tolerance expression for NAA in 

plant commodities. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for NAA. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the data supporting the 

petition, EPA revised the proposed 

tolerance on rambutan from 3.0 ppm to 


pmangrum on DSK3VPTVN1PROD with RULES
30218 Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 

2.0 ppm. The Agency revised this 

tolerance level based on analysis of the 

residue field trial data using the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. 

Finally, the Agency has revised the 

tolerance expression to clarify: (1) That, 

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

the tolerance covers metabolites and 

degradates of NAA 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 residues of NAA, 1- 

naphthaleneacetic acid, in or on 

avocado at 0.05 ppm; fruit, pome, group 

11–10 at 0.15 ppm; sapote, mamey at 

0.05 ppm; mango at 0.05 ppm; and 

rambutan at 2.0 ppm. This regulation 

additionally removes the tolerance in or 

on fruit, pome, group 11 at 0.15 ppm 

and the time-limited tolerance in or on 

avocado 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: May 14, 2013. 

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. Section 180.155 is revised to read 

as follows: 

§ 180.155 1-Naphthaleneacetic acid; 

tolerances for residues. 

(a) General. Tolerances are 

established for the residues of 1- 

naphthaleneacetic acid, including its 

metabolites and degradates in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified is to be determined by 

measuring only 1-naphthaleneacetic 

acid and its conjugates, calculated as the 

Stoichiometric equivalent of 1- 

naphthaleneacetic acid, in or on the 

commodity. 

Commodity Parts per 

million 

Avocado ................................ 0 .05 

Cherry, sweet ....................... 0 .1 

Fruit, pome, group 11–10 ..... 0 .15 

Mango ................................... 0 .05 

Olive ...................................... 0 .7 

Orange .................................. 0 .1 

Pineapple1 ............................ 0 .05 

Potato ................................... 0 .01 

Rambutan ............................. 2 .0 

Sapote, mamey .................... 0 .05 

Tangerine .............................. 0 .1 

1There are no U.S. registrations since 1988. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2013–12207 Filed 5–21–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 152 

[CMS–9995–IFC3] 

RIN 0938–AQ70 

Pre-Existing Condition Insurance Plan 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule with 

comment period sets the payment rates 

for covered services furnished to 

individuals enrolled in the Pre-Existing 

Condition Insurance Plan (PCIP) 

program administered directly by HHS 

beginning with covered services 

furnished on June 15, 2013. This interim 


pmangrum on DSK3VPTVN1PROD with RULES