Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 40513 

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) (Public Law 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). 

XII. 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: July 31, 2009. 

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. In § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

Inert ingredients Limits Uses 

* * * * * * * 

Carbon Black (CAS Reg. No. 1333–86–4) ............................ For seed treatment use only Colorant. 

* * * * * * * 

[FR Doc. E9–19193 Filed 8–11–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0373; FRL–8428–3] 

1-Naphthaleneacetic Acid Ethyl Ester; 

Pesticide Tolerance for Emergency 

Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 1- 

naphthaleneacetic acid ethyl ester in or 

on avocados. This action is in response 

to EPA’s granting of an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on avocado trees. 

This regulation establishes a maximum 

permissible level for residues of 1- 

naphthaleneacetic acid ethyl ester in 

this food commodity. The time-limited 

tolerance expires and is revoked on 

December 31, 2012. 

DATES: This regulation is effective 

August 12, 2009. Objections and 

requests for hearings must be received 

on or before October 13, 2009, 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–2009–0373. All documents in the 

docket are listed in the docket index 

available in 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@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: 

•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 provides 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 


jlentini on DSKJ8SOYB1PROD with RULES
40514 Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 

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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2009–0373 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before October 13, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2009–0373, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing a timelimited tolerance for residues of the 

plant growth regulator 1- 

naphthaleneacetic acid ethyl ester in or 

on avocados at 0.05 parts per million 

(ppm). This time-limited tolerance 

expires and is revoked on December 31, 

2012. EPA will publish a document in 

the Federal Register to remove the 

revoked tolerances from the CFR. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related timelimited tolerances to set binding 

precedents for the application of section 

408 of FFDCA and the new safety 

standard to other tolerances and 

exemptions. Section 408(e) of FFDCA 

allows EPA to establish a tolerance or an 

exemption from the requirement of a 

tolerance on its own initiative, i.e., 

without having received any petition 

from an outside party. 

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. . . .’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 1- 

Naphthaleneacetic Acid Ethyl Ester on 

Avocados and FFDCA Tolerances 

Avocado growers in Southern 

California are dealing with emergency 

conditions in their orchards caused by 

unique environmental factors including 

a hard freeze, strong Santa Ana winds, 

drought, and fires that burned through 

orchards damaging or killing trees. 

Trees adversely affected by these 

conditions need to be ‘‘stumped’’ to be 

brought back into production. The 

processing of ‘‘stumping’’ entails cutting 

the primary scaffolding limbs of the tree 

back to stumps and painting them with 

white latex paint to protect them from 

sunburn and disease. The treatment of 

the pruned branches and cut stumps 

with naphthalene acetic acid ethyl ester 

slows the re-growth of vegetative 

sprouts by about 70%. This growth 

inhibition results in several lateral 

sprouts instead of literally hundreds of 

sprouts growing at and below the 

pruning cuts. This shortens the pruning 

time per tree or stump and the 

management of the re-growth can be 

accomplished with only one pruning 

per season. After having reviewed the 

submission, EPA determined that 

emergency conditions exist for this 

State, and that the criteria for an 

emergency exemption are met. EPA has 

authorized under FIFRA section 18 the 

use of 1-naphthaleneacetic acid ethyl 

ester on avocado trees limbs that have 

been pruned or cut back to a stump for 

control of excess sprout growth in 

California. As part of its evaluation of 

the emergency exemption application, 

EPA assessed the potential risks 

presented by residues of 1- 

naphthaleneacetic acid ethyl ester in or 

on avocados. In doing so, EPA 

considered the safety standard in 

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

decided that the necessary tolerance 

under section 408(l)(6) of FFDCA would 

be consistent with the safety standard 

and with FIFRA section 18. Consistent 

with the need to move quickly on the 

emergency exemption in order to 

address an urgent non-routine situation 


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Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 40515 

and to ensure that the resulting food is 

safe and lawful, EPA is issuing this 

tolerance without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of FFDCA. 

Although this time-limited tolerance 

expires and is revoked on December 31, 

2012, under section 408(l)(5) of FFDCA, 

residues of the pesticide not in excess 

of the amounts specified in the 

tolerance remaining in or on avocados 

after that date will not be unlawful, 

provided the pesticide was applied in a 

manner that was lawful under FIFRA, 

and the residues do not exceed a level 

that was authorized by this time-limited 

tolerance at the time of that application. 

EPA will take action to revoke this timelimited tolerance earlier if any 

experience with, scientific data on, or 

other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because this time-limited tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decisions about whether 1- 

naphthaleneacetic acid ethyl ester meets 

FIFRA’s registration requirements for 

use on avocados or whether a 

permanent tolerance for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this time-limited tolerance decision 

serves as a basis for registration of 1- 

naphthaleneacetic acid ethyl ester by a 

State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance serve as the basis for persons 

in any State other than California to use 

this pesticide on this crop under FIFRA 

section 18 absent the issuance of an 

emergency exemption applicable within 

that State. For additional information 

regarding the emergency exemption for 

1-naphthaleneacetic acid ethyl ester, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. 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 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 expected as a result 

of this emergency exemption request 

and the time-limited tolerances for 

residues of 1-naphthalene acetic acid 

ethyl ester on avocado at 0.05 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing timelimited tolerances follows. 

A. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

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 greater than that 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-naphthaleneacetic acid 

ethyl ester used for human risk 

assessment can be found at http:// 

www.regulations.gov in document 

Naphthalene Acetates HED Risk 

Assessment for Section 18 Use of 

Naphthalene Acetic Acid Ethyl Ester on 

Avocado Trees, page 11 in docket ID 

number EPA–HQ–OPP–2009–0373. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 1-naphthaleneacetic acid 

ethyl ester, EPA considered exposure 

under the time-limited tolerances 

established by this action as well as all 

existing naphthalene acetic acid 

tolerances in 40 CFR 180.155(a), 

naphthalene acetic acid ethyl ester 

tolerances in 40 CFR 180.155(b), and anaphthaleneacetamide and its 

metabolite a-naphthalene acetic acid 

(calculated as a-naphthalene acetic 

acid) tolerances in 40 CFR 180.309. For 

commodities having tolerances for both 

naphthalene acetic acid and the 

acetamide of naphthalene acetic acid, 

the total amount of residues calculated 

as naphthalene acetic acid shall not 

exceed the higher of the two tolerances 

(40 CFR 180.3(d)(7)). Collectively, these 

chemicals are referred to as the 

naphthalene acetates. For the purpose of 

the human health risk assessment, all 

forms of the naphthalene acetates are 

combined (1-Naphthaleneacetic acid 

(NAA), its salts, ester, and acetamide) 

because they are structurally related and 

are metabolized to the acid form and 

eliminated from the body as glycine and 

glucuronic acid conjugates within 48 

hours after exposure EPA assessed 

dietary exposures from the naphthalene 

acetates in food as follows: 

i. Acute exposure. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, the acute dietary 

exposure/risk analyses for all supported 

naphthalene acetates food uses were 

conducted using conservative, Tier 1 

exposure assessments. The Tier I 

analyses assume tolerance level residues 

for all registered uses, 100 PCT for all 

commodities with existing tolerances, 

and default processing factors. 


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40516 Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 

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, the 

chronic dietary exposure/risk analyses 

for all supported food uses for the 

naphthalene acetates were conducted 

using conservative, Tier 1 exposure 

assessments. The Tier I analyses assume 

tolerance level residues for all registered 

uses, 100 PCT for all commodities with 

existing tolerances, and default 

processing factors. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA has classified the naphthalene 

acetates as ‘‘not likely to be carcinogenic 

to humans’’ therefore, a quantitative 

cancer exposure assessment is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for the naphthalene acetates. 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 the naphthalene acetates in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of the naphthalene 

acetates. 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 (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

naphthalene acetates for acute 

exposures are estimated to be 12.9 parts 

per billion (ppb) for surface water and 

0.0008 ppb for ground water and for 

chronic exposures for non-cancer 

assessments are estimated to be 0.71 

ppb for surface water and 0.0008 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model for 

acute dietary risk assessment, the water 

concentration value of 12.9 ppb was 

used to assess the contribution to 

drinking water, and for chronic dietary 

risk assessment, the water concentration 

of value 0.71 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). 

Although there are residential uses for 

the naphthalene acetates, the uses are 

for ornamentals only (i.e., not turf) and 

post-application residential exposure is 

expected to be negligible. Therefore, a 

quantitative assessment is not required. 

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 the naphthalene 

acetates to share a common mechanism 

of toxicity with any other substances, 

and the naphthalene acetates do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that the 

naphthalene acetates do 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 the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

C. 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 SF 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-natal and postnatal 

toxicity resulting from exposure to the 

naphthalene acetates. The available data 

provided no indication of increased 

susceptibility (quantitative or 

qualitative) in rats or rabbits to in utero 

exposure to naphthalene acetates or to 

pre-natal and post-natal exposure in rat 

reproduction studies. 

3. Conclusion. Therefore, the FQPA 

safety factor is reduced to 1x for risk 

assessment for this chemical. A 

developmental neurotoxicity study is 

not required since there was no 

evidence of neurotoxicity or 

neuropathology from the available 

studies and there is no concern or 

residual uncertainty for pre-natal or 

post-natal toxicity. 

EPA has determined that reliable data 

show that the safety of infants and 

children would be adequately protected 

if the FQPA SF were reduced to 1X. 

That decision is based on the following 

findings: 

i. The toxicity database for the 

naphthalene acetates is complete. 

ii. There is no indication that the 

naphthalene acetates are neurotoxic 

chemicals and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that the 

naphthalene acetates result 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. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to the 

naphthalene acetates in drinking water. 

EPA used similarly conservative 

assumptions to assess postapplication 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by the naphthalene acetates. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shorttern, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 


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residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to the 

naphthalene acetates will occupy 10% 

of the aPAD for children 1–2 years old, 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to the 

naphthalene acetates from food and 

water will utilize 8% of the cPAD for 

children 1–2 years old, the population 

group receiving the greatest exposure. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Although the naphthalene acetates are 

registered for residential use, the uses 

are for ornamentals only (i.e., not turf) 

and post-application residential 

exposure is expected to be negligible. 

Therefore, the short-term and 

intermediate-term aggregate risks 

consist of the sum of the risk from 

exposure to the naphthalene acetates 

through food and water and will not be 

greater than the chronic aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. EPA has classified the 

naphthalene acetates as ‘‘not likely to be 

carcinogenic to humans.’’ The 

naphthalene acetates are not expected to 

pose a cancer risk 

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 naphthalene 

acetic acid residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology is available to enforce the 

tolerance expression of a-naphthalene 

acetic acid and 1-naphthaleneacetamide 

in or on 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 

There are no CODEX MRLs for 

residues of 1-naphthaleneacetic acid 

ethyl ester on avocados. 

VI. Conclusion 

Therefore, a time-limited tolerance is 

established for residues of 1- 

naphthaleneacetic acid ethyl ester in or 

on avocado at 0.05 ppm. This tolerance 

expires and is revoked on December 31, 

2012. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under sections 408(e) and 408(l)(6) 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 in accordance with 

sections 408(e) and 408(l)(6) of FFDCA, 

such as the tolerances in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 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). 

VIII. 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: July 31, 2009. 

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. Section 180.155 is amended by 

redesignating paragraphs (a) and (b) as 

paragraphs (a)(1) and (a)(2) and adding 

a heading to paragraph (a); by adding a 

new paragraph (b); and by adding and 

reserving paragraphs (c) and (d)to read 

as follows: 


jlentini on DSKJ8SOYB1PROD with RULES
40518 Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 

§ 180.155 1-Naphthaleneacetic acid; 

tolerances for residues. 

(a) General. (1) * * *

(2) * * *

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the ethyl ester of 1- 

naphthaleneacetic acid in or on the 

following raw agricultural commodities 

resulting from use of the pesticide 

pursuant to FIFRA section 18 

emergency exemptions. The tolerances 

expire and are revoked on the date 

specified in the following table. 

Commodity Parts per million Expiration/revocation date 

avocado 0.05 December 31, 2012 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

* * * * * 

[FR Doc. E9–19200 Filed 8–11–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R08–RCRA–2009–0341; FRL–8941–1] 

Colorado: Final Authorization of State 

Hazardous Waste Management 

Program Revisions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Immediate final rule. 

SUMMARY: The Solid Waste Disposal Act, 

as amended, commonly referred to as 

the Resource Conservation and 

Recovery Act (RCRA), allows the 

Environmental Protection Agency (EPA) 

to authorize states to operate their 

hazardous waste management programs 

in lieu of the federal program. Colorado 

has applied to the EPA for final 

authorization of changes to its 

hazardous waste program under RCRA. 

EPA has determined that these changes 

satisfy all requirements needed to 

qualify for final authorization, and is 

authorizing the state’s changes through 

this immediate final action. 

DATES: This final authorization will 

become effective on October 13, 2009 

unless the EPA receives adverse written 

comments by September 11, 2009. If 

adverse written comments are received, 

EPA will publish a timely withdrawal of 

this immediate final rule in the Federal 

Register and inform the public that this 

authorization will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket No. EPA–R08– 

RCRA–2009–0341, by any of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• E-mail: cosentini.christina@epa.gov. 

• Fax: (303) 312–6341. 

• Mail: Christina Cosentini, Region 8, 

Solid and Hazardous Waste Program, 

U.S. EPA, Region 8, 1595 Wynkoop 

Street, Denver, Colorado 80202–1129, 

phone number: (303) 312–6231. 

• Hand Delivery or Courier: Deliver 

your comments to Christina Cosentini, 

Region 8, Solid and Hazardous Waste 

Program, Mailcode 8P–HW, U.S. EPA, 

Region 8, 1595 Wynkoop Street, Denver, 

Colorado 80202–1129, phone number: 

(303) 312–6231. 

Instructions: Direct your comments to 

Docket ID No. EPA–R08–RCRA–2009– 

0341. EPA’s policy is that all comments 

received will be included in the public 

docket without change, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information, 

disclosure of which is restricted by 

statute. Do not submit information that 

you consider to be CBI or otherwise 

protected from disclosure through 

http://www.regulations.gov, or e-mail. 

The federal Web site, http:// 

www.regulations.gov, 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 

e-mail comment directly to EPA without 

going through http:// 

www.regulations.gov, your e-mail 

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. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

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 hard 

copy. Publicly available docket 

materials are available either 

electronically through http:// 

www.regulations.gov or in hard copy 

from 9 a.m. to 4 p.m. at: EPA Region 8, 

1595 Wynkoop Street, Denver, 

Colorado, contact: Christina Cosentini, 

phone number (303) 312–6231, or the 

Colorado Department of Public Health 

and Environment, 4300 Cherry Creek 

Drive South, Denver, Colorado 80222– 

1530, contact: Randy Perila, phone 

number (303) 692–3364. The public is 

advised to call in advance to verify 

business hours. 

FOR FURTHER INFORMATION CONTACT: 

Christina Cosentini, (303) 312–6231, 

cosentini.christina@epa.gov or Randy 

Perila, (303) 692–3364, 

randy.perila@state.co.us. 

SUPPLEMENTARY INFORMATION: 

A. Why Are Revisions to State 

Programs Necessary? 

States that have received final 

authorization from EPA under RCRA 

section 3006(b), 42 U.S.C. 6926(b), must 

maintain a hazardous waste program 

that is equivalent to, consistent with, 

and no less stringent than the Federal 

program. As the Federal program 

changes, states must change their 

programs and ask the EPA to authorize 

the changes. Changes to state programs 

may be necessary when Federal or state 

statutory or regulatory authority is 

modified or when certain other changes 

occur. Most commonly, states must 

change their programs because of 

changes to the EPA’s regulations in 40 

Code of Federal Regulations (CFR) parts 

124, 260 through 266, 268, 270, 273, and 

279. 

B. What Decisions Have We Made in 

This Rule? 

We conclude that Colorado’s 

application to revise its authorized 

program meets all of the statutory and 


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