Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 40509 

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 exemption 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: August 6, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In §180.940(a), the table is amended 

by revising the following entry to read 

as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) *** 

Pesticide chemical CAS Reg. No. Limits 

* * * * * * * 

Sulfuric acid monododecyl ester, sodium salt (sodium lauryl sulfate). 151–21–3 When ready for use, the end-use concentration is not to exceed 350 ppm. 

* * * * * * * 

* * * * * 

[FR Doc. E9–19314 Filed 8–11–09 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0129; FRL–8426–3] 

Carbon Black; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of carbon black 

(CAS Reg. No. 1333–86–4) under 40 

CFR 180.920 when used as an inert 

ingredient (colorant) in pesticide 

formulations applied to seeds used to 

grow agricultural and horticultural 

crops. Becker Underwood, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of carbon black. 

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–2009–0129. 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 


jlentini on DSKJ8SOYB1PROD with RULES
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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: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; e-mail address: 

fertich.elizabeth@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 

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 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–2009–0129 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–2009–0129, 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 

In the Federal Register of May 6, 2009 

(74 FR 20947) (FRL–8412–7), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, as amended 

by the Food Quality Protection Act 

(FQPA) (Public Law 104–170), 

announcing the filing of a pesticide 

petition (PP 8E7484) by Becker 

Underwood, Inc., 801 Dayton Ave., P.O. 

Box 667, Ames, IA 50010. The petition 

requested that 40 CFR 180.920 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of carbon black when used as 

an inert ingredient (colorant) in 

pesticide formulations applied to seeds 

used to grow agricultural and 

horticultural crops. That notice 

included a summary of the petition 

prepared by the petitioner. There were 

no comments received in response to 

the notice of filing. 

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

allows EPA to establish an exemption 

from the requirement for 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....’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 


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exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Toxicological Profile 

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

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information 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. The 

nature of the toxic effects caused by 

carbon black are discussed in this unit. 

Based on the limited systemic 

toxicity, carbon black is not expected to 

pose a hazard when used for its 

proposed use pattern as an inert 

ingredient (colorant) in pesticide 

formulations applied to seeds used to 

grow agricultural and horticultural 

crops. Six acute toxicity studies were 

submitted by the petitioner to support 

this action. The results indicate that 

carbon black is very low in toxicity. The 

acute oral toxicity of carbon black to rats 

and the acute dermal toxicity to rabbits 

are both low. The lethal dose (LD)50 for 

both was determined to be greater than 

5,050 milligrams/kilogram (mg/kg) and 

the EPA Toxicity Category is IV. The 

acute inhalation toxicity to rats was also 

low with a lethal concentration (LC)50 of 

greater than 2.54 mg/Liter (L) and the 

toxicity category is IV. Acute eye and 

dermal irritation to rabbits were both 

rated as non-irritating with a Toxicity 

category of IV. A skin sensitization 

study on guinea pigs determined that 

carbon black is not a dermal sensitizer. 

The toxicity of carbon black is 

summarized in a 2005 Tolerance 

Reassessment Document (http:// 

www.epa.gov/opprd001/inerts/ 

carbonblack.pdf). No systemic toxicity 

was identified in a chronic toxicity/ 

carcinogenicity study in mice and rats 

fed carbon black at doses up to 1,000 

mg/kg/day for 2 years (Gandhi, 2005). 

No developmental or reproductive 

studies were identified in this report for 

carbon black. However, there was no 

evidence of effects on reproductive 

organs observed in a 2 year, long term 

study in rats. The lack of systemic 

toxicity identified at doses up to 1,000 

mg/kg/day in the 2 year chronic toxicity 

study also supports the lack of 

developmental and reproductive effects. 

It has also been determined that assays 

for mutagenicity are negative for carbon 

black. No neurotoxicity information is 

available, however, no neurological 

effects were observed in any of the 

available studies. There is no evidence 

of carcinogenicity by oral route. 

However, there is some evidence of lung 

tumors in occupational exposure 

scenarios via inhalation route. 

V. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

Residential exposures (inhalation and 

dermal) are not expected since there are 

no existing or proposed residential uses. 

Dietary exposure (food and drinking 

water) to carbon black is not expected 

since it is a solid, insoluble particle that 

adsorbs to the seed surface only. It is not 

likely that it will be absorbed into the 

seed and translocated to the plant and 

harvested plant parts. In addition, 

carbon black has limited toxicity, 

therefore no harm is expected. 

As stated above, no hazard was 

identified for dietary and residential 

exposures to carbon black. Therefore, no 

aggregate risk assessments were 

performed. For carbon black, a 

qualitative assessment for all pathways 

of human exposure (food, drinking 

water, and residential) is appropriate 

given the lack of human health 

concerns, associated with the exposure 

to carbon black when used as an inert 

ingredient (colorant) in pesticide 

formulations applied to seed used to 

grow agricultural and horticultural 

crops. 

VI. Cumulative Effects 

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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

carbon black and any other substances 

and carbon black does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance exemption, therefore, EPA 

has not assumed that carbon black has 

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/. 

VII. Safety Factor for Infants and 

Children 

Section 408 of the 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 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 supports the choice of a different 

factor. 

The toxicity database is sufficient for 

carbon black and potential exposure is 

adequately characterized given the low 

toxicity of the chemical. In terms of 

hazard, there are low concerns and no 

residual uncertainties regarding prenatal 

and/or postnatal toxicity. ‘‘Carbon black 

has low subchronic and chronic 

toxicities. Although no developmental 

or reproductive studies, per se, were 

identified, long-term studies have not 

demonstrated any effects on the 

reproductive organs of male or female 

rats. Additionally, the poor to nil 

absorption of carbon black as 

demonstrated by the lack of significant 

adverse effects by the oral route even at 

high doses would mitigate any 

concerns’’ (Gandhi, 2005). No acute or 

subchronic neurotoxicity studies are 

available, but there were no signs of 

neurological effects observed in the 

database at doses up to 1,000 mg/kg/ 

day. Therefore, the Agency concluded 

that these studies are not required. 

Based on this information, there is no 

concern at this time for increased 

sensitivity to infants and children to 

carbon black when used as an inert 

ingredient in pesticide formulations as a 

colorant for pesticides applied as seed 

treatment to seed used to grow 

agricultural and horticultural crops and 

a safety factor analysis has not been 

used to assess risk. 


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40512 Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 

Further, given the limited exposure 

potential based on the proposed use and 

limited systemic toxicity, a safety factor 

analysis has not been used to assess the 

risks resulting from the inert pesticidal 

use of carbon black. For the same 

reason, EPA has determined that an 

additional safety factor is not needed to 

protect the safety of infants and 

children. 

VIII. Determination of Safety for U.S. 

Population 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Residues of concern are not 

anticipated for dietary exposure (food 

and drinking water) or for residential 

exposure (dermal and inhalation) from 

the use of carbon black for the proposed 

use pattern as an inert ingredient in 

pesticide products. As discussed above, 

EPA expects aggregate exposure to 

carbon black to pose no appreciable 

dietary risk given that the data on 

carbon black shows a lack of systemic 

toxicity at doses up to 1,000 mg/kg/day. 

In addition, dietary exposure is not 

expected since carbon black is a solid, 

insoluble particle that adsorbs to the 

seed surface only. It is not likely that it 

will be absorbed into the seed and 

translocated to the plant and harvested 

plant parts. Also, carbon black will be 

used in very small amounts as a 

colorant for pesticides applied as a seed 

treatment to seed used to grow 

agricultural and horticultural crops. 

Based on the available exposure and 

toxicity information, a safety factor 

analysis has not been used to assess the 

risks resulting from the inert pesticidal 

use of carbon black. 

Taking into consideration all available 

information on carbon black, 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 

carbon black. Therefore, the 

establishment of an exemption from 

tolerance under 40 CFR 180.920 for 

residues of carbon black when used as 

an inert ingredient (colorant) in 

pesticide formulations applied to seeds 

used to grow agricultural and 

horticultural crops can be considered 

safe under section 408 of the FFDCA. 

IX. Other Considerations 

A. Endocrine Disruptors 

EPA is required under FFDCA, as 

amended by FQPA, to develop a 

screening program to determine whether 

certain substances (including all 

pesticide active and other ingredients) 

‘‘may have an effect in humans that is 

similar to an effect produced by a 

naturally occurring estrogen, or other 

such endocrine effects as the 

Administrator may designate.’’ 

Following recommendations of its 

Endocrine Disruptor and Testing 

Advisory Committee (EDSTAC), EPA 

determined that there was a scientific 

basis for including, as part of the 

program, the androgen and thyroid 

hormone systems, in addition to the 

estrogen hormone system. EPA also 

adopted EDSTAC’s recommendation 

that the Program include evaluations of 

potential effects in wildlife. For 

pesticide chemicals, EPA will use the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) and, to the 

extent that effects in wildlife may help 

determine whether a substance may 

have an effect in humans, FFDCA 

authority to require the wildlife 

evaluations. As the science develops 

and resources allow, screening of 

additional hormone systems may be 

added to the Endocrine Disruptor 

Screening Program (EDSP). 

When additional appropriate 

screening and/or testing protocols being 

considered under the Agency’s EDSP 

have been developed, carbon black may 

be subjected to further screening and/or 

testing to better characterize effects 

related to endocrine disruption. 

B. Analytical Method(s) 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

C. Existing Exemptions 

Currently, carbon black is exempted 

from tolerance requirements in pesticide 

formulations applied to animals when 

used as a colorant/pigment in animal 

tags (40 CFR 180.930). 

D. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for carbon 

black nor have any CODEX Maximum 

Residue Levels been established for any 

food crops at this time. 

X. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

for carbon black (CAS Reg. No. 1333– 

86–4) when used as an inert ingredient 

(colorant) in pesticide formulations 

applied to seed used to grow 

agricultural and horticultural crops. 

XI. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance 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 


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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 


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