Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58299

and pests, Reporting and recordkeeping 

requirements.

Dated:lllllllllll

llllllllllllllll

Director, 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 180.601 is added to read as 

follows:

§ 180.601 Cyazofamid; tolerances for 

residues.

(a) General. Tolerances are 

established for the combined residues of 

cyazofamid, 4-chloro-2-cyano-N,Ndimethyl-5-(4-methylphenyl)-1Himidazole-1-sulfonamide, and its 

metabolite CCIM, 4-chloro-5-(4-

methylphenyl)-1H-imidazole-2-

carbonitrile, expressed as cyazofamid, 

in or on the following commodities:

Commodity Parts per million 

Cucurbit vegetables (Group 

9) ..................................... 0.10

Grape, wine,* import ........... 1.5

Potato ................................. 0.02

Tomato ................................ 0.20

*No domestic registrations. 

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional 

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 04–21931 Filed 9–29–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0298; FRL–7678–7]

Octanal; 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 octanal on 

growing crops or raw agricultural 

commodities (RAC) when used as an 

inert ingredient in pesticide 

formulations applied to growing crops, 

RAC after harvest, or to animals. 

Firmenich submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act (FQPA) 

of 1996, requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of octanal.

DATES: This regulation is effective 

September 30, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VIII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0298. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Princess Campbell, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8033; e-mail address: 

campbell.princess@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 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 

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 and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/) you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

In the Federal Register of December 

20, 2000 (65 FR 79834) (FRL–6751–9), 

EPA issued a notice pursuant to section 

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

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (6E4757) by 

Firmenich, P.O. 5880, Princeton, NJ 

08543.

Firmenich requested that octanal, also 

known as caprylic aldehyde, or 1-

octanal, be approved for use as an inert 

ingredient in pesticide formulations 

applied to growing crops, RACs after 

harvest, or to animals at an amount that 

was not to exceed 0.2% of the 

formulated product. This notice 

included a summary of the petition 

prepared by the petitioner Firmenich.

The petition requested that 40 CFR 

180.1001, (c) and (e), newly redesignated as § 180.910 and § 180.930 

April 28, 2004 (69 FR 23113) (FRL–

7335–4), be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of octanal, (CAS 

Registration No. 124–13–0). There were 

no comments received in response to 

the notice of filing.

Section 408(c)(2)(A)(i) of the 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(c)(2)(A)(ii) 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 

58300 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

section 408(c)(2)(B), in establishing or 

maintaining in effect an exemption from 

the requirement of a tolerance, EPA 

must take into account the factors set 

forth in section 408(b)(2)(C), which 

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. 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 

octanal are discussed in this unit.

A. Toxicity data

Table 1 below summarizes the 

toxicological aspects of octanal (C8

aldehyde), and its surrogates, heptanal 

(C7 aldehyde) and nonanal (C9

aldehyde). All three chemicals belong to 

a group of short-chained linear 

(unbranched) aliphatic acyclic 

aldehydes. Based on their structural 

similarities, and the fact that studies 

indicate that these aldehydes are 

biochemically similar, toxicity data can 

be used almost interchangeably as 

surrogate data for these three 

substances. These aliphatic aldehydes 

are oxidized in the body to form the 

corresponding fatty acids. Thus, the 

corresponding fatty acids, octanoic and 

nonanoic acid, which are essentially 

metabolites of the original aldehyde can 

also be used as surrogate data. The 

Agency used the surrogate data from 

heptanal, nonanal, octanoic acid, and 

nonanoic acid as discussed in table 1 

below, to supplement the available 

information on octanal.

TABLE 1.—COMPARATIVE TOXICITY DATA FOR OCTANAL, HEPTANAL, AND NONANAL

Study Type Octanal Heptanal Nonanal 

Acute oral toxicity - rat LD50 = 5.63 mL/kg 

*LD50 = 4,616 mg/kg 

*LD50 > 5,000 mg/kg LD50 > 5,000 mg/kg

Acute dermal toxicity - rabbit *LD50 = 5,207 mg/kg *LD50 > 5,000 mg/kg *LD50 > 5,000 mg/kg

Acute eye irritation - rabbit 0.01 mL is irritating, 0.5 mL 

severe burn

NA NA

Acute dermal irritation - rabbit At 0.5 mL moderate dermal 

reaction (irritant)

NA NA

Acute dermal irritation - 

human

Non-irritant at 500 mmol, irritant at 1,000 and 2,000 

mmol

NA NA

14 day dermal (5 days per 

week for two weeks with a 

two week recovery period)

NA In this single dose study, at 

500 mg/kg/day there was 

local dermal irritation that 

healed after a 2 week recovery period 

*The NOAEL would be less 

than 500 mg/kg/day

Rabbit/New Zealand White 

M/F 

NOAEL < 500 mg/kg/day 

(nonanoic acid surrogate 

data) i.e., 28 day dermal 

toxicity assay

Acute inhalation toxicity NA *LC50 = 4.7 mg/L LC50 between 0.46 - 3.8 mg/L 

Rats/Sprague - Dawley M/F 

(Data from nonanoic acid) 

Gene mutation-Ames test-with 

and without S-9 activation, 

strains used TA98, TA100, 

TA1535, and TA 1537

*There was no increase in 

the frequency of reverse 

mutations with or without 

S9 activation

Included strain TA97

*Negative results in all strains 

with and without S9 activation

Activation at 3 units = mmol/

plate *(486 g/plate) nonmutagenic

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58301

TABLE 1.—COMPARATIVE TOXICITY DATA FOR OCTANAL, HEPTANAL, AND NONANAL—Continued

Study Type Octanal Heptanal Nonanal 

Developmental toxicity - rat 

dose levels of 0, 1,125 or 

1,500 mg/kg/day

Maternal NOAEL undetermined but likely to be less 

than 1,125 mg/kg/day 

LOAEL= 1,125 mg/kg/day 

based on decreased body 

weight in dams 

Developmental NOAEL = 

1,125 mg/kg/day 

LOAEL = 1,500 mg/kg/day 

based on significant decrease in the number of 

live pups. (Data from 

octanoic acid)

NA NA

Embryo-fetotoxicity NA NA Rat/Sprague-Dawley M/F 

NOAEL (maternity toxicity 

1,500) mg/kg/day (nonanoic acid)

Reproduction (1-generation) - 

rat

This single-dose study was 

used as a range finding 

study to design another 

study. 2,050 mg/kg/day 

*No evidence of reproductive 

toxicity although only a limited number of parameters 

measured (octanoic acid)

NA NA

Mammaliam mutation assay - 

mouse lymphoma forward 

mutation assay

*Did not result in any evidence of mutagenicityL5178Y mouse lymphoma 

cell with metabolic activation Aroclor 1,245 from 

Fisher N334 male rats. 

Conc. Up to 25 nl/ml without activation non-mutagenic. 60 to 120 nl/ml with 

activation weak mutagenic

Teratogenesis Low to moderate hazard (surrogate data for octanal and 

nonanal from nonanoic 

acid)

*Source of Data is a submission by the Flavor Extract Manufacturers Association (FEMA), Washington, DC, under EPA’s High Production 

Volume (HPV) Challenger Program (http://www.epa.gov/chemrtk/opptsrch.htm)

B. Structure Activity Relationship

Toxicity for octanal was assessed, in 

part, by a process called structureactivity relationship (SAR). In this 

process, the chemical’s structural 

similarity to other chemicals (for which 

data are available) is used to determine 

toxicity. For human health, this process, 

can be used to assess absorption and 

metabolism, mutagenicity, 

carcinogenicity, developmental and 

reproductive effects, neurotoxicity, 

systemic effects, immunotoxicity, and 

sensitization and irritation. This is a 

qualitative assessment using terms such 

as good, not likely, poor, moderate, or 

high.

Octanal is absorbed via all routes. It 

is expected that oxidation of the 

aldehyde group to a carboxylic acid 

group would occur. There is concern for 

irritation to all tissues, especially at a 

high percentage in a product. There is 

uncertain concern for dermal 

sensitization based on analogs, and 

developmental toxicity based on 

aldehydes.

C. Conclusions

Octanal is a member of a class of 

chemicals (aldehydes) which are 

metabolized in the body to the 

corresponding fatty acids. The 

mammalian body has a demonstrated 

pathway to process octanal. Octanal is 

metabolized to octanoic acid.

There are developmental studies on 

octanoic acid performed as part of two 

investigations on the developmental 

effects of valproic acid. Unlike octanoic 

acid which is an eight carbon chain 

linear (unbranched) aliphatic acid that 

exhibits low toxicity, valproic acid is an 

eight carbon (branched chain) aliphatic 

acid. Valproic acid is teratogenic in 

humans and rodents. Based on results of 

these investigations, however, octanoic 

acid was not even included in the list 

of chemicals that were considered to 

have caused developmental effects.

The toxicity data from octanoic acid, 

was used to assess the toxicity of 

octanal. Even though as a group the 

staliphatic aldehydes and acids, which 

include octanoic acid and octanal, can 

exhibit developmental toxicity, the 

toxicity data for octanoic acid indicate 

that developmental effects were seen 

only at very high doses (1,125 

milligrams/kiligram/day (mg/kg/day)). 

Also there was no evidence of 

reproductive toxicity for octanoic acid, 

even at very high doses (2,050 mg/kg/

day).

The petitioner has accepted the 

Agency’s limitation of 0.2% octanal in 

the formulated pesticide product. At 

this low percentage in the formulated 

products the residues from the use of 

58302 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

octanal as an inert ingredient will be 

much lower than the amounts which 

can possibly cause developmental or 

reproductive toxicity.

The SAR also indicated concerns for 

dermal sensitization, and irritation to 

mucous membranes. These concerns 

can be appropriately addressed through 

labeling and the use of protective 

equipment.

IV. Aggregate Exposures

In examining aggregate exposure, 

FFDCA section 408 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).

A. Dietary Exposure

Octanal has been used in foodstuffs as 

a flavoring agent since the 1900’s. The 

FDA has approved octanal for use as a 

direct food additive as a flavoring agent 

(21 CFR 172.515-Synthetic flavoring 

substances and adjuvants) and it is 

sponsored by EPA and the Flavor and 

Fragrance High Production Volume 

Consortia as a high production volume 

chemical. The Joint FAO/WHO (Food 

and Agriculture Organization/World 

Health Organization) Expert Committee 

on Food Additives concluded that linear 

aliphatic alcohols, aldehydes, and acids, 

which include octanal and octanoic 

acid, are ubiquitous in nature. In fact, 

low molecular weight alcohols and 

acids such as octanal and octanoic acid 

have been detected in almost every 

known fruit and vegetable. Given the 

natural occurrence, there is a 

background (naturally occurring) level 

of exposure to octanal that cannot be 

regulated, and cannot be decreased.

At its twenty-eighth meeting (1984), 

the Expert Committee established a 

group ADI (Acceptable Daily Intake) of 

0–0.1 mg/kg bwt for octanal and 

nonanal singly or in combination. The 

Agency interprets this as an ADI of 0–

0.1 mg/kg bwt for octanal alone. The use 

of octanal and octanoic acid was reevaluated by the Expert Committee in 

1998 (http://www.inchem.org/

documents/jecfa/jecmono/

v040je10.htm) as part of a group of 

flavoring agents. Using 1987 production 

volumes and other available 

information, JECFA estimated the 

exposure to octanal from use as a 

flavoring agent to be 0.0015 mg/kg bwt 

and for octanoic acid to be 0.011 mg/kg 

bwt. The available data indicates that 

consumption of octanal and octanoic 

acid as naturally occurring in fruit and 

vegetables is much greater than 

consumption as a flavoring agent. 

Exposure resulting from the use of 

octanal in only herbicide formulations 

at less than 0.2 % in the formulated 

product is anticipated to be much 

smaller than either the ADI, the 

naturally occurring background level of 

exposure, or exposure from its use as a 

flavoring agent.

2. Drinking water exposure. Due to its 

rapid volatilization octanal’s half life in 

rivers is 2 hours and in lakes is 5 days. 

Because of this high volatility there 

would be only very low drinking water 

exposure and consequently no concern 

for risk to human health.

B. Other Non-Occupational Exposure

Octanal is used as a fragrance for 

soaps, detergents, and perfumes. 

Because it constitutes such a low 

percentage of the formulation exposure 

is likely to be minimal.

V. Cumulative Effects

Section 408(b)(2)(D)(v) of the 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 the 

above chemical substances and any 

other substances. Octanal does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that this 

chemical substance 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/.

VI. Determination of Safety for U.S 

Population, Infants and Children

FFDCA section 408 provides that EPA 

shall apply an additional 10-fold 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 data unless EPA 

concludes that a different margin of 

safety will be safe for infants and 

children. For octanal, based on an 

understanding of the metabolic 

pathway, the expected low oral toxicity, 

the available toxicity data which 

indicates low toxicity, and especially 

considering the developmental toxicity 

no observed adverse effect level of 1,125 

mg/kg/day for octanoic acid, a 

metabolite of octanal, EPA has not used 

a safety factor analysis to assess the risk. 

For the same reasons a 10-fold safety 

factor is unnecessary.

Based on the information in this 

preamble, EPA concludes that there is a 

reasonable certainty of no harm from 

aggregate exposure to residues of 

octanal, and that under reasonably 

forseeable circumstances aggregate 

exposure to octanal will pose no 

appreciable risk to human health. 

Accordingly, EPA finds that exempting 

octanal (CAS Registration No. 124–13–

0) from the requirement of a tolerance 

will be safe.

VII. Other Considerations

A. Endocrine Disruptors

FQPA requires EPA to develop a 

screening program to determine whether 

certain substances, including all 

pesticide chemicals (both inert and 

active ingredients), may have an effect 

in humans that is similar to an effect 

produced by a naturally occurring 

estrogen, or such other endocrine effect. 

EPA has been working with interested 

stakeholders to develop a screening and 

testing program as well as a priority 

setting scheme. As the Agency proceeds 

with implementation of this program, 

further testing of products containing 

octanal for endocrine effects may be 

required.

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 Tolerances

There are no existing tolerance 

exemptions for octanal.

D. International Tolerances

The Agency is not aware of any 

country requiring a tolerance for octanal 

nor have any CODEX Maximum Residue 

Levels been established for any food 

crops at this time.

VIII. Conclusions

The mammalian body has a 

demonstrated pathway to process 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58303

octanal. Octanal is metabolized to the 

corresponding fatty acid, octanoic acid, 

so there are no concerns for dietary 

exposure. Given that the petitioner will 

use octanal at levels not to exceed 0.2% 

of the formulation, and its metabolic 

transformation to octanoic acid, its use 

as an inert ingredient would not 

significantly increase the levels of 

octanal in the food supply, and should 

result in human exposure far below any 

dose level that could possibly produce 

an adverse effect

Based on the information discussed in 

this preamble, the expected low oral 

toxicity, and the developmental toxicity 

data for the metabolite (octanoic acid), 

EPA concludes that there is reasonable 

certainty of no harm from aggregate 

exposure to residues of 1-octanal. 

Therefore, EPA is establishing a 

tolerance exemption for 1-octanal (CAS 

Reg. No. 124–13– 0) with a limitation in 

the pesticide formulation of not more 

than 0.2%.

IX. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as 

amended by the FQPA, 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. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA of 1996, EPA will 

continue to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d), as was provided in the 

old FFDCA sections 408 and 409. 

However, the period for filing objections 

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing?

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket Identification 

(ID) number OPP–2004–0298 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 November 29, 2004.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit IX.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0298, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460. In person or by 

courier, bring a copy to the location of 

the PIRIB described in ADDRESSES. You 

may also send an electronic copy of 

your request via e-mail to: oppdocket@epa.gov. Please use an ASCII 

file format and avoid the use of special 

characters and any form of encryption. 

Copies of electronic objections and 

hearing requests will also be accepted 

on disks in WordPerfect 6.1/8.0 or 

ASCII file format. Do not include any 

CBI in your electronic copy. You may 

also submit an electronic copy of your 

request at many Federal Depository 

Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

X. Statutory and Executive Order 

Reviews

This final rule establishes an 

exemption from the tolerance 

requirement 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 rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this rule is not subject to Executive 

Order 13211, Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under FFDCA section 408(d), 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

58304 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications ’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of FFDCA section 408(n)(4). 

For these same reasons, the Agency has 

determined that this rule does not have 

any ‘‘tribal implications’’ as described 

in Executive Order 13175, entitled 

Consultation and Coordination with 

Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

XI. Congressional Review Act

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 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: September 23, 2004.

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 § 180.910, the table is amended by 

adding alphabetically the following inert 

ingredient to read as follows:

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance.

* * * * *

Inert Ingredients Limits Uses 

*****

1-Octanal 

(CAS Reg. 

No. 124–

13–0) 

Not more 

than 0.2% 

of the pesticide formulation

Odor masking 

agent

*****

■ 3. In § 180.930, the table is amended by 

adding alphabetically the following inert 

ingredient to read as follows:

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance.

* * * * *

Inert Ingredients Limits Uses 

*****

1-Octanal 

(CAS Reg. 

No. 124–

13–0)

Not more 

than 0.2% 

of the pesticide formulation

Odor masking 

agent

Inert Ingredients Limits Uses 

*****

[FR Doc. 04–21937 Filed 9–29–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0313; FRL–7678–8]

Mesotrione; Pesticide Tolerances for 

Emergency Exemptions

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

mesotrione, 2-[4-(methylsulfonyl)-2-

nitrobenzoyl]-1,3-cyclohexanedione, in 

or on cranberry. 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 

cranberry. This regulation establishes a 

maximum permissible level for residues 

of mesotrione in this food commodity. 

The tolerance will expire and is revoked 

on December 31, 2007.

DATES: This regulation is effective 

September 30, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0313. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 South Bell 

St., Arlington, VA. This docket facility 

is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal