[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Rules and Regulations]
[Pages 58299-58304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21937]


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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.

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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 <greek-i>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: 
<a href="/cdn-cgi/l/email-protection#7516141805171019195b05071c1b16100606351005145b121a03"><span class="__cf_email__" data-cfemail="5231333f2230373e3e7c22203b3c31372121123722337c353d24">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS 111)
    <bullet> Animal production (NAICS 112)
    <bullet> Food manufacturing (NAICS 311)
    <bullet> 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 re-
designated as Sec.  180.910 and Sec.  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

[[Page 58300]]

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 
(C<INF>8</INF> aldehyde), and its surrogates, heptanal (C<INF>7</INF> 
aldehyde) and nonanal (C<INF>9</INF> 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 > 5,000 mg/kg      LD50 > 5,000 mg/kg
                                       *LD50 = 4,616 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,   NA                       NA
                                        0.5 mL severe burn
----------------------------------------------------------------------------------------------------------------
Acute dermal irritation - rabbit       At 0.5 mL moderate       NA                       NA
                                        dermal reaction
                                        (irritant)
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
14 day dermal (5 days per week for     NA                       In this single dose      Rabbit/New Zealand
 two weeks with a two week recovery                              study, at 500 mg/kg/     White M/F
 period)                                                         day there was local     NOAEL < 500 mg/kg/day
                                                                 dermal irritation that   (nonanoic acid
                                                                 healed after a 2 week    surrogate data) i.e.,
                                                                 recovery period          28 day dermal toxicity
                                                                *The NOAEL would be       assay
                                                                 less than 500 mg/kg/
                                                                 day.
----------------------------------------------------------------------------------------------------------------
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       *There was no increase   Included strain TA97     Activation at 3 units =
 without S-9 activation, strains used   in the frequency of     *Negative results in      mmol/plate *(486 g/
 TA98, TA100, TA1535, and TA 1537       reverse mutations with   all strains with and     plate) non-mutagenic
                                        or without S9            without S9 activation.
                                        activation
----------------------------------------------------------------------------------------------------------------

[[Page 58301]]

 
Developmental toxicity - rat dose      Maternal NOAEL           NA                       NA
 levels of 0, 1,125 or 1,500 mg/kg/     undetermined but
 day                                    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).
----------------------------------------------------------------------------------------------------------------
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   NA                       NA
                                        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).
----------------------------------------------------------------------------------------------------------------
Mammaliam mutation assay - mouse                                *Did not result in any   L5178Y mouse lymphoma
 lymphoma forward mutation assay                                 evidence of              cell with metabolic
                                                                 mutagenicity             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 
structure-activity 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

[[Page 58302]]

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 non-occupational 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 re-evaluated 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

[[Page 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 14<SUP>th</SUP> 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: <a href="/cdn-cgi/l/email-protection#1e716e6e337a717d757b6a5e7b6e7f30797168"><span class="__cf_email__" data-cfemail="3a554a4a175e5559515f4e7a5f4a5b145d554c">[email protected]</span></a>. 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

[[Page 58304]]

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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.910, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


Sec.  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-   Not more than 0.2%  Odor masking agent
 0)                                of the pesticide
                                   formulation
                                * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.930, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


Sec.  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-   Not more than 0.2%  Odor masking agent
 0)                                of the pesticide
                                   formulation
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 04-21937 Filed 9-29-04; 8:45 am]
BILLING CODE 6560-50-S


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