[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Rules and Regulations]
[Pages 7895-7900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2975]



[[Page 7895]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0031; FRL-7698-3]


Octanamide, N,N-dimethyl and Decanamide, N,N-dimethyl; Exemptions 
from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of N,N-dimethyloctanamide or octanamide, N,N-
dimethyl (CAS Reg. No. 1118-92-9), and N,N-dimethyldecanamide or 
decanamide, N,N-dimethyl (CAS Reg. No. 14433-76-2) when used as inert 
ingredients (emulsifier, solvent, and cosolvent) in pesticide 
formulations applied only to growing crops. The C.P. Hall Company, now 
doing business as CPH Services, submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA), requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of N,N-
dimethyloctanamide and N,N-dimethyldecanamide.

DATES: This regulation is effective February 16, 2005. Objections and 
requests for hearings must be received on or before April 18, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0031. 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 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: 
[email protected].

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 Get Electronic Documents and Other Related Information?

    In addition to using EDOCKET at (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 November 15, 2001 (66 FR 57450) (FRL-
6808-6), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing 
the filing of a pesticide petition (PP 1E6257) by The C.P. Hall 
Company, 311 S. Wacker, Suite 4700, Chicago, IL 60606, now doing 
business as CPH Services. The petition requested that 40 CFR part 180 
be amended by establishing exemptions from the requirement of a 
tolerance for residues of N,N-dimethyloctanamide (CAS Reg. No. 1118-92-
9) and N,N-dimethyldecanamide (CAS Reg. No. 14433-76-2) when used as 
inert ingredients as an emulsifier, solvent, and cosolvent in pesticide 
formulations applied only to growing crops at less than 15% of the 
total formulation by weight. That notice included a summary of the 
petition prepared by the petitioner.
    In 2003, EPA received an amendment to the pending PP 1E6257. 
Subsequent to the publication of that notice of filing, the petitioner 
requested to amend the pending pesticide petition to remove the 15% 
limitation on the percentage of N,N-dimethyloctanamide and N,N-
dimethyldecanamide used in formulated products. There were no other 
changes to the information presented by the petitioner in the 2001 
notice. The amended notice was published in the Federal Register of 
November 19, 2003 (68 FR 65279) (FRL-7332-6). There were no comments 
received in response to either of the notices of filing.
    Section 408(b)(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(b)(2)(A)(ii) of the 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 the 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

[[Page 7896]]

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 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 the 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 N,N-dimethyloctanamide and N,N-dimethyldecanamide are discussed in 
this unit.

A. Submitted Studies

    The petitioner has also submitted information to the Agency as part 
of the High Production Volume Challenge Program. According to that 
information, N,N-dimethyldecanamide (CAS No. 14433-76-2) is produced 
commercially in a purified form (98%) as Hallcomid M-10. N,N-
dimethyloctanamide (CAS No. 1118-92-9) and N,N-dimethyldecanamide are 
produced as a commercial mixture, Hallcomid M-8-10, containing 50-65% 
N,N-dimethyloctanamide, 37-50% of N,N-dimethyldecanamide, 0-5% N,N-
dimethylhexanamide, and 0-2% N,N-dimethyldodecanamide.
    The test substance for all of the studies reviewed by the Agency 
was identified as Hallcomid M-8-10. Thus, both the N,N-
dimethyloctanamide and N,N-dimethyldecanamide were present in the test 
substance. Given that the octanamide and decanamide differ only in the 
carbon length (C8 versus C10) of the alkyl chain, the two chemicals can 
be considered as surrogates for each other.
    The acute toxicity profile is presented in Table 1. below:

   Table 1.--Acute Toxicity Profile of N,N-dimethyloctanamide and N,N-
                           dimethyldecanamide
------------------------------------------------------------------------
              Study                     Result             Category
------------------------------------------------------------------------
Acute oral                        LD50 = 1.77 g/kg    III
                                   (confidence
                                   limits is 95% for
                                   a range of 1.02
                                   to 3.08 g/kg)
------------------------------------------------------------------------
Acute dermal                      Female LD50 > 400   II
                                   and < 2,000 mg/kg
                                  Male LD50 > 2,000
                                   mg/kg.
------------------------------------------------------------------------
Acute inhalation                  LC50 > 3.55 mg/L    IV
------------------------------------------------------------------------
Eye irritation                    Corrosive           I
------------------------------------------------------------------------
Dermal irritation                 Moderate to severe  II
                                   erythema at 48
                                   hours
------------------------------------------------------------------------
Dermal sensitization              Not a sensitizer    N/A
------------------------------------------------------------------------

    The petitioner submitted oral subchronic studies in the rat and 
dog, a rat inhalation study, and developmental toxicity studies in the 
rat and rabbit. The results of the Agency's review of these studies are 
in Table 2. below:

               Table 2.--Toxicity Studies Using N,N-dimethyloctanamide and N,N-dimethyldecanamide
----------------------------------------------------------------------------------------------------------------
      Type of Study/Route/Species                   Doses                              Results
----------------------------------------------------------------------------------------------------------------
6-week oral gavage dog                   0, 20, 100, or 500 mg/kg/   No observed adverse effect level (NOAEL) =
                                          day                         100 mg/kg/day
                                         Note that 500 mg/kg/day     Lowest observed adverse effect level
                                          was increased to 1,000 mg/  (LOAEL) = 500/1,000 mg/kg/day based on
                                          kg/day at 2 weeks.          clinical signs
----------------------------------------------------------------------------------------------------------------
90-day in the diet rat                   0, 400, 2,000, or 10,000    NOAEL = 136.8 (M) and 894.6 (F) mg/kg/day
                                          parts per million (ppm)    LOAEL = 787.6 (M) based on kidney effects.
                                          equivalent to 0, 27.4/      A LOAEL was not determined for females but
                                          35.2, 136.8/178.5, 787.5/   would be greater than 894.6 mg/kg/day, the
                                          894.6 (M/F) mg/kg/day       highest dose tested
----------------------------------------------------------------------------------------------------------------
5-day inhalation rat                     0, 24.6, 111.2, or 521.2    NOAEL = 111.2 mg/m\3\
                                          mg/m\3\                    LOAEL = 521.2 mg/m\3\ based on clinical
                                                                      signs, decreased body temperature,
                                                                      decreased body weight and weight gain, and
                                                                      histopathological findings in the
                                                                      respiratory tract
----------------------------------------------------------------------------------------------------------------

[[Page 7897]]

 
Developmental gavage rat gestation days  0, 50, 150, or 450 mg/kg/   Maternal NOAEL = 150 mg/kg/day
 6-15                                     day                        Maternal LOAEL = 450 mg/kg/day based on
                                                                      clinical signs, decreased weight gain, and
                                                                      food consumption
                                                                     Developmental NOAEL = 150 mg/kg/day
                                                                     Developmental LOAEL = 450 mg/kg/day based
                                                                      on increased post-implantation loss,
                                                                      decreased fetal body weight, increased
                                                                      incidence of skeletal malformations/
                                                                      variations
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    The petitioner also submitted the following mutagenicity assays, as 
described in Table 3. below:

         Table 3.--Mutagenicity Assays Conducted Using N,N-dimethyloctanamide and N,N-dimethyldecanamide
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             Type of Assay                      Test Culture                           Results
----------------------------------------------------------------------------------------------------------------
In vitro (bacterial reverse gene         TA 98, 100, 1535, 1537 S.   No evidence of induced mutant colonies over
 mutation)                                typhimurium                 background
--------------------------------------------------------------------- In vitro mutagenicity (mammalian forward
---------------------------------------------------------------------
----------------------------------------=============================
----------------------------------------------------------------------------------------------------------------

B. Structure Activity Relationship (SAR) Assessment

    Toxicity for N,N-dimethyloctanamide and several structurally-
related analogs was assessed, in part, by a process called 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. Since N,N-dimethyldecanamide is of 
a chain length intermediate between N,N-dimethyloctanamide and the 
analogs assessed, the SAR conclusions also apply to N,N-
dimethyloctanamide.
    The SAR conclusions were as follows: Absorption would be poor via 
all routes of exposure. Thus, no significant effects are expected. The 
SAR did indicate concerns that one of the analogs might be an irritant. 
These concerns can be appropriately addressed through labeling and the 
use of protective equipment.

C. Conclusions

    The acute toxicity data indicated that N,N-dimethyloctanamide and 
N,N-dimethyldecanamide are eye and dermal irritants.
    Subchronic toxicity studies revealed no significant treatment 
related effects for N,N-dimethyloctanamide and N,N-dimethyldecanamide. 
In the 6-week oral gavage study in dogs, there were no significant 
differences between treated and control groups. During a 90-day oral 
toxicity study in rats, N,N- dimethyloctanamide and N,N-
dimethyldecanamide did not produce any significant effects on 
mortality, clinical signs, food consumption, hematology, or gross 
pathology. In the 5-day inhalation study, test animals exhibited signs 
of respiratory tract irritation. However, this respiratory irritant 
effect occurred only at high inhalation doses.
    N,N-dimethyloctanamide and N,N-dimethyldecanamide showed no 
evidence of mutagenicity, or chromosome aberration, and did not show 
any signs of developmental toxicity in the study in rabbits at dose 
levels up to 1,000 mg/kg/day. In a rat developmental toxicity study 
there was a decrease in weight gain in the high dose group, which could 
possibly be explained by a decrease in food consumption. It is noted 
that the SAR did not identify any developmental or reproductive 
concerns.
    There is a consistent pattern of NOAELs of 100 mg/kg/day or greater 
in both subchronic toxicity studies and the maternal NOAELs in the 
developmental toxicity studies. But, the effects noted were not 
clinically or toxicologically relevant especially when compared to the 
control groups. These effects were mainly decreased weight gain in all 
species tested, but this occurred in such a small number of animals 
that it was not even statistically significant. Also, there was a 
corresponding decrease in food consumption. Additionally, it is noted 
that the spacing between the NOAELs and LOAELs is large.

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide

[[Page 7898]]

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).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be 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.
    Both N,N-dimethyloctanamide and N,N-dimethyldecanamide are 
sponsored under the High Production Volume Challenge Program. This is 
indicative of over 1 million pounds of N,N-dimethyloctanamide and N,N-
dimethyldecanamide either produced or imported per year. Information 
indicates that N,N-dimethyloctanamide and N,N-dimethyldecanamide are 
used in personal care products and in paints.
    The Agency has used various screening-level models to estimate some 
of the existing levels of exposure and those that could occur as a 
result of establishing this tolerance exemption. To assure 
protectiveness, the estimates in Table 4. below are deliberately 
intended to over-estimate exposure.

    Table 4.--Exposure Estimates for N,N-dimethyloctanamide and N,N-
                           dimethyldecanamide
------------------------------------------------------------------------
          Type of Exposure                      Exposure Level
------------------------------------------------------------------------
Dietary - Food (as a result of        Acute exposure: All population
 application to crops)                 subgroups less than 1 mg/kg/day
                                       at 95\th\ percentile
                                      Chronic exposure: All population
                                       subgroups less than 1 mg/kg/day
------------------------------------------------------------------------
-------------------------------------===================================
------------------------------------------------------------------------

VI. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance or tolerance 
exemption, the Agency consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.''
    Unlike other pesticide chemicals 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 N,N-
dimethyloctanamide and N,N-dimethyldecanamide and any other substances. 
N,N-dimethyloctanamide and N,N-dimethyldecanamide do not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
N,N-dimethyloctanamide and N,N-dimethyldecanamide have a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the policy statements released by EPA's Office of Pesticide Programs 
(OPP) 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

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold 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. The Agency has 
reviewed the results of two developmental toxicity studies conducted 
using N,N-dimethyloctanamide and N,N-dimethyldecanamide. Based on the 
observed insignificant clinical toxic effects such as decreased weight 
gain due to decreased food intake, and the fact that developmental 
signs were observed only at very high doses, EPA has not used a safety 
factor analysis to assess the risk. For the same reasons a tenfold 
safety factor is unnecessary.

VIII. Determination of Safety for U.S. Population, Infants, and 
Children

    The Agency has reviewed and evaluated a toxicity database of 15 
studies conducted using N,N-dimethyloctanamide and N,N-
dimethyldecanamide. Studies indicate that N,N-dimethyloctanamide and 
N,N-dimethyldecanamide have a low systemic toxicity via oral exposure 
and are not mutagenic. Developmental effects were observed only at very 
high doses. The SAR assessments did not indicate any concerns for 
carcinogenicity, developmental, or reproductive effects. Based on the 
available information on toxicity and exposure, EPA finds that 
exempting N,N-dimethyloctanamide and N,N-dimethyldecanamide from the 
requirement of a tolerance will be safe for the general population 
including infants and children.

IX. 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

[[Page 7899]]

proceeds with implementation of this program, further testing of 
products containing N,N-dimethyloctanamide and N,N-dimethyldecanamide 
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 Exemptions

    There are no existing tolerances or tolerance exemptions for N,N-
dimethyloctanamide and N,N-dimethyldecanamide.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
N,N-dimethyloctanamide and N,N-dimethyldecanamide nor have any CODEX 
Maximum Residue Levels (MRLs) been established for any food crops at 
this time.

X. Conclusions

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
residues of N,N-dimethyloctanamide or octanamide, N,N-dimethyl (CAS 
Reg. No. 1118-92-9), and N,N-dimethyldecanamide or decanamide, N,N-
dimethyl (CAS Reg. No. 14433-76-2). Accordingly, EPA finds that 
exempting octanamide, N,N-dimethyl (CAS Reg. No. 1118-92-9) and 
decanamide, N,N-dimethyl (CAS Reg. No. 14433-76-2) from the requirement 
of a tolerance will be safe.

XI. 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of 
the FFDCA. 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 ID number OPP-2005-0031 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 April 18, 
2005.
    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\th\ 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 XI.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-2005-0031, 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-
0001. 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: [email protected]. 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).

XII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the 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 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

[[Page 7900]]

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 
section 408(d) of the 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. 
In addition, the Agency has determined that this action will not have a 
substantial direct effect 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 section 408(n)(4) of the FFDCA. 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.

XIII. 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: February 7, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 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.  180.920, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Decanamide, N,N-dimethyl (CAS     ..................  Emulsifier,
 Reg. No. 14433-76-2).                                 solvent,
                                                       cosolvent
                                * * * * *
Octanamide, N,N-dimethyl (CAS     ..................  Emulsifier,
 Reg. No. 1118-92-9).                                  solvent,
                                                       cosolvent
                                * * * * *
------------------------------------------------------------------------


[FR Doc. 05-2975 Filed 2-15-05; 8:45 am]
BILLING CODE 6560-50-S