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OPP ID: [OPP-2005-0031; FRL-7698-3]
SUBJECT CATEGORY: Octanamide, N,N-dimethyl and Decanamide, N,N-dimethyl; Exemptions from the Requirement of a Tolerance
DOCUMENT SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of N,Ndimethyloctanamide or octanamide, N,N
dimethyl (CAS Reg. No. 1118929), and N,Ndimethyldecanamide or
decanamide, N,Ndimethyl (CAS Reg. No. 14433762) 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,Ndimethyldecanamide.
SUMMARY: Octanamide, etc.,
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:
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 ECFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .
In the Federal Register of November 15, 2001 (66 FR 57450) (FRL 68086), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104170), 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,Ndimethyloctanamide (CAS Reg. No. 111892 9) and N,Ndimethyldecanamide (CAS Reg. No. 14433762) 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,Ndimethyloctanamide 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) (FRL73326). 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.
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.
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,Ndimethyloctanamide and N,Ndimethyldecanamide are discussed in this unit.
The petitioner has also submitted information to the Agency as part of the High Production Volume Challenge Program. According to that information, N,Ndimethyldecanamide (CAS No. 14433762) is produced commercially in a purified form (98%) as Hallcomid M10. N,N dimethyloctanamide (CAS No. 1118929) and N,Ndimethyldecanamide are produced as a commercial mixture, Hallcomid M810, containing 5065% N,Ndimethyloctanamide, 3750% of N,Ndimethyldecanamide, 05% N,N dimethylhexanamide, and 02% N,Ndimethyldodecanamide.
The test substance for all of the studies reviewed by the Agency was identified as Hallcomid M810. Thus, both the N,N
dimethyloctanamide and N,Ndimethyldecanamide 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,Ndimethyloctanamide 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
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,Ndimethyloctanamide and N,Ndimethyldecanamide
Type of Study/Route/Species Doses Results
6week 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
90day 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
5day 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
615 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 postimplantation loss,
decreased fetal body weight, increased
incidence of skeletal malformations/
variations
The petitioner also submitted the following mutagenicity assays, as described in Table 3. below:
Table 3.Mutagenicity Assays Conducted Using N,Ndimethyloctanamide and N,Ndimethyldecanamide
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
=============================
Toxicity for N,Ndimethyloctanamide 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,Ndimethyldecanamide is of a chain length intermediate between N,Ndimethyloctanamide and the analogs assessed, the SAR conclusions also apply to N,N
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.
The acute toxicity data indicated that N,Ndimethyloctanamide and N,Ndimethyldecanamide are eye and dermal irritants.
Subchronic toxicity studies revealed no significant treatment
related effects for N,Ndimethyloctanamide and N,Ndimethyldecanamide.
In the 6week oral gavage study in dogs, there were no significant
differences between treated and control groups. During a 90day 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 5day inhalation study, test animals exhibited signs
of respiratory tract irritation. However, this respiratory irritant effect occurred only at high inhalation doses.
N,Ndimethyloctanamide and N,Ndimethyldecanamide 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.
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 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).
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,Ndimethyloctanamide and N,Ndimethyldecanamide are sponsored under the High Production Volume Challenge Program. This is indicative of over 1 million pounds of N,Ndimethyloctanamide and N,N dimethyldecanamide either produced or imported per year. Information indicates that N,Ndimethyloctanamide and N,Ndimethyldecanamide are used in personal care products and in paints.
The Agency has used various screeninglevel 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 overestimate exposure.
Table 4.Exposure Estimates for N,Ndimethyloctanamide 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 ===================================
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,Ndimethyldecanamide and any other substances. N,Ndimethyloctanamide and N,Ndimethyldecanamide 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,Ndimethyloctanamide and N,Ndimethyldecanamide 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,Ndimethyloctanamide and N,Ndimethyldecanamide. 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,Ndimethyloctanamide and N,N
dimethyldecanamide. Studies indicate that N,Ndimethyloctanamide and
N,Ndimethyldecanamide 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,Ndimethyloctanamide and N,Ndimethyldecanamide from the
requirement of a tolerance will be safe for the general population including infants and children.
IX. Other Considerations
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,Ndimethyloctanamide and N,Ndimethyldecanamide for endocrine effects may be required.
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.
There are no existing tolerances or tolerance exemptions for N,N dimethyloctanamide and N,Ndimethyldecanamide.
The Agency is not aware of any country requiring a tolerance for N,Ndimethyloctanamide and N,Ndimethyldecanamide nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.
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,Ndimethyloctanamide or octanamide, N,Ndimethyl (CAS Reg. No. 1118929), and N,Ndimethyldecanamide or decanamide, N,N dimethyl (CAS Reg. No. 14433762). Accordingly, EPA finds that exempting octanamide, N,Ndimethyl (CAS Reg. No. 1118929) and decanamide, N,Ndimethyl (CAS Reg. No. 14433762) from the requirement of a tolerance will be safe.
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 OPP20050031 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 204600001. 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) 5646255.
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 OPP20050031, 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 email 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).
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 1044). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and LowIncome 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
104113, 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.
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. Therefore, 40 CFR part 180 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 Sec. 180.920, the table is amended by adding alphabetically the following inert ingredients to read as follows:
Sec. 180.920 Inert ingredients used preharvest; exemptions from the requirement of a tolerance.
* * * * *
Inert ingredients Limits Uses * * * * *
Decanamide, N,Ndimethyl (CAS .................. Emulsifier,
Reg. No. 14433762). solvent,
cosolvent * * * * *
Octanamide, N,Ndimethyl (CAS .................. Emulsifier,
Reg. No. 1118929). solvent,
cosolvent * * * * *
[FR Doc. 052975 Filed 21505; 8:45 am]
BILLING CODE 656050S
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) 3088033; email address:
campbell.princess@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 26 CFR Part 1 40 CFR Part 180 47 CFR Part 73 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 26 CFR Part 301 50 CFR Part 622 39 CFR Part 111 40 CFR Part 300 44 CFR Part 65 50 CFR Part 660 40 CFR Part 271 40 CFR Parts 52 and 81 47 CFR Part 64 50 CFR Part 665 49 CFR Part 571 44 CFR Part 64 21 CFR Part 522 14 CFR Part 23 47 CFR Part 76