[Federal Register: June 1, 2005 (Volume 70, Number 104)]
[Rules and Regulations]
[Page 31365-31370]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn05-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0115; FRL-7712-1]
Two Isopropylamine Salts of Alkyl C4 and Alkyl
C8- 10 Ethoxyphosphate esters; Exemption from the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes two exemptions from the
requirement of a tolerance for residues of 2-propanamine, compound with
[alpha]-phosphono- [omega] -butoxypoly (oxy-1,2-ethanediyl) (2:1) and
2-propanamine, compounds with polyethylene glycol dihydrogen phosphate
C8- 10- alkyl ether (2:1), referred to as 2 isopropylamine
salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters, when used as inert ingredients (emulsifier,
solvent and cosolvent) in pesticide formulations applied only to
growing crops. Rhodia, Inc, CN 7500, Cranbury, NJ 08512-7500, 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 these two chemicals.
DATES: This regulation is effective June 1, 2005. Objections and
requests for hearings must be received on or before August 1, 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-2005-0115. 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:
campbell.princess@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 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.
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 March 17, 1999 (64 FR 13195) (FRL-6065-
5) 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 pesticide petitions (PP 8E4990 and 8E4956) by Rhodia Inc, CN
7500, Cranbury, NJ 08512-7500.
The petitions requested that 40 CFR 180.1001(d) newly re-designated
as 40 CFR 180.920 be amended to include exemptions from the requirement
of a tolerance for residues of 2-Propanamine, compound with [alpha]-
phosphono- [omega]- butoxypoly (oxy-1,2-ethanediyl) (2:1) (CAS Reg. No.
43140-31-2) and 2-Propanamine, compounds with polyethylene glycol
dihydrogen phosphate C8- 10- alkyl ether (2:1) (CAS Reg. No.
431062-72-5). The 1999 notice included a summary of the petition
prepared by the petitioner requesting, to amend 40 CFR part 180 to
establish an exemption from the requirement of a tolerance for these
two chemicals when used as inert ingredients in pesticide formulations
applied only to growing crops. There were no comments received in
response to the notice 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
[[Page 31366]]
exposure to pesticide residues. First, EPA determines the toxicity of
pesticides. Second, EPA examines exposure to the pesticide through
food, drinking water, and through other exposures that occur as a
result of pesticide use in residential settings.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has 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 these 2 isopropylamine salts of alkyl C4 and alkyl
C8- 10 ethoxyphosphate esters are discussed in this unit.
A. Submitted Studies
The petitioner has also submitted supporting toxicity information
to the Agency which is summarized in Table 1.
The acute toxicity profile is presented in Table 1.
Table 1: Acute Toxicity Profile of 2 isopropylamine salts of alkyl C4 and alkyl C8 10 ethoxyphosphate esters
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Study Result Category
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Acute oral (Rats) LD50 > 2,000 mg/kg III
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Acute dermal (Rats) LD50 > 2,000 mg/kg III
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Eye irritation Slightly irritating III
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Dermal irritation (Rabbits) Not irritating III
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Dermal sensitizer (GP) Not a sensitizer NA
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The petitioner also submitted the following mutagenicity assays, as
described in Table 2:
Table 2: Mutagenicity Assays Conducted Using:
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Type of Assay Test Culture Results
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Ames S. typhimurium TA 98, TA 100, TA Negative
102, TA 1535, TA 1537
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B. Structure Activity Relationship (SAR) Assessment
Toxicity for these 2 isopropylamine salts of alkyl C4
and alkyl C8- 10 ethoxyphosphate esters 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.
The SAR conclusions for these 2 isopropylamine salts of alkyl
C4 and alkyl C8- 10 ethoxyphosphate esters and
several structurally related analogs were as follows: Absorption would
be poor through the skin, good through the lungs, and moderate through
the GI tract. Absorption of the amine will be good through the lungs
and GI tract based on analogs. The SAR also indicated a concern for
lung toxicity and irritation to mucous membranes if inhaled based on
surfactancy. There is concern for neurotoxicity from the amine salt. No
concerns for developmental or reproductive effects, carcinogenicity, or
mutagenicity were noted. The overall rating for human health is low/
moderate concern.
C. Conclusions
EPA has reviewed the toxicity data for these 2 isopropylamine salts
of alkyl C4 and alkyl C8- 10 ethoxyphosphate
esters and concludes as follows:
The acute toxicity data demonstrated that these 2 isopropylamine
salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters exhibited low acute toxicity, Category III,
based on the Agency's rating of toxicity categories I through IV,
highest to lowest. These 2 isopropylamine salts of alkyl C4
and alkyl C8- 10 ethoxyphosphate esters are slight eye
irritants. Other data reviewed by the Agency indicated that these two
salts are not mutagenic.
The SAR indicated that absorption would be poor through the skin,
good through the lungs, and moderate through the GI tract. The SAR also
[[Page 31367]]
reflected the typical concerns for lung toxicity and irritation to
mucous membranes if inhaled based on surfactancy. Such concerns are
addressed by use of personal protection equipment as determined by end-
product acute inhalation testing, or by limitations on the amount of
surfactant in a formulated pesticide. There are also typical concerns
for neurotoxicity based on the inclusion of an amine salt in the
chemical structure, and for lung toxicity and irritation to mucous
membranes if inhaled based on surfactancy. As a chemical class amine
salts are generally reported to have neurotoxic effects. However, there
is an overall lack of documentation in the public literature to support
a specific concern for neurotoxicity for isopropylamine salts. The SAR
rated these two isopropylamine salts as low to moderate for human
health concerns. This rating reflects the concerns associated with the
irritation to mucous membranes commonly caused by surfactants.
The SAT in OPPT (Office of Pollution Prevention and Toxics) has
reviewed information on several surfactants. As a broad class of
chemicals surfactants are often corrosive and irritating to mucous
membranes. These properties make animal toxicity testing of surfactants
difficult, and require interpretation of the test results as to whether
the effects are attributed to the corrosive/irritant effects or other
mechanisms of toxicity.
Based on the SAR assessment, the review and evaluation of the
submitted data, and given the Agency's understanding of the
toxicological properties of surfactants, EPA concludes that these 2
isopropylamine salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters are of lower toxicity. There is a concern for
corrosive/irritation effects of these 2 isopropylamine salts of alkyl
C4 and alkyl C8- 10 ethoxyphosphate esters. Based
on these concerns which are those of surfactants as a class, EPA is
requiring a limitation on the use of these 2 isopropylamine salts of
alkyl C4 and alkyl C8- 10 ethoxyphosphate esters,
not to exceed 15% in the formulated product. Based on previously
conducted quantitative and qualitative risk assessments on related
surfactant chemicals which the Agency has exempted from the requirement
of a tolerance, the Agency believes that this limitation is
sufficiently protective for the corrosive effects common to the
surfactancy of these two salts.
V. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA 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).
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
1. Dietary exposure -- Food. In order to assess dietary exposure
the Agency considered that these two isopropylamine salts could be
present in all raw and processed agricultural commodities. The Agency
has estimated a generic dietary exposure estimate for an inert
ingredient of 0.12 milligrams/kilogram/day (mg/kg/day). To assure that
the exposure is not underestimated, it is assumed that the inert
ingredients are used on all crops and 100% of all crops are ``treated''
with the inert ingredient. The generic dietary exposure estimate is
based on an application rate of 5 pounds per acre. Information from the
petitioner indicates that the anticipated use rate of these 2
isopropylamine salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters is expected to be much less than one pound per
acre. The expected dietary exposure estimate would therefore be
considerably less than 0.024 mg/kg/day. Given the low levels of
exposure and the low systemic toxicity of these 2 isopropylamine salts
of alkyl C4 and alkyl C8- 10 ethoxyphosphate
esters, the concern for risk to human health is low.
2. Drinking water. Based on its biodegradation models, the Agency
estimated that the time for complete ultimate biodegradation is weeks
to months. There is also strong to very strong sorption to soils and
sediments. Due to the strong adherence to soils and sediments, and
ready biodegradation the substances would only be minimally available
in surface waters. Thus, only low drinking water exposure is expected,
and the concern for risk to human health is low.
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 these 2
isopropylamine salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters and any other substances. These 2 isopropylamine
salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters 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 these 2 isopropylamine
salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters 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 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 the Protection of 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. For 2
isopropylamine salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters, the SAR did not identify any concerns for
developmental or reproductive toxicity. The identified concerns for 2
isopropylamine salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters are corrosion/irritation. EPA has not used a
safety factor analysis to assess the risk.
[[Page 31368]]
For the same reasons a tenfold safety factor is unnecessary.
VIII. Determination of Safety for U.S. Population
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
residues of 2 isopropylamine salts of alkyl C4 and alkyl
C8- 10 ethoxyphosphate esters, and that under reasonably
foreseeable circumstances aggregate exposure to 2 isopropylamine salts
of alkyl C4 and alkyl C8- 10 ethoxyphosphate
esters will pose no appreciable risk to human health. Accordingly, EPA
finds that exempting 2-Propanamine, compound with [alpha]-phosphono -
[omega]- butoxypoly (oxy-1,2-ethanediyl) (2:1) (CAS Reg. No. 43140-31-
2)and 2-Propanamine, compounds with polyethylene glycol dihydrogen
phosphate C8- 10- alkyl ether (2:1) (CAS Reg. No. 431062-72-
5) 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 proceeds with
implementation of this program, further testing of these products, 2
isopropylamine salts of alkyl C4 and alkyl C8- 10
ethoxyphosphate esters, 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 these
2 isopropylamine salts of alkyl C4 and alkyl
C8- 10 ethoxyphosphate esters.
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for
these 2 isopropylamine salts of alkyl C4 and alkyl
C8- 10 ethoxyphosphate esters nor have any CODEX Maximum
Residue Levels (MRLs) been established for any food crops at this time.
X. Conclusions
Therefore, an exemption from the requirement for a tolerance is
established for 2-Propanamine, compound with [alpha]-phosphono -
[omega]- butoxypoly (oxy-1,2-ethanediyl) (2:1) (CAS Reg. No. 43140-31-
2) and 2-Propanamine, compounds with polyethylene glycol dihydrogen
phosphate C8- 10- alkyl ether (2:1) (CAS Reg. No. 431062-72-
5).
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-2005-0115 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 August 1,
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 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit 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-2005-0115, 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: opp-docket@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).
[[Page 31369]]
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 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: May 20, 2005.
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. 180.920, 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
------------------------------------------------------------------------
* * * * * * *
2-Propanamine, compound with Not more than 15% Surfactant
[alpha]-phosphono -[omega]- in the formulated
butoxypoly (oxy-1,2-ethanediyl) product.
(2:1) (CAS Reg. No. 43140-31-2).
2-Propanamine, compounds with Not more than 15% Surfactant
polyethylene glycol dihydrogen in the formulated
phosphate C8 10- alkyl ether product.
(2:1) (CAS Reg. No. 431062-72-
5).
* * * * * * *
------------------------------------------------------------------------
[[Page 31370]]
* * * * *
[FR Doc. 05-10845 Filed 5-31-05; 8:45 am]
BILLING CODE 6560-50-S