Inert Ingredient; Revocation of a Tolerance Exemption with Insufficient Data for Reassessment, 32895-32899 [E6-8826]
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Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Proposed Rules
and reasonably feasible alternatives
considered by the Agency.
This regulation is not subject to
Executive Order 13045 because it is not
economically significant as defined
under E.O. 12866, and because the
Agency does not have reason to believe
that it addresses environmental health
and safety risks that present a
disproportionate risk to children.
Today’s proposed rule would simply
clarify Congress’s intent that water
transfers generally be subject to
oversight by water resource
management agencies and State nonNPDES authorities, rather than the
permitting program under section 402 of
the CWA.
Dated: June 1, 2006.
Stephen L. Johnson,
Administrator.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
§ 122.3
For the reasons set forth in the
preamble, 40 CFR part 122 is proposed
to be amended as follows:
PART 122—EPA ADMINISTERED
PERMIT PROGRAMS: THE NATIONAL
POLLUTANT DISCHARGE
ELIMINATION SYSTEM
1. The authority citation for part 122
continues to read as follows:
Authority: The Clean Water Act, 33 U.S.C.
1251 et seq.
2. Section 122.3 is amended by
adding paragraph (i) to read as follows:
Exclusions.
*
This proposed rule would not be
subject to Executive Order 13211,
‘‘Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355 (May
22, 2001)) because it is not an
economically significant regulatory
action under Executive Order 12866.
*
*
*
*
(i) Discharges from a water transfer.
Water transfer means an activity that
conveys waters of the United States to
another water of the United States
without subjecting the water to
intervening industrial, municipal, or
commercial use. This exclusion does
not apply to pollutants added by the
water transfer activity itself to the water
being transferred.
[FR Doc. E6–8814 Filed 6–6–06; 8:45 am]
I. National Technology Transfer and
Advancement Act
BILLING CODE 6560–50–P
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) directs EPA to use voluntary
consensus standards in its regulatory
activities unless to do so would be
inconsistent with applicable law or
otherwise impractical. Voluntary
consensus standards are technical
standards (e.g., materials specifications,
test methods, sampling procedures, and
business practices) that are developed or
adopted by voluntary consensus
standard bodies. The NTTAA directs
EPA to provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards. This
proposed rulemaking does not involve
technical standards. Therefore, EPA is
not considering the use of any voluntary
consensus standards.
ENVIRONMENTAL PROTECTION
AGENCY
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List of Subjects in 40 CFR Part 122
Environmental protection,
Administrative practice and procedure,
Confidential business information,
Hazardous substances, Reporting and
recordkeeping requirements, Water
pollution control.
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40 CFR Part 180
[EPA–HQ–OPP–2006–0493; FRL–8072–4]
Inert Ingredient; Revocation of a
Tolerance Exemption with Insufficient
Data for Reassessment
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: This document proposes
under section 408(e)(1) of the Federal
Food, Drug, and Cosmetic Act (FFDCA)
to revoke the existing exemption from
the requirement of a tolerance for
residues of one inert ingredient because
there are insufficient data to make the
determination of safety required by
FFDCA section 408(b)(2). The inert
ingredient tolerance exemption under
40 CFR 180.920 is ‘‘a-Alkyl (C10-C16)-whydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the
phosphate esters; the poly(oxyethylene)
content averages 3–20 moles.’’ The
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32895
revocation action in this document
contributes towards the Agency’s
tolerance reassessment requirements
under FFDCA section 408(q), as
amended by the Food Quality Protection
Act (FQPA) of 1996. By law, EPA is
required by August 2006 to reassess the
tolerances that were in existence on
August 2, 1996. The regulatory action in
this document pertains to the revocation
of one tolerance exemption which is
counted as tolerance reassessment
toward the August 2006 review
deadline.
DATES: Comments must be received on
or before July 7, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2006–0493, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2006–
0493. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The Federal regulations.gov
website is an ‘‘anonymous access’’
system, which means EPA will not
know your identity or contact
information unless you provide it in the
body of your comment. If you send an
e-mail comment directly to EPA without
going through regulations.gov, your email address will be automatically
captured and included as part of the
comment that is placed in the docket
and made available on the Internet. If
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you submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD-ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket: All documents in the docket
are listed in the docket index. Although
listed in the index, some information is
not publicly available, e.g., 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 in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The hours of operation
of this Docket Facility are 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:
Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8811; e-mail address:
leifer.kerry@epa.gov.
SUPPLEMENTARY INFORMATION:
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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
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assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit II. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
II. Background and Statutory Findings
A. What Action is the Agency Taking?
On May 3, 2006, EPA published a
proposed rule in the Federal Register
(71 FR 25993; FRL–8060–9) to revoke
exemptions from the requirement of a
tolerance for certain inert ingredients
used in pesticide products.
Unfortunately, one inert ingredient
tolerance exemption was inadvertently
omitted from this Federal Register
proposed rule: ‘‘a-Alkyl (C10–C16)-whydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the
phosphate esters; the poly(oxyethylene)
content averages 3–20 moles.’’
Therefore, in this proposed rule, EPA is
proposing to revoke this one inert
ingredient tolerance exemption because
sufficient data are not available to the
Agency to make the safety
determination required by FFDCA
section 408(c)(2).
As described in the Federal Register
of May 3, 2006, described in this unit,
EPA is now in the process of reassessing
all inert ingredient exemptions from the
requirement of a tolerance (‘‘tolerance
exemptions’’) established prior to
August 2, 1996, as required by FFDCA
section 408(q). Under FFDCA section
408(q), tolerance reassessment may lead
to regulatory action under FFDCA
section 408(e)(1). When taking action
under FFDCA section 408(e)(1), EPA
may leave a tolerance exemption in
effect only if the Agency determines that
the tolerance exemption is safe. As is
the case for the inert ingredient
tolerance exemptions identified in the
May 3 Federal Register, EPA has
insufficient data available to make the
safety determination required by FFDCA
section 408(c)(2) for this one inert
ingredient and is proposing to revoke
the tolerance exemption.
In making the FFDCA reassessment
safety determination, EPA considers the
validity, completeness, and reliability of
the data that are available to the Agency,
FFDCA section 408 (b)(2)(D), and the
available information concerning the
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special susceptibility of infants and
children (including developmental
effects from in utero exposure), FFDCA
section 408 (b)(2)(C). Data gaps exist for
this inert ingredient in areas critical to
reassessment. Without these data, the
assessment of possible effects to infants
and children cannot be made. Thus,
EPA has insufficient data to make the
safety finding of FFDCA section
408(c)(2) and is revoking the inert
ingredient tolerance exemption
identified in this document.
In developing risk assessment
documents for inert ingredient tolerance
exemptions, EPA currently reviews data
submitted to the Agency as well as
information from reputable, publicly
available sources. For example, studies
may be available in professional (peerreviewed) journals, and chemical
assessments may be available on the
Internet from U.S. Government agencies
(e.g., EPA, the Agency for Toxic
Substances and Disease Registry,
National Institutes of Health, Food and
Drug Administration (FDA)) and
international organizations (e.g., World
Health Organization, Organization for
Economic Cooperation and
Development (OECD)). In some cases,
representatives from chemical and
pesticide manufacturing industry
associations endeavored to locate data
to support reassessment of surfactant
chemicals. Nonetheless, sufficient valid
and reliable data were not available to
make the requisite FFDCA safety
finding.
EPA could not have made the
requisite FFDCA safety finding unless,
at the very least, a set of basic toxicity
studies had been available to the
Agency. It is possible that the tests
agreed to under OECD’s Screening
Information Data Set (SIDS) program
would have sufficed. Especially
important to inert ingredient
reassessment is an acceptable repeatdose study. The preferred test for repeatdose toxicity is the ‘‘Combined
Repeated Dose Toxicity Study with the
Reproduction/Developmental Toxicity
Screening Test’’ (OECD Test Guideline
422). More information about the OECD
SIDS and EPA’s High Production
Volume (HPV) programs is found at
https://www.epa.gov/oppt/chemrtk/
sidsappb.htm. For the inert ingredient
subject to this proposed rule and the
inert ingredients identified in the May
3 Federal Register, the full OECD SIDS
may not have been necessary in some
cases because EPA has available a
limited number of studies and
information on the inert ingredient in
question (e.g., acute toxicity studies). In
other cases, the limited toxicity
information available to the Agency may
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indicate a need for further testing. EPA
always recommends that parties
interested in supporting an inert
ingredient consult with the Agency
prior to embarking on a testing strategy
in order to determine existing data gaps
and if testing certain chemicals within
a multi-chemical exemption would
serve to represent the entire exemption.
In summary, the safety finding
required by FFDCA section 408(b)(2)
cannot be made for the one inert
ingredient tolerance exemption due to
insufficient data. Therefore, EPA is
revoking under FFDCA section 408(e)(1)
the tolerance exemption identified at
the end of this document under 40 CFR
180.920 with the revocation effective 2
years after the date of publication of the
final rule in the Federal Register.
The inert ingredient tolerance
exemption that is the subject of this
revocation proposal is found in 40 CFR
180.920 and reads as follows: ‘‘a-Alkyl
(C10–C16)-w-hydroxypoly(oxyethylene)
mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the
phosphate esters; the poly(oxyethylene)
content averages 3–20 moles.’’ It is
noted that the chemical described in
this tolerance exemption is included in
a broader tolerance exemption also
found in 40 CFR 180.920 that was
proposed for revocation for insufficient
data in the May 3 Federal Register,
which reads as follows: ‘‘a-Alkyl (C10–
C16)-w-hydroxypoly (oxyethylene)poly
(oxypropylene) mixture of di- and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the
phosphate esters; the combined
poly(oxyethylene) poly(oxypropylene)
content averages 3–20 moles.’’ The
public has had an opportunity to
comment on the proposed revocation of
the broader tolerance exemption since
May 3. Because the public has had an
opportunity since May 3 to comment on
the broader exemption that
encompasses this more narrow tolerance
exemption, a 30–day comment period is
provided for this proposed revocation of
the more narrow tolerance exemption.
requirements, modifications in
tolerances, and revocation of tolerances
for residues of pesticide chemicals in or
on raw agricultural commodities and
processed foods. Without a tolerance or
exemption, food containing pesticide
residues is considered to be unsafe and
therefore ‘‘adulterated’’ under FFDCA
section 402(a), 21 U.S.C. 342(a). Such
food may not be distributed in interstate
commerce (21 U.S.C. 331(a)). For a fooduse pesticide to be sold and distributed,
the pesticide must not only have
appropriate tolerances under FFDCA,
but also must be registered under
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136
et seq.). Food-use pesticides not
registered in the United States must
have tolerances in order for
commodities treated with those
pesticides to be imported into the
United States.
B. What is the Agency’s Authority for
Taking this Action?
A ‘‘tolerance’’ represents the
maximum level for residues of pesticide
chemicals legally allowed in or on raw
agricultural commodities and processed
foods. Section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA, Public Law
104–170, authorizes the establishment
of tolerances, exemptions from tolerance
By law, EPA is required by August
2006 to reassess the tolerances and
exemptions from tolerances that were in
existence on August 2, 1996. This
document revokes one inert ingredient
tolerance exemption, which counts as a
tolerance reassessment toward the
August 2006 review deadline under
FFDCA section 408(q), as amended by
FQPA in 1996.
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C. When do These Actions Become
Effective?
EPA is revoking the tolerance
exemption identified in this proposed
rule that has insufficient data effective
2 years after the date of publication of
the final rule in the Federal Register.
Any commodities listed in this rule
treated with pesticide products
containing the inert ingredient and in
the channels of trade following the
tolerance revocation shall be subject to
FFDCA section 408(1)(5), as established
by FQPA. Under this section, any
residues of this pesticide chemical in or
on such food shall not render the food
adulterated so long as it is shown to the
satisfaction of FDA that:
1. The residue is present as the result
of an application or use of the pesticide
at a time and in a manner that was
lawful under FIFRA.
2. The residue does not exceed the
level that was authorized at the time of
the application or use to be present on
the food under a tolerance or exemption
from tolerance. Evidence to show that
food was lawfully treated may include
records that verify the dates when the
pesticide was applied to such food.
D. What is the Contribution to Tolerance
Reassessment?
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III. Are the Actions Consistent with
International Obligations?
The tolerance revocation in this rule
is not discriminatory and is designed to
ensure that both domestically produced
and imported foods meet the food safety
standard established by FFDCA. The
same food safety standards apply to
domestically produced and imported
foods.
EPA is working to ensure that the U.S.
tolerance reassessment program under
FQPA does not disrupt international
trade. EPA considers Codex Maximum
Residue Limits (MRLs) in setting U.S.
tolerances and in reassessing them.
MRLs are established by the Codex
Committee on Pesticide Residues, a
committee within the Codex
Alimentarius Commission, an
international organization formed to
promote the coordination of
international food standards. It is EPA’s
policy to harmonize U.S. tolerances
with Codex MRLs to the extent possible,
provided that the MRLs achieve the
level of protection required under
FFDCA. EPA’s effort to harmonize with
Codex MRLs is summarized in the
tolerance reassessment section of
individual Reregistration Eligibility
Decision (RED) documents. EPA has
developed guidance concerning
submissions for import tolerance
support which was published in the
Federal Register of June 1, 2000 (65 FR
35069) (FRL–6559–3). This guidance
will be made available to interested
persons. Electronic copies are available
on the Internet at https://www.epa.gov.
On the Home Page select ‘‘Laws,
Regulations, and Dockets,’’ then select
‘‘Regulations and Proposed Rules’’ and
then look up the entry for this document
under ‘‘Federal Register—
Environmental Documents.’’ You can
also go directly to the ‘‘Federal
Register’’ listings at https://
www.epa.gov/fedrgstr.
IV. Statutory and Executive Order
Reviews
The Office of Management and Budget
(OMB) has exempted this type of action
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 rule does
not contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
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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).
Pursuant to the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 et seq.), the
Agency previously assessed whether
establishment of tolerances, exemptions
from tolerances, raising of tolerance
levels, expansion of exemptions, or
revocations might significantly impact a
substantial number of small entities and
concluded that, as a general matter,
these actions do not impose a significant
economic impact on a substantial
number of small entities. These analyses
for tolerance establishments and
modifications, and for tolerance
revocations were published on May 4,
1981 (46 FR 24950) and on December
17, 1997 (62 FR 66020) (FRL–5753–1),
respectively, and were provided to the
Chief Counsel for Advocacy of the Small
Business Administration. Taking into
account this analysis, and available
information concerning the pesticide
chemical listed in this rule, the Agency
hereby certifies that this action will not
have a significant negative economic
impact on a substantial number of small
entities. Specifically, the Agency has
concluded in a memorandum dated May
25, 2001 that for import tolerance
revocation there is a negligible joint
probability of certain defined conditions
holding simultaneously which would
indicate an RFA/Small Business
Regulatory Enforcement Fairness Act of
1996 (SBREFA) concern and require
more analysis. (This Agency document
is available in the docket of this rule).
Furthermore, for the pesticide chemical
named in this rule, the Agency knows
of no extraordinary circumstances that
exist as to the present rule that would
change the EPA’s previous analysis.
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 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 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
Inert Ingredients
*
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*
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Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 31, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, the table is amended
by revising the entry in the table to read
as follows:
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
Expires June 9, 2008
*
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Uses
*
a-Alkyl (C10–C16)-w-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters;
the poly(oxyethylene) content averages 3–20 moles ..........................................................
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List of Subjects in 40 CFR Part 180
Limits
*
*
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.
*
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Surfactant; related
adjuvants of surfactants
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[FR Doc. E6–8826 Filed 6–6–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0036; FRL–8062–7]
p-Chlorophenoxyacetic acid,
Glyphosate, Difenzoquat, and
Hexazinone; Proposed Tolerance
Actions
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
rwilkins on PROD1PC63 with PROPOSAL
AGENCY:
SUMMARY: EPA is proposing to revoke
certain tolerances for the plant growth
regulator p-chlorophenoxyacetic acid
and the herbicide hexazinone. Also,
EPA is proposing to modify certain
tolerances for the plant growth regulator
p-chlorophenoxyacetic acid and the
herbicides glyphosate, difenzoquat, and
hexazinone. In addition, EPA is
proposing to establish new tolerances
for the herbicides difenzoquat and
hexazinone. The regulatory actions
proposed in this document are part of
the Agency’s reregistration program
under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), and the tolerance reassessment
requirements of the Federal Food, Drug,
and Cosmetic Act (FFDCA) section
408(q), as amended by the Food Quality
Protection Act (FQPA) of 1996. By law,
EPA is required by August 2006 to
reassess the tolerances that were in
existence on August 2, 1996. No
tolerance reassessments will be counted
at the time of a final rule because
tolerances in existence on August 2,
1996 that are associated with actions
proposed herein were previously
counted as reassessed at the time of the
completed Reregistration Eligibility
Decision (RED), Report of the FQPA
Tolerance Reassessment Progress and
Risk Management Decision (TRED), or
Federal Register action.
DATES: Comments must be received on
or before August 7, 2006.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0036. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
VerDate Aug<31>2005
17:51 Jun 06, 2006
Jkt 208001
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
2777 S. Crystal Drive, Arlington, VA.
The 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: Jane
Smith, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave, NW., Washington, DC 20460–0001;
telephone number: (703) 308–0048; email address: smith.jane-scott@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. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit IIA. 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. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to EPA, mark the outside of the
disk or CD ROM as CBI and then
identify electronically within the disk or
PO 00000
Frm 00027
Fmt 4702
Sfmt 4702
32899
CD ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
C. What Can I do if I Wish the Agency
to Maintain a Tolerance that the Agency
Proposes to Revoke?
This proposed rule provides a
comment period of 60 days for any
person to state an interest in retaining
a tolerance proposed for revocation. If
EPA receives a comment within the 60–
day period to that effect, EPA will not
proceed to revoke the tolerance
immediately. However, EPA will take
steps to ensure the submission of any
needed supporting data and will issue
an order in the Federal Register under
FFDCA section 408(f) if needed. The
order would specify data needed and
the time frames for its submission, and
would require that within 90 days some
person or persons notify EPA that they
will submit the data. If the data are not
submitted as required in the order, EPA
will take appropriate action under
FFDCA.
EPA issues a final rule after
considering comments that are
submitted in response to this proposed
E:\FR\FM\07JNP1.SGM
07JNP1
Agencies
[Federal Register Volume 71, Number 109 (Wednesday, June 7, 2006)]
[Proposed Rules]
[Pages 32895-32899]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8826]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0493; FRL-8072-4]
Inert Ingredient; Revocation of a Tolerance Exemption with
Insufficient Data for Reassessment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes under section 408(e)(1) of the Federal
Food, Drug, and Cosmetic Act (FFDCA) to revoke the existing exemption
from the requirement of a tolerance for residues of one inert
ingredient because there are insufficient data to make the
determination of safety required by FFDCA section 408(b)(2). The inert
ingredient tolerance exemption under 40 CFR 180.920 is ``[alpha]-Alkyl
(C10-C16)-[omega]-hydroxypoly(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen phosphate esters and
the corresponding ammonium, calcium, magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the phosphate esters; the
poly(oxyethylene) content averages 3-20 moles.'' The revocation action
in this document contributes towards the Agency's tolerance
reassessment requirements under FFDCA section 408(q), as amended by the
Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by
August 2006 to reassess the tolerances that were in existence on August
2, 1996. The regulatory action in this document pertains to the
revocation of one tolerance exemption which is counted as tolerance
reassessment toward the August 2006 review deadline.
DATES: Comments must be received on or before July 7, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0493, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0493. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If
[[Page 32896]]
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., 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 in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are 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: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8811; e-mail address: leifer.kerry@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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II. If you have
any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
II. Background and Statutory Findings
A. What Action is the Agency Taking?
On May 3, 2006, EPA published a proposed rule in the Federal
Register (71 FR 25993; FRL-8060-9) to revoke exemptions from the
requirement of a tolerance for certain inert ingredients used in
pesticide products. Unfortunately, one inert ingredient tolerance
exemption was inadvertently omitted from this Federal Register proposed
rule: ``[alpha]-Alkyl (C10-C16)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, monoethanolamine, potassium, sodium, and zinc salts of the
phosphate esters; the poly(oxyethylene) content averages 3-20 moles.''
Therefore, in this proposed rule, EPA is proposing to revoke this one
inert ingredient tolerance exemption because sufficient data are not
available to the Agency to make the safety determination required by
FFDCA section 408(c)(2).
As described in the Federal Register of May 3, 2006, described in
this unit, EPA is now in the process of reassessing all inert
ingredient exemptions from the requirement of a tolerance (``tolerance
exemptions'') established prior to August 2, 1996, as required by FFDCA
section 408(q). Under FFDCA section 408(q), tolerance reassessment may
lead to regulatory action under FFDCA section 408(e)(1). When taking
action under FFDCA section 408(e)(1), EPA may leave a tolerance
exemption in effect only if the Agency determines that the tolerance
exemption is safe. As is the case for the inert ingredient tolerance
exemptions identified in the May 3 Federal Register, EPA has
insufficient data available to make the safety determination required
by FFDCA section 408(c)(2) for this one inert ingredient and is
proposing to revoke the tolerance exemption.
In making the FFDCA reassessment safety determination, EPA
considers the validity, completeness, and reliability of the data that
are available to the Agency, FFDCA section 408 (b)(2)(D), and the
available information concerning the special susceptibility of infants
and children (including developmental effects from in utero exposure),
FFDCA section 408 (b)(2)(C). Data gaps exist for this inert ingredient
in areas critical to reassessment. Without these data, the assessment
of possible effects to infants and children cannot be made. Thus, EPA
has insufficient data to make the safety finding of FFDCA section
408(c)(2) and is revoking the inert ingredient tolerance exemption
identified in this document.
In developing risk assessment documents for inert ingredient
tolerance exemptions, EPA currently reviews data submitted to the
Agency as well as information from reputable, publicly available
sources. For example, studies may be available in professional (peer-
reviewed) journals, and chemical assessments may be available on the
Internet from U.S. Government agencies (e.g., EPA, the Agency for Toxic
Substances and Disease Registry, National Institutes of Health, Food
and Drug Administration (FDA)) and international organizations (e.g.,
World Health Organization, Organization for Economic Cooperation and
Development (OECD)). In some cases, representatives from chemical and
pesticide manufacturing industry associations endeavored to locate data
to support reassessment of surfactant chemicals. Nonetheless,
sufficient valid and reliable data were not available to make the
requisite FFDCA safety finding.
EPA could not have made the requisite FFDCA safety finding unless,
at the very least, a set of basic toxicity studies had been available
to the Agency. It is possible that the tests agreed to under OECD's
Screening Information Data Set (SIDS) program would have sufficed.
Especially important to inert ingredient reassessment is an acceptable
repeat-dose study. The preferred test for repeat-dose toxicity is the
``Combined Repeated Dose Toxicity Study with the Reproduction/
Developmental Toxicity Screening Test'' (OECD Test Guideline 422). More
information about the OECD SIDS and EPA's High Production Volume (HPV)
programs is found at https://www.epa.gov/oppt/chemrtk/sidsappb.htm.
For the inert ingredient subject to this proposed rule and the inert
ingredients identified in the May 3 Federal Register, the full OECD
SIDS may not have been necessary in some cases because EPA has
available a limited number of studies and information on the inert
ingredient in question (e.g., acute toxicity studies). In other cases,
the limited toxicity information available to the Agency may
[[Page 32897]]
indicate a need for further testing. EPA always recommends that parties
interested in supporting an inert ingredient consult with the Agency
prior to embarking on a testing strategy in order to determine existing
data gaps and if testing certain chemicals within a multi-chemical
exemption would serve to represent the entire exemption.
In summary, the safety finding required by FFDCA section 408(b)(2)
cannot be made for the one inert ingredient tolerance exemption due to
insufficient data. Therefore, EPA is revoking under FFDCA section
408(e)(1) the tolerance exemption identified at the end of this
document under 40 CFR 180.920 with the revocation effective 2 years
after the date of publication of the final rule in the Federal
Register.
The inert ingredient tolerance exemption that is the subject of
this revocation proposal is found in 40 CFR 180.920 and reads as
follows: ``[alpha]-Alkyl (C10-C16)-[omega]-
hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, monoethanolamine, potassium, sodium, and zinc salts of the
phosphate esters; the poly(oxyethylene) content averages 3-20 moles.''
It is noted that the chemical described in this tolerance exemption is
included in a broader tolerance exemption also found in 40 CFR 180.920
that was proposed for revocation for insufficient data in the May 3
Federal Register, which reads as follows: ``[alpha]-Alkyl
(C10-C16)-[omega]-hydroxypoly (oxyethylene)poly
(oxypropylene) mixture of di- and monohydrogen phosphate esters and the
corresponding ammonium, calcium, magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the phosphate esters; the combined
poly(oxyethylene) poly(oxypropylene) content averages 3-20 moles.'' The
public has had an opportunity to comment on the proposed revocation of
the broader tolerance exemption since May 3. Because the public has had
an opportunity since May 3 to comment on the broader exemption that
encompasses this more narrow tolerance exemption, a 30-day comment
period is provided for this proposed revocation of the more narrow
tolerance exemption.
B. What is the Agency's Authority for Taking this Action?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA, Public Law 104-170, authorizes the establishment of
tolerances, exemptions from tolerance requirements, modifications in
tolerances, and revocation of tolerances for residues of pesticide
chemicals in or on raw agricultural commodities and processed foods.
Without a tolerance or exemption, food containing pesticide residues is
considered to be unsafe and therefore ``adulterated'' under FFDCA
section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in
interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be
sold and distributed, the pesticide must not only have appropriate
tolerances under FFDCA, but also must be registered under Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et
seq.). Food-use pesticides not registered in the United States must
have tolerances in order for commodities treated with those pesticides
to be imported into the United States.
C. When do These Actions Become Effective?
EPA is revoking the tolerance exemption identified in this proposed
rule that has insufficient data effective 2 years after the date of
publication of the final rule in the Federal Register. Any commodities
listed in this rule treated with pesticide products containing the
inert ingredient and in the channels of trade following the tolerance
revocation shall be subject to FFDCA section 408(1)(5), as established
by FQPA. Under this section, any residues of this pesticide chemical in
or on such food shall not render the food adulterated so long as it is
shown to the satisfaction of FDA that:
1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA.
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates when the
pesticide was applied to such food.
D. What is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 2006 to reassess the tolerances
and exemptions from tolerances that were in existence on August 2,
1996. This document revokes one inert ingredient tolerance exemption,
which counts as a tolerance reassessment toward the August 2006 review
deadline under FFDCA section 408(q), as amended by FQPA in 1996.
III. Are the Actions Consistent with International Obligations?
The tolerance revocation in this rule is not discriminatory and is
designed to ensure that both domestically produced and imported foods
meet the food safety standard established by FFDCA. The same food
safety standards apply to domestically produced and imported foods.
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. It is EPA's policy to
harmonize U.S. tolerances with Codex MRLs to the extent possible,
provided that the MRLs achieve the level of protection required under
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual Reregistration Eligibility
Decision (RED) documents. EPA has developed guidance concerning
submissions for import tolerance support which was published in the
Federal Register of June 1, 2000 (65 FR 35069) (FRL-6559-3). This
guidance will be made available to interested persons. Electronic
copies are available on the Internet at https://www.epa.gov. On the Home
Page select ``Laws, Regulations, and Dockets,'' then select
``Regulations and Proposed Rules'' and then look up the entry for this
document under ``Federal Register--Environmental Documents.'' You can
also go directly to the ``Federal Register'' listings at https://
www.epa.gov/fedrgstr.
IV. Statutory and Executive Order Reviews
The Office of Management and Budget (OMB) has exempted this type of
action 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 rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA), 44
[[Page 32898]]
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).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether establishment of
tolerances, exemptions from tolerances, raising of tolerance levels,
expansion of exemptions, or revocations might significantly impact a
substantial number of small entities and concluded that, as a general
matter, these actions do not impose a significant economic impact on a
substantial number of small entities. These analyses for tolerance
establishments and modifications, and for tolerance revocations were
published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR
66020) (FRL-5753-1), respectively, and were provided to the Chief
Counsel for Advocacy of the Small Business Administration. Taking into
account this analysis, and available information concerning the
pesticide chemical listed in this rule, the Agency hereby certifies
that this action will not have a significant negative economic impact
on a substantial number of small entities. Specifically, the Agency has
concluded in a memorandum dated May 25, 2001 that for import tolerance
revocation there is a negligible joint probability of certain defined
conditions holding simultaneously which would indicate an RFA/Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) concern
and require more analysis. (This Agency document is available in the
docket of this rule). Furthermore, for the pesticide chemical named in
this rule, the Agency knows of no extraordinary circumstances that
exist as to the present rule that would change the EPA's previous
analysis.
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 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 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.
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 31, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.920, the table is amended by revising the entry in
the table to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
----------------------------------------------------------------------------------------------------------------
Inert Ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * *
[alpha]-Alkyl (C10-C16)-[omega]-hydroxypoly(oxyethylene) Expires June 9, 2008 Surfactant; related
mixture of dihydrogen phosphate and monohydrogen phosphate adjuvants of
esters and the corresponding ammonium, calcium, magnesium, surfactants
monoethanolamine, potassium, sodium, and zinc salts of the
phosphate esters; the poly(oxyethylene) content averages 3-20
moles........................................................
* * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 32899]]
[FR Doc. E6-8826 Filed 6-6-06; 8:45 am]
BILLING CODE 6560-50-S