Return to Index Page
http://www.epa.gov/fedrgstr/EPA-PEST/2005/May/Day-18/p9778.htm
Fludioxonil; Pesticide Tolerance [Federal Register: May 18,
2005 (Volume 70, Number 95)]
[Rules and Regulations]
[Page 28452-28454]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18my05-14]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0095; FRL-7711-9]
Fludioxonil; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
fludioxonil (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-H-pyrrole-3-
carbonitrile) in or on pomegranate. Interregional
Research Project
Number 4 (IR-4) requested this tolerance under the Federal
Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection
Act
of 1996 (FQPA).
DATES: This regulation is effective May 18, 2005. Objections and
requests for hearings must be received on or before July 18, 2005.
ADDRESSES: To submit a written objection or hearing request follow
the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under
docket
identification (ID) number OPP-2005-0095. 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: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery,
and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by
this
action. Other types of entities not listed in this unit could also
be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have
any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you
may
access this Federal Register document electronically through the
EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/ . A frequently updated electronic version of 40 CFR part
180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/
.
II. Background and Statutory Findings
In the Federal
Register of March 17, 2004 (69 FR 12680) (FRL-7347-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA,
21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition
(PP
3E6803) by IR-4, 681 US Highway #1 South, North Brunswick,
NJ
08902-3390. The petition requested that
40 CFR 180.516 be amended by
establishing a tolerance for residues of the fungicide fludioxonil
(4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-H-pyrrole-3-carbonitrile)
in or on
pomegranate at 2.0 parts per million (ppm). This
petition has
subsequently been amended to propose pomegranate (post-harvest)
at 5.0
ppm. That notice included a summary of the petition prepared by
Syngenta Crop Protection, the registrant. There were no comments
received in response to the notice of filing.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 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 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
* *
*.''
[[Page 28453]]
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion
of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997)
(FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed
the
available scientific data and other relevant information in support
of
this action. EPA has sufficient data to assess the hazards of and
to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of fludioxonil
on
pomegranate at 5.0 ppm.
On September
29, 2004 (69 FR 58084) (FRL-7682-3), the Agency
published a final rule establishing tolerances for residues of
fludioxonil in or on bean, dry; bean, succulent; citrus, crop group
10;
fruit, pome, group 11; grapefruit, oil; kiwifruit; leafy greens
subgroup 4A, except spinach; melon subgroup 9A; and yam, true.
When the
Agency conducted the risk assessments in support of this tolerance
action it assumed that fludioxonil residues would be present on
pomegrante as well as on all foods covered by the proposed and
established tolerances. Residues on pomegrante were included
because
there was a pending application under the Federal Insecticide,
Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq., to register
fludioxonil on pomegrante. Therefore, establishing the pomegranate
tolerance will not change the most recent estimated aggregate risks
resulting from use of fludioxonil, as discussed in the September
29,
2004 Federal Register. Refer to the September
29, 2004 Federal Register
document for a detailed discussion of the aggregate risk assessments
and determination of safety. EPA relies upon those risk assessments
and
the findings made in the Federal Register document in support of
this
action.
Based on the risk assessments discussed in the final rule published
in the Federal Register of September 29, 2004 (69 FR 58084) FRL-7682-
3), EPA concludes that there is a reasonable certainty that no harm
will result to the general population, and to infants and children
from
aggregate exposure to fludioxonil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. Apple, pear, kiwifruit, cantaloupe, yam, citrus,
and pomegranate were analyzed for fludioxonil using Syngenta tolerance
enforcement method AG-597B, Analytical Method for the Determination
of
CGA-219417 in Crops by High Performance Liquid Chromatography Including
Validation Data, with Modifications. The method may be requested
from:
Chief, Analytical Chemistry Branch, Environmental Science Center,
701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX, Canadian, or Mexican tolerances/maximum residue
levels (MRLs) for fludioxonil residues on pomegranate. Thus,
harmonization is not an issue at this time.
V. Conclusion
Therefore, the tolerance is established for residues of fludioxonil
(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-H-pyrrole-3-carbonitrile),
in or
on pomegranate at 5.0 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA,
EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of 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 FFDCA, as was
provided in the old sections 408 and 409 of 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-2005-0095 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 July
18,
2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds
for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on
which a
hearing is requested, the requestor's contentions on such issues,
and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of
that
information as CBI. Information so marked will not be disclosed
except
in accordance with procedures set forth in 40 CFR part 2. A copy
of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to
the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from
8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.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-2005-0095, 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
[[Page 28454]]
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).
VIII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
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 FFDCA, such as the tolerance 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 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 (59 FR 22951, 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.
VIII. 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 6, 2005.
Betty Shackleford,
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. Section 180.516 is amended by alphabetically adding
the following
commodity to the table in paragraph (a) to read as follows:
Sec. 180.516 Fludioxonil; tolerances for residues.
(a) * * *
Commodity |
Parts per
million |
Pomegranate
|
5.0 |
[FR Doc. 05-9778 Filed 5-17-05; 8:45 am]
BILLING CODE 6560-50-S
|