[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Rules and Regulations]
[Page 55290-55293]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se06-5]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0773; FRL-8093-3]
Fenamidone; Pesticide Tolerance for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of fenamidone in or on carrots. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on carrots. This regulation establishes a maximum
permissible level for residues of fenamidone in this food commodity.
The tolerance expires and is revoked on December 31, 2009.
DATES: This regulation is effective September 22, 2006. Objections and
requests for hearings must be received on or before November 21, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0773. All documents in the
docket are listed on the regulations.gov website. 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 available only in hard copy form. Publicly available docket
materials are available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office
of Pesticide Programs (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: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9356; e-mail address: conrath.andrea@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.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
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. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0773 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 November 21, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0773, by one of the following methods:
Federal eRulemaking Portal: http://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.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a time-limited tolerance for residues of
the fungicide fenamidone, (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-
(methylthio)-5-phenyl-3-(phenylamino), (S)-), in or on carrot at 0.20
parts per million (ppm). This tolerance expires and is revoked on
[[Page 55291]]
December 31, 2009. EPA will publish a document in the Federal Register
to remove the revoked tolerance from the Code of Federal Regulations
(CFR).
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the 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 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. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Fenamidone on Carrot and FFDCA Tolerances
The applicant stated that the only registered fungicide treatment
for controlling cavity spot in carrots in southern California appears
to be losing efficacy due to the development of resistant isolates of
the fungal pathogen to the only registered fungicide. Data was
submitted showing yield and significant economic losses have occurred
and are expected to recur without this requested emergency exemption
use. EPA has authorized under FIFRA section 18 the use of fenamidone on
carrots for control of cavity spot in California. After having reviewed
the submission, EPA concurs that emergency conditions exist for this
State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of fenamidone in or on
carrots. In doing so, EPA considered the safety standard in section
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance
under section 408(l)(6) of the FFDCA would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment as provided in section 408(l)(6) of the FFDCA.
Although this tolerance expires and is revoked on December 31, 2009,
under section 408(l)(5) of the FFDCA, residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
carrot after that date will not be unlawful, provided the pesticide is
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke this tolerance earlier
if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether fenamidone
meets EPA's registration requirements for use on carrot or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of fenamidone by a State for special local needs
under FIFRA section 24(c). Nor does this tolerance serve as the basis
for any State other than California to use this pesticide on this crop
under section 18 of FIFRA without following all provisions of EPA's
regulations implementing FIFRA section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
fenamidone, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
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 the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
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. EPA has sufficient data to assess the hazards of
fenamidone and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for a time-limited
tolerance for residues of fenamidone in or on carrot at 0.20 ppm.
On September 29, 2004 the Agency published a Final Rule (69 FR
58058, FRL-7681-3) establishing tolerances for residues of fenamidone
(4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-
(phenylamino), (S)-) in or on garlic, bulb; garlic, great headed; grape
(imported); leek; onion, dry bulb; onion, green; onion, welsh; shallot,
bulb; shallot, fresh leaves; tomato; tomato, paste; tomato, puree;
vegetable, cucurbit, group 09; vegetable, tuberous and corm, subgroup
01C and establishing tolerances for combined residues of fenamidone
(4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-
(phenylamino), (S)-) and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl) in or on fat (beef, goat, and
sheep); meat (beef, goat, and sheep); meat byproducts (beef, goat, and
sheep); milk; wheat, grain; wheat forage; wheat, hay; and wheat, straw.
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, hazard selections,
and related findings and assumptions made in that Federal Register
document in support of this action.
Relying upon the 2004 risk assessment detailed in the September 29,
2004 Federal Register document, the Agency calculated the additional
dietary risk from fenamidone residues on carrots in association with
the requested emergency exemption and at a residue level of 0.2 ppm.
Acute dietary exposure
[[Page 55292]]
from this use is estimated to utilize an additional 1% of the aPAD for
the general U.S. population, and a negligible contribution to the aPAD
for children 1-2 years old, the most highly exposed population subgroup
on an aggregate basis. Aggregate acute exposure for registered uses,
including drinking water, and this use on carrot is estimated to
utilize 17% of the aPAD for the general U.S. population, and 24% of the
aPAD for children 1-2 years old, the most highly exposed population
subgroup.
Chronic dietary exposure for this use is estimated to utilize an
additional 7% of the cPAD for the general U.S. population, and an
additional 13% of the cPAD for children 1-2 years old, the most highly
exposed population subgroup. Aggregate chronic exposure for registered
uses, including drinking water, and the proposed use on carrot is
estimated to utilize 36% of the cPAD for the general U.S. population,
and 82% of the cPAD for children 1-2 years old, the most highly exposed
population subgroup.
Establishing the carrot tolerance will increase some of the most
recent estimated aggregate risks resulting from use of fenamidone, as
discussed in the September 29, 2004 Federal Register. However, all
estimated risks are still below levels of concern. Therefore, based on
this incremental risk assessment, and the risk assessment discussed in
the final rule published in the Federal Register of September 29, 2004,
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 fenamidone residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. The Registrant of fenamidone has proposed a
liquid chromatograph/mass spectroscopy (LC/MS) method for the
enforcement of the plant tolerances (the method does not distinguish
the S- and R-enantiomers). Adequate method validation, radiovalidation,
and independent method validation (ILV) of the proposed enforcement
method have been submitted.
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 currently no established Codex, Canadian, or Mexican
maximum residue limits (MRLs) for fenamidone in or on carrot;
therefore, harmonization is not an issue for this action.
VI. Conclusion
Therefore, the time-limited tolerance is established for residues
of fenamidone, (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-
5-phenyl-3-(phenylamino), (S)-), in or on carrot at 0.20 ppm.
VII. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of the FFDCA. 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 FIFRA
section 18 exemption under section 408 of the 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 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.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement
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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: September 12, 2006.
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. Section 180.579 is amended by adding text and a table to paragraph
(b) to read as follows:
Sec. 180.579 Fenamidone; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for residues of the fungicide fenamidone, (4H-imidazol-4-
one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino), (S)-
) in connection with use of the pesticide under a section 18 emergency
exemption granted by EPA. The tolerance will expire and is revoked on
the date specified in the following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
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Carrot............................ 0.20 12/31/2009
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[FR Doc. 06-7956 Filed 9-21-06; 8:45 am]
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