[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Rules and Regulations]
[Pages 55290-55293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7956]


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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: [email protected].

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: 
[email protected].

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

[[Page 55293]]

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
------------------------------------------------------------------------
Carrot............................               0.20         12/31/2009
------------------------------------------------------------------------

[FR Doc. 06-7956 Filed 9-21-06; 8:45 am]
BILLING CODE 6560-50-S