

[Federal Register: August 23, 2006 (Volume 71, Number 163)]
[Rules and Regulations]               
[Page 49354-49358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au06-15]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0461; FRL-8078-1]

 
Triflumizole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of triflumizole in or on turnip, greens. 
Additionally, this regulation increases the tolerance levels and 
extends time-limited tolerances for Chinese Napa cabbage, collards, 
coriander leaves (cilantro), kale, kohlrabi, mustard greens and 
parsley. Further, this regulation extends time-limited tolerances for 
broccoli, dandelion and Swiss chard. This action is in response to 
EPA's granting of emergency exemptions under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
the pesticide on parsley, dandelion, Swiss chard, collards, kale, 
kohlrabi, mustard greens, Chinese Napa cabbage, broccoli, coriander 
leaves (cilantro), and turnip greens. This regulation establishes, 
revises, and/or extends a maximum permissible level for residues of 
triflumizole in these food commodities. These tolerances expire and are 
revoked on December 31, 2009.

DATES: This regulation is effective August 23, 2006. Objections and 
requests for hearings must be received on or before October 23, 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-2006-0461. 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: Libby Pemberton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9364; e-mail address: Sec-18-Mailbox@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

[[Page 49355]]

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-2006-0461 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 October 23, 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-2006-0461, 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 tolerances for combined residues of the 
fungicide triflumizole,1-(1-((4-chloro-2-trifluoromethyl)phenyl)imino)-
2-propoxyethyl)-1H-imidazole, and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent 
compound, in or on turnip, greens at 20 parts per million (ppm) and 
increasing the tolerance levels in or on cabbage, Chinese, Napa at 20 
ppm; collards at 20 ppm; coriander, leaves at 20 ppm; kale at 20 ppm; 
kohlrabi at 20 ppm; mustard, greens at 20 ppm; and parsley, leaves at 
20 ppm. Further, this regulation extends time-limited tolerances for 
broccoli at 1.0 ppm; dandelion, leaves at 7.0 ppm and Swiss chard at 
7.0 ppm. These tolerances expire and are revoked on December 31, 2009. 
EPA will publish a document in the Federal Register to remove the 
revoked tolerances 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 Triflumizole on Parsley, Dandelion, Swiss 
Chard, Collards, Kale, Kohlrabi, Mustard Greens, Chinese Napa Cabbage, 
Broccoli, Coriander Leaves (Cilantro), and Turnip Greens and FFDCA 
Tolerances

    Texas has declared a crisis exemption under FIFRA section 18 for 
the use of triflumizole on parsley, dandelion, Swiss chard, collards, 
kale, kohlrabi, mustard greens, Chinese Napa cabbage, broccoli, 
coriander leaves (cilantro), and turnip greens for control of powdery 
mildew. Texas states that the effective control of powdery mildew over 
the 70-90 day growing season requires two additional applications of a 
systemic pesticide beyond those permitted on the currently registered 
alternative labels. After having reviewed the submission,

[[Page 49356]]

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 triflumizole in or on 
parsley, dandelion, Swiss chard, collards, kale, kohlrabi, mustard 
greens, Chinese Napa cabbage, broccoli, coriander leaves (cilantro), 
and turnip greens. In doing so, EPA considered the safety standard in 
section 408(b)(2) of the FFDCA, and EPA decided that the necessary 
tolerances 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 exemptions in order to address 
urgent non-routine situations and to ensure that the resulting foods 
are safe and lawful, EPA is issuing these tolerances without notice and 
opportunity for public comment as provided in section 408(l)(6) of the 
FFDCA. Although these tolerances expire and are revoked on June 30, 
2009, under section 408(l)(5) of the FFDCA, residues of the pesticide 
not in excess of the amounts specified in the tolerances remaining in 
or on parsley, dandelion, Swiss chard, collards, kale, kohlrabi, 
mustard greens, Chinese Napa cabbage, broccoli, coriander leaves 
(cilantro), and turnip greens 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 
these tolerances at the time of that application. EPA will take action 
to revoke these tolerances earlier if any experience with, scientific 
data on, or other relevant information on this pesticide indicate that 
the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether triflumizole 
meets EPA's registration requirements for use on parsley, dandelion, 
Swiss chard, collards, kale, kohlrabi, mustard greens, Chinese Napa 
cabbage, broccoli, coriander leaves (cilantro), and turnip greens or 
whether permanent tolerances for these uses would be appropriate. Under 
these circumstances, EPA does not believe that these tolerances serve 
as a basis for registration of triflumizole by a State for special 
local needs under FIFRA section 24(c). Nor do these tolerances serve as 
the basis for any State other than Texas to use this pesticide on these 
crops 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 exemptions 
for triflumizole, 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 triflumizole and to make a determination on aggregate 
exposure, consistent with section 408(b)(2) of the FFDCA, for time-
limited tolerances for combined residues of triflumizole in or on 
parsley, leaves at 20 ppm; dandelion, leaves at 7.0 ppm; Swiss chard at 
7.0 ppm; collards at 20 ppm; kale at 20 ppm; kohlrabi at 20 ppm; 
mustard, greens at 20 ppm; Cabbage, Chinese, Napa at 20 ppm; broccoli 
at 1.0 ppm; coriander, leaves at 20 ppm; and turnip, greens at 20 ppm. 
The most recent estimated aggregate risks resulting from the use of 
triflumizole are discussed in the Federal Register for April 8, 2005 
(70 FR 17908) (FRL-7701-6). This final rule established time-limited 
tolerances for residues of triflumizole in or on parsley, leaves; 
dandelion, leaves; Swiss chard; collards; kale; kohlrabi; mustard 
greens; cabbage, Chinese, Napa; broccoli; and coriander, leaves 
(cilantro) in connection with a crisis exemption declared by the state 
of Texas, December 21, 2004.
     A new risk assessment was conducted for the current action to 
include the proposed use on turnip greens and due to the submission of 
new residue chemistry data and subsequent necessary revision to the 
time-limited tolerances on the aforementioned crops. Refer to the April 
8, 2005 Federal Register document for a detailed discussion of the 
aggregate risk assessments and determination of safety. Below is a 
brief summary of the aspects of the risk assessment which are affected 
by the change of tolerances.
    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. A summary of the toxicological dose and endpoints for 
triflumizole for use in human risk assessment is discussed in Unit 
IV.A. of the Federal Register of April 8, 2005 (70 FR 17908).
     EPA assessed risk scenarios for triflumizole under acute and 
chronic aggregate exposure (food + drinking water). Short-, 
intermediate-, and long-term aggregate risk assessments were not 
performed because there are no registered or proposed residential uses 
for triflumizole. A cancer aggregate risk assessment was not performed 
because triflumizole is not carcinogenic.
    The Dietary Exposure Evaluation Model - Food Commodity Intake 
Database (DEEM- FCID\TM\) analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1994-1996, 1998 
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity.
    Acute dietary exposure assessments were conducted for the general 
U.S. population (including infants and children) and females 13-49 
years old using tolerance level residues and 100% crop treated (CT) 
information for all registered and proposed uses). Drinking water was 
incorporated directly in the dietary assessment using the acute (peak) 
concentration for surface water generated by the FIRST model.
     Using these exposure assessments, the EPA concluded that 
triflumizole exposure from food and water consumption will utilize 9.3 
% of the aPAD for U.S. Population, 21% of the a PAD for all infants 
less than 1 year old, 25% of the aPAD for children 1-2 years old, the 
subpopulation at greatest exposure and 17% of the aPAD for females 13-
49 years old. Therefore, EPA does not expect the aggregate exposure to 
exceed 100% of the aPAD.
    A refined, chronic dietary exposure assessment was performed for 
the general U.S. population and various population subgroups using 
anticipated residues (ARs) from average field trial residues for apple, 
grape, pear, cherry, cucurbit, strawberry, and milk commodities; 
registered and proposed tolerance for all other commodities; % CT 
information for apples, grapes and pear commodities; and 100% CT 
information for all other uses. Drinking water was incorporated 
directly into the dietary assessment using the chronic (annual average) 
concentration for surface water generated by the FIRST model.
    Using these exposure assumptions, the EPA concluded that exposure 
to

[[Page 49357]]

triflumizole from food and water will utilize 17% of the cPAD for the 
general U.S. population, 24% of the cPAD for all infants less that 1 
year old and 31% of the cPAD for children 1-2 years old, the 
subpopulation at greatest exposure. Therefore, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography(GC)/nitrogen-
phosphorus detector (NPD) method) has been deemed acceptable as a 
tolerance enforcement method. 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 maximum residue limits 
established for triflumizole residues in/on crop commodities. 
Therefore, no compatibility issues exist with regard to the proposed 
U.S. tolerances discussed in this risk assessment.

VI. Conclusion

    Therefore, tolerances are established/revised for combined residues 
of triflumizole, 1- (1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-
propoxyethyl)-1H-imidazole, and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent 
compound, in or on parsley, leaves at 20 ppm; dandelion, leaves at 7.0 
ppm; Swiss chard at 7.0 ppm; collards at 20 ppm; kale at 20 ppm; 
kohlrabi at 20 ppm; mustard, greens at 20 ppm; cabbage, Chinese, Napa 
at 20 ppm; broccoli at 1.0 ppm; coriander, leaves at 20 ppm; and 
turnip, greens at 20 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes/revises time-limited tolerances 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/exemption] in this final rule, do not require the issuance 
of a proposed rule, the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.) do not apply. [If this rule is adopting a 
proposed rule add the following sentence: The Agency hereby certifies 
that this rule will not have significant negative economic impact on a 
substantial number of small entities.] 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 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.



[[Page 49358]]


    Dated: August 11, 2006.
Daniel J. Rosenblatt,
Acting 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 180.476 is amended, in paragraph (b), by revising the table 
to read as follows:


Sec.  180.476  Triflumizole; tolerances for residues.

* * * * *
    (b) * * *

----------------------------------------------------------------------------------------------------------------
                Commodity                    Parts per million               Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Broccoli................................                      1.0                                       12/31/09
Cabbage, chinese, napa..................                       20                                       12/31/09
Collards................................                       20                                       12/31/09
Coriander, leaves.......................                       20                                       12/31/09
Dandelion, leaves.......................                      7.0                                       12/31/09
Kale....................................                       20                                       12/31/09
Kohlrabi................................                       20                                       12/31/09
Mustard, greens.........................                       20                                       12/31/09
Parsley, leaves.........................                       20                                       12/31/09
Swiss chard.............................                      7.0                                       12/31/09
Turnip, greens..........................                       20                                       12/31/09
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. E6-13659 Filed 8-22-06; 8:45 am]

BILLING CODE 6560-50-S
