

[Federal Register: March 22, 2006 (Volume 71, Number 55)]
[Rules and Regulations]               
[Page 14409-14411]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr06-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0168; FRL-7768-3]

 
Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of hexythiazox (trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-
oxothiazolidine-3-carboxamide) and its metabolites containing the (4-
chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as 
parent) in or on grape; citrus fruit, crop group 10 (CA, AZ, TX only); 
citrus, oil; citrus, dried pulp; fruit, pome, group 11; apple, wet 
pomace; and cattle, sheep, goat, and horse meat byproducts.

DATES: This regulation is effective March 22, 2006. Objections and 
requests for hearings must be received on or before May 22, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit IV. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number EPA-HQ-OPP-2006-0168. All documents in the 
docket are listed on the http://www.regulations.gov web site. EDOCKET, EPA's 

electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced Federal-wide electronic docket management and 
comment system located at http://www.regulations.gov/. Follow the on-

line instructions. 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: Olga Odiott, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9369; e-mail address:odiott.olga@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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.


II. Background and Statutory Findings

    In the Federal Register of December 30, 2005 (70 FR 77363-77371) 
(FRL-7752-1), EPA issued a proposed rule pursuant to section 408(d)(3) 
of FFDCA, 21 U.S.C. 346a(d)(3), proposing that 40 CFR Part 180 be 
amended by establishing tolerances for combined residues of the 
insecticide hexythiazox and its metabolites containing the (4-
chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as 
parent), in or on grape at 0.75 ppm; citrus fruit, crop group 10 (CA, 
AZ, TX only) at 0.35 ppm; citrus, oil at 0.90 ppm; citrus, dried pulp 
at 1.5 ppm; fruit, pome, group 11 at 1.7 ppm; apple, wet pomace at 2.5 
ppm; and cattle, sheep, goat, and horse meat byproducts at 0.12 ppm. 
That notice followed a notice of filing (Federal Register of June 1, 
2005, 70 FR, 31455-31459, FRL-7711-8) of a pesticide petition (PP 
3F6569) by Gowan Company, the registrant.
    There was one comment received on the proposal. The commenter, B. 
Sachua, requested that a zero tolerance be set for hexythiazox based on 
the commenter's generalized criticisms of EPA's risk assessment process 
and EPA's alleged ``poor record on keeping tabs of incident reports of 
negative reports from use of pesticides. . . .'' EPA has responded to 
B. Sachua's generalized comments on several occasions. (See the Federal 
Register of

[[Page 14410]]

January 7, 2005 (70 FR 1349, 1354) (FRL-7691-4) and the Federal 
Register of October 29, 2004 (69 FR 63083, 63096) (FRL-7681-9). As to 
EPA's handling of incident reports, the Agency uses information from 
various reporting systems, including the National Institute of 
Occupational Safety and Health's Sentinel Event Notification System for 
Occupational Risks (NIOSH SENSOR), the National Pesticide Information 
Center (NPIC), Poison Control Centers, the California Department of 
Pesticide Regulation, and OPP Incident Data System to track and 
evaluate pesticide incident reports. These systems collect data from 
various sources including Federal and State health and environmental 
agencies, and individual consumers. In addition, Federal law requires 
registrants of pesticides to inform the Agency about harmful effects of 
their products. EPA specialists analyze the human and animal incident 
reports to determine if there is sufficient evidence to challenge the 
safety of a registered pesticide product and take action to reduce or 
eliminate the risks.
    Many of the incident reports gathered from these sources represent 
anecdotal, not verifiable information. Nevertheless, unusual risk 
patterns observed and documented from these anecdotal reports prompt 
further evaluation by the Agency and may lead to risk mitigation 
measures to assure that pesticides do not result in unsafe residues in 
food or cause unreasonable risks when they are used according to label 
directions and precautions.
    EPA's aggregate assessment of exposures and risks associated with 
establishing the proposed tolerances for hexythiazox are discussed in 
the Federal Register of December 30, 2005 (70 FR 77363-77371) (FRL-
7752-1).

III. Conclusion

    Based on the risk assessments discussed in the proposed rule and 
the findings made therein there is reasonable certainty that no harm 
will result to the U.S. population and to infants and children from 
aggregate exposure to residues of hexythiazox. Therefore, tolerances 
are established as set forth below.

IV. 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 EPA-HQ-OPP-2006-0168 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 May 22, 
2006.
    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 issue(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 IV.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 EPA-HQ-OPP-2006-0168, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resources Management 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. 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 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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

V. 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

[[Page 14411]]

Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review 
or any Agency action under Executive Order 13045, entitled Protection 
of Children from Environmental Health Risks and Safety Risks (62 FR 
19885, April 23, 1997). This action does not involve any technical 
standards that would require Agency consideration of voluntary 
consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d)(15 U.S.C. 272 note). Pursuant to the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby 
certifies that this action will not have significant negative economic 
impact on a substantial number of small entities. Establishing a 
tolerance, in effect, removes the statutory bar on the use of a 
pesticide on the specified crops and thus has no negative economic 
impact. 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 (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.

VI. 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: March 13, 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 180.448 is amended as follows:
0
a. In the table to paragraph (a) by removing the entries for ``apple'' 
and ``pear;'' by adding alphabetically entries for ``citrus, dried 
pulp;'' ``citrus, oil;'' ``fruit, pome, group 11;'' and ``grape;'' and 
by revising the entries for ``apple, wet pomace;'' ``cattle, meat 
byproducts;'' ``goat, meat byproducts;'' ``horse, meat byproducts;'' 
and ``sheep, meat byproducts.''
0
b. In the table to paragraph (c) by adding an entry for ``fruit, citrus 
group 10 ( CA, AZ, TX only).''


Sec.  180.448  Hexythiazox; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Apple, wet pomace..........................................          2.5
                                * * * * *
Cattle, meat byproducts....................................         0.12
Citrus, dried pulp.........................................          1.5
Citrus, oil................................................         0.90
                                * * * * *
Fruit, pome, group 11......................................          1.7
                                * * * * *
Goat, meat byproducts......................................         0.12
Grape......................................................         0.75
                                * * * * *
Horse, meat byproducts.....................................         0.12
                                * * * * *
Sheep, meat byproducts.....................................         0.12
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Fruit, citrus group 10 (CA, AZ, TX only)..                          0.35
------------------------------------------------------------------------

* * * * *

[FR Doc. 06-2632 Filed 3-21-06; 8:45 am]

BILLING CODE 6560-50-S
