[Federal Register Volume 70, Number 80 (Wednesday, April 27, 2005)]
[Rules and Regulations]
[Pages 21628-21631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8119]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0080; FRL-7709-2]


Benoxacor; Partial Grant and Partial Denial of Petition, and 
Amendment of Tolerance to Include S-Metolachlor

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  EPA is granting, in part, and denying, in part, pesticide 
petition 7E3489 submitted by Syngenta Crop Protection, Inc., and is 
amending the tolerance for benoxacor at 40 CFR 180.460 to include a 
reference to S-metolachlor, in addition to the existing reference to 
metolachlor. EPA issued a notice pursuant to section 408(d)(3) of 
FFDCA, 21 U.S.C. 346a(d)(3) in the Federal Register of August 3, 2003 
(68 FR 46620) (FRL-7317-6) announcing the filing of a petition 
requesting that the tolerance expression for the inert ingredient 
benoxacor (safener) in 40 CFR 180.460 be amended to remove references 
to metolachlor and replace it with references to S-metoloachlor. 
Although EPA finds it is safe to add a reference to S-metolachlor to 
this tolerance regulation, EPA does not agree that grounds exist to 
remove the reference to metolachlor. Thus, EPA is granting Syngenta's 
petition in as far as it seeks to add the reference to S-metolachlor 
but is denying the request to remove metolachlor.

DATES: This regulation is effective April 27, 2005. Objections and 
requests for hearings must be received on or before June 27, 2005.

ADDRESSES: To submit a written objection or hearing request, follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0080. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:  Karen Angulo, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0404; 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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of August 6, 2003 (68 FR 46620) (FRL-7317-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petition (7E3489) 
by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 
27419-8300. The petition requested that the tolerance expression for 
the inert ingredient benoxacor (safener) in 40 CFR 180.460

[[Page 21629]]

be amended to remove the references to metolachlor and replace it with 
references to S-metolachlor. Currently, the benoxacor tolerance permits 
residues of benoxacor in or on raw agricultural commodities for which 
tolerances have been established for the herbicide metolachlor when 
benoxacor is used in pesticide formulations containing metolachlor. 
Syngenta's petition seeks this amendment because it has voluntarily 
canceled all its metolachlor product registrations, including its 
metolachlor registrations containing the safener benoxacor, and has 
registered products containing S-metolachlor in their place. Some or 
all of these new registrations contain not only S-metolachlor but 
benoxacor as well.
    The notice of filing included a summary of Syngenta's petition. EPA 
received one comment, which is discussed further in Unit IV.
    This final rule is issued pursuant to section 408(d) of FFDCA, as 
amended by the FQPA (21 U.S.C. 346a(d)). Section 408 of FFDCA 
authorizes the establishment of tolerances, exemptions from the 
requirement of a tolerance, modifications in tolerances, and revocation 
of tolerances for residues of pesticide chemicals in or on raw 
agricultural commodities and processed foods. Without a tolerance or 
tolerance exemption, food containing pesticide residues is considered 
to be unsafe and therefore ``adulterated'' under section 402(a) of the 
FFDCA. If food containing pesticide residues is found to be 
adulterated, the food may not be distributed in interstate commerce (21 
U.S.C. 331(a) and 342 (a)).

III. What Action is the Agency Taking?

    In this action, EPA is ruling on a petition (7E3489) filed by 
Syngenta Crop Protection pursuant to FFDCA section 408(d) to amend a 
tolerance regulation. Section 408(d)(4) authorizes EPA to act on a 
petition by issuing a final rule adopting the amendment sought by the 
petition, issuing a final rule that varies from the amendment sought by 
the petition, or completely denying the petition. For the reasons 
described below, EPA has chosen the middle course with regard to 
Syngenta's petition - granting it only in part and denying the 
remainder.
    The Agency is granting Syngenta's petition in part. The Agency has 
determined that the tolerance for benoxacor at 40 CFR 180.460 should be 
amended to include a reference to both metolachlor and S-metolachlor. 
EPA agrees there are sufficient grounds to amend the tolerance 
expression for benoxacor to include a reference to S-metolachlor, the 
product Syngenta is now marketing in place of the metolachlor 
registrations it has voluntarily canceled. EPA has previously 
determined that the existing benoxacor tolerances meet the safety 
standard of FFDCA section 408(b)(2)(A)(i). See the Federal Register of 
February 13, 1998, (63 FR 7299) (FRL-5771-1).
    A chronic dietary exposure and risk assessment was conducted using 
Dietary Exposure Evaluation Model-Food Commodity Intake Database (DEEM-
FCID\TM\), which uses food consumption data from the United States 
Department of Agriculture's (USDA's) Continuing Surveys of Food Intakes 
by Individuals (CSFII) from 1994-1996 and 1998. The chronic analysis 
assumes tolerance-level residues on all crops with established, 
pending, or proposed tolerances for metolachlor and/or S-metolachlor. 
The analysis also assumes that 100% of the crops included in the 
assessment were treated with metolachlor and/or S-metolachlor and its 
safener, benoxacor. These assumptions result in over estimates of 
exposure and are, therefore, highly conservative with respect to 
dietary risk assessment. Even with these assumptions, the dietary risk 
estimates for all population subgroups are less than 15% of the chronic 
Population-Adjusted Dose (cPAD). Generally EPA is concerned when risk 
estimates exceed 100% of the cPAD. Therefore, the dietary risk 
estimates are below EPA's level of concern for all population 
subgroups, including those of infants and children. There are no acute 
toxicological or cancer concerns for benoxacor.
    Accordingly, EPA finds for the reasons set forth in the Federal 
Register notice of February 13, 1998 (63 FR 7299), establishing the 
existing benoxacor tolerances, that these tolerances, as amended today, 
are safe for the general population, including infants and children, 
within the meaning of FFDCA section 408(b)(2)(A)(i).
    EPA does not agree, however, that grounds exist to remove the 
reference to metolachlor in 40 CFR 180.460 as requested by the 
petition. As noted, EPA has found previously that residues of benoxacor 
resulting from its use with metolachlor, are safe and will be safe 
under the regulation when amended to also reference S-metolachlor. 
Further, while Syngenta may have canceled its metolachlor 
registrations, there are existing metolachlor registrations currently 
held by other persons. The fact that one registrant of several has 
chosen to stop marketing the pesticide does not constitute the 
``abandonment'' of a pesticide as contemplated by 40 CFR 180.32(b) that 
would justify the administrative amendment or repeal of a tolerance. 
Further, as the commenter has made clear, existing metolachlor 
registrants are interested in retaining the reference to metolachlor in 
the benoxacor tolerance expression. For these reasons, EPA is denying 
Syngenta's request to remove metolachlor from the existing tolerance 
expression.
    Based on its decision to grant, in part, and deny, in part, 
Syngenta's petition, EPA is today amending the tolerance expression for 
benoxacor at 40 CFR 180.460(a) as found in the regulatory section of 
this document.

IV. Public Comments

    As noted in Unit.II. of this document, EPA received a comment 
objecting to Syngenta's petition to replace the references to 
metolachlor in 40 CFR 180.460 with references to S-metolachlor. 
Specifically, the commenter argues that the proposed amendment is 
unnecessary to protect public health; that it would establish an 
inappropriate precedent prior to the adoption of an isomer active 
ingredient policy; and that the rationale for action that Syngenta has 
offered is materially incomplete and inadequate. Because EPA has 
decided for reasons set forth in Unit.III. of this document to retain 
the references to metolachlor in 40 CFR 180.460, EPA need not reach the 
commenter's arguments objecting to Syngenta's proposed deletion of 
metolachlor from that regulation. The commenter also argues, however, 
that as a general matter Syngenta's petition provides no pertinent new 
``data, information and arguments'' or ``reasonable grounds'' in 
support of the petition. EPA disagrees with this comment to the extent 
it suggests there are inadequate grounds for adding references to S-
metolachlor to the tolerance expression at 40 CFR 180.460. As discussed 
above, the petition noted that EPA has previously found that benoxacor 
residues are safe and has determined that this action will not alter 
the assumptions upon which that determination relied. Accordingly, EPA 
believes reasonable grounds exist to add references to S-metolachlor to 
40 CFR 180.460.

V. Objections and Hearing Requests

    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

[[Page 21630]]

for hearings appear in 40 CFR part 178. Although the procedures in 
those regulations require some modification to reflect the amendments 
made to the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0080 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 June 27, 
2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th 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 VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2005-0080, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in ADDRESSES. You may also send an electronic copy of your 
request via e-mail to: [email protected]. 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 issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VI. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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

[[Page 21631]]

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.

VII. 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: April 14, 2005.
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 180.460 paragraph (a) is revised to read as follows:


Sec.  180.460  Benoxacor; tolerances for residues.

    (a) General. Tolerances are established for residues of the inert 
ingredient (safener) benoxacor (4-(dichloroacetyl)-3,4-dihydro-3-
methyl-2H-1, 4-benzoxazine) at 0.01 parts per million (ppm) when used 
in pesticide formulations containing metolachlor or S-metolachlor in or 
on raw agricultural commodities for which tolerances have been 
established for metolachlor or S-metolachlor.
* * * * *

[FR Doc. 05-8119 Filed 4-26-05; 8:45 am]
BILLING CODE 6560-50-S