[Federal Register: March 20, 2002 (Volume 67, Number 54)]
[Rules and Regulations]               
[Page 12875-12879]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20mr02-16]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301224; FRL-6828-5]
2070-AB78

 
Isoxadifen-ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate, 
(CAS No. 163520-33-0), and its metabolite: 4,5-dihydro-5,5-diphenyl-3-
isoxazolecarboxylic acid, in or on corn commodities. Aventis 
CropScience requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
(FQPA) of 1996.

DATES: This regulation is effective March 20, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301224, 
must be received by EPA on or before May 20, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301224 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Kathryn Boyle, Registration

[[Page 12876]]

Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 305-6304; and e-mail address: 
boyle.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry........................  111...............  Crop production
  ..............................  112...............  Animal production
  ..............................  311...............  Food manufacturing
  ..............................  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------


    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301224. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 30, 2000 (65 FR 40632) (FRL-6592-
6), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the FQPA 
of 1996 (Public Law 104-170) announcing the filing of a pesticide 
petition (PP 0E6162) for a tolerance by Aventis CropScience, P.O. Box 
12014, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. This 
notice included a summary of the petition prepared by Aventis 
CropScience, the petitioner. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180.570 be amended by 
establishing a tolerance for the combined residues of the inert 
ingredient, herbicide safener isoxadifen-ethyl (ethyl 5,5-diphenyl-2-
isoxazoline-3-carboxylate, (CAS No. 163520-33-0), and its metabolite: 
4,5-dihydro-5,5-diphenyl-3-isoxazolecarboxylic acid, in or on corn, 
grain at 0.10 part per million (ppm); corn, forage at 0.30 ppm; and 
corn, stover 0.50 (ppm). The Agency determined that the tolerance 
levels should be changed (lowered) and that the corn commodities should 
be expressed as in the Food and Feed Vocabulary; therefore, the 
tolerance levels are corn, field, grain and corn, field, forage both at 
0.10 ppm and corn, field, stover at 0.20 ppm.
    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) 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) 
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. . . .''
    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 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances November 26, 1997 (62 FR 62961) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), 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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for combined residues of isoxadifen-ethyl 
(ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate, (CAS No. 163520-33-0), 
and its metabolite: 4,5-dihydro-5,5-diphenyl-3-isoxazolecarboxylic 
acid, on corn commodities.
    EPA's assessment of exposures and risks associated with 
establishing the above tolerances was published in the Federal Register 
of June 21, 2001 (66 FR 33179) (FRL-6786-1), when the time-limited 
tolerances (expiring June 21, 2004) for combined residues of 
isoxadifen-ethyl for rice commodities were established. The assessment 
that was discussed in the above final rule considered both corn and 
rice. All risks were less than the Agency's level of concern. The corn 
tolerances were not established at that time, since the enforcement 
method for corn had not yet been validated. For a complete description 
of the toxicological profile and endpoints, the uncertainty factors, 
the exposure assessment which includes dietary exposure for both food 
and drinking water, the safety factor for infants and children, and 
aggregate risk

[[Page 12877]]

for isoxadifen-ethyl see the final rule of June 21, 2001.
    Based on the previous published assessment, 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 
residues of isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-
carboxylate, (CAS No. 163520-33-0), and its metabolite: 4,5-dihydro-
5,5-diphenyl-3-isoxazolecarboxylic acid, on corn, field, grain and 
corn, field, forage both at 0.10 ppm and corn, field, stover at 0.20 
ppm.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner submitted the results of an Independent Laboratory 
Validation (ILV) for isoxadifen-ethyl and its major metabolites. The 
method is gas chromotography using ion trap mass selective detection. 
The ILV reported that overall the method worked well. There is thus a 
practical method suitable to enforce the tolerance expression. The 
method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 
305-5229; e-mail address: furlow.calvin@epa.gov.

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican tolerances/MRLs for 
isoxadifen-ethyl residues.

C. Conditions

    The following data gap has been identified for isoxadifen-ethyl in/
on corn: storage stability data. Preliminary results only have been 
submitted as the study is still on-going. The Agency believes that the 
available data and risk assessment support the determination that there 
is a reasonable certainty of no harm and the establishment of permanent 
tolerances for isoxadifen-ethyl in/on corn. The registration of a 
formulation containing isoxadifen-ethyl will be time-limited and 
conditional upon submission of this information.

V. Conclusion

    Therefore, tolerances are established for residues of isoxadifen-
ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate, (CAS No. 163520-
33-0), and its metabolite: 4,5-dihydro-5,5-diphenyl-3-
isoxazolecarboxylic acid, on corn, field, grain and corn, field, forage 
both at 0.10 ppm and corn, field, stover at 0.20 ppm.

VI. 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 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 control number OPP-301224 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 20, 
2002.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301224, 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 Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: opp-docket@epa.gov. 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

[[Page 12878]]

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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance 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 (October 4, 1993 58 FR 51735). 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 May 22, 2001 (66 FR 28355). 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 February 16, 1994, 
(59 FR 7629) 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 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. Submission to Congress and the Comptroller General

    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 11, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.570 is amended by revising paragraph (a) to read as 
follows:


Sec. 180.570  Isoxadifen-ethyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate, (CAS 
No. 163520-33-0), and its metabolite: 4,5-dihydro-5,5-diphenyl-3-
isoxazolecarboxylic acid, when used as an inert ingredient (safener) in 
or on the following raw agricultural commodities when applied at an 
annual application rate of 0.08 pound of safener per acre.

[[Page 12879]]



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                       Commodity                                            Parts per million
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Corn, field, grain....................................                                                      0.10
Corn, field, forage...................................                                                      0.10
Corn, field, stover...................................                                                      0.20
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    (2) Tolerances that expire as indicated in the table below are 
established for residues of isoxadifen-ethyl (ethyl 5,5-diphenyl-2-
isoxazoline-3-carboxylate, CAS No. 163520-33-0) and its metabolites: 
4,5-dihydro-5,5-diphenyl-3-isoxazolecarboxylic acid and -
hydroxy--benezenepropanenitrile when in the commodities listed 
below. This safener will be used only in conjunction with the active 
ingredient fenoxaprop-p-ethyl, at a rate of 0.17 pound of safener per 
acre.

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                Commodity                          Parts per million              Expiration/Revocation Date
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Rice, bran..............................                                0.80                             6/21/04
Rice, grain.............................                                0.10                             6/21/04
Rice, hulls.............................                                0.50                             6/21/04
Rice, straw.............................                                0.25                             6/21/04

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[FR Doc. 02-6727 Filed 3-19-02; 8:45 am]
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