[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Rules and Regulations]
[Pages 45411-45415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12591]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0251; FRL-8082-2]


Inert Ingredient; Revocation of the Tetrahydrofurfuryl Alcohol 
(THFA) Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking, under the Federal Food, Drug, and Cosmetic 
Act (FFDCA) section 408(e)(1), the existing exemption from the 
requirement of a tolerance for residues of the inert ingredient 
``Tetrahydrofurfuryl alcohol'' (THFA) under 40 CFR 180.910, and 
establishes a limited tolerance for THFA under 40 CFR 180.1263. The 
regulatory action contributes toward the Agency's tolerance 
reassessment requirements under FFDCA section 408(q), as amended by the 
Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by 
August 2006 to reassess the tolerances that were in existence on August 
2, 1996. This regulatory action counts as a tolerance reassessment 
toward the August 2006 review deadline.

DATES: This rule is effective February 9, 2008.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0251. All documents in the 
docket are listed in the index for the docket. 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 in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The 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 
(7505P), 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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit II. 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-2006-0251 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 10, 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-2006-0251, 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),

[[Page 45412]]

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 
Bldg.), 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

A. What Action is the Agency Taking?

    On April 12, 2006, EPA published in the Federal Register (71 FR 
18689; FRL-7771-3) proposed actions for the inert ingredient 
tetrahydrofurfuryl alcohol (THFA). This final rule revokes the 
exemption from the requirement of a tolerance for THFA under 40 CFR 
180.910 and establishes a limited tolerance exemption for THFA under 40 
CFR 180.1263. In evaluating THFA, EPA determined that dietary risks of 
concern may result from the use of THFA under the current tolerance 
exemption in 40 CFR 180.910, which allows an unlimited amount of THFA 
to be applied to growing crops and raw agricultural commodities after 
harvest. The hazard characterization of THFA shows effects of concern, 
including significant developmental and reproductive effects from 
repeated oral exposures. The available data show there is evidence of 
increased susceptibility (both quantitative and qualitative) of the 
offspring after in utero exposure to THFA, including decreased fetal 
body weights. The Agency concluded that THFA's unlimited tolerance 
exemption under 40 CFR 180.910 does not meet the safety requirements of 
FFDCA section 408(b)(2), and proposed the revocation of the tolerance 
exemption 18 months after the publication of the final rule in the 
Federal Register. In the same document, EPA proposed to establish a new 
exemption under 40 CFR 180.1263 for applications to cotton, use with 
herbicides with one application to wheat and barley prior to the pre-
boot stage, for use as a seed treatment, and applications at the time 
of planting.
    EPA's responses to comments received on the proposed rule are given 
in Unit II.B. EPA maintains its conclusion that THFA's tolerance 
exemption under 40 CFR 180.910 does not meet the safety standard of 
FFDCA section 408(b)(2), therefore, this tolerance exemption is revoked 
in this final rule. The revocation will take effect 18 months after the 
publication date of this final rule in the Federal Register.
     EPA has evaluated the scope of the new limited THFA tolerance 
exemption under 40 CFR 180.1263 and has added limited uses on canola, 
soybeans, and field corn, and has clarified that applications will now 
be permitted prior to planting. EPA finds that exempting THFA with the 
limitations in 40 CFR 180.1263 will be safe for the general population 
including infants and children.

B. EPA's Responses to Comments

    1. Applications at the time of planting. Several commentors 
requested the proposed use of THFA ``at-plant'' be expanded to include 
all applications prior to planting. EPA agrees. The proposed limitation 
``For application at the time of planting.'' under 40 CFR 180.1263 is 
replaced with ``For applications prior to planting and at the time of 
planting.'' This includes uses such as applications made in preparation 
for the planting of the crop, in the furrow during planting of seeds 
and transplants, and to the soil surface at the time of planting. This 
small expansion of the proposed limitation is in keeping with the uses 
of currently registered pesticide products containing THFA. Considering 
THFA's physical-chemical properties and biodegradation potential in the 
environment, the new limitation does not change EPA's safety finding 
for the new 40 CFR 180.1263.
    2. Requests to expand uses, and establish application rates and 
pre-harvest intervals. One commentor stated that EPA does not have to 
restrict the crops that THFA can be applied to if the Agency would set 
either a maximum THFA percentage limit in pesticide concentrates, or a 
maximum THFA percentage limit for dilute product rates applied to food 
crops. In addition, several commentors suggested the establishment of 
pre-harvest intervals as a way to limit or eliminate the potential for 
residues of THFA on harvested commodities.
    In determining whether uses of THFA could be maintained, the Agency 
evaluated the uses of all currently registered pesticide products that 
contained THFA. The products were registered for applications to a very 
large number of crops and most permitted multiple applications (e.g., 
six) including on the day of harvest. For many pesticide products, the 
quantity of THFA in formulation was unusually high, with more than half 
containing 75 - 98 % THFA. The Agency discussed its toxicity concerns 
for THFA with the registrants of these pesticide products, and the 
large majority elected to reformulate their products with another 
solvent. Of the pesticide products that continued to contain THFA, EPA 
determined that the safety finding could be made for their uses and 
crafted the limitations of the new tolerance exemption under 40 CFR 
180.1263 to include only those uses. The available reliable information 
on THFA's physical-chemical properties and biodegradation potential in 
soil was considered in making the safety finding for the uses described 
in the new exemption. The uses in the new exemption significantly 
reduce the number of times that THFA may be applied per season - often 
to one application only -- and, therefore, reduce the potential for 
dietary exposures below the Agency's level of concern.
    EPA believes that defining the scope of a tolerance exemption for 
THFA requires a cautious approach considering the significant toxicity 
concerns. THFA's toxicity profile is more similar to pesticide active 
ingredients or safeners than to minimal risk inert ingredients. 
Therefore, certain supporting data typically required for active 
ingredients and safeners may also be necessary for petitions requesting 
applications of THFA to most growing food crops (especially 
applications to edible parts). Considering THFA's significant 
reproductive and developmental toxicity and lack of neurotoxicity data 
(a sub-chronic study reported whole body spasms), EPA does not believe 
it can pick a safe maximum application rate or pre-harvest interval in 
the absence of the appropriate acceptable guideline studies (such as 
crop residue data) normally used by EPA to set these use limitations. 
Unfortunately, the Agency does not have acceptable, reliable crop 
residue data that could assist in setting THFA application rates and 
pre-harvest intervals.
    Several commentors requested that 40 CFR 180.1263 permit the 
application of THFA to many crops, such as all cereal grains in crop 
group 15. Considering the chemical's toxicity profile, EPA does not 
believe it has the necessary data to broadly grant more uses of THFA 
now without knowing exact application scenarios. EPA needs to evaluate 
the uses of a pesticide product in order to estimate the potential for 
residues of THFA and determine whether residue data may be necessary. 
In the future, 40 CFR 180.1263 will be amended if the Agency receives a 
petition that is supported by data and information

[[Page 45413]]

sufficient for the request, and the Agency determines that the safety 
finding can be made for these new and/or expanded uses. EPA suggests 
that parties interested in petitioning for new and/or expanded uses of 
THFA first consult with the Agency to determine data needs.
    Several commentors requested 40 CFR 180.1263 include two early 
season (pre-bloom) applications in herbicides on soybeans, canola, and 
field corn. The Agency evaluated the requested application scenarios 
for these crops and determined that the FQPA safety finding could be 
made for these limited early season uses.
    3. Availability of acceptable crop residue data for THFA. All 
commenters asserted that a residue study (MRID 56444) provides 
sufficient data to demonstrate the rapid rate of decline of THFA 
residues from treated crops, and that the results of this study support 
the use of THFA on all crops. EPA disagrees that any reliable data have 
been submitted to the Agency concerning residues on food resulting from 
applications of pesticide products containing THFA. The study 
identified by the commentors, MRID 56444, was developed by Chemagro in 
1972 and submitted to EPA in 1973 by Quaker Oats Company. The three 
crops used (alfalfa, Roma variety tomato, and soybeans in pod) do not 
represent the broad range of crops requested by the commentors. It is 
not an acceptable study for a number of reasons. MRID 56444 is an 
unpublished summary of data (one page per crop) that lacks 
documentation about how the study was conducted or method validation, 
and does not include a discussion of the study results. The data are 
considered to be of low reliability because of the low rates of 
recoveries. It appears that sampling was done at 0, 4, and 24 hours 
after application of THFA. The results on Roma variety tomato between 
the 4 and 24 hour sampling times were contradictory and no discussion 
was provided. No results for the 24th hour sample were included in the 
comments submitted by Penn Specialty Chemicals, Inc. The study MRID 
56444 is considered unacceptable and cannot be used to support a 
tolerance or tolerance exemption for THFA.
    The Agency disagrees with the commentors who asserted that THFA is 
naturally occurring, and is sufficiently volatile that it will not be 
available for uptake into plants and treated crops. An acceptable plant 
metabolism study that would describe the potential for plant uptake of 
THFA is not available to the Agency. In addition, EPA cannot locate any 
reliable information that THFA is a naturally occurring substance and 
is ubiquitous in the environment, as the commentor inferred. On the 
contrary, Quaker Oats stated that THFA is produced commercially by 
catalytic hydrogenation of furfural or furfuryl alcohol.
    4. Use of DEEM in the THFA assessment. All commentors objected to 
Agency's use of the inert ingredient screening level DEEM as a basis 
for its decision to limit the uses of THFA, and they proposed 
refinements that support their THFA use proposals. The Agency's 
regulatory decision that the current unlimited THFA tolerance exemption 
under 40 CFR 180.910 does not meet the safety requirements of FFDCA 
section 408(b)(2) was based on a consideration of the significant 
hazard profile of THFA rather than the result of the inert ingredient 
screening level DEEM. The results of the screening level DEEM was 
provided in the Public Docket for informational purposes in order to 
provide some information regarding the potential for exposure from the 
use of THFA on food crops under the unlimited 40 CFR 180.910 tolerance 
exemption. It should be noted that while the inert ingredient DEEM 
screening model is designed to be conservative, it is not conservative 
enough to cover the registered uses of THFA under the 40 CFR 180.910 
tolerance exemption because the quantity of THFA in the formulations of 
many pesticide products was quite high, with more than half containing 
75 - 98 % THFA.
    EPA disagrees with the commentors who asserted that the Agency must 
refine the inert ingredient DEEM with the dissipation and decline data 
they calculated from MRID 56444. The inert ingredient DEEM is used as a 
screening level model only, and refinements to the screening model are 
inappropriate and do not meet the standards of sound science. Residue 
decline data are used in refined exposure modeling and assessments, 
which were not performed for THFA because the remaining supported 
registered uses included in 40 CFR 180.1263 did not need a refined 
exposure assessment. Also, EPA will not consider the results of MRID 
56444 in any future refined exposure modeling because the study is 
unacceptable (see above).

C. What is the Agency's Authority for Taking this Action?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by the FQPA of 1996, Public Law 104-170, authorizes the 
establishment of tolerances, exemptions from tolerance requirements, 
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 exemption, food containing 
pesticide residues is considered to be unsafe and therefore 
``adulterated'' under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such 
food may not be distributed in interstate commerce (21 U.S.C. 331(a)). 
For a food-use pesticide to be sold and distributed, the pesticide must 
not only have appropriate tolerances under FFDCA, but also must be 
registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not 
registered in the United States must have tolerances in order for 
commodities treated with those pesticides to be imported into the 
United States.

D. When do These Actions Become Effective?

    The revocation of the tolerance exemption for THFA under 40 CFR 
180.910 becomes effective 18 months after the publication date of this 
final rule in the Federal Register. Any commodities listed in the 
regulatory text of this document that are treated with the pesticide 
chemical subject to this final rule, and that are in the channels of 
trade following the tolerance exemption revocations, shall be subject 
to FFDCA section 408(1)(5), as established by the FQPA. Under this 
section, any residue of the pesticide chemical in or on such food shall 
not render the food adulterated so long as it is shown to the 
satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide chemical at a time and in a manner that was lawful under 
FIFRA, and
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under an 
exemption from tolerance. Evidence to show that food was lawfully 
treated may include records that verify the dates that the pesticide 
chemical was applied to such food.
    The establishment of the new tolerance exemption for THFA under 40 
CFR 180.1263 becomes effective on the publication date of this final 
rule in the Federal Register.

E. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006, to reassess the tolerances 
and exemptions from tolerances that were in

[[Page 45414]]

existence on August 2, 1996. This document revokes one inert ingredient 
tolerance exemption which is counted as a tolerance reassessment toward 
the August 2006, review deadline under FFDCA section 408(q), as amended 
by FQPA in 1996.

VI. Statutory and Executive Order Reviews

    In this final rule, EPA is establishing and revoking specific 
tolerance exemptions established under section 408(d) of FFDCA. The 
Office of Management and Budget (OMB) has exempted this type of action 
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 final 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). 
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency previously assessed whether revocations of tolerances 
might significantly impact a substantial number of small entities and 
concluded that, as a general matter, these actions do not impose a 
significant economic impact on a substantial number of small entities. 
This analysis was published on December 17, 1997 (62 FR 66020), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration. Taking into account this analysis, and available 
information concerning the pesticide listed in this rule, the Agency 
hereby certifies that this final action will not have a significant 
economic impact on a substantial number of small entities. 
Specifically, as per the 1997 notice, EPA has reviewed its available 
data on imports and foreign pesticide usage and concludes that there is 
a reasonable international supply of food not treated with pesticides 
containing the ingredients being revoked in this notice. Furthermore, 
for the pesticide named in this final rule, the Agency knows of no 
extraordinary circumstances that exist as to the present revocations 
that would change the EPA's previous analysis. 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 final 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 final 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 final rule.

IV. 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 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 the rule in the Federal Register. This 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: Juky 26, 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. In Sec.  180.910, the table is amended by revising the entry for 
Tetrahydrofurfuryl alcohol to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

[[Page 45415]]



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            Inert ingredients                               Limits                              Uses
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Tetrahydrofurfuryl alcohol (THFA) (CAS                    Expires February 9, 2008             Solvent/cosolvent
 Reg. No 97-99-4)
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------


0
3. Section 180.1263 is added to subpart D to read as follows:


Sec.  180.1263  Tetrahydrofurfuryl alcohol; exemption from the 
requirement of a tolerance.

    Tetrahydrofurfuryl alcohol (THFA, CAS Reg. No. 97-99-4) is exempt 
from the requirement of a tolerance in or on all raw agricultural 
commodities when used in accordance with good agricultural practices as 
an inert ingredient applied only:
    (a) For use as a seed treatment.
    (b) For applications prior to planting and at the time of planting.
    (c) For use on cotton.
    (d) For use in herbicides with one application to wheat and barley 
prior to the pre-boot stage, and two applications to canola and 
soybeans pre-bloom.
    (e) For use in herbicides with two applications to field corn up to 
24 inches tall (V 5 stage).
[FR Doc. E6-12591 Filed 8-8-06; 8:45 am]
BILLING CODE 6560-50-S