Document ID: EPA-HQ-OPP-2005-0508-0001
Agency: epa
Document Type: Rule
Title: Imazethapyr; Pesticide Tolerance
Posted Date: 2006-02-08T15:13:40Z

[Federal Register: February 8, 2006 (Volume 71, Number 26)]
[Rules and Regulations]
[Page 6356-6359]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe06-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0508; FRL-7755-8]

Imazethapyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an increase in tolerances for the
sum of the residues of imazethapyr and its metabolites, CL 288511, (2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(1-
hydroxyethyl)-3-pyridine carboxylic acid), and CL 182704, (5-[1-(beta-
D-glucopyranosyloxy)ethyl]-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-
oxo-1H-imidazol-2-yl]-3-pyridinecarboxylic acid), applied as its acid
or ammonium salt in or on rice grain at 0.3 ppm, rice straw at 0.4 ppm,
and imazethapyr and its metabolite, CL 288511 in or on crayfish at 0.15
ppm. BASF Corporation requested the tolerances for rice grain and rice
straw under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA), because of a
requested increase in the use rate of imazethapyr in rice. In addition,
this regulation increases the tolerance on crayfish from 0.10 ppm to
0.15 ppm due to exposure of crayfish raised in rice fields to
imazethapyr.

DATES: This regulation is effective February 8, 2006. Objections and
requests for hearings must be received on or before April 10, 2006.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0508. 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: James A. Tompkins, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5697; e-mail address: 
tompkins.jim@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 June 29, 2005 (70 FR 37392) (FRL-7718-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F
6947) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, North Carolina 27709-3528. The petition requested that
40 CFR 180.447 be amended by establishing a tolerance for the sum of
the residues of the herbicide Imazethapyr, and its metabolites CL
288511 and CL182704, in or on rice grain at 0.3 parts per million
(ppm), and rice straw at 0.4 ppm. That notice included a summary of the
petition prepared by BASF Corporation, the registrant. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C.
    In addition, after completion of the dietary risk analysis for
imazethapyr residues on rice, the Agency determined that the tolerance
for combined residues for imazethapyr and the metabolite CL 288511 in
crayfish needs to be increased from 0.10 ppm to 0.15 ppm. Crayfish are
often raised in flooded rice fields, and thus are exposed to residues
of pesticides that are applied to rice.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section

[[Page 6357]]

408(b)(2)(C) of FFDCA requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerances for the sum of the residues of
imazethapyr and its metabolites CL 288511 and CL 182704 on rice grain
at 0.3 ppm, rice straw at 0.4 ppm, and for the sum of residues of
imazethapyr and its metabolite 288511 in crayfish at 0.15 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by imazethapyr are
discussed in Unit III.A. of the final rule that established imazethapyr
tolerances in or on rice, crayfish, and meat byproducts of certain
cattle (FR notice dated August 29, 2002, 67 FR 55323, FRL-7193-4).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides.

    A summary of the toxicological endpoints for imazethapyr used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of (FR notice dated August 29, 2002,
67 FR 55323).

C. Exposure Assessment

    The Registrant, BASF Corporation, has requested an amended
registration to increase the use rate of, 2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid
from 0.125 lbs acid equivalent (ae)/application/acre/crop season and a
45-day preharvest interval (PHI) to 0.188 lbs ae/application/acre per
crop season and an 85-day PHI.
    The dietary exposure for all populations continues to be < 1%
chronic population adjusted dose (cPAD) with the minor changes in
tolerances for rice grain and straw, and crayfish established in this
Federal Register Notice. The exposure assessment for imazethapyr is
discussed in Unit III.C. of the final rule that established the
original imazethapyr tolerances in or on rice, crayfish, and meat
byproducts of certain cattle (FR notice dated August 29, 2002, 67 FR
55323). In this action, the tolerances for rice grain are increased
from 0.2 ppm to 0.3 ppm, for rice straw are increased from 0.15 ppm to
0.4 ppm) and in crayfish are increased from 0.10 ppm to 0.15 ppm. These
increases resulted in an increase in dietary exposure for the general
population from 0.000393 milligram/kilogram/day (mg/kg/day) to 0.002367
mg/kg/day, which is still much less than 1% of the cPAD of 2.5 mg/kg/
day. The highest dietary exposure as a result of the increased
tolerances is 0.008824 mg/kg/day for non-nursing infants, which is also
less than 1% of the cPAD. (Since dietary exposure for non-nursing
infants was not calculated separately in the previous dietary
assessment, but was included as part of all infants, there is no
meaningful comparison to previous dietary risk exposures.)

D. Safety Factor for Infants and Children

    The safety factors for infants and children for imazethapyr are
discussed in Unit III.D. of the final rule that established imazethapyr
tolerances in or on rice, crayfish, and meat byproducts of certain
cattle (FR notice dated August 29, 2002, 67 FR 55323).

E. Aggregate Risks and Determination of Safety

    The aggregate risks and determination of safety for imazethapyr are
discussed in Unit III.E. of the final rule that established imazethapyr
tolerances in or on rice, crayfish, and meat byproducts of certain
cattle (notice dated August 29, 2002, 67 FR 55323). Based on these risk
assessments, 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 imazethapyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The enforcement method for use on rice grain and rice straw is
Method M3120. This method measures the concentrations of imazethapyr
and its metabolites CL 288511 and CL 182704. The method extracts
residues with acidic aqueous methanol, and the extract is then eluted
through C18, strong anion exchange, and strong cation exchange columns.
Residues are quantified via capillary electrophoresis with a UV
detector.
    The enforcement method for use on crayfish is Method 3512. This
method quantifies the residues for imazethapyr and its metabolite CL
299511. This method involves extraction of residues using acidic
acetone, followed by elution through a C18 column, and residues are
quantified using LC/MS analysis. The enforcement methods may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex maximum residue levels established or proposed
for residues of imazethapyr on rice.

[[Page 6358]]

C. Response to Comments

    Public comments were received from B. Sachau. She objected that the
several of the proposed tolerances levels, including the level for
chicken, are too high. She questions who performed the tests showing
these levels are necessary and whether EPA checked the tests. Ms.
Sachau also objected to the use of animal testing, and the use of food
intake survey data from 1994.
    Response: EPA requires that petitioners submit data from studies on
residue levels in treated crops and in animals that consume treated
crops. Such studies are performed according to established protocols
and EPA carefully examines the data from the studies after it is
submitted. That was done with regard to the tolerance levels for
imazethapyr. It is noted that imazethapyr tolerances in chicken are not
being increased by this action. EPA has responded to B. Sachau's
generalized comments, in including her generalized objections to animal
testing, on numerous previous occasions (see January 7, 2005, 70 FR
1349, 1354, FRL-7691-4); (October 29, 2004, 69 FR 63083, 63096, FRL-
7681-9). As to her claim that food consumption data from 1994 is out of
date, EPA would note that the food consumption data relied upon was
collected between 1994 and 1998 by the United States Department of
Agriculture (USDA) in there (Continuing Survey of Food Intakes by
Individuals (CSFII)). Generally, major surveys of consumption patterns
have been conducted by the USDA every 5 to 10 years or so. EPA has
found that changes between surveys are on the margin and EPA has no
reason to believe that there have been significant shifts in food
consumption patterns in the last several years. B. Sachau's comments
contained no scientific data or evidence to rebut the Agency's
conclusion that there is a reasonable certainty that no harm will
result from aggregate exposure to imazethapyr, including all
anticipated dietary exposures and all other exposures for which there
is reliable information.

V. Conclusion

    Therefore, tolerances are established for the sum of the residues
of imazethapyr, and its metabolites CL 288511 and CL 182704, in or on
rice, grain at 0.3 ppm, and rice, straw at 0.4 ppm and for the sum of
the residues of imazethapyr and its metabolite CL 288511 in or on
crayfish at 0.15 ppm.

VI. 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 ID number EPA-HQ-OPP-2005-0508 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 April 10,
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 EPA. 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 ADDRESSES. Mail your
copies, identified by docket ID number EPA-HQ-OPP-2005-0508, to: Public
Information and Records Integrity Branch, Information Technology and
Resource 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. 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 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).

VII. 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,

[[Page 6359]]

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 section 408(d) of FFDCA, 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 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.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: January 25, 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 180.447 is amended by increasing the tolerance level for the
following commodities in the tables in paragraphs (a)(2) and (a)(3) to
read as follows:

Sec.  180.447  Imazethapyr; tolerances for residues.

    (a)(1) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Rice, grain................................................          0.3
Rice, straw................................................          0.4
------------------------------------------------------------------------

    (3)* * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Crayfish...................................................         0.15
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 06-1036 Filed 2-7-06; 8:45 am]

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