Document ID: EPA-HQ-OPP-2006-0204-0003
Agency: epa
Document Type: Rule
Title: Quizalofop ethyl; Pesticide Tolerance
Posted Date: 2006-09-27T13:12:41Z

[Federal Register: September 27, 2006 (Volume 71, Number 187)]
[Rules and Regulations]               
[Page 56374-56378]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se06-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0204; FRL-8094-5]

 
Quizalofop ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of quizalofop ethyl in or on the raw agricultural commodities barley, 
grain; barley, hay; barley, straw; flax, seed; milk, fat; sunflower, 
seed; wheat, forage; wheat, grain; wheat, hay; and wheat, straw. Nissan 
Chemical Industries, Ltd requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 27, 2006. Objections and 
requests for hearings must be received on or before November 27, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0204. 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 Building), 2777 S. Crystal Drive, 
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: James A. Tompkins, Registration 
Division (7505P), 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?

    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

[[Page 56375]]

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-
2006-0204 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 November 27, 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-2006-0204, 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), 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 
Building), 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

    In the Federal Register of August 2, 2006 (71 FR 43762) (FRL-8057-
2), 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 
0F6076) by Nissan Chemical Industries, Ltd (Nissan), 7-1,3-Chome, 
Kanda-Nishiki-Cho Chiyoda-Ku, Tokyo, 101-0054, Japan. The petition 
requested that 40 CFR 180. 441 be amended by establishing a tolerance 
for residues of the herbicide quizalofop-p-ethyl on barley, flax (seed) 
and wheat at 0.05 part per million (ppm) and sunflower (seed) at 2.0 
part per million. That notice included a summary of the petition 
prepared by Nissan Chemical Industries, Ltd, the registrant. There were 
no comments received in response to the notice of filing.
    During the course of the review, the Agency determined that based 
on the calculated maximum dietary burdens (MTDBs) for quizalofop-p 
ethyl the current tolerance for milk, fat should be increased. 
Therefore, the petition was subsequently amended to propose that 40 CFR 
180.441(a)(2) be amended by proposing a tolerance be established for 
the combined residues of the herbicide quizalofop, (2-[4-(6-
chloroquinoxalin-2-yloxy)phenoxy]propanoic acid), quizalop-ethyl 
(ethyl-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propanoate), and 
quizalofop-methyl (methyl 2-[4-(6-chloroquinoxalin-2-
yloxy)phenoxy]propanoate), all expressed as quizalofop ethyl on milk, 
fat at 0.25 ppm. This tolerance will replace the current milk, fat 
tolerance listing of 0.05 ppm. During the course of the review the 
Agency also determined that the available data supported a reduction in 
the proposed tolerance for sunflower, seed and that the commodities for 
barley and wheat needed to be defined based on current terminology. The 
petition was also amended propose that 40 CFR 180.441(a)(3) be amended 
by proposing that tolerances be established for the combined residues 
of the herbicide quizalofop-p ethyl ester (ethyl (R)-2-(4-((6-
chloroquinoxalin-2-yl)oxy)phenoxy)propanonate) and its acid metabolite 
quizalofop-p [R-(2-(4-((6-quinoxalin-2-yl)phenoxy)propanoic acid] and 
the S enantiomers of both the ester and the acid, all expressed as 
quizalofop-p-ethyl ester, in or on the raw agricultural commodities 
barley, grain at 0.05 ppm; barley, hay at 0.05 ppm; barley, straw at 
0.05 ppm; flax, seed at 0.05 ppm; sunflower, seed at 1.9 ppm; wheat, 
forage at 0.05 ppm; wheat, grain at 0.05 ppm; wheat, hay at 0.05 ppm; 
and wheat, straw at 0.05 ppm.
    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 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 the 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 tolerance for combined residues of 
quizalofop, quizalofop-ethyl, and quizalofop-methyl, all expressed as 
quizalofop ethyl on milk, fat at 0.25 ppm, and for the combined 
residues of quizalofop-p ethyl ester, quizalop-p, and the S-enantiomers 
of both the ester and the acid , all expressed as quizalofop ethyl in 
or barley, grain at 0.05 ppm; barley, hay at 0.05 ppm; barley, straw at 
0.05 ppm; flax, seed at 0.05 ppm; sunflower, seed at 1.9 ppm; wheat, 
forage at 0.05 ppm; wheat, grain at 0.05 ppm; wheat, hay at 0.05 ppm; 
and wheat, straw at 0.05 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. Specific information on the studies received and the nature 
of the toxic effects caused by quizalofop ethyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found in the 
Federal Register of June 16, 1998 http://www.epa.gov/fedrgstr/EPA-PEST/1998/June/Day-16/p15746.htm
.

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

[[Page 56376]]

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/health/human/htm.

    A summary of the toxicological endpoints for quizalofop ethyl used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of June 16, 1998 http://www.epa.gov/fedrgstr/EPA-PEST/1998/June/Day-16/p15746.htm
.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.441) for the combined residues of quizalofop, 
quizalofop-p ethyl and associated metabolites, all expressed as 
quizalofop ethyl , in or on a variety of raw agricultural commodities. 
Tolerances have been established under 40 CFR 180.441(a)(2) for 
quizalofop, quizalofop-ethyl, and quizalofop-methyl, all expressed as 
quizalofop ethyl in meat, fat, and meat byproducts of cattle, goat, 
hog, horse poultry, and sheep; milk and milk, fat and egg. Risk 
assessments were conducted by EPA to assess dietary exposures from 
quizalofop ethyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a one-day or single exposure.
    No such effects were identified in the toxicological studies for 
quizalofop ethyl; therefore, a quantitative acute dietary exposure 
assessment is unnecessary
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCIDTM), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: tolerance level residues for all commodities and 100 
percent crop treated. The assessment included existing food uses as 
well as the newly proposed tolerances for uses on barley, wheat, 
sunflower, and flax. PCT and/or anticipated residues were not used.
    iii. Cancer. EPA concluded that quizalofop ethyl should be 
classified as a Category D carcinogen (not classifiable as to human 
carcinogenicity), based on results of rat and mouse cancer studies 
along with other relevant short-term toxicity, mutagenicity studies, 
and structure-activity relationships. The Group D classification is 
based on an approximate doubling in the incidence of mice liver tumors 
between controls and the high-dose. This finding was not considered 
strong enough to warrant the classification of a Category C (possible 
human carcinogen); the increase was of marginal statistical 
significance, occurred at high dose which exceeded the MTD, and 
occurred in a study in which the concurrent control for liver tumors 
was somewhat low as compared to the historical controls, while the 
high-dose control group was at the upper end of the previous historical 
control groups. Based on the results of the above adequate studies, the 
Agency believes that quizalofop-p ethyl does not pose a significant 
cancer risk to humans and a quantitative cancer exposure assessment is 
unnecessary.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for quizalofop ethyl in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of quizalofop ethyl. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.go/oppefed/models/water/index.htm.

    Based on the PRZM/EXAMS and SCI-GROW models, the estimated 
environmental concentrations (EECs) of quizalofop ethyl for chronic 
exposures are 1.99 parts per billion (ppb) for surface water and 0.15 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM-FCID). For chronic 
dietary risk assessment, the annual average concentration in surface 
water of 1.99 ppb was used to assess the contribution to drinking 
water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Quizalofop ethyl is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to quizlalofop ethyl and any 
other substances and quizalofop ethyl does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that quizalofop ethyl 
has a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a

[[Page 56377]]

different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a MOE analysis or through using uncertainty 
(safety) factors in calculating a dose level that poses no appreciable 
risk to humans. In applying this provision, EPA either retains the 
default value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional uncertainty factors and/or special FQPA safety factors, as 
appropriate.
    2. Prenatal and postnatal sensitivity. There are no concerns and no 
residual uncertainties for increased qualitative or quantitative 
susceptibility following in utero or prenatal/postnatal exposure or for 
prenatal and postnatal toxicity. See the Federal Register of June 16, 
1998 http://www.epa.gov/fedrgstr/EPA-PEST/1998/June/Day-16/p15746.htm.

    A developmental neurotoxicity study is not required for quizalofop 
ethyl based on the following:
    i. Quizalofop ethyl does not appear to be a neurotoxic chemical.
    ii. No-treatment -related effects on brain weight or histopathology 
of the nervous system were observed in studies that measured these 
endpoints.
    iii. No evidence of developmental anamalies of the fetal nervous 
system were observed in either rats or rabbits, at maternally toxic 
doses up to 300 and 600 mg/kg/day, respectively.
    iv. No evidence of an effect on functional development was observed 
in a postnatal segment of the developmental toxicity study in rats.
    3. Conclusion. There is a complete toxicity data base for 
quizalofop ethyl and exposure data are complete or are estimated based 
on data that reasonably accounts for potential exposures. EPA 
determined that the 10X SF to protect infants and children should be 
removed. The FQPA factor is removed because the toxicology data base is 
complete; a developmental neurotoxicity study is not required; 
developmental toxicity studies showed no increased sensitivity in 
fetuses as compared to maternal animals following in utero exposures in 
rats and rabbits; a 2-generatioin reproduction study showed no 
increased sensitivity in pups as compared to adults; and exposure data 
are complete or are estimated based on data that reasonably accounts 
for potential exposures.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Quizalofop-ethyl is not expected to pose an acute 
risk because no toxicological endpoints attributable to a single 
exposure (dose) were identified in the toxicology data base.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
quizalofop-ethyl from food will utilize 11% of the cPAD for the U.S. 
population, 27% of the cPAD for infants < 1 year old, and 29% of the 
cPAD for children 1 to 2 years old.. There are no current or requested 
residential uses for quizalofop-ethyl that result in chronic 
residential exposure to quizalofop-ethyl. Therefore, EPA does not 
expect the aggregate exposures, which are equivalent to chronic dietary 
exposures, to exceed 100% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Quizalofop ethyl is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Quizalofop ethyl is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. For the reasons 
stated in this unit, quizalofop ethyl is not expected to pose a greater 
than negligible cancer risk.
    6. Determination of safety. 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 quizalofop ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High Performance Liquid 
Chromatography (HPLC) Methods, SARS-98-06 (for flax and sunflower) and 
Morse Method Meth-147 (for wheat and barley)) are available to enforce 
the tolerance expression. The method 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 is a Canadian maximum residue limit (MRL) in/on flax at 0.05 
mg/kg, which is in agreement with the proposed tolerance on flax, seed. 
There are no Mexican or Codex MRLs established for quizalofop ethyl, 
therefore compatibility is not a problem at this time.

V. Conclusion

    Therefore, the tolerance is established under 40 CFR 180.441(a)(2) 
for the combined residues of the herbicide quizalofop (2-[4-(6-
chloroquinoxalin-2-yloxy)phenoxy]propanoic acid), quizalop-ethyl 
(ethyl-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propanoate), and 
quizalofop-methyl (methyl 2-[4-(6-chloroquinoxalin-2-
yloxy)phenoxy]propanoate), all expressed as quizalofop ethyl in or on 
milk, fat at 0.25 ppm. This tolerance will replace the current milk, 
fat tolerance listing of 0.05 ppm. Tolerances are also established 
under 40 CFR 180.441(a)(3) for the combined residues of the herbicide 
quizalofop-p ethyl ester (ethyl (R)-2-(4-((6-chloroquinoxalin-2-
yl)oxy)phenoxypropanonate] and its acid metabolite quizalofop-p [R-(2-
(4-((6-quinoxalin-2-yl)phenoxy)propanoic acid] and the S enantiomers of 
both the ester and the acid, all expressed as quizalofop-p-ethyl ester, 
in or on the raw agricultural commodities barley, grain at 0.05 ppm; 
barley, hay at 0.05 ppm; barley, straw at 0.05 ppm; flax, seed at 0.05 
ppm; sunflower, seed at 1.9 ppm; wheat, forage at 0.05 ppm; wheat, 
grain at 0.05 ppm; wheat, hay at 0.05 ppm; and wheat, straw at 0.05 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May

[[Page 56378]]

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.

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: September 19, 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 180.441 is amended by revising the listing for milk, fat in 
the table to paragraph (a)(2) and by amending the table in paragraph 
(a)(3) by alphabetically adding commodities to read as follows:

Sec.  180.441  Quizalofop ethyl; tolerances for residues.

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

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Milk, fat............................................               0.25
                                * * * * *
------------------------------------------------------------------------

    (3) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Barley, grain........................................               0.05
Barley, hay..........................................               0.05
Barley, straw........................................               0.05
                                * * * * *
Flax, seed...........................................               0.05
Sunflower, seed......................................                1.9
                                * * * * *
Wheat, forage........................................               0.05
Wheat, grain.........................................               0.05
Wheat, hay...........................................               0.05
Wheat, straw.........................................               0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 06-8253 Filed 9-26-06; 8:45 am]

BILLING CODE 6560-50-S