[Federal Register Volume 74, Number 41 (Wednesday, March 4, 2009)]
[Rules and Regulations]
[Pages 9373-9377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4352]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0065; FRL-8400-4]


Propoxycarbazone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of propoxycarbazone and its Pr-2-OH metabolite in or on grass, forage 
and grass, hay. Bayer CropScience requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 4, 2009. Objections and 
requests for hearings must be received on or May 4, 2009, 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-2008-0065. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. 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 Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: 
<a href="/cdn-cgi/l/email-protection#c7aaaeababa2b5e9ada8a6a9a9a287a2b7a6e9a0a8b1"><span class="__cf_email__" data-cfemail="4a272326262f386420252b24242f0a2f3a2b642d253c">[email protected]</span></a>.

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 those 
engaged in the following activities:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide 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 electronically available documents 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 EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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

[[Page 9374]]

identify docket ID number EPA-HQ-OPP-2008-0065 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 as required by 40 CFR 
part 178 on or before May 4, 2009.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0065, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of February 6, 2008 (73 FR 6964) (FRL-8350-
9), 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 
7F7304) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.600 be amended by establishing tolerances for combined residues of 
the herbicide propoxycarbazone, 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-
propoxy-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl] benzoate in or 
on grass, forage and grass, hay at 20 parts per million (ppm) and 25 
ppm and to amend the tolerances in 40 CFR 180.600 by increasing the 
established tolerances for residues of the herbicide propoxycarbazone, 
methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-
yl)carbonyl]amino]sulfonyl]benzoate (Pr-2-OH MKH-6561) in or on the 
food commodities cattle, goat, horse, sheep meat from 0.05 ppm to 0.1 
ppm; meat byproducts from 0.3 ppm to 1.0 ppm; and milk from 0.03 ppm to 
0.05 ppm. That notice referenced a summary of the petition prepared by 
Bayer CropScience, the registrant, which is available to the public in 
the docket, http://www.regulations.gov.
    Based upon review of the data supporting the petition, EPA 
recalculated a maximum reasonable dietary burden (MRDB) for cattle that 
is lower than used previously. No changes are required in the 
established tolerances for milk or livestock commodities for this 
petition.
    Comments were received on the notice of filing. EPA's response to 
these comments is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    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. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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 for the petitioned-for 
tolerances for combined residues of propoxycarbazone and its Pr-2-OH 
metabolite on grass, forage and grass, hay at 20 ppm and 25 ppm, 
respectively. EPA's assessment of exposures and risks associated with 
establishing tolerances 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.
    Propoxycarbazone has low acute toxicity via the oral, dermal, and 
inhalation routes. It is not an eye or dermal irritant or a dermal 
sensitizer. No toxicity was seen at the limit dose in a 28-day dermal 
toxicity study in rats. The main target organ appears to be the 
gastrointestinal (GI) tract (gastric irritation), with irritation 
observed in the 2-generation reproduction toxicity study in rats, 
developmental toxicity study in rabbits, and the 90-day feeding study 
in rats. In the 64-day and 1-year toxicity studies in dogs, no toxicity 
was observed at doses >=1,181 milligram/kilogram/day (mg/kg/day) and, 
>=605 mg/kg/day, respectively. Increased incidence of gastric 
irritation was observed at a very high-dose (limit dose) in a 90-day 
feeding study in rats. In a combined chronic toxicity/carcinogenicity 
study in rats, decreased body weight, increased urinary pH and 
histopathological changes in the kidney, indicate the kidney as the 
target organ. An effect on body weight was evident in both subchronic 
and chronic toxicity studies in mice.
    There was no evidence of neurotoxicity in any study. No 
quantitative or qualitative evidence of increased susceptibility was 
seen following in utero exposure to rats or rabbits in developmental 
toxicity studies. No quantitative or qualitative evidence of increased 
susceptibility was seen following the prenatal or postnatal exposure to 
rats in a 2-generation reproduction toxicity study in rats. No evidence 
of carcinogenicity was observed in a carcinogenicity study in mice at 
doses up to the limit dose. In a chronic toxicity/carcinogenicity study 
in rats, there was an increase in the incidence of mononuclear cell 
leukemia (MNCL) in mid- and high-dose males; however, EPA concluded 
that MNCL was not treatment-related. Propoxycarbazone has been 
classified as ``not likely to be carcinogenic to human'' based on lack 
of carcinogenicity in mice and rats and negative findings in various 
mutagenicity assays.
    Specific information on the studies received and the nature of the 
adverse effects caused by propoxycarbazone 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 at http://www.regulations.gov in document Propoxycarbazone-sodium; Human-

[[Page 9375]]

Health Risk Assessment for Proposed Section 3 New Use on Pasture and 
Rangeland Grasses at page 12 in docket ID number EPA-HQ-OPP-2008-0065 
and in the Federal Register of July 7, 2004 (69 FR 40774) (FRL-7365-7).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effect of concern are identified (the LOAEL) or a 
Benchmark Dose (BMD) approach is sometimes used for risk assessment. 
Uncertainty/safety factors (UFs) are used in conjunction with the POD 
to take into account 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. Safety 
is assessed for acute and chronic dietary risks by comparing aggregate 
food and water exposure to the pesticide to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD are calculated by dividing the POD by all applicable UFs. 
Aggregate short-term, intermediate-term, and chronic-term risks are 
evaluated by comparing food, water, and residential exposure to the POD 
to ensure that the margin of exposure (MOE) called for by the product 
of all applicable UFs is not exceeded. This latter value is referred to 
as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for propoxycarbazone used 
for human risk assessment can be found at http://www.regulations.gov in 
document Propoxycarbazone-sodium; Human-Health Risk Assessment for 
Proposed Section 3 New Use on Pasture and Rangeland Grasses at page 12 
in docket ID number EPA-HQ-OPP-2008-0065 and in the Federal Register of 
July 7, 2004 (69 FR 40774) (FRL-7365-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to propoxycarbazone, EPA considered exposure under the 
petitioned-for tolerances as well as all existing propoxycarbazone 
tolerances in (40 CFR 180.600). EPA assessed dietary exposures from 
propoxycarbazone 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 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
propoxycarbazone; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed that tolerance-level 
residues were for all food commodities at current or proposed 
propoxycarbazone tolerances, and that 100% of the crops included in the 
analysis were treated.
    iii. Cancer. The Agency has determined that propoxycarbazone is 
``not likely to be a carcinogenic to humans'' based on the lack of 
evidence of carcinogenicity in mice and rats and no mutagenicity 
concerns. Therefore, a quantitative exposure assessment to evaluate 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for propoxycarbazone. Tolerance level residues and/
or 100% crop treated (CT) were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for propoxycarbazone in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of propoxycarbazone. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of propoxycarbazone for 
chronic exposures for non-cancer assessments are estimated to be 1.79 
parts per billion (ppb) for surface water and 0.36 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 1.79 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).
    Propoxycarbazone is not registered for any specific use patterns 
that would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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.''
    EPA has not found propoxycarbazone to share a common mechanism of 
toxicity with any other substances, and propoxycarbazone does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
propoxycarbazone does not have 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 EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.

[[Page 9376]]

    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
to propoxycarbazone. In the rat developmental toxicity study, no 
developmental or maternal toxicity was observed at doses up to 1,000 
mg/kg/day (limit dose). In the developmental toxicity study in rabbits, 
developmental effects (abortion, post-implantation loss) were seen at a 
higher dose (limit dose) than the maternally toxic dose. There is no 
qualitative and/or quantitative evidence of increased susceptibility to 
propoxycarbazone following prenatal or postnatal exposure in a 2-
generation reproduction study in rats. Although propoxycarbazone caused 
increased post implantation loss and decreased live litter size in the 
F2 litters at a dose level of 1,230.7-1,605.3 mg/kg/day, EPA did not 
consider this as evidence for increased susceptibility since it 
occurred in the presence of severe maternal toxicity (histopathological 
lesions in the stomach) and only at doses above the limit dose.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for propoxycarbazone is complete, except 
for immunotoxicity testing. EPA began requiring functional 
immunotoxicity testing of all food and non-food use pesticides on 
December 26, 2007. Since this requirement went into effect well after 
the tolerance petition was submitted, these studies are not yet 
available for propoxycarbazone. In the absence of specific 
immunotoxicity studies, EPA has evaluated the available 
propoxycarbazone toxicity data to determine whether an additional 
database uncertainty factor is needed to account for potential 
immunotoxicity. There was no evidence of adverse effects on the organs 
of the immune system in any study with propoxycarbazone. In addition, 
propoxycarbazone does not belong to a class of chemicals (e.g., the 
organotins, heavy metals, or halogenated aromatic hydrocarbons) that 
would be expected to be immunotoxic. Based on these considerations, EPA 
does not believe that conducting a special series (Harmonized Guideline 
870.7800) immunotoxicity study will result in a point of departure less 
than the NOAEL of 74.8 mg/kg/day used in calculating the cPAD for 
propoxycarbazone; therefore, an additional database uncertainty factor 
is not needed to account for potential immunotoxicity.
    ii. There is no indication that propoxycarbazone is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that propoxycarbazone results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to propoxycarbazone in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
propoxycarbazone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
propoxycarbazone is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
propoxycarbazone from food and water will utilize less than 1% of the 
cPAD for (children 1 to 2 years old) the population group receiving the 
greatest exposure. There are no residential uses for propoxycarbazone.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Propoxycarbazone is not registered for any use patterns that would 
result in residential exposure. Therefore, the short-term aggregate 
risk is the sum of the risk from exposure to propoxycarbazone through 
food and water and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Propoxycarbazone is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to propoxycarbazone through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Propoxycarbazone is 
classified as ``not likely to be a carcinogenic to humans'' based on 
the lack of evidence of carcinogenicity in mice and rats and no 
mutagenicity concerns. Therefore, propoxycarbazone is not expected to 
pose a cancer risk to humans.
    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, or to infants and children from aggregate 
exposure to Propoxycarbazone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology--liquid chromatography with tandem 
mass spectrometry detection (LC/MS/MS), is 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: <a href="/cdn-cgi/l/email-protection#a1d3c4d2c8c5d4c4ccc4d5c9cec5d2e1c4d1c08fc6ced7"><span class="__cf_email__" data-cfemail="641601170d0011010901100c0b0017240114054a030b12">[email protected]</span></a>.

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits 
established for propoxycarbazone.

C. Response to Comments

    Public comments were received from B. Sachau who objected to the 
proposed tolerances because of the amounts of pesticides already 
consumed and carried by the American population. She further indicated 
that testing

[[Page 9377]]

conducted on animals have absolutely no validity and are cruel to the 
test animals. 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 
propoxycarbazone, including all anticipated dietary exposures and all 
other exposures for which there is reliable information. EPA has 
responded to B. Sachau's generalized comments on numerous previous 
occasions. January 7, 2005, (70 FR 1349)(FRL-7691-4); October 29, 2004, 
(69 FR 63083) (FRL-7681-9).

V. Conclusion

    Therefore, tolerances are established for combined residues of 
propoxycarbazone, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-
1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl] benzoate and its Pr-2-OH 
metabolite, methyl 2-[[[(4,5-dihydro-3-(2-hydroxypropoxy)-4-methyl-5- 
oxo-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl] benzoate in or on 
grass, forage and grass, hay at 20 ppm and 25 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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.

     February 12, 2009.
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 180.600 is amended by adding alphabetically the following 
commodities to the table in paragraph (a)(1) to read as follows:


Sec.  180.600  Propoxycarbazone: tolerance for residue.

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

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Grass, forage.........................................                                                        20
Grass, hay............................................                                                        25
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E9-4352 Filed 3-3-09; 8:45 am]
BILLING9 CODE 6560-50-S


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