Federal Register: March 4, 2009 (Volume 74, Number 41)
DOCID: fr04mr09-9 FR Doc E9-4368
ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
CFR Citation: 40 CFR Part 180
EPA ID: [EPA-HQ-OPP-2008-0066; FRL-8401-1]
NOTICE: RULES
DOCID: fr04mr09-9
ACTION: Pesticide Tolerances:
DOCUMENT ACTION: Final rule.
SUBJECT CATEGORY:
Fluazifop-P-butyl; Pesticide Tolerances
DATES: This regulation is effective March 4, 2009. Objections and requests for hearings must be received on or before 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).
DOCUMENT SUMMARY:
This regulation establishes tolerances for residues of fluazifopPbutyl in or on beans, dry, seed; peanut; peanut, meal and soybean, seed. Syngenta Crop Protection, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
SUMMARY:
Fluazifop-P-butyl,
SUPPLEMENTAL 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:
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
[[Page 9368]]
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 eCFR site 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 identify docket ID number EPAHQOPP20080066 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 EPAHQOPP20080066, by one of the following methods:
In the Federal Register of February 6, 2008 (73 FR 6964) (FRL8350
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
7F7289) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.411 be amended by
establishing tolerances for residues of the herbicide fluazifopP butyl, butyl(R)2[4[[5(trifluoromethyl)2
pyridinyl]oxy]phenoxy]propanoate, in or on dry beans at 25 parts per
million (ppm); peanuts at 1.5 ppm; soybean at 2.5 ppm; soybean meal at
2.5 ppm; and soybean refined oil at 0.01 ppm. That notice referenced a
summary of the petition prepared by Syngenta Crop Protection, Inc., the
registrant, which is available to the public in the docket, http://
www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the field trial data supporting the petition and to harmonize with the Food and Feed Commodity Vocabulary at http:// www.epa.gov/opphed01/foodfeed/index.htm. EPA has amended the commodity listing to read: Beans, dry, seed at 50 ppm; peanut at 1.5 ppm; peanut, meal at 2.2 ppm; and soybean, seed at 2.5 ppm. EPA is also editorially combining the tolerance sections and correcting the tolerance expressions to delete references to the unresolved isomer fluazifop butyl that is no longer a registered pesticide under FIFRA. Background information is provided in the docket associated fluazifopPbutyl; Tolerance Reassessment Decision. The Notice of Availability was published in the Federal Register of October 21, 2005 (70 FR 61287) (FRL77262).
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 petitionedfor tolerances for residues of fluazifopPbutyl on beans, dry, seed; peanut; peanut, meal; and soybean, seed at 50 ppm, 1.5 ppm, 2.2 ppm, 2.5 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.
In characterizing the toxicity of fluazifopPbutyl, EPA considered
data on both fluazifopPbutyl and fluazifopbutyl. FluazifopPbutyl
is the purified (R) enantiomer of the mixed isomeric (RS) fluazifop
butyl product and the data show them to be toxicological equivalent.
FluazifopPbutyl has shows no indication of being an eye or skin
irritant in acute or 21day dermal studies, and is not a skin
sensitizer. FluazifopPbutyl does show similar toxicity by both the
inhalation and oral routes because of its metabolization by blood into
the acid form and excretion in this manner. The liver and kidney have
demonstrated to be its target organs expressed for the most part as
liver toxicity in the presence of peroxasome proliferation and
exacerbation of age related kidney toxicity. In general, there were no
carcinogenicity concerns in any acceptable studies in the rat with
fluazifopbutyl or in the hamster for fluazifopPbutyl. The hamster was selected for cancer study because liver
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peroxasome proliferation more closely resembled what was found for
human liver cells. There were no mutagenicity concerns evident for
fluazifopbutyl or fluazifopPbutyl. There were no concerns for
neurotoxicity resulting from fluazifopPbutyl which were evident at
relevant exposure levels. There was also no evidence of clinical signs
which would indicate neurotoxicity or neuropathology in the available
studies as well. Marginal increases in brain weights at termination
were observed in a subchronic toxicity study in rats, and in a
carcinogenicity study performed on hamsters, but only at higher doses.
In all, it was concluded that there is no concern for developmental
neurotoxicity resulting from exposure to fluazifopbutyl or fluazifop Pbutyl.
Specific information on the studies received and the nature of the adverse effects caused by fluazifoppbutyl as well as the noobserved adverseeffectlevel (NOAEL) and the lowestobservedadverseeffect level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in the document FluazifopPButyl. Amended Human Health Risk Assessment to Support Use on Dry Beans, Peanuts, and the PostBloom Application to Soybeans, page 11 in docket ID number EPAHQ OPP20080066.
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 no adverse effects are observed (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 effects 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, intermediate , and chronicterm 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 nonthreshold 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 fluazifopPbutyl used for human risk assessment is discussed at http://www.regulations.gov in the document FluazifopPButyl. Amended Human Health Risk Assessment to Support Use on Dry Beans, Peanuts, and the PostBloom Application to Soybeans, page 11 in docket ID number EPAHQOPP20080066..
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluazifopPbutyl, EPA considered exposure under the petitionedfor tolerances as well as all existing fluazifopPbutyl tolerances in (40 CFR 180.411). EPA assessed dietary exposures from fluazifopPbutyl in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a fooduse pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1day or single exposure.
In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 19941996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances (current and proposed) were treated (100% crop treated (PCT) assumption)) and contain tolerance level residues with ratio adjustments to account for additional metabolites of concern. PCT and/or anticipated residues were not used in the acute risk assessment.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 19941996 and 1998 CSFII. As to residue levels in food, EPA assumed average residue levels observed in applicable field trials and PCT were used.
iii. Cancer. The Agency has determined that fluazifopPbutyl is ``not likely to be a human carcinogen'' based on the lack of evidence of carcinogenicity in rats and hamsters and no mutagenicity concerns. Therefore, a quantitative exposure assessment to evaluate cancer risk is unnecessary.
iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows: Almonds 100%, asparagus 1%, carrots 10%, nectarines 1%, onions 15%, peaches 1%, pistachios 100%, pomegranates 100%, soybeans 100%, and watermelons 100%.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.
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The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computerbased model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which fluazifopPbutyl may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fluazifopPbutyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of fluazifopPbutyl. 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 Pesticide Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI GROW) models, the estimated drinking water concentrations (EDWCs) of fluazifopPbutyl for acute exposures are estimated to be 23.9 parts per billion (ppb) for surface water and 0.59 ppb for ground water. For chronic exposures assessments are estimated to be 5.1 ppb for surface water and 0.59 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 23.9 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 5.1 ppb was used to assess the contribution to drinking water.
3. From nondietary exposure. The term ``residential exposure'' is used in this document to refer to nonoccupational, nondietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).
FluazifopPbutyl is currently registered for the following uses that could result in residential exposures: Lawns, walks, driveways, and ornamental planting beds. EPA assessed residential exposure using the following assumptions: Homeowners that apply fluazifopPbutyl products may become exposed for shortterm durations via the dermal and inhalation routes. FluazifopPbutyl can be used in a number of residential areas which may be frequented by the general population such as on home lawns. This provides the potential for shortterm dermal (adults and children) and incidental oral exposure (children) following residential applications of fluazifopPbutyl.
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 fluazifopPbutyl to share a common mechanism of toxicity with any other substances, and fluazifopPbutyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluazifopPbutyl 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.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for fluazifopPbutyl includes the rat and rabbit developmental toxicity studies and the 2generation reproduction toxicity study in rats. There is some evidence of quantitative susceptibility following oral and dermal exposures to rats. Following inutero exposures, developmental effects (characterized as delayed ossification) were seen in the absence of maternal toxicity in two strains of rats. There is no evidence (quantitative or qualitative) of susceptibility following inutero oral exposure in rabbits or in the 2 generation reproduction toxicity study in rats. No evidence of neurotoxicity was seen.
Although increased prenatal and postnatal quantitative susceptibility was seen in rats, the Agency concluded that there is a low degree of concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of fluazifopPbutyl because:
i. The shortterm dermal and inhalation endpoint of concern (delayed ossification) is considered to be a developmental delay rather than a malformation or variation.
ii. The developmental endpoint of concern (diaphragmatic hernia) used for assessing acute dietary risk was only found in one of the five developmental rat toxicity studies conducted.
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 fluazifopPbutyl is complete except
for a confirmatory immunotoxicity study. EPA began requiring functional
immunotoxicity testing of all food and nonfood 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 fluazifopPbutyl. In the absence of specific
immunotoxicity studies, EPA has evaluated the available fluazifopP
butyl toxicity data to determine whether an additional database
uncertainty factor is needed to account for potential immunotoxicity.
The slight immunotoxicity findings in the chronic dog study are
unreliable due to the fact the dogs were unhealthy and no immunotoxic
effects were noted in the subchronic dog study where the dogs [[Page 9371]]
were healthy. No other potential immunotoxicity effects were evident in
the toxicity database for fluazifopPbutyl. The liver and kidney are
the primary target organs and the most sensitive species is the rat
(due to longer retention time of the major metabolite in this species).
Based on these considerations, EPA does not believe that conducting a
special series 870.7800 immunotoxicity study will result in a point of
departure less than the NOAEL of 0.74 milligram/kilogram/day used in
calculating the cPAD for fluazifopPbutyl; therefore, an additional
database uncertainty factor is not needed to account for potential immunotoxicity.
ii. There is no indication that fluazifopPbutyl is a neurotoxic chemical at relevant exposure levels and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There are no residual uncertainties for prenatal and/or postnatal toxicity.
iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessments were performed based on reliable data on average residue levels observed in applicable field trials and PCT. Chronic exposure will not be underestimated. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fluazifopPbutyl in drinking water. EPA used similarly conservative assumptions to assess post application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fluazifopPbutyl.
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, intermediate, and chronicterm 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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fluazifopPbutyl will occupy 12.1% of the aPAD for (females 1349 years old) the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluazifopPbutyl from food and water will utilize 74.9% of the cPAD for (children 12 years old) the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluazifopPbutyl is not expected.
3. Shortterm risk. Shortterm aggregate exposure takes into account shortterm residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
FluazifopPbutyl is currently registered for uses that could result in shortterm residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with shortterm residential exposures to fluazifopPbutyl.
Using the exposure assumptions described in this unit for short term exposures, EPA has concluded the combined shortterm food, water, and residential exposures aggregated result in aggregate margins of exposure (MOEs) of 150 for the general U.S. population, 150 for adult females and 240 for children; all below EPA's level of concern.
4. Intermediateterm risk. Intermediateterm aggregate exposure takes into account intermediateterm residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
FluazifopPbutyl is not registered for any use patterns that would result in intermediateterm residential exposure. Therefore, the intermediateterm aggregate risk is the sum of the risk from exposure to fluazifopPbutyl through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.
5. 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 fluazifopPbutyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatographymass
spectrometry) 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 207555350; telephone number: (410) 3052905; email address:
residuemethods@epa.gov. B. International Residue Limits
There are no Codex Maximum Residue Limits (MRLs) established for fluazifop residues. Canada has established a 1 ppm tolerance for fluazifopbutyl calculated as the acid in soybeans, and a Mexico MRL is established for fluazifoppbutyl in soya at 1 ppm. The proposed U.S. tolerances cannot be harmonized with the Canadian or Mexican MRLs for soybean, because higher residues were observed in the U.S. crop field trials.
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 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 fluazifopPbutyl, 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, 70 FR 13491354 (January 7, 2005); 69 FR 63083 63096 (October 29, 2004).
V. Conclusion
Therefore, tolerances are established for residues of fluazifopP butyl, butyl(R)2[4[[5(trifluoromethyl)2
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of
the resolved isomer of fluazifop, (R)2[4[[5(trifluoromethyl)2
pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on
beans, dry, seed; peanut; peanut, meal; and soybean, seed at 50 ppm, 1.5 ppm, 2.2 ppm, and 2.5 ppm, respectively.
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
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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 LowIncome 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 1044).
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 104113, 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.
Dated: February 12, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows:
PART 180[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.411 is amended by revising the section heading and paragraphs (a) and (c) to read as follows:
Sec. 180.411 FluazifopPbutyl; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide, fluazifopPbutyl, butyl(R)2[4[[5(trifluoromethyl)2
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of
the resolved isomer of fluazifop, (R)2[4[[5(trifluoromethyl)2
pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on the following commodities:
Commodity Parts per million
Beans, dry, seed...................................... 50
Carrot, roots......................................... 2.0
Cattle, fat........................................... 0.05
Cattle, meat.......................................... 0.05
Cattle, meat byproducts............................... 0.05
Cotton, oil........................................... 0.2
Cotton, undelinted seed............................... 0.1
Egg................................................... 0.05
Endive................................................ 6.0
Fruit, stone.......................................... 0.05
Goat, fat............................................. 0.05
Goat, meat............................................ 0.05
Goat, meat byproducts................................. 0.05
Hog, fat.............................................. 0.05
Hog, meat............................................. 0.05
Hog, meat byproducts.................................. 0.05
Horse, fat............................................ 0.05
Horse, meat........................................... 0.05
Horse, meat byproducts................................ 0.05
Milk.................................................. 0.05
Nut, macadamia........................................ 0.1
Onion, bulb........................................... 0.5
Peanut................................................ 1.5
Peanut, meal.......................................... 2.2
Pecans................................................ 0.05
Poultry, fat.......................................... 0.05
Poultry, meat......................................... 0.05 [[Page 9373]]
Poultry, meat byproducts.............................. 0.05
Sheep, fat............................................ 0.05
Sheep, meat........................................... 0.05
Sheep, meat byproducts................................ 0.05
Soybean, seed......................................... 2.5
Spinach............................................... 6.0
Sweet Potato, roots................................... 0.05 * * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registrations are established for residues of the herbicide, fluazifopPbutyl, butyl(R)2[4[[5(trifluoromethyl)2
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of
the resolved isomer of fluazifop, (R)2[4[[5(trifluoromethyl)2
pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on the following commodities:
Commodity Parts per million
Asparagus............................................. 3.0
Coffee, bean.......................................... 0.1
Pepper, tabasco....................................... 1.0
Rhubarb............................................... 0.5 * * * * *
[FR Doc. E94368 Filed 3309; 8:45 am]
BILLING CODE 656050S
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) 3056224; email address: miller.joanne @epa.gov.