Federal Register: March 25, 2009 (Volume , Number )
DOCID: fr25mr09-17 FR Doc E9-6253
ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
CFR Citation: 40 CFR Part 180
EPA ID: [EPA-HQ-OPP-2008-0845; FRL-8401-5]
NOTICE: RULES
DOCID: fr25mr09-17
DOCUMENT ACTION: Final rule.
SUBJECT CATEGORY:
Dinotefuran; Pesticide Tolerances for Emergency Exemptions
DATES: This regulation is effective March 25, 2009. Objections and requests for hearings must be received on or before May 26, 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 time-limited tolerances for combined residues of dinotefuran, [ N methyl N 'nitro N''
((tetrahydro3furanyl)methyl)guanidine] and its metabolites DN [1 methyl3(tetrahydro3furylmethyl)guanidine] and UF [1methyl3
(tetrahydro3furylmethyl)urea], expressed as dinotefuran in or on
rice, grain. This action is in response to EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on rice. This regulation establishes a maximum permissible level for
residues of dinotefuran in this food commodity. The timelimited
tolerance expires and is revoked on December 31, 2009.
SUMMARY:
Pesticide Tolerances; Emergency Exemptions: ; Dinotefuran,
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:
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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 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 40 CFR part 180 through the Government Printing Office's eCFR cite at http://www.gpoaccess.gov/ ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (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. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPAHQOPP 20080845 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 May 26, 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 your copies, identified by docket ID number EPAHQOPP20080845, by one of the following methods:
EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing timelimited tolerances for combined residues of dinotefuran. This timelimited tolerance expires and is revoked on December 31, 2009. EPA will publish a document in the Federal Register to remove the revoked tolerances for the combined residues of the insecticide, dinotefuran, [N methyl N 'nitro N'' ((tetrahydro3furanyl)methyl)guanidine] and its metabolites DN [1methyl3(tetrahydro3furylmethyl)guanidine] and UF [1methyl3(tetrahydro3furylmethyl)urea], expressed as dinotefuran from the CFR.
Section 408(l)(6) of FFDCA requires EPA to establish a timelimited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related timelimited tolerances to set binding precedents for the application of section 408 of FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.
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. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ``emergency conditions exist which require such exemption.'' EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Dinotefuran on Rice and FFDCA Tolerances
Texas declared a crisis exemption under FIFRA section 18 for the use of dinotefuran on rice for control of rice stink bug (Oebalus pugnax (F.).
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by the combined residues of dinotefuran, [ N methyl N 'nitro N'' ((tetrahydro3
furanyl)methyl)guanidine] and its metabolites DN [1methyl3
(tetrahydro3furylmethyl)guanidine] and UF [1methyl3(tetrahydro3
furylmethyl)urea], expressed as dinotefuran in or on rice, grain. In
doing so, EPA considered the safety standard in section 408(b)(2) of
FFDCA, and EPA decided that the necessary tolerance under section
408(l)(6) of FFDCA would be consistent with the safety standard and
with FIFRA section 18. Consistent with the need to move quickly on the
emergency exemption in order to address an urgent nonroutine situation
and to ensure that the resulting food is safe and lawful, EPA is
issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6) of FFDCA. Although these time
limited tolerances expire and are revoked on December 31, 2009, under
section 408(l)(5) of FFDCA, residues of the pesticide not in excess of
the amounts specified in the tolerance remaining in or on rice, grain
after that date will not be unlawful, provided the pesticide was applied in a
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manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these timelimited tolerances at the time
of that application. EPA will take action to revoke these timelimited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are not safe.
Because these timelimited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether dinotefuran meets FIFRA's registration requirements for use on rice or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this timelimited tolerance decision serves as a basis for registration of dinotefuran by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for persons in any State other than Texas to use this pesticide on these crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for dinotefuran, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.
IV. 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 the factors specified in FFDCA section
408(b)(2)(D), 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 expected as a result of this emergency exemption request and
the timelimited tolerances for combined residues of the insecticide, dinotefuran, [ N methyl N 'nitro N'' ((tetrahydro3
furanyl)methyl)guanidine] and its metabolites DN [1methyl3
(tetrahydro3furylmethyl)guanidine] and UF [1methyl3(tetrahydro3
furylmethyl)urea], expressed as dinotefuran. EPA's assessment of
exposures and risks associated with establishing timelimited tolerances follows.
A. 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 shortterm, intermediateterm, 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 dinotefuran used for human risk assessment can be found at http://www.regulations.gov in document Section 18 Emergency Exemptions for the Use of Dinotefuran on Rice in Texas to Control Stink Bugs, on page number 6 in docket ID number EPAHQOPP20080845.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to dinotefuran, EPA considered exposure under the timelimited tolerance established by this action as well as all existing dinotefuran tolerances in 40 CFR 180.603. EPA assessed dietary exposures from dinotefuran in food as follows:
i. Acute 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 100% crop treated (PCT) and tolerance level residues.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA insert 19941996 and 1998 CSFII. As to residue levels in food, EPA assumed 100 PCT and tolerance level residues.
iii. Cancer. Dinotefuran is classified as not likely to be a carcinogen, so no dietary assessment was performed for cancer.
iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for dinotefuran. Tolerance level residues and/or 100 PCT 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 dinotefuran in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of dinotefuran. 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 (SCIGROW) models, the
estimated drinking water concentrations (EDWCs) of dinotefuran for
surface water, the acute and chronic total EDWCs (parent + metabolites) are 281 parts per billion
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(ppb) for acute and 139 ppb for chronic, respectively. The acute and
chronic ground water total EDWC (parent + metabolites) is 4.9 ppb.
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).
Dinotefuran is currently registered for uses that could result in residential exposures during the application of products containing dinotefuran and from entering areas previously treated with dinotefuran, such as lawns where children might play, or golf courses and home gardens that could lead to exposures for adults. The Agency combines risks resulting from exposures to individual chemicals when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. For this assessment, the Agency has added together risk values for adults applying dinotefuran to residential lawns and then being exposed to the treated lawn. For children, dermal and incidental oral exposures from activities on treated lawn were combined. These are considered to represent worst case scenarios for cooccurring residential exposures. The proposed section 18 uses of dinotefuran do not add any additional residential exposures or risks.
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 dinotefuran to share a common mechanism of toxicity with any other substances, and dinotefuran does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that dinotefuran 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 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.
C. 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 SF when reliable data available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. EPA evaluated the potential for increased susceptibility of infants and children from exposure to dinotefuran. EPA concluded that the toxicology database for dinotefuran is adequate for FQPA assessment. Available studies include developmental toxicity studies in rats and rabbits, a reproductive toxicity study in rats, and acute and subchronic neurotoxicity studies in rats. EPA concluded that there is low concern for prenatal and/or postnatal toxicity resulting from exposure to dinotefuran. However, there is a concern for neurotoxicity and developmental neurotoxicity resulting from exposure to dinotefuran, and also a concern for immunotoxicity following exposure to dinotefuran during the period of organogenesis.
3. Conclusion. Considering the overall toxicity profile and the doses and endpoints selected for risk assessment for dinotefuran, the EPA characterized the degree of concern for the effects observed in the rat reproduction study as low, noting these effects occurred in the presence of parental toxicity and only at the highest dose tested. For all toxicity endpoints established for dinotefuran, a NOAEL lower than this offspring NOAEL is used. No residual uncertainties were identified.
The absence of a NOAEL for the chronic dog study and the need for a developmental immunotoxicity (DIT) study generate some uncertainty regarding the protectiveness of the chronic regulatory endpoint and longterm LOC. Accordingly, EPA does not have reliable data supporting adoption of a safety factor other than the default additional 10x factor as specified in FFDCA section 408(b)(2)(C). The chronic endpoint and longterm LOC have therefore been generated using an overall safety/uncertainty factor of 1,000 (representing 100x for interspecies extrapolation and intraspecies variation, and an additional 10x pursuant to FFDCA section 408(b)(2)(C), i.e., use of a LOAEL). However, the Agency does not have similar concerns regarding acute, shortterm, and intermediateterm risk assessments, since the absence of a NOAEL only occurred in a chronic study.
EPA concluded that there is concern for developmental neurotoxicity following exposure to dinotefuran, and recommended that a developmental neurotoxicity (DNT) study in rats be conducted. However, EPA determined that a database uncertainty factor (UFDB) is not needed to account for the lack of the DNT study. The Agency believes there are reliable data showing that the regulatory endpoints are protective of children despite the need for a developmental neurotoxicity study. Developmental neurotoxicity data received and reviewed for other compounds in this chemical class (i.e., neonicotinoids) including thiacloprid, clothianidin, and imidacloprid, indicate that the results of the required DNT study will not likely impact the regulatory doses selected for dinotefuran.
EPA also concluded that there is a concern for immunotoxicity following exposure to dinotefuran during the period of organogenesis. This concern was based on the decreases in absolute and adjusted thymus and spleen weights observed in several species in various studies. In addition, the available data indicate that the juvenile rats appeared to be more sensitive/susceptible to these effects than adults in the 2 generation reproduction study. Therefore, EPA recommended that testing be conducted to assess immune system function in adults and young animals following exposure during the period of organogenesis. A protocol for this testing was developed by the registrant and these studies are now ongoing.
D. 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. Shortterm, intermediateterm, and chronic
[[Page 12600]]
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. The aggregate acute risk estimates include exposure to residues of dinotefuran in food and drinking water. Since the acute dietary exposure assessment already includes the highest acute exposure from the drinking water modeling data, no further calculations are necessary. The acute risk estimate for all populations, resulting from aggregate exposure to dinotefuran in food and drinking water is below EPA's LOC. The food and drinking water exposure estimates for the most highly exposed subgroup, children 12 yrs old, is 4.4% of the aPAD.
2. Chronic risk. The aggregate chronic risk estimates include exposure to residues of dinotefuran in food and drinking water. Since the chronic dietary exposure assessment already includes the highest chronic exposure from the drinking water modeling data, no further calculations are necessary. The EPA concluded that dinotefuran exposure from food consumption will utilize 42% of the cPAD for the general U. S. population and 86% for children 12 years old, the most sensitive subgroup. Dinotefuran is not expected to pose a chronic dietary risk for the general population (including children and infants). The chronic risk estimate for all populations, resulting from aggregate exposure to dinotefuran in food and drinking water is below EPA's LOC.
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). Because there
are existing residential uses of dinotefuran, shortterm aggregate risk
assessments based on exposure from oral, inhalation, and dermal routes
were considered. However, the toxicological effects for oral and
inhalation routes of exposure are different (i.e., neurotoxicity for
oral and decrease in body weight for inhalation); and therefore, these
exposure scenarios have not been combined. Also, because no systemic
toxicity was seen at the limit dose in a 28day dermal toxicity study,
no quantification of shortterm dermal risk is required. Therefore, a shortterm aggregate risk assessment was not performed. An
intermediateterm aggregate risk assessment was performed as a
screening level assessment, which will apply to shortterm aggregate risk.
4. Intermediateterm risk. An intermediateterm aggregate risk assessment was performed as a screening level assessment. Intermediate term aggregate risk assessments were performed for adults and children. For children, the subgroup with the highest estimated chronic dietary exposure (children 12 years old) was aggregated with residential exposures to children playing on treated lawns (dermal and oral hand tomouth exposures) in order to calculate the worst case intermediate term aggregate risk to children. The reciprocal MOE method was used to conduct the intermediateterm aggregate risk assessment for children, since the LOCs are identical for all MOEs in the calculation. For adults, the aggregate risk index (ARI) method was used, since LOC are not identical for all types of exposure in the calculation. For children, the aggregate MOE is 400 which is greater than 100, and therefore does not exceed EPA's LOC. For adults, the total aggregate ARI is 5.5 which is greater than 1, and therefore does not exceed EPA's LOC.
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 dinotefuran residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (for plant commodities (High Performance Liquid Chromatography (HPLC)/Mass Spectrometry (MS); HPLC/ Ultraviolet (UV); and HPLC/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 207555350; telephone number: (410) 3052905; email address: residuemethods@epa.gov. B. International Residue Limits
There are currently no established Codex, Canadian, or Mexican maximum residue limits for residues of dinotefuran in/on plant or livestock commodities.
VI. Conclusion
Therefore, timelimited tolerances are established for combined
residues of the insecticide, dinotefuran, [ N methyl N 'nitro N''
((tetrahydro3furanyl)methyl)guanidine] and its metabolites DN [1 methyl3(tetrahydro3furylmethyl)guanidine] and UF [1methyl3
(tetrahydro3furylmethyl)urea], expressed as dinotefuran, in or on
rice, grain at 2.8 parts per million (ppm). These tolerances expire and are revoked on December 31, 2011.
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under sections 408(e) and 408(l)(6) 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 LowIncome Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances 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,
[[Page 12601]]
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).
VIII. 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 24, 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 180.603 is amended by revising paragraph (b) to read as follows:
Sec. 180.603 Dinotefuran; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Timelimited tolerances
specified in the following table are established for combined residues of Dinotefuran, [ N methyl N 'nitro N'' ((tetrahydro3
furanyl)methyl)guanidine] and its metabolites DN [1methyl3
(tetrahydro3furylmethyl)guanidine] and UF [1methyl3(tetrahydro3
furylmethyl)urea], expressed as dinotefuran in or on the specified
agricultural commodities, resulting from use of the pesticide pursuant
to FFIFRA section 18 emergency exemptions. The tolerances expire and are revoked on the date specified in the table.
Expiration/
Commodity Parts per million revocation date
Rice, grain....................... 2.8 12/31/09 * * * * *
[FR Doc. E96253 Filed 32409; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT
Libby Pemberton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3089364; email address: pemberton.libby@epa.gov.