Pesticides; tolerances in food, animal feed and raw agricultural products: Fenpropathrin,
[Federal Register: September 23, 2005 (Volume 70, Number 184)]
[Rules and Regulations]
[Page 55740-55748]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se05-13]
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0133; FRL-7738-7]
Fenpropathrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of fenpropathrin in or on bushberry subgroup 13B; lingonberry; juneberry; salal; pea, succulent; and vegetable, fruiting, group 8. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 23, 2005. Objections and requests for hearings must be received on or before November 22, 2005.
ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP-2005-0133. All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket.
Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305- 5805.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 308-3194; e-mail address: brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does this Action Apply to Me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also
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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.
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How Can I Access Electronic Copies of this Document and Other Related Information?
In addition to using EDOCKET(http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/ .
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Background and Statutory Findings
In the Federal Register of March 24, 2004 (69 FR 13833) (FRL-7347- 2-), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP 1E6261, PP 1E6331, PP 1E6336, and PP 3E6588 by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 180.466 be amended by establishing tolerances for residues of the insecticide fenpropathrin, [alpha]-cyano-3-phenoxy- benzyl 2,2,3,3-tetra-methylcyclopropanecarboxylate, in or on currant at 3.0 parts per million (ppm) requested by PP 1E6261; vegetable, fruiting, group 8, except tomato at 1.0 ppm requested by PP 1E6331; pea, succulent at 0.02 ppm requested by PP 1E6336, and bushberry subgroup 13B, lingonberry, juneberry, and salal at 3.0 ppm requested by PP 3E6588. Currant is a member of the bushberry subgroup, and will receive a tolerance at 3.0 ppm as requested for the bushberry subgroup. Therefore, a separate tolerance will not be established for currant under PP 1E6261. The proposed petition (1E6331) for vegetable, fruiting, group 8, except tomato at 1.0 ppm was subsequently amended to establish a tolerance for vegetable, fruiting, group 8 at 1.0 ppm. The Agency will delete the existing tolerance for tomato at 0.6 ppm since tomato is covered by the vegetable, fruiting group 8 tolerance promulgated under this ruling. That notice included a summary of the petition prepared by Valent U.S.A. Corporation, the registrant. One comment was received. EPA's response to this comment is discussed in Unit IV.C. below.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....''
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .
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Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of these actions. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) ofFFDCA, for tolerances for residues of fenpropathrin on vegetable, fruiting, group 8 at 1.0 ppm; pea, succulent at 0.02 ppm; and bushberry subgroup 13B, lingonberry, juneberry, and salal at 3.0 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follows.
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Toxicological Profile
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by fenpropathrin is discussed in Table 1 of this unit as well as the no-observed-adverse- effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
Guideline No.
Study Type
Results
870.3100
90-Day oral
NOAEL = 15 milligrams/ toxicity--
kilogram/day (mg/kg/ rodents (Rat) day) LOAEL = 30 mg/kg/day based on clinical signs of tremors, body weight reductions, decreased blood clotting time in females, and possibly increased alkaline phosphatase levels (both sexes)
870.3150
90-Day oral
NOAEL = 3,000 mg/kg/ toxicity (NZW day rabbit)
Only local irritation was seen. There were no systemic effects, thus the LOAEL was not determined
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870.3700
Prenatal
Maternal NOAEL = 3 mg/ developmental-- kg/day rodents(Fischer The maternal NOAEL Rats)
for the developmental rat study was 3.0 mg/kg/ day based on decreased food consumption and body weight gains. However, these effects are not characteristic of an acute exposure and are not a suitable option for this exposure scenario. One of the factors to consider in selecting an acute dietary endpoint is when the toxic effects occur. For an acute effect, a relevant endpoint would occur as the result of a single dose. Since the neurotoxic signs observed in the dams of the developmental rat study were most severe within two hours after dosing, the clinical effects are resultant from a single dose, and are therefore appropriate endpoints for acute exposure scenarios. Maternal LOAEL = 6 mg/kg/day based on decreased food consumption and body weight gains. At 10 mg/kg/day, 6 dams died between days 7 and 13, and one dam was sacrificed moribund on day 8. The remaining 23 dams survived through the end of gestation. Also in the high dose group, many clinical signs were observed in the dams including ataxia, sensitivity to external stimuli, spastic jumping, and tremors. These signs were most severe 2 hours post-dosing and during the first days of dosing. Developmental NOAEL = 6 mg/kg/day Developmental LOAEL = 10 mg/kg/day based on increased incidence of asymmetrical ossification of sternabrae and incomplete ossification of the 5th and 6th sternabrae.
870.3700
Prenatal
Maternal NOAEL = 4 mg/ developmental-- kg/day nonrodents (NZW Maternal LOAEL = 12 rabbit)
mg/kg/day based on flicking of the forepaws Developmental NOAEL = >36 mg/kg/day No dose related effects were seen, thus the LOAEL was not determined
870.3800
Reproduction and Parental/Systemic fertility
NOAEL = M:3.0; F: effects (Sprague- 3.0 mg/kg/day Dawley rats) LOAEL = M: 8.9; F: 10.1 mg/kg/day based on death and clinical signs of neurotoxicity in females. Offspring NOAEL = M:3.0; F:3.4 mg/kg/ day LOAEL = M: 8.9; F: 10.1 mg/kg/day based on increased mortality and body tremors.
870.4100
Chronic toxicity NOAEL = 2.5 mg/kg/day (Beagle Dog) LOAEL = 6.25 mg/kg/ day based on tremors and ataxia in both sexes
870.4200
Carcinogenicity- NOAEL = Not CD-1 mice
established LOAEL = M: >56.0; F: >65.2 mg/kg/day There was an overall lack of toxic response. However an aborted mouse carcinogenicity study demonstrated that at a slightly higher maximum tolerated dose (MTD) of 1,000 ppm, the test article was lethal to 15% of the mice after only 13 weeks. Thus the maximum dose used in this completed study (600 ppm) was very close to the MTD. A repeat study is not justified. no evidence of carcinogenicity
870.4300
Carcinogenicity- NOAEL = M:17.06; F: rat
7.23 mg/kg/day LOAEL = 19.45 mg/kg/ day based on increase mortality and body tremors in the females no evidence of carcinogenicity
870.5100
Gene mutation Negative in Bacterial Reverse Salmonella Mutation Test. typhimurium TA 1535, TA1537, TA1538, TA98, and TA100 and Escerichia coli Wp2 uvrA up to the limit concentration with evidence of compound insolubility
870.5300
Gene Mutation There was no clear In vitro
evidence (or a mammalian cell concentration gene mutation related positive test.
response) of induced mutant colonies over background
870.5375
Cytogenetics Negative in Chinese In vitro
hamster ovary (CHO) mammalian cell cells (cytotoxicity chromosomal
observed at >=30 aberration assay. [mu]g/mL -S9 and compound precipitation at 1,000 [mu]g/mL +S9)
870.5500
Other effects Negative in Bacillus Bacterial DNA subtilis H17 (DNA damage or repair repair proficient) test.
and M45 (DNA repair deficient)
870.5900
Other effects Negative in CHO cells In vitro sister up to the solubility chromatid
limit. exchange assay.
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870.7485
Metabolism and Greater than 99% of pharmacokinetics the administered (Sprague-Dawley dose was excreted rat)
within 168 hours with 28% to 56% excreted in the urine and the remainder in the feces. Major biotransformations of the absorbed compound included the oxidation of the methyl group of the acid moiety, hydroxylation at the 4'-position of the alcohol moiety, cleavage of the ester linkage, and conjugation with sulfuric acid or glucuronic acid. Mean dermal absorption for the 10-hour interval was 33.3%, 20.1%, and 17.6% in the low, mid, and high dose groups, respectively
870.7600
Dermal
Dermal absorption penetration-rats increased with dose but not proportionally. The percentage of the dose absorbed decreased with the increasing administered dose. The total body burden could be expected to rapidly decrease due to excretion via urine and feces. Mean dermal absorption for the 10-hour interval was 33.3%, 20.1%, and 17.6% in the low, mid, and high dose groups, respectively
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Toxicological Endpoints
For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for fenpropathrin used for human risk assessment is shown in the following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints for Fenpropathrin for Use in Human Risk Assessment
Dose Used in Risk Assessment,
Special FQPA SF and Exposure Scenario
Interspecies and Level of Concern for Study and Toxicological Intraspecies and any Risk Assessment
Effects Traditional UF
Acute Dietary (General population NOAEL = 6 mg/kg/day Special FQPA SF = 1X Developmental Toxicity including infants and children) UF = 1,000............. aPAD = acute RfD /
in Rats Acute RfD = 0.006 mg/kg/ Special FQPA SF = LOAEL = 10 mg/kg/day day.
0.006 mg/kg/day.
based on death and neurological signs At 10 mg/kg high dose death in 6 out of 30
Chronic Dietary (All populations) NOAEL= 2.5 mg/kg/day Special FQPA SF = 1X 52-Week Chronic Oral UF = 1,000............ cPAD = chronic RfD / Toxicity in Dogs Chronic RfD = 0.0025 mg/ Special FQPA SF = LOAEL = 6.25 mg/kg/day kg/day.
0.0025 mg/kg/day.
based on tremors and ataxia in both sexes
Cancer (oral, dermal, inhalation)
Classification: Not likely to be carcinogen to humans
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Exposure Assessment
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Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.466) for the residues of fenpropathrin, in or on the following raw agricultural commodities: Cotton; grapes; strawberries; peanuts; tomatoes; Brassica, head and stem, Crop Subgroup 5A; fruit, citrus, group 10; fruit, pome, group 11; eggs; milk fat; and the meat; meat byproducts, and fat of cattle, goats, hogs, horses, sheep, and poultry. Risk assessments were conducted by EPA to assess dietary exposures from fenpropathrin in food as follows
i. Acute exposure. Acute dietary 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. In conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID, Version 2.03), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The acute dietary exposure analysis was a refined one. It was refined through the use of crop field trial data, Pesticide Data Program (PDP) monitoring data, anticipated residues (ARs) in animal commodities, processing factors, and percent crop treated and projected percent crop treated estimates.
ii. Chronic exposure. In conducting the chronic dietary risk assessment EPA used the Dietary Exposure Evaluation
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Model software with the Food Commodity Intake Database (DEEM- FCIDTM), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The chronic dietary exposure analysis was also a refined one. It was refined through the use of crop field trial data, PDP monitoring data, ARs in animal commodities, processing factors, and average percent crop treated and projected market share estimates.
iii. Cancer. A cancer dietary exposure analysis was not performed because fenpropathrin was classified as ``not likely to be carcinogenic to humans.''
iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such data call-ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such data call-ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance.
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 the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. 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 maximum PCT information as follows: Apples 15%; broccoli 18 Sep Pak chromatography, and measured by gas chromatography equipped with an electron capture detector. The limit of detection of this method is 0.01 ppm. An EPA trial of this method for the determination of fenpropathrin residues in apples has been successfully conducted. No additional animal commodity tolerances are being established with these petitions. As a result, enforcement methods for animal commodities are not being addressed. Recovery of fenpropathrin was tested through FDA multiresidue methods, and fenpropathrin was found to be completely recovered by the PAM I Section 302 Method (Luke Method).
Adequate enforcement methodology 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: residuemethods@epa.gov.
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International Residue Limits
There are no Codex, Canadian, or Mexican MRLs for fenpropathrin in or on the proposed commodities. Therefore, harmonization of tolerances is not an issue.
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Response to Comments
One comment was received from a private citizen who opposed the authorization to sell any pesticide that leaves a residue on food. The Agency has received this same comment from this commenter on numerous previous occasions and rejects it for the reasons previously stated (70 FR 1349, 1354, January 7, 2005).
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Conclusion
Therefore, the tolerances are established for residues of fenpropathrin, [alpha]-cyano-3-phenoxy-benzyl 2,2,3,3-tetra- methylcyclopropanecarboxylate, in or on bushberry subgroup 13B; lingonberry; juneberry, and salal at 3.0 ppm; pea, succulent at 0.02 ppm, and vegetable, fruiting, group 8 at 1.0 ppm.
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Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of FFDCA provides essentially the same process for persons to ``object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.
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What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2005-0133 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 22, 2005.
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Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14thSt., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564-6255.
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Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP-2005-0133, to: Public Information and Records Integrity Branch, Information Technology and Resource Management Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a
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copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.
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When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
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Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of FFDCA in response to petitions submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
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Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: September 19, 2005. 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 180.466 is amended in the table to paragraph (a) by by removing the commodity ``tomato'' and by adding alphabetically commodities to the table to read as follows:
Sec. 180.466 Fenpropathrin; tolerances for residues.
(a) * * *
Parts per Commodity
million
* * * * * Bushberry subgroup 13B.....................................
3.0 * * * * * Juneberry..................................................
3.0 * * * * * Lingonberry................................................
3.0
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* * * * * Pea, succulent.............................................
0.02 * * * * * Salal......................................................
3.0 * * * * * Vegetable, fruiting, group 8...............................
1.0
* * * * *
[FR Doc. 05-19062 Filed 9-22-05; 8:45 am]
BILLING CODE 6560-50-S
