Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Clethodim,

[Federal Register: June 5, 2001 (Volume 66, Number 108)]

[Rules and Regulations]

[Page 30073-30080]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr05jn01-7]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301133; FRL-6783-5]

RIN 2070-AB78

Clethodim; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for combined residues of clethodim in or on the root vegetable (except sugar beet) subgroup. The Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996. This final rule establishes permanent tolerances for clethodim and as part of that process the Agency has reassessed existing tolerances. By law, EPA is required to reassess 66% of the tolerances in existence on August 2, 1996, by August 2002, or about 6,400 tolerances. All permanent tolerances for clethodim that existed on August 2, 1996, were previously reassessed by April 1998. Consequently, regarding the actions in this final rule, no tolerance reassessments are counted toward the August 2002 review deadline of FFDCA section 408(q).

DATES: This regulation is effective June 5, 2001. Objections and requests for hearings, identified by docket control number OPP-301133, must be received by EPA on or before August 6, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301133 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-3194; and e-mail address: brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

      Examples of Categories

      NAICS codes

      potentially affected entities

      Industry

      111

      Crop production 112

      Animal production 311

      Food manufacturing 32532

      Pesticide manufacturing

      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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

   2. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

      1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select ``Laws and Regulations,'' ``Regulations and Proposed Rules,'' and then look up the entry for this document under the ``Federal Register--Environmental Documents.'' You can also go directly to theFederal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/ nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

      2. In person. The Agency has established an official record for this action under docket control number OPP-301133. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents.

      [[Page 30074]]

      The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

2. Background and Statutory Findings

   In the Federal Register of March 29, 2000 (65 FR 16602) (FRL-6495- 5), EPA issued notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of pesticide petition (PP 0E6097) for tolerances by IR-4, Rutgers, the State University of New Jersey, 681 U.S. Highway No. 1 South, North New Brunswick, NJ 08902 and Valent USA Corporation, Walnut Creek, CA 94596-8025. This notice included a summary of the petition prepared by Valent USA Corporation, the registrant.

   The petition requested that 40 CFR 180.458 be amended by establishing tolerances for combined residues of the herbicide clethodim, [(E)-()-2-[1-[[(3-chloro-2- propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2- cyclohexen-1-one] and its metabolites containing the 5-(2- (ethylthiopropyl)cyclohexene-3-one and 5-(2-(ethylthiopropyl)-5- hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, on various commodities with the following tolerance levels at parts per million (ppm): root vegetables subgroup at 1.0 ppm, leaves of root and tuber vegetables group at 2.0 ppm, leafy petiole vegetables subgroup at 0.5 ppm, melon subgroup at 2.0 ppm, squash/cucumber subgroup at 0.5 ppm, cranberry at 0.5 ppm, clover forage at 10 ppm, clover hay at 20.0 ppm, and strawberry at 5.0 ppm. In response to IR-4's petition, EPA issued a final rule in the Federal Register of March 14, 2001 (66 FR 14829) (FRL-6770-8) establishing tolerances for combined residues of clethodim and its metabolites in or on carrots at 0.50 ppm, radish roots at 0.50 ppm, radish tops at 0.70 ppm, leaf petioles subgroup at 0.60 ppm, melon subgroup at 2.0 ppm, squash/cucumber subgroup at 0.50 ppm, cranberry at 0.5 ppm, strawberry at 3.0 ppm, clover forage at 10.0 ppm, and clover hay at 20.0 ppm. Tolerances were established for carrot and radish roots, which are members of the root vegetable (except sugar beet) subgroup, in the final rule of March 14, 2001, but not the subgroup since EPA had not completed its evaluation of the residue data submitted in support of the subgroup tolerance. EPA has now completed the review of the residue data and has concluded that the data support a tolerance for combined residues of clethodim and its metabolites in or on the root vegetable (except sugar beet) subgroup at 1.0 ppm.

   Section 408(b)(2)(A)(i) of the 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) 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) 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 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

3. Aggregate Risk Assessment and Determination of Safety

   Consistent with 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, consistent with section 408(b)(2), for a tolerance for combined residues of clethodim on the root vegetable (except sugar beet) subgroup at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing this tolerance follows.

   1. 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 clethodim are discussed in Unit III.A. of the Federal Register of March 14, 2001.

   2. Toxicological Endpoints

      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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

      For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

      For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

      The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-6or one in a million). Under certain specific circumstances, MOE calculations will

      [[Page 30075]]

      be used for the carcinogenic risk assessment. In this non-linear approach, a ``point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer= point of departure/exposures) is calculated. A summary of the toxicological endpoints for clethodim used for human risk assessment is shown in the following Table 1:

      Table 1.--Summary of Toxicological Dose and Endpoints for Clethodim for Use in Human Risk Assessment

      FQPA SF* and Level of Exposure Scenario

      Dose Used in Risk Concern (LOC) for Risk Study and Toxicological Assessment, UF

      Assessment

      Effects

      Acute dietary all populations

      N/A

      N/A

      None selected. There were no effects observed in oral toxicity studies including developmental toxicity studies in rats and rabbits that could be attributable to a single dose (exposure). Therefore, a dose and endpoint were not selected for this risk assessment.

      Chronic dietary all populations

      NOAEL= 1.0 mg/kg/day FQPA SF = 1

      Chronic toxicity-dog (1 UF = 100............... cPAD =chronic RfD...... year). Chronic RfD = 0.01mg/ FQPA SF = 0.01mg/kg/ Alterations in kg/day.

      day.

      hematology and clinical chemistry parameters and increased absolute and relative liver weights observed at the LOAEL of 75 mg/kg/day.

      Short-term dermal (1 to 7 days)

      Oral study maternal LOC for MOE = 100

      Developmental toxicity- (residental)......................... NOAEL= 100 mg/kg/day... (residential).......... rat. (dermal absorption rate

      LOAEL = 350 mg/kg/day = 30%).

      based on decreased body weight gain and clinical signs of toxicity (salivation).

      Intermediate-term dermal (1 week to Oral study NOAEL = LOC for MOE = 100

      Subchronic toxicity-dog several months)

      25 mg/kg/day........... (residential).......... (90 days). (residential)........................ (dermal absorption rate

      LOAEL = 75 mg/kg/day = 30%).

      based on increased absolute and relative liver weights.

      Long-term dermal (several months to Oral study NOAEL = 1.0 LOC for MOE =100

      Chronic toxicity-dog (1 lifetime)

      mg/kg/day

      (residential).......... year). (residential)........................ (dermal absorption rate

      LOAEL = 75 mg/kg/day = 30%).

      based on alterations in hematology and clinical chemistry parameters as well as increases in absolute and relative liver weights.

      Short-term inhalation (1 to 7 days) Oral study maternal LOC for MOE =100

      Developmental-rat. (residential)........................ NOAEL= 100 mg/kg/day... (residential).......... LOAEL = 350 mg/kg/day (inhalation absorption

      based on decreased rate = 100%).

      body weight gain and clinical signs of toxicity (salivation).

      Intermediate-term inhalation (1 week Oral study NOAEL = 25 LOC for MOE = 100

      Subchronic toxicity-dog to several months)

      mg/kg/day

      (residential).......... (90 days). (residential)........................ (inhalation absorption

      LOAEL = 75 mg/kg/day rate = 100%).

      based on increased absolute and relative liver weights.

      Long-term inhalation (several months Oral study NOAEL = LOC for MOE = 100

      Chronic toxicity-dog (1 to lifetime)

      1.0 mg/kg/day.......... (residential).......... year). (residential)........................ (dermal absorption rate

      LOAEL = 75 mg/kg/day = 30%).

      based on alterations in hematology and clinical chemistry parameters as well as increases in absolute and relative liver weights.

      Cancer (oral, dermal, inhalation) N/A

      N/A

      Clethodim is classified as a ``Not Likely'' carcinogen.

      *The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.458) for the residues of clethodim in or on a variety of food commodities: including the representative commodities of the root vegetable (except sugar beet) subgroup (carrots and radish roots at 0.5 ppm) and the related tuberous and corm vegetable subgroup at 1.0 ppm. Risk assessments were conducted by EPA to assess dietary exposures from clethodim 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. An endpoint was not identified for acute dietary exposure and risk assessment because no effects were observed in oral toxicity studies including developmental toxicity studies in rats or rabbits that could be attributable to a single dose (exposure). Therefore, an acute dietary exposure assessment was not performed.

         [[Page 30076]]

         ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM) analysis evaluated the individual food consumption as reported by respondents in the USDA [1989-1992] 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 3-day average of consumption for each sub-population is combined with residues to determine average exposure as milligram/ kilogram/day (mg/kg/day).

         The chronic analysis was performed using tolerance level residues for all crops and animal commodities. The weighted average percent of crop treated data for existing registrations, and 100 percent crop treated (PCT) data (for new uses) were used for the analyses.

         iii. Cancer. Clethodim has been classified as a group E carcinogen. Therefore, a cancer risk assessment was not performed.

         iv. Anticipated residue and PCT information. Section 408(b)(2)(F) 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), EPA may require registrants to submit data on PCT.

         The Agency used PCT information as follows:

         Cotton 3%, onions 8%, peanuts 3%, soybeans 4%, sugar beets 15%, and tomatoes 1%.

         The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based 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 information on the regional consumption of food to which clethodim may be applied in a particular area.

      2. Dietary exposure from drinking water. Known environmental characteristics of clethodim depict a compound which is stable to hydrolysis, except in acid conditions, but highly susceptible to photolysis and metabolism.

         Parent clethodim is mobile, but has a short metabolic half-life of 1-3 days in soil under aerobic conditions. Therefore, parent compound should not be a ground water concern in most environments. In the event that parent clethodim did reach ground water, the available routes of disappearance would be dilution, some metabolism to persistent degradates, and slow hydrolysis with the rate depending on the pH of the ground water.

         The environmental fate data indicate that clethodim, and its sulphoxide and sulphone metabolites may migrate into surface water bodies through run-off which occurs shortly after application (e.g., rainfall). Since they are not adsorbed readily to soil (Kds of 0129

         24.2

         0.49

         250

         All infants (0143

         24.2

         0.49

         57

         Children 1-6 years

         0.0160

         24.2

         0.49

         40

         Children 7-12 years

         0.0142

         24.2

         0.49

         58

         Females 13-50 years

         0.0122

         24.2

         0.49

         230

      3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

         Clethodim is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

      4. Aggregate cancer risk for U.S. population. Clethodim has been classified as a group E carcinogen. Therefore, clethodim is not expected to pose a cancer risk to humans.

      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, and to infants and children from aggregate exposure to clethodim residues.

4. Other Considerations

   1. Analytical Enforcement Methodology

      Method RM-26B-2 was validated by IR-4 for the analyses of residues of clethodim in/on radish and carrots. The limit of quantitation (LOQ) was determined to be 0.1 ppm for carrots and 0.16 ppm for radish. Average recoveries were within the acceptable range for all fortification levels tested and all commodities. The method RM-26B-2 for the determination of clethodim and its metabolites in radish and carrots is acceptable for data collection and meets the requirements for a residue analytical method to enforce tolerances.

      The common moiety method RM-26B-3 for the determination of clethodim and its metabolites is similar to the common moiety method RM-26B-2. The method RM-26B-2 and RM-26D-2 have completed an Independent Laboratory Validation (ILV) and also have completed Tolerance Methods Validations (TMVs) in the Agency's laboratory. Additionally, the compound specific method, EPA-RM-26D-2 is also available and is suitable for residue data collection and as a residue analytical methold to enforce tolerances. Both methods have been forwarded to FDA for inclusion in a future edition of the Pesticide Analytical Manual, Volume II (PAM II).

      The methods may be requested from: Francis Griffith, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort George G. Mead, Maryland, 20755-5350; telephone number: (410) 305-2905; e-mail address: griffith.francis@epa.gov.

   2. International Residue Limits

      There are no established Codex maximum residue limits (MRLs) for residues of clethodim and its metabolites in/on commodity members of the root vegetable (except sugar beet subgroup); therefore, there are no questions with respect to Codex/U.S. tolerance compatibility.

5. Conclusion

   Therefore, this tolerance is established for combined residues of clethodim, [[(E)-()-2-[1-[[(3-chloro-2- propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2- cyclohexen-1-one] and its metabolites containing the 5-(2- (ethylthiopropyl)cyclohexene-3-one and 5-(2-(ethylthiopropyl)-5- hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, in or on the root vegetable (except sugar beet) subgroup at 1.0 ppm.

6. Objections and Hearing Requests

   Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

   1. 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 control number OPP-301133 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 August 6, 2001.

      1. 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 issues(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 (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You

         [[Page 30079]]

         may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. 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) 260-4865.

      2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.''

         EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

         If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

      3. 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 Unit I.B.2. Mail your copies, identified by docket control number OPP-301133, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. 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.

   2. 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 issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

7. Regulatory Assessment Requirements

   This final rule establishes a tolerance under FFDCA section 408(d) 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). 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 as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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.

8. Submission to Congress and the Comptroller General

   The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement

   [[Page 30080]]

   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: May 23, 2001.

   James Jones,

   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), 346(a) and 371.

   2. Section 180.458 is amended by alphabetically adding the entry vegetable, root (except sugar beet) subgroup to the table in paragraph (a)(3), by revising the entry for vegetable, tuberous and corm group, and by deleting the entries for carrot and radish roots to read as follows:

      Sec. 180.458 [((E)-()-2-[1-[[(3-chloro-2- propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2- cyclohexen-1-one); tolerances for residues.

      (a) * * *

      (3) * * *

      Commodity

      Parts per million

      *

      *

      *

      *

      * Vegetable, root (except sugar beet) subgroup..........

      1.0 *

      *

      *

      *

      * Vegetable, tuberous and corm, subgroup................

      1.0

      * * * * *

      [FR Doc. 01-14086Filed6-4-01; 8:45 am]

      BILLING CODE 6560-50-S