Cyhexatin; Tolerance Actions, 55268-55272 [05-18581]

Download as PDF 55268 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations Parts per million Commodity Almond ...................................... Almond, hulls ............................ Apple ......................................... Apricot ....................................... Banana ..................................... Bean, lima ................................. Bean, snap, succulent .............. Beet, garden, roots ................... Beet, garden, tops .................... Beet, sugar, roots ..................... Beet, sugar, tops ...................... Blackberry ................................. Blueberry .................................. Carrot, roots .............................. Cattle, fat .................................. Celery ....................................... Cherry ....................................... Citrus ........................................ Corn, field, forage ..................... Corn, sweet, forage .................. Corn, sweet, kernel plus cob with husks removed .............. Cranberry .................................. Cucumber ................................. Endive ....................................... Fig ............................................. Filbert ........................................ Ginseng, roots .......................... 0.5 3.0 0.5 0.5 0.2 0.5 0.5 0.75 0.7 0.5 10.0 0.5 0.5 0.75 0.7 0.7 0.75 0.7 40.0 40.0 0.7 0.5 0.75 0.7 0.5 0.5 0.75 Parts per million Commodity Grape ........................................ Hop, dried cones ...................... Kiwifruit ..................................... Lettuce ...................................... Loganberry ................................ Melon ........................................ Mushroom ................................. Nectarine .................................. Olive .......................................... Onion, dry bulb ......................... Onion, green ............................. Parsley, leaves ......................... Parsnip ...................................... Peach ........................................ Pear .......................................... Pea, field, hay ........................... Pea, field, vines ........................ Pea, succulent .......................... Pepper ...................................... Pineapple .................................. Plum, prune, fresh .................... Potato ....................................... Potato, sweet ............................ Radicchio .................................. Radish ....................................... Raspberry ................................. Rutabaga .................................. Sheep, fat ................................. 0.75 0.75 0.75 0.7 0.75 0.75 0.75 0.5 1. 0 0.75 0.75 0.75 0.5 0.7 0.5 10.0 25.0 0.5 0.5 0.5 0.5 0.1 0.1 0.7 0.5 0.5 0.75 0.7 Sheep, meat (fat basis) ............ Sheep, meat byproducts (fat basis) ..................................... Spinach ..................................... Squash, summer ...................... Squash, winter .......................... Strawberry ................................ Swiss chard .............................. Tomato ...................................... Turnip, greens .......................... Turnip, roots ............................. Vegetable, brassica, leafy, group 5 .................................. Walnut ....................................... Watercress ................................ * * * * § 180.312 4-Aminopyridine; tolerances for residues. (a) General. Tolerances are established for residues of the bird repellent 4-aminopyridine in or on the following food commodities: § 180.380 Vinclozolin; tolerances for residues. (a) General. Tolerances are established for the combined residues of the fungicide vinclozolin (3-(3,5dichlorophenyl)-5-ethenyl-5-methyl-2,4oxazolidinedione) and its metabolites containing the 3,5-dichloroaniline moiety in or on the food commodities in the table below. There are no U.S. registrations for grape (wine) as of July 30, 1997. Parts per million Commodity Bean, succulent Canola, seed .... Cattle, fat .......... Cattle, meat ...... Cattle, meat byproducts ........ Egg ................... VerDate Aug<31>2005 Expiration/ Revocation Date 2.0 1.0 0.05 0.05 11/30/05 11/30/08 11/30/08 11/30/08 0.05 0.05 11/30/08 11/30/08 14:27 Sep 20, 2005 Jkt 205001 Goat, fat ............ Goat, meat ........ Goat, meat byproducts ........ Grape, wine ...... Hog, fat ............. Hog, meat ......... Hog, meat byproducts ........ Horse, fat .......... Horse, meat ...... Horse, meat byproducts ........ Lettuce, head .... Lettuce, leaf ...... Milk ................... Poultry, fat ........ Poultry, meat .... Poultry, meat byproducts ..... Sheep, fat ......... Sheep, meat ..... Sheep, meat byproducts ........ PO 00000 Frm 00044 Expiration/ Revocation Date * 0.05 0.05 11/30/08 11/30/08 0.05 6. 0 0.05 0.05 11/30/08 None 11/30/08 11/30/08 0.05 0.05 0.05 11/30/08 11/30/08 11/30/08 0.05 10.0 10.0 0.05 0.1 0.1 11/30/08 11/30/05 11/30/05 11/30/08 11/30/08 11/30/08 0.1 0.05 0.05 11/30/08 11/30/08 11/30/08 0.05 11/30/08 Fmt 4700 Sfmt 4700 §§ * Expiration/Revocation Date 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 * * 1/15/06 1/15/06 1/15/06 1/15/06 1/15/06 1/15/06 1/15/06 1/15/06 1/15/06 I Parts per million Commodity 0.7 0.5 0.7 3. Section 180.312 is amended by revising paragraph (a) to read as follows: Corn, field, forage .................................................................................................................................................. Corn, field, grain .................................................................................................................................................... Corn, field, stover .................................................................................................................................................. Corn, pop, grain ..................................................................................................................................................... Corn, pop, stover ................................................................................................................................................... Corn, sweet, forage ............................................................................................................................................... Corn, sweet, kernel plus cob with husks removed ............................................................................................... Corn, sweet, stover ................................................................................................................................................ Sunflower, seed ..................................................................................................................................................... * * * * 4. Section 180.380 is amended by revising paragraph (a) to read as follows: 0.7 0.7 0.5 0.75 0.5 0.7 0.75 0.75 0.5 * Parts per million * 0.7 I Commodity I Parts per million Commodity * 180.528 and 180.529 [Removed] 5. Sections 180.528 and 180.529 are removed. 6. Section 180.539 is amended by revising paragraph (a)(1) to read as follows: I §180.539 d-Limonene; tolerances for residues. (a) * * * (1) The insecticide dlimonene may be safely used in insectrepellent tablecloths and in insectrepellent strips used in food- or feedhandling establishments. * * * * * §§ 180.1003 and 180.1008 [Removed] 7. Sections 180.1003 and 180.1008 are removed. I [FR Doc. 05–18579 Filed 9–20–05; 8:45 am] BILLING CODE 6560–50–S E:\FR\FM\21SER1.SGM 21SER1 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP–2005–0160; FRL–7732–8] Cyhexatin; Tolerance Actions Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: EPA is revoking, under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(e)(1), all existing tolerances for residues of the insecticide/acaricide cyhexatin because they do not meet requirements of FFDCA section 408(b)(2). EPA canceled food use registrations for cyhexatin in 1989. Currently, EPA determined that acute dietary risks from use of cyhexatin on commodities for which import tolerances exist exceed the Agency’s level of concern. However, EPA also determined that if the only cyhexatin tolerance is for orange juice, there is a reasonable certainty that no harm to any population subgroup will result from exposure to cyhexatin treated oranges. Because manufacturers support a cyhexatin tolerance on orange juice for purposes of importation and the Agency has made a determination of safety for such a tolerance, EPA is establishing, concurrent with the revocation of the citrus fruit group tolerance, an individual time-limited tolerance on orange juice. The regulatory actions in this document contribute toward the Agency’s tolerance reassessment requirements of the FFDCA section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances in existence on August 2, 1996. The regulatory actions in this document pertain to the revocation of 41 tolerances which count as tolerance reassessments toward the August, 2006 review deadline. DATES: This regulation is effective September 21, 2005. Objections and requests for hearings must be received on or before November 21, 2005. ADDRESSES: To submit a written objection or hearing requestfollow the detailed instructions as provided in Unit IV. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under docket identification (ID) number OPP–2005– 0160. All documents in the docket are listed in the EDOCKET index at https:// www.epa.gov/edocket. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is VerDate Aug<31>2005 14:27 Sep 20, 2005 Jkt 205001 55269 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. B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using EDOCKET (https:// www.epa.gov/edocket/), you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at https:// www.gpoaccess.gov/ecfr/. FOR FURTHER INFORMATION CONTACT: A. What Action is the Agency Taking? In the Federal Register of July 27, 2005 (70 FR 43368) (FRL–7723–5), EPA issued a proposed rule to revoke all existing tolerances for residues of the insecticide/acaricide cyhexatin and establish a time-limited tolerance on orange juice. Also, the proposal of July 27, 2005 provided a 30–day comment period which invited public comment. In response to the proposal published in the Federal Register of July 27, 2005 (70 FR 43368), EPA received two comments during the 30–day public comment period, as follows: Comments by private citizens. A private citizen stated opposition to the sale and use of cyhexatin, and stated that cyhexatin tolerances should not be extended for use on any food commodity. Another private citizen asked whether the final rule actions would mean that any amount of cyhexatin could be used on imported foods. Agency response. Recently, EPA completed its Tolerance Reassessment Eligibility Decision (TRED) for cyhexatin. In the Federal Register of July 13, 2005 (70 FR 40341) (FRL–7720–3), EPA published a decision notice for the cyhexatin TRED. The TRED and documents in support of the TRED are available in Edocket ID number OPP– 2004–0295 at https://www.epa.gov/ edocket, and at https://www.epa.gov/ pesticides/reregistration/status.htm. Because there are no active U.S. registrations, human exposure to this pesticide is strictly through the consumption of treated imported foods. Residential and occupational exposures as well as dietary exposure through drinking water are not expected because there is no domestic use of cyhexatin. Because there have been no active U.S. registrations for cyhexatin since 1989, the comment on its sale and use is not relevant to this rulemaking. However, cyhexatin tolerances were maintained for purposes of importation. The commenters did not address EPA’s determination that acute dietary Joseph Nevola, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (703) 308– 8037; e-mail address: nevola.joseph@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 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 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. PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 II. Background E:\FR\FM\21SER1.SGM 21SER1 55270 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations exposure estimates for cyhexatin and orange juice only are below the Agency’s level of concern for all population subgroups and that a timelimited import tolerance for orange juice should be established. The commenters did not refer to any scientific studies or specific data that should be considered by the Agency. EPA determined that acute dietary risks from use of cyhexatin on commodities for which import tolerances exist exceed the Agency’s level of concern. Therefore, manufacturers had indicated that they would support only the import tolerances for apple (fresh, juice, sauce, and dried) and citrus (orange juice). However, the estimated acute dietary risks from use of cyhexatin on these commodities exceed the Agency’s level of concern. The assessment concluded that for apples and oranges, the acute dietary exposure estimate for children 12 years of age is at 223% of the acute population-adjusted dose (aPAD) at the 99.9th percentile; for all infants < 1–year of age at 187% of the aPAD, and for children 3-5 years of age at 151% of the aPAD. Apple juice and apple sauces were the risk drivers. Because of this acute dietary concern, manufacturers have withdrawn support for cyhexatin tolerances, except for orange juice. EPA has evaluated the dietary risks from the importation of orange juice concentrate to be processed into orange juice and has determined that there is reasonable certainty that no harm to any population subgroup will result from exposure to cyhexatin treated oranges. The acute dietary exposure estimates for orange juice only are below the Agency’s level of concern for all population subgroups. The most highly exposed sub-population was children 1-2 years of age, at 35% of the aPAD. Therefore, EPA is revoking all existing tolerances for residues of the insecticide/acaricide cyhexatin under FFDCA section 408(e)(1) because existing tolerances do not meet requirements of FFDCA section 408(b)(2). Specifically, EPA is revoking the tolerances in 40 CFR 180.144 for combined residues of cyhexatin and its organotin metabolites (calculated as cyhexatin) in or on the following food commodities: Almond; almond, hulls; apple; cattle, fat; cattle, kidney; cattle, liver; cattle, meat byproducts, except kidney and liver; cattle, meat; citrus, dried pulp; fruit, citrus; goat, fat; goat, kidney; goat, liver; goat, meat byproducts, except kidney and liver; goat, meat; hog, fat; hog, kidney; hog, liver; hog, meat byproducts, except VerDate Aug<31>2005 14:27 Sep 20, 2005 Jkt 205001 kidney and liver; hog, meat; hop; hop, dried cone; horse, fat; horse, kidney; horse, liver; horse, meat byproducts, except kidney and liver; horse, meat; milk, fat (=N in whole milk); nectarine; nut, macadamia; peach; pear; plum, prune, dried; plum, prune, fresh; sheep, fat; sheep, kidney; sheep, liver; sheep, meat byproducts, except kidney and liver; sheep, meat; strawberry; and walnut. However, concurrent with the revocation of the crop group tolerance on fruit, citrus in 40 CFR 180.144 at 2 parts per million (ppm), a tolerance on orange juice should be established at 0.1 ppm. Available processing data indicate that cyhexatin residues of concern in orange juice concentrate were less than the limit of quantitation; i.e., less than 0.1 ppm. Nevertheless, additional generic data is needed for EPA to confirm processing, analytical method, and toxicological data. Under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerance provide the necessary information. Therefore, EPA is establishing an individual timelimited tolerance in 40 CFR 180.144 for combined residues of cyhexatin and its organotin metabolites (calculated as cyhexatin) in orange, juice at 0.1 ppm with an expiration/revocation date of June 13, 2009; i.e., the time-limited tolerance will be established for a period of 4 years from the TRED completion date of June 13, 2005 in order to allow sufficient time for the Agency to issue a data call-in request, the manufacturers to submit the needed data, and for the Agency to review it. After reviewing the available data, EPA will decide whether there is sufficient data to support the orange juice tolerance as a permanent one. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue or allow the timelimited tolerance to expire. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore ‘‘adulterated’’ under section 402(a) of the FFDCA (21 U.S.C. 342(a)). Such food may not be distributed in interstate commerce (21 U.S.C. 331(a)). Food-use pesticides not registered in the United States must have tolerances in order for commodities treated with those pesticides to be imported into the United States. A printed copy of the cyhexatin TRED may be obtained from EPA’s National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 42419, Cincinnati, OH 45242–2419, telephone 1–800–490–9198; fax 1–513– 489–8695; internet at https:// www.epa.gov/ncepihom/ and from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 1– 800–553–6847 or (703) 605–6000; internet at https://www.ntis.gov/. An electronic copy of the cyhexatin TRED is available on the internet at https:// www.epa.gov/pesticides/reregistration/ status.htm. B. What is the Agency’s Authority for Taking this Action? EPA’s general practice is to revoke tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore, no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as ‘‘import tolerances,’’ are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse. C. When Do These Actions Become Effective? EPA is revoking specific cyhexatin tolerances and establishing a timelimited tolerance on orange juice effective on the date of publication of this final rule in the Federal Register. Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by the FQPA. Under this section, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration (FDA) that: (1) The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and (2) the residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance E:\FR\FM\21SER1.SGM 21SER1 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food. D. What is the Contribution to Tolerance Reassessment? By law, EPA is required by August 2006 to reassess the tolerances in existence on August 2, 1996. As of September 6, 2005, EPA has reassessed over 7,430 tolerances. This document revokes a total of 41 tolerances which are counted as tolerance reassessments toward the August 2006 review deadline of FFDCA section 408(q), as amended by FQPA in 1996. For counting purposes, the Agency counts the citrus fruit group tolerance as one revocation (where a time-limited tolerance on orange juice is established in its place). III. Are There Any International Trade Issues Raised by this Final Action? EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain in a Federal Register document the reasons for departing from the Codex level. EPA’s effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs. EPA has developed guidance concerning submissions for import tolerance support of June 1, 2000 (65 FR 35069) (FRL–6559–3). This guidance will be made available to interested persons. Electronic copies are available on the internet at https:// www.epa.gov/. On the Home Page select ‘‘Laws and Regulations,’’ then select ‘‘Regulations and Proposed Rules’’ and then look up the entry for this document under ‘‘Federal Register— Environmental Documents.’’ You can also go directly to the ‘‘Federal Register’’ listings at https:// www.epa.gov/fedrgstr/. IV. 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 VerDate Aug<31>2005 14:27 Sep 20, 2005 Jkt 205001 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. A. 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–2005–0160 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 21, 2005. 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 (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 14th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 55271 excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564–6255. 2. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IV.A.1., 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–2005–0160, 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 20460–0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via email 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. B. 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). V. Statutory and Executive Order Reviews In this final rule EPA revokes specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (i.e., a tolerance revocation for which extraordinary circumstances do not exist) 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, E:\FR\FM\21SER1.SGM 21SER1 55272 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 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 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 OMB review or any other 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 104–13, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this rule, the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with canceled pesticides. Furthermore, for the pesticides named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA’s previous analysis. 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 VerDate Aug<31>2005 14:27 Sep 20, 2005 Jkt 205001 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. VI. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et 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 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 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 9, 2005. James Jones, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.144 is amended by revising the table under paragraph (a) to read as follows: I § 180.144 Cyhexatin; tolerances for residues. (a) General. * * * Commodity Parts per million Orange, juice * * * Expiration/ Revocation Date 0.1 * 6/13/09 * [FR Doc. 05–18581 Filed 9–20–05; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP–2005–0221; FRL–7730–3] Reynoutria Sachalinensis Extract; Exemption from the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the biochemical pesticide Reynoutria sachalinensis extract on all food commodities. The Interregional Research Project Number 4 (IR-4), on behalf of KHH Bioscience, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), E:\FR\FM\21SER1.SGM 21SER1

Agencies

[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Rules and Regulations]
[Pages 55268-55272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18581]



[[Page 55269]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0160; FRL-7732-8]


Cyhexatin; Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is revoking, under the Federal Food, Drug, and Cosmetic 
Act (FFDCA) section 408(e)(1), all existing tolerances for residues of 
the insecticide/acaricide cyhexatin because they do not meet 
requirements of FFDCA section 408(b)(2). EPA canceled food use 
registrations for cyhexatin in 1989. Currently, EPA determined that 
acute dietary risks from use of cyhexatin on commodities for which 
import tolerances exist exceed the Agency's level of concern. However, 
EPA also determined that if the only cyhexatin tolerance is for orange 
juice, there is a reasonable certainty that no harm to any population 
subgroup will result from exposure to cyhexatin treated oranges. 
Because manufacturers support a cyhexatin tolerance on orange juice for 
purposes of importation and the Agency has made a determination of 
safety for such a tolerance, EPA is establishing, concurrent with the 
revocation of the citrus fruit group tolerance, an individual time-
limited tolerance on orange juice. The regulatory actions in this 
document contribute toward the Agency's tolerance reassessment 
requirements of the FFDCA section 408(q), as amended by the Food 
Quality Protection Act (FQPA) of 1996. By law, EPA is required by 
August 2006 to reassess the tolerances in existence on August 2, 1996. 
The regulatory actions in this document pertain to the revocation of 41 
tolerances which count as tolerance reassessments toward the August, 
2006 review deadline.

DATES: This regulation is effective September 21, 2005. Objections and 
requests for hearings must be received on or before November 21, 2005.

ADDRESSES: To submit a written objection or hearing requestfollow the 
detailed instructions as provided in Unit IV. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0160. All documents in the docket 
are listed in the EDOCKET index at https://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: Joseph Nevola, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8037; e-mail 
address: nevola.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 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 and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of July 27, 2005 (70 FR 43368) (FRL-7723-
5), EPA issued a proposed rule to revoke all existing tolerances for 
residues of the insecticide/acaricide cyhexatin and establish a time-
limited tolerance on orange juice. Also, the proposal of July 27, 2005 
provided a 30-day comment period which invited public comment.
    In response to the proposal published in the Federal Register of 
July 27, 2005 (70 FR 43368), EPA received two comments during the 30-
day public comment period, as follows:
    Comments by private citizens. A private citizen stated opposition 
to the sale and use of cyhexatin, and stated that cyhexatin tolerances 
should not be extended for use on any food commodity. Another private 
citizen asked whether the final rule actions would mean that any amount 
of cyhexatin could be used on imported foods.
    Agency response. Recently, EPA completed its Tolerance Reassessment 
Eligibility Decision (TRED) for cyhexatin. In the Federal Register of 
July 13, 2005 (70 FR 40341) (FRL-7720-3), EPA published a decision 
notice for the cyhexatin TRED. The TRED and documents in support of the 
TRED are available in Edocket ID number OPP-2004-0295 at https://
www.epa.gov/edocket, and at https://www.epa.gov/pesticides/
reregistration/status.htm. Because there are no active U.S. 
registrations, human exposure to this pesticide is strictly through the 
consumption of treated imported foods. Residential and occupational 
exposures as well as dietary exposure through drinking water are not 
expected because there is no domestic use of cyhexatin.
    Because there have been no active U.S. registrations for cyhexatin 
since 1989, the comment on its sale and use is not relevant to this 
rulemaking. However, cyhexatin tolerances were maintained for purposes 
of importation. The commenters did not address EPA's determination that 
acute dietary

[[Page 55270]]

exposure estimates for cyhexatin and orange juice only are below the 
Agency's level of concern for all population subgroups and that a time-
limited import tolerance for orange juice should be established. The 
commenters did not refer to any scientific studies or specific data 
that should be considered by the Agency.
    EPA determined that acute dietary risks from use of cyhexatin on 
commodities for which import tolerances exist exceed the Agency's level 
of concern. Therefore, manufacturers had indicated that they would 
support only the import tolerances for apple (fresh, juice, sauce, and 
dried) and citrus (orange juice). However, the estimated acute dietary 
risks from use of cyhexatin on these commodities exceed the Agency's 
level of concern. The assessment concluded that for apples and oranges, 
the acute dietary exposure estimate for children 1-2 years of age is at 
223% of the acute population-adjusted dose (aPAD) at the 
99.9th percentile; for all infants < 1-year of age at 187% 
of the aPAD, and for children 3-5 years of age at 151% of the aPAD. 
Apple juice and apple sauces were the risk drivers.
    Because of this acute dietary concern, manufacturers have withdrawn 
support for cyhexatin tolerances, except for orange juice. EPA has 
evaluated the dietary risks from the importation of orange juice 
concentrate to be processed into orange juice and has determined that 
there is reasonable certainty that no harm to any population subgroup 
will result from exposure to cyhexatin treated oranges. The acute 
dietary exposure estimates for orange juice only are below the Agency's 
level of concern for all population subgroups. The most highly exposed 
sub-population was children 1-2 years of age, at 35% of the aPAD.
    Therefore, EPA is revoking all existing tolerances for residues of 
the insecticide/acaricide cyhexatin under FFDCA section 408(e)(1) 
because existing tolerances do not meet requirements of FFDCA section 
408(b)(2).
    Specifically, EPA is revoking the tolerances in 40 CFR 180.144 for 
combined residues of cyhexatin and its organotin metabolites 
(calculated as cyhexatin) in or on the following food commodities: 
Almond; almond, hulls; apple; cattle, fat; cattle, kidney; cattle, 
liver; cattle, meat byproducts, except kidney and liver; cattle, meat; 
citrus, dried pulp; fruit, citrus; goat, fat; goat, kidney; goat, 
liver; goat, meat byproducts, except kidney and liver; goat, meat; hog, 
fat; hog, kidney; hog, liver; hog, meat byproducts, except kidney and 
liver; hog, meat; hop; hop, dried cone; horse, fat; horse, kidney; 
horse, liver; horse, meat byproducts, except kidney and liver; horse, 
meat; milk, fat (=N in whole milk); nectarine; nut, macadamia; peach; 
pear; plum, prune, dried; plum, prune, fresh; sheep, fat; sheep, 
kidney; sheep, liver; sheep, meat byproducts, except kidney and liver; 
sheep, meat; strawberry; and walnut.
    However, concurrent with the revocation of the crop group tolerance 
on fruit, citrus in 40 CFR 180.144 at 2 parts per million (ppm), a 
tolerance on orange juice should be established at 0.1 ppm. Available 
processing data indicate that cyhexatin residues of concern in orange 
juice concentrate were less than the limit of quantitation; i.e., less 
than 0.1 ppm. Nevertheless, additional generic data is needed for EPA 
to confirm processing, analytical method, and toxicological data. Under 
FFDCA section 408(f), if the Agency determines that additional 
information is reasonably required to support the continuation of a 
tolerance, EPA may require that parties interested in maintaining the 
tolerance provide the necessary information. Therefore, EPA is 
establishing an individual time-limited tolerance in 40 CFR 180.144 for 
combined residues of cyhexatin and its organotin metabolites 
(calculated as cyhexatin) in orange, juice at 0.1 ppm with an 
expiration/revocation date of June 13, 2009; i.e., the time-limited 
tolerance will be established for a period of 4 years from the TRED 
completion date of June 13, 2005 in order to allow sufficient time for 
the Agency to issue a data call-in request, the manufacturers to submit 
the needed data, and for the Agency to review it. After reviewing the 
available data, EPA will decide whether there is sufficient data to 
support the orange juice tolerance as a permanent one. If the requisite 
information is not submitted, EPA may issue an order revoking the 
tolerance at issue or allow the time-limited tolerance to expire.
    Without a tolerance or exemption, food containing pesticide 
residues is considered to be unsafe and therefore ``adulterated'' under 
section 402(a) of the FFDCA (21 U.S.C. 342(a)). Such food may not be 
distributed in interstate commerce (21 U.S.C. 331(a)). Food-use 
pesticides not registered in the United States must have tolerances in 
order for commodities treated with those pesticides to be imported into 
the United States.
    A printed copy of the cyhexatin TRED may be obtained from EPA's 
National Service Center for Environmental Publications (EPA/NSCEP), 
P.O. Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; 
fax 1-513-489-8695; internet at https://www.epa.gov/ncepihom/ and from 
the National Technical Information Service (NTIS), 5285 Port Royal 
Road, Springfield, VA 22161, telephone 1-800-553-6847 or (703) 605-
6000; internet at https://www.ntis.gov/. An electronic copy of the 
cyhexatin TRED is available on the internet at https://www.epa.gov/
pesticides/reregistration/status.htm.

B. What is the Agency's Authority for Taking this Action?

    EPA's general practice is to revoke tolerances for residues of 
pesticide active ingredients on crops for which FIFRA registrations no 
longer exist and on which the pesticide may therefore, no longer be 
used in the United States. EPA has historically been concerned that 
retention of tolerances that are not necessary to cover residues in or 
on legally treated foods may encourage misuse of pesticides within the 
United States. Nonetheless, EPA will establish and maintain tolerances 
even when corresponding domestic uses are canceled if the tolerances, 
which EPA refers to as ``import tolerances,'' are necessary to allow 
importation into the United States of food containing such pesticide 
residues. However, where there are no imported commodities that require 
these import tolerances, the Agency believes it is appropriate to 
revoke tolerances for unregistered pesticides in order to prevent 
potential misuse.

C. When Do These Actions Become Effective?

    EPA is revoking specific cyhexatin tolerances and establishing a 
time-limited tolerance on orange juice effective on the date of 
publication of this final rule in the Federal Register.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this final rule, and that 
are in the channels of trade following the tolerance revocations, shall 
be subject to FFDCA section 408(1)(5), as established by the FQPA. 
Under this section, any residues of these pesticides in or on such food 
shall not render the food adulterated so long as it is shown to the 
satisfaction of the Food and Drug Administration (FDA) that: (1) The 
residue is present as the result of an application or use of the 
pesticide at a time and in a manner that was lawful under FIFRA, and 
(2) the residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under a 
tolerance

[[Page 55271]]

or exemption from tolerance. Evidence to show that food was lawfully 
treated may include records that verify the dates that the pesticide 
was applied to such food.

D. What is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006 to reassess the tolerances 
in existence on August 2, 1996. As of September 6, 2005, EPA has 
reassessed over 7,430 tolerances. This document revokes a total of 41 
tolerances which are counted as tolerance reassessments toward the 
August 2006 review deadline of FFDCA section 408(q), as amended by FQPA 
in 1996. For counting purposes, the Agency counts the citrus fruit 
group tolerance as one revocation (where a time-limited tolerance on 
orange juice is established in its place).

III. Are There Any International Trade Issues Raised by this Final 
Action?

    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. When possible, EPA seeks 
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain in a Federal Register document the 
reasons for departing from the Codex level. EPA's effort to harmonize 
with Codex MRLs is summarized in the tolerance reassessment section of 
individual REDs. EPA has developed guidance concerning submissions for 
import tolerance support of June 1, 2000 (65 FR 35069) (FRL-6559-3). 
This guidance will be made available to interested persons. Electronic 
copies are available on the internet at https://www.epa.gov/. On the 
Home Page select ``Laws and Regulations,'' then select ``Regulations 
and Proposed Rules'' and then look up the entry for this document under 
``Federal Register--Environmental Documents.'' You can also go directly 
to the ``Federal Register'' listings at https://www.epa.gov/fedrgstr/.

IV. 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.

A. 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-2005-0160 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 
21, 2005.
    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 (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 14th St., 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.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IV.A.1., 
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-2005-0160, 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-
0001. In person or by courier, bring a 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.

B. 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).

V. Statutory and Executive Order Reviews

    In this final rule EPA revokes specific tolerances established 
under FFDCA section 408. The Office of Management and Budget (OMB) has 
exempted this type of action (i.e., a tolerance revocation for which 
extraordinary circumstances do not exist) 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,

[[Page 55272]]

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 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 OMB review or any other 
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 104-13, section 12(d) 
(15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency previously assessed whether 
revocations of tolerances might significantly impact a substantial 
number of small entities and concluded that, as a general matter, these 
actions do not impose a significant economic impact on a substantial 
number of small entities. This analysis was published on December 17, 
1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy 
of the Small Business Administration. Taking into account this 
analysis, and available information concerning the pesticides listed in 
this rule, the Agency hereby certifies that this final rule will not 
have a significant economic impact on a substantial number of small 
entities. Specifically, as per the 1997 notice, EPA has reviewed its 
available data on imports and foreign pesticide usage and concludes 
that there is a reasonable international supply of food not treated 
with canceled pesticides. Furthermore, for the pesticides named in this 
final rule, the Agency knows of no extraordinary circumstances that 
exist as to the present revocations that would change EPA's previous 
analysis. 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.

VI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et 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 9, 2005.
James Jones,
Director, 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 180.144 is amended by revising the table under paragraph (a) 
to read as follows:


Sec.   180.144 Cyhexatin; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
Orange, juice                                           0.1      6/13/09
------------------------------------------------------------------------

* * * * *
[FR Doc. 05-18581 Filed 9-20-05; 8:45 am]
BILLING CODE 6560-50-S
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