Alternaria destruens Strain 059; Exemption from the Requirement of a Tolerance, 28455-28459 [05-9903]

Download as PDF Federal Register / Vol. 70, No. 95 / Wednesday, May 18, 2005 / Rules and Regulations 40 CFR Part 180 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–0455; e-mail address: milofsky.tessa@epa.gov. [OPP–2005–0048; FRL–7708–3] SUPPLEMENTARY INFORMATION: Alternaria destruens Strain 059; Exemption from the Requirement of a Tolerance I. General Information ENVIRONMENTAL PROTECTION AGENCY Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the microbial pesticide Alternaria destruens Strain 059 (also referred to in this document as A. destruens) on all agricultural commodities when applied/used in accordance with label directions. Loveland Products 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), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of A. destruens. This regulation is effective May 18, 2005. Objections and requests for hearings must be received on or before July 18, 2005. ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP–2005– 0048. 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: Tessa Milofsky, Biopesticides and Pollution Prevention Division (7511C), Environmental Protection Agency, 1200 DATES: VerDate jul<14>2003 16:58 May 17, 2005 Jkt 205001 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 code 111) • Animal production (NAICS code 112) • Food manufacturing (NAICS code 311) • Pesticide manufacturing (NAICS code 32532) 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 and Statutory Findings In the Federal Register of January 17, 2001 (66 FR 4017) (FRL–6755–1), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 0F6191) by Loveland Products, Inc, 419 18th Street, Greenley, CO 80632–1286. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Alternaria destruens Strain 059. This notice included a summary of the petition prepared by the petitioner Loveland Products, Inc. There were no comments PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 28455 received in response to the notice of filing. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(2)(A)(ii) of the FFDCA defines ‘‘safe ’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require 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 * * *.’’ Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider ‘‘available information concerning the cumulative effects of a particular pesticide’s residues ’’ and ‘‘other substances that have a common mechanism of toxicity.’’ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information 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. Alternaria destruens Strain 059 is toxic to several Cuscuta species including dodder, swamp dodder, largeseed dodder, field dodder, and smallseed dodder. This fungal pathogen is well-characterized, naturallyoccurring, and has been isolated in the E:\FR\FM\18MYR1.SGM 18MYR1 28456 Federal Register / Vol. 70, No. 95 / Wednesday, May 18, 2005 / Rules and Regulations United States, from fields located in Wisconsin and Massachusetts. Results of the acute toxicology, pathogenicity, and irritation studies required of the petitioner under FFDCA section 408(d)(2)(A), in support of the petition for an exemption from the requirement of a tolerance for A. destruens Strain 059, indicate that the fungus is nontoxic, non-pathogenic, non-irritating to skin, and minimally irritating to eyes. Tests performed by Loveland Products, Inc. and cited in support of its food tolerance exemption petition are summarized below: 1. Acute oral toxicity - Rat (OPPTS Guideline 870.1100) MRID 451664–02: Test material: Alternaria destruens Strain 059. Test dose: 1 x 107 CFU/ animal. Result: No mortality, no observable abnormalities on necropsy, and minor clinical signs (hair loss in one male, colored material around nose on a second male, and reduced fecal production in one female) with complete symptom clearance by day seven. The pesticide was classified as Toxicity Category IV for acute oral toxicity (C. Etsitty/J. Kough memorandum to S. Matten, 10/25/02 (hereafter referred to as BPPD Review 10/25/02)). 2. Acute pulmonary toxicity / pathogenicity - Rat (OPPTS Guideline 885.3150) MRID 451664–03: Test material: Alternaria destruens Strain 059. Test dose: 5.0 x 105 CFU/animal. Result: Strain 059 was shown to be nontoxic, non-infective, and non-pathogenic to rats when administered intratracheally at 5.0 x 105 CFU/animal. Rats exhibited rales, colored material around nose/eyes, anogenital staining, few feces, labored breathing, and/or rough hair coat after dosing, however full recovery was seen within six days of test administration. Four test animals died following exposure and rats sacrificed on days three, seven, or 14, exhibited lungs with multifocal areas of congestion and consolidation, mottled colored areas, and enlargement. These symptoms are characteristic of an immune response and are considered normal when test material is delivered using this vehicle of exposure (BPPD Review - 10/25/02). 3. Acute injection toxicity / pathogenicity - Rat (OPPTS Guideline 885.3200) MRID 451664–04: Test material: Alternaria destruens Strain 059. Test dose: 9.6 x 106 CFU/animal. Result: No mortality lethal dose ((LD)50 > 9.6 x 106 CFU per animal). Following exposure to A. destruens, rats exhibited soiled hair coat, emission of colored material around the nose, anogenital staining, and soft/few/no feces for up to eight days following test material VerDate jul<14>2003 16:58 May 17, 2005 Jkt 205001 administration. Gross necropsy provided evidence of an inflammatory response to the test substance in the form of multiple adhesions associated with liver, spleen, diaphragm, stomach, and/or testes/ovaries. Some males exhibited one or more of the following: Enlarged testis, small testis, lump in the scrotum, subcutaneous lump, multiple adhesions and nodular masses associated with the testes. Subcutaneous lumps and/or multiple nodules in the abdominal cavity were noted in some females. Adhesions and lumps identified in the abdominal and peritoneal area are indicative of an inflammatory response to administration of the test material and are considered normal (BPPD Review 10/25/02). 4. Acute dermal toxicity - Rat (OPPTS 870.1200) MRID 451664–05: Test material: Alternaria destruens Strain 059. Test dose: 5,000 milligrams/ kilogram (mg/kg) of animal weight. Result: No mortality (LD50 > 5,000 mg/ kg animal weight), no observable abnormalities on necropsy. The pesticide is considered non-toxic and is therefore classified as Toxicity Category IV for acute dermal toxicity. 5. Acute inhalation toxicity - Rats (OPPTS 870.1300) MRID 451664–06: Test material: Alternaria destruens Strain 059. Test dose: 2.03 mg/liter (L). Result: No mortality (LD50 > 2.03 mg/L). Ocular and nasal discharge, hunched posture, and hypoactivity were noted during exposure. Upon removal from the exposure chamber, rats exhibited ocular and/or nasal discharge. Full recovery was noted within 17 hours of test completion. The acute lethal dose (LC50) was greater than 2.03 mg/L. The pesticide is considered non-irritating and is therefore classified as Toxicity Category IV for acute inhalation toxicity. 6. Primary eye irritation - Rabbits (OPPTS 870.2400) MRID 451664–07: Test material: Alternaria destruens Strain 059. Test dose: 0.1 gram (g)/ animal. Result: No corneal opacity or iritis. All test animals showed an initial positive conjunctival irritation response to A. destruens. Full resolution was seen within 48 hours of test administration. The pesticide is considered to be minimally irritating and is therefore classified as Toxicity Category III for primary eye irritation. 7. Primary dermal irritation - Rabbits (OPPTS 870.2500) MRID 451664–08: Test material: Alternaria destruens Strain 059. Test dose: 0.5 g/animal. Result: No dermal irritation was noted. The test substance was found to be nonirritating. The pesticide is considered non-irritating and is PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 therefore classified as Toxicity Category IV for primary dermal irritation. 8. Hypersensitivity study - (OPPTS 870.2600) Test material: Not applicable (N/A). Test dose: N/A. Result: Loveland Products, Inc. submitted a request for a data waiver of this study. A waiver was granted due to the following considerations: i. The non-toxicity and low irritation potential of the test substance, as demonstrated by acute oral, acute dermal, acute pulmonary, injection toxicity/pathogenicity, and dermal irritation studies; ii. Few opportunities for exposure via dermal and inhalation routes; and iii. No documented reports of hypersensitivity incidents during production and testing of the active ingredient and end use product. 9. Immune response study - (OPPTS 885.3800) Test material: N/A. Test dose: N/A. Result: Loveland Products, Inc. submitted a request for a data waiver of this study. The submitted acute toxicity and pathogenicity studies demonstrated that A. destruens is not toxic, infective, or pathogenic to test animals. This finding justifies the data waiver request. Therefore, the Agency waived the data requirement for immune response testing. IV. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure Alternaria destruens may be applied early-season, as a granular formulation that is sprinkled on soil, or mid- to lateseason as a foliar spray on fruit and vegetable crops. Proposed use sites include vegetables, fruits, field crops, and nonagricultural areas such as uncultivated rights-of-way, roadsides, and fallow areas. 1. Food. Because of the proposed use of A. destruens on food crops, fungal residues may be present on agricultural commodities. However, negligible to no risk is expected for the general population, including infants and children, because A. destruens demonstrated no pathogenicity or oral toxicity at the maximum doses tested (see Unit III of this document). 2. Drinking water exposure. Alternaria destruens does not thrive in aquatic E:\FR\FM\18MYR1.SGM 18MYR1 Federal Register / Vol. 70, No. 95 / Wednesday, May 18, 2005 / Rules and Regulations environments and there are no aquatic use sites for the pesticide. Although cranberry is listed as a use site, the product may only be applied to dry bogs. Accordingly, application of this pesticide to agricultural crops is not expected to increase drinking water exposure to A. destruens. Furthermore, any material that is consumed through drinking water would pose negligible to no risk for the general population, including infants and children, due to the pesticide’s low toxicity classification (see Unit III of this document). B. Other Non-Occupational Exposure Alternaria destruens will be applied to agricultural fields and dry bogs. Since these application sites are not generally located near residential areas, there will be little opportunity for nonoccupational exposures to A. destruens. Moreover, in the unlikely event of such exposure, no harm would be expected due to the active ingredient’s low toxicity classification. V. Cumulative Effects Section 408(b)(2)(D)(v) of FFDCA requires the Agency, when considering whether to establish, modify, or revoke a tolerance, to consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ These considerations include the possible cumulative effects of such residues on infants and children. Due to the overall minimal toxicity and nonpathogenicity of the active ingredient, cumulative effects from the residues of this product are not anticipated. VI. Determination of Safety for U.S. Population, Infants and Children There is a reasonable certainty that no harm to the U.S. population, including infants and children, will result from aggregate exposure to residues of A. destruens due to its use as a microbial pest control agent. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed in Unit III, above, A. destruens is minimally toxic, non-pathogenic, and non-infective to mammals. Accordingly, exempting A. destruens from the requirement of a tolerance is considered safe and poses no significant risks. FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of exposure (safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity VerDate jul<14>2003 16:58 May 17, 2005 Jkt 205001 and exposure, unless EPA determines that a different margin of exposure (safety) will be safe for infants and children. Margins of exposure (safety), which often are referred to as uncertainty factors, are incorporated into EPA risk assessment either directly or through the use of a margin of exposure analysis or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk. Actual exposures to adults and children through diet are expected to be several orders of magnitude less than the doses used in the toxicity and pathogenicity tests referenced in Unit III of this document. Thus, the Agency has determined that an additional margin of safety for infants and children is unnecessary. VII. Other Considerations A. Endocrine Disruptors EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) ‘‘may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate.’’ Alternaria destruens is not a known endocrine disruptor nor is it related to any class of known endocrine disruptors. Consequently, endocrinerelated concerns did not adversely impact the Agency’s safety finding for A. destruens. B. Analytical Method(s) The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation for the reasons stated above, including the active ingredient’s low mammalian toxicity. Alternaria destruens is a common and naturallyoccurring fungus. There is likelihood of prior exposure for some individuals and exposure to this fungus is not expected to increase dramatically though use of the pesticide in approved use sites. For these reasons, an analytical method is not required. C. Codex Maximum Residue Level There is no Codex Alimentarium Commission Maximum Residue Level for A. destruens. VIII. Conclusions There is no evidence of adverse effects from oral, dermal, or inhalation exposure to this microbial agent (see Unit III of this document), nor is A. destruens expected to disrupt hormone or endocrine systems. Further, A. PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 28457 destruens is not expected to negatively impact the quality of drinking water. Consequently, there is reasonable certainty that no harm to the U.S. population, including infants and children, will result from aggregate exposure to residues of A. destruens. IX. 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, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the 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 the FFDCA, as was provided in the old sections 408 and 409 of the 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–2005–0048 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 July 18, 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 E:\FR\FM\18MYR1.SGM 18MYR1 28458 Federal Register / Vol. 70, No. 95 / Wednesday, May 18, 2005 / Rules and Regulations 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 VIII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP–2005–0048, 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). X. Statutory and Executive Order Reviews This final rule establishes an exemption from the requirement of tolerance under section 408(d) of the FFDCA in response to a petition VerDate jul<14>2003 16:58 May 17, 2005 Jkt 205001 submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption 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 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 ‘‘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 the 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. XI. 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, E:\FR\FM\18MYR1.SGM 18MYR1 Federal Register / Vol. 70, No. 95 / Wednesday, May 18, 2005 / Rules and Regulations Agricultural commodities, Pesticides and pests, Reporting and record keeping requirements. Dated: May 5, 2005. James Jones, Director, Office of Pesticide Programs. contact Umeki Gray Thorne, Office of Governmentwide Policy, Travel Management Policy, at (202) 208–7636. Please cite FTR Amendment 2005–03; FTR case 2005–304. SUPPLEMENTARY INFORMATION: A. Background I Therefore, 40 CFR chapter I is The changes in this final rule clarify amended as follows: existing sections of chapters 301 and 304 as follows: PART 180—[AMENDED] 1. In section 301–2.5(a) ‘‘premiumclass’’ is replaced with ‘‘first-class or I 1. The authority citation for part 180 business-class’’. continues to read as follows: 2. In section 301–10.106(b) ‘‘premium Authority: 21 U.S.C. 321(q), 346a and 371. class’’ is replaced with ‘‘business-class’’. I 2. Section 180.1256 is added to subpart 3. In section 301–10.121 an D to read as follows: introductory paragraph is added and the § 180.1256 Alternaria destruens Strain 059; definition of ‘‘coach-class’’ is revised; the term and definition of ‘‘premiumExemption from the Requirement of a class’’ is deleted; the term and Tolerance definition of ‘‘business-class’’ is added; An exemption from the requirement of a tolerance is established for residues the definition of ‘‘first-class’’ is revised; the term and definition of ‘‘premiumof the microbial pesticide Alternaria destruens Strain 059 when used in or on class other than first-class’’ is deleted; and the definition of ‘‘single-class’’ is all raw agricultural commodities when moved from paragraph (e) to paragraph applied/used in accordance with label (d). directions. 4. In section 301–10.123 the [FR Doc. 05–9903 Filed 5–17–05; 8:45 am] introductory paragraph is revised and in BILLING CODE 6560–50–S paragraph (a) ‘‘premium-class other than first-class’’ is replaced with ‘‘businessclass’’. 5. In section 301–10.124 the section GENERAL SERVICES heading and the note to section 301– ADMINISTRATION 10.124 ‘‘premium-class other than first41 CFR Parts 301–2, 301–10, 301–11, class’’ is replaced with ‘‘business-class’’. 301–13, 301–50, 301–70, 301–71, 304–3, In section 301–10.124 ‘‘premium-class’’ and 304–5 is replaced with ‘‘first-class and [FTR Amendment 2005–03; FTR Case 2005– business-class’’. 6. In section 301–11.20(a)(4) ‘‘less 304] than premium-class’’ is replaced with RIN 3090–AI10 ‘‘coach-class’’. 7. In section 301–13.3(f) ‘‘premiumFederal Travel Regulation; class’’ is replaced with ‘‘first-class’’ and Transportation Expenses ‘‘business-class’’. 8. Section 301–50.6(a)(2) is revised. AGENCY: Office of Governmentwide 9. Section 301–70.102(b)(1) is revised. Policy, General Services Administration 10. In section 301–71.105(a) (GSA). ‘‘premium-class’’ is replaced with ‘‘firstACTION: Final rule. class or business-class’’. 11. In Appendix C to Chapter 301— SUMMARY: The General Services Standard Data Elements for Federal Administration (GSA) is amending the Travel, the phrases ‘‘premium class’’ Federal Travel Regulation (FTR), by and ‘‘Non-premium class’’ are replaced clarifying various provisions regarding with the phrases ‘‘first-class and temporary duty (TDY) travel. The business class’’ and ‘‘Non-first-class and explanation of changes is addressed in Non-business-class’’ respectively, the supplementary information below. wherever they appear. The FTR and any corresponding 12. In section 304–3.9 ‘‘premium-class documents may be accessed at GSA’s other than first-class common carrier’’ is website at https://www.gsa.gov/ftr. replaced with ‘‘business-class’’. DATES: Effective Date: May 18, 2005. 13. In section 304–5.5 ‘‘premium FOR FURTHER INFORMATION CONTACT: The other than first-class’’ is replaced with Regulatory Secretariat (VIR), Room ‘‘business-class’’. 4035, GS Building, Washington, DC, B. Executive Order 12866 20405, (202) 208–7312, for information pertaining to status or publication This is not a significant regulatory schedules. For clarification of content, action and, therefore, was not subject to VerDate jul<14>2003 16:58 May 17, 2005 Jkt 205001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 28459 review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804. C. Regulatory Flexibility Act This final rule is not required to be published in the Federal Register for notice and comment; therefore, the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., does not apply. D. Paperwork Reduction Act The Paperwork Reduction Act does not apply because the changes to the FTR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq. E. Small Business Regulatory Enforcement Fairness Act This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel. List of Subjects in 41 CFR Parts 301–2, 301–10, 301–11, 301–13, 301–50, 301– 70, 301–71, 304–3, and 304–5. Government employees, Travel and transportation expenses. Dated: May 5, 2005. Stephen A. Perry, Administrator of General Services. For the reasons set forth in the preamble, under 5 U.S.C. 5701–5709, GSA amends 41 CFR parts 301–2, 301– 10, 301–11, 301–13, 301–50, 301–70, 301–71, 304–3, and 304–5 as set forth below: I CHAPTER 301—TEMPORARY DUTY (TDY) TRAVEL ALLOWANCES PART 301–2—GENERAL RULES 1. The authority citation for 41 CFR part 301–2 continues to read as follows: I Authority: 5 U.S.C. 5707, 31 U.S.C. 1353; 49 U.S.C. 40118. § 301–2.5 [Amended] 2. Amend § 301–2.5(a) by removing ‘‘premium-class service’’ and adding ‘‘first-class or business-class service’’ in its place. I PART 301–10—TRANSPORTATION EXPENSES 3. The authority citation for 41 CFR part 301–10 is revised to read as follows: I Authority: 5 U.S.C. 5707, 40 U.S.C. 121(c); 49 U.S.C. 40118, Office of Management and Budget Circular No. A–126, ‘‘Improving the E:\FR\FM\18MYR1.SGM 18MYR1

Agencies

[Federal Register Volume 70, Number 95 (Wednesday, May 18, 2005)]
[Rules and Regulations]
[Pages 28455-28459]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9903]



[[Page 28455]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0048; FRL-7708-3]


Alternaria destruens Strain 059; Exemption from the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the microbial pesticide Alternaria 
destruens Strain 059 (also referred to in this document as A. 
destruens) on all agricultural commodities when applied/used in 
accordance with label directions. Loveland Products 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), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of A. destruens.

DATES: This regulation is effective May 18, 2005. Objections and 
requests for hearings must be received on or before July 18, 2005.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0048. 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:  Tessa Milofsky, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0455; e-mail address: milofsky.tessa@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 code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    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 and Statutory Findings

    In the Federal Register of January 17, 2001 (66 FR 4017) (FRL-6755-
1), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 0F6191) by Loveland Products, Inc, 419 18th Street, 
Greenley, CO 80632-1286. The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of Alternaria destruens Strain 059. This notice 
included a summary of the petition prepared by the petitioner Loveland 
Products, Inc. There were no comments received in response to the 
notice of filing.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA 
defines ``safe '' to mean that ``there is a reasonable certainty that 
no harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which require 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 * * *.'' 
Additionally, section 408(b)(2)(D) of the FFDCA requires that the 
Agency consider ``available information concerning the cumulative 
effects of a particular pesticide's residues '' and ``other substances 
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity, completeness, and 
reliability and the relationship of this information 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.
    Alternaria destruens Strain 059 is toxic to several Cuscuta species 
including dodder, swamp dodder, largeseed dodder, field dodder, and 
smallseed dodder. This fungal pathogen is well-characterized, 
naturally-occurring, and has been isolated in the

[[Page 28456]]

United States, from fields located in Wisconsin and Massachusetts. 
Results of the acute toxicology, pathogenicity, and irritation studies 
required of the petitioner under FFDCA section 408(d)(2)(A), in support 
of the petition for an exemption from the requirement of a tolerance 
for A. destruens Strain 059, indicate that the fungus is non-toxic, 
non-pathogenic, non-irritating to skin, and minimally irritating to 
eyes.
    Tests performed by Loveland Products, Inc. and cited in support of 
its food tolerance exemption petition are summarized below:
    1. Acute oral toxicity - Rat (OPPTS Guideline 870.1100) MRID 
451664-02: Test material: Alternaria destruens Strain 059. Test dose: 1 
x 107 CFU/animal. Result: No mortality, no observable 
abnormalities on necropsy, and minor clinical signs (hair loss in one 
male, colored material around nose on a second male, and reduced fecal 
production in one female) with complete symptom clearance by day seven. 
The pesticide was classified as Toxicity Category IV for acute oral 
toxicity (C. Etsitty/J. Kough memorandum to S. Matten, 10/25/02 
(hereafter referred to as BPPD Review - 10/25/02)).
    2. Acute pulmonary toxicity / pathogenicity - Rat (OPPTS Guideline 
885.3150) MRID 451664-03: Test material: Alternaria destruens Strain 
059. Test dose: 5.0 x 105 CFU/animal. Result: Strain 059 was 
shown to be non-toxic, non-infective, and non-pathogenic to rats when 
administered intratracheally at 5.0 x 105 CFU/animal. Rats 
exhibited rales, colored material around nose/eyes, anogenital 
staining, few feces, labored breathing, and/or rough hair coat after 
dosing, however full recovery was seen within six days of test 
administration. Four test animals died following exposure and rats 
sacrificed on days three, seven, or 14, exhibited lungs with multifocal 
areas of congestion and consolidation, mottled colored areas, and 
enlargement. These symptoms are characteristic of an immune response 
and are considered normal when test material is delivered using this 
vehicle of exposure (BPPD Review - 10/25/02).
    3. Acute injection toxicity / pathogenicity - Rat (OPPTS Guideline 
885.3200) MRID 451664-04: Test material: Alternaria destruens Strain 
059. Test dose: 9.6 x 106 CFU/animal. Result: No mortality 
lethal dose ((LD)50 > 9.6 x 106 CFU per animal). 
Following exposure to A. destruens, rats exhibited soiled hair coat, 
emission of colored material around the nose, anogenital staining, and 
soft/few/no feces for up to eight days following test material 
administration. Gross necropsy provided evidence of an inflammatory 
response to the test substance in the form of multiple adhesions 
associated with liver, spleen, diaphragm, stomach, and/or testes/
ovaries. Some males exhibited one or more of the following: Enlarged 
testis, small testis, lump in the scrotum, subcutaneous lump, multiple 
adhesions and nodular masses associated with the testes. Subcutaneous 
lumps and/or multiple nodules in the abdominal cavity were noted in 
some females. Adhesions and lumps identified in the abdominal and 
peritoneal area are indicative of an inflammatory response to 
administration of the test material and are considered normal (BPPD 
Review - 10/25/02).
    4. Acute dermal toxicity - Rat (OPPTS 870.1200) MRID 451664-05: 
Test material: Alternaria destruens Strain 059. Test dose: 5,000 
milligrams/kilogram (mg/kg) of animal weight. Result: No mortality 
(LD50 > 5,000 mg/kg animal weight), no observable 
abnormalities on necropsy. The pesticide is considered non-toxic and is 
therefore classified as Toxicity Category IV for acute dermal toxicity.
    5. Acute inhalation toxicity - Rats (OPPTS 870.1300) MRID 451664-
06: Test material: Alternaria destruens Strain 059. Test dose: 2.03 mg/
liter (L). Result: No mortality (LD50 > 2.03 mg/L). Ocular 
and nasal discharge, hunched posture, and hypoactivity were noted 
during exposure. Upon removal from the exposure chamber, rats exhibited 
ocular and/or nasal discharge. Full recovery was noted within 17 hours 
of test completion. The acute lethal dose (LC50) was greater 
than 2.03 mg/L. The pesticide is considered non-irritating and is 
therefore classified as Toxicity Category IV for acute inhalation 
toxicity.
    6. Primary eye irritation - Rabbits (OPPTS 870.2400) MRID 451664-
07: Test material: Alternaria destruens Strain 059. Test dose: 0.1 gram 
(g)/animal. Result: No corneal opacity or iritis. All test animals 
showed an initial positive conjunctival irritation response to A. 
destruens. Full resolution was seen within 48 hours of test 
administration. The pesticide is considered to be minimally irritating 
and is therefore classified as Toxicity Category III for primary eye 
irritation.
    7. Primary dermal irritation - Rabbits (OPPTS 870.2500) MRID 
451664-08: Test material: Alternaria destruens Strain 059. Test dose: 
0.5 g/animal. Result: No dermal irritation was noted. The test 
substance was found to be nonirritating. The pesticide is considered 
non-irritating and is therefore classified as Toxicity Category IV for 
primary dermal irritation.
    8. Hypersensitivity study - (OPPTS 870.2600) Test material: Not 
applicable (N/A). Test dose: N/A. Result: Loveland Products, Inc. 
submitted a request for a data waiver of this study. A waiver was 
granted due to the following considerations:
    i. The non-toxicity and low irritation potential of the test 
substance, as demonstrated by acute oral, acute dermal, acute 
pulmonary, injection toxicity/pathogenicity, and dermal irritation 
studies;
    ii. Few opportunities for exposure via dermal and inhalation 
routes; and
    iii. No documented reports of hypersensitivity incidents during 
production and testing of the active ingredient and end use product.
    9. Immune response study - (OPPTS 885.3800) Test material: N/A. 
Test dose: N/A. Result: Loveland Products, Inc. submitted a request for 
a data waiver of this study. The submitted acute toxicity and 
pathogenicity studies demonstrated that A. destruens is not toxic, 
infective, or pathogenic to test animals. This finding justifies the 
data waiver request. Therefore, the Agency waived the data requirement 
for immune response testing.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).

A. Dietary Exposure

    Alternaria destruens may be applied early-season, as a granular 
formulation that is sprinkled on soil, or mid- to late-season as a 
foliar spray on fruit and vegetable crops. Proposed use sites include 
vegetables, fruits, field crops, and nonagricultural areas such as 
uncultivated rights-of-way, roadsides, and fallow areas.
    1. Food. Because of the proposed use of A. destruens on food crops, 
fungal residues may be present on agricultural commodities. However, 
negligible to no risk is expected for the general population, including 
infants and children, because A. destruens demonstrated no 
pathogenicity or oral toxicity at the maximum doses tested (see Unit 
III of this document).
    2. Drinking water exposure. Alternaria destruens does not thrive in 
aquatic

[[Page 28457]]

environments and there are no aquatic use sites for the pesticide. 
Although cranberry is listed as a use site, the product may only be 
applied to dry bogs. Accordingly, application of this pesticide to 
agricultural crops is not expected to increase drinking water exposure 
to A. destruens. Furthermore, any material that is consumed through 
drinking water would pose negligible to no risk for the general 
population, including infants and children, due to the pesticide's low 
toxicity classification (see Unit III of this document).

B. Other Non-Occupational Exposure

    Alternaria destruens will be applied to agricultural fields and dry 
bogs. Since these application sites are not generally located near 
residential areas, there will be little opportunity for non-
occupational exposures to A. destruens. Moreover, in the unlikely event 
of such exposure, no harm would be expected due to the active 
ingredient's low toxicity classification.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires the Agency, when 
considering whether to establish, modify, or revoke a tolerance, to 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and `` other substances that have a 
common mechanism of toxicity.'' These considerations include the 
possible cumulative effects of such residues on infants and children. 
Due to the overall minimal toxicity and non-pathogenicity of the active 
ingredient, cumulative effects from the residues of this product are 
not anticipated.

VI. Determination of Safety for U.S. Population, Infants and Children

    There is a reasonable certainty that no harm to the U.S. 
population, including infants and children, will result from aggregate 
exposure to residues of A. destruens due to its use as a microbial pest 
control agent. This includes all anticipated dietary exposures and all 
other exposures for which there is reliable information. As discussed 
in Unit III, above, A. destruens is minimally toxic, non-pathogenic, 
and non-infective to mammals. Accordingly, exempting A. destruens from 
the requirement of a tolerance is considered safe and poses no 
significant risks.
    FFDCA section 408(b)(2)(C) provides that EPA shall apply an 
additional tenfold margin of exposure (safety) for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure, 
unless EPA determines that a different margin of exposure (safety) will 
be safe for infants and children. Margins of exposure (safety), which 
often are referred to as uncertainty factors, are incorporated into EPA 
risk assessment either directly or through the use of a margin of 
exposure analysis or by using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk. Actual 
exposures to adults and children through diet are expected to be 
several orders of magnitude less than the doses used in the toxicity 
and pathogenicity tests referenced in Unit III of this document. Thus, 
the Agency has determined that an additional margin of safety for 
infants and children is unnecessary.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of the FFDCA, as amended by 
FQPA, to develop a screening program to determine whether certain 
substances (including all pesticide active and other ingredients) ``may 
have an effect in humans that is similar to an effect produced by a 
naturally-occurring estrogen, or other such endocrine effects as the 
Administrator may designate.'' Alternaria destruens is not a known 
endocrine disruptor nor is it related to any class of known endocrine 
disruptors. Consequently, endocrine-related concerns did not adversely 
impact the Agency's safety finding for A. destruens.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement 
of a tolerance without any numerical limitation for the reasons stated 
above, including the active ingredient's low mammalian toxicity. 
Alternaria destruens is a common and naturally-occurring fungus. There 
is likelihood of prior exposure for some individuals and exposure to 
this fungus is not expected to increase dramatically though use of the 
pesticide in approved use sites. For these reasons, an analytical 
method is not required.

C. Codex Maximum Residue Level

    There is no Codex Alimentarium Commission Maximum Residue Level for 
A. destruens.

VIII. Conclusions

    There is no evidence of adverse effects from oral, dermal, or 
inhalation exposure to this microbial agent (see Unit III of this 
document), nor is A. destruens expected to disrupt hormone or endocrine 
systems. Further, A. destruens is not expected to negatively impact the 
quality of drinking water. Consequently, there is reasonable certainty 
that no harm to the U.S. population, including infants and children, 
will result from aggregate exposure to residues of A. destruens.

IX. 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the 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 the FFDCA, as was provided in the old sections 408 and 409 of the 
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-2005-0048 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 July 18, 
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

[[Page 28458]]

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 VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2005-0048, 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).

X. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of 
tolerance under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the 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.

XI. 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,

[[Page 28459]]

Agricultural commodities, Pesticides and pests, Reporting and record 
keeping requirements.


    Dated: May 5, 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 180.1256 is added to subpart D to read as follows:


Sec.  180.1256  Alternaria destruens Strain 059; Exemption from the 
Requirement of a Tolerance

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Alternaria destruens Strain 059 
when used in or on all raw agricultural commodities when applied/used 
in accordance with label directions.

[FR Doc. 05-9903 Filed 5-17-05; 8:45 am]
BILLING CODE 6560-50-S
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