Ethyl Maltol; Exemption from the Requirement of a Tolerance, 37688-37692 [05-12920]

Download as PDF 37688 Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Rules and Regulations ‘‘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. IX. 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: June 21, 2005. Lois Rossi, Director, Registration Division, 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. § 180.532 [Amended] 2. In § 180.532, in the table to paragraph (a)(2), amend the entries for ‘‘Onion, dry bulb’’; ‘‘Onion, green’’; and I VerDate jul<14>2003 15:12 Jun 29, 2005 Jkt 205001 ‘‘Strawberry’’ by revising the expiration date ‘‘12/31/04’’ to read ‘‘12/31/07.’’ [FR Doc. 05–12921 Filed 6–29–05; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 I. General Information [OPP–2005–0153; FRL–7717–1] A. Does this Action Apply to Me? Ethyl Maltol; 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 2-ethyl-3hydroxy- 4H-pyran-4-one, also known as ethyl maltol when used as an inert ingredient in or on growing crops, when applied to raw agricultural commodities after harvest, or to animals. Firmenich Incorporated 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 ethyl maltol. DATES: This regulation is effective June 30, 2005. Objections and requests for hearings must be received on or before August 29, 2005. ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit XI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP–2005– 0153. All documents in the docket are listed in the EDOCKET index at http:/ /www.epa.gov/edocket. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305–5805. PO 00000 Frm 00042 Fmt 4700 FOR FURTHER INFORMATION CONTACT: Princess Campbell, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–8033; e-mail address: campbell.princess@epa.gov. SUPPLEMENTARY INFORMATION: Sfmt 4700 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 (http:/ /www.epa.gov/edocket/), you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http:// www.gpoaccess.gov/ecfr/. II. Background and Statutory Findings In the Federal Register of December 20, 2000 (65 FR 79834) (FRL–6751–9), 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 6E4758) by Firmenich Incorporated, P.O. 5880, Princeton, NJ 08543. The petition requested that 40 CFR 180.1001(c) and (e), re-designated as 40 CFR 180.910 and 40 CFR 180.930, respectively (69 FR 23113, April 28, 2004 (FRL–7335–4)), be E:\FR\FM\30JNR1.SGM 30JNR1 Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Rules and Regulations amended by establishing an exemption from the requirement of a tolerance for residues of ethyl maltol (CAS Reg. No. 4940–11–8) when used as an inert ingredient. This notice included a summary of the petition prepared by the petitioner, Firmenich Incorporated. There were no comments received in response to the notice of filing. In later correspondence with the Agency, the petitioner, Firmenich Incorporated, offered to accept a limitation for ethyl maltol of not more than 0.2% of the formulated product. The tolerance exemption established today includes that limitation. 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 tolerance is ‘‘safe.’’ Section 408(c)(2)(A)(ii) defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. 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 requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. 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. carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ‘‘inert’’ is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. TOXICITY DATA FOR ETHYL MALTOL— Continued IV. Toxicological Profile Consistent with section 408(b)(2)(D) of 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. The nature of the toxic effects caused by ethyl maltol are discussed in this unit. A. Toxicity Data The following table summarizes the toxicological aspects of ethyl maltol. Even though the studies which yielded the data were not conducted in accordance with the Agency guidelines, and lacked some experimental details, the studies appear to be well conducted. Thus, the results of these studies can be used for regulatory purposes. In addition to using the toxicity data, the Agency also conducted a Structure Activity Relationship (SAR) analysis for ethyl maltol. This analysis supports the conclusions suggested by the toxicity data, namely, that ethyl maltol poses a low concern for adverse effects on human health. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as VerDate jul<14>2003 15:12 Jun 29, 2005 Jkt 205001 37689 PO 00000 TOXICITY DATA FOR ETHYL MALTOL Study Study Result 90–Day subchronic oral toxicity (dogs) Dose = 0, 125, 250, or 500 mg/kg/day NOAEL ≥ 500 mg/ kg/day (highest dose tested (HDT)) LOAEL = not observed but would be > 500 mg/kg/ day 2–year chronic oral toxicity (rats) Dose= 0, 50, 100, or 200 mg/kg/day NOAEL ≥ 200 mg/ kg/day LOAEL = not observed but would be > 200 mg/kg/ day 2–year chronic toxicity (dogs) Dose= 0, 50, 100, or 200 mg/kg/day NOAEL ≥ 200 mg/ kg/day LOAEL = not observed but would be > 200 mg/kg/ day Reproduction and fertility effects Parental/Systemic NOAEL ≥ 200 mg/ kg/day Parental/Systemic LOAEL = not observed but would be > 200 mg/kg/ day No significant treatment related effects on fertility, gestation, parturition, lactation, or fetal development. Carcinogenicity rats no evidence of carcinogenicity Carcinogenicity mice no evidence of carcinogenicity Gene Mutation Ames (5 strains of S. typhimurium) non-mutagenic Gene MutationDrosophila no increase in sex linked recessive lethal mutations Gene Mutationmouse micronucleus no increase in polynucleated cells Metabolism and pharmacokinetics 64% of the 10 mg/ kg total dose excreted within 24 hours Result Acute oral toxicity mice (male) Dose= 5% Lethal Dose (LD) 50 = 780 milligram/ kilogram/day (mg/ kg/day) Acute oral toxicity rats (male) Dose = 10% LD 50 = 1,150 mg/ kg/day Acute oral toxicity rats (female) Dose = 10% LD 50 = 1,200 mg/ kg/day B. Structure Activity Relationship 90–Day subchronic oral toxicity (rats) Dose = 0, 250, 500, or 1,000 mg/kg/ day NOAEL = 250 mg/ kg/day LOAEL = 500 mg/ kg/day Toxicity for ethyl maltol was assessed, in part, by a process called SAR. In this process, the chemical’s structural similarity to other chemicals (for which data are available) is used to determine toxicity. For human health, this process, can be used to assess Frm 00043 Fmt 4700 Sfmt 4700 E:\FR\FM\30JNR1.SGM 30JNR1 37690 Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Rules and Regulations absorption and metabolism, mutagenicity, carcinogenicity, developmental and reproductive effects, neurotoxicity, systemic effects, immunotoxicity, and sensitization and irritation. This is a qualitative assessment using terms such as good, not likely, poor, moderate, or high. Ethyl maltol is not absorbed from the skin if it is not in solution, and moderately absorbed from the skin if it is in solution based on physio-chemical properties (pchem). It is absorbed from the lung and GI tract based on data from surrogate chemicals. There is an uncertain concern for mutagenicity. Overall, health concern is rated as low. C. Regulatory Characterizations of Toxicity by Other Governmental Organizations The Food and Drug Administration has classified ethyl maltol as GRAS (generally recognized as safe) for use as a direct food additive as a flavoring agent (21 CFR 172.515-Synthetic Flavoring Substances and Adjuvants). In 1970, the Joint Food and Agricultural Organization of the United Nations/ World Health Organization (FAO/WHO) Expert Committee on Food Additives established a group ADI (Acceptable Daily Intake) of 0-2mg/kg-bodyweight (bw) for ethyl maltol (http:// www.inchem.org/documents/jecfa/ jecmono/v048aje01.htm) D. Conclusions Ethyl maltol is a member of a class of chemicals known as flavor enhancers. It is almost completely absorbed from the gut and appears in the urine as gluconamide or sulfate within two hours. The toxicity data in the previous Table was used to assess the toxicity of ethyl maltol. The acute oral LD50 values which ranged from 780 mg/kg and 1,270 mg/kg place ethyl maltol in Toxicity Category III. EPA categorizes acute toxicity as I, II, III, or IV, with Category IV being the Agency’s lowest level of acute toxicity. Also, there were no effects observed on the skin of rabbits when ethyl maltol was used at a dose of 5,000 mg/kg. The report from the structure activity team (SAT) cites an uncertain concern for mutagenicity. This uncertainty was based on positive dose-related activity against only one Salmonella strain (TA 100), but the mutagenic effects were not reproducible. Given the lack of reproducibility, ethyl maltol was classified as non-mutagenic in the Ames test. The SAR assessment did not indicate any concerns for carcinogenicity, developmental or reproductive concerns. The available repeated dose VerDate jul<14>2003 15:12 Jun 29, 2005 Jkt 205001 toxicity studies have NOAELs that are equal to or greater than 200 mg/kg/day. V. Aggregate Exposures In examining aggregate exposure, FFDCA section 408 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 1. Food. Ethyl maltol has been used in foodstuffs as a flavoring agent since the 1950’s. Ethyl maltol is estimated to have a per capita daily intake of 0.0045 mg/ kg from use as a food additive (http:// www.inchem.org/documents/jecfa/ jecmono/v048aje01.htm). Using a 60 kg person the daily intake becomes 0.27 mg/day, based on ethyl maltol’s use as a food additive. The use of ethyl maltol as an inert ingredient in a pesticide product, especially considering the limitation of no more than 0.2% of the formulated product, should not significantly increase this estimate. 2. Drinking water exposure. The SAT report states that migration of ethyl maltol to ground water is moderate to rapid. Ethyl maltol has an estimated water solubility of 1.5 to 24 grams/Liter (g/L), a volatilization half-life of 81 hours in rivers and 41 days in lakes, and biodegrades rapidly. Based on biodegradation models and on the SAT’s professional judgement, ethyl maltol undergoes primary (partial) aerobic biodegradation in days to weeks, and is completely biodegraded in weeks. The biodegradability estimate and Henry’s Law Constant suggest that the residence time of ethyl maltol in surface waters is controlled by the biodegradation rate and not the rate of volatilization. Ethyl maltol has the potential to be mobile in soil, but if released to aerobic soils its migration would be mitigated by biodegradation. If it enters anaerobic soils (as in a landfill leachate scenario) biodegradation would be expected to be somewhat slower but still relatively rapid. Therefore, significant concentrations of ethyl maltol are very unlikely in sources of drinking water. B. Other Non-Occupational Exposure Ethyl maltol is used as a flavor enhancer for cigarettes, antiseptics, and perfumes. Because use as a flavoring substance generally constitutes such a low percentage of the formulation exposure is likely to be minimal. PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 VI. Cumulative Effects Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to the above chemical substances and any other substances. Ethyl maltol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that this chemical substance has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/ pesticides/cumulative/. VII. Safety Factor for Infants and Children FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data unless EPA concludes that a different margin of safety will be safe for infants and children. For ethyl maltol, based on the expected minimal oral toxicity, as demonstrated by toxicity studies with NOAELs greater than 200 mg/kg/day, the available toxicity data which indicates no significant treatment related effects on fertility, gestation, parturition, lactation, or fetal development, EPA has not used a safety factor analysis to assess the risk. For the same reasons a tenfold safety factor is unnecessary. VIII. Determination of Safety for U.S. Population Based on its review and evaluation of the available data on toxicity and exposure, and considering the 0.2% limitation in the formulation offered by the petitioner, EPA finds that exempting ethyl maltol (CAS Reg. No. 4940–11–8) E:\FR\FM\30JNR1.SGM 30JNR1 Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Rules and Regulations from the requirement of a tolerance will be safe for the general population including infants and children. IX. Other Considerations A. Endocrine Disruptors FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect. EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing ethyl maltol for endocrine effects may be required. B. Analytical Method An analytical method is not required for tolerance enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance. C. Existing Tolerances There are no existing tolerance exemptions for ethyl maltol. D. International Tolerances The Agency is not aware of any country requiring a tolerance for ethyl maltol nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time. X. Conclusions Therefore, EPA is establishing a tolerance exemption for ethyl maltol (CAS Reg. No. 4940–11–8) with a limitation in the pesticide formulation of not more than 0.2%. XI. Objections and Hearing Requests Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to ‘‘object’’ to a regulation for an exemption from the requirement of a tolerance issued by EPA under new VerDate jul<14>2003 15:12 Jun 29, 2005 Jkt 205001 section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days. 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–2005–0153 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 29, 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 XI.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–2005–0153, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 37691 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: oppdocket@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). XII. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 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, E:\FR\FM\30JNR1.SGM 30JNR1 37692 Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Rules and Regulations entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the 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 FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any ‘‘tribal implications’’ as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.’’ ‘‘Policies that have tribal implications’’ is defined in the Executive Order to include regulations that have ‘‘substantial direct effects on one or more Indian tribes, on the relationship between the Federal VerDate jul<14>2003 15:12 Jun 29, 2005 Jkt 205001 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. XIII. Congressional Review Act Inert ingredients Limits * * * * Ethyl maltol (CAS Reg. No.4940–11–8) * * * * Uses * * * Not more Odor than mask0.2 % ing of the agent pesticide formulation * * * * * * * * 3. In § 180.930 the table is amended by adding alphabetically the following inert ingredient to read as follows: I 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). § 180.930 Inert ingredients applied to animals; exemption from the requirement of a tolerance. List of Subjects in 40 CFR Part 180 BILLING CODE 6560–50–S Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 20, 2005. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I * * * Inert ingredients Limits * * * * Ethyl maltol (CAS Reg. No.4940–11–8) * * * * * * * * Uses * * * Not more Odor than mask0.2 % ing of the agent pesticide formulation * * * * [FR Doc. 05–12920 Filed 6–29–05; 8:45 am] ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP–2005–0143; FRL–7722–3] Extension of Tolerances for Emergency Exemptions (Multiple Chemicals) Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation extends timelimited tolerances for the pesticides listed in Unit II. of the SUPPLEMENTARY I 1. The authority citation for part 180 INFORMATION. These actions are in continues to read as follows: response to EPA’s granting of emergency Authority: 21 U.S.C. 321(q), 346a and 371. exemptions under section 18 of the Federal Insecticide, Fungicide, and I 2. In § 180.910 the table is amended by adding alphabetically the following inert Rodenticide Act (FIFRA) authorizing use of these pesticides. Section 408(l)(6) ingredient to read as follows: of the Federal Food, Drug, and Cosmetic § 180.910 Inert ingredients used pre- and Act (FFDCA) requires EPA to establish PART 180—[AMENDED] post-harvest; exemption from the requirement of a tolerance. PO 00000 * * * Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\30JNR1.SGM 30JNR1

Agencies

[Federal Register Volume 70, Number 125 (Thursday, June 30, 2005)]
[Rules and Regulations]
[Pages 37688-37692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12920]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0153; FRL-7717-1]


Ethyl Maltol; 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 2-ethyl-3-hydroxy- 4H-pyran-4-one, also 
known as ethyl maltol when used as an inert ingredient in or on growing 
crops, when applied to raw agricultural commodities after harvest, or 
to animals. Firmenich Incorporated 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 ethyl 
maltol.

DATES: This regulation is effective June 30, 2005. Objections and 
requests for hearings must be received on or before August 29, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0153. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Princess Campbell, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8033; e-mail address: 
campbell.princess@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 (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of December 20, 2000 (65 FR 79834) (FRL-
6751-9), 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 6E4758) by Firmenich Incorporated, P.O. 5880, 
Princeton, NJ 08543. The petition requested that 40 CFR 180.1001(c) and 
(e), re-designated as 40 CFR 180.910 and 40 CFR 180.930, respectively 
(69 FR 23113, April 28, 2004 (FRL-7335-4)), be

[[Page 37689]]

amended by establishing an exemption from the requirement of a 
tolerance for residues of ethyl maltol (CAS Reg. No. 4940-11-8) when 
used as an inert ingredient. This notice included a summary of the 
petition prepared by the petitioner, Firmenich Incorporated. There were 
no comments received in response to the notice of filing.
    In later correspondence with the Agency, the petitioner, Firmenich 
Incorporated, offered to accept a limitation for ethyl maltol of not 
more than 0.2% of the formulated product. The tolerance exemption 
established today includes that limitation.
    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 tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. 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 requires EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. 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. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of 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. The nature of the toxic effects caused by ethyl 
maltol are discussed in this unit.

A. Toxicity Data

    The following table summarizes the toxicological aspects of ethyl 
maltol. Even though the studies which yielded the data were not 
conducted in accordance with the Agency guidelines, and lacked some 
experimental details, the studies appear to be well conducted. Thus, 
the results of these studies can be used for regulatory purposes. In 
addition to using the toxicity data, the Agency also conducted a 
Structure Activity Relationship (SAR) analysis for ethyl maltol. This 
analysis supports the conclusions suggested by the toxicity data, 
namely, that ethyl maltol poses a low concern for adverse effects on 
human health.

                     Toxicity Data for Ethyl Maltol
------------------------------------------------------------------------
                   Study                               Result
------------------------------------------------------------------------
Acute oral toxicity mice (male)             Lethal Dose (LD) 50 = 780
Dose= 5%..................................   milligram/kilogram/day (mg/
                                             kg/day)
------------------------------------------------------------------------
Acute oral toxicity rats (male)             LD 50 = 1,150 mg/kg/day
Dose = 10%................................
------------------------------------------------------------------------
Acute oral toxicity rats (female)           LD 50 = 1,200 mg/kg/day
Dose = 10%................................
------------------------------------------------------------------------
90-Day subchronic oral toxicity (rats)      NOAEL = 250 mg/kg/day
Dose = 0, 250, 500, or 1,000 mg/kg/day....  LOAEL = 500 mg/kg/day
------------------------------------------------------------------------
90-Day subchronic oral toxicity (dogs)      NOAEL >= 500 mg/kg/day
Dose = 0, 125, 250, or 500 mg/kg/day......   (highest dose tested (HDT))
                                            LOAEL = not observed but
                                             would be > 500 mg/kg/day
------------------------------------------------------------------------
2-year chronic oral toxicity (rats)         NOAEL >= 200 mg/kg/day
Dose= 0, 50, 100, or 200 mg/kg/day........  LOAEL = not observed but
                                             would be > 200 mg/kg/day
------------------------------------------------------------------------
2-year chronic toxicity (dogs)              NOAEL >= 200 mg/kg/day
Dose= 0, 50, 100, or 200 mg/kg/day........  LOAEL = not observed but
                                             would be > 200 mg/kg/day
------------------------------------------------------------------------
Reproduction and fertility effects          Parental/Systemic NOAEL >=
                                             200 mg/kg/day
                                            Parental/Systemic LOAEL =
                                             not observed but would be >
                                             200 mg/kg/day
                                            No significant treatment
                                             related effects on
                                             fertility, gestation,
                                             parturition, lactation, or
                                             fetal development.
------------------------------------------------------------------------
Carcinogenicity rats                        no evidence of
                                             carcinogenicity
------------------------------------------------------------------------
Carcinogenicity mice                        no evidence of
                                             carcinogenicity
------------------------------------------------------------------------
Gene Mutation - Ames (5 strains of S.       non-mutagenic
 typhimurium)
------------------------------------------------------------------------
Gene Mutation- Drosophila                   no increase in sex linked
                                             recessive lethal mutations
------------------------------------------------------------------------
Gene Mutation- mouse micronucleus           no increase in polynucleated
                                             cells
------------------------------------------------------------------------
Metabolism and pharmacokinetics             64% of the 10 mg/kg total
                                             dose excreted within 24
                                             hours
------------------------------------------------------------------------

B. Structure Activity Relationship

    Toxicity for ethyl maltol was assessed, in part, by a process 
called SAR. In this process, the chemical's structural similarity to 
other chemicals (for which data are available) is used to determine 
toxicity. For human health, this process, can be used to assess

[[Page 37690]]

absorption and metabolism, mutagenicity, carcinogenicity, developmental 
and reproductive effects, neurotoxicity, systemic effects, 
immunotoxicity, and sensitization and irritation. This is a qualitative 
assessment using terms such as good, not likely, poor, moderate, or 
high.
    Ethyl maltol is not absorbed from the skin if it is not in 
solution, and moderately absorbed from the skin if it is in solution 
based on physio-chemical properties (pchem). It is absorbed from the 
lung and GI tract based on data from surrogate chemicals. There is an 
uncertain concern for mutagenicity. Overall, health concern is rated as 
low.

C. Regulatory Characterizations of Toxicity by Other Governmental 
Organizations

    The Food and Drug Administration has classified ethyl maltol as 
GRAS (generally recognized as safe) for use as a direct food additive 
as a flavoring agent (21 CFR 172.515-Synthetic Flavoring Substances and 
Adjuvants). In 1970, the Joint Food and Agricultural Organization of 
the United Nations/World Health Organization (FAO/WHO) Expert Committee 
on Food Additives established a group ADI (Acceptable Daily Intake) of 
0-2mg/kg-bodyweight (bw) for ethyl maltol (http://www.inchem.org/
documents/jecfa/jecmono/v048aje01.htm)

D. Conclusions

    Ethyl maltol is a member of a class of chemicals known as flavor 
enhancers. It is almost completely absorbed from the gut and appears in 
the urine as gluconamide or sulfate within two hours. The toxicity data 
in the previous Table was used to assess the toxicity of ethyl maltol. 
The acute oral LD50 values which ranged from 780 mg/kg and 
1,270 mg/kg place ethyl maltol in Toxicity Category III. EPA 
categorizes acute toxicity as I, II, III, or IV, with Category IV being 
the Agency's lowest level of acute toxicity. Also, there were no 
effects observed on the skin of rabbits when ethyl maltol was used at a 
dose of 5,000 mg/kg.
    The report from the structure activity team (SAT) cites an 
uncertain concern for mutagenicity. This uncertainty was based on 
positive dose-related activity against only one Salmonella strain (TA 
100), but the mutagenic effects were not reproducible. Given the lack 
of reproducibility, ethyl maltol was classified as non-mutagenic in the 
Ames test.
    The SAR assessment did not indicate any concerns for 
carcinogenicity, developmental or reproductive concerns. The available 
repeated dose toxicity studies have NOAELs that are equal to or greater 
than 200 mg/kg/day.

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 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

    1. Food. Ethyl maltol has been used in foodstuffs as a flavoring 
agent since the 1950's. Ethyl maltol is estimated to have a per capita 
daily intake of 0.0045 mg/kg from use as a food additive (http://
www.inchem.org/documents/jecfa/jecmono/v048aje01.htm). Using a 60 kg 
person the daily intake becomes 0.27 mg/day, based on ethyl maltol's 
use as a food additive. The use of ethyl maltol as an inert ingredient 
in a pesticide product, especially considering the limitation of no 
more than 0.2% of the formulated product, should not significantly 
increase this estimate.
    2. Drinking water exposure. The SAT report states that migration of 
ethyl maltol to ground water is moderate to rapid. Ethyl maltol has an 
estimated water solubility of 1.5 to 24 grams/Liter (g/L), a 
volatilization half-life of 81 hours in rivers and 41 days in lakes, 
and biodegrades rapidly. Based on biodegradation models and on the 
SAT's professional judgement, ethyl maltol undergoes primary (partial) 
aerobic biodegradation in days to weeks, and is completely biodegraded 
in weeks. The biodegradability estimate and Henry's Law Constant 
suggest that the residence time of ethyl maltol in surface waters is 
controlled by the biodegradation rate and not the rate of 
volatilization. Ethyl maltol has the potential to be mobile in soil, 
but if released to aerobic soils its migration would be mitigated by 
biodegradation. If it enters anaerobic soils (as in a landfill leachate 
scenario) biodegradation would be expected to be somewhat slower but 
still relatively rapid. Therefore, significant concentrations of ethyl 
maltol are very unlikely in sources of drinking water.

B. Other Non-Occupational Exposure

    Ethyl maltol is used as a flavor enhancer for cigarettes, 
antiseptics, and perfumes. Because use as a flavoring substance 
generally constitutes such a low percentage of the formulation exposure 
is likely to be minimal.

VI. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to the above chemical 
substances and any other substances. Ethyl maltol does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
this chemical substance has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://
www.epa.gov/pesticides/cumulative/.

VII. Safety Factor for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data unless EPA concludes that a different 
margin of safety will be safe for infants and children. For ethyl 
maltol, based on the expected minimal oral toxicity, as demonstrated by 
toxicity studies with NOAELs greater than 200 mg/kg/day, the available 
toxicity data which indicates no significant treatment related effects 
on fertility, gestation, parturition, lactation, or fetal development, 
EPA has not used a safety factor analysis to assess the risk. For the 
same reasons a tenfold safety factor is unnecessary.

VIII. Determination of Safety for U.S. Population

    Based on its review and evaluation of the available data on 
toxicity and exposure, and considering the 0.2% limitation in the 
formulation offered by the petitioner, EPA finds that exempting ethyl 
maltol (CAS Reg. No. 4940-11-8)

[[Page 37691]]

from the requirement of a tolerance will be safe for the general 
population including infants and children.

IX. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect. EPA has been working with interested 
stakeholders to develop a screening and testing program as well as a 
priority setting scheme. As the Agency proceeds with implementation of 
this program, further testing of products containing ethyl maltol for 
endocrine effects may be required.

B. Analytical Method

    An analytical method is not required for tolerance enforcement 
purposes since the Agency is establishing an exemption from the 
requirement of a tolerance.

C. Existing Tolerances

    There are no existing tolerance exemptions for ethyl maltol.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
ethyl maltol nor have any CODEX Maximum Residue Levels (MRLs) been 
established for any food crops at this time.

X. Conclusions

    Therefore, EPA is establishing a tolerance exemption for ethyl 
maltol (CAS Reg. No. 4940-11-8) with a limitation in the pesticide 
formulation of not more than 0.2%.

XI. Objections and Hearing Requests

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

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-2005-0153 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before August 
29, 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 XI.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-2005-0153, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in 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).

XII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). 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,

[[Page 37692]]

entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the 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 FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XIII. 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: June 20, 2005.

Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.910 the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


Sec.  180.910   Inert ingredients used pre- and post-harvest; exemption 
from the requirement of a tolerance.

    * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Ethyl maltol (CAS Reg. No.4940-   Not more than 0.2   Odor masking agent
 11-8)                             % of the
                                   pesticide
                                   formulation
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
0
3. In Sec.  180.930 the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemption from the 
requirement of a tolerance.

    * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Ethyl maltol (CAS Reg. No.4940-   Not more than 0.2   Odor masking agent
 11-8)                             % of the
                                   pesticide
                                   formulation
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-12920 Filed 6-29-05; 8:45 am]
BILLING CODE 6560-50-S