Sodium 1,4-Dialkyl Sulfosuccinates; Exemption from the Requirement of a Tolerance, 32433-32437 [E9-16086]

Download as PDF Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321–4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2–1, paragraph (34)(h), of the Instruction. This rule involves implementation of regulations within 33 CFR part 100 that apply to organized marine events on the navigable waters of the United States that may have potential for negative impact on the safety or other interests of waterway users and shore side activities in the event area. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, and sailboard racing. Under figure 2–1, paragraph (34)(h), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. 32433 For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows: ■ PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: ■ Authority: 33 U.S.C. 1233. 2. In the Table to § 100.501: ■ a. Suspend line No. 41 from July 12, 2009 to July 31, 2009; and ■ b. From 9 a.m. to 5:30 p.m., on July 12, 2009, add line No. 63. The addition reads as follows: ■ § 100.501. Special Local Regulations; Marine Events in the Fifth Coast Guard District. * * * * * Table to § 100.501.—All coordinates listed in the Table to § 100.501 reference Datum NAD 1983. COAST GUARD SECTOR HAMPTON ROADS—COTP ZONE Number Date * 63 ......... Event * * Watermen’s Heritage Festival Workboat Races. July 12, 2009 Dated: June 24, 2009. Fred M. Rosa, Jr., Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District. [FR Doc. E9–16063 Filed 7–2–09; 4:15 pm] BILLING CODE 4910–15–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2008–0739; FRL–8423–3] sroberts on DSKD5P82C1PROD with RULES Sodium 1,4-Dialkyl Sulfosuccinates; 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 sodium 1,4- VerDate Nov<24>2008 16:30 Jul 07, 2009 Jkt 217001 Sponsor * Watermen’s Museum of Yorktown, VA. Location * * * The waters of the York River, Yorktown, Virginia, bounded on the west by a line drawn along longitude 076°31′25″ W, bounded on the east by a line drawn along longitude 076°30′55″ W, bounded on the south by the shoreline and bounded on the north by a line drawn parallel and 400 yards north of the southern shoreline. dialkyl sulfosuccinates including sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006–15–3); sodium 1,4– diisobutyl sulfosuccinate (CAS Reg. No. 127–39–9); and sodium 1,4–dipentyl sulfosuccinate (CAS Reg. No. 922–80–5) when used as inert ingredients in pesticide formulations applied to growing crops. The Joint Inerts Task Force (JITF), Cluster Support Team Number 13 submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of sodium 1,4–dialkyl sulfosuccinates. DATES: This regulation is effective July 8, 2009. Objections and requests for hearings must be received on or before September 8, 2009, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2008–0739. All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (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 in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The E:\FR\FM\08JYR1.SGM 08JYR1 32434 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–8811; e-mail address: leifer.kerry@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 those engaged in the following activities: • 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 to provide 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. sroberts on DSKD5P82C1PROD with RULES B. How Can I Access Electronic Copies of this Document? In addition to accessing electronically available documents at https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR cite at https://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at https:// www.epa.gpo/opptsfrs/home/ guidelin.htm. VerDate Nov<24>2008 16:30 Jul 07, 2009 Jkt 217001 C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2008–0739 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 as required by 40 CFR part 178 on or before September 8, 2009. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA– HQ–OPP–2008–0738, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Background In the Federal Register of December 3, 2008 (73 FR 73640) (FRL–8390–4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8E7423) by The Joint Inerts Task Force (JITF), Cluster Support Team Number 23 (CST 13), c/ o CropLife America, 1156 15th Street, N.W., Suite 400, Washington, DC 20005. The petition was subsequently redesignated as PP 8E7422. The petition requested that 40 CFR 180.920 be amended by establishing an exemption PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 from the requirement of a tolerance for residues of the inert ingredients sodium 1,4-dialkyl sulfosuccinates including sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006–15–3); sodium 1,4diisobutyl sulfosuccinate (CAS Reg. No. 127–39–9); and sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922–80–5) (these substances are also collectively referred to throughout this document as SDSS). That notice referenced a summary of the petition prepared by the JITF CST 13, the petitioner which is available to the public in the docket, https://www.regulations.gov. There were no substantive comments received in response to the notice of filing. This petition was submitted in response to a final rule of August 9, 2006, (71 FR 45415) (FRL–8084–1) in which the Agency revoked, under section 408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA), the existing exemptions from the requirement of a tolerance for residues of certain inert ingredients because of insufficient data to make the determination of safety required by FFDCA section 408(b)(2). The expiration date for the tolerance exemptions subject to revocation was August 9, 2008, which was later extended to August 9, 2009 (73 FR 45317) to allow for data to be submitted to support the establishment of tolerance exemptions for these inert ingredients prior to the effective date of the tolerance exemption revocation. 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. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the E:\FR\FM\08JYR1.SGM 08JYR1 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations sroberts on DSKD5P82C1PROD with RULES legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....’’ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. 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. Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for exemption from the requirement of a tolerance for residues of sodium 1,4dialkyl sulfosuccinates when used as inert ingredients in pesticide formulations applied to growing crops or food-producing animals. EPA’s assessment of exposures and risks associated with establishing tolerances follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Sodium 1,4-dialkyl sulfosuccinates have moderate to low acute oral toxicity and low dermal acute toxicity. There was no hazard identified in a combined repeat dose rat reproductive/ developmental screening study at the limit dose of 1,000 milligrams/kilogram/ VerDate Nov<24>2008 16:30 Jul 07, 2009 Jkt 217001 day (mg/kg/day) to either parental animals or their offspring. There is no concern for neurotoxicity, immunotoxicity or carcinogenicity for SDSS. Specific information on the studies received and the nature of any observed effects caused by the sodium 1,4-dialkyl sulfosuccinates as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document ‘‘Sodium 1,4-Dialkyl Sulfosuccinates (JITF CST 13 Inert Ingredients). Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations’’ pages 6–8 in docket ID number EPA–HQ–OPP–2008–0739. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 32435 in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/ pesticides/factsheets/riskassess.htm. There was no hazard identified in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats with SDSS at the limit dose of 1,000 milligrams/ kilogram/day (mg/kg/day) to either parental animals or their offspring. Thus, due to their low potential hazard and the lack of a hazard endpoint, the Agency has determined that a quantitative risk assessment using safety factors applied to a point of departure protective of an identified hazard endpoint is not appropriate. No mutagenicity, genotoxicity or chronic toxicity data have been located for any of the sodium 1,4-dialkyl sulfosuccinates. However, no structural alerts for genotoxicity or carcinogenicity were identified in a qualitative structure activity relationship (SAR) database, DEREK Version 11. In addition, data for similar compounds showed they are not mutagenic or carcinogenic. The primary alcohol mammalian metabolites of SDSS have been shown to be negative in the in vitro Ames test. Furthermore, a structurally similar compound that is also used as an inert ingredient, sodium dioctyl sulfosuccinate (CAS Reg. No. 577–11–7) was not mutagenic, or carcinogenic in a chronic rat study or a tumor promotion study. Based on the above, sodium 1,4-dialkyl sulfosuccinates are not expected to be carcinogenic. C. Exposure Assessment 1. Dietary exposure (from food and feed uses and drinking water). Since an endpoint for risk assessment was not identified, an exposure assessment for SDSS was not conducted. Any possible dietary exposure SDSS from their use as inert ingredients in pesticide products would be through consumption of food to which pesticide products containing SDSS have been applied and through drinking water (from runoff). 2. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Since an endpoint for risk assessment was not identified, a quantitative residential exposure assessment for SDSS was not conducted. Residential exposures to SDSS may occur as a result of the use of pesticide products containing SDSS as inert ingredients (such as E:\FR\FM\08JYR1.SGM 08JYR1 32436 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations sroberts on DSKD5P82C1PROD with RULES antimicrobial hard surface cleaners) as well as from other, nonpesticidal, residential use products containing SDSS. 3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of 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.’’ EPA has not found SDSS to share a common mechanism of toxicity with any other substances, and sodium 1,4dialkyl sulfosuccinates do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that sodium 1,4-dialkyl sulfosuccinates do not have 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 EPA’s website at https:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. The toxicity database for SDSS is adequate for FQPA assessment and the potential exposure is adequately characterized given the low toxicity of the chemical. There was no hazard identified in a combined repeat dose rat reproductive/developmental screening study at the limit dose of 1,000 mg/kg/ day to either parental animals or their offspring. There is no concern for neurotoxicity, immunotoxicity or carcinogenicity for the sodium 1,4dialkyl sulfosuccinates. Based on this information, there is no concern, at this time, for increased sensitivity to infants and children to VerDate Nov<24>2008 16:30 Jul 07, 2009 Jkt 217001 sodium 1,4-dialkyl sulfosuccinates when used as inert ingredients in pesticide formulations applied to growing crops and a safety factor analysis has not been used to assess risk. For the same reason, EPA has determined that an additional safety factor is not needed to protect the safety of infants and children. B. International Residue Limits E. Aggregate Risks and Determination of Safety Therefore, an exemption from the requirement of a tolerance is established for residues of sodium 1,4-dialkyl sulfosuccinates when used inert ingredients in pesticide formulations applied to growing crops or to animals. EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert ingredient in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Since an endpoint for risk assessment was not identified, a quantitative dietary risk assessment for sodium 1,4-dialkyl sulfosuccinates was not conducted. Given the lack of concern for hazard posed by SDSS, EPA concludes that there are no dietary risks of concern as a result of exposure to SDSS in food and water. Similarly, based on the lack of concern for hazard posed by the SDSS inert ingredients, the Agency concludes that there are no non-dietary/nonoccupational (residential) risks of concern for these inert ingredients. The Agency has not identified any concerns for carcinogenicity relating to sodium 1,4-dialkyl sulfosuccinates. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of sodium 1,4-dialkyl sulfosuccinates. V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 The Agency is not aware of any country requiring a tolerance for sodium 1,4-dialkyl sulfosuccinates nor have any CODEX Maximum Residue Levels been established for any food crops at this time. VI. Conclusion VII. Statutory and Executive Order Reviews This final rule establishes exemptions from the requirement of a tolerance under section 408(d) of 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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., 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). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the exemptions 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. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, E:\FR\FM\08JYR1.SGM 08JYR1 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not 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). 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). VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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, Inert Ingredients * * * * * [FR Doc. E9–16086 Filed 7–7–09; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 d-Phenothrin; Pesticide Tolerances sroberts on DSKD5P82C1PROD with RULES AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of the insecticide d-phenothrin [(3phenoxyphenyl)methyl] 2,2-Dimethyl-3(2-methyl-1propenyl)cyclopropanecarboxylate in or on all food/feed crops at 0.01 parts per million (ppm) following wide-area mosquito adulticide applications. McLaughlin Gormley King Company requested these tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA). 16:30 Jul 07, 2009 Jkt 217001 Dated: June 25, 2009. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: ■ PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.920, the table is amended by adding alphabetically the following inert ingredients to read as follows: ■ § 180.920 Inert ingredients used preharvest; exemptions from the requirement of a tolerance. * * * Uses * * * * ..................................................... Surfactants, related adjuvants of surfactants * * * EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2008–0140. All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (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 in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Room S– 4400, One Potomac Yard (South Frm 00049 * * * * * ..................................................... Surfactants, related adjuvants of surfactants DATES: This regulation is effective July 8, 2009. Objections and requests for hearings must be received on or before September 8, 2009, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). PO 00000 * * * * * ..................................................... Surfactants, related adjuvants of surfactants ADDRESSES: [EPA–HQ–OPP–2008–0140; FRL–8417–4] VerDate Nov<24>2008 Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Limits * * * Sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006–15– 3). * * * Sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127– 39–9). * * * Sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922–80– 5). * * * 32437 Fmt 4700 Sfmt 4700 * Building), 2777 S. Crystal Dr., Arlington, VA 22202–4501. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460–0001; telephone number: (703) 306–0327; fax number: (703) 308–0029; e-mail address: rodia.carmen@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, those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). E:\FR\FM\08JYR1.SGM 08JYR1

Agencies

[Federal Register Volume 74, Number 129 (Wednesday, July 8, 2009)]
[Rules and Regulations]
[Pages 32433-32437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16086]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0739; FRL-8423-3]


Sodium 1,4-Dialkyl Sulfosuccinates; Exemption from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of sodium 1,4-dialkyl sulfosuccinates 
including sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006-15-3); 
sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127-39-9); and 
sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922-80-5) when used as 
inert ingredients in pesticide formulations applied to growing crops. 
The Joint Inerts Task Force (JITF), Cluster Support Team Number 13 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of sodium 1,4-dialkyl sulfosuccinates.

DATES: This regulation is effective July 8, 2009. Objections and 
requests for hearings must be received on or before September 8, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0739. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (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 in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The

[[Page 32434]]

Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The Docket Facility telephone number 
is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; e-mail address: leifer.kerry@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 those 
engaged in the following activities:
     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 to 
provide 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?

    In addition to accessing electronically available documents at 
https://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at https://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at https://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at https://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0739 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 as required by 40 CFR part 178 
on or before September 8, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0738, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background

    In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8E7423) by The Joint Inerts Task Force (JITF), Cluster Support Team 
Number 23 (CST 13), c/o CropLife America, 1156 15th Street, N.W., Suite 
400, Washington, DC 20005. The petition was subsequently redesignated 
as PP 8E7422. The petition requested that 40 CFR 180.920 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of the inert ingredients sodium 1,4-dialkyl sulfosuccinates 
including sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006-15-3); 
sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127-39-9); and 
sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922-80-5) (these 
substances are also collectively referred to throughout this document 
as SDSS). That notice referenced a summary of the petition prepared by 
the JITF CST 13, the petitioner which is available to the public in the 
docket, https://www.regulations.gov. There were no substantive comments 
received in response to the notice of filing.
    This petition was submitted in response to a final rule of August 
9, 2006, (71 FR 45415) (FRL-8084-1) in which the Agency revoked, under 
section 408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
the existing exemptions from the requirement of a tolerance for 
residues of certain inert ingredients because of insufficient data to 
make the determination of safety required by FFDCA section 408(b)(2). 
The expiration date for the tolerance exemptions subject to revocation 
was August 9, 2008, which was later extended to August 9, 2009 (73 FR 
45317) to allow for data to be submitted to support the establishment 
of tolerance exemptions for these inert ingredients prior to the 
effective date of the tolerance exemption revocation.

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. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the

[[Page 32435]]

legal limit for a pesticide chemical residue in or on a food) only if 
EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) 
of FFDCA defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) of 
FFDCA requires EPA to give special consideration to exposure of infants 
and children to the pesticide chemical residue in establishing a 
tolerance and to ``ensure that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to the 
pesticide chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. 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.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
exemption from the requirement of a tolerance for residues of sodium 
1,4-dialkyl sulfosuccinates when used as inert ingredients in pesticide 
formulations applied to growing crops or food-producing animals. EPA's 
assessment of exposures and risks associated with establishing 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Sodium 1,4-dialkyl sulfosuccinates have moderate to low acute oral 
toxicity and low dermal acute toxicity. There was no hazard identified 
in a combined repeat dose rat reproductive/developmental screening 
study at the limit dose of 1,000 milligrams/kilogram/day (mg/kg/day) to 
either parental animals or their offspring. There is no concern for 
neurotoxicity, immunotoxicity or carcinogenicity for SDSS.
    Specific information on the studies received and the nature of any 
observed effects caused by the sodium 1,4-dialkyl sulfosuccinates as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be 
found at https://www.regulations.gov in document ``Sodium 1,4-Dialkyl 
Sulfosuccinates (JITF CST 13 Inert Ingredients). Human Health Risk 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as Inert Ingredients in Pesticide Formulations'' 
pages 6-8 in docket ID number EPA-HQ-OPP-2008-0739.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    There was no hazard identified in a combined repeated dose toxicity 
study with the reproduction/developmental toxicity screening test in 
rats with SDSS at the limit dose of 1,000 milligrams/kilogram/day (mg/
kg/day) to either parental animals or their offspring. Thus, due to 
their low potential hazard and the lack of a hazard endpoint, the 
Agency has determined that a quantitative risk assessment using safety 
factors applied to a point of departure protective of an identified 
hazard endpoint is not appropriate.
    No mutagenicity, genotoxicity or chronic toxicity data have been 
located for any of the sodium 1,4-dialkyl sulfosuccinates. However, no 
structural alerts for genotoxicity or carcinogenicity were identified 
in a qualitative structure activity relationship (SAR) database, DEREK 
Version 11. In addition, data for similar compounds showed they are not 
mutagenic or carcinogenic. The primary alcohol mammalian metabolites of 
SDSS have been shown to be negative in the in vitro Ames test. 
Furthermore, a structurally similar compound that is also used as an 
inert ingredient, sodium dioctyl sulfosuccinate (CAS Reg. No. 577-11-7) 
was not mutagenic, or carcinogenic in a chronic rat study or a tumor 
promotion study. Based on the above, sodium 1,4-dialkyl sulfosuccinates 
are not expected to be carcinogenic.

C. Exposure Assessment

    1. Dietary exposure (from food and feed uses and drinking water). 
Since an endpoint for risk assessment was not identified, an exposure 
assessment for SDSS was not conducted. Any possible dietary exposure 
SDSS from their use as inert ingredients in pesticide products would be 
through consumption of food to which pesticide products containing SDSS 
have been applied and through drinking water (from runoff).
    2. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Since an endpoint for 
risk assessment was not identified, a quantitative residential exposure 
assessment for SDSS was not conducted. Residential exposures to SDSS 
may occur as a result of the use of pesticide products containing SDSS 
as inert ingredients (such as

[[Page 32436]]

antimicrobial hard surface cleaners) as well as from other, 
nonpesticidal, residential use products containing SDSS.
    3. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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.''
    EPA has not found SDSS to share a common mechanism of toxicity with 
any other substances, and sodium 1,4-dialkyl sulfosuccinates do not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
sodium 1,4-dialkyl sulfosuccinates do not have 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 EPA's website at 
https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    The toxicity database for SDSS is adequate for FQPA assessment and 
the potential exposure is adequately characterized given the low 
toxicity of the chemical. There was no hazard identified in a combined 
repeat dose rat reproductive/developmental screening study at the limit 
dose of 1,000 mg/kg/day to either parental animals or their offspring. 
There is no concern for neurotoxicity, immunotoxicity or 
carcinogenicity for the sodium 1,4-dialkyl sulfosuccinates.
    Based on this information, there is no concern, at this time, for 
increased sensitivity to infants and children to sodium 1,4-dialkyl 
sulfosuccinates when used as inert ingredients in pesticide 
formulations applied to growing crops and a safety factor analysis has 
not been used to assess risk. For the same reason, EPA has determined 
that an additional safety factor is not needed to protect the safety of 
infants and children.

E. Aggregate Risks and Determination of Safety

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert ingredient in conjunction with possible exposure to residues of 
the inert ingredient through food, drinking water, and through other 
exposures that occur as a result of pesticide use in residential 
settings. If EPA is able to determine that a finite tolerance is not 
necessary to ensure that there is a reasonable certainty that no harm 
will result from aggregate exposure to the inert ingredient, an 
exemption from the requirement of a tolerance may be established.
    Since an endpoint for risk assessment was not identified, a 
quantitative dietary risk assessment for sodium 1,4-dialkyl 
sulfosuccinates was not conducted. Given the lack of concern for hazard 
posed by SDSS, EPA concludes that there are no dietary risks of concern 
as a result of exposure to SDSS in food and water. Similarly, based on 
the lack of concern for hazard posed by the SDSS inert ingredients, the 
Agency concludes that there are no non-dietary/non-occupational 
(residential) risks of concern for these inert ingredients. The Agency 
has not identified any concerns for carcinogenicity relating to sodium 
1,4-dialkyl sulfosuccinates.
    Based on these risk assessments, EPA concludes that there is a 
reasonable certainty that no harm will result to the general population 
or to infants and children from aggregate exposure to residues of 
sodium 1,4-dialkyl sulfosuccinates.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for 
sodium 1,4-dialkyl sulfosuccinates nor have any CODEX Maximum Residue 
Levels been established for any food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of sodium 1,4-dialkyl sulfosuccinates when 
used inert ingredients in pesticide formulations applied to growing 
crops or to animals.

VII. Statutory and Executive Order Reviews

    This final rule establishes exemptions from the requirement of a 
tolerance under section 408(d) of 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 final rule has been exempted from review under 
Executive Order 12866, this final rule is not subject to Executive 
Order 13211, entitled Actions Concerning Regulations That Significantly 
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) 
or Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the exemptions 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments,

[[Page 32437]]

on the relationship between the national government and the States or 
tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 9, 
2000) do not apply to this final rule. In addition, this final rule 
does not 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).
    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).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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 25, 2009.
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.  180.920, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Sodium 1,4-dihexyl                ..................  Surfactants,
 sulfosuccinate (CAS Reg. No.                          related adjuvants
 3006-15-3).                                           of surfactants
                              * * * * * * *
Sodium 1,4-diisobutyl             ..................  Surfactants,
 sulfosuccinate (CAS Reg. No.                          related adjuvants
 127-39-9).                                            of surfactants
                              * * * * * * *
Sodium 1,4-dipentyl               ..................  Surfactants,
 sulfosuccinate (CAS Reg. No.                          related adjuvants
 922-80-5).                                            of surfactants
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-16086 Filed 7-7-09; 8:45 am]
BILLING CODE 6560-50-S
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