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Sodium 1,4-Dialkyl Sulfosuccinates; Exemption from the Requirement of a Tolerance
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PDF Version (5 pp, 132K, About PDF) [Federal Register: July 8, 2009 (Volume 74, Number 129)] [Rules and Regulations] [Page 32433-32437] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr08jy09-15] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 http:// 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 http://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 http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://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 http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/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: http://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, http://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 http://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 http://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 http://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 (59 FR 22951, 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. • 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 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