[Federal Register: September 30, 2004 (Volume 69, Number 189)] [Rules and Regulations] [Page 58310-58314] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr30se04-16] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP-2004-0289; FRL-7677-1] Sodium Thiosulfate; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation amends an existing exemption from the requirement of a tolerance for residues of sodium thiosulfate on raw agricultural commodities when used in pesticide formulations as an inert ingredient on raw agricultural commodities after harvest. Eden Bioscience Corporation 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 unlimited exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of sodium thiosulfate. DATES: This regulation is effective September 30, 2004. Objections and requests for hearings must be received on or before November 29, 2004. ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit IX. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP-2004-0289. 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 Mall2, 1801 South 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. [[Page 58311]] 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 response to the original pesticide petition (PP OE6177) submitted in 2000 by Eden Bioscience, EPA established tolerance exemptions for sodium thiosulfate also known as thiosulfuric acid, disodium salt, anhydrous, (CAS Reg. No. 7772-98-7) or sodium thiosulfate pentahydrate also known as thiosulfuric acid disodium salt, pentahydrate, (CAS Reg. No. 10102-17-7). The exemptions as established specified that the percent of sodium thiosulfate was not to exceed 6% of the formulated product. For a discussion of the information submitted and the results of the Agency's review and evaluation, see the Federal Register of December 21, 2001 (66 FR 65850) (FRL-6811-6). In the Federal Register of November 26, 2003 (68 FR 66416) (FRL- 7333-8), EPA issued a notice pursuant to section 408(d)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP OE6177) by Eden Bioscience, 3830 Monte Villa Parkway, Bothell, Washington, 98021- 6942. This notice included a summary of the petition prepared by the petitioner Eden Bioscience. The petition requested that the existing exemption in 40 CFR 180.1001, newly re-designated as 180.910, be amended by removing the 6% in the formulation limitation for residues of sodium thiosulfate (CAS Reg No.10102-17-7). There were no comments received in response to the notice of filing. The petition was amended by Eden Bioscience Corporation because recent research indicates that higher levels of sodium thiosulfate than the currently allowed 6% are needed in certain situations, such as the use of very high water volumes with products containing a low percentage of active ingredient. Therefore, Eden Bioscience proposed to amend the existing exemption to permit the use of sodium thiosulfate in a pesticide formulated product as an inert ingredient with no numerical limitation when used on growing crops or on raw agricultural commodities after harvest. 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. 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 sodium thiosulfate are discussed in this unit. In support of the sodium thiosulfate petition submitted in 2000, the petitioner submitted mutagenicity information obtained from open literature, an acute oral toxicity study, and FDA's review and evaluation of the developmental studies conducted in the mouse, rat, hamster, and rabbit. There was no indication of any effect on maternal or fetal survival, or in incidences of visceral or skeletal abnormalities. There was no effect on genotoxicity, or mutagenicity for sodium thiosulfate. The Agency's review and evaluation of all submitted information was cited in the final rule published in the Federal Register of December 21, 2001, (66 FR 65850). No new or additional information was submitted to the Agency as a result of the amendment to the petition. IV. 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). EPA evaluated the use of sodium thiosulfate as an inert ingredient in addition to its use as a GRAS (Generally Recognized As Safe) substance as part of the previous action. A complete discussion on the possible dietary, and other non-occupational exposures is contained in the final rule published in the Federal Register of December 21, 2001, (66 FR 65850). [[Page 58312]] In that final rule, EPA considered that sodium thiosulfate could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. Sodium thiosulfate is considered to be GRAS when used as a formulation aid or reducing agent in alcoholic beverages (not to exceed 0.00005%) and table salt (not to exceed 0.1%), and the per capita consumption was estimated to be 12 micrograms per day based on a population of 210 million. This implies a dose of 0.0002 milligrams/ kilogram/day (mg/kg/day) for a 60 kg body weight female. This dose is orders of magnitude lower than the dose levels (550, 400, and 580 mg/ kg/day) used in the developmental toxicity studies which were evaluated by the Agency. No effects were noted at these levels. The use of sodium thiosulfate in pesticide products as a dechlorinator when mixed with certain proteins such as harpin protein (a limited use pattern), and especially given the reactive nature of sodium thiosulfate, should not significantly increase the amount of sodium thiosulfate in the food supply above the levels that currently exist as a result of uses that are regulated by the FDA. The final rule of December 21, 2001 (66 FR 65850), established a tolerance exemption for the use of sodium thiosulfate as an inert ingredient when it constituted no more than 6% of the formulation. Thus, the Agency concludes that the reported uses of sodium thiosulfate, including its use as a GRAS substance, and its use as an inert ingredient, even without the 6% limitation, should result in human exposure far below any dose level that could possibly produce an adverse effect. V. 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. Sodium thiosulfate 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 sodium thiosulfate 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/ . VI. Determination of Safety for U.S. Population, Infants and Children Due to the expected low toxicity of sodium thiosulfate, and the low potential for exposure, the Agency believes that aggregate exposures to thiosulfuric acid, disodium salt, anhydrous, and thiosulfuric acid, disodium salt, pentahydrate under reasonably forseeable circumstances will pose no appreciable risks to human health. 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. EPA has not used a safety factor analysis to assess the risk. For the same reasons a tenfold safety factor is unnecessary. Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of thiosulfuric acid, disodium salt, anhydrous (CAS Reg. No. 7772-98-7), and thiosulfuric acid, disodium salt, pentahydrate (CAS Reg. No. 10102-17-7), and that a tolerance is not necessary. VII. 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 thiosulfuric acid, disodium salt, anhydrous, and thiosulfuric acid, disodium salt, pentahydrate, for endocrine effects may be required. B. Analytical Method 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. C. Existing Tolerances There is an existing tolerance exemption in 40 CFR 180.910 for sodium thiosulfate anhydrous, (CAS Reg. No. 7772-98-7) or sodium thiosulfate pentahydrate, (CAS Reg. No. 10102-17-7). The Agency is amending this tolerance exemption to remove the 6% in the formulation limitation. D. International Tolerances The Agency is not aware of any country requiring a tolerance or tolerance exemption for sodium thiosulfate. VIII. Conclusions Based on this information in the record, summarized in this preamble, and in the final rule published on December 21, 2001 (66 FR 65850), EPA concludes that there is reasonable certainty of no harm from aggregate exposure to residues of sodium thiosulfate. Accordingly, EPA finds that exempting thiosulfuric acid, disodium salt, anhydrous, (CAS Reg. No. 7772-98-7) or thiosulfuric acid, disodium salt, pentahydrate, (CAS Reg. No. 10102-17-7) from the requirement of a tolerance will be safe. IX. Objections and Hearing Requests Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA 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 [[Page 58313]] 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-2004-0289 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 29, 2004. 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 VIII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP-2004-0289, 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). X. 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, 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 [[Page 58314]] responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XI. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 24, 2004. Donald R. Stubbs, Acting 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 revising the entry for ``sodium thiosulfate'' to read as two separate entries and inserting them alphabetically as follows: Sec. 180.910 Inert ingredients used pre- and post-harvest.; exemptions from the requirement of a tolerance. * * * ---------------------------------------------------------------------------------------------------------------- Inert Ingredients Limits Uses ---------------------------------------------------------------------------------------------------------------- * * * * * * * Thiosulfuric acid, disodium salt, anhydrous. (CAS .............. Dechlorinator, reducing agent Reg. No 7772-98-7). Thiosulfuric acid, disodium salt, pentahydrate. .............. Dechlorinator, reducing agent (CAS Reg. No. 10102-17-7). * * * * * * * ---------------------------------------------------------------------------------------------------------------- [FR Doc. 04-21933 Filed 9-30-04; 8:45 am] BILLING CODE 6560-50-S