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Lignosulfonates; Exemptions from the Requirement of a Tolerance
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[Federal Register: July 27, 2005 (Volume 70, Number 143)] [Rules and Regulations] [Page 43309-43313] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr27jy05-11] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP-2005-0171; FRL-7720-3] Lignosulfonates; Exemptions from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Agency is establishing 44 exemptions from the requirement of a tolerance for residues of various lignosulfonate chemicals in or on raw agricultural commodities when used as inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest, or to animals under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). This regulation eliminates the need to establish a maximum permissible level for residues of these lignosulfonate chemicals. DATES: This regulation is effective July 27, 2005. Objections and requests for hearings must be received on or before September 26, 2005. ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit III. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under docket identification (ID) number OPP-2005-0171. All documents in the docket are listed in the EDOCKET index at http://www.regulations.gov/. Although listed in the index, some information is not publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., [[Page 43310]] 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: Kathryn Boyle, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6304; fax number: (703) 305-0599; e-mail address: boyle.kathryn@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: ? Crop production (NAICS code 111). ? Animal production (NAICS code 112). ? Food manufacturing (NAICS code 311). ? Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using EDOCKET (http://www.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/. A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.II. Background and Statutory Findings In the Federal Register of February 16, 2005 (70 FR 7912) (FRL- 7691-9), EPA issued a proposed rule under section 408(e) of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170). The Agency proposed to establish 44 tolerance exemptions for residues of various lignosulfonate chemicals in or on raw agricultural commodities when used as inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest, or to animals. The 22 specific chemicals are identified in the regulatory text. One comment was received from a private citizen. The comment consisted of the following statement ``I oppose and object to any use or sale of this product. I certainly find its use as a feed for animals to be highly dangerous to Americans.'' Attached to the comment was a news article critical of EPA's regulation of rat poisons. The Agency understands the commentor's concerns and recognizes that some individuals believe that pesticides should be banned completely. However, under the existing legal framework provided by section 409 of FFDCA, EPA is authorized to establish pesticide tolerances or exemptions after demonstrating that the pesticide meets the safety standard imposed by the statute. The commentor has not provided the Agency with specific rationale or additional information pertaining to the legal standards in section 409 of FFDCA for opposing the establishment of a tolerance exemption for these lignosulfonate chemicals. In the absence of any additional information of a factual nature, the Agency can not effectively respond to the commentor's disagreement with the Agency's decision. Additionally, EPA would note that this action applies to inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest, or to animals, and not rat poisons. No other comments were received. Accordingly, based on the reasons set forth in the preamble to the proposed rule, EPA is establishing 44 new tolerance exemptions for lignosulfonate chemicals. III. Objections and Hearing Requests Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of FFDCA provides essentially the same process for persons to ``object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old FFDCA sections 408 and 409 of FFDCA. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2005-0171 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 September 26, 2005. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues 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 14\th\ 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 III.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP-2005-0171, to: Public Information and Records Integrity Branch, [[Page 43311]] Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). IV. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement 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 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). The Agency hereby certifies that this rule will not have significant negative economic impact on a substantial number of small entities. 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, entitledFederalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (59 FR 22951, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. V. 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: July 18, 2005. 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), 346(a) and 371. Sec. 180.910 [Amended] ? 2. Section 180.910 is amended by removing the following entries from the table: Ethoxylated lignosulfonic acid, sodium salt; lignosulfonate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts; oxidized pine lignin, sodium salt; and pine lignin. ? 3. Section 180.910 is amended by adding alphabetically the following entries to the table to read as follows: [[Page 43312]] Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Inert ingredients Limits Uses ------------------------------------------------------------------------ * * * * * * * Lignin (CAS Reg. No. 9005-53-2) .................. Surfactant, related adjuvants of surfactants Lignin, alkali (CAS Reg. No. .................. Do. 8068-05-1). Lignin, alkali, oxidized, sodium .................. Do. salt (CAS Reg. No. 68201-23-0). Lignin alkali reaction products .................. Do. with disodium sulfite and formaldehyde (CAS Reg. No. 105859-97-0). Lignin alkali reaction products .................. Do. with formaldehyde and sodium bisulfite (CAS Reg. No. 68512- 35-6). Lignosulfonic acid (CAS Reg. No. .................. Do. 8062-15-5). Lignosulfonic acid, ammonium .................. Do. calcium salt (CAS Reg. No. 12710-04-2). Lignosulfonic acid, ammonium .................. Do. magnesium salt (CAS Reg. No. 123175-37-1). Lignosulfonic acid, ammonium .................. Do. salt (CAS Reg. No. 8061-53-8). Lignosulfonic acid, ammonium .................. Do. sodium salt (CAS Reg. No. 166798-73-8). Lignosulfonic acid, calcium .................. Do. magnesium salt (CAS Reg. No. 55598-86-2). Lignosulfonic acid, calcium salt .................. Do. (CAS Reg. No. 8061-52-7). Lignosulfonic acid, calcium .................. Do. sodium salt (CAS Reg. No. 37325- 33-0). Lignosulfonic acid, ethoxylated, .................. Do. sodium salt (CAS Reg. No. 68611- 14-3). Lignosulfonic acid, magnesium .................. Do. salt (CAS Reg. No. 8061-54-9). Lignosulfonic acid, potassium .................. Do. salt (CAS Reg. No. 37314-65-1). Lignosulfonic acid, sodium salt .................. Do. (CAS Reg. No. 8061-51-6). Lignosulfonic acid, sodium salt, .................. Do. oxidized (CAS Reg. No. 68855-41- 4). Lignosulfonic acid, sodium salt, .................. Do. polymer with formaldehyde and phenol (CAS Reg. No. 37207-89- 9). Lignosulfonic acid, sodium salt, .................. Do. sulfomethylated (CAS Reg. No. 68512-34-5). Lignosulfonic acid, zinc salt .................. Do. (CAS Reg. No. 57866-49-6). * * * * * * * Sulfite liquors and cooking .................. Surfactant, liquors, spent, oxidized (CAS related adjuvants Reg. No. 68514-09-0). of surfactants * * * * * * * ------------------------------------------------------------------------ * * * * * Sec. 180.930 [Amended] ? 4. Section 180.930 is amended by removing the following entries from the table: Lignosulfonate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts; oxidized pine lignin, sodium salt; and pine lignin. ? 5. Section 180.930 is amended by adding alphabetically the following entries to the table to read as follows: Sec. 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Inert ingredients Limits Uses ------------------------------------------------------------------------ * * * * * * * Lignin (CAS Reg. No. 9005-53-2) .................. Surfactant, related adjuvants of surfactants Lignin, alkali (CAS Reg. No. .................. Do. 8068-05-1). Lignin, alkali, oxidized, sodium .................. Do. salt (CAS Reg. No. 68201-23-0). Lignin alkali reaction products .................. Do. with disodium sulfite and formaldehyde (CAS Reg. No. 105859-97-0). Lignin alkali reaction products .................. Do. with formaldehyde and sodium bisulfite (CAS Reg. No. 68512- 35-6). Lignosulfonic acid (CAS Reg. No. .................. Do. 8062-15-5). Lignosulfonic acid, ammonium .................. Do. calcium salt (CAS Reg. No. 12710-04-2). Lignosulfonic acid, ammonium .................. Do. magnesium salt (CAS Reg. No. 123175-37-1). [[Page 43313]] Lignosulfonic acid, ammonium .................. Do. salt (CAS Reg. No. 8061-53-8). Lignosulfonic acid, ammonium .................. Do. sodium salt (CAS Reg. No. 166798-73-8). Lignosulfonic acid, calcium .................. Do. magnesium salt (CAS Reg. No. 55598-86-2). Lignosulfonic acid, calcium salt .................. Do. (CAS Reg. No. 8061-52-7). Lignosulfonic acid, calcium .................. Do. sodium salt (CAS Reg. No. 37325- 33-0). Lignosulfonic acid, ethoxylated, .................. Do. sodium salt (CAS Reg. No. 68611- 14-3). Lignosulfonic acid, magnesium .................. Do. salt (CAS Reg. No. 8061-54-9). Lignosulfonic acid, potassium .................. Do. salt (CAS Reg. No. 37314-65-1). Lignosulfonic acid, sodium salt .................. Do. (CAS Reg. No. 8061-51-6). Lignosulfonic acid, sodium salt, .................. Do. oxidized (CAS Reg. No. 68855-41- 4). Lignosulfonic acid, sodium salt, .................. Do. polymer with formaldehyde and phenol (CAS Reg. No. 37207-89- 9). Lignosulfonic acid, sodium salt, .................. Do. sulfomethylated (CAS Reg. No. 68512-34-5). Lignosulfonic acid, zinc salt .................. Do. (CAS Reg. No. 57866-49-6). * * * * * * * Sulfite liquors and cooking .................. Surfactant, liquors, spent, oxidized (CAS related adjuvants Reg. No. 68514-09-0). of surfactants * * * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 05-14887 Filed 7-26-05; 8:45 am] BILLING CODE 6560-50-S