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OPP ID: [OPP-2004-0322; FRL-7714-4]
SUBJECT CATEGORY: Potassium Triiodide; Pesticide Chemical Not Requiring a Tolerance or an Exemption from Tolerance
DOCUMENT SUMMARY: EPA is designating the use of the active ingredient, potassium triiodide as a nonfood use pesticide when applied to melons, grapes and bananas grown in foreign countries, and is adding an entry to 40 CFR 180.2020 noting the nonfood use determination. This determination is based on the Agency's evaluation of data which indicates that dietary exposure to iodide and/or iodine resulting from the application of potassium triiodide to melons, grapes, and bananas is expected, to the extent any is present, to be indistinguishable from the background levels of existing dietary exposure resulting from the naturally occurring sources of iodine chemicals. The effect of this designation is that EPA does not require that a tolerance or exemption from tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, be established as a condition of registration of the pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et. seq.
SUMMARY: Potassium triiodide,
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:
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 ECFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. C. Under What Authority is This Action Being Taken?
This final rule is issued pursuant to FFDCA sections 408(e) and 701(a). Section 408(e) of FFDCA authorizes EPA to establish, modify, or revoke tolerances and exemptions from the requirement of a tolerance for residues of pesticide chemicals in or on raw and processed foods and to establish general procedures and requirements for the implementation of section 408. FFDCA section 701 authorizes the establish of regulations for the efficient enforcement of the FFDCA. II. Background
In the Federal Register of August 27, 2004 (69 FR 52679) (FRL7676 7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 3E6572) by Ajay North America, L.L.C., 1400 Industry Road, Powder Springs, GA 30127. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the fungicide, iodinepotassium iodide, in or on imported bananas, grapes, and melons. This notice included a summary of the petition prepared by the petitioner Ajay North America. There were no comments received in response to the notice of filing.
The Agency reviewed and evaluated residue data on potassium triiodide and public literature on iodine and iodide salts submitted in support of the petition. The Agency determined that for potassium triiodide which is reactive in nature, the residue of concern is iodide ion (I). Iodide is an ubiquitous, naturallyoccurring component of all soils, plants, and animals, and as such, there is an existing background level of iodine and iodide in the environment which varies depending on the naturallyoccurring sources of iodine chemicals in the region. Additionally, iodine is an essential human dietary nutrient which is required for the synthesis of thyroid hormones.
The Agency's review and evaluation of the residue data indicated that residues of iodide in fruit treated with potassium triiodide were indistinguishable from the background levels of existing iodide in untreated fruit, and therefore, no additional dietary exposure to iodide is expected. Based on this finding, the Agency decided that a nonfood use determination was more appropriate than an exemption from the requirement of a tolerance as requested by the petitioner. Therefore, EPA is designating the use of potassium triiodide when applied to growing crops in foreign countries, as a nonfood use, not requiring the issuance of a tolerance or an exemption from the requirement of a tolerance.
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP20040322 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 12, 2005.
1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001. 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) 5646255.
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 OPP20040322, 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 email to: opp
[[Page 40201]]
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.
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).
This final rule establishes a nonfood determination under FFDCA section 408(e) 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) (Pub. L. 1044). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome 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 104113, section 12(d) (15 U.S.C. 272 note). Since regulations that are established on the basis of a petition under FFDCA section 408(d), such as the regulation in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: June 28, 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), 346a and 371.
2. In Sec. 180.2020, the table is amended by adding alphabetically the following chemical substance to read as follows:
Sec. 180.2020 Nonfood determinations.
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[[Page 40202]]
Pesticide chemical CAS reg. No. Limits Uses
Potassium triiodide (KI3) 12298689 When applied to growing crops in Bananas, grapes, and melons
foreign countries
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[FR Doc. 0513701 Filed 71205; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Mary L. Waller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3089354; email address: waller.mary@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 26 CFR Part 1 40 CFR Part 180 47 CFR Part 73 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 50 CFR Part 622 26 CFR Part 301 39 CFR Part 111 40 CFR Part 300 50 CFR Part 660 44 CFR Part 65 40 CFR Parts 52 and 81 40 CFR Part 271 47 CFR Part 64 50 CFR Part 665 47 CFR Part 76 50 CFR Part 229 14 CFR Part 23 14 CFR Part 25 21 CFR Part 522