Inert Ingredients; Revocation of Two Tolerance Exemptions, 43664-43667 [E6-12344]

Download as PDF 43664 Federal Register / Vol. 71, No. 148 / Wednesday, August 2, 2006 / Rules and Regulations mstockstill on PROD1PC61 with RULES 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 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 (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. VII. 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 VerDate Aug<31>2005 14:52 Aug 01, 2006 Jkt 208001 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 21, 2006. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). The two tolerance exemptions are considered ‘‘reassessed’’ for purposes of FFDCA’s section 408(q) and count as a tolerance reassessment toward the August 2006 review deadline. DATES: This rule is effective August 2, 2006. Objections and requests for hearings must be received on or before October 2, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). EPA has established a docket for this action under docket identification (ID) number EPA–HQ– I 1. The authority citation for part 180 OPP–2006–0307. All documents in the continues to read as follows: docket are listed in the index for the Authority: 21 U.S.C. 321(q), 346a and 371. docket. Although listed in the index, I 2. Section 180.553 is amended by some information is not publicly alphabetically adding commodities to available, e.g., Confidential Business the table in paragraph (a) to read as Information (CBI) or other information follows: whose disclosure is restricted by statute. Certain other material, such as § 180.553 Fenhexamid; tolerances for copyrighted material, is not placed on residues. the Internet and will be publicly (a) * * * available only in hard copy form. Parts per mil- Publicly available docket materials are Commodity lion available in the electronic docket at https://www.regulations.gov, or, if only * * * * * available in hard copy, at the OPP Cilantro, leaves 30.0 Regulatory Public Docket in Rm. S– * * * * * 4400, One Potomac Yard (South Bldg.), Pepper, nonbell 0.02 2777 S. Crystal Dr., Arlington, VA. The * * * * * Pomegranate 2.0 Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, * * * * * excluding legal holidays. The Docket [FR Doc. E6–12348 Filed 8–1–06; 8:45 am] Facility telephone number is (703) 305– 5805. BILLING CODE 6560–50–S FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division ENVIRONMENTAL PROTECTION (7505P), Office of Pesticide Programs, AGENCY Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, 40 CFR Part 180 DC 20460–0001; telephone number: [EPA–HQ–OPP–2006–0307; FRL–8079–9] (703) 306–0404; e-mail address: angulo.karen@epa.gov. Inert Ingredients; Revocation of Two SUPPLEMENTARY INFORMATION: Tolerance Exemptions I. General Information AGENCY: Environmental Protection Agency (EPA). A. Does this Action Apply to Me? ACTION: Final rule. You may be potentially affected by this action if you are an agricultural SUMMARY: EPA is revoking two producer, food manufacturer, or exemptions from the requirement of a pesticide manufacturer. Potentially tolerance that are associated with two affected entities may include, but are inert ingredients (ethylene glycol not limited to: monomethyl ether and methylene blue) • Crop production (NAICS code 111). because these substances are no longer • Animal production (NAICS code contained in active Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 112). • Food manufacturing (NAICS code pesticide product registrations. These 311). ingredients are subject to reassessment by August 2006 under section 408(q) of • Pesticide manufacturing (NAICS the Federal Food, Drug, and Cosmetic code 32532). PART 180—AMENDED PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 ADDRESSES: E:\FR\FM\02AUR1.SGM 02AUR1 Federal Register / Vol. 71, No. 148 / Wednesday, August 2, 2006 / Rules and Regulations 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II. 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 an electronic copy of this Federal Register document through the electronic docket athttps:// 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 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at https:// www.gpoaccess.gov/ecfr. mstockstill on PROD1PC61 with RULES C. Can I File an Objection or Hearing Request? 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. 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–2006–0307 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 October 2, 2006. 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 your copies, identified by docket ID number VerDate Aug<31>2005 14:52 Aug 01, 2006 Jkt 208001 EPA–HQ–OPP–2006–0307, 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 Drive, Arlington, VA. Deliveries are only accepted during the Docket’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 and Statutory Findings A. What Action is the Agency Taking? In the Federal Register of May 3, 2006 (71 FR 26001) (FRL–8068–3), EPA issued a proposed rule to revoke two exemptions from the requirement of a tolerance that are associated with two inert ingredients because those substances are no longer contained in pesticide products. The proposed rule provided a 60–day comment period that invited public comment for consideration and for support of tolerance exemption retention under the FFDCA standards. In this final rule, EPA is revoking two exemptions from the requirement of a tolerance that are associated with two inert ingredients because these specific tolerance exemptions correspond to uses no longer current or registered under FIFRA in the United States. The tolerance exemptions revoked by this final rule are no longer necessary to cover residues of the relevant pesticide chemicals in or on domestically treated commodities or commodities treated outside but imported into the United States. EPA has historically been concerned that retention of tolerances and tolerance exemptions that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Thus, it is EPA’s policy to issue a final rule revoking those tolerances and tolerance exemptions for residues of pesticide chemicals for which there are no active registrations or uses under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 43665 imported commodities or domestic commodities legally treated. Generally, EPA will proceed with the revocation of these tolerances and tolerance exemptions on the grounds discussed in Unit II. if one of the following conditions applies: 1. Prior to EPA’s issuance of a section 408(f) order requesting additional data or issuance of a section 408(d) or (e) order revoking the tolerances or tolerance exemptions on other grounds, commenters retract the comment identifying a need for the tolerance to be retained. 2. EPA independently verifies that the tolerance or tolerance exemption is no longer needed. 3. The tolerance or tolerance exemption is not supported by data that demonstrate that the tolerance or tolerance exemption meets the requirements under FQPA. No comments were received on the proposed rule. Therefore, for the reasons stated herein and in the proposed rule, EPA is revoking the two exemptions from the requirement of a tolerance identified in the Federal Register Notice of May 3, 2006 (71 FR 26001). B. What is the Agency’s Authority for Taking this Action? This final rule is issued pursuant to section 408(d) of FFDCA (21 U.S.C. 346a(d)). Section 408 of FFDCA authorizes the establishment of tolerances, exemptions from the requirement of a tolerance, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or tolerance exemption, food containing pesticide residues is considered to be unsafe and therefore ‘‘adulterated’’ under section 402(a) of the FFDCA. If food containing pesticide residues is found to be adulterated, the food may not be distributed in interstate commerce (21 U.S.C. 331(a) and 342 (a)). EPA’s general practice is to revoke tolerances and tolerance exemptions for residues of pesticide chemicals on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances and tolerance exemptions that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances and tolerance exemptions even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as E:\FR\FM\02AUR1.SGM 02AUR1 43666 Federal Register / Vol. 71, No. 148 / Wednesday, August 2, 2006 / Rules and Regulations ‘‘import tolerances,’’ are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances and tolerance exemptions for unregistered pesticide chemicals in order to prevent potential misuse. C. When Do These Actions Become Effective? These actions become effective on August 2, 2006. Any commodities listed in the regulatory text of this document that are treated with the pesticide chemicals subject to this final rule, and that are in the channels of trade following the tolerance exemption revocations, shall be subject to FFDCA section 408(1)(5), as established by the FQPA. Under this section, any residues of these pesticide chemicals in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that: 1. The residue is present as the result of an application or use of the pesticide chemical at a time and in a manner that was lawful under FIFRA, and 2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under an exemption from a tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide chemical was applied to such food. mstockstill on PROD1PC61 with RULES D. What Is the Contribution to Tolerance Reassessment? By law, EPA is required by August 2006, to reassess the tolerances and exemptions from tolerances that were in existence on August 2, 1996. This document revokes two inert ingredient tolerance exemptions which are counted as tolerance reassessments toward the August 2006 review deadline under FFDCA section 408(q), as amended by FQPA in 1996. III. Statutory and Executive Order Reviews In this final rule, EPA is revoking specific tolerance exemptions established under section 408(d) of FFDCA. The Office of Management and Budget (OMB) has exempted this type of action 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 final rule is not subject VerDate Aug<31>2005 14:52 Aug 01, 2006 Jkt 208001 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. 3501et 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). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticide listed in this rule, the Agency hereby certifies that this final action will not have a significant economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket of this final rule). Furthermore, for the pesticides named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change the EPA’s previous analysis. In addition, PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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 section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this final 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 final 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 final rule. IV. 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 E:\FR\FM\02AUR1.SGM 02AUR1 Federal Register / Vol. 71, No. 148 / Wednesday, August 2, 2006 / Rules and Regulations 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 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 the rule in the Federal Register. This 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 24, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. § 180.920 [Amended] 2. In § 180.920, the table is amended by removing the entries for ‘‘Ethylene glycol monomethyl ether’’ and ‘‘Methylene blue.’’ I [FR Doc. E6–12344 Filed 8–1–06; 8:45 am] BILLING CODE 6560–50–S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 54 and 64 [WC Docket No. 05–68; FCC 06–79] Regulation of Prepaid Calling Card Services Federal Communications Commission. ACTION: Interim rule. mstockstill on PROD1PC61 with RULES AGENCY: SUMMARY: In this document, the Federal Communications Commission (Commission) takes steps necessary to protect the federal universal service program and promote stability in the market for prepaid calling cards. In particular, the Commission will treat certain prepaid calling card service providers as telecommunications service providers. As such, these providers must pay intrastate access charges for interexchange calls that VerDate Aug<31>2005 14:52 Aug 01, 2006 Jkt 208001 originate and terminate in the same state and interstate access charges on interexchange calls that originate and terminate in different states. They also must contribute to the federal Universal Service Fund (USF) based on their interstate revenues, subject to the limitations set forth below. The Commission also addresses a petition for interim relief filed by AT&T and adopts interim rules to facilitate compliance with the universal service and access charge rules. Specifically, on an interim and prospective basis, the Commission requires all prepaid calling card providers to comply with certain reporting and certification requirements. DATES: Effective October 31, 2006 except for §§ 64.5001(a), (b), and (c) which contain information collection requirements that have not yet been approved by the Office of Management and Budget. The Federal Communications Commission will publish a document in the Federal Register announcing the effective date for those sections. ADDRESSES: Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. In addition to filing comments with the Office of the Secretary, a copy of any comments on the Paperwork Reduction Act information collection requirements contained herein should be submitted to Judith Boley Herman, Federal Communications Commission, Room 1– C804, 445 12th Street, SW., Washington, DC 20554, or via the Internet to JudithB.Herman@fcc.gov. FOR FURTHER INFORMATION CONTACT: Lynne Hewitt Engledow, Wireline Competition Bureau, Pricing Policy Division, (202) 418–1520. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Declaratory Ruling and Report and Order in WC Docket No. 05–68, adopted on June 1, 2006, and released on June 30, 2006. The complete text of this Declaratory Ruling and Report and Order is available for public inspection Monday through Thursday from 8 a.m. to 4:30 p.m. and Friday from 8 a.m. to 11:30 a.m. in the Commission’s Consumer and Governmental Affairs Bureau, Reference Information Center, Room CY–A257, 445 12th Street, SW., Washington, DC 20554. The complete text is available also on the Commission’s Internet site at https:// www.fcc.gov. Alternative formats are available to persons with disabilities by contacting the Consumer and Governmental Affairs Bureau, at (202) 418–0531, TTY (202) 418–7365, or at fcc504@fcc.gov. The complete text of the decision may be purchased from the PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 43667 Commission’s duplicating contractor, Best Copying and Printing, Inc., Room CY–B402, 445 12th Street, SW., Washington, DC 20554, telephone (202) 488–5300, facsimile (202) 488–5563, TTY (202) 488–5562, or e-mail at fcc@bcpiweb.com. Synopsis of Declaratory Ruling and Report and Order 1. On May 15, 2003, AT&T filed a petition for declaratory ruling that intrastate access charges did not apply to calls made using its ‘‘enhanced’’ prepaid calling cards when the calling card platform is located outside the state in which either the calling or the called party is located. On November 22, 2004, AT&T submitted an ex parte letter requesting a declaratory ruling on two additional types of ‘‘enhanced’’ prepaid calling card offerings: one card that offers the caller a menu of options to access non-call-related information, and a second card that utilizes Internet Protocol (IP) technology, accessed by 8YY dialing, to transport a portion of the calling card call. 2. On February 16, 2005, the Commission denied AT&T’s May 2003 Petition. See AT&T Corp. Petition for Declaratory Ruling Regarding Enhanced Prepaid Calling Card Services; Regulation of Prepaid Calling Card Services, Order and Notice of Proposed Rulemaking, 70 FR 12828, March 16, 2005 (Calling Card Order & NPRM). The Commission found that the service described in the original petition was a jurisdictionally-mixed telecommunications service and that intrastate access charges apply when a call originates and terminates in the same state. The Commission initiated a Notice of Proposed Rulemaking (NPRM) to address additional types of ‘‘enhanced’’ prepaid calling cards, including those described in AT&T’s November 2004 letter. On May 3, 2005, AT&T filed a petition seeking the adoption of interim rules pending a final decision by the Commission in this docket. AT&T’s Emergency Petition seeks interim rules imposing federal universal service funding obligations on all prepaid calling card services regardless of whether the Commission ultimately decides they are telecommunications services or information services. Declaratory Ruling 3. In this Order, the Commission addresses the two prepaid calling card variants described in the NPRM portion of the Calling Card Order and NPRM: (1) Menu-driven prepaid calling cards; and (2) prepaid calling cards that utilize IP transport to deliver all or a portion of E:\FR\FM\02AUR1.SGM 02AUR1

Agencies

[Federal Register Volume 71, Number 148 (Wednesday, August 2, 2006)]
[Rules and Regulations]
[Pages 43664-43667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12344]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0307; FRL-8079-9]


Inert Ingredients; Revocation of Two Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is revoking two exemptions from the requirement of a 
tolerance that are associated with two inert ingredients (ethylene 
glycol monomethyl ether and methylene blue) because these substances 
are no longer contained in active Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) pesticide product registrations. These 
ingredients are subject to reassessment by August 2006 under section 
408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended 
by the Food Quality Protection Act of 1996 (FQPA). The two tolerance 
exemptions are considered ``reassessed'' for purposes of FFDCA's 
section 408(q) and count as a tolerance reassessment toward the August 
2006 review deadline.

DATES: This rule is effective August 2, 2006. Objections and requests 
for hearings must be received on or before October 2, 2006, 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-2006-0307. All documents in the 
docket are listed in the index for the docket. 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 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: Karen Angulo, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0404; e-mail address: angulo.karen@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).

[[Page 43665]]

    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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit II. 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 an electronic copy of this Federal 
Register document through the electronic docket athttps://
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 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    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. 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-2006-0307 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 October 2, 2006.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0307, 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 Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 and Statutory Findings

A. What Action is the Agency Taking?

    In the Federal Register of May 3, 2006 (71 FR 26001) (FRL-8068-3), 
EPA issued a proposed rule to revoke two exemptions from the 
requirement of a tolerance that are associated with two inert 
ingredients because those substances are no longer contained in 
pesticide products. The proposed rule provided a 60-day comment period 
that invited public comment for consideration and for support of 
tolerance exemption retention under the FFDCA standards.
    In this final rule, EPA is revoking two exemptions from the 
requirement of a tolerance that are associated with two inert 
ingredients because these specific tolerance exemptions correspond to 
uses no longer current or registered under FIFRA in the United States. 
The tolerance exemptions revoked by this final rule are no longer 
necessary to cover residues of the relevant pesticide chemicals in or 
on domestically treated commodities or commodities treated outside but 
imported into the United States.
    EPA has historically been concerned that retention of tolerances 
and tolerance exemptions that are not necessary to cover residues in or 
on legally treated foods may encourage misuse of pesticides within the 
United States. Thus, it is EPA's policy to issue a final rule revoking 
those tolerances and tolerance exemptions for residues of pesticide 
chemicals for which there are no active registrations or uses under 
FIFRA, unless any person commenting on the proposal demonstrates a need 
for the tolerance to cover residues in or on imported commodities or 
domestic commodities legally treated.
    Generally, EPA will proceed with the revocation of these tolerances 
and tolerance exemptions on the grounds discussed in Unit II. if one of 
the following conditions applies:
    1. Prior to EPA's issuance of a section 408(f) order requesting 
additional data or issuance of a section 408(d) or (e) order revoking 
the tolerances or tolerance exemptions on other grounds, commenters 
retract the comment identifying a need for the tolerance to be 
retained.
    2. EPA independently verifies that the tolerance or tolerance 
exemption is no longer needed.
    3. The tolerance or tolerance exemption is not supported by data 
that demonstrate that the tolerance or tolerance exemption meets the 
requirements under FQPA.
    No comments were received on the proposed rule. Therefore, for the 
reasons stated herein and in the proposed rule, EPA is revoking the two 
exemptions from the requirement of a tolerance identified in the 
Federal Register Notice of May 3, 2006 (71 FR 26001).

B. What is the Agency's Authority for Taking this Action?

    This final rule is issued pursuant to section 408(d) of FFDCA (21 
U.S.C. 346a(d)). Section 408 of FFDCA authorizes the establishment of 
tolerances, exemptions from the requirement of a tolerance, 
modifications in tolerances, and revocation of tolerances for residues 
of pesticide chemicals in or on raw agricultural commodities and 
processed foods. Without a tolerance or tolerance exemption, food 
containing pesticide residues is considered to be unsafe and therefore 
``adulterated'' under section 402(a) of the FFDCA. If food containing 
pesticide residues is found to be adulterated, the food may not be 
distributed in interstate commerce (21 U.S.C. 331(a) and 342 (a)).
    EPA's general practice is to revoke tolerances and tolerance 
exemptions for residues of pesticide chemicals on crops for which FIFRA 
registrations no longer exist and on which the pesticide may therefore 
no longer be used in the United States. EPA has historically been 
concerned that retention of tolerances and tolerance exemptions that 
are not necessary to cover residues in or on legally treated foods may 
encourage misuse of pesticides within the United States. Nonetheless, 
EPA will establish and maintain tolerances and tolerance exemptions 
even when corresponding domestic uses are canceled if the tolerances, 
which EPA refers to as

[[Page 43666]]

``import tolerances,'' are necessary to allow importation into the 
United States of food containing such pesticide residues. However, 
where there are no imported commodities that require these import 
tolerances, the Agency believes it is appropriate to revoke tolerances 
and tolerance exemptions for unregistered pesticide chemicals in order 
to prevent potential misuse.

C. When Do These Actions Become Effective?

    These actions become effective on August 2, 2006. Any commodities 
listed in the regulatory text of this document that are treated with 
the pesticide chemicals subject to this final rule, and that are in the 
channels of trade following the tolerance exemption revocations, shall 
be subject to FFDCA section 408(1)(5), as established by the FQPA. 
Under this section, any residues of these pesticide chemicals in or on 
such food shall not render the food adulterated so long as it is shown 
to the satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide chemical at a time and in a manner that was lawful under 
FIFRA, and
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under an 
exemption from a tolerance. Evidence to show that food was lawfully 
treated may include records that verify the dates that the pesticide 
chemical was applied to such food.

 D. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006, to reassess the tolerances 
and exemptions from tolerances that were in existence on August 2, 
1996. This document revokes two inert ingredient tolerance exemptions 
which are counted as tolerance reassessments toward the August 2006 
review deadline under FFDCA section 408(q), as amended by FQPA in 1996.

III. Statutory and Executive Order Reviews

    In this final rule, EPA is revoking specific tolerance exemptions 
established under section 408(d) of FFDCA. The Office of Management and 
Budget (OMB) has exempted this type of action 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 final 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. 3501et 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). 
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.), 
the Agency previously assessed whether revocations of tolerances might 
significantly impact a substantial number of small entities and 
concluded that, as a general matter, these actions do not impose a 
significant economic impact on a substantial number of small entities. 
This analysis was published on December 17, 1997 (62 FR 66020), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration. Taking into account this analysis, and available 
information concerning the pesticide listed in this rule, the Agency 
hereby certifies that this final action will not have a significant 
economic impact on a substantial number of small entities. In a 
memorandum dated May 25, 2001, EPA determined that eight conditions 
must all be satisfied in order for an import tolerance or tolerance 
exemption revocation to adversely affect a significant number of small 
entity importers, and that there is a negligible joint probability of 
all eight conditions holding simultaneously with respect to any 
particular revocation. (This Agency document is available in the docket 
of this final rule). Furthermore, for the pesticides named in this 
final rule, the Agency knows of no extraordinary circumstances that 
exist as to the present revocations that would change the EPA's 
previous analysis. 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 section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this final 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 final 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 final rule.

IV. 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

[[Page 43667]]

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 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 
the rule in the Federal Register. This 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 24, 2006.
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.


Sec.  180.920  [Amended]

0
2. In Sec.  180.920, the table is amended by removing the entries for 
``Ethylene glycol monomethyl ether'' and ``Methylene blue.''

[FR Doc. E6-12344 Filed 8-1-06; 8:45 am]
BILLING CODE 6560-50-S
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