Rules and Regulations. Temporary final rule

26,516 words·~121 min read·/register/2006/08/11/06-6868

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4410-FY-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD01-06-102] RIN 1625-AA00 Safety Zone; R. Ozzie Wedding Fireworks Display, Manchester By The Sea, MA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone for the R. Ozzie Wedding Fireworks display on August 12, 2006 in Manchester By The Sea, MA, temporarily closing all waters in the vicinity of Manchester Bay and Manchester Harbor within a four hundred

(400)yard radius of the fireworks barge located at approximate position 42°50.00′ N, 070°47.00′ W. This zone is necessary to protect the maritime public from the potential hazards posed by a fireworks display. The safety zone temporarily prohibits entry into or movement within this portion of Manchester Bay and Manchester Harbor during its closure period, unless authorized by the Captain of the Port, Boston, MA. DATES: This rule is effective from 9 p.m. EDT on August 12, 2006 until 10:15 p.m. EDT on August 12, 2006. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket CGD01-06-102 and are available for inspection or copying at Sector Boston, 427 Commercial Street, Boston, MA, between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Chief Petty Officer Paul English, Sector Boston, Waterways Management Division, at

(617)223-5456. SUPPLEMENTARY INFORMATION: Regulatory Information We did not publish a notice of proposed rulemaking

(NPRM)for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM because the logistics with respect to the fireworks presentation were not presented to the Coast Guard with sufficient time to draft and publish an NPRM. Any delay encountered in this regulation's effective date would be contrary to the public interest since the safety zone is needed to prevent traffic from transiting a portion of Manchester Bay and Manchester Harbor during the fireworks display and to provide for the safety of life on navigable waters. For the same reasons, the Coast Guard finds, under 5 U.S.C. 553(d)(3), that good cause exists for making this rule effective less than 30 days after publication in the **Federal Register** . The zone should have a minimal negative impact on vessel transits in Manchester Bay and Manchester Harbor because vessels will be excluded from the area for only one and one quarter hours, and vessels can still safely operate in other areas of Manchester Bay and Manchester Harbor during the event. Background and Purpose The Ozzie Family is holding a fireworks display to celebrate a wedding. This rule establishes a temporary safety zone on the waters in the vicinity of Manchester Bay and Manchester Harbor within a four hundred

(400)yard radius of the fireworks barge located at approximate position 42°50.00′ N, 070°47.00′ W. This safety zone is necessary to protect the life and property of the maritime public from the potential dangers posed by this event. It will protect the public by prohibiting entry into or movement within the proscribed portion of Manchester Bay and Manchester Harbor during the fireworks display. Marine traffic may transit safely outside of the zone during the effective period. The Captain of the Port does not anticipate any negative impact on vessel traffic due to this event. Public notifications will be made prior to and during the effective period via marine information broadcasts and Local Notice to Mariners. Discussion of Rule This rule is effective from 9 p.m. EDT on August 12, 2006 until 10:15 p.m. EDT on August 12, 2006. Marine traffic may transit safely outside of the safety zone in the majority of Manchester Bay and Manchester Harbor during the event. Given the limited time-frame of the effective period of the zone, and the actual size of the zone relative to the amount of navigable water around it, the Captain of the Port anticipates minimal negative impact on vessel traffic due to this event. Public notifications will be made prior to and during the effective period via Local Notice to Mariners and marine information broadcasts. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. We expect the economic impact of this rule to be so minimal that a full Regulatory evaluation is unnecessary. Although this rule will prevent traffic from transiting a portion of Manchester Bay and Manchester Harbor during this event, the effect of this rule will not be significant for several reasons: Vessels will be excluded from the area of the safety zone for only one and one quarter hours; although vessels will not be able to transit the area in the vicinity of the zone, they will be able to safely operate in other areas of Manchester Bay and Manchester Harbor during the effective period; and advance notifications will be made to the local maritime community by marine information broadcasts and Local Notice to Mariners. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Manchester Bay and Manchester Harbor from 9 p.m. EDT on August 12, 2006 until 10:15 p.m. EDT on August 12, 2006. This safety zone will not have a significant economic impact on a substantial number of small entities for the reason described under the Regulatory Evaluation section. Assistance for Small Entities Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If this rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call Chief Petty Officer Paul English, Sector Boston, Waterways Management Division, at

(617)223-5456. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, 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. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969

(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation. This rule is categorically excluded under paragraph (34)(g), because the rule establishes a safety zone. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add temporary § 165.T01-102 to read as follows: § 165.T01-102 Safety Zone; R. Ozzie Wedding Fireworks Display, Manchester By The Sea, MA.

(a)*Location.* The following area is a safety zone: All waters in the vicinity of Manchester Bay and Manchester Harbor, from surface to bottom, within a four hundred

(400)yard radius of the fireworks barge located at approximate position 42°50.00′ N, 070°47.00′ W.

(b)*Effective Date.* This rule is effective from 9 p.m. EDT on August 12, 2006 until 10:15 p.m. EDT on August 12, 2006.

(c)*Definitions.*

(1)*Designated representative* means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port (COTP).

(2)*[Reserved]*

(d)*Regulations.*

(1)In accordance with the general regulations in 165.23 of this part, entry into or movement within this zone by any person or vessel is prohibited unless authorized by the Captain of the Port (COTP), Boston or the COTP's designated representative.

(2)The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or the COTP's designated representative.

(3)Vessel operators desiring to enter or operate within the safety zone must contact the COTP or the COTP's designated representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or the COTP's designated representative. Dated: August 1, 2006. James L. McDonald, Captain, U.S. Coast Guard, Captain of the Port, Boston, Massachusetts. [FR Doc. E6-13200 Filed 8-10-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 59 RIN 2900-AM42 Priority for Partial Grants to States for Construction or Acquisition of State Home Facilities AGENCY: Department of Veterans Affairs. ACTION: Interim final rule. SUMMARY: This document amends the Department of Veterans Affairs

(VA)regulations regarding grants to States for construction or acquisition of State homes. This amendment is necessary to ensure that projects designed to remedy conditions at an existing State home that have been cited as threatening to the lives or safety of the residents receive priority for receiving VA grants in the future (including in fiscal year 2007). DATES: *Effective Date:* This interim final rule is effective August 11, 2006. Comments must be received on or before October 10, 2006. ADDRESSES: Written comments may be submitted by: mail or hand-delivery to Director, Regulations Management (00REG1), Department of Veterans Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20042; fax to

(202)273-9026; or e-mail through *http://www.Regulations.gov.* Comments should indicate that they are submitted in response to “RIN 2900-AM42.” All comments received will be available for public inspection in the Office of Regulations Management, Room 1063B, between the hours of 8 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call

(202)273-9515 for an appointment. FOR FURTHER INFORMATION CONTACT: Frank Salvas, Chief, State Home Construction Grant Program (114), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave., NW., Washington, DC 20420, 202-273-8534. SUPPLEMENTARY INFORMATION: Congress has authorized VA to provide grants to States for the construction and acquisition of State homes for the care of veterans. See 38 U.S.C. 8131-8137. The law mandates that VA use certain priorities in establishing a list of approved projects to receive funding. VA has used these priorities to establish the priority and subpriority groups that are set forth in 38 CFR 59.50. For instance, the top priority group is for projects from States that have made sufficient funds available for their projects. That group is divided into six sub-groups, which are (in order of priority):

(1)Projects to remedy conditions found to threaten the lives or safety of patients (i.e., life safety projects that may include, for example, seismic concerns, egress, smoke barriers and fire walls, fire alarm and detection, or asbestos and other hazardous materials),

(2)projects from States that have not previously applied for the construction or acquisition of a State nursing home,

(3)projects from States that have a great need for new State home beds,

(4)other projects for the renovation of a State home,

(5)projects from States that have a significant need for new State home beds, and

(6)projects from States that have a limited need for new State home beds. Sometimes, States with higher-ranking applications within the top priority group deplete the available funding to the extent that VA is able to offer the State with the lowest-ranking application (for which grant funds are available) only a partial grant. Currently, 38 CFR 59.50(b) provides that if a State accepts a partial grant in a given fiscal year, that State's project will have the highest priority for funding in the next fiscal year. This provision was promulgated originally because States were hesitant to accept a partial grant if there was uncertainty of receiving sufficient grant funding in the next fiscal year. The existing regulation encourages States to accept a partial grant by giving them the highest priority for appropriated grant funds in the subsequent fiscal year. Without receiving the highest priority for appropriated grant funds, States offered a partial grant would likely turn it down, and the money would go to lower-priority projects. VA foresees that the regulatory provision granting the highest priority for appropriated funds in the subsequent fiscal year to States accepting partial grants may render VA unable to meet its statutory obligations for prioritizing grant applications, especially for giving top priority to life safety projects. A revision is needed immediately due to the pendency of one large construction project from a State with “great” need which is in line to receive a partial grant this year and which would otherwise then consume all the funding expected for grants during fiscal year

(FY)2007. This would result in no available funds for grants for life safety projects during FY 2007, contrary to the statutory priority that is to be given those projects. This rule changes the priority that a project receiving a partial grant may receive during the next fiscal year. Rather than receiving highest priority in the next fiscal year, a project receiving a partial grant would receive highest priority only with respect to 30 percent of the funds actually appropriated for grants. In other words, such a project would qualify to receive no more than 30 percent of the funds appropriated for this purpose. The partial-grant project could receive more funding but would have to compete for it without the advantage of any special priority. For example, a State seeking a grant for $160 million that has received a partial grant of $70 million in the 2006 fiscal year would qualify to receive up to 30 percent of the funds available to VA for the award of State home grants during FY 2007. If VA has $85 million available for State home grants for FY 2007, the partial-grant State would receive 30 percent of that amount ($25.5 million) because of its highest priority as a partial-grant recipient. If the partial-grant recipient also ranks number 15 on the priority list with respect to the rest of the 70 percent of available funds, and the higher-ranked applicants seek only $45.5 million, the partial-grant recipient would be awarded an additional $14 million for a total of $39.5 million. This rule provides VA with the flexibility to set aside at least 70 percent of the grant funds for life safety projects consistent with the priority for such projects mandated by Congress. Based on past experience and our best estimates, we anticipate a 70-percent allocation would provide sufficient funds to cover anticipated life safety projects in FY 2007 and subsequent years. Life safety projects used 10 percent of available funds in FY 2004 and 5 percent of available funds in FY 2005, and will use about 34 percent of available funds in FY 2006. However, based on existing and recent life safety applications, and indications from States that more such applications will be submitted, we estimate that the demand for life safety projects in FY 2007 may require up to 70 percent of the available funds. At the same time, we believe a 30-percent allocation to partial-grant recipients in the following year will provide some incentive for States to accept a partial grant. It is possible that there may be more than one partial-grant recipient in a given fiscal year. In the above example, another higher-priority applicant seeking a $25 million grant could receive the remaining $14 million from the 70 percent of the funds as a partial grant. Under this regulation, this partial-grant recipient would also receive priority over all other applicants for up to 30 percent of the funding that would be set aside for partial-grant recipients during the next fiscal year. To address this possibility, this regulation further prioritizes the partial-grant recipients on the priority list for the next fiscal year based on the date that VA first awarded a partial grant for the projects (the earlier the grant was awarded, the higher the priority given). Administrative Procedure Act In accordance with 5 U.S.C. 553(b)(3)(B), the Secretary of Veterans Affairs finds that there is good cause to dispense with the opportunity for prior comment with respect to this rule. The Secretary finds that it is impracticable, unnecessary, and contrary to the public interest to delay this regulation for the purpose of soliciting prior public comment. This action is consistent with the priorities established by Congress and is needed on an expedited basis because the current regulation may preclude VA from funding life safety projects during FY 2007. While it is important to give States receiving partial grants priority for continued funding, these regulations need to recognize the other priorities for awarding State home grants including the top priority for projects that protect the lives and safety of veterans residing in existing State homes. For the foregoing reasons, the Secretary of Veterans Affairs is issuing this rule as an interim final rule. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by the State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This amendment would have no such effect on State, local, and tribal governments, or on the private sector. Executive Order 12866 Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million or more; creating a serious inconsistency or interfering with an action of another agency; materially altering the budgetary impact of entitlements or the rights of entitlement recipients, or raising novel legal or policy issues. VA has examined the economic, legal, and policy implications of this interim final rule and has concluded that it is a significant regulatory action because it raises novel policy issues. Paperwork Reduction Act This document contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Regulatory Flexibility Act The Secretary hereby certifies that this regulatory amendment will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The rule will affect grants to States and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analyses requirements of sections 603 and 604. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance program number and title for this rule are as follows: 64.005, Grants to States for Construction of State Home Facilities. List of Subjects in 38 CFR Part 59 Administrative practice and procedure; Alcohol abuse; Alcoholism; Claims; Day care; Dental health; Drug abuse; Foreign relations; Government contracts; Grant programs-health; Grant programs-veterans; Health care; Health facilities; Health professions; Health records; Homeless; Medical and dental schools; Medical devices; Medical research; Mental health programs; Nursing homes; Reporting and Recordkeeping requirements; Travel and transportation expenses, Veterans. Approved: June 23, 2006 R. James Nicholson, Secretary of Veterans Affairs. For the reasons stated above, the Department of Veterans Affairs amends 38 CFR part 59 as follows: PART 59—GRANTS TO STATES FOR CONSTRUCTION OR ACQUISITION OF STATE HOMES 1. The authority citation for part 59 continues to read as follows: Authority: 38 U.S.C. 101, 501, 1710, 1742, 8105, 8131-8137. 2. Amend § 59.50 by revising paragraph

(b)to read as follows: § 59.50 Priority List. (b)(1) If a State accepts a partial grant for a project under § 59.80(a)(2), VA will give that project the highest priority for the next fiscal year within the priority group to which it is assigned (without further prioritization of that priority group) to receive up to 30 percent of the funds available for that year. Funds available do not include funds conditionally obligated in the previous fiscal year under § 59.70(a)(2).

(2)If, in a given fiscal year, more than one State previously accepted a partial grant under § 59.80(a)(2), these partial-grant recipients will be further prioritized on the priority list for that fiscal year based on the date that VA first awarded a partial grant for the project (the earlier the grant was awarded, the higher the priority given). The partial-grant recipients, in aggregate, may receive up to 30 percent of the funds available for that year that would be set aside for partial-grant recipients. [FR Doc. E6-13153 Filed 8-10-06; 8:45 am] BILLING CODE 8320-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-R04-OAR-2005-TN-0007-200527(c) FRL-8208-9] Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; Tennessee; Redesignation of the Montgomery County, Tennessee Portion of the Clarksville-Hopkinsville 8-Hour Ozone Nonattainment Area to Attainment; Correcting Amendment AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule; correcting amendment. SUMMARY: This action corrects the effective date for the 8-hour ozone attainment designation for the Montgomery County, Tennessee portion of the Clarksville-Hopkinsville 8-hour ozone nonattainment area. The effective date for this attainment designation, which appears in title 40 Code of Federal Regulation

(CFR)81.343, was erroneously identified as October 24, 2005, in the Part 81 chart at the end of EPA's September 22, 2005, direct final redesignation rulemaking (70 FR 55559). This error is being corrected to reflect an effective date of November 21, 2005, for Montgomery County, Tennessee's 8-hour ozone attainment designation. DATES: *Effective Date:* This correcting amendment is effective on August 11, 2006. ADDRESSES: Copies of the documentation used in the action being corrected are available for inspection during normal business hours at the following location: U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding federal holidays. FOR FURTHER INFORMATION CONTACT: Dr. Egide Louis, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number is

(404)562-9240. Dr. Louis can also be reached via electronic mail at *louis.egide@epa.gov.* SUPPLEMENTARY INFORMATION: On September 22, 2005 (70 FR 55559), EPA published a direct final rulemaking action approving the redesignation of the Montgomery County, Tennessee portion of the Clarksville-Hopkinsville 8-hour ozone nonattainment area to attainment status. In the “Dates” section and in section VIII of the September 22, 2005, action, EPA stated that the rule would be effective on November 21, 2005, unless EPA received adverse written comments by October 24, 2005. 70 FR 55559, 55566. However, in the part 81 chart at the end of the rulemaking action, EPA erroneously identified the effective date for the attainment designation as October 24, 2005, instead of November 21, 2005. (70 FR 55568). Today, we are correcting the effective date of the Montgomery County, Tennessee 8-hour ozone attainment redesignation that appears in 40 CFR 81.343, so that it correctly reflects the effective date of the redesignation rulemaking, which is November 21, 2005. EPA has determined that today's action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act

(APA)which, upon finding “good cause,” authorizes agencies to dispense with public participation where public notice and comment procedures are impracticable, unnecessary or contrary to the public interest. Public notice and comment for this action are unnecessary because today's action to correct the effective date of the 8-hour ozone attainment redesignation for Montgomery County, Tennessee has no substantive impact on EPA's September 22, 2005, redesignation approval. That is, the correction of the 8-hour ozone attainment redesignation effective date makes no substantive difference to EPA's redesignation analysis as set out in our September 22, 2005, rule, and merely corrects an error made in that prior rulemaking. In addition, EPA can identify no particular reason why the public would be interested in being notified of the correction of this error or in having the opportunity to comment on the correction prior to this action being finalized, since this correction action does not change the redesignation approval and merely conforms the effective date of the attainment redesignation to coincide with the effective date of the redesignation rulemaking. See, 70 FR 55559, 55568. EPA also finds that there is good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action. Section 553(d)(3) of the APA allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed in APA section 553(d)(3) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Today's rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, today's rule merely corrects an inadvertent error by conforming the effective date of the 8-hour ozone attainment redesignation for Montgomery County, Tennessee to the effective date of EPA's rulemaking approving the redesignation. For these reasons, EPA finds good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely corrects an inadvertent error by conforming the effective date of the 8-hour ozone attainment redesignation for Montgomery County, Tennessee to the effective date of EPA's rulemaking approving the redesignation, and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule merely corrects an inadvertent error by conforming the effective date of the 8-hour ozone attainment redesignation for Montgomery County, Tennessee to the effective date of EPA's rulemaking approving the redesignation, and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, 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 by Executive Order 13175 (65 FR 67249, November 9, 2000). This rule also does not have Federalism implications because it does not 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This rule merely corrects an inadvertent error by conforming the effective date of the 8-hour ozone attainment redesignation for Montgomery County, Tennessee to the effective date of EPA's rulemaking approving the redesignation, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In addition, this rule does not involve technical standards, thus the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule also does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). 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 the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act (CAA), petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 10, 2006. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).) List of Subjects in 40 CFR Part 81 Environmental protection, Air pollution control, National parks, Wilderness areas. Dated: July 20, 2006. A. Stanley Meiburg, Acting, Regional Administrator, Region 4. 40 CFR part 81 is amended as follows: PART 81—[CORRECTED] 1. The authority citation for part 81 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* 2. In § 81.343, the table entitled “Tennessee_Ozone (8-Hour Standard)” is amended by revising the entry for “Clarksville-Hopkinsville, TN-KY: Montgomery County” to read as follows: § 81.343 Tennessee. Tennessee—Ozone (8-Hour Standard) Designated area Designation a Date 1 Type Category/classification Date 1 Type * * * * * * * Clarksville-Hopkinsville, TN-KY Area: Montgomery County 11/ 21/05 Attainment * * * * * * * a Includes Indian Country located in each county or area, except as otherwise specified. 1 This date is June 15, 2004, unless otherwise noted. [FR Doc. E6-13161 Filed 8-10-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0314; FRL-8085-3] Copper Sulfate Pentahydrate; Tolerance Exemption in or on Various Food and Feed Commodities AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance exemption for residues of copper sulfate pentahydrate when applied in or on meat, fat and meat by-products of cattle, sheep, hogs, goats, horses, poultry, milk and eggs when applied as a bactericide/fungicide to animal premises and bedding. DATES: This regulation is effective August 11, 2006. Objections and requests for hearings must be received on or before October 10, 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-2005-0314. All documents in the docket are listed on the regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are 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: Marshall Swindell, Antimicrobials Division (7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-6341; e-mail: *swindell.marshall@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? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://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-2005-0314 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 10, 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-2005-0314, by one of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 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 telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of December 21, 2005 (70 FR 75807) (FRL-7748-3), EPA issued a notice pursuant to section 408(d)(2) of Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act

(FQPA)(Public Law 104-107) announcing the filing of a pesticide petition (PP 5F6982), by ArchAngel, LLC, 636 Hampshire St., Suite 208, Quincy, IL 62301. EPA did not receive any public comments in response to this petition. The petition requested that 40 CFR part 180 be amended to exempt from the requirement of a tolerance residues of the bactericide/fungicide copper sulfate pentahydrate when applied as a bactericide/fungicide in or on meat, fat and meat by-products of cattle, sheep, hogs, goats, horses, poultry, milk and eggs when applied as a bactericide/fungicide to animal premises and bedding. Various copper containing substances, including copper sulfate pentahydrate, have been exempted from tolerance requirements for numerous uses. 40 CFR 180.1021 exempts the listed copper compounds when applied, among other things, to growing crops as well as shellfish, meat, milk, poultry, eggs, and irrigated crops. 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 copper sulfate pentahydrate are discussed in this unit. There is adequate information available to characterize the toxicity of the copper ion. Copper is ubiquitous in nature and is a necessary nutritional element for both animals (including humans) and plants. Copper is found naturally in the food we eat including fruits, vegetables, meats and seafood. It is found in the water we drink, the air we breathe and in our bodies themselves. Some of the environmental copper is due to direct modification of the environment by man such as mining and smelting of the natural ore. It is one of the elements found essential to life. The National Academy of Science establishes recommended daily allowances

(RDAs)of vitamins and minerals for the diet. The RDA for copper ranges from approximately 400 micrograms per day (μg/d) in young children to 900 μg/d in adults. Additionally, over-the-counter dietary supplements containing copper at levels ranging from 0.33 milligram

(mg)to 3 mg are available for individuals with low levels of copper. The copper ion is present in the adult human body with nearly two-thirds of the body copper content located in the skeleton and muscle. The liver is the primary organ for the maintenance of plasma copper concentrations. Oral ingestion of excessive amounts of the copper ion from pesticidal uses including the proposed use is unlikely. Copper compounds are irritating to the gastric mucosa. Ingestion of large amounts of copper results in prompt emesis. This protective reflex reduces the amount of copper ion available for absorption into the human body. Additionally, at high levels humans are also sensitive to the taste of copper. Because of this organoleptic property, oral ingestions would also serve to limit high doses. Only a small percentage of ingested copper is absorbed, and most of the absorbed copper is excreted. The human body appears to have efficient mechanisms in place to regulate total body copper. The copper ion occurs naturally in food and the metabolism of copper is well understood. The Agency has conducted a risk assessment in connection with the development and issuance of the Reregistration Eligibility Decision Document for Copper (EPA-HQ-OPP-2005-0558; Human Health Chapter). No endpoints of toxicology concern were identified for risk assessment purposes for a number of reasons. One of the foremost of these is the fact that copper is a required nutritional element for both plants and animals. Indeed, current available data and literature studies indicate that there is a greater risk from the deficiency of copper intake than from excess intake. Copper also occurs naturally in a number of food items including fruits, vegetables, meats and seafood. Although there is little known about the minimum levels of dietary copper necessary to cause evidence of adverse effect, this situation is likely due to the existence of an effective homeostatic mechanism that is involved in the dietary intake of copper and that protects man from excess body copper. Given that copper is ubiquitous and is routinely consumed as part of the daily diet, it is unlikely that with the current exposure pattern there would be any long term adverse effects. Finally, sulfate has little toxic effect and is routinely used in medicine as a cathartic when combined with magnesium or sodium, the only adverse manifestation from this use being dehydration if water intake is concurrently limited. 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 establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide chemicals, the Agency considers the toxicity of the chemical in conjunction with possible exposure to residues of the chemical through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure, an exemption from the requirement of a tolerance may be established. A. Dietary Exposure Copper is ubiquitous in nature and is a necessary nutritional element for both animals (including humans) and plants. It is one of several elements found essential to life. The human body must have copper to stay healthy. In fact, for a variety of biochemical processes in the body to operate normally, copper must be part of our daily diet. Copper is needed for certain critical enzymes to function in the body. Actually, too little copper in the body can actually lead to disease. 1. *Food* . The main source of copper for infants, children, and adults, regardless of age, is the diet. Copper is typically present in mineral rich foods like vegetables (potato, legumes (beans and peas), nuts (peanuts and pecans), grains (wheat and rye), fruits (peaches and raisins), and chocolate in levels that range from 0.3 to 3.9 ppm. A single day's diet may contain 10 mg or more of copper. The daily recommended allowance of copper for adult nutritional needs is 2 mg. It is not likely that the approval of this petition would significantly increase exposure over that of the existing levels of copper. 2. *Drinking water exposure* . Copper is a natural element found in the earth's crust. As a result, most of the world's surface water and ground water that is used for drinking purposes contains copper. The actual amount varies from region to region, depending on how much is present in the earth, but in almost all cases the amount of copper in water is extremely low. Naturally occurring copper in drinking water is safe for human consumption, even in rare instances where it is at levels high enough to impart a metallic taste to the water. Residues of copper in drinking water are regulated under the Safe Drinking Water Act. A Maximum Contaminant Level Goal of 1.3 ppm has been set by the Agency for copper. According to the National Research Council's Committee on Copper in Drinking Water, this level is “set at a concentration at which no known or expected adverse health effects occur and for which there is an adequate margin of safety.” The Agency believes that this level of protection would not cause any potential health problems, i.e. stomach and intestinal distress, liver and kidney damage and anemia. It is not likely that the approval of this petition would significantly increase exposure over that of the existing levels of copper. B. Other Non-Occupational Exposure Copper compounds have many uses on crops (food as well as non-food) and ornamentals as a fungicide. *Dermal exposure* . Given the prevalence of copper in the environment, no significant dermal exposure increase above current levels would be expected from the non-occupational use of copper sulfate pentahydrate. *Inhalation exposure* . Air concentrations of copper are relatively low. A study based on several thousand samples assembled by EPA's Environmental Monitoring Systems Laboratory showed copper levels ranging from 0.003 to 7.32 micrograms per cubic meter. Other studies indicated that air levels of copper are much lower. The Agency does not expect the air concentrations of copper to be significantly affected by the use of copper sulfate pentahydrate. V. Cumulative Effects The Agency believes that copper has no significant toxicity to humans and that no cumulative adverse effects are expected from long-term exposure to copper salts including copper sulfate pentahydrate. For the purposes of this tolerance action, EPA has not assumed that copper compounds have a common mechanism of toxicity with other substances. VI. Determination of Safety for U.S. Population, Infants and Children Copper sulfate pentahydrate is considered as Generally Recognized as Safe

(GRAS)by the Food and Drug Administration (FDA). EPA has also exempted various copper compounds from the requirement of a tolerance when used as aquatic herbicides (40 CFR 180.1021). Copper compounds, including copper sulfate pentahydrate, are also exempt from the requirements of a tolerance when applied to growing crops when used as a plant fungicide in accordance with good agricultural practices (40 CFR 180.1021). 1. *U.S. population* . Copper is a component of the human diet and an essential element. In addition, no acute or chronic dietary end points were selected because no endpoints of toxicological concerns have been identified for risk assessment purposes. Use of copper sulfate pentahydrate is not expected to increase the amount of copper in the diet as a result of its use on growing crops and post harvest use. 2. *Infants and children* . Copper is also a component of the diet of infants and children and also an essential element of their diet. Since no endpoints of concern have been identified, EPA has not conducted a quantitative risk assessment for copper sulfate pentahydrate. The Agency has also determined that the special FQPA safety factor to protect infants and children was not needed since there are no toxicity endpoints or uncertainty surrounding exposure. Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm to the general population, including infants and children, from aggregate exposure to copper sulfate pentahydrate residues. VII. Other Considerations A. 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. B. Existing Tolerance Exemptions Copper sulfate pentahydrate has been exempted from the requirement of a tolerance under 40 CFR 180.1021

(c)when applied to growing crops or to raw agricultural commodities after harvest. C. International Tolerances The Agency is not aware of any country requiring a tolerance for copper sulfate pentahydrate nor have any CODEX Maximum Residue Levels

(MRLs)been established for any food crops at this time. VIII. Conclusions Based on the information contained in the document, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of copper sulfate pentahydrate. According, EPA finds that the exemption for residues in or on meat, fat and meat by-products of cattle, sheep, hogs, goats, horses and poultry, milk and eggs when applied as a bactericide/fungicide to animal premises and bedding will be safe. IX. 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. 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, 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. X. 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, copper sulfate pentahydrate. Dated: August 3, 2006. Frank Sanders, Director, Antimicrobials 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. Section 180.1021 is amended by revising paragraph

(c)to read as follows: § 180.1021 Copper; exemption from the requirement of a tolerance.

(c)Copper sulfate pentahydrate (CAS Reg. No. 7758-99-8) is exempt from the requirement of a tolerance when applied as a fungicide to growing crops or to raw agricultural commodities after harvest, and as a bactericide/fungicide in or on meat, fat and meat by-products of cattle, sheep, hogs, goats, horses and poultry, milk and eggs when applied as a bactericide/fungicide to animal premises and bedding. [FR Doc. E6-13082 Filed 8-10-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0542; FRL-8081-8] Imidacloprid; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as the parent in or on caneberry subgroup 13A; coffee, green bean; seed of: Black mustard, borage, crambe, field mustard, flax, Indian mustard, Indian rapeseed, rapeseed, safflower, and sunflower; atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar apple; almond hulls, pistachio and tree nut group 14; pomegranate; banana; herbs subgroup 19A dried; and herbs subgroup 19A fresh. Interregional Research Project No. 4 (IR-4), requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective August 11, 2006. Objections and requests for hearings must be received on or before October 10, 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-2005-0542. 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 *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The 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: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-6463; e-mail address: *madden.barbara@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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. 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? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm* . 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-2005-0542 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 10, 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-2005-0542, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of March 22, 2006 (71 FR 14524) (FRL-7769-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 3E6543, PP 3E6561, PP 3E6738, PP 3E6760, PP 5E6920, PP 5E6921, PP 5E6922, PP 5E6923) by Interregional Research Project No. 4 (IR-4), 681 U.S. Highway No. 1 South, North Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 180.472 be amended by establishing tolerances for residues of the insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]- *N* -nitro-2-imidazolidinimine, and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid in or on the raw agricultural commodities as follows: Caneberry subgroup 13A at 0.05 parts per million

(ppm)(PP 3E6543); coffee at 0.6 ppm (PP 3E6561); seed of: Black mustard, borage, crambe, field mustard, flax, Indian mustard, Indian rapeseed, rapeseed, safflower, and sunflower at 0.05 ppm (PP 3E6738); atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 0.2 ppm (PP 3E6760); almond hulls at 2.5 ppm; and pistachio and tree nut group 14 at 0.01 ppm (PP 5E6920); pomegranate at 0.7 ppm (PP 5E6921); banana at 0.6 ppm (PP 5E6922); herbs subgroup 19A dried at 62.0 ppm and herbs subgroup 19A fresh at 6.0 ppm (PP 5E6923). Tolerances were later amended as follows: Coffee at 0.80 ppm (PP 3E6561); atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 0.30 ppm (PP 3E6760); almond hulls at 4.0 ppm; and pistachio and tree nut group 14 at 0.05 ppm (PP 5E6920); pomegranate at 0.90 ppm (PP 5E6921); banana at 0.50 ppm (PP 5E6922); herb subgroup, 19A, herbs, dried at 48.0 ppm and herb subgroup, 19A, herbs, fresh at 8.0 ppm (PP 5E6923). In addition to establishing tolerances, EPA is also deleting several established tolerances from the tables in § 180.472(a), (b), and

(d)that are no longer needed as a result of this action. The tolerance deletions under § 180.472(b) are time-limited tolerances established under section 18 emergency exemptions that are superceded by the establishment of general tolerances for imidacloprid and its metabolites under § 180.472(a). Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety 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. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for combined residues of the insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]- *N* -nitro-2-imidazolidinimine, and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid in or on caneberry subgroup 13A at 0.05 parts per million (ppm); coffee, green bean at 0.80 ppm; seed of: Black mustard, borage, crambe, field mustard, flax, Indian mustard, Indian rapeseed, rapeseed, safflower, and sunflower at 0.05 ppm; atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 0.30 ppm; almond hulls at 4.0 ppm; pistachio and tree nut group 14 at 0.05 ppm; pomegranate at 0.90 ppm; banana at 0.50 ppm; herb subgroup, 19A, herbs, dried at 48.0 ppm and herb subgroup, 19A, herbs, fresh at 8.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by imidacloprid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.epa.gov/fedrgstr/EPA-PEST/2003/June/Day-13/p14880.htm* . B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for imidacloprid used for human risk assessment is discussed in Unit III.B. of the final rule published in the **Federal Register** of June 13, 2003 (68 FR 35303) (FRL-7310-8), or at *http://www.epa.gov/fedrgstr/EPA-PEST/2003/June/Day-13/p14880.htm* . C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.472) for the combined residues of imidacloprid, in or on a variety of raw agricultural commodities. Meat, milk, poultry, and egg tolerances have also been established for the combined residues of imidacloprid. Risk assessments were conducted by EPA to assess dietary exposures from imidacloprid in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model - Food Commodity Intake Database (DEEM-FCID TM ) analysis evaluated the individual food consumption as reported by respondents in the U.S. Department of Agriculture

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: An unrefined, acute dietary exposure assessment using tolerance-level residues and assuming 100 pecent crop treated

(PCT)for all registered and proposed commodities was conducted for the general U.S. population and various population subgroups. Drinking water was incorporated directly in the dietary assessment using the acute

(peak)concentration for surface water generated by the FQPA Index Reservoir Screening Tool (FIRST) model. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID TM , which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A partially refined, chronic dietary exposure assessment using tolerance-level residues for all registered and proposed commodities, and PCT information for some commodities was conducted for the general U.S. population and various population subgroups. Drinking water was incorporated directly into the dietary assessment using the chronic (annual average) concentration for surface water generated by the FIRST model. iii. *Cancer* . An exposure assessment related to cancer risk is unnecessary. The Agency has classified imidacloprid as a “Group E” chemical, no evidence of carcinogenicity for humans, by all routes of exposure based upon lack of evidence of carcinogenicity in rats and mice. iv. *Anticipated residue and PCT information.* Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: For the acute assessment, 100 PCT was assumed for all registered and proposed commodities. For the chronic assessment, average weighted PCT information was used for the following commodities: Apple 30%; artichokes 5%; beets 15%; blueberries 10%; broccoli 35%; brussels sprouts 55%; cabbage 20%; cantaloupe 30%; carrots 1%; cauliflower 40%; celery 5%; cherries 5%; collards 10%; corn, field 1%; cotton 5%; cucumber 5%; eggplant 45%; grapefruit 5%; grape 30%; honeydew 10%; hops 90%; kale 30%; lemon 1%; lettuce, head 60%; orange 5%; peaches 5%; pear 10%; pepper 25%; potatoes 35%; pumpkin 5%; spinach 20%; squash 10%; strawberries 10%; sugarbeet 1%; sweet corn 1%; tangerine 10%; tomato 15%; watermelon 10%. A default value of 1% was used for all commodities which were reported as having 1 PCT. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available Federal, State, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of 5% except for those situations in which the average PCT is less than 1. In those cases 1% is used as the average and 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available Federal, State, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of 5%. In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent 6 years. 2. *Dietary exposure from drinking water.* The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for imidacloprid in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of imidacloprid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the FIRST and screening concentration in ground water (SCI-GROW) models, the estimated environmental concentrations

(EECs)of imidacloprid for acute exposures are estimated to be 36.0 parts per billion

(ppb)for surface water and 2.09 ppb for ground water. The EECs for chronic exposures are estimated to be 17.2 ppb for surface water and 2.09 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM , Version 2.03). For acute dietary risk assessment, the peak water concentration value of 36.0 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the annual average concentration of 17.2 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Imidacloprid is currently registered for use on the following residential non-dietary sites: Granular products for application to lawns and ornamental plants; ready-to-use spray for application to flowers, shrubs and house plants; plant spikes for application to indoor and outdoor residential potted plants; ready-to-use potting medium for indoor and outdoor plant containers; liquid concentrate for application to lawns, trees, shrubs and flowers; ready-to-use liquid for directed spot application to cats and dogs. In addition, there are numerous registered products intended for use by commercial applicators to residential sites. These include gel baits for cockroach control; products intended for commercial ornamental, lawn and turf pest control; products for ant control; and products used as preservatives for wood products, building materials, textiles and plastics. As these products are intended for use by commercial applicators only, they are not to be addressed in terms of residential pesticide handlers. The risk assessment was conducted using the following residential exposure assumptions: EPA has determined that residential handlers are likely to be exposed to imidacloprid residues via dermal and inhalation routes during handling, mixing, loading, and applying activities. Based on the current use patterns, EPA expects duration of exposure to be short-term (1-30 days). EPA does not expect imidacloprid to result in exposure durations that would result in intermediate-term or long-term exposure. The scenarios likely to result in adult dermal and/or inhalation residential handler exposures are as follows: • Dermal and inhalation exposure from using a granular push-type spreader; • Dermal exposure from using potted plant spikes; • Dermal exposure from using a plant potting medium; • Dermal and inhalation exposure from using a garden hose-end sprayer (dermal and inhalation exposure from using a RTU trigger pump spray is expected to be negligible); • Dermal and inhalation exposure from using a water can/bucket for soil drench applications; and • Dermal exposure from using pet spot-on. EPA has also determined that there is potential for short-term (1 to 30 days), post-application exposure to adults and children/toddlers from the many residential uses of imidacloprid. Due to residential application practices and the half-lives observed in the turf transferable residue study, intermediate-term and long-term post-application exposures are not expected. The scenarios likely to result in dermal (adult and child/toddler), and incidental non-dietary (child/toddler) short-term post-application exposures are as follows: • Toddler oral hand-to-mouth exposure from contacting treated turf; • Toddler incidental oral ingestion of granules; • Toddler incidental oral ingestion of pesticide-treated soil; • Toddler incidental oral exposure from contacting treated pet; • Toddler dermal exposure from contacting treated turf; • Toddler dermal exposure from hugging treated pet/contacting treated pet; • Adult dermal exposure from contacting treated turf; • Adult golfer dermal exposure from contacting treated turf; • Adolescent golfer dermal exposure from contacting treated turf; and • Adult dermal exposure from contacting treated pet; 4. *Cumulative effects from substances with a common mechanism of toxicity* . 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 imidacloprid and any other substances and imidacloprid 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 imidacloprid 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* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA 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 base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure

(MOE)analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor

(SF)value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no quantitative or qualitative evidence of increased susceptibility of rat and rabbit fetuses to *in utero* exposure in developmental studies. There is no quantitative or qualitative evidence of increased susceptibility of rat offspring in the multi-generation reproduction study. There is evidence of increased qualitative susceptibility in the rat developmental neurotoxicity study, but the concern is low since: i. The effects in pups are well-characterized with a clear NOAEL; ii. The pup effects occur in the presence of maternal toxicity with the same NOAEL for effects in pups and dams; and, iii. The doses and endpoints selected for regulatory purposes are protective of the pup effects noted at higher doses in the developmental neurotoxicity study. Therefore, there are no residual uncertainties for prenatal-/postnatal toxicity in this study. 3. *Conclusion* . There is a complete toxicity data base for imidacloprid and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be reduced to 1X for the following reasons: The toxicological data base is complete for FQPA assessment. The acute dietary food exposure assessment utilizes existing and proposed tolerance level residues and 100 PCT information for all commodities. By using these screening-level assessments, actual exposures/risks will not be underestimated. The chronic dietary food exposure assessment utilizes existing and proposed tolerance level residues and PCT data verified by the Agency for several existing uses. For all proposed uses, 100 PCT is assumed. The chronic assessment is somewhat refined and based on reliable data and will not underestimate exposure/risk. The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded. The residential handler assessment is based upon the residential standard operating procedures

(SOPs)in conjunction with chemical-specific study data in some cases and the Pesticide Handlers Exposure Database

(PHED)unit exposures in other cases. The majority of the residential post-application assessment is based upon chemical-specific turf transferrable residue data or other chemical-specific post-application exposure study data. The chemical-specific study data as well as the surrogate study data used are reliable and also are not expected to underestimate risk to adults as well as to children. In a few cases where chemical-specific data were not available, the SOPs were used alone. The residential SOPs are based upon reasonable worst-case assumptions and are not expected to underestimate risk. These assessments of exposure are not likely to underestimate the resulting estimates of risk from exposure to imidacloprid. E. Aggregate Risks and Determination of Safety The Agency currently has two ways to estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses. First, a screening assessment can be used, in which the Agency calculates drinking water levels of comparison (DWLOCs) which are used as a point of comparison against estimated drinking water concentrations (EDWCs). The DWLOC values are not regulatory standards for drinking water, but are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. More information on the use of DWLOCs in dietary aggregate risk assessments can be found at *http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf* . More recently the Agency has used another approach to estimate aggregate exposure through food, residential and drinking water pathways. In this approach, modeled surface water and ground water EDWCs are directly incorporated into the dietary exposure analysis, along with food. This provides a more realistic estimate of exposure because actual body weights and water consumption from the CSFII are used. The combined food and water exposures are then added to estimated exposure from residential sources to calculate aggregate risks. The resulting exposure and risk estimates are still considered to be high end, due to the assumptions used in developing drinking water modeling inputs. The risk assessment for imidacloprid used in this tolerance document uses this approach of incorporating water exposure directly into the dietary exposure analysis. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to imidacloprid will occupy 26% of the acute population adjusted dose

(aPAD)for the U.S. population, 18% of the aPAD for females 13 years and older, 54% of the aPAD for all infants 1 year old, and 67% of the aPAD for children 1-2 years old. EPA does not expect the aggregate exposure to exceed 100% of the aPAD. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to imidacloprid from food and water will utilize 11% of the chronic population adjusted dose

(cPAD)for the U.S. population, 22% of the cPAD for all infants 1 year old, and 33% of the cPAD for children 1-2 years old. Based on the use pattern, chronic residential exposure to residues of imidacloprid is not expected. EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Imidacloprid is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for imidacloprid. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in worst-case aggregate MOEs of 320 for the general U.S. population and 170 for children 1-2 years old, the sub-population at greatest exposure. These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food, water and residential uses. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Intermediate- and long-term aggregate risk assessments were not performed because, based on the current use patterns, the Agency does not expect exposure durations that would result in intermediate- or long-term exposures. 5. *Aggregate cancer risk for U.S. population* . The Agency has classified imidacloprid as a “Group E” chemical, no evidence of carcinogenicity for humans, by all routes of exposure based upon lack of evidence of carcinogenicity in rats and mice. Imidacloprid is not expected to pose a cancer risk. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to imidacloprid residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methods are available for determination of imidacloprid residues of concern in plant (Bayer Gas Chromatography/Mass Spectrometry (GC/MS) Method 00200) and livestock commodities (Bayer GC/MS Method 00191). These methods have undergone successful EPA petition method validations (PMVs), and the registrant has fulfilled the remaining requirements for additional raw data, method validation, independent laboratory validation (ILV), and an acceptable confirmatory method (High Performance Liquid Chromatography/Ultraviolet (HPLC/UV) Method 00357). The validated limit of detection

(LOD)and limit of quantitation

(LOQ)for the GC/MS Method 00200 are 0.01 and 0.05 ppm, respectively, in plant commodities. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov.* B. International Residue Limits There are no established Mexican maximum residue limits

(MRLs)for the proposed uses. There are established Codex MRLs for the sum of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, expressed as imidacloprid, in or on rapeseed at 0.05 ppm and banana at 0.05 ppm. In addition, there is currently Canadian MRLs for: 1-[(6-chloro-3-pyridinyl) methyl]-4,5-dihydro- *N* -nitro-1H-imidazol-2-amine, including metabolites containing the 6-chloropicolyl moiety in or on mustard, seed at 0.05 ppm, rapeseed (canola) at 0.05 ppm and pecans at 0.05 ppm. The Codex and Canadian MRLs for rapeseed (canola) is the same as the U.S. recommended tolerance for rapeseed, seed; and the Canadian MRL for pecans is the same as the U.S. recommended tolerance. However, the Canadian MRL for banana is not equivalent to the U.S. recommended tolerance as the available crop field trial data supported a higher tolerance level. Therefore, harmonization is not possible at this time. V. Conclusion Therefore, the tolerances are established for combined residues of the insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]- *N* -nitro-2- imidazolidinimine, and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid in or on caneberry subgroup 13A at 0.05 ppm; coffee, green bean at 0.80 ppm; seed of: Black mustard, borage, crambe, field mustard, flax, Indian mustard, Indian rapeseed, rapeseed, safflower, and sunflower at 0.05 ppm; atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 0.30 ppm; almond hulls at 4.0 ppm; pistachio at 0.05 ppm; tree nut group 14 at 0.05 ppm; pomegranate at 0.90 ppm; banana at 0.50 ppm; herb subgroup, 19A, herbs, dried at 48.0 ppm and herb subgroup, 19A herbs, fresh at 8.0 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(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 section 408(d) of FFDCA, such as the tolerance 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 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 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: August 1, 2006. 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. Section 180.472 is revised to read as follows: § 180.472 Imidacloprid; tolerances for residues.

(a)*General* . Tolerances are established permitting the combined residues of the insecticide imidacloprid (1-[6-chloro-3-pyridinyl) methyl]- *N* -nitro-2-imidazolidinimine) and its metabolites containing the 6-chloropyridinyl moiety, all expressed as 1-[(6-chloro-3-pyridinyl)methyl]- *N* -nitro-2-imidazolidinimine, in or on the following food commodities: Commodity Parts Per Million Acerola 1.0 Almond, hulls 4.0 Apple 0.5 Apple, wet pomace 3.0 Atemoya 0.30 Artichoke, globe 2.5 Avocado 1.0 Banana 0.50 Barley, grain 0.05 Barley, hay 0.5 Barley, straw 0.5 Beet, sugar, roots 0.05 Beet, sugar, tops 0.5 Beet, sugar, molasses 0.3 Biriba 0.30 Blueberry 3.5 Borage, seed 0.05 Caneberry, subgroup 13A 0.05 Canistel 1.0 Canola, seed 0.05 Cattle, fat 0.3 Cattle, meat byproducts 0.3 Cattle, meat 0.3 Cherimoya 0.3 Citrus, dried pulp 5.0 Coffee, green bean 0.80 Corn, field, forage 0.10 Corn, field, grain 0.05 Corn, field, stover 0.20 Corn, pop, grain 0.05 Corn, pop, stover 0.20 Corn, sweet, forage 0.10 Corn, sweet, kernel plus cob with husks removed 0.05 Corn, sweet, stover 0.20 Cotton, gin byproducts 4.0 Cotton, undelinted seed 6.0 Cotton, meal 8.0 Crambe, seed 0.05 Cranberry 0.05 Currant 3.5 Custard apple 0.30 Egg 0.02 Elderberry 3.5 Feijoa 1.0 Flax, seed 0.05 Fruit, citrus, group 10 0.7 Fruit, pome, group 11 0.6 Fruit, stone, group 12 3.0 Goat, fat 0.3 Goat, meat byproducts 0.3 Goat, meat 0.3 Gooseberry 3.5 Grape, juice 1.5 Grape, pomace (wet or dried) 5.0 Grape, raisin 1.5 Grape, raisin, waste 15.0 Grape 1.0 Guava 1.0 Herbs subgroup 19A, dried herbs 48.0 Herbs subgroup 19B, fresh herbs 8.0 Hog, fat 0.3 Hog, meat byproducts 0.3 Hog, meat 0.3 Hop, dried cone 6.0 Horse, fat 0.3 Horse, meat byproducts 0.3 Horse, meat 0.3 Huckleberry 3.5 Ilama 0.30 Jaboticaba 1.0 Juneberry 3.5 Leaf petioles subgroup 4B 6.0 Leafy greens subgroup 4A 3.5 Lettuce, head and leaf 3.5 Lingonberry 3.5 Longan 3.0 Lychee 3.0 Mango 1.0 Milk 0.1 Mustard, black, seed 0.05 Mustard, field, seed 0.05 Mustard, Indian, seed 0.05 Mustard, rapeseed, seed 0.05 Mustard, seed 0.05 Nut, tree, group 14 0.05 Oats, forage 2.0 Oats, grain 0.05 Oats, hay 6.0 Oats, straw 3.0 Okra 1.0 Passionfruit 1.0 Papaya 1.0 Pecans 0.05 Persimmon 3.0 Pistachio 0.05 Pomegranate 0.90 Potato, chip 0.4 Potato, waste 0.9 Poultry, fat 0.05 Poultry, meat byproducts 0.05 Poultry, meat 0.05 Pulasan 3.0 Rambutan 3.0 Rapeseed, seed 0.05 Rye, forage 2.0 Rye, grain 0.05 Rye, hay 6.0 Rye, straw 3.0 Safflower, seed 0.05 Salal 3.5 Sapodilla 1.0 Sapote, black 1.0 Sapote, mamey 1.0 Sheep, fat 0.3 Sheep, meat byproducts 0.3 Sheep, meat 0.3 Sorghum, forage 0.10 Sorghum, grain 0.05 Sorgum, stover 0.10 Soursop 0.30 Soybean, meal 4.0 Soybean, seed 1.0 Spanish lime 3.0 Star apple 1.0 Starfruit 1.0 Strawberry 0.50 Sugar apple 0.30 Sunflower, seed 0.05 Tomato, paste 6.0 Tomato, pomace (wet or dried) 4.O Tomato, puree 3.0 Vegetable, brassica leafy, group 5 3.5 Vegetable, cucurbit, group 9 0.5 Vegetable, fruiting, group 8 1.0 Vegetable, leaves of root and tuber, group 2 4.0 Vegetable, legume, except soybean, group 6 4.0 Vegetable, root and tuber, group 1, except sugar beet 0.40 Watercress 3.5 Watercress, upland 3.5 Wax jambu 1.0 Wheat, forage 7.0 Wheat, grain 0.05 Wheat, hay 0.5 Wheat, straw 0.5

(b)*Section 18 emergency exemptions* . [Reserved]

(c)*Tolerances with regional registrations* . [Reserved]

(d)*Indirect or inadvertent residues* . Tolerances are established for indirect or inadvertent combined residues of the insecticide imidacloprid (1-[(6-chloro-3-pyridinyl)methyl]- *N* -nitro-2-imidazolidinimine) and its metabolites containing the 6-chloropyridinyl moiety, all expressed as 1-[(6-chloro-3-pyridinyl)methyl]- *N* -nitro-2-imidazolidinimine, when present therein as a result of the application of the pesticide to growing crops listed in this section and other non-food crops as follows: Commodity Parts Per Million Forage, fodder, and straw of Grain, cereal crop group (forage) 2.0 Forage, fodder, and straw of Grain, cereal crop group

(hay)6.0 Forage, fodder, and straw of Grain, cereal crop group (stover) 0.3 Forage, fodder, and straw of Grain, cereal crop group (straw) 3.0 Grain, cereal, group 15 0.05 Sweet corn, kernel plus cob with husks removed 0.05 Vegetable, foliage of legume, group 7 2.5 Vegetable, legume, crop group 6 0.3 [FR Doc. E6-13092 Filed 8-10-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0366; FRL-8081-7] Bifenthrin; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of bifenthrin in or on Vegetable, tuberous and corm, subgroup 1C; Brassica, leafy greens, subgroup 5B; turnip, greens; Pea and bean, dried shelled, except soybean, subgroup 6C; coriander, leaves; coriander, dried leaves; coriander, seed and okra. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). EPA is also deleting an existing time-limited bifenthrin tolerance that is no longer needed as a result of this action. DATES: This regulation is effective August 11, 2006. Objections and requests for hearings must be received on or before October 10, 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-2006-0366. 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

(703)305-6463; e-mail address: *madden.barbara@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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. 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? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://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-2006-0366 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 10, 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-2006-0366, by one of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of May 10, 2006 (71 FR 27246) (FRL-8067-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions

(PP)2E6451, 3E6882, 2E6492, 2E6423, and 4E6843 by Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 180.442 be amended by establishing tolerances for residues of the insecticide bifenthrin (2-methyl [1,1′-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate, in or on leafy brassica greens, subgroup 5B at 3.0 parts per million

(ppm)and turnip greens at 3.0 ppm (2E6451); tuberous and corm vegetables, subgroup 1C at 0.1 ppm (3E2688); okra at 0.5 ppm (2E6492); dried shelled pea and bean (except soybean), subgroup 6C at 0.1 ppm (2E6423); and cilantro at 5.0 ppm (4E6843). That notice included a summary of the petition prepared by FMC, the registrant. There were no comments received in response to the notice of filing. The proposed tolerances were later amended as follows: Vegetable, tuberous and corm, subgroup 1C at 0.05 ppm (3E2688); Brassica, leafy greens, subgroup 5B at 3.5 ppm and turnip, greens at 3.5 ppm (2E6451); Pea and bean, dried shelled, except soybean, subgroup 6C at 0.15 ppm, coriander, leaves at 6.0 ppm, coriander, dried leaves at 25 ppm, and coriander, seed at 5.0 ppm (4E6843); okra at 0.5 ppm (2E6492). EPA is also deleting an established tolerance in 40 CFR 180.442(b) that is no longer needed, as a result of this action. The tolerance deletion under 40 CFR 180.442(b) is a time-limited tolerance established under section 18 emergency exemptions that is superceded by the establishment of a general tolerance for bifenthrin section 40 CFR 180.442(a). The revision to 40 CFR 180.442 is as follows: Delete the time-limited tolerance for sweet potato, roots at 0.05 ppm under 40 CFR 180.442(b). The tolerance for vegetable, tuberous and corm, subgroup 1C at 0.05 ppm that is being established includes sweet potato. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety 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. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of bifenthrin (2-methyl [1,1′-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate on Brassica, leafy greens, subgroup 5B at 3.5 ppm; coriander, dried leaves at 25 ppm; coriander, leaves at 6.0 ppm; coriander, seed at 5.0 ppm; okra at 0.50 ppm; Pea and bean, dried shelled, except soybean, subgroup 6C at 0.15 ppm; turnip, greens at 3.5 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by bifenthrin as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effectlevel (LOAEL) from the toxicity studies can be found at *http://www.epa.gov/fedrgstr/EPA-PEST/2003/April/Day-30/p10400.htm* . B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for bifenthrin used for human risk assessment is discussed in Unit III.B. of the final rule published in the **Federal Register** of April 30, 2003 (68 FR 23056) (FRL-7304-4). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.442) for the residues of bifenthrin (2-methyl [1,1′-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate in or on a variety of raw agricultural commodities. In addition, tolerances for livestock commodities have been established for the residues of bifenthrin (2-methyl [1,1′-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate in or on egg; milk fat; meat, fat, and meat byproducts

(mbyp)of cattle, goat, hog, horse, poultry and sheep. Risk assessments were conducted by EPA to assess dietary exposures from bifenthrin in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEM-FCID( TM ), Version 2.03) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: A Tier 3, acute probabilistic dietary exposure assessment was conducted for all registered and pending food uses and drinking water. Anticipated residues

(ARs)were developed based on 1998-2003 USDA's Pesticide Data Program

(PDP)monitoring data, Food and Drug Administration

(FDA)data, or field trial data for bifenthrin. ARs were further refined using percent crop treated

(PCT)data and processing factors where appropriate. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID( TM ), Version 2.03), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A dietary exposure assessment was conducted for all registered and pending food uses and drinking water. Anticipated residues

(ARs)were developed based on 1998-2003 USDA's Pesticide Data Program

(PDP)monitoring data, Food and Drug Administration

(FDA)data, or field trial data for bifenthrin. ARs were further refined using percent crop treated

(PCT)data and processing factors where appropriate. iii. *Cancer* . Bifenthrin was classified as a group “C” (possible human carcinogen). The Agency concluded that the chronic risk and exposure assessment, making use of the cPAD, to be protective of any potential carcinogenic risk. Therefore, no separate exposure assessment was conducted pertaining to cancer risk. iv. *Anticipated residue and percent crop treated

(PCT)information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Artichokes at 10%, Blackberries at 20%, Broccoli at 1%, Cabbage at 10%, Cantaloupe at 15%, Cauliflower at 1%, Corn at 15%, Sweet corn at 15%, Cucumber at 5%, Brussel Sprouts at 1%, Dried Beans at 9%, Dried Peas at 9%, Grapes at 1%, Orange at 1%, Lettuce at 1%, Sweet peas at 5%, Pears at 1%, Nonbell Peppers at 5%, Potatoes at 39%, Honeydew melon at 55%, Pumpkin and squash at <15%, Raspberry at 65%, Spinach at 1%, Tomato at 5%, Watermelon at 5%, Nuts (almonds, pecan, and walnuts) at 1%, Hops at 63%, Green Beans at 25%, Sweet Bell Pepper at 5%, Okra at 47%, Strawberry at 15%, Cotton at < 1%, Sorghum < at 1%, and Soybeans at < 1%. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available federal, state, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases < 1% is used as the average and < 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent 6 years. EPA estimates projected percent crop treated

(PPCT)for a new pesticide use by assuming that the PCT during the pesticide's initial 5 years of use on a specific use site will not exceed the average PCT of the market leader (i.e., the one with the greatest PCT) on that site over the three most recent surveys. Comparisons are only made among pesticides of the same pesticide types (i.e., the dominant miticide on the use site is selected for comparison with the new miticide). The PCTs included in the average may be each for the same pesticide or for different pesticides since the same or different pesticides may dominate for each year selected. Typically, EPA uses USDA/NASS as the source for the PCT data because they are publicly available. When a specific use site is not surveyed by USDA/NASS, EPA uses proprietary data and calculates the estimated PCT. This estimated PPCT, based on the average PCT of the market leader, is appropriate for use in the chronic dietary risk assessment. This method of estimating a PPCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial 5 years of actual use. The predominant factors that generally can be analyzed based on readily available information and that bear on whether the estimated PPCT could be exceeded are whether there are concerns with pest pressures as indicated in emergency exemption requests or other readily available information, whether the new pesticide controls a broader spectrum of pests than the dominant pesticide(s) and/or whether the new pesticide has a shorter pre-harvest interval (PHI). All such relevant information currently available has been considered for bifenthrin on dry beans/peas, potatoes and okra, and it is unlikely that actual PCT for bifenthrin will exceed the estimated PPCT for bifenthrin on each of these three crops during the next five years mainly because of the relatively longer PHI of bifenthrin relative to each of the respective leading insecticides. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for bifenthrin in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of bifenthrin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the First Index Reservoir Screening Tool and Screening Concentrations in Groundwater models, the estimated environmental concentrations

(EECs)of bifenthrin for acute exposures are estimated to be 0.014 parts per billion

(ppb)for surface water and 0.00300 ppb for ground water. The EECs for chronic exposures are estimated to be 0.0140 ppb for surface water and 0.00300 ppb for ground water. The estimated drinking water concentrations (EDWCs) for bifenthrin were calculated based on a maximum application rate of 0.5 lb ai/A/season. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID( TM ), Version 2.03). For acute dietary risk assessment, the peak water concentration value of 0.0140 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the annual average concentration of 0.0140 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Bifenthrin is currently registered for both indoor and outdoor residential non-dietary sites. Adults are potentially exposed to bifenthrin residues during residential application of bifenthrin. Adults and children are potentially exposed to bifenthrin residues after application (post-application) of bifenthrin products in residential settings. Exposure estimates were generated for residential handler exposures, and potential post-application contact with lawn, soil, and treated indoor surfaces using the EPA's Draft Standard Operating Proceedures

(SOPs)for Residential Exposure Assessment, and dissipation data from a turf transferable residue

(TTR)study. These estimates are considered conservative, but appropriate, since the study data were generated at maximum application rates. The risk assessment was conducted using the following residential exposure assumptions: Short- to intermediate-term dermal and inhalation exposures may occur for residential handlers of bifenthrin products. Although residential handler risks from inhalation exposures to bifenthrin gas/vapor are considered unlikely, since the vapor pressure of bifenthrin is low, inhalation exposure was assessed for aerosols/particulates during residential mixing, loading, and application of granular products. Adults and children may be potentially exposed to bifenthrin residues after application of bifenthrin products in residential settings. Short- and intermediate-term post-application dermal exposures for adults, and short- and intermediate-term post-application dermal and incidental oral exposures for children are anticipated. Exposure estimates were generated for potential contact with lawn, soil, and treated indoor surfaces. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Bifenthrin is a member of the pyrethroid class of pesticides. EPA is not currently following a cumulative risk approach based on a common mechanism of toxicity for the pyrethroids. Although all pyrethroids alter nerve function by modifying the normal biochemistry and physiology of nerve membrane sodium channels, available data show that there are multiple types of sodium channels and it is currently unknown whether the pyrethroids as a class have similar effects on all channels or whether modifications of different types of sodium channels would have a cumulative effect. Nor do we have a clear understanding of effects on key downstream neuronal function, e.g., nerve excitability, or how these key events interact to produce their compound specific patterns of neurotoxicity. Without such understanding, there is no basis to make a common mechanism of toxicity finding. There is ongoing research by the EPA's Office of Research and Development and pyrethroid registrants to evaluate the differential biochemical and physiological actions of pyrethroids in mammals. This research is expected to be completed by 2007. When available, the Agency will consider this research and make a determination of common mechanism as a basis for assessing cumulative risk. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA 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 base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . EPA concluded that there is not a concern for prenatal and/or postnatal toxicity resulting from exposure to bifenthrin. There was no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure to bifenthrin in developmental toxicity studies and no quantitative or qualitative evidence of increased susceptibility of neonates (as compared to adults) to bifenthrin in a 2-generation reproduction study in rats. In addition, there are no concerns or residual uncertainties for prenatal and/or postnatal toxicity following exposure to bifenthrin. 3. *Conclusion.* EPA has concluded that in light of the lack of the developmental neurotoxicity

(DNT)study the acute RfD, based on the no observed adverse effect level (NOAEL) of 32.8 milligrams/kilograms/day (mg/kg/day) be divided by an uncertainty factor

(UF)of 1,000 (10X for interspecies extrapolation, 10X for intraspecies variations, and a 10X FQPA factor for an incomplete database for lack of a DNT study). EPA has concluded that, based on reliable data, an additional FQPA factor of 3X in the form of a database uncertainty factor is required for all repeated-dose exposure scenarios to address the lack of a developmental neurotoxicity study

(DNT)because existing data indicate that the results of the DNT study might impact the current toxicology endpoint selection and RfDs. Further explanation for the choice of 3X is provided in Unit III.D. of the final rule published in the **Federal Register** of April 30, 2003 (68 FR 23056) (FRL-7304-4). An UFDB of 10X is applied to single dose exposure scenarios (i.e., acute RfD) to account for the lack of the DNT. Acceptable developmental studies in the rat and rabbit revealed no increased susceptibility of rat or rabbit fetuses following *in utero* exposure to bifenthrin. In addition, there was no evidence of increased susceptibility of young rats in the reproduction study with bifenthrin. There are no residual uncertainties in the exposure databases. The dietary food exposure assessment were refined using percent crop treated

(CT)information, and anticipated residue

(AR)values calculated from the available monitoring data and field trial results. Dietary drinking water exposure is based on conservative modeling estimates, and the Agency's Residential standard operating procedures (SOPs), in conjunction with some chemical specific data, were used to assess residential handler and post-application exposure to adults and children. These assessments will not underestimate the exposure and risks posed by bifenthrin. E. Aggregate Risks and Determination of Safety The Agency currently has two ways to estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses. First, a screening assessment can be used, in which the Agency calculates drinking water levels of comparison (DWLOCs) which are used as a point of comparison against estimated drinking water concentrations (EDWCs). The DWLOC values are not regulatory standards for drinking water, but are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. More information on the use of DWLOCs in dietary aggregate risk assessments can be found at *http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf* . More recently the Agency has used another approach to estimate aggregate exposure through food, residential and drinking water pathways. In this approach, modeled surface and ground water EDWCs are directly incorporated into the dietary exposure analysis, along with food. This provides a more realistic estimate of exposure because actual body weights and water consumption from the CSFII are used. The combined food and water exposures are then added to estimated exposure from residential sources to calculate aggregate risks. The resulting exposure and risk estimates are still considered to be high end, due to the assumptions used in developing drinking water modeling inputs. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and drinking water to bifenthrin will occupy 24% of the aPAD for the U.S. population, 18% of the aPAD for females 13 years and older, 38% of the aPAD for all infants less than 1 year old, and 43% of the aPAD for children 3-5 years old, the subpopulation at greatest exposure. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the aPAD. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to bifenthrin from food and drinking will utilize 10% of the cPAD for the U.S. population, 12% of the cPAD for All infants less than 1 year old, and 26% of the cPAD for children 1-2 years old, the subpopulation at greatest exposure. Based the use pattern, chronic residential exposure to residues of bifenthrin is not expected. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Bifenthrin is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for bifenthrin. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water and residential exposures aggregated result in aggregate MOEs of 530 for the general U.S. population, 380 for all infants less than 1 year old, and 350 for children 1-2 years old the subpopulation at greatest exposure. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food, water and residential uses. Therefore, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Bifenthrin is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for bifenthrin. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food, water and residential exposures aggregated result in aggregate MOEs of 530 for the general U.S. population, 380 for all infants less than 1 year old, and 350 for children 1-2 years old the subpopulation at greatest exposure. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food, water, and residential uses. Therefore, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern. 5. *Aggregate cancer risk for U.S. population* . The Agency considers the chronic aggregate risk assessment, making use of the cPAD, to be protective of any aggregate cancer risk. See Unit III.E.2. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to bifenthrin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography (GC)/electron-capture detection (ECD)) are available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits The Codex Alimentarius Commission has established maximum residue limits

(MRLs)for residues of bifenthrin in/on various commodities. Codex MRLs are expressed in terms of bifenthrin *per se* , as are U.S. tolerances. The only established Codex MRL relevant to the current petitions is for potato at 0.05 mg/kg. As the recommended tolerance of tuberous and corm vegetables is also 0.05 ppm, this tolerance is in harmony with the Codex MRL for potato. There are no equivalent Canadian or Mexican MRLs for the tolerances being requested in the current petition. V. Conclusion Therefore, tolerances are established for residues of bifenthrin, (2-methyl [1,1′-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate on Brassica, leafy greens, subgroup 5B at 3.5 ppm; coriander, dried leaves at 25 ppm; coriander, leaves at 6.0 ppm; coriander, seed at 5.0 ppm; okra at 0.50 ppm; Pea and bean, dried shelled, except soybean, subgroup 6C at 0.15 ppm; turnip, greens at 3.5 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.05 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this 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 section 408(d) of FFDCA, such as the tolerance 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 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 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:August 1, 2006. 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. Section 180.442 is amended by alphabetically adding commodities to the table in paragraph

(a)and by removing Sweet potato, roots from the table in paragraph

(b)to read as follows: § 180.442 Bifenthrin; tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Brassica, leafy greens, subgroup 5B 3.5 * * * * * Coriander, dried leaves 25 Coriander, leaves 6.0 Coriander, seed 5.0 * * * * * Okra 0.50 Pea and bean, dried shelled, expect soybean, subgroup 6C 0.15 * * * * * Turnip, greens 3.5 * * * * * Vegetable, tuberous and corm, subgroup 1C 0.05 [FR Doc. E6-13058 Filed 8-10-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0495; FRL-8086-1] Sanitizers with No Food-Contact Uses in Registered Pesticide Products; Revocation of Tolerance Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is revoking eight exemptions from the requirement of a tolerance that are associated with six food-contact surface sanitizing solutions because these specific tolerance exemptions correspond to uses no longer current or registered in the United States under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and because there are insufficient data to make the determination of safety required by the Federal Food, Drug, and Cosmetic Act (FFDCA). These ingredients are subject to reassessment by August 2006 under section 408(q) of FFDCA, as amended by the Food Quality Protection Act of 1996 (FQPA). The eight 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 90 days from August 11, 2006. Objections and requests for hearings must be received on or before October 10, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit V. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0495. 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 *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 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: Laura Bailey, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone number: 703-308-6212; e-mail address: *bailey.laura@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. 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 at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://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-2006-0495 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 10, 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-2006-0495, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings A. What Action is the Agency Taking? In the **Federal Register** of June 9, 2006 (71 FR 33416-3419; FRL-8072-8), EPA issued a proposed rule to revoke 10 exemptions from the requirement of a tolerance that are associated with 7 ingredients because those substances are no longer contained in pesticide products. The proposed rule provided a 30-day comment period that invited public comment for consideration and for support of tolerance exemption retention under the FFDCA standards. EPA received one comment expressing a need to retain two exemptions and an interest in providing data to support these exemptions from the requirement of a tolerance for one ingredient. Therefore, in this final rule, EPA is revoking eight exemptions from the requirement of a tolerance that are associated with six 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. 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 “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 90 days following publication of a final rule in the **Federal Register** to ensure that all affected parties receive notice of EPA's actions. For this rule, the revocations will affect exemptions for active or inert ingredients which have not been used in registered products, in some cases, for many years. The Agency believes that existing stocks of pesticide products containing active or inert ingredients covered by the exemptions have been completely exhausted and that treated commodities have had sufficient time for passage through the channels of trade. However, if EPA is presented with information that existing stocks would still be available and that information is verified, the Agency will consider extending the expiration date of the exemption. If you have comments regarding existing stocks and whether the effective date allows sufficient time for treated commodities to clear the channels of trade, please submit comments as described under SUPPLEMENTARY INFORMATION . 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 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 eight tolerance exemptions for food-contact surface sanitizing solutions 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. 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

(RFA)(5 U.S.C. 601 et 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. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with pesticides containing the ingredients being revoked in this notice. Furthermore, for the pesticide 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. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Antimicrobial, Sanitizers, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 2, 2006. Frank Sanders, Director, Antimicrobials 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. § 180.940 [Amended] 2. Section 180.940 is amended as follows: i. In the table to paragraph

(a)by removing the entry for “Potassium Permanganate” (CAS Reg. No.7722-64-7). ii. In the table to paragraph

(b)by removing the entry for “Sodium mono-and didodecylphenoxy-benzenedisulfonate” (CAS Reg. No. None). iii. In the table to paragraph

(c)by removing the entries for “Alkyl (C <sup>12</sup> -C <sup>15</sup> ) monoether of mixed (ethylene-propylene) polyalkylene glycol, cloud point of 70-77 °C in 1% aqueous solution, average molecular weight (in amu), 807;” (CAS Reg. No. None); “Benzensulfonamide, N-chloro-4-methyl, sodium salt;” (CAS Reg. No. 127-65-1); “Benzenesulfonic acid, oxybis[dodecyl-” (CAS Reg. No. 30260-73-2); “Calcium bromide” (CAS Reg. No. 7789-41-5); “Potassium Permanganate” (CAS Reg. No.7722-64-7); and “Sodium mono-and didodecylphenoxy-benzenedisulfonate” (CAS Reg. No. None) [FR Doc. E6-13173 Filed 8-10-06; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 060216045-6045-01; I.D. 080806B] Fisheries of the Exclusive Economic Zone Off Alaska; Rock Sole, Flathead Sole, and “Other Flatfish” by Vessels Using Trawl Gear in Bering Sea and Aleutian Islands Management Area AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; closure. SUMMARY: NMFS is closing directed fishing for rock sole, flathead sole, and “other flatfish” by vessels using trawl gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2006 halibut bycatch allowance specified for the trawl rock sole, flathead sole, and “other flatfish” fishery category in the BSAI. DATES: Effective 1200 hrs, Alaska local time (A.l.t.), August 8, 2006, through 2400 hrs, A.l.t., December 31, 2006. FOR FURTHER INFORMATION CONTACT: Josh Keaton, 907-586-7228. SUPPLEMENTARY INFORMATION: NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area

(FMP)prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. The 2006 halibut bycatch allowance specified for the trawl rock sole, flathead sole, and “other flatfish” fishery category in the BSAI is 779 metric tons as established by the 2006 and 2007 final harvest specifications for groundfish in the BSAI (71 FR 10894, March 3, 2006). In accordance with § 679.21(e)(7)(v), the Administrator, Alaska Region, NMFS, has determined that the 2006 halibut bycatch allowance specified for the trawl rock sole, flathead sole, and “other flatfish” fishery category in the BSAI has been caught. Consequently, NMFS is closing directed fishing for rock sole, flathead sole, and “other flatfish” by vessels using trawl gear in the BSAI. “Other flatfish” includes Alaska plaice, as well as all other flatfish species except for Pacific halibut (a prohibited species), Greenland turbot, rock sole, yellowfin sole, flathead sole, and arrowtooth flounder. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and

(f)apply at any time during a trip. Classification This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for rock sole, flathead sole, and “other flatfish” by vessels using trawl gear in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 7, 2006. The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment. This action is required by § 679.21 and is exempt from review under Executive Order 12866. Authority: 16 U.S.C. 1801 *et seq.* Dated: August 8, 2006. James P. Burgess, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 06-6868 Filed 8-8-06; 3:39 pm]

Connectionstraces to 25

Traces to 25 documents

U.S. Code