In preparing the notice for publication in the Federal Register , an error was inadvertently made when stating the Code of Federal Regulations parts in the Effective Date caption.

Accordingly, the Effective Date caption should read as follows: EFFECTIVE DATE: The regulation amending 12 CFR parts 611 and 614 published on April 12, 2002 (67 FR 17907) is effective May 13, 2002.

The FAA has determined that the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received; therefore, good cause exists for making these special conditions effective upon issuance. However, the FAA invites interested persons to participate in this rulemaking by submitting comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning these special conditions. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m. and 4:00 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions in light of the comments we receive.

If you want the FAA to acknowledge receipt of your comments on this proposal, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.

On April 12, 2002, Garrett Aviation Services, 1200 North Airport Drive, Capital Airport, Springfield, IL 62707, applied for a supplemental type certificate (STC) to modify Dassault Aviation Mystere-Falcon 50 airplanes approved under Type Certificate No. A46EU. The Dassault Aviation Mystere-Falcon 50 is a small transport category airplane. The Dassault Aviation Mystere-Falcon 50 airplanes are powered by three Turbofan Engines with a maximum takeoff weight of 40,780 pounds. The aircraft operate with a 2-pilot crew and can hold up to 19 passengers. The modification incorporates the installation of a Rockwell Collins ProLine 21 Display System, a Collins AHS-3000 Attitude-Heading Reference System, and a Goodrich GH-3000 Electronic Standby Display. The ProLine 21 system consists of dual Electronic Primary Flight Display systems that replace the existing Primary Flight Display systems. These systems have the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane.

Under the provisions of 14 CFR 21.101, Garrett Aviation Services must show that the Dassault Aviation Mystere-Falcon 50 airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A46EU, or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The certification basis for the modified Dassault Aviation Mystere-Falcon 50 airplanes include 14 CFR part 25, dated February 1, 1965, as amended by Amendment 25-1 through Amendment 25-34 except for special conditions and exceptions noted in Type Certificate Data Sheet (TCDS) A46EU.

If the Administrator finds that the applicable airworthiness regulations (that is, 14 CFR part 25, as amended) do not contain adequate or appropriate safety standards for the Dassault Aviation Mystere-Falcon 50 airplanes because of novel or unusual design features, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Dassault Aviation Mystere-Falcon 50 airplanes must comply with the fuel vent and exhaust emission requirement of 14 CFR part 34 and the noise certification requirement of part 36.

Special conditions, as defined in 14 CFR 11.19, are issued in accordance with § 11.38, and become part of the type certification basis in accordance with § 21.101(b)(2).

Special conditions are initially applicable to the model for which they are issued. Should Garrett Aviation Services apply at a later date for a supplemental type certificate to modify any other model already included on the same type certificate to incorporate the same novel or unusual design features, these special conditions would also apply to the other model under the provisions of 14 CFR 21.101(a)(1).

The Dassault Aviation Mystere-Falcon 50 airplanes modified by Garrett Aviation Services will incorporate dual Electronic Primary Flight Display systems that will perform critical functions. The modification incorporates the installation of a Rockwell Collins ProLine 21 Display System, a Collins AHS-3000 Attitude-Heading Reference System, and a Goodrich GH-3000 Electronic Standby Display. The ProLine 21 system consists of dual Electronic Primary Flight Display systems that replace the existing Primary Flight Display systems. These systems have the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane. The current airworthiness standards (14 CFR part 25) do not contain adequate or appropriate safety standards for the protection of this equipment from the adverse effect of HIRF. Accordingly, this system is considered to be a novel or unusual design feature.

There is no specific regulation that addresses protection requirements for electrical and electronic systems from HIRF. Increased power levels from ground-based radio transmitters and the growing use of sensitive electrical and electronic systems to command and control airplanes have made it necessary to provide adequate protection.

To ensure that a level of safety is achieved equivalent to that intended by the regulations incorporated by reference, special conditions are needed for the Dassault Aviation Mystere-Falcon 50 airplanes modified by Garrett Aviation Services. These special conditions require that new avionics/electronics and electrical systems, which perform critical functions, be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.

With the trend toward increased power levels from ground-based transmitters, plus the advent of space and satellite communications, coupled with electronic command and control of the airplane, the immunity of critical digital avionics systems to HIRF must be established.

It is not possible to precisely define the HIRF to which the airplane will be exposed in service. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling of electromagnetic energy to cockpit-installed equipment through the cockpit window apertures is undefined. Based on surveys and analysis of existing HIRF emitters, an adequate level of protection exists when compliance with the HIRF protection special condition is shown with either paragraph 1, or 2 below:

1. A minimum threat of 100 volts rms (root-mean-square) per meter electric field strength from 10 KHz to 18 GHz.

a. The threat must be applied to the system elements and their associated wiring harnesses without the benefit of airframe shielding.

b. Demonstration of this level of protection is established through system tests and analysis.

2. A threat external to the airframe of the field strengths indicated in the table below for the frequency ranges indicated. Both peak and average field strength components from the table below are to be demonstrated.

The Civil Aviation Administration of Israel (CAAI), which is the airworthiness authority for Israel, recently notified the FAA that an unsafe condition may exist on certain Model Galaxy and Gulfstream 200 airplanes. The CAAI advises that fuel was found on service door 310AB and in the aft service compartment on several airplanes. The cause of the fuel leakage has not yet been determined. This condition, if not corrected, could result in a fire in the aft service compartment of the airplane.

Gulfstream has issued GALAXY Alert Service Bulletin GALAXY-28A-130, dated March 22, 2002, which describes procedures for repetitive general visual inspections for evidence of fuel accumulation inside of the aft service compartment; and follow-on actions, if necessary. The follow-on actions include performing a leak test to identify the source of any fuel leak if there is fuel accumulation; repairing any fuel leak found; or, if the source of the leak cannot be found, performing an engine run-up leak test, and sealing certain drain holes and the access door with speed tape prior to a ferry flight to an authorized service center. The CAAI classified this alert service bulletin as mandatory and issued Israeli airworthiness directive 28-02-03-15, dated March 26, 2002, in order to assure the continued airworthiness of these airplanes in Israel.

Since the issuance of the Israeli airworthiness directive, the manufacturer has issued Gulfstream Service Bulletin 200-53-127, dated May 2, 2002, which describes procedures for modification of the aft fuselage area, which eliminates the need for the repetitive inspections. The modification includes ensuring that certain drain holes are present and are eight millimeters in diameter; installing a diverter around the access door of the aft service compartment; installing grommets on fuselage drain holes; installing an extension to the existing auxiliary power unit diverter; drilling fastener holes, installing, and sealing an angle for tail cone drainage; removing certain fuel vent tubes; repairing or replacing the form in-place gasket between the service door and fuselage, if necessary; and applying finishing treatment. The CAAI classified this service bulletin as mandatory in order to assure the continued airworthiness of these airplanes in Israel.

These airplane models are manufactured in Israel and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the CAAI has kept the FAA informed of the situation described above. The FAA has examined the findings of the CAAI, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD requires accomplishment of the actions specified in the alert service bulletin described previously, except as discussed below.

This AD differs from the parallel Israeli airworthiness directive and GALAXY alert service bulletin in that it requires accomplishment of the initial inspection within five flight cycles after the effective date of this AD. The alert service bulletin and the Israeli airworthiness directive recommend accomplishment of the initial inspection prior to further flight. In developing an appropriate compliance time for this AD, the FAA considered not only the CAAI's recommendation, but the degree of urgency associated with addressing the subject unsafe condition, and the average utilization of the affected fleet. In light of these factors, we have determined that requiring the inspection within five flight cycles after the effective date of the AD will not adversely affect safety and allows reasonable time for operators to accomplish the inspection without immediately taking airplanes out of service.

Additionally, operators should note that, although the Israeli airworthiness directive does not reference a modification, this AD mandates modification of the aft fuselage area for conditions where fuel leakage cannot be found.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification ( e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NM-123-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

On March 11, 2002, the FAA proposed to amend Title 14 Code of Federal Regulations, part 71 (14 CFR part 71) by revising Class E Airspace at Newport, OR in order to provide a safer IFR environmental at Newport Municipal Airport, Newport, OR (67 FR 10864). This amendment provides additional Class E5 700 and 1,200 foot controlled Airspace at Newport, OR to contain aircraft conducting instrument flight operations at Newport Municipal Airport. Additionally, this action modifies the effective hours of the Class E-2 Surface Area from part-time to continuous. Interested parties were invited to participate in the rulemaking proceeding by submitting written comments on the proposal. No comments were received.

This amendment to Title 14 Code of Federal Regulations, part 71 (14 CFR part 71) modifies Class E Airspace at Newport, OR, in order to provide adequate controlled Airspace for IFR operations at Newport Municipal Airport, Newport, OR. Newly developed RNAV RWY 16 SIAP at the Newport Municipal Airport and newly installed 24-hour weather reporting equipment made this modification necessary. Additional Class E 700-feet and E 1,200-feet controlled Airspace, above the surface of the earth is required to contain aircraft executing the Instrument Flight Rules (IFR) operations, at Newport Municipal Airport. New weather reporting equipment has been installed and certified; therefore, this action modifies the Class E-2 Airspace at Newport, OR to a 24-hour operation. The FAA establishes Class E Airspace where necessary to contain aircraft transitioning between the terminal and en route environments. This rule is designed to provide for the safe and efficient use of the navigable Airspace and to promote safe flight operations under IFR at the Newport Municipal Airport and between the terminal and en route transition stages.

The area will be depicted on aeronautical charts for pilot reference. The coordinates for this Airspace docket are based on North American Datum 83. Class E Airspace designated as surface area for an airport, are published in Paragraph 6002; Class E Airspace areas extending upward from 700-feet or more above the surface of the earth, are published in Paragraph 6005, of FAA Order 7400.9J, dated August 31, 2001, and effective September 16, 2001, which is incorporated by reference in 14 CFR 71.1. The Class E Airspace designation listed in this document will be published subsequently in the Order.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The Liberty, NC Class E5 airspace includes the May Airport Class E5 airspace. On April 20, 2000, the May Airport reverted from a public use facility to private use and cancelled the SIAP serving the airport. Cancellation of the SIAP eliminated the need for Class E5 airspace at the May Airport, and requires that the Liberty, NC Class E5 airspace legal description be amended to delete the May Airport Class E5 airspace. This rule will become effective on the date specified in the EFFECTIVE DATE section. Since this action eliminates the impact on controlled airspace on the users of the airspace in the vicinity of the May Airport, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Class E airspace designations for airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9J, dated August 31, 2001, and effective September 16, 2001, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) amends Class E5 airspace at Liberty, NC.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 2979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

On February 21, 2002, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulation, Pelican Island Causeway, Galveston Channel, TX in the Federal Register (67 FR 7989). We received one response commenting on the proposed rule. No public hearing was requested, and none was held.

Presently, the draw of the Pelican Island Causeway bridge, Galveston Channel mile 4.5 (GIWW mile 356.1), at Galveston, Texas, shall open on signal; except that, from 7 a.m. to 8:30 a.m., 12 noon to 1 p.m., and 4:15 p.m. to 5:15 p.m. Monday through Friday, except Federal holidays, the draw need not be opened for passage of vessels. Public vessels of the United States and vessels in distress shall be passed at any time. The bridge owner has requested to modify the morning bridge closure periods to allow the bridge to remain closed to navigation from 6:40 a.m. until 8:10 a.m. vice 7 a.m. to 8:30 a.m. Approximately 4,000 vehicles cross the bridge in each direction daily. The adjustment to the morning closure times reflects changes to align the closure periods with the work times of the businesses located on the island. The bridge has been observing the morning closure times of 6:40 a.m. to 8:10 a.m. for several years without properly codifying the times in the regulation. This change will reflect the actual times the bridge remains closed in the morning hours.

Additionally, by this rulemaking, the Coast Guard plans to clarify the published location of the bridge in the Code of Federal Regulations. In 33 CFR 117.977, the section heading is for Galveston Channel. The mile mark for the bridge in that section, 356.1, is for the GIWW. The bridge is actually located at mile 4.5 of the Galveston Channel. This rulemaking will clarify the mile mark for the bridge by including both the Galveston Channel mile mark and the GIWW mile mark.

One response was received in response to the Federal Register notice and the Public Notice. The Gulf Intracoastal Canal Association had no objections to the proposed change.

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. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT)(44 FR 11040, February 26, 1979).

The Coast Guard expects the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary.

This rule allows vessels ample opportunity to transit this waterway with proper notification before and after the peak vehicular traffic periods.

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 not have a significant impact on the number of small entities because the bridge has been operating on this revised schedule for several years.

Under section 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.

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).

This rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

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.

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 the preamble.

This rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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.

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 cause an environmental risk to health or risk to safety that may disproportionately affect children.

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.

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. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph 32(e), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation. This final rule only involves the operation of an existing drawbridge and will not have any impact on the environment. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES.

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 a NPRM. Publishing a NPRM, which would incorporate a comment period before a final rule could be issued, would be contrary to the public interest because immediate action is needed to facilitate repairs to the bridge.

For the same reason, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

The Christa McAuliffe, SR 3 bridge, mile 1.0, across the Canaveral Barge Canal, is a twin, double bascule leaf bridge, with a vertical clearance of 21.6 feet at mean high water and a horizontal clearance of 90.3 feet between fenders. The existing operating regulations for this bridge in 33 CFR 117.273(a) require the bridge to open on signal from 6 a.m. to 10 p.m. except that, from 6:15 a.m. to 7:45 a.m. and from 3:30 p.m. to 5:15 p.m. Monday through Friday, except Federal holidays, the draws need not open for the passage of vessels. From 10 p.m. to 6 a.m., everyday, the draws shall open on signal if at least three hours notice is given to the bridge tender. The draws shall open as soon as possible for the passage of public vessels of the United States, tugs with tows and vessels in distress.

The Florida Department of Transportation requested that the Christa McAuliffe, SR 3 bridge operations be temporarily changed to allow needed repairs to the structure. This rule temporarily changes the bridge's operating regulations to require the bridge to open on signal, except from 6:15 a.m. to 8:15 a.m. and from 3 p.m. to 6 p.m., Monday through Friday except Federal holidays, the draws need not open for the passage of vessels. From 8:15 a.m. to 3 p.m., Monday through Friday except Federal holidays, the draws need only open on the hour and half hour for the passage of vessels. From 10 p.m. until 6 a.m., everyday, the draws shall open on signal if at least three hours notice is given to the bridge tender. The draws shall open as soon as possible for the passage of public vessels of the United States, tugs with tows and vessels in distress.

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. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT)(44 FR 11040, February 26, 1979). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary because the regulations will only affect an area of limited marine traffic and this temporary rule still provides for scheduled openings.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic effect upon 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. This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit the Canaveral Barge Canal under the Christa McAuliffe, SR 3 bridge between May 15, 2002 and September 1, 2002. 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 because the regulations will only affect an area of limited marine traffic and this rule still provides for scheduled openings.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104—121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. Small entities may contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding and participating in this rulemaking. We also have a point of contact for commenting on actions by employees of the Coast Guard. 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).

This rule calls for no new collection of information requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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.

The unfunded Mandates Reform Act of 1995 (2 U.S.C. 1521-1538) 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 the preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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.

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 safety that may disproportionately affect children.

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.

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. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The Coast Guard has considered the environmental impact of this rule and has concluded that under figure 2-1, paragraph 32(e) of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket we have indicated under ADDRESSES .

On February 5, 2002, the Westchester County Department of Public Works, requested a temporary deviation from the drawbridge operating regulations for the Glen Island Bridge, mile 0.8, across New Rochelle Harbor, in New York. The purpose of the temporary deviation was to facilitate necessary maintenance, replacement of deteriorated concrete and structural supports, at the bridge. On March 21, 2002, the Commander, First Coast Guard District, issued a temporary deviation from the drawbridge operating regulations for the Glen Island Bridge. A notice of that deviation was published on March 29, 2002 (66 FR 15117).

On April 10, 2002, the bridge owner advised the Coast Guard that some potential problems were discovered concerning the temporary manual bridge opening system that will be utilized to open the bridge. The temporary manual system takes thirty-minutes to fully open and close the bridge compared to the normal ten-minute cycle time for bridge openings. This lengthy operating cycle is expected to cause vehicular traffic delays for vehicles traveling to and from the Glen Island County Park.

As a result of the above information, the Commander, First Coast Guard District issued a revised deviation on May 10, 2002, to help mitigate traffic delays during the effective period of necessary maintenance at the bridge.

The Coast Guard and the owner of the bridge coordinated this schedule with the mariners that normally use this waterway to help facilitate this necessary bridge repair and to minimize any disruption to the marine transportation system and to vehicular traffic.

Under the revised temporary deviation the Glen Island Bridge will operate from May 12, 2002 through June 26, 2002, as follows:

• From 11 p.m. to 7 a.m., Sunday through Friday, the draw need not open for vessel traffic.

• From 7 a.m. to 2 p.m., Monday through Wednesday, the draw shall open on signal, every other hour, on the odd hour and from 2 p.m. to 11 p.m., the draw shall open every hour on the hour.

• From 7 a.m. to 2:30 p.m., Thursday and Friday, the draw shall open on signal every other hour on the odd hour and from 2:30 p.m. to 10:30 p.m. every hour on the half hour.

• The draw shall open on signal, every hour on the hour all day on Saturday and on Sunday until 11 p.m.

This deviation from the operating regulations is authorized under 33 CFR 117.35, and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.

On April 2, 2002, we published a notice of proposed rulemaking (NPRM) entitled Safety Zone; Lake Champlain Challenge, Cumberland Bay, NY in the Federal Register (67 FR 15507). We received no letters commenting on the proposed rule. No public hearing was requested, and none was held.

The New England Inboard Racing Association sponsors the Lake Champlain Challenge, a high-speed powerboat race with less than 100 powerboats, propelled by 1.5 to 6 liter engines, at the north end of Cumberland Bay, Plattsburgh, NY. The safety zone includes all waters of Cumberland Bay north of a line drawn from the east end of the old Canal Terminal Pier in approximate position 44°42′26.0″ N 073°26′28.5″ W, to approximate position 44°43′00.8″ N 073°24′37.3″ W (NAD 1983) on Cumberland Head.

Marine traffic will still be able to transit through the Saranac River and southern Cumberland Bay while the safety zone is in effect. Additionally, vessels will not be precluded from mooring at or getting underway from recreational piers in the vicinity of the safety zone. Commercial piers located within the safety zone are no longer used.

The rule will be enforced from 11:30 a.m. to 6:30 p.m. on Saturday, June 29, and Sunday, June 30, 2002. All vessels and swimmers will be prohibited from transiting the portion of Cumberland Bay designated as a safety zone. This rule is needed to protect the waterway users from the hazards associated with high-speed powerboats racing in confined waters.

The Coast Guard received no letters commenting on the proposed rulemaking. No changes were made to this rulemaking.

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. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.

This finding is based on the minimal time that vessels will be restricted from the zone, and the relatively small number of vessels that normally operate in the vicinity of the zone. Vessels may transit through the Saranac River and southern Cumberland Bay throughout the safety zone's duration. Vessels will not be precluded from getting underway, or mooring at, any piers or marinas currently located in the vicinity of the safety zone. Advance notifications will be made to the local maritime community by the Local Notice to Mariners and marine information broadcasts.

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 might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Cumberland Bay during the times this zone is activated.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: vessel traffic can still transit through the Saranac River and southern Cumberland Bay during the event; vessels will not be precluded from getting underway, or mooring at, any piers or marinas currently located in the vicinity of the safety zone before the effective period. Further, we will ensure wide dissemination of maritime advisories to users of Lake Champlain via Local Notice to Mariners and marine information broadcasts.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

This rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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.

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.

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.

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.

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 might disproportionately affect children.

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.

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. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph 34(g), of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation. This rule fits paragraph 34(g) as it establishes a safety zone. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

We did not publish a notice of proposed rulemaking (NPRM) for this rule. Under 5 U.S.C. 553(b)(3), the Coast Guard finds that good cause exists for not publishing an NPRM. Due to the date the Application for Approval of Marine Event was received, there was insufficient time to draft and publish an NPRM. An annual safety zone has been published for this event in 33 CFR 165.161 effective on the Saturday and Sunday before Father's Day. The date for this year's event has been moved to the Friday before Father's Day. Further, it is an annual local event, recreational vessels may still transit around the zone during the event, the zone is only in effect for 1 and a half hours, and vessels can be given permission to transit the zone for all but about 25 minutes during this time. Any delay encountered in this rule's effective date would be unnecessary and contrary to public interest since immediate action is needed to close the waterway and protect the maritime public from the hazards associated with fireworks launched from a barge in the area.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Due to the date the Application for Approval of Marine Event was received, there was insufficient time to draft and publish a temporary final rule (TFR) more than 30 days before the event. An annual safety zone has been published for this event in 33 CFR 165.161 effective on the Saturday and Sunday before Father's Day. The date for this year's event has been moved to the Friday before Father's Day. Further, it is an annual local event, recreational vessels may still transit around the zone during the event, the zone is only in effect for 1 1/2 hours, and vessels can be given permission to transit the zone for all but about 25 minutes during this time. Any delay encountered in this rule's effective date would be unnecessary and contrary to public interest since immediate action is needed to close the waterway and protect the maritime public from the hazards associated with this fireworks display.

The Coast Guard has received an application to hold a fireworks program on the waters of Sandy Hook Bay. This rule establishes a safety zone in all waters of Sandy Hook Bay within a 125-yard radius of the fireworks barge in approximate position 40°24′33.8″ N 073°59′46.2″ W (NAD 1983), about 1,200 yards west of Plum Island. The safety zone is in effect from 8:30 p.m. until 10 p.m. on Friday, June 14, 2002.

This rule prevents vessels from transiting a portion of Sandy Hook Bay and is needed to protect boaters from the hazards associated with fireworks launched from a barge in the area. Recreational traffic will still be able to transit around the safety zone during this event. Other vessels can be given permission to transit the zone for all but about 25 minutes during this time. Public notifications will be made prior to the event via the Local Notice to Mariners and Marine Information Broadcasts.

The size of this safety zone was determined using National Fire Protection Association and New York City Fire Department standards for 5 inch mortars fired from a barge, combined with the Coast Guard's knowledge of tide and current conditions in the area.

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. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.

This finding is based on the minimal time that vessels will be restricted from the zone. Further, it is an annual local event, recreational vessels may still transit around the zone during the event, the zone is only in effect for 1 1/2 hours, and vessels can be given permission to transit the zone for all but about 25 minutes during this time. Advance notifications will be made to the local maritime community by the Local Notice to Mariners and marine information broadcasts.

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 proposed 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 might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Sandy Hook Bay during the times this zone is activated.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: it is an annual local event, recreational vessels may still transit around the zone during the event, the zone is only in effect for 1 and a half hours, and vessels can be given permission to transit the zone for all but about 25 minutes during this time. We will ensure wide dissemination of maritime advisories to users of Sandy Hook Bay via Local Notice to Mariners and marine information broadcasts.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

This rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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.

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.

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.

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.

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 might disproportionately affect children.

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.

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. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph 34(g), of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation. This rule fits paragraph 34(g) as it establishes a safety zone. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

You may be potentially affected by this action if you have a prefilled, nonrefillable termite insecticide bait station not designed or intended to be opened or activated in a manner that exposes the contents to human contact. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this table could also be affected. The North American Industrial Classification System (NAICS) codes are provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 157 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr157_00.html, a beta site currently under development.

2. In person . The Agency has established an official record for this action under docket control number OPP-2002-0059. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

Section 25(c)(3) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) authorizes EPA to establish CRP standards that are consistent with those of the Consumer Product Safety Commission (CPSC). Accordingly, EPA's CRP regulations at 40 CFR 157.32 require that CRP for pesticides meet the CPSC packaging standards (effectiveness specifications) and testing procedures set forth in 16 CFR 1700.15(b) and 1700.20. The CPSC Poison Prevention Packaging Standards in 16 CFR 1700.15(b) provide that CRP, when tested by the method described in 16 CFR 1700.20, shall meet certain child-resistant test, senior-adult test, and younger-adult test effectiveness specifications. In 16 CFR 1700.15(b)(2), the senior-adult test and younger-adult test effectiveness specifications are discussed with reference to the senior-adult panel test of 16 CFR 1700.20(a)(3) and the younger-adult panel test of 16 CFR 1700.20(a)(4), respectively.

EPA's CRP regulations at 40 CFR 157.24(b)(3) provide that exemptions from compliance may be granted on a case-by-case basis for specific products based on technical factors. The regulations further provide that, if granted, any such exemption decision will be published in the Federal Register , will be for a specified length of time, and will be applicable to any product with substantially similar composition and intended uses. When EPA's CRP regulations were published in the Federal Register on March 9, 1979 (44 FR 13019), the Agency explained that a decision to grant an exemption shall be applicable to any product with identical or substantially similar composition and intended uses “[t]o insure fairness . . . to any product in the identical situation. Some of the factors for consideration in determining whether or not a situation is identical may include the type of formulation and size and type of container.”

FMC Corporation APG Specialty Products, Griffin L. L. C., and United Industries Corporation requested an exemption from the senior-adult test and younger-adult test effectiveness specifications, described in 16 CFR1700.15(b)(2) (Ease of adult opening), for prefilled, nonrefillable termite insecticide bait stations that are not designed or intended to be opened or activated in a manner that exposes the contents to human contact.

As support for the exemption request, FMC Corporation APG Specialty Products, Griffin L. L. C., and United Industries Corporation advanced the following arguments: The purpose of adult testing is to ensure that the package is not difficult for adults to use properly. If CRP is difficult for adults to open, the concern arises that the package may be disabled or left unsecured to eliminate the difficulty of reopening it. Under such circumstances, the contents would be accessible to children. In the case of prefilled, nonrefillable termite insecticide bait stations not designed or intended to be opened, this concern does not arise. There is no risk that an adult will disable or fail to re-secure a difficult to open package, because the packages need not be opened or activated in order to function properly. As there is no concern that an adult will disable or fail to re-secure such a package, there is also no concern that the contents of disabled or unsecured packages will be accessible to children. Instead, from a child safety standpoint, the only relevant question regarding such packages is whether they can prevent a child from gaining access to the bait.

The Agency has considered the FMC Corporation APG Specialty Products, Griffin L. L. C., and United Industries Corporation exemption requests and the basis therefore and agrees that it is unnecessary to test the ability of a senior-adult or younger-adult to open and properly re-secure a package not designed or intended to be opened or activated. No benefits in terms of improved child safety would be gained by such testing. Therefore, the Agency has decided to grant an exemption from the senior-adult test and younger-adult test effectiveness specifications, described in 16 CFR 1700.15(b)(2), for prefilled, nonrefillable termite insecticide bait stations not designed or intended to be opened or activated in a manner that exposes the contents to human contact. This exemption order is effective on May 22, 2002 and expires on December 31, 2016. In addition, this exemption applies to any product with substantially similar composition and intended uses. Products that qualify for this exemption must fully comply with all other CRP effectiveness, compatibility, and durability standards, as well as all other requirements of 40 CFR part 157. CRP certification for products relying on this exemption must specify that the package does not comply with the senior and younger adult effectiveness specifications per the exemption announced in this document.

The Congressional Review Act, 5 U.S.C. 801 et seq ., does not apply because this action is not a rule, as that term is defined in 5 U.S.C. 804(3).

You may be potentially affected by this action if you have a prefilled, nonrefillable ant or roach insecticide bait station not designed or intended to be opened or activated in a manner that exposes the contents to human contact. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this table could also be affected. The North American Industrial Classification System (NAICS) codes are provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 157 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr157_00.html, a beta site currently under development.

2. In person . The Agency has established an official record for this action under docket control number OPP-2002-0058. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

Section 25(c)(3) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) authorizes EPA to establish CRP standards that are consistent with those of the Consumer Product Safety Commission (CPSC). Accordingly, EPA's CRP regulations at 40 CFR 157.32 require that CRP for pesticides meet the CPSC packaging standards (effectiveness specifications) and testing procedures set forth in 16 CFR 1700.15(b) and 1700.20. The CPSC Poison Prevention Packaging Standards in 16 CFR 1700.15(b) provide that CRP, when tested by the method described in 16 CFR 1700.20, shall meet certain child-resistant test, senior-adult test, and younger-adult test effectiveness specifications. In 16 CFR 1700.15(b)(2), the senior-adult test and younger-adult test effectiveness specifications are discussed with reference to the senior-adult panel test of 16 CFR 1700.20(a)(3) and the younger-adult panel test of 16 CFR 1700.20(a)(4), respectively.

EPA's CRP regulations at 40 CFR 157.24(b)(3) provide that exemptions from compliance may be granted on a case-by-case basis for specific products based on technical factors. The regulations further provide that, if granted, any such exemption decision will be published in the Federal Register , will be for a specified length of time, and will be applicable to any product with substantially similar composition and intended uses. When EPA's CRP regulations were published in the Federal Register on March 9, 1979 (44 FR 13019), the Agency explained that a decision to grant an exemption shall be applicable to any product with identical or substantially similar composition and intended uses “[t]o insure fairness . . . to any product in the identical situation. Some of the factors for consideration in determining whether or not a situation is identical may include the type of formulation and size and type of container.”

S.C. Johnson & Son, Inc. requested an exemption from the senior-adult test and younger-adult test effectiveness specifications, described in 16 CFR1700.15(b)(2) (Ease of adult opening), for prefilled, nonrefillable ant or roach insecticide bait stations that are not designed or intended to be opened or activated in a manner that exposes the contents to human contact.

As support for the exemption request, S.C. Johnson &Son, Inc. advanced the following arguments: The purpose of adult testing is to ensure that the package is not difficult for adults to use properly. If CRP is difficult for adults to open, the concern arises that the package may be disabled or left unsecured to eliminate the difficulty of reopening it. Under such circumstances, the contents would be accessible to children. In the case of prefilled, nonrefillable ant or roach insecticide bait stations not designed or intended to be opened, this concern does not arise. There is no risk that an adult will disable or fail to re-secure a difficult to open package, because the packages need not be opened or activated in order to function properly. As there is no concern that an adult will disable or fail to re-secure such a package, there is also no concern that the contents of disabled or unsecured packages will be accessible to children. Instead, from a child safety standpoint, the only relevant question regarding such packages is whether they can prevent a child from gaining access to the bait.

The Agency has considered the S.C. Johnson & Son, Inc. exemption request and the basis therefore and agrees that it is unnecessary to test the ability of a senior-adult or younger-adult to open and properly re-secure a package not designed or intended to be opened or activated. No benefits in terms of improved child safety would be gained by such testing. Therefore, the Agency has decided to grant an exemption from the senior-adult test and younger-adult test effectiveness specifications, described in 16 CFR 1700.15(b)(2), for prefilled, nonrefillable ant or roach insecticide bait stations not designed or intended to be opened or activated in a manner that exposes the contents to human contact. This exemption order is effective on May 22, 2002 and expires on December 31, 2016. In addition, this exemption applies to any product with substantially similar composition and intended uses. Products that qualify for this exemption must fully comply with all other CRP effectiveness, compatibility, and durability standards, as well as all other requirements of 40 CFR part 157. CRP certification for products relying on this exemption must specify that the package does not comply with the senior and younger adult effectiveness specifications per the exemption announced in this document.

The Congressional Review Act, 5 U.S.C. 801 et seq ., does not apply because this action is not a rule, as that term is defined in 5 U.S.C. 804(3).

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person . The Agency has established an official record for this action under docket control number OPP-2002-0035. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

This final rule revokes certain FFDCA tolerances for residues of nicotine-containing compounds used as insecticides and for the insecticide nicotine in or on specified commodities listed in the regulatory text because nicotine is no longer registered under FIFRA for use on those commodities. The tolerances revoked by this final rule are no longer necessary to cover residues of nicotine or nicotine-containing compounds in or on domestically treated commodities or commodities treated outside but imported into the United States. Nicotine or nicotine-containing compounds are no longer used on those specified commodities within the United States, and no one commented that there was a need for EPA to retain the tolerances to cover nicotine residues in or on imported foods. EPA has historically expressed a concern that retention of tolerances that are not necessary to cover residues in or on legally treated foods has the potential to encourage misuse of pesticides within the United States. Thus, it is EPA's policy to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated.

In the Federal Register of January 16, 2002 (67 FR 2175) (FRL-6810-3), EPA issued a proposed rule to revoke the tolerances listed in this final rule. Also, the January 16, 2002 proposal invited public comment for consideration and for support of tolerance retention under FFDCA standards. No comments were received by the Agency.

Currently, with the exception of cucumber, lettuce, and tomato, there are no other active food use registrations existing for nicotine-containing compounds or nicotine. Because no active food use registrations have existed since 1994 and because no comments expressed a need to retain these tolerances for import purposes, EPA is revoking 62 tolerances in 40 CFR 180.167 for residues of nicotine-containing compounds used as insecticides in or on apples; apricots; artichokes; asparagus; avocados; beans; beets (with or without tops) or beet greens alone; blackberries; boysenberries; broccoli; brussels sprouts; cabbage; cauliflower; celery; cherries; citrus fruits; collards; corn; cranberries; currants; dewberries; eggplants; gooseberries; grapes; kale; kohlrabi; loganberries; melons; mushrooms; mustard greens; nectarines; okra; onions; parsley; parsnips (with or without tops) or parsnip greens alone; peaches; pears; peas; peppers; plums (fresh prunes); pumpkins; quinces; radishes (with or without tops) or radish tops; raspberries; rutabagas (with or without tops) or rutabaga tops; spinach; squash; strawberries; summer squash; Swiss chard; turnips (with or without tops) or turnip greens; and youngberries. Also, EPA is revoking the four tolerances in 40 CFR 180.167a for residues of the insecticide nicotine in eggs; poultry, fat; poultry, meat; and poultry, meat byproducts by removing section 180.167a in its entirety.

Because some of the tolerances in 40 CFR 180.167 will not be revoked and will remain in the Code of Federal Regulations, EPA is revising the commodity terminology changes for the remaining tolerances to conform with current Agency administrative practice as follows: “cucumbers” to “cucumber” and “tomatoes” to “tomato.”

It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist. EPA has historically been concerned that retention of tolerances 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 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 for unregistered pesticides in order to prevent potential misuse.

These actions become effective 90 days following publication of this final rule in the Federal Register. EPA has delayed the effectiveness of these revocations for 90 days following publication of this final rule to ensure that all affected parties receive notice of EPA's actions. Consequently, the effective date is August 20, 2002. For this final rule, tolerances that were revoked because registered uses did not exist concerned uses which have been canceled for many years. Therefore, commodities containing these pesticide residues should have cleared the channels of trade.

Any commodities listed in the regulatory text of this document that are treated with the pesticide subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by the FQPA. Under this section, any residue of this pesticide in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of FDA that, (1) the residue is present as the result of an application or use of the pesticide 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 a tolerance or exemption from a tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.

By law, EPA is required by August 2002 to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996. EPA is also required to assess the remaining tolerances by August, 2006. As of May 1, 2002, EPA has reassessed over 4,140 tolerances. For counting purposes, the tolerances depicted as “with or without tops” were each counted as two tolerances. In this rule, EPA is revoking 66 tolerances which count as reassessments toward the August, 2002 review deadline of FFDCA section 408(q), as amended by FQPA in 1996.

EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain in a Federal Register document the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs. EPA has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the internet at http://www.epa.gov/. On the Home Page select “Laws and Regulations,” then select “Regulations and Proposed Rules” and then look up the entry for this document under “ Federal Register —Environmental Documents.” You can also go directly to the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-2002-0035 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 July 22, 2002.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Objection/hearing fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IV.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-2002-0035, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule will revoke tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (i.e., a tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final 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 (UMRA) (Public Law 104--4). Nor does it require any special considerations as required by 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 other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 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, I certify that this 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 nicotine-containing compounds used as insecticides or the insecticide nicotine. Furthermore, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change 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 FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under the section FOR FURTHER INFORMATION CONTACT.

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations”, “Regulations and Proposed Rules” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr 180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-2002-0052. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of November 14, 2001 (66 FR 57074) (FRL-6806-6), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP) 0F6121 for tolerances by Bayer Corporation, 8400 Hawthorn Road, P.O. Box 4913, Kansas City, MO 64121-0013. This notice included a summary of the petition prepared by Bayer Corporation, the registrant. No comments were received in response to the amendment.

The petition requested that 40 CFR 180.555 be amended by establishing tolerances for combined residues of the fungicide trifloxystrobin and the free form of its acid metabolite CGA-321113, in or on fruit, stone, group at 2 parts per million (ppm); nut, tree, group at 0.05 ppm; pistachio at 0.05 ppm; corn, field, grains at 0.05 ppm; corn, field, forage at 0.05 ppm; corn, field, stover at 7 ppm; corn, field, refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8 ppm; rice, straw at 7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus, oil at 7 ppm; fruit, citrus, group at 0.3 ppm; egg at 0.04 ppm; poultry, fat; and poultry, meat; poultry, kidney; poultry, liver; and poultry, meat by products at 0.05 ppm. Bayer, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

Section 408(b)(2)(A)(i) of the 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) 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) 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 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), 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 trifloxystrobin and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for combined residues of trifloxystrobin and the free form of its acid metabolite CGA-321113 on fruit, stone, group at 2 ppm; nut, tree, group at 0.04 ppm; pistachio at 0.04 ppm; corn, field, grains at 0.05 ppm; corn, field, forage at 0.2 ppm; corn, field, stover at 7 ppm; corn, field, refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8 ppm; rice, straw at 7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus oil at 30 ppm; fruit, citrus, grroup at 0.3 ppm; egg at 0.04 ppm; poultry, fat at 0.04 ppm; poultry, meat at 0.04 ppm; poultry, meat by products at 0.04 ppm. In examining the data for corn field forage and citrus oil the Agency found that the residue data supports a higher tolerance than was proposed. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

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. The nature of the toxic effects caused by trifloxystrobin and the free form of its acid metabolite CGA-321113 are discussed below as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

1. Subchronic-feeding study—rat. The No Observed Adverse Effects Level (NOAEL) was 500 ppm (30.6-32.8 mg/kg/day). Decreased body weight, hypertrophy of hepatocytes in males and pancreatic atrophy were observed at the Lowest Observed Adverse Effects Level (LOAEL) of 2,000 ppm (127-133 mg/kg/day).

2. Subchronic-feeding study—mouse. The NOAEL was 500 ppm (76.9-110 mg/kg/day). Increased liver weights and necrosis of hepatocytes were observed at the LOAEL of 2,000 ppm (315-425 mg/kg/day).

3. Subchronic-feeding study—dog. The NOAEL was 30 mg/kg/day. Increased liver weight and hepatocyte hypertrophy in males were observed at the LOAEL of 150 mg/kg/day.

4. 28-day dermal toxicity study—rat. The NOAEL was 100 mg/kg/day. Increased liver and kidney weight were observed at the LOAEL of 1,000 mg/kg/day.

5. Developmental toxicity study—rat. The maternal NOAEL was 10 mg/kg/day. Decreased body weight gain and food consumption were observed at the maternal LOAEL of 100 mg/kg/day. The developmental NOAEL was 1,000 mg/kg/day. No developmental effects were observed. The developmental LOAEL was equal to or greater than 1,000 mg/kg/day.

6. Developmental toxicity study—rabbit. The maternal NOAEL was 10 mg/kg/day. Decreased mean body weights and decreased mean body weight gain (compared to control), food consumption and efficiency were observed at the maternal LOAEL of 50 mg/kg/day. The developmental NOAEL was 250 mg/kg/day. Skeletal anomolies were observed at the Developmental LOAEL of 500 mg/kg/day.

7. Reproductive toxicity study—rat. The parental NOAEL was 50 ppm (3.8 mg/kg/day). Decreased mean body weight and decreased mean weight gain (compared to control), decreased food consumption, and increased incidence of liver, kidney and spleen effects were observed at the parental LOAEL of 750 ppm (55.3 mg/kg/day). The reproductive NOAEL was 1,500 ppm (110.6 mg/kg/day). The reproductive LOAEL was greater than 1,500 ppm (110.6 mg/kg/day).

8. Chronic-feeding study—dog. The NOAEL was 5 mg/kg/day. Increased clinical signs, increased liver weight and hepatocellular hypertrophy were observed at the LOAEL of 50 mg/kg/day.

9. Carcinogenicity study—mouse. The NOAEL was 300 ppm (39.4 mg/kg/day). Liver effects were observed at the LOAEL of 1,000 ppm (131.1 mg/kg/day).

10. Chronic toxicity/carcinogenicity study—rat. The NOAEL was 250 ppm (9.81-11.37 mg/kg/day). Decreased mean body weight and decreased mean body weight gain (compared to control) were observed at the LOAEL of 750 ppm (29.7-34.5 mg/kg/day).

11. Gene mutation study—Salmonella. Negative.

12. Gene mutation study—Chinese Hamster Cultured V-79. Positive.

13. Structural chromosome aberration-micronucleus study—mouse. Negative.

14. Structural chromosome aberration-cytogenetics study—Chinese Hamster. Negative.

15. DNA Repair study-hepatocytes—rat. Negative.

16. Acute oral neurotoxicity study—rat. The NOAEL and LOAEL could not be determined.

17. Metabolism study—rat. The tissue half-lives ranged from 13 to 42 hours. The highest residues were found in liver, kidneys, spleen and blood. The parent compound was extensively metabolized to approximately 35 metabolites.

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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 - 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for trifloxystrobin used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Tolerances have been established for the combined residues of trifloxystrobin and the free form of its acid metabolite CGA-321113 on several commodities; including almonds, bananas, sugarbeets, pomefruit, grapes, peanuts, potatoes, cucurbit vegetables, fruiting vegetables, and wheat. The Agency conducted a new assessment incorporating these commodities and the following additional tolerances: fruit, stone, group at 2 ppm; nut, tree, group at 0.04 ppm; pistachio at 0.04 ppm; corn, field, grains at 0.05 ppm; corn, field, forage at 0.2 ppm; corn, field, stover at 7 ppm; corn, field, refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8 ppm; rice, straw at 7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus oil at 30 ppm; fruit, citrus, group at 0.3 ppm; egg at 0.04 ppm; poultry, fat at 0.04 ppm; poultry, meat at 0.04 ppm; poultry, meat by products at 0.04 ppm. Risk assessments were conducted by EPA to assess dietary exposures from trifloxystrobin in food as follows:

i. Acute exposure. The acute dietary exposure analysis for trifloxystrobin is a Tier 1 assessment because no additional data were used to refine the analysis. One hundred percent of proposed and registered crops are assumed treated with trifloxystrobin (100% CT) and tolerance-level residues were used in the analysis. The acute dietary endpoint (increased fetal incidence of fused sternebrae) is only applicable to the population subgroup Females 13-50 years old. An acute dietary endpoint for the general population including infants and children was not identified. The estimated dietary exposure for females 13-50 years old occupies less than 1 percent of the acute PAD and does not exceed EPA's level of concern.

ii. Chronic exposure. The chronic dietary exposure analysis for trifloxystrobin is a Tier 1 assessment because no additional data were used to refine the analysis. One hundred percent of proposed and registered crops are assumed treated with trifloxystrobin (100% CT) and tolerance-level residues were used in the analysis. The chronic dietary endpoint applies to all population subgroups including infants and children. A listing of the subgroups with the highest exposure are reported below in Table 3.

The results of the chronic dietary analysis show that risk ranges from 9% of the cPAD for adult males (20 years and older), to 39% of the cPAD for all infants ( < 1 year). Risk estimates for all population subgroups are below EPA's level of concern (100% of the cPAD).

iii. Cancer. Trifloxystrobin was classified as a “not likely human carcinogen.” Therefore, a cancer risk assessment was not conducted.

2. Water exposure. Trifloxystrobin is immobile, degrades and transforms rapidly, in soil (half life is about 2 days) and aquatic environments (half life is about 15-55 days), mostly to a series of isomers and the primary acid metabolite, CGA-321113. The major isomer forms at the average rate of 80% of the applied parent, is persistent, (half life is about 301 days), and soluble, 30.9 ppm and is also mobile. The major degradate minimum Koc is 49, the median Koc is 127 and is also stable to hydrolysis. The major degradate, CGA-321113 is persistent and mobile and has a potential to leach into groundwater. CGA-321113 has been found in the soil profile at the 36 inch depth.

Estimated environmental concentrations (EECs) were calculated for total trifloxystrobin residues (parent trifloxystrobin and its major degradate, CGA-321113 ) using EPA's FIRST model for surface water and the screeninig concentration in ground water (SCI-GROW) model. EPA's interim method for drinking water estimates for pesticides used in rice paddies was also used to generate EECs. No degradation process of the chemical and no dilution with uncontaminated water outside of the paddy were taking into account. The rice estimates are “expected to vastly exceed the `true' values found in the environment, especially for trifloxystrobin, since available environmental fate data show that this compound degrades fairly rapidly in water and soil.”

EECs were estimated for total trifloxystrobin residues because the environmental fate studies indicated that the parent compound forms transformation compounds (isomers) which are similar in structure to the parent under most conditions. Further, the EPA concluded that both trifloxystrobin and the free form of its acid metabolite CGA-321113 are of concern for both regulatory and risk assessment purposes for plant and livestock commodities.

The use site with the highest application rate is turfgrass, with a maximum label rate of 1.078 pounds active ingredient per acre per year (lbs/ai/ac/yr) (three applications at 0.359 lbs/ai/ac/yr). Drinking water estimates were also provided for rice paddies that may be treated with trifloxystrobin.

Surface water concentrations of trifloxystrobin and its major degradate CGA-321113 are 92 parts per billion (ppb) for the peak value (acute) and 50 ppb for the chronic value using the FIRST model. The groundwater screening concentration to be used for both acute and chronic assessments is 3.4 ppb. These values represent upper-bound estimates of the concentrations of total residues of trifloxystrobin that might be found in surface water and groundwater from the use of trifloxystrobin on turfgrass at the maximum application rate.

3. Non-dietary exposure . Trifloxystrobin's residential uses include turfgrass/ornamental disease control (Compass®). Because the FQPA requires consideration of aggregate exposure to all likely non-occupational uses, this assessment uses non-occupational postapplication contact with trifloxystrobin following Compass® use on turfgrass as the most common and worst case contributor to such exposures. The margin of exposure (MOEs) for applicable residential scenarios (i.e., postapplication dermal exposure from pesticide residues on lawns, incidental non-dietary ingestion of pesticide residues on lawns from hand-to-mouth transfer, incidental non-dietary ingestion of residues from pesticide-treated turfgrass from object-to-mouth activities, and incidental non-dietary ingestion of soil from pesticide-treated residential areas) were calculated separately, and then combined.

i. Residential handler. This current petition does not propose residential uses for trifloxystrobin. However, the label for the trifloxystrobin product, Compass® , includes residential use on turfgrass and ornamentals. This product may only be applied by a Certified Pest Control Operartor (PCO), not by homeowners directly.

ii. Postapplication. There is potential for dermal (adults and children) and oral exposure (children only) during postapplication activities. The following postapplication exposure scenarios resulting from lawn treatment were assessed: (1) Dermal exposure from pesticide residues on lawns, (2) incidental non-dietary ingestion of pesticide residues on lawns from hand-to-mouth transfer, (3) incidental non-dietary ingestion of residues from object-to-mouth activities (pesticide-treated turfgrass), and (4) incidental non-dietary ingestion of soil from pesticide-treated residential areas. Postapplication exposures from various activities following lawn treatment are considered to be the most common and significant in residential settings. Exposure via incidental non-dietary ingestion involving other plant material may occur but is expected to result in much less exposure than the four exposure scenarios listed above.

The exposure and risk estimates for the four residential exposure scenarios are assessed for the day of application (day “0”) because it is assumed that adults and toddlers could contact the lawn immediately after application. On the day of application, it was assumed that 5 percent of the application rate is available from the turfgrass as transferrable residue (20 percent for object-to-mouth activities). Intermediate-term exposure (1 to 6 months) is not expected based on trifloxystrobin's short half-life in soil (about 2 days). Chronic or long-term (continuous exposure over more than 6 months) exposure is not expected. The short-term MOEs for adults and children are above 100, they DO NOT exceed EPA's level of concern.

iii. Recreational. Trifloxystrobin may be used on turf at recreational use sites, and, therefore may result in postapplication exposure to adults and children involved in recreational activities. Exposures to adults and children from the use of trifloxystrobin at recreational use sites are assumed to be the same as those assessed for residential use sites. Residential turf exposure assessment results in what are considered upper bound risk estimates. Therefore, it is not expected that the upper bound residential exposure scenario would occur on the same day as an upper bound recreational exposure scenario. Exposure from these two exposure scenarios are not aggregated. Rather, the residential risk estimate should serve as an upper bound for both residential and recreational exposure.

Postapplication exposures from various activities following lawn treatment are considered to be the most common and significant in residential settings. There is potential for dermal (adults and children) and oral exposure (children only) during postapplication activities. Four postapplication exposure scenarios resulting from lawn treatment were assessed. Postapplication exposure and risk estimates for adults and children resulted in MOE's that were above 100 and all risks were considered below EPA's level of concern.

iv. Other exposure sources. Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from the groundboom application. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices. The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/labeling. The Agency has completed its evaluation of the new database submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off-target drift and risks associated with aerial as well as other application types where appropriate.

4. Cumulative exposure to substances with common mechanism of toxicity. Section 408(b)(2)(D)(v) 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.” Trifloxystrobin belongs to a new class of fungicides, the MAEs (beta-methoxyacryl esters), which are synthetic analogs of strobilurin A, an antifungal secondary metabolite of the fungus Strobilurus tenacellus . Trifloxystrobin works by interfering with respiration in plant pathogenic fungi. The site of action of strobilurin compounds is located in the mitochondrial respiration pathway between cytochromes b and c1 at the level of the hydroquinone binding site. As a result of this mode of action, trifloxystrobin is a potent inhibitor of fungal spore germination and mycelial growth. Trifloxystrobin can be referred to more specifically as an oximinoacetate.

EPA does not have, at this time, available data to determine whether trifloxystrobin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, trifloxystrobin 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 trifloxystrobin has a common mechanism of toxicity with other substances. For information regarding EPA efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

EPA determined the 10x safety factor for the protection of infants and children should be removed for the following reasons:

1. The toxicology database is complete for FQPA assessment.

2. There is no indication of increased susceptibility of rat or rabbits to trifloxystrobin. In the developmental and reproductive toxicity studies, effects in the fetuses/offspring were observed only at or above treatment levels which resulted in evidence of parental toxicity.

3. It was determined that a developmental neurotoxicity study in rats is not required.

4. The exposure assessments will not underestimate the potential dietary (food and drinking water) or nondietary exposures for infants and children from the use of trifloxystrobin.

Acute and chronic aggregate risk estimates were calculated in this risk assessment. Acute aggregate risk was calculated by comparing acute drinking water levels of concern (DWLOCs) to potential drinking water exposure to trifloxystrobin. Similarly, chronic aggregate risk was calculated by comparing chronic DWLOCs to potential drinking water exposure.

Short-term aggregate risk estimates were also calculated. Short-term risk is based on exposures occurring over 1 to 30 days. Short-term aggregate risk was calculated by combining risk estimates for high-end residential oral and/or dermal exposures with chronic food and drinking water risks. Intermediate-term risk is based on 30 to 180 days of exposure (1 to 6 months). Intermediate-term exposure is not expected to occur based on the short soil half-life (about 2 days). Chronic non-dietary aggregate risk was not calculated as chronic dermal and oral exposures (from residential treatment) are not expected. Cancer aggregate risk was not calculated because trifloxystrobin is classified as “not likely human carcinogen.”

1. Acute risk (food + drinking water) . The acute aggregate risk assessment takes into account exposure estimates from dietary consumption of trifloxystrobin from food and drinking water sources. The acute risk estimate for Females 13-50 years, resulting from aggregate exposure to trifloxystrobin in food and drinking water is below EPA's level of concern. Acute aggregate risk was not calculated for the U.S. population including infants and children or other population subgroups as EPA did not identify an endpoint for risk assessment for those groups.

The surface and groundwater EECs were used to compare against back-calculated DWLOCs for aggregate risk assessments. To calculate the DWLOC for acute exposure relative to an acute toxicity endpoint, the acute dietary food exposure (from DEEM®) was subtracted from the aPAD to obtain the acceptable acute exposure to trifloxystrobin in drinking water. The acute DWLOCs are listed in the following Table 4:

For the acute aggregate risk scenario, food and drinking water exposures were taken into account. DWLOCs were calculated for females (13-50 years old) the only subgroup to which the acute dietary endpoint applies. The DWLOC was 75,000 ppb for females. This value is well above the EECs for drinking water, and therefore, acute aggregate risk is below EPA's level of concern.

2. Short-term risk (food + drinking water + residential). The short-term aggregate risk assessment estimates risks likely to result from 1- to 30-day exposure to trifloxystrobin residues are from food, drinking water, and residential pesticide uses. High-end estimates of residential exposure are used in the short-term assessment, while average values are used for food and drinking water exposure (i.e. chronic exposures).

A short-term risk assessment is required for adults because there is a residential exposure scenario (postapplication only). In addition, a short-term risk assessment is required for infants and children because there are residential post-application dermal and oral exposure scenarios. Toddlers' incidental oral exposure is assumed to include hand-to-mouth exposure, object-to-mouth exposure and exposure through incidental ingestion of soil.

Different endpoints were identified by EPA for short-term incidental oral and dermal risk assessment. The basis for the oral endpoint is reduced pup body weights and the dermal endpoint is based on increases in liver and kidney weights. Therefore, it is not possible to combine the exposure from both dietary/oral exposure with that from dermal exposure.

For the short-term aggregate risk scenario, food, drinking water and residential exposures are taken into account. DWLOCs were calculated for the U.S. population, males (13-19 years old), all infants (less than 1 year old) and females (13-50 years old). DWLOCs ranged from 170 ppb for all infants to 1,200 pbb for the U.S. population and males (13-19 years old). These values are above the EECs for drinking water and therefore, short-term aggregate risk is below EPA's level of concern.

3. Intermediate-term risk. The intermediate-term aggregate risk assessment estimates risks likely to result from 1 to 6 months of exposure (30 to 180 days) to trifloxystrobin residues from food, drinking water, and residential pesticide uses. High-end estimates of residential exposure are used in the short-term assessment, while average values are used for food and drinking water exposure (i.e. chronic exposures).

Intermediate-term exposure is not expected to occur based on the short soil half-life (about 2 days). Therefore, an intermediate-term aggregate risk assessment was not performed.

4. Chronic risks. The chronic aggregate risk assessment takes into account exposure estimates from dietary consumption of trifloxystrobin from food and drinking water sources. Chronic risk estimates resulting from aggregate exposure to trifloxystrobin in food and drinking water are below EPA's level of concern from all population subgroups.

The surface and groundwater EECs were used to compare against back-calculated DWLOCs for aggregate risk assessments. To calculate DWLOCs for chronic exposure relative to a chronic toxicity endpoint, the chronic dietary food exposure (from DEEM®) was subtracted from the cPAD to obtain the acceptable chronic exposure to trifloxystrobin in drinking water. The chronic DWLOCs are listed in the following Table 5:

Chronic DWLOCs for all population subgroups are above the estimated concentrations of trifloxystrobin and its metabolites in drinking water, and are therefore not of concern.

5. Aggregate cancer risk. Not applicable. There is no evidence of carcinogenicity.

6. Determination of safety. EPA concludes with reasonable certainty that aggregate exposure from trifloxystrobin will not result in harm to the adult U.S. population or infants and children.

1. For plants. The qualitative nature of the residue in plants is adequately understood for fruits, fruiting vegetables, cucurbit vegetables and peanuts, based on acceptable metabolism studies conducted on apples, cucumbers, peanuts, and a supplementary study on wheat. For the current petition, Bayer submitted two sugar beet trifloxystrobin metabolism studies. As result of these studies the nature of trifloxystrobin in/on sugar beets is adequately understood. The sugar beet metabolism studies, however, do not fulfill the wheat metabolism data requirement because the two crops are too dissimilar.

2. For animals. No livestock data were submitted. The qualitative nature of the residue in livestock is adequately understood based on acceptable studies conducted on goats and laying hens. The EPA has determined that the total toxic residues for livestock, both for regulatory and risk assessment purposes, is trifloxystrobin and the free form of its acid metabolite CGA-321113. Additionally, metabolite L7a (taurine conjugate of trifloxystrobin) in the liver should be included in the risk assessment.

EPA has completed a method validation trial of AG-659A on apples, wet apple pomace, grapes, summer squash, peanut hay, peanuts, cow liver, cow milk and raisins, and concluded that AG-659A is suitable for enforcement of trifloxystrobin and the free form of its acid metabolite in plant and livestock commodities. The enforcement method has been submitted to the Food and Drug Administration for publication in the Pesticides Assessment Manual II.

The analytical methods, AG-659A or AG-659A/REM 177.04, are adequate for collecting data for residues of trifloxystrobin and its acid metabolite CGA-321113 in/on all crops associated with this petition.

There are no Codex, Canadian, or Mexican maximum residue limits (MRLs) established for trifloxystrobin. Harmonization is thus not an issue at this time.

Therefore, tolerances are established for combined residues of trifloxystrobin and the free form of its acid metabolite CGA-321113 in/on fruit, stone, group at 2 ppm; nut, tree, group at 0.04 ppm; pistachio at 0.04 ppm; corn, field, grains at 0.05 ppm; corn, field, forage at 0.2 ppm; corn, field, stover at 7 ppm; corn, field, refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8 ppm; rice, straw at 7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus oil at 30 ppm; fruit, citrus, grroup at 0.3 ppm; egg at 0.04 ppm; poultry, fat at 0.04 ppm; poultry, meat at 0.04 ppm; poultry, meat by products at 0.04 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-2002-0052 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 July 22, 2002.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Room M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission be labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A. of this preamble, you should also send a copy of your request to the PIRB for its inclusion in the official record that is described in Unit I.B.2. of this preamble. Mail your copies, identified by docket number OPP-2002-0052, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PRIB described in Unit I.B.2. of this preamble. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.1 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established EPA, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance 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 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 FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any ”tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” ”Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq. ,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).

Please follow these instructions to access the rule: From the World Wide Web (WWW), type http://www.epa.gov/epaoswer/hazwaste/ldr.

The official record for this action will be kept in paper form. Accordingly, EPA has transferred any comments received electronically into paper form and placed them in the official record which also includes comments submitted directly in writing. The official record is the paper record maintained at the RIC listed in the ADDRESSES section at the beginning of this document.

Under section 3004(m) of the Resource Conservation and Recovery Act (RCRA) as amended by the Hazardous and Solid Waste Amendments of 1984, EPA is required to set “levels or methods of treatment, if any, which substantially diminish the toxicity of the waste or substantially reduce the likelihood of migration of hazardous constituents from the waste so that short-term and long-term threats to human health and the environment are minimized.” We have interpreted this language to authorize treatment standards based on the performance of best demonstrated available technology (BDAT). This interpretation was sustained by the court in Hazardous Waste Treatment Council vs. EPA, 886 F. 2d 355 (D.C.Cir.1989).

We recognize that there may be wastes that cannot be treated to levels specified in the regulation (see 40 CFR 268.40) (51 FR 40576, November 7, 1986). For such wastes, a treatment variance exists (40 CFR 268.44) that, if granted, becomes the treatment standard for the waste at issue.

Treatment variances may be national or site-specific. A national generic variance can result in the establishment of a new treatability group and a corresponding treatment standard that applies to all wastes that meet the criteria of the new waste treatability group (55 FR 22526, June 1, 1990). A site-specific variance applies only to a specific waste from a specific facility. See 62 FR at 64505 (December 5, 1997). Under 40 CFR 268.44(h), a generator or treatment facility may apply to the Administrator, or EPA's delegated representative, for a site-specific variance in cases where a waste that is generated under conditions specific to one site cannot or should not be treated to the specified level(s). Under 40 CFR 268.44(h)(1), the applicant for a site-specific variance must demonstrate that because the physical or chemical properties of the waste differ significantly from the waste analyzed in development of the treatment standard, the waste cannot be treated to the specified levels or by the specified method(s). Although there are other grounds for obtaining treatment variances, we will not discuss those in this notice because this is the only provision relevant to the present petitions. U.S. Ecology Idaho, Incorporated (USEII) (Grandview, ID) submitted their request for a treatment variance in September 2000. CWM Chemical Services LLC (CWM) (Model City, NY) submitted their request in December 2000. All information and data used in the development of this proposal can be found in the RCRA docket supporting this rule.

On July 24, 2001 (66 FR 38405), we proposed to grant two site-specific treatment variances from the K088 (spent potliners from primary aluminum reduction) treatment standard for arsenic. The first proposed variance is for arsenic in the K088-derived emission control dust from an air pollution control system from a stabilization and containment building at the USEII facility. The second proposed variance is for arsenic in roll-off boxes of K088-derived baghouse dust and incinerator ash at the CWM Model City facility. This variance also covers wastewater treatment filtercake from the CWM facility (66 FR 38405, July 24, 2001). To date, no K088 filtercake has been generated. At both facilities, these waste streams are derived from the treatment of multiple listed and characteristic hazardous wastes, including K088. Under the RCRA regulations, when different hazardous wastes are combined for treatment and there are different treatment standards for a particular hazardous constituent, the treatment residue must meet the most stringent of the applicable treatment standards. Section 268.40 (c). With the advent of the Universal Treatment Standards, this situation does not arise often because most of the treatment standards are identical. However, K088 has a “non-universal” treatment standard for arsenic, which arguably might be considered more stringent than the universal treatment standard. (63 FR 51257, September 24, 1998.) The treatment standard for arsenic in K088 waste is to achieve a total concentration of arsenic of less than 26.1 mg/kg. The wastes which are the subject of these petitions would likely not achieve this treatment standard. The treatment residues, however, feasibly can be treated to meet the arsenic Universal Treatment Standard of 5 ppm measured using the TCLP.

In the proposal, we concluded that an alternative treatment standard of 5.0 mg/l for arsenic, measured using the TCLP, is warranted for the following reasons. First, the chemical properties of the derived-from waste at both facilities differ significantly from the waste used to establish the LDR treatment standard for arsenic in K088 non-wastewaters. Second, the alternative standard of 5.0 mg/l TCLP is currently the standard applicable to arsenic in all other hazardous wastes, except K088 non-wastewaters. Third, arsenic concentrations in USEII's K088-derived emission control dust and in CWM's K088-derived baghouse dust, incinerator ash and filtercake cannot be treated to a lower treatment standard based on a total analysis. This is because arsenic, as an element, cannot be destroyed and must be immobilized. In the proposal, we concluded that these reasons meet the criteria for granting a site-specific variance under 40 CFR 268.44(h)(1). (66 FR 38407, July 24, 2001.)

We received three comments on the proposed rule. One commenter supports EPA's decision to grant these variances based on its experiences in meeting the relevant Land Disposal Restrictions. Another commenter requests clarification regarding whether the alternate treatment standard of 5.0 mg/l, measured using the TCLP, is limited to CWM's wastes that are currently managed on-site. Our answer is that the treatment standard granted under today's variance applies to existing and future incinerator residue treated at the facility. It also applies to existing and future baghouse dust generated at the facility, as well as to any K088 derived-from filtercake generated in the future at the facility (since the reasons for granting the treatment variance apply in all of these situations).

A commenter also requested clarification regarding which incinerator residue at CWM's Model City facility is covered by this final regulation. The commenter sought clarification as to whether the variance applies to just those wastes that are received from off-site and treated on-site or to these wastes plus any K088 derived baghouse dust and incinerator ash received from off-site and directly disposed in CWM's Model City Subtitle C landfill without treatment. The variance granted to CWM's Model City facility under this rulemaking is limited to wastes generated or treated at the Model City facility. Facilities other than CWM's Model City facility who believe their wastes meet the criteria for a variance from the KO88 standard can submit their own variance petition to the Agency for consideration.

Two commenters believe that the 26.1 mg/kg arsenic standard should apply only to newly-generated K088 and that all other mixture, derived-from and contained-in K088 should use the 5.0 arsenic TCLP universal treatment standard (UTS). These commenters believe that the cost and time spent by industry and EPA in preparing and responding to petitions for variances would be more than offset by a revised treatment standard. One commenter suggests that the rationale that EPA has used in previous final and proposed variances—that the treatment residues are physically and chemically different from the waste analyzed in establishing the treatment standard—is applicable in all cases where K088 is treated with other hazardous waste and a K088-derived residue is generated. This commenter believes that, as a result, the most effective course of action is to revise the regulations and adopt a treatment standard of 5.0 mg/l for arsenic, measured using the TCLP, in K088 derived-from waste. Under this suggested approach, the 26.1 ppm total arsenic standard would continue to apply to newly-generated K088 at the primary aluminum facility. EPA would finalize a new standard for all other mixture, derived-from and contained-in K088 wastes; this new standard would use the existing UTS standard of 5.0 ppm arsenic.

Based on the limited number of variance requests we have received, we believe that the existing regulation is sufficient. We disagree with the commenter's cost estimate of revising the regulation versus continuing to use variances. In cases where site-specific variances from this standard are appropriate, EPA's regulations set forth a means by which generators or treaters of hazardous waste can file petitions for variances from the K088 treatment standard. To date, EPA has responded to only four petitions regarding the treatment standard for arsenic in K088. (66 FR 33887, June 26, 2001 and 65 FR 45978, July 26, 2000, plus the two granted today.) There are no outstanding treatment variance petitions.

In conclusion, for USEII, EPA is granting an alternate treatment standard of 5.0 mg/l for arsenic, measured using the TCLP, in existing and future K088 derived-from emission control dust from its air pollution control system. Likewise, at CWM's Model City facility, EPA is granting an alternate treatment standard of 5.0 mg/l for arsenic, measured using the TCLP, for existing and future K088 derived baghouse dust, incinerator ash and filtercake.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether a regulatory action is “significant” and therefore subject to OMB review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Because this final rule does not create any new regulatory requirements, it is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to OMB review.

The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This final rule will not impose any requirements on small entities. These treatment variances do not create any new regulatory requirements. Rather, they establish an alternative treatment standard for a regulated constituent at two specific facilities. This action, therefore, does not require a regulatory flexibility analysis.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal Agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. If a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives. Under section 205, EPA must adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule, unless the Administrator publishes with the final rule an explanation why that alternative was not adopted. The provisions of section 205 do not apply when they are inconsistent with applicable law.

EPA has determined that this final rule does not include a Federal mandate that may result in estimated costs of $100 million or more in the aggregate to either State, local, or tribal governments or the private sector in one year. The final rule would not impose any federal intergovernmental mandate because it imposes no enforceable duty upon State, tribal or local governments. States, tribes, and local governments would have no compliance costs under this rule. EPA has also determined that this final rule contains no regulatory requirements that might significantly or uniquely affect small governments. In addition, as discussed above, the private sector is not expected to incur costs exceeding $100 million. EPA has fulfilled the requirement for analysis under the Unfunded Mandates Reform Act. Thus, today's final rule is not subject to the requirements of sections 202, 204 and 205 of UMRA.

Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

EPA has determined that this rule will not significantly or uniquely affect small governments. This final rule will not impose any requirements on small entities. These treatment variances do not create any new regulatory requirements. Rather, they establish an alternative treatment standard for a regulated constituent at two specific facilities. Today's final rule is not, therefore, subject to the requirements of section 203 of UMRA.

Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

Today's final rule is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The subject wastes will comply with all other treatment standards and be disposed of in RCRA Subtitle C landfills. Therefore, we have identified no risks that may disproportionately affect children.

EPA is committed to addressing environmental justice concerns and is assuming a leadership role in environmental justice initiatives to enhance environmental quality for all residents of the United States. The Agency's goals are to ensure that no segment of the population, regardless of race, color, national origin, or income bears disproportionately high and adverse human health and environmental impacts as a result of EPA's policies, programs, and activities, and that all people live in clean and sustainable communities. In response to Executive Order 12898 and to the concerns voiced by many groups outside the Agency, EPA's Office of Solid Waste and Emergency Response formed an Environmental Justice Task Force to analyze the array of environmental justice issues specific to waste programs and to develop an overall strategy to identify and address these issues (OSWER Directive No. 9200.3-17).

Today's final rule applies to wastes that will be treated and disposed of in a RCRA Subtitle C hazardous waste landfill, ensuring a high degree of protection to human health and the environment. Therefore, the Agency does not believe that today's action will result in any disproportionately negative impacts on minority or low-income communities relative to affluent or non-minority communities.

This rule only changes the treatment standards applicable to a sub-category of K088 wastes at two facilities. It does not change in any way the paperwork requirements already applicable to these wastes. Therefore, this rule is not affected by the requirements of the Paperwork Reduction Act.

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) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This action does not involve technical standards based on new methodologies. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), 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 does not have tribal implications. It 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. These treatment variances do not create any new regulatory requirements. Rather, they establish an alternative treatment standard for a regulated constituent at two specific facilities. Thus, Executive Order 13175 does not apply to this final rule.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), 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” are 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 governments.”

This final rule does not have federalism implications. It will 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. These treatment variances do not create any new regulatory requirements. Rather, they establish an alternative treatment standard for a regulated constituent at two specific facilities. Thus, Executive Order 13132 does not apply to this rule.

This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that this rule is not likely to have any adverse energy effects.

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). This rule will be effective May 22, 2002.

The monkfish fishery is jointly managed by the New England and Mid-Atlantic Fishery Management Councils (Councils), with the New England Fishery Management Council having the administrative lead. The objectives of the management program established by the FMP are to eliminate overfishing by May 2002 and to rebuild the stock by 2009. In order to ensure the elimination of overfishing by May 2002, the FMP specified that restrictive measures be implemented for Year 4 of the management program (May 1, 2002—April 30, 2003), unless a 3-year review of the stock status indicates that these restrictive measures are not necessary. The Year 4 default measures, which became effective on May 1, 2002, eliminated the directed monkfish fishery by allocating zero monkfish days-at-sea (DAS) and by allowing only incidental landings of monkfish.

As required by the regulations at 50 CFR 648.96(b), a 3-year review of the management program was conducted by the Monkfish Monitoring Committee. Based on the results of this review, the Councils submitted Framework 1, which presented alternative management measures for Year 4. A proposed rule seeking public comment on Framework 1 was published in the Federal Register on April 4, 2002 (67 FR 16079). The measures proposed in Framework 1 were as follows: (1) A 1-year delay in implementing the restrictive Year 4 default management measures; (2) a target TAC of 19,595 metric tons (mt), with area-specific TACs of 11,674 mt and 7,921 mt for the Northern Fishery Management Area (NFMA) and the Southern Fishery Management Area (SFMA), respectively; (3) allocation of 40 DAS to limited access monkfish vessels for the 2002 fishing year (May 1, 2002 - April 30, 2003); (4) a revision to the monkfish trip limits in the SFMA to 550 lb (249 kg) (tail weight per DAS) for vessel permit categories A and C, and 450 lb (204 kg) (tail weight per DAS) for vessel permit categories B and D while fishing on a monkfish DAS in the SFMA; and (5) maintenance of all other measures as established for Year 3 of the FMP, including less restrictive incidental catch limits.

Based upon the F criteria recommended by SAW 34 and the 2001 NMFS fall trawl survey, the measures contained in Framework 1 were initially determined to be consistent with the FMP objectives of ending overfishing in 2002. However, that determination was based on the F criteria recommended by SAW 34, not the F criteria in the FMP. Therefore, during a closer review of the F criteria in the FMP, NMFS determined that Framework 1 was not consistent with the FMP because the F criteria in the FMP have not yet been formally amended to reflect the best available information on the monkfish stock. Therefore, NMFS is disapproving Framework 1 because it is inconsistent with the FMP.

The FMP authorizes the Councils to revise the F criteria through framework action. However, the results of SAW 34 were not available until late January 2002, when the Councils approved Framework 1, which was too late to incorporate the new scientific information into the framework action in order to have measures in place before the default measures became effective on May 1, 2002.

The F thresholds defined in the FMP are F=0.05 for the NFMA and F=0.14 for the SFMA. The FMP F targets and thresholds were generated using reference points and estimates of contemporaneous fishing mortality from SAW 23 (March 1997). Estimates of those reference points were recalculated during SAW 31 (October 2000) using updated data and under different hypotheses, which were considered to be more reasonable, regarding the mean length at full selection. 1 This resulted in negative estimates of the F threshold for the NFMA, which is an unrealistic result, indicating that the F reference points in the FMP are not reliable as indicators of stock status with respect to exploitation rates. As a result, the 31 st Stock Assessment Review Committee (SARC) concluded that the fishing mortality reference points established in the FMP needed to be reevaluated.

The 34 th SARC recognized inherent flaws in the method used to establish the F criteria in the FMP and discussed potential alternatives for establishing revised F criteria. The SARC stated that information now exists to estimate current F rates by age, and that yield per recruit (YPR) analyses could be used to establish revised reference points. Based on a provisional YPR analysis, the SARC recommended F thresholds of F=0.2 and F targets of F=0.14 for the stock units in both the NFMA and the SFMA.

The FMP includes target TAC levels projected to be consistent with the fishing mortality objectives of the FMP. The FMP's planned reductions in the target TACs were based on achieving the F threshold in the fourth year of management. However, when the F thresholds were found to be invalid, the TACs also became invalid.

The current assessment methodology is adequate to estimate the level of F in recent fishing years. In Framework 1, the Councils considered information from SAW 34 that provided a range of F estimates for calendar year 2000. Within the range of estimates, the SAW attached the most significance to those derived from the recent cooperative industry survey, which was conducted in February—April 2001. The most probable estimates of F derived from the cooperative survey ranged from about 0.25 to about 0.4. These estimates include only 7 months of monkfish DAS restrictions and trip limits and, therefore, underestimate the effect of the management measures in reducing F. Furthermore, the results of the 2001 NMFS fall trawl survey indicate that the NFMA component of the stock is no longer overfished and that the SFMA stock biomass is at its highest level since 1986.

NMFS implements this emergency rule to amend temporarily the F criteria in the FMP to be consistent with those recommended by SAW 34. Amendment 2 to the FMP, which is currently under development by the Councils, will permanently amend these F criteria and establish a revised stock rebuilding program using the best scientific information available. Because the measures proposed in Framework 1 were found to be consistent with the F criteria recommended by SAW 34, this temporary revision to the F criteria contained in the FMP provides a clear basis for implementing the management measures proposed in Framework 1. Therefore, this action also enacts the management measures proposed in Framework 1, which are described in the preamble to this emergency rule. These measures achieve the FMP objective of ending overfishing in 2002 since setting the target TACs for the 2002 fishing year based on 2000 landings is consistent with the amended F threshold of F=0.2. Moreover, with stock survey indices showing increasing biomass, F should decrease further if monkfish catch remains stable. To achieve the target TACs recommended for Framework 1, the Councils and NMFS considered combinations of trip limits and DAS. The combination of restrictive trip limits and 40 DAS to keep landings at the 2000 level was selected by the Councils over other (higher) trip limits and a reduced number of DAS based on industry testimony favoring the maintenance of the 40 DAS.