The FAA has determined that good cause exists for making these special conditions effective upon issuance; however, interested persons are invited to submit such written data, views, or arguments, as they may desire. Communications should identify the regulatory docket number and be submitted in duplicate to the address specified above. All communications received on or before the closing date for comments will be considered by the Administrator. These special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to these special conditions must include a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. NM201.” The postcard will be date stamped and returned to the commenter.

On April 4, 2001, ElectroSonics, 4391 International Gateway, Columbus, Ohio, applied for a Supplemental Type Certificate (STC) to modify Gulfstream Aerospace Corporation Model G-1159B airplanes. The Gulfstream Aerospace Corporation Model G-1159B is a small transport category airplane. These airplanes are powered by two Rolls Royce Spey RB (163-25) 511-8 engines, with a maximum takeoff weight of 69,700 pounds. This airplane operates with a 2-pilot crew and can hold up to 19 passengers. The modification incorporates the installation of a Honeywell Dual Airdata Computer System. The Honeywell Dual Airdata Computer System is a replacement for the existing Analog Flight Instrumentation, while also providing additional functional capability and redundancy in the system. The avionics/electronics and electrical systems installed in this airplane have the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane.

Under the provisions of 14 CFR 21.101, ElectroSonics must show that the Gulfstream Aerospace Corporation Model G-1159B airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A12EA, 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 regulations in the certification basis for the Gulfstream Aerospace Corporation G-1159B airplanes include:

• Civil Air Regulations (CAR) 4b, dated December 31, 1953, including Amendments 4b-1 thru 4b-14.

• Special Regulation SR450A.

• Special Conditions in “Attachment A” of FAA letter to Grumman dated September 27, 1965.

• 14 CFR (Code of Federal Regulations) 25.1325 ( effective February 1, 1965).

• Section 25.175 (effective March 1, 1965), in lieu of CAR 4b.155(b).

• Section 36.7(d)(3)(ii).

• CAR 4b.450, cooling systems.

• Part 25, dated February 1, 1965, as amended by Amendments No. 25-2 through 25-8, 25-10, 25-12, 25-16 thru 25-22, 25-24, and 25-26.

If the Administrator finds that the applicable airworthiness regulations (part 25, as amended) do not contain adequate or appropriate safety standards for the Gulfstream Aerospace Corporation Model G-1159B airplanes modified by ElectroSonics, because of a novel or unusual design feature, special conditions are prescribed under the provisions of 21.16.

In addition to the applicable airworthiness regulations and special conditions, these Gulfstream Aerospace Corporation Model G-1159B airplanes must comply with the fuel vent and exhaust emission requirements of part 34 and the noise certification requirements of part 36.

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

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

As noted earlier, the Gulfstream Aerospace Corporation Model G-1159B airplanes modified by ElectroSonics will incorporate the Honeywell Dual Airdata Computer System that will perform critical functions. This system may be vulnerable to high-intensity radiated fields external to the airplane. The current airworthiness standards of part 25 do not contain adequate or appropriate safety standards for the protection of this equipment from the adverse effects 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 avionics/electronics and electrical systems to command and control airplanes have made it necessary to provide adequate protection.

To ensure that a level of safety is achieved that is equivalent to that intended by the regulations incorporated by reference, special conditions are needed for the Gulfstream Aerospace Corporation Model G-1159B airplanes modified by ElectroSonics. These special conditions require that new avionics/electronics and electrical systems that 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 avionics/electronics and electrical 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 in accordance 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 following field strengths for the frequency ranges indicated. Both peak and average field strength components from the Table are to be demonstrated.

The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.

As discussed above, these special conditions are applicable to Gulfstream Aerospace Corporation Model G-1159B airplanes modified by ElectroSonics. Should ElectroSonics apply at a later date for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well under the provisions of § 21.101(a)(1).

This action affects only certain novel or unusual design features on Gulfstream Aerospace Corporation Model G-1159B airplanes modified by ElectroSonics. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. For this reason, and because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay certification of the airplane and thus delivery of the affected aircraft. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

Interested persons are invited to submit such written data, views, or arguments as they may desire. Communications should identify the rules docket number and be submitted in duplicate to the address specified above. The Administrator will consider all communications received on or before the closing date for comments. The special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. Persons wishing the FAA to acknowledge receipt of their comments submitted in response to these special conditions must include with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. NM199.” The postcard will be date stamped and returned to the commenter.

On October 13, 1997, Hollingsead International, Inc., 7416 Hollister Avenue, Goleta, California 93117-2538, applied for a Supplemental Type Certificate (STC) for the Boeing Model 747-200/-300 series airplanes. The Boeing Model 747-200/-300 series airplanes are equipped with four CF650E2 turbofan engines. The aircraft have a crew of three with additional seating for one, consisting of a jump seat in the cockpit. The aircraft are operated by KLM Royal Dutch airlines in “freighter,” “combi,” and “full passenger” configurations. The Boeing 747-200/-300 airplanes will incorporate Smiths Industries 5-ATI liquid crystal flight instruments. The modified airplanes are scheduled for certification in November 2001.

The functions of the liquid crystal flight instruments can be susceptible to disruption of both command and response signals as a result of electrical and magnetic interference caused by HIRF external to the airplane. This disruption of signals could result in loss of critical flight displays and annunciations, or could present misleading information to the pilot.

Under the provisions of 14 CFR 21.101, Hollingsead International, Inc, must show that the Boeing 747-200/-300 series airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A20WE, 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 regulations included in the certification basis for the Boeing Model 747-200/-300 series airplanes include 14 CFR part 25, as amended by Amendment 25-1 through Amendment 25-91.

If the Administrator finds that the applicable airworthiness regulations ( i.e. , part 25, as amended) do not contain adequate or appropriate safety standards for the Boeing Model 747-200/300 series airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 747-200/-300 series airplanes must comply with the fuel vent and exhaust emission requirement of 14 CFR part 34 and the noise certification requirement of 14 CFR part 36.

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

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model 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 § 21.101(a)(1).

The Boeing Model 747-200/-300 series airplanes will incorporate the Smiths Industries 5-ATI liquid crystal flight instruments as ADI, HSI and EDIS, which perform critical functions. The liquid crystal flight instruments contain electronic equipment for which the current airworthiness standards (14 CFR part 25) do not contain adequate or appropriate safety standards that address protecting this equipment from the adverse effects of HIRF. These instruments may be vulnerable to HIRF external to the airplane. Accordingly, these instruments are 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 avionics/electronics and electrical systems to command and control airplanes have made it necessary to provide adequate protection.

To ensure that a level of safety is achieved that is equivalent to that intended by the regulations incorporated by reference, special conditions are needed for the Boeing Model 747-200/-300 airplanes modified to include the Smiths Industries 5-ATI liquid crystal flight instruments as ADI, HSI and EDIS. These special conditions will require that these instruments, 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 avionics/electronics and electrical 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 in accordance with either paragraph 1 or 2 below:

1. A minimum threat of 100 volts rms 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 following field strengths for the frequency ranges indicated. Both peak and average field strength components from the Table are to be demonstrated.

The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.

As discussed above, these special conditions are applicable to the Boeing Model 747-200/-300 series airplanes modified by Hollingsead International, Inc. to include the Smiths Industries 5-ATI liquid crystal flight instruments, as ADI, HSI and EDIS. Should Hollingsead International apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A20WE to incorporate the same novel or unusual design features, these special conditions would apply to that model as well under the provisions of § 21.101(a)(1).

This action affects only certain novel or unusual design features on the Boeing Model 747-200/-300 series airplanes modified by Hollingsead International, Inc. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplanes.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. Because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Has FAA taken any action on the engine truss assemblies of Raytheon Beech Models 1900, 1900C (C-12J), and 1900D airplanes to this point? Continued problems with fatigue cracking of the engine truss assemblies on Raytheon Beech Models 1900, 1900C (C-12J), and 1900D airplanes caused FAA to issue AD 95-02-18, Amendment 39-9136 (60 FR 6652, February 3, 1995). This AD currently requires the following:

What has happened since AD 95-02-18 to initiate this action? The FAA continues to receive reports of engine truss fatigue cracks on Raytheon Beech Models 1900, 1900C (C-12J), and 1900D airplanes. The reports reference airplanes that are in compliance with AD 95-02-18.

The fatigue cracks are developing as a result of operational stresses in joints, welded bracketry, and linoil holes sealed by drive screws.

Has FAA taken any action to this point? The FAA issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Raytheon Beech Models 1900, 1900C (C-12J), and 1900D airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on July 11, 2001 (66 FR 36215). The NPRM proposed to supersede AD 95-02-18. The NPRM also proposed to require engine truss assembly replacement, periodic inspections and replacements, and the eventual incorporation of a cowling support installation kit as terminating action. The repetitive inspections of AD 95-02-18 would be retained until mandatory engine truss assembly replacement.

Was the public invited to comment? The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any comments on the proposed rule or on our determination of the cost to the public.

What is FAA's final determination on this issue? After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:

How many airplanes does this AD impact? We estimate that this AD affects 236 airplanes in the U.S. registry.

What is the cost impact of this AD on owners/operators of the affected airplanes? We estimate the following costs to accomplish the following actions:

Does this AD impact various entities? 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.

Does this AD involve a significant rule or regulatory action? For the reasons discussed above, I certify that this action (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) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES .

What events have caused this AD? The Federal Office for Civil Aviation (FOCA), which is the airworthiness authority for Switzerland, recently notified FAA that an unsafe condition may exist on all Pilatus Models PC-12 and PC-12/45 airplanes. The FOCA reports that, during production, some PC-12 and PC-12/45 airplanes were equipped with cargo doors that do not have reinforcing flanges on the lightening holes in the front and rear end of the cargo door frames.

What is the potential impact if FAA took no action? If not detected and corrected, cracking at the edges of the unflanged lightening holes could result in major structural damage to the airplane. Such damage could result in possible loss of control of the airplane.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all Pilatus Aircraft Ltd. Models PC-12 and PC-12/45 airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on August 22, 2001 (66 FR 44093). The NPRM proposed to require you to inspect the cargo doors to identify front and rear end frames with plain lightening holes; and install reinforcing plates on any frame with plain lightening holes.

The Swiss AD and the manufacturer's service information applies to manufacturer serial numbers (MSN) 301 through 370 and all part-number (P/N) 552.30.12.051 and P/N 552.30.12.052, held as spares. We are expanding the applicability of this AD to all serial numbered airplanes. We are expanding the inspection and installation actions to cover MSN 101 through MSN 370, instead of MSN 301 through MSN 370, because these cargo doors may have been installed on MSN 101 through MSN 370 through field approval or other methods. Since cargo doors, part-number P/N 552.30.12.051 and P/N 552.30.12.052, held as spares, may be installed on airplanes not covered by the applicability of the service information, the cargo doors on all serial numbered airplanes will have to be inspected and modified if necessary, prior to installation.

Was the public invited to comment? The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any comments on the proposed rule or on our determination of the cost to the public.

What is FAA's final determination on this issue? After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:

How many airplanes does this AD impact? We estimate that this AD affects 230 airplanes in the U.S. registry.

What is the cost impact of this AD on owners/operators of the affected airplanes? We estimate the following costs to accomplish the inspection:

Does this AD impact various entities? 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.

Does this AD involve a significant rule or regulatory action? For the reasons discussed above, I certify that this action (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) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES .

This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.

The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.

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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

On August 16, 2001, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulation, Lake Pontchartrain, LA in the Federal Register (66 FR 15373). We received three letters commenting on the proposed rule. No public hearing was requested, and none was held.

The bascule span of the dual bridges of the Greater New Orleans Expressway Commission Causeway across Lake Pontchartrain presently opens on signal if at least three hours notice is given. The Greater New Orleans Expressway Commission has requested a change in the operating schedule of the dual bridges to allow the draw to remain closed during peak vehicular traffic periods. Approximately 15,000 vehicles cross the dual bridges in each direction daily. Of the nearly 15,000 vehicles that cross the southbound bridge from St. Tammany Parish to Jefferson Parish, approximately 50% of these vehicles cross this bridge between the hours of 5:30 a.m. and 9:30 a.m. Of the nearly 15,000 vehicles that cross the northbound bridge from Jefferson Parish to St. Tammany Parish, approximately 50% of these vehicles cross this bridge between the hours of 3 p.m. and 7 p.m. During these peak traffic periods, an opening of the draw can cause traffic to back up approximately four to five miles.

Tender logs for the past year indicate that only six vessels have required the draw to open during these times.

Three letters were received in response to the NPRM. National Mariner Fisheries Service offered no objections to the proposed change. Pontchartrain Materials offered no objections to the proposed project; however, they did offer comments regarding delays to vessels in distress. The Coast Guard explained that the drawbridge is required to open for vessels in distress. The U. S. Fish and Wildlife Service officer no objections to the proposed changes.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 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. According to the vehicle traffic surveys provided by the applicant, these periods occur between 5:30 a.m. and 9:30 a.m. and between 3 p.m. and 7 p.m.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we 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.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 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.

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

We have analyzed this rule under Executive Order 13132, Federalism, and have determined that this rule would not have implications for federalism under that Order. No comments were received with regards to federalism during the NPRM comment period.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those costs. This rule does not impose an unfunded mandate. No comments were received with regards to unfunded mandates during the NPRM comment period.

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. No comments were received with regards to private property during the NPRM comment period.

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. No comments were received with regards to civil justice reform during the NPRM comment period.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not economically significant 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.

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

A notice of proposed rulemaking (NPRM) was not published for this regulation. In accordance with 5 U.S.C. 553 (b)(B), the Coast Guard finds good cause exists for not publishing an NPRM. The Coast Guard is taking this action for the immediate protection of the national security interests in light of the terrorist acts perpetrated on September 11, 2001. Also, in accordance with 5 U.S.C. 553 (d)(3), the Coast Guard finds good cause to exist for making this regulation effective less than 30 days after publication in the Federal Register . Publication of a notice of proposed rulemaking and delay of effective date would be contrary to the public interest because immediate action is necessary to provide for the safety of tank vessels calling at the Trans-Alaska Pipeline Valdez Terminal complex in Valdez, Alaska.

The Coast Guard is establishing temporary security zones around all tank vessels greater than 20,000 deadweight tons (DWT) while transiting, mooring, unmooring, or loading within the Prince William Sound Captain of the Port (COTP) Zone, defined in 33 CFR 3.85-20 (b) as encompassing waters within the boundary that starts at Cape Puget at 148°26′ W, 59°56.06′ N; and proceeds northerly to 61°30′ N; thence easterly to the United States-Canadian boundary; thence southerly along the United States-Canadian boundary to 60°18.7′ N; thence southwesterly to the sea at 60°01.3′ N, 142°00′ W; thence southerly along 142°00′ W to the outermost boundary of the Exclusive Economic Zone (EEZ); thence along the outermost boundary of the EEZ to 148°26′ N; thence northerly along 148°26′ W to the place of origin at Cape Puget. These 200-yard security zones are activated when the subject vessels enter the Prince William Sound COTP Zone. These security zones are necessary to protect the subject tank vessels transiting the Prince William Sound COTP Zone from damage or injury from sabotage, destruction or other subversive acts.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. It has not been reviewed by the Office of Management and Budget 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). Because of the transitory nature of the zones, the Coast Guard expects 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.

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. The number of small entities impacted by this rule is expected to be minimal because of the short duration of this rule and the transitory nature of these moving security zones.

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. 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 contains no information collection requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Coast Guard has analyzed this rule under the principles and criteria contained in Executive Order 13132 and has determined that this temporary final rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

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 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 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.

The Coast Guard considered the environmental impact of this rule and concluded that, under Figure 2-1, paragraph 34(g) of Commandant Instruction M16745.1C, this rule is categorically excluded from further environmental documentation.

A notice of proposed rulemaking (NPRM) was not published for this regulation. In accordance with 5 U.S.C. 553 (b)(B), the Coast Guard finds good cause exists for not publishing an NPRM. The Coast Guard is taking this action for the protection of the national security interests in light of the terrorist acts perpetrated on September 11, 2001. Also, in accordance with 5 U.S.C. 553 (d)(3), the Coast Guard finds good cause to exist for making this regulation effective less than 30 days after publication in the Federal Register . Publication of a notice of proposed rulemaking and delay of effective date would be contrary to the public interest because immediate action is necessary to provide for the safety of the Port of Valdez.

The Coast Guard is establishing a temporary security zone for Port Valdez, Alaska. This security zone is necessary to protect the facilities and vessels transiting within Port Valdez from damage or injury from sabotage, destruction or other subversive acts. The geographic area covered by this regulation is within the area defined in 33 CFR 165.1704(a) and encompasses the waters of Port Valdez north and east of a line drawn 307 degrees True and 127 degrees True from Middle Rock (61°04.7′ N, 146°39.3′ W), excluding the waters within the Alyeska Marine Terminal security zone defined in § 165.T17-003 of this part published in this same issue of the Federal Register .

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. It has not been reviewed by the Office of Management and Budget 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 10e of the regulatory policies and procedures of DOT is unnecessary. Economic impact is expected to be minimal because of the short duration this rule is in effect, the season in which it is effect, and vessels are permitted in the zone by the COTP on a case-by-case basis.

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. The number of small entities impacted by this rule is expected to be minimal because of the short duration that this rule is in effect. Moreover, the Captain of the Port will consider on a case-by-case basis whether an entity can enter this zone; therefore, it is likely that very few, if any, small entities will be impacted by this rule.

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. 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 contains no information collection requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Coast Guard has analyzed this rule under the principles and criteria contained in Executive Order 13132 and has determined that this temporary final rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

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 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 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.

The Coast Guard considered the environmental impact of this rule and concluded that, under Figure 2-1, paragraph 34(g) of Commandant Instruction M16745.1C, this rule is categorically excluded from further environmental documentation.

A notice of proposed rulemaking (NPRM) was not published for this regulation. In accordance with 5 U.S.C. 553(b)(B), the Coast Guard finds good cause exists for not publishing an NPRM. The Coast Guard is taking this action for the immediate protection of the national security interests in light of terrorist acts perpetrated on September 11, 2001. Also, in accordance with 5 U.S.C. 553(d)(3), the Coast Guard finds good cause to exist for making this regulation effective less than 30 days after publication in the Federal Register . Publication of a notice of proposed rulemaking and delay of effective date would be contrary to the public interest because immediate action is necessary to provide for the safety of the TAPS terminal and TAPS tank vessels.

The Coast Guard is establishing a temporary security zone around the TAPS terminal, Port Valdez, Valdez, Alaska. This security zone is necessary to protect the TAPS terminal and TAPS tank vessels transiting to, from and within Port Valdez from damage or injury from sabotage, destruction or other subversive acts. The security zone encompasses all waters approximately one mile north and east and two miles west of all terminal berths. The specific boundaries are enclose waters within a line beginning on the southern shoreline of Port Valdez at 61°04.8′ N, 146°29.4′ W; thence northerly to 61°06.5′ N, 146°29.4′ W; thence west to 61°06.5′ N, 146°19.7′ W; thence south to 61°05.0′ N, 146°19.7′ W; thence east along the shoreline and including the area 2000 yards inland along the shoreline to the starting point at 61°04.8′ N, 146°29.4′ W. This security zone includes the current 200-yard safety zone as set forth in 33 CFR 165.1701.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. It has not been reviewed by the Office of Management and Budget 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 10e of the regulatory policies and procedures of DOT is unnecessary. Economic impact is expected to be minimal because of the short duration of this rule and the season in which it is in effect.

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. The number of small entities impacted by this rule is expected to be minimal because of the short duration of the rule. The entities most likely affected are commercial and native subsistence fishermen. The time frame this rule is in effect does not cover any commercial harvests of fish in the area delineated by this rule; therefore, it is likely that very few, if any, small entities will be impacted by this rule.

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. 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 contains no information collection requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

The Coast Guard has analyzed this rule under the principles and criteria contained in Executive Order 13132 and has determined that this temporary final rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

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 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 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.

The Coast Guard considered the environmental impact of this rule and concluded that, under Figure 2-1, paragraph 34(g) of Commandant Instruction M16745.1C, this rule is categorically excluded from further environmental documentation.

We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number (CGD01-01-197), indicate the specific section of this document to which each comment applies, and give the reason for each comment. You may submit your comments and material by mail or hand delivery to Coast Guard Group/Marine Safety Office Long Island Sound, Waterways Management Branch, at the address under ADDRESSES in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you would like to confirm receipt of your comments or material, please enclose a stamped, self-addressed postcard or envelope. We will consider all material received during the comment period. We may change this rule in view of them.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The safety zone is being established to enable the continued renovation of the Mystic River Route 1 Bascule Bridge. This operation is the final phase of a multi-year bridge renovation project. The project was divided into two phases to help alleviate the burden upon local mariners. The renovation takes place during the winter months when recreational boating traffic is minimal.

At the outset of the project, the State of Connecticut Department of Transportation held two public information meetings to discuss the need for and timing of a safety zone that effectively closes the navigable channel beneath the bridge. No opposition to the proposed dates was received. In addition, Connecticut DOT corresponded with a number of known waterway users for the same purpose. No objections to the proposed dates were registered.

The first phase of the project requiring channel closure began December 1, 2000 and ended April 15, 2001. The closure period during the winter months had minimal impact on the needs of navigation. No complaint or objection was registered by any waterway users. Similarly, the effective dates of the present safety zone should have minimal impact on navigation. Accordingly, we determined that it was unnecessary to engage in the NPRM process for the waterway closure during the effective period of this rule. The public is invited to submit comments during the prescribed period. We may change this rule after consideration of any comments we receive.

Under 5 U.S.C. 553(d), we have determined that good cause exists for making this rule effective less than 30 days following its publication in the Federal Register . Construction crews will begin rehabilitation work on the bridge December 1, 2001. Any delay in the effective date of the safety zone beyond the start of construction would be contrary to the public interest insofar as that work may pose hazards to mariners who would otherwise pass beneath the bridge.

The Coast Guard is establishing a temporary safety zone on all waters of the Mystic River within 100 feet of both the north and south side of the Mystic River Route 1 Bascule Bridge, located in approximate position 41°21′3″ N, 071°58′1″ W. This safety zone is effective from 7 a.m. (EST) on December 1, 2001 to 7 a.m. (EST) on April 15, 2002. The safety zone will enable the state of Connecticut to complete the second phase of a two-year bridge renovation project that began in December 2000. A large construction barge will be placed near the bridge during renovation work thus blocking the waterway and preventing mariners from transiting through this portion of the Mystic River. The safety zone is also necessary to prevent mariners from the hazards associated with renovation and rehabilitation work on the bridge.

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).

Although this regulation prevents traffic from transiting a portion of the Mystic River, the effect of this regulation will not be significant for the following reasons: The bridge will not open to traffic during the construction period, therefore potential traffic will be limited to those vessels that could fit under the closed bridge; commercial traffic on the Mystic River north of the Route 1 Bascule Bridge is very limited; recreational traffic is minimal during the time of year the construction will occur; extensive advance notifications will be made to the maritime community via the Local Notice to Mariners, and marine information broadcasts; and prior to commencement of phase-one of this construction project the Mystic River Chamber of Commerce Task Group conducted several open meetings and communicated with local mariners regarding the closure 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 may affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit the boundaries of the safety zone during its effective dates. This rule will not have a substantial affect on small entities for the following reasons. There is very little commercial traffic north of the Route 1 Bascule Bridge. Recreational traffic needing to transit through the boundaries of the safety zone is minimal during the time of year the construction will occur. The Mystic River Chamber of Commerce Task Group has conducted several public meetings and corresponded with local mariners regarding the need for and timing of the waterway closure. Any entities that might be affected by the closure have had sufficient advance notice to make alternate arrangements. In addition, extensive advance notifications will be made to the maritime community via the 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. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and in what way and to what degree this proposed rule would economically affect it.

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 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 expenditure, we do discuss the effects of this rule elsewhere in this 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 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 (34)(g), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation.

Pursuant to 5 U.S.C. 553, a notice of proposed rulemaking (NPRM) was not published for this regulation. Good cause exists for not publishing a NPRM and for making this regulation effective in less than 30 days after publication in the Federal Register . The parameters of the zone will not unduly impair business and transits of vessels. The Coast Guard will announce via Broadcast Notice to Mariners the anticipated date and time of each launch and will grant general permission to enter the safety zone during those times in which the launch does not pose a hazard to mariners. Because the hazardous condition is expected to last for approximately 4 hours of each day for 13 days, and because general permission to enter the safety zone will be given during non-hazardous times, the impact of this rule on commercial and recreational traffic is expected to be minimal. Therefore, notice and comment is unnecessary. Additionally, the process of scheduling a rocket launch is uncertain due to unforeseen delays that can cause cancellation of the launch. The Coast Guard attempts to publish a Final Rule, with a 30-day window, as close to the expected launch date as possible, when it is conveyed to them in time. Any delay encountered in this regulation's effective date would be unnecessary and contrary to public interest since immediate action is needed to protect human life and property from possible fallout from the rocket launch. This safety zone should have minimal impact on vessel transits and announcements via Broadcast Notice to Mariners will give vessels advanced notice of the launch.

The Alaska Aerospace Development Corporation (AADC) will attempt to launch an unmanned rocket from their facility at Narrow Cape, Kodiak Island, Alaska sometime between 8:24 a.m. and 10:10 a.m. each day from November 9, 2001 through November 14, 2001 and between 7:02 a.m. and 8:54 a.m. each day from November 15, 2001 through November 21, 2001. The safety zone is necessary to protect spectators and transiting vessels from the potential hazards associated with the launch.

The Coast Guard will announce via Broadcast Notice to Mariners the anticipated date and time of the launch and will grant general permission to enter the safety zone during those times in which the launch does not pose a hazard to mariners. Because the hazardous condition is expected to last for approximately 4 hours of each day for 13 days, and because general permission to enter the safety zone will be given during non-hazardous times, the impact of this rule on commercial and recreational traffic is expected to be minimal.

From the latest information received from the Alaska Aerospace Development Corporation, the launch window is scheduled for 4 hours each day from November 9, 2001 through November 21, 2001. The size of the safety zone has been set based upon the trajectory information in order to provide a greater safety buffer in the event that the launch is aborted shortly after take-off. The proposed safety zone includes an area in the Gulf of Alaska, southeast of Narrow Cape, Kodiak Island, Alaska. Specifically, the zone includes the waters of the Gulf of Alaska that are within the area by a line drawn from a point located at 57°26′53″ North, 152°22′14″ West, then south to a point located at 57°24′42″ North, 152°23′18″ West, then southeast to a point located at 57°11′32″ North, 152°05′35″ West, then northeast to a point located at 57°18′45″ North, 151°53′47″ West, then west northwest to the point located at 57°27′45″ North, 152°18′31″ West, then back to the first point. All coordinates reference Datum: NAD 1983.

This safety zone is necessary to protect spectators and transiting vessels from the potential hazards associated with the launch of the rocket. The Coast Guard will announce via Broadcast Notice to Mariners the anticipated date and time of the launch and will grant general permission to enter the safety zone during those times in which the launch does not pose a hazard to mariners.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential cost 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. Because the hazardous condition is expected to last for only approximately 4 hours of each day for 13 days, and because general permission to enter the safety zone will be given during non-hazardous times, the economic impact of this rule on commercial traffic should be minimal. In addition, before the effective period, we will issue maritime advisories widely available to users of the affected portion of the Gulf of Alaska. We believe there will be minimal economic impact on commercial traffic.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit, anchor, or fish in a portion of the Gulf of Alaska off Ugak Island and Narrow Cape from 6:30 a.m. to 10:30 a.m. each day starting November 9, 2001 through November 14, 2001, and then from 5 a.m. to 9:15 a.m. each day starting November 15, 2001 through November 21, 2001. Because the hazardous condition is expected to last for approximately 4 hours of each day for 13 days, and because general permission to enter the safety zone will be given during non-hazardous times, the impact of this rule on commercial and recreational traffic should be minimal. Before the effective period, we will issue maritime advisories widely available to users of the affected portion of the Gulf of Alaska. We believe there will be minimal impact to small entities.

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 calls 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 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 economically significant and does not cause an environmental risk to health or risk to safety that may disproportionately affect children.

This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct affect 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 considered the environmental impact of this rule and concluded that, under Figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation. This rule is excluded under paragraph (34)(g) because it is a safety zone. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

On November 1, 2000, the State of Alabama submitted an attainment demonstration for the 1-hour ozone NAAQS for the Birmingham nonattainment area for inclusion into the Alabama SIP. The rule for the fuel program (the subject of this final rulemaking) is included in this submittal in Appendix I; the request for a waiver from Federal preemption pursuant to 211(c)(4)(C) of the Act (also the subject of this final rulemaking) is included as Appendix II of this submittal. Specifically, Appendix II of the Alabama submittal contains data and analyses to support a finding under section 211(c)(4)(C) that the State's low-sulfur and low-RVP requirements are necessary for the Birmingham nonattainment area to achieve the ozone NAAQS. On September 11, 2001, (66 FR 47142) EPA published a notice of proposed rulemaking (NPR) to approve the fuel waiver request and fuel rule. That NPR provides a detailed description of this action and EPA's rationale for proposed approval. The public comment period for this action ended on October 11, 2001. No comments, adverse or otherwise, were received on EPA's proposal.

EPA is approving Alabama's low-sulfur/low-RVP fuel program into the federally enforceable SIP because the fuel requirements are in accordance with the Act, are necessary for the Birmingham nonattainment area to achieve the 1 hour ozone NAAQS in a timely manner, and will supply some or all of the reductions needed to achieve the ozone NAAQS.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2001). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of prior existing requirements for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1195 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Action of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 7, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

On July 2, 2001, the Maryland Department of Environment (MDE) requested that EPA parallel-process its approval of three proposed state regulations as revisions to the Maryland SIP. These regulations control VOC emissions from (1) distilled spirits facilities, COMAR 26.11.19.29, (2) aerospace coating operations, COMAR 26.11.19.13-1, and (3) kraft pulp mills, COMAR 26.11.14.01, 26.11.14.02 and 26.11.14.06. These regulations impose RACT requirements for the control of VOC emissions at affected facilities in Maryland. EPA published its notices of proposed rulemaking (NPRs) to approve the aerospace coating and kraft pulp mills regulations on August 24, 2001 (66 FR 44574), and the distilled spirits facilities regulation on August 27, 2001 (66 FR 44995), as revisions to the Maryland SIP.

EPA proposed approval of Maryland's proposed regulations under a procedure called parallel-processing, whereby EPA proposes rulemaking action concurrently with the state's procedures for amending and/or adopting its regulations. These regulations have now been fully adopted by Maryland and were formally submitted to EPA for approval into the Maryland SIP on October 5, 2001. The adopted regulations were not changed from the proposed versions submitted for parallel-processing. The specific requirements of Maryland's regulations to control VOC emissions from distilled spirits facilities, aerospace coating operations, and kraft pulp mills; and the rationale for EPA's proposed actions are explained in the NPRs and will not be restated here. No public comments were received on the NPR pertaining to aerospace coating operations. EPA did receive comments on the NPRs pertaining to kraft pulp mills and distilled spirits facilities. They are not adverse comments which oppose EPA's approval of Maryland's regulations, but rather comments that request to make certain clarifications in its final rulemaking.

Comment: EPA should make it clear that the terms and provisions of the kraft pulp mills and the distilled spirits facilities, for this rulemaking, only apply to the affected facilities in Maryland.

Response: The terms and provisions of the Maryland's RACT regulations to control VOC emissions from kraft pulp mills and distilled spirits facilities, only apply to the affected facilities located in Maryland, namely Westvaco's Luke Mill (for kraft pulp mills) and Seagram Americas (for the distilled spirits facilities), respectively.

Comment: It is not possible to control emissions of VOCs from aging houses from distilled spirits facilities.

Response: Neither the proposed nor adopted version of Maryland's RACT to control VOC emissions from distilled spirits facilities requires that VOCs be controlled from the aging warehouses. The Maryland regulation is not to be construed to mean that the required good operating practices manual extends to the aging process at the affected facility in Maryland. There are, however, other emission sources at the affected facility in Maryland where fugitive VOC emissions can be minimized. The requirements of Maryland's distilled spirits facilities regulation to minimize VOC emissions by implementing good operating practices at fugitive emission sources, other than the aging warehouses, is unique to the affected facility in Maryland.

EPA is approving revisions submitted by the State of Maryland on October 5, 2001 pertaining to RACT requirements to reduce VOC from distilled spirits facilities, COMAR 26.11.19.29; aerospace coating operations, COMAR 26.11.19.13-1; and kraft pulp mills, COMAR 26.11.14.01, 26.11.14.02 and 26.11.14.06.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note ) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action, must be filed in the United States Court of Appeals for the appropriate circuit by January 7, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action to approve Maryland's RACT regulations to control VOCs from distilled spirits facilities, aerospace coating operations, and kraft pulp mills, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

On July 31, 2001 (66 FR 39471), EPA published a notice of proposed rulemaking (NPR) for the State of Maryland. The NPR proposed approval of a SIP revision, which establishes reasonably available control technology (RACT) for the control of emissions of volatile organic compounds (VOCs) from iron and steel production installations in Maryland. The formal SIP revision was submitted by the State of Maryland on January 8, 2001. Other specific requirements of the SIP revision pertaining to VOC RACT from iron and steel production installations in Maryland, and the rationale for EPA's proposed action are explained in the NPR, and will not be restated here. No comments were received on the NPR.

EPA is approving reasonably available control technology (RACT) for the control of emissions of volatile organic compounds (VOCs) from iron and steel production installations in Maryland as a revision to the Maryland SIP.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this final rule must be filed in the United States Court of Appeals for the appropriate circuit by January 7, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action approving Maryland VOC RACT regulation for iron and steel production facilities may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On November 1, 2000, the Alabama Department of Environmental Management (ADEM) submitted a revision to its ground-level 1-hour ozone attainment SIP to meet the requirements of the CAA as amended in 1990, related to 1-hour ozone attainment demonstrations. The revision consists of the adoption of the regulatory section, chapter 335-3-8 Control of Nitrogen Oxide Emissions: (.03) NO X Emissions from Electric Utility Generating Units, and the adoption of the non-regulatory ground-level 1-hour ozone attainment demonstration. On September 11, 2001, (66 FR 47145) EPA published a notice proposing to approve the November 1, 2000, ground-level 1-hour ozone attainment demonstration and the associated regulations. That notice provided for a public comment period ending on October 11, 2001. A detailed description of this attainment demonstration and EPA's rationale for approving it was provided in the proposal notice and will not be restated here. No adverse comments were received on EPA's proposal.

EPA is approving the ground-level 1-hour ozone attainment demonstration for Birmingham and the associated regulations, which were submitted to EPA on November 1, 2000. EPA finds that Alabama's submittal is fully approvable.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 7, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

You may be potentially 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-301187. 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, 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.

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for combined residues of the insecticide imidacloprid, [(1-[6-chloro-3-pyridinyl) methyl] -N -nitro-2-imidazolidinimine) and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent, in or on almond nutmeat at 0.05 part per million (ppm), almond hulls at 4.0 ppm, cranberries at 0.5 ppm and modifying the existing time limited tolerances for stone fruit from 1.0 ppm to 3.0 ppm and prunes from 3.5 ppm to 10.0 ppm. These tolerances will expire and are revoked on December 31, 2003. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.

Section 408(1)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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. . . .”

Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The glassy-winged sharpshooter (GWSS) poses a significant threat to viticulture throughout California. Native to Southeast United States, this large leafhopper was inadvertently introduced into Southern California about 10 years ago. It went unrecognized for several years due to its similarity to the smoke tree sharpshooter, a native insect. It is of particular concern to grape growers due to its ability to transmit Xylella fastidiosa, the bacterium that causes Pierce's Disease. EPA has authorized under FIFRA section 18 the use of imidacloprid on stone fruit and almonds for control of the glassy- winged sharpshooter in California. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

EPA has also authorized under FIFRA section 18 the use of imidacloprid on cranberries for control of cranberry weevils in Massachusetts. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of imidacloprid in or on stone fruit, almonds and cranberries. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6). Although these tolerances will expire and are revoked on December 31, 2003, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on stone fruit, prunes, almond nutmeat, almond hulls and cranberries after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether imidacloprid meets EPA's registration requirements for use on stone fruit, almonds, and/or cranberries or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of imidacloprid by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any States other than California to use this pesticide on stone fruit and almond or Massachusetts on cranberries under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for imidacloprid, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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 imidacloprid and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerance for the combined residues of imidacloprid in or on almond nutmeat at 0.05 ppm, almond hulls at 4.0 ppm, stone fruit at 3.0 ppm, prunes at 10.0 ppm, and cranberries at 0.5 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

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 endpoint. 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 (aRfD or cRfD) 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 level of concern (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 x10 -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 imidacloprid used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Tolerances, some time-limited, are currently established (40 CFR 180.472) for the combined residues of the insecticide imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent, in or on a variety of raw agricultural and animal commodities at levels ranging from 0.02 ppm in eggs to 15 ppm in raisins, waste. Risk assessments were conducted by EPA to assess dietary exposures from [imidacloprid] in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992-nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: 100% crop treated and tolerance level residues.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the DEEM TM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992- nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues and some percent crop treated data used of selected commodities.

iii. Cancer . Imidacloprid has been classified by the Agency as a Group E chemical, no evidence of carcinogenicity for humans, thus, a cancer risk assessment is not required.

iv. Anticipated residue and percent crop treated information . Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent crop treated (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency used tolerance level residues and some percent crop treated data on selected commodities. The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which imidacloprid may be applied in a particular area.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for imidacloprid in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of imidacloprid.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and Screening Concentrations in Ground Water (SCI-GROW), which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to imidacloprid they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the estimated environmental concentrations (EECs) of imidacloprid for acute exposures are estimated to be 4.1 parts per billion (ppb) for surface water and 1.1 ppb for ground water. The EECs for chronic exposures are estimated to be 0.1 ppb for surface water and 1.1 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Imidacloprid is currently registered for use on the following residential non-dietary sites: Ornamentals (e.g., flowering and foliage plants, ground covers, turf, and lawns), tobacco, golf courses, walkways, recreational areas, household or domestic dwellings (indoor/outdoor), and cats/dogs. The risk assessment was conducted using the following exposure assumptions: Short- and intermediate-term oral exposure are not expected for adult population subgroups. However, since imidacloprid is registered for use on turf, home gardens and pets, the Agency has identified potential short-term oral exposures to children for these uses. Thus, a residential short-term risk assessment via the oral route is required.

The DWLOC for short-term exposure to imidacloprid was calculated relative to the aPAD which was utilized for estimating risk for short-term oral exposure to imidacloprid. To calculate the DWLOC for short-term exposure relative to an acute toxicity endpoint, the sum of average dietary food exposure and the oral exposure from imidacloprid home garden, turf, and pet uses was subtracted from the aPAD to obtain the maximum allowable short-term exposure to imidacloprid in drinking water (Chronic food exposure = 0.011 mg/kg/day. Oral exposure from home garden and turf uses = 0.0059 mg/kg bwt/day, oral exposure from pet uses = 0.10 mg/kg bwt/day). DWLOCs were then calculated using default body weights and drinking water consumption figures, and then compared to the chronic water number.

4. Cumulative exposure to substances with a 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.”

EPA does not have, at this time, available data to determine whether imidacloprid 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, imidacloprid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that imidacloprid has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. In general . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Developmental toxicity studies . In a developmental toxicity study with Sprague-Dawley rats, groups of pregnant animals (25/group) received oral administration of imidacloprid (94.2%) at 0, 10, 30, or 100 mg/kg bwt/day during gestation days 6 through 16. Maternal toxicity was manifested as decreased body weight gain at all dose levels and reduced food consumption at 100 mg/kg bwt/day. No treatment-related effects were seen in any of the reproductive parameters (i.e., Caesarean section evaluation). At 100 mg/kg bwt/day, developmental toxicity manifested as wavy ribs (fetus =7/149 in treated vs. 2/158 in controls and litters, 4/25 vs. 1/25). For maternal toxicity, the LOAEL was 10 mg/kg bwt/day (LDT) based on decreased body weight gain; a NOAEL was not established. For developmental toxicity, the NOAEL was 30 mg/kg bwt/day and the LOAEL was 100 mg/kg bwt/day based on increased wavy ribs.

In a developmental toxicity study with Chinchilla rabbits, groups of 16 pregnant does were given oral doses of imidacloprid (94.2%) at 0, 8, 24 or 72 mg/kg bwt/day during gestation days 6 through 18. For maternal toxicity, the NOAEL was 24 mg/kg bwt/day and the LOAEL was 72 mg/kg bwt/day based on mortality, decreased body weight gain, increased resorptions, and increased abortions. For developmental toxicity, the NOAEL was 24 mg/kg bwt/day and the LOAEL was 72 mg/kg bwt/day based on decreased fetal body weight, increased resorptions, and increased skeletal abnormalities.

3. Reproductive toxicity study . In a 2-generation reproductive toxicity study, imidacloprid (95.3%) was administered to Wistar/Han rats at dietary levels of 0, 100, 250, or 700 ppm (0, 7.3, 18.3, or 52.0 mg/kg bwt/day for males and 0, 8.0, 20.5, or 57.4 mg/kg bwt/day for females). For parental/systemic/reproductive toxicity, the NOAEL was 250 ppm (18.3 mg/kg bwt/day) and the LOAEL was 750 ppm (52 mg/kg bwt/day), based on decreases in body weight in both sexes in both generations. Based on these factors, the Agency determined that the review be revised to indicate the parental/systemic/reproductive NOAEL and LOAEL to be 250 and 700 ppm, respectively, based upon the body weight decrements observed in both sexes in both generations.

4. Prenatal and postnatal sensitivity. The developmental toxicity data demonstrated no increased sensitivity of rats or rabbits to in utero exposure to imidacloprid. In addition, the multi-generation reproductive toxicity study data did not identify any increased sensitivity of rats to in utero or postnatal exposure. Parental NOAELs were lower or equivalent to developmental or offspring NOAELs.

5. Conclusion . There is a need for a developmental neurotoxicity study for assessment of potential alterations of functional development. However, the Agency has determined that this data gap does not preclude the establishment/continuance of tolerances. The 10X safety factor to account for enhanced sensitivity of infants and children (as required by FQPA) was reduced to 3x and the factor applies to all population subgroups.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + chronic non-dietary, non-occupational exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to imidacloprid in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of imidacloprid on drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to imidacloprid will occupy 24% of the aPAD for the U.S. population, 18% of the aPAD for females 13 years and older, 47% of the aPAD for non-nursing infants less than 1 year old and 47% of the aPAD for children 1-6 years old. In addition, despite the potential for acute dietary exposure to imidacloprid in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of imidacloprid in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to imidacloprid from food will utilize 26% of the cPAD for the U.S. population, 68% of the cPAD for non-nursing infants and 58% of the cPAD for children 1-6 years old. Based on the use pattern, chronic residential exposure to residues of imidacloprid is not expected. In addition, despite the potential for chronic dietary exposure to imidacloprid in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of imidacloprid in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Imidacloprid is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for imidacloprid.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 350 for children 1-6 years old (the population sub-group of concern. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of imidacloprid in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 4:

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level).

Though residential exposure could occur with the use of imidacloprid, no toxicological effects have been identified for intermediate-term toxicity. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed.

5. Aggregate cancer risk for U.S. population . Imidacloprid has been classified by the Agency as a Group E chemical, no evidence of carcinogenicity for humans, thus, a cancer risk assessment is not required.

6. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to imidacloprid residues.

Adequate enforcement methodology (example - gas chromatography) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no CODEX, Canadian, or Mexican Maximum Residue Limits for imidacloprid on stone fruit, almonds or cranberries.

Therefore, the tolerance is established for the combined residues of imidacloprid, (1-[6-chloro-3-pyridinyl) methyl]- N -nitro-2-imidazolidinimine) and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent, in or on almond nutmeat at 0.05 ppm, almond hulls at 4.0 ppm, cranberries at 0.5 ppm, and the exisiting time limited tolerance for stone fruit is modified from 1.0 ppm to 3.0 ppm and for prunes is modified from 3.5 ppm to 10.0 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-301187 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 January 7, 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. 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 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 VII.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 the docket control number OPP-301187, 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 establishes time-limited tolerances under FFDCA section 408. 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 prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); 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 require 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 FIFRA section 18 exemption under FFDCA section 408, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

You may be potentially 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-301188. 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, 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.

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is re-establishing a tolerance for combined residues of the fungicide chlorothalonil and its metabolite, 4-hydroxy-2,5,6- trichloroisophthalonitrile, in or on ginseng at 0.10 part per million (ppm). This tolerance will expire and is revoked on December 31, 2003. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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. . . .”

Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

Ginseng is a valuable root crop that is used as a health supplement in a variety of foods such as teas, wine, herbal medicines and gum. Ginseng is grown over multiple growing seasons, so disease control is necessary to ensure that the harvested roots and seeds are not damaged by intensifying disease pressure over successive seasons. Roots are not harvested until the plants are four years old. Growers are concerned about the damage that the fungal disease Alternaria panax causes to ginseng gardens. The fungus can produce leaf and stem blight which defoliates and diminishes the overall vigor of effected ginseng. These blights can result in high or complete yield loss of the harvested ginseng root.

Growers have typically relied upon mancozeb treatments to protect gardens against Alternaria panax . However, during the 2001 growing season, Wisconsin experienced significant precipitation and also hot humid conditions. This weather cycle further heightened the probability of significant disease pressure. At the same time, the rain events negated the effectiveness of the traditional control means, mancozeb. If applied prior to rain events, mancozeb will wash off of the ginseng plants. The Applicant identified a weather-stick formulation of chlorothalonil that has the characteristic of adhering strongly to the ginseng plants. Thus, on June 15, 2001, the Wisconsin Department of Agriculture, Trade, and Consumer Protection availed itself of its authority to declare a crisis situation under section 18, thereby permitting growers to immediately use a weather-stick formulation of chlorothalonil on ginseng.

EPA acknowledges that there are not sufficient registered alternatives and concurred on the crisis declaration by the State to control leaf and stem blight in ginseng.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of chlorothalonil in or on ginseng. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6). Although this tolerance will expire and is revoked on December 31, 2003, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on ginseng after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether chlorothalonil meets EPA's registration requirements for use on ginseng or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of chlorothalonil by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than Wisconsin to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for chlorothalonil, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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 chlorothalonil and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for combined residues of chlorothalonil and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile in or on ginseng at 0.10 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

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 endpoint. 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 level of concern (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 x10 -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 chlorothalonil used for human risk assessment is shown in the following Table 1.

1. Mechanistic data . In a cell proliferation study, 28 male Fischer 344 rats received technical chlorothalonil (97.9%) in the diet at 175 mg/kg/day for up to 91 days. Mean labeling index was statistically increased in the kidneys of male rats treated with 175 mg/kg/day chlorothalonil at all scheduled sacrifice times. From Day 7 to Day 28, the increase in labeling index was relatively stable (approximately 10-fold over control), with a decrease to approximately 3.5-fold over control on Day 91. Increased cell proliferation correlated with histopathological lesions of degeneration of the proximal convoluted tubules and epithelial hyperplasia. The results of this study demonstrate a sustained cell proliferative response as a result of dietary administration of technical chlorothalonil at a dose of 175 mg/kg/day.

In another study, 96 male SPR rats were divided into test groups of 6 animals per group. Rats received technical chlorothalonil (98.98% a.i.) in the diet at dose levels of 0, 1.5, 15, or 175 mg/kg/day for either 7, 14, 21, or 28 days (total of 24 rats per time point). Histological examination of kidney and stomach tissue was performed for each group after the appropriate exposure. In addition, kidneys were subjected to PCNA staining and stomachs to BrdU staining, and the labeling index and labeling count of cell nuclei were performed. Duodenum was used as a negative control for PCNA and BrdU staining. Increased absolute and relative weight of the kidneys was observed at 175 mg/kg/day at all time points, and, in one animal, at 15 mg/kg/day on Day 28. Increased incidence of vacuolization of the epithelium of the proximal convoluted tubules was observed at all time points at 175 mg/kg/day on Days 7, 14, and 21 at 15 mg/kg/day. PCNA immunostaining of the proximal convoluted tubule epithelial cells showed increased labeling of cells at the 175 mg/kg/day dose level at all time points, and increased labeling at 15 mg/kg/day on Days 7, 14 and 21. BrdU labeling of the rat forestomach showed marked labeling at 175 mg/kg/day at all time points, and increased labeling on Day 28 at 15 mg/kg/day. The results of this study demonstrate a toxic response of the kidney and forestomach to repeated dietary administration of chlorothalonil at doses of 15 and 175 mg/kg/day.

2. Summary of toxicological dose and levels of concern for SDS-3701 for use in human risk assessment . There is no evidence of carcinogenicity for the SDS-3701 metabolite in either rats or mice. For the acute and chronic non-cancer exposure assessments, residues of SDS-3701 were combined with residues of chlorothalonil and the sum compared to chlorothalonil levels of concern (the LOAEL for acute dietary risk and the RfD for chronic non-dietary risk).

3. Summary of toxicological dose and levels of concern for HCB for use in human risk assessment . A summary of the toxicological endpoints for HCB used for human risk assessment is shown in the following Table 2.

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.275) for the combined residues of chlorothalonil and its metabolite 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on a variety of raw agricultural commodities. Because it is a low consumption specialty crop, ginseng is not uniquely identified in the dietary exposure system the Agency uses to estimate food consumption behaviors in the U.S. Thus, there is not likely to be a measurable difference in the exposures and risks from chlorothalonil when ginseng is added into the exposure scenario. Also, there are not likely to be implications for livestock as ginseng is not a feed item. However, in connection with another registration action involving chlorothalonil, EPA recently completed a comprehensive risk assessment for chlorothalonil. These risk assessments were conducted by EPA to assess dietary exposures from chlorothalonil and its metabolite in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1977-1978-nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Each analysis assumes uniform distribution of chlorothalonil in the commodity supply. Acute dietary exposure was estimated based on the theoretical maximum residue contribution (TMRC) or anticipated residues for combined residues of chlorothalonil and SDS-3701. Percent crop treated and anticipated residue refinements were used.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Risk Evaluation System (DRES) was used. The following assumptions were made for the chronic exposure assessments: Tolerance level residues and percent of crop treated information were used in the analysis for chlorothalonil and SDS-3701. Anticipated residues were used in the chronic dietary exposure analysis from food for HCB.

iii. Cancer . In this analysis, dietary exposure from chlorothalonil was estimated based on anticipated residues (excluding meat and milk, eggs and poultry). Meat and milk, eggs and poultry were not included in this analysis since chlorothalonil residues are not expected in these commodities. SDS-3701 was not included in this analysis since it is not carcinogenic. The dietary exposure from food from HCB was estimated based on anticipated residues (includes meat and milk, eggs, and poultry). Since HCB is a contaminant in several other pesticides, an aggregate exposure assessment for HCB was conducted with food uses of chlorothalonil, pentachlorobenzene, picloram, and dacthal. HCB is present in five other food-use pesticides but at low levels which do not significantly add to the aggregate dietary exposure. Pentachlorobenzene (PCB) is also present in PCNB, and the Agency has concluded that the carcinogenic potential of PCB is comparable to HCB. In estimating dietary carcinogenic risk from HCB in these four pesticides, the Q* for PCB is assumed to be equal to that for HCB. The assumption was made that the impurities would occur on food commodities at the same ratio to the active ingredient as was present in the formulation applied to these crops. It is also assumed that the impurity would dissipate from the food commodity at an equal or greater rate than the active ingredient. The Agency believes these are reasonable assumptions because there are data from studies with chlorothalonil, picloram, and dacthal which support this approach.

iv. Anticipated residue and percent crop treated information . Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent crop treated (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency used percent crop treated (PCT) information as shown in the following Table 3.

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which chlorothalonil may be applied in a particular area.

2. Dietary exposure from drinking water —i. Ground water exposure - chlorothalonil and SDS-3701 . Exposure to chlorothalonil in drinking water is derived from the monitoring data. The metabolites (SDS-46851, SDS-47525, SDS-3701, and SDS-19221) were measured at a combined concentration of approximately 16 parts per billion (ppb) in Suffolk County, Long Island in 1981. Chlorothalonil itself has been detected in the Sates of California, Florida, Massachusetts, and Maine at levels typically below 1 ppb. These observations are predictable based on laboratory mobility studies and evidence of metabolite persistence. It is expected that the levels of chlorothalonil metabolites detected in the ground water in New York are relatively high compared to the country as a whole, because (a) they were the highest values reported in the data base, (b) potatoes are a major crop on Long Island, and (c) Long Island ground water is generally shallow and vulnerable. The Long Island values were used to represent a high-end potential exposure. In the absence of data demonstrating otherwise, this assessment is based on the conservative assumption that the detected metabolites of chlorothalonil have the same toxicity as the parent. As indicated above, this assessment relies on other conservative factors.

ii. Surface water exposure chlorothalonil and SDS-3701 . Chlorothalonil can contaminate surface water at application via spray drift or after application through runoff and erosion. The intermediate soil/water partitioning of chlorothalonil indicates that its concentration is suspended and bottom sediment will be substantially greater than its concentration in water. The major degradate of chlorothalonil in the soil under aerobic conditions is SDS-3701. SDS-3701 appears to be more persistent and mobile than chlorothalonil, based on ground water detections. Substantial amounts of SDS-3701 could be available for runoff for longer periods than chlorothalonil, and SDS-3701 may be more persistent in water/sediment systems than chlorothalonil. The apparent greater mobility of SDS-3701 suggests that it exhibits lower soil/water partitioning than chlorothalonil. Therefore, the ratio of SDS-3701 runoff loss via dissolution in runoff to runoff loss via adsorption to eroding soil for SDS-3701 may be greater than for chlorothalonil. In addition, the ratios of concentrations dissolved in the water column to concentrations adsorbed to suspended and bottom sediment may be higher for SDS-3701 than for chlorothalonil. The Agency has be unable to calculate drinking water risk for SDS-3701 in surface water because no monitoring data were available.

The South Florida Water Management District (SFWMD) summarized chlorothalonil detections in samples collected every 2 to 3 months from surface water sites within the SFWMD from November 1988 through November 1993. Approximately 810 samples (30 sampling intervals x 27 sites sampled/interval) were collected during that time. Chlorothalonil was detected in 25 samples at concentrations ranging from 0.003 ppb to 0.35 ppb. Six of the samples had concentrations greater than 0.01 ppb.

iii. Ground and surface water exposure HCB and PCB . HCB and pentachlorobenzene are present in ground water and surface water from sources other than current usage of contaminated pesticides, including manufacturer of solvents and tires, incineration of wastes, and coal combustion. HCB and PCB are persistent and relatively immobile in the environment; the major route of dissipation is through sorption to soil, sediment, and suspended particulates in water. HCB and PCB contamination of ground water sources is relatively unlikely due to the high binding potential of both compounds. Detections of HCB in ground water generally have ranged between 0.0002 to 0.100 ppb. Based on monitoring data and fate properties, it seems unlikely that long-term HBC and PCB concentration in surface water would exceed 10 parts per trillion (ppt) (0.01 ppb).

Surface water detection shows much more variability than concentrations in ground water and have been measured at up to 750 ppb. These values appear to include sorbed HCB. The HCB concentration which actually appear to be dissolved in the water are generally less than 0.001 ppb. Great Lakes region concentrations generally ranged from 0.00002 to 0.0001 ppb. When concentrations exceeded this range, they appeared to be related to industrial areas or areas of historic contamination (more than 20 years ago). Concentrations of PCB in surface water have ranged between 0.00002 and 0.0001 ppb. Concentrations of HCB and PCB in drinking water can be greatly reduced through treatment with activated granular charcoal.

Higher concentrations of HCB and PCB have been reported in surface and ground water, but tend to be related to hazardous waste, landfill sites, and suspended sediment. The U.S. Department of Health and Human Services in 1996 estimated that the average exposure in the United States from drinking HCB contaminated water is 0.00085 μg/kg/year (-0.000082 ppb). Since potential exposures are generally so low, and because pesticides are just one source of HCB and PCB in drinking water, the Agency concluded that there are insufficient data to quantify risk and that drinking water risk estimates from HCB in pesticides do not exceed the Agency's level of concern.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Chlorothalonil is currently registered for use on the following residential non-dietary sites: Home vegetable gardens, ornamentals, paint, stain, and wood preservatives. The risk assessment was conducted using the following exposure assumptions: The Agency completed an exposure assessment for uses of chlorothalonil as an additive contained 40.4% active ingredient for use in caulks, sealants, polymer lattices, grouts, joint compounds, and paper coatings. All relevant occupational and residential exposures were considered. Data were not available to estimate application and post application exposure and risk for primary and secondary homeowner exposure. Primary homeowner exposure occurs in individuals who use or install chlorothalonil-containing material; secondary residential exposure occurs when other individuals live and work in places where chlorothalonil-containing materials have been used. For these exposures, no risk assessment could be conducted, but the Agency believes that secondary and homeowner exposures to these products by themselves are generally lower than primary occupational application exposures.

Since other residential risks could not be quantified, risk concerns and uncertainties about exposure resulted in the following agreements with the registrants. To mitigate potential residential exposure concerns and uncertainties about the packaging and concentration of chlorothalonil additives for paint, the registrants have agreed that chlorothalonil mildewicidal additives must be labeled to prohibit sale over-the-counter in retail outlets. The registrants have committed to working with the Agency to develop measures for the protection of employees of paint sales outlets who mix mildewicidal additives into paint for sale. To mitigate potential residential exposure concerns and uncertainties about the in-container preservative use of chlorothalonil, particularly because the chlorothalonil content of products in which the preservative is used may not be known to the purchaser, and because such preservatives may be used in paints intended for use by children, the registrants have agreed that the in-container preservative use of chlorothalonil is prohibited.

The contact rate for activities with ornamentals (5,800 cm 2 /hr) is based on a study by Brouwer et al., in which chlorothalonil was applied to carnation sprays and carnations grown for cut flowers. Rates for dermal contact with treated turf by adults (1,000 cm 2 /hr)and toddlers (8,700 cm 2 /hr) are based on EPA estimates for low exposure activities. Contact rates for hand-to-mouth transfer by toddlers (1.56 events/hour), ingestion of treated grass by toddlers (25 cm 2 /day, and ingestion of soil from treated areas by children (100 mg/day) are default values which originate with high-end exposure scenarios. For the cancer risk estimates, the Agency assumed that activities with ornamentals occur 4 days per year for 50 years, and that an application is made once a year, for adults in dermal contact with treated turf, that contact occurred 40 days per year for 50 years, and that three applications were made each year. The Agency also assumed that reentry occurred on the day of treatment.

For residential post-application exposures related to the use of chlorothalonil on turf and ornamentals, short- and intermediate-term MOEs ranged from 14 to 26,000. Only the MOEs for toddlers exposed to treated turf were at a risk level of concern at which the EPA typically takes regulatory action. To address this risk, the registrants have agreed to delete the home lawn use from their manufacturing-use and end-use products registered solely for this use. When considering the elimination of the home lawn use of chlorothalonil, EPA had determined that residential post-application exposures to toddlers exposed to treated turf do not exceed EPA's level of concern.

A summary of the residential post-application scenarios and cancer risks from chlorothalonil is shown in the following table 4.

4. Cumulative exposure to substances with a 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.”

EPA does not have, at this time, available data to determine whether chlorothalonil 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, chlorothalonil 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 chlorothalonil has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. In general . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity. The developmental and reproductive data for chlorothalonil indicate that there is no evidence of increased sensitivity to chlorothalonil from prenatal and postnatal exposures. In the rat developmental toxicity study, the developmental NOAEL and LOAEL were based on an increase in total resoprtions per dam with a related increase in post-implantation loss. These observations occurred at a dose (400 mg/kg/day) which produced increased mortality and reduced body weight gain in maternal animals. No developmental toxicity was observed in the rabbit developmental toxicity study, and no maternal toxicity was observed at the highest dose tested (20 mg/kg/day).

iii. Conclusion . There is a complete toxicity data base for chlorothalonil and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because no reproductive effects were observed in any study and developmental effects occurred only in the presence of significant maternal toxicity. HCB was not considered in this evaluation of the special sensitivity of infants and children. HCB will be considered at a future date when the Agency is better equipped to understand the implications of FQPA for HCB, which is a common contaminant of at lest nine other pesticides and which also enters the environment from non-pesticidal sources.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the estimated MOEs from exposure to chlorothalonil and SDS-3701 residues from food and water do not exceed the Agency's LOC. A summary of the aggregate risk assessment for acute exposure to chlorothalonil is shown in the following Table 5.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to chlorothalonil and SDS-3701 from food will utilize 34% of the cPAD for the U.S. population and 68% of the cPAD for children. Based on the use pattern, chronic residential exposure to residues of chlorothalonil is not expected. EPA does not have chronic non-cancer concerns for HCB in chlorothalonil. EPA does not expect the aggregate exposure to exceed 100% of the cPAD.

3. Short- and intermediate-term risk . Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The estimated MOEs from residential uses ranged from 310 for adults transplanting, pruning or bundling flowers to 110,000 for infants ingesting paint chips. Though residential exposure could occur with the use of chlorothalonil, the potential short- and intermediate-term exposure were not aggregated with chronic food and water exposures because the toxic effects are different. Therefore, based on the best available data and current policies, potential risks do not exceed the Agency's level of concern.

4. Aggregate cancer risk for U.S. population . HCB and pentachlorobenzene are present in ground water and surface water from sources other than current usage of contaminated pesticides, including manufacturing of solvents and tires, incineration of wastes, and coal combustion. Both are persistent and relatively immobile in the environment; the major route of dissipation is through sorption to soil, sediment, and suspended particulates in water.

HCB and PCB contamination of ground water sources is relatively unlikely due to the high binding potential of both compounds. Detections of HCB in ground water generally have ranged between 0.0002 to 0.100 μg/L. PCB levels in ground water at a hazardous waste site ranged from 0.001 to 62 μg/L.

Based on monitoring data and fate properties, it seems unlikely that long-term HCB and PCB concentrations in surface water would exceed 10 ppt (0.01 μg/L). As discussed previously, surface water detections show much more variability than concentrations in ground water but concentrations which actually appear to be dissolved in the water are generally less than 0.001 μg/L.

The upper bound carcinogenic risk from food uses of HCB for the general U.S. population was calculated using the following equation: HCB Upper Bound Cancer Risk = Dietary Exposure (ARC) x Q*, where the Q* of 1.02 mg/kg/day)-\1\, the upper bound cancer risk was calculated to be 2.4 x 10-\7\, contributed through all the published, pending and new uses for chlorothalonil.

The upper bound risk for HCB in chlorothalonil is in the range the Agency generally considers negligible for excess lifetime cancer risk. The exposure assessment for carcinogenic risk from HCB in chlorothalonil includes many a assumptions and uncertainties which impact the Agency's confidence in the calculated risk.

HCB is also a contaminant in several other pesticides, and an aggregate risk assessment for HCB from chlorothalonil and these other sources has been conducted. The exposure assessment for aggregate risk is subject to the same kinds of uncertainties and assumptions as the risk assessment for HCB in chlorothalonil. For some of the individual pesticide contributors, these limitations impact the assessment to an even greater extent.

Four pesticides that are used on food/feed crops have been assessed for cancer risk due to contamination with HCB -- chlorothalonil, dacthal, picloram, and pentachlornitrobenzene (PCNB). Pentachlorobenzene (PCB) is also present in PCNB, and the Agency has concluded that the carcinogenic potential of PCB is comparable to HCB, based on the similarities of the chemical structures and toxicities of HCB and PCB. In estimated dietary risk from HCB in these four pesticides, the Q* for PCB is assumed to be equal to that for HCB.

HCB is also present in pentachlorophenol, but pentachlorophenol is not a food use pesticide and so that contaminant in pentachlorophenol does not contribute to aggregate dietary risk (the contribution to drinking water risk is discussed below). HCB and/or PCB is present in five other food-use pesticides, but at low levels which do not significantly add to the aggregate dietary exposure.

The estimated aggregate dietary cancer risk from HCB from all known pesticide sources is 1.34 x 10-\6\. An additional 0.46 x 10-\6\ may be attributed to PCB for a total of 1.8 x 10-\6\.

A summary of the cancer risks for chlorothalonil, HCB, and PCB are shown in the following Table 6.

EPA has estimated cancer risk using both the Q* and MOE approaches. Under the MOE approach, cancer risk is estimated at MOE = 9,500. At this time, EPA is not able to conclusively determine that chlorothalonil is a non-linear carcinogen nor to apply approved policy determinations on non-linear carcinogens to chlorothalonil, and so cannot determine whether the MOE of 9,500 represents an excess lifetime risk. Under the Q* approach, cancer risk is estimated at 1.2 x 10-\6\. This figure is at a level which the EPA considers negligible for excess lifetime cancer risk estimates.

Cancer risk for HCB is estimated at 2.4 x 10-\7\, and EPA does not have cancer risk concerns for chlorothalonil alone. Although subject to considerable uncertainty, cancer risk from HCB from chlorothalonil and other pesticides, combined with cancer risk from the related contaminate PCB present in other pesticides, is estimated at 1.8 x 10-\6\. a level at which the EPA typically takes regulatory action. To address this risk, the registrants of chlorothalonil have agreed that the level of HCB in all chlorothalonil products must be reduced to no greater than 0.004% (40 ppm). This is the lowest level that has been shown to be technologically feasible for chlorothalonil. All registrations are conditional on achieving this level, and failure to achieve this level will result in a suspension of manufacture or import of the subject products. In addition, registrants of chlorothalonil products will maintain approximately historic levels of production and import of chlorothalonil manufacturing use product to assure that chlorothalonil with higher levels of HCB will not be stockpiled and formulated. When this decrease in the amount of HCB is considered, EPA has determined that the cancer risk estimates do not exceed the level for regulatory action.

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to combined residues of chlorothalonil and SDS-3701 or from residues of the contaminant HCB.

Adequate enforcement methodology using gas chromotography is available to enforce the established tolerance expressions. The Pesticide Analytical Manual (PAM) vol. II lists Method I, a gas chromatography method with electron capture detection (ECD), for enforcement of tolerances for plant commodities. An acceptable enforcement method for residues of SDS-3701, a modification of the method for chlorothalonil, is also available.

There are no Canadian, Mexican, or Codex tolerances for chlorothalonil on ginseng.

Therefore, the tolerance is re-established for combined residues of chlorothalonil and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on ginseng at 0.10 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-301188 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 January 7, 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. 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 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 VII.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 the docket control number OPP-301188, 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 establishes a time-limited tolerance under FFDCA section 408. 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 FIFRA section 18 exemption under FFDCA section 408, 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. , 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).

On September 25, 2000, the Board proposed that commonly controlled railroads (and their railroad-related affiliates) whose combined annual operating revenues meet the $250 million threshold be required to file consolidated financial reports. See 65 FR 57650 (2000). The Board's objective was to gather more meaningful and accurate information on the large rail systems operating in the United States by conforming its regulatory reporting requirements as closely as practical to Financial Accounting Standards Board Statement No. 94, Consolidation of All Majority-Owned Subsidiaries . After evaluating the comments filed by interested parties, the Board has concluded that consolidated reports should be required for commonly controlled railroads that operate as a single, integrated United States rail system and whose cumulative operating revenues meet the Class I threshold. Accordingly, the Board will amend its regulations at 49 CFR part 1201 to reflect this change. A printed copy of the full Board decision served November 7, 2001 in this proceeding is available for a fee by contacting Da 2 Da Legal, Room 405, 1925 K Street, NW., Washington, DC 20006, telephone (202) 293-7776. The decision also is available for viewing and downloading via the Board's website at www.stb.dot.gov .

For the reasons set forth in the preamble, Title 49, part 1201 of the Code of Federal Regulations will be amended as follows: