In an interim rule effective and published in the Federal Register on December 4, 2000 (65 FR 75581-75582, Docket No. 00-103-1), we amended the brucellosis regulations in 9 CFR part 78 by removing South Dakota from the list of Class A States in paragraph (b) of § 78.41 and adding it to the list of Class Free States in paragraph (a) of that section.

Comments on the interim rule were required to be received on or before February 2, 2001. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived the review process required by Executive Order 12866.

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 in the ADDRESSES section, 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. NM188.” The postcard will be date stamped and returned to the commenter.

On August 10, 2000, ElectroSonics, 4391 International Gateway, Columbus, Ohio, applied for a Supplemental Type Certificate (STC) to modify Cessna Aircraft Company Model 500, 550, S550, and 560 airplanes. These models are certificated under 14 CFR part 25 as (small) transport category airplanes.

• The Cessna Model 500 airplane is powered by two Pratt & Whitney JT15D-1(A/B) turbofans with a maximum takeoff weight of 11,850 pounds. This airplane operates with a two-pilot crew and can hold up to 7 passengers.

• The Cessna Model 550 airplane is powered by two Pratt & Whitney JT15D-4 turbofans with a maximum takeoff weight of 14,100 pounds. This airplane operates with a two-pilot crew and can hold up to 11 passengers.

• The Cessna Model S550 airplane is powered by two Pratt & Whitney JT15D-4B turbofans with a maximum takeoff weight of 15,100 pounds. This airplane operates with a two-pilot crew and can hold up to 11 passengers.

• The Cessna Model 560 airplane is powered by two Pratt & Whitney JT15D-5A/D turbofans with a maximum takeoff weight of 16,300 pounds. This airplane operates with a two-pilot crew and can hold up to 11 passengers.

The modification that is the subject of these special conditions incorporates the installation of Innovative Solutions & Support air data display units (ADDU). The ADDU is a replacement for the existing analog flight instrumentation, and provides additional functional capability and redundancy in the system. The avionics/electronics and electrical systems installed in the subject Cessna airplanes have the potential to be vulnerable to HIRF external to the airplane.

Under the provisions of 14 CFR 21.101, ElectroSonics must show that the Cessna Model 500, 550, S550, and 560 airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A22CE, 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 theses airplanes are as follows:

• 14 CFR part 25, effective February 1, 1965, as amended by Amendments 25-1 through 25-17; §§ 25.934 and 25.1091(d)(2) as amended by Amendments 25-1 through 25-23;

• § 25.1387 as amended by Amendments 25-1 through 25-30;

• §§ 25.1385 and 25.1303(a)(2) as amended by Amendments 25-1 through 25-38;

• Special Conditions 25-25-CE-4; and

• additional requirements listed in the type certificate data sheet that are not relevant to these special conditions.

• 14 CFR part 25 effective February 1, 1965, as amended by Amendments 25-1 through 25-17;

• §§ 25.934 and 25.1091(d)(2) as amended by Amendments 25-1 through 25-23;

• § 25.1401 as amended by Amendments 25-1 through 25-27;

• § 25.1387 as amended by Amendments 25-1 through 25-30;

• §§ 25.1303(a)(2) and 25.1385(c) as amended by Amendments 25-1 through 25-38;

• Special Conditions 25-25-CE-4; and

• additional requirements listed in the type certificate data sheet that are not relevant to these special conditions.

• 14 CFR part 25 effective February 1, 1965, as amended by Amendments 25-1 through 25-17;

• §§ 25.251(e), 25.934, and 25.1091(d)(2) as amended by Amendments 25-1 through 25-23;

• § 25.1401 as amended by Amendments 25-1 through 25-27;

• § 25.1387 as amended by Amendments 25-1 through 25-30;

• §§ 25.787, 25.789, 25.791, 25.853, 25.855, 25.857, and 25.1359 as amended by Amendments 25-1 through 25-32;

• §§ 25.1303(a)(2) and 25.1385(c) as amended by Amendments 25-1 through 25-38;

• Special Conditions 25-25-CE-4; and

• additional requirements listed in the type certificate data sheet that are not relevant to these special conditions.

• 14 CFR part 25 effective February 1, 1965, as amended by Amendments 25-1 through 25-17;

• §§ 25.251(e), 25.934, and 25.1091(d)(2) as amended by Amendments 25-1 through 25-23;

• § 25.1401 as amended by Amendments 25-1 through 25-27;

• § 25.1387 as amended by Amendments 25-1 through 25-30;

• §§ 25.787, 25.789, 25.791, 25.853, 25.855, 25.857, and 25.1359 as amended by Amendments 25-1 through 25-32;

• §§ 25.1303(a)(2) and 25.1385(c) as amended by Amendments 25-1 through 25-38;

• Special Conditions 25-25-CE-4; and

• additional requirements listed in the type certificate data sheet that are not relevant to these special conditions.

• 14 CFR part 25 effective February 1, 1965, as amended by Amendments 25-1 through 25-17;

• §§ 25.251(e), 25.934, and 25.1091(d)(2) as amended by Amendments 25-1 through 25-23;

• § 25.1401 as amended by Amendments 25-1 through 25-27;

• § 25.1387 as amended by Amendments 25-1 through 25-30;

• §§ 25.787, 25.789, 25.791, 25.853, 25.855, 25.857, and 25.1359 as amended by Amendments 25-1 through 25-32;

• §§ 25.1303(a)(2) and 25.1385(c) as amended by Amendments 25-1 through 25-38;

• § 25.305 as amended by Amendments 25-1 through 25-54; and

• § 25.1001 as amended by Amendments 25-1 through 25-57.

In addition to the applicable airworthiness regulations and special conditions, these Cessna Model 500, 550, S550, and 560 airplanes must comply with the fuel vent and exhaust emission requirements of part 34 and the noise certification requirements of part 36.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25, as amended) do not contain adequate or appropriate safety standards for the Cessna Model 500, 550, S550, and 560 airplanes modified by ElectroSonics because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions, as defined in § 11.19, are issued in accordance with § 11.38. In accordance with § 21.101(b)(2), the special conditions approved in this document will form an additional part of the type certification basis for these airplanes.

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 Cessna Model 500, 550, S550, and 560 airplanes modified by ElectroSonics will incorporate a dual electronic primary flight display system that will perform critical functions. This system may be vulnerable to HIRF 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 Cessna Model 500, 550, S550, and 560 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 with either paragraph 1, or, alternatively, paragraph 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 for both of the following field strengths for the frequency ranges indicated. Both peak and average field strength components from Table 1 are to be demonstrated.

The threat levels identified in Table 1 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 Cessna Model 500, 550, S550, and 560 airplanes modified by ElectroSonics. Should ElectroSonics apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate A22CE 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 the Cessna Model 500, 550, S550, and 560 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.

On November 30, 2000, the FAA issued AD 2000-25-03, Amendment 39-12037 (65 FR 77780), to require, within 25 hours time-in-service (TIS), inspecting the tab on the NAS513-6 locking washer on all actuators, part number (P/N) 41105950, serial number with an “HR” prefix up to and including 490 and P/N 41000470, serial numbers with a prefix of “HR” up to and including 10010, for a twisted or damaged tab. P/N's 41105950 and 41000470 were assigned by HR Textron, the manufacturer; the BHTI P/N's are 205-076-036 and 212-076-005. Replacing any twisted or damaged locking washer with an airworthy NAS1193K6C locking device is required before further flight. Replacing any NAS513-6 locking washer with an airworthy NAS1193K6C locking device, regardless of the condition of the tab, is required within 100 hours TIS or at the next actuator overhaul, whichever occurs first. Installing an airworthy NAS 1193K6C locking device on all actuators constitutes terminating action for the requirements of that AD. That action was prompted by the discovery of a damaged locking washer. The damage to the locking washer was discovered when an operator experienced a problem with a collective control while attempting to take off. The collective control could not be moved upward from the full down position. Further inspection revealed that the lower piston of the actuator had unthreaded and separated from the lower rod end, causing the piston to make contact with the rod end support assembly and lodge against the rod end shank at an angle limiting any movement of the collective control. The collective servo cylinder assembly is used to provide irreversible collective control of the main rotor. Because the actuator end locking washer failed, the servo lower piston could rotate inside the lower servo head assembly and unthread itself from the rod end. That condition, if not corrected, could cause loss of control of the main rotor and subsequent loss of control of the helicopter.

Since the issuance of that AD, we discovered that we inadvertently omitted the BHTI Model 412EP helicopters from the applicability of the AD.

The FAA has reviewed HR Textron Alert Service Bulletin (ASB) No. 41000470-67A-05, Revision 1 and HR Textron ASB No. 41105950-67A-01, Basic Issue, both dated October 19, 2000, which describe procedures for inspecting and replacing certain locking washers. BHTI has issued ASB No.”s 205-00-79, 205B-00-33, 212-00-109, 412-00-105, and 412CF-00-12, all dated October 19, 2000, which include the applicable HR Textron ASB's.

Since an unsafe condition has been identified that is likely to exist or develop on other BHTI Model 205A-1, 205B, 212, 412, 412CF, and 412EP helicopters of the same type designs, this AD is being issued to prevent an actuator piston from unthreading from the rod end causing loss of collective control and subsequent loss of control of the helicopter. This AD requires the same actions as the previous AD and adds the BHTI Model 412EP helicopters to the applicability. The actions must be accomplished in accordance with the ASB's described previously. The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the controllability of the helicopter. Therefore, the actions described previously are required at the specified time intervals, and this AD must be issued immediately.

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

The FAA estimates that 550 helicopters will be affected by this AD. It will take approximately 1 work hour to inspect the locking washer, 6 work hours per helicopter to replace the three locking devices on each helicopter, and the average labor rate is $60 per work hour. Required parts will cost approximately $20 per helicopter. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $209,000, assuming all the locking devices on all the helicopters are replaced without any inspections.

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

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

Commenters wishing the FAA to acknowledge receipt of their mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2001-SW-06-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the 1 distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

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

On March 17, 2000, the FAA published a Notice of Proposed Rulemaking to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing Class D and Class E airspace areas in the vicinity of Oxford, CT. This action resulted from notice by the State of Connecticut that it had approved plans for the construction of a permanent Air Traffic Control Tower (ATCT) at Waterbury-Oxford Airport (KOXC), Oxford, Connecticut. The State has applied to have the ATCT operated under the FAA Contract Tower Program. Accordingly, the State requested that the FAA establish a Class D airspace area in vicinity of the Waterbury-Oxford Airport commensurate with the commissioning of the new ATCT. Air traffic at the Waterbury-Oxford Airport has grown over recent years and presently includes both high-speed jets and slower speed reciprocating powered light aircraft, as well as rotorcraft.

The FAA establishes Class D airspace where necessary to provide a safe environment for aircraft transiting between the enroute and terminal airspace structures. This is particularly true when aircraft with greatly different performance characteristics operate at the same airport. Class D airspace areas encompass that airspace in the vicinity of an airport from the surface upward to a specified altitude in which pilots of aircraft must establish and maintain two-way radio communications with the ATCT at that airport. This action creates a Class D airspace area in the vicinity of the Waterbury-Oxford Airport extending upward from the surface to 3,200 feet MSL within a 5-mile radius of the airport. In addition, the FAA finds that a Class E airspace area, extending from the surface as an extension of the Class D airspace area, is necessary in order to provide sufficient controlled airspace to accommodate those aircraft arriving at the airport using a standard instrument approach procedure (SIAP). The Waterbury-Oxford Airport has a SIAP that requires the establishment of a Class E surface airspace area extending to northwest of the airport along the Waterbury (TBY) NDB 353° bearing to a point 7.6 miles from the airport. This action provides for the safe and efficient use of the navigable airspace in the vicinity of the Waterbury-Oxford Airport, and promote safe flight operations under both Instrument Flight Rules (IFR) and Visual Flight Rules (VFR) by aircraft transiting to and from the enroute airspace structure.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments were received. Based on further review of the proposal, the FAA had corrected the latitude coordinate for the Waterbury-Oxford Airport from 41°28′46″ N to 41°28′43″ N, and has added the latitude and longitude coordinates for the Waterbury (TBY) Non-Directional Beacon (NDB) to the description of the new Class E airspace area. The coordinates for this airspace action are based on North American Datum 83. These changes neither increase the scope of this action nor change any of the agency's findings with respect to this action.

Class D airspace designations are published in Paragraph 5000 of FAA Order 7400.9H, and Class E airspace designations for airspace designated as extensions of a Class D airspace area are published in paragraph 6004 of FAA Order 7400.9H. FAA Order 7400.9H, dated September 1, 2000, and effective September 16, 2000, is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in this Order.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) establishes Class D and Class E airspace areas in the vicinity of Oxford, CT.

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. Therefore, this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as these routine matters will only affect air traffic procedures and air navigation. It is certified that these proposed rules will not have significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

On February 12, 2001 a document proposing to amend Part 71 of the Federal Aviation Regulations (14 CFR Part 71) by establishing Class E airspace extending upward from 700 feet to 1200 feet Above Ground Level (AGL) for the Helicopter Point in Space approach to the Culpepper Memorial Hospital Heliport, Culpepper, VA, was published in the Federal Register (65 FR 70322-70323).

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA on or before March 5, 2001. No comments to the proposal were received. The rule is adopted as proposed.

The coordinates for this airspace docket are based on North American Datum 83. Class E airspace areas designations for airspace extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9H, dated September 1, 2000 and effective September 16, 2000, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be amended in the order.

This amendment to Part 71 of the Federal Aviation Regulations (14 CFR Part 71) provides controlled Class E airspace extending upward from 700 feet above the surface for aircraft conducting IFR operations at the Culpepper Memorial Hospital Heliport, Culpepper, VA.

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. Therefore, this regulation: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation it is certified that this rule will not have significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed a supplement to NADA 96-298 that provides for the use of Avatec® (lasalocid sodium) Premix, a Type A medicated article. The supplement provides for establishing tolerances for residues of lasalocid in edible tissues of chickens and turkeys. The supplement is approved as of February 20, 2001, and the regulations in § 556.347 (21 CFR 556.347) are amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, the agency is taking the opportunity to codify the acceptable daily intake (ADI) for total residues of lasalocid which was previously established, and to establish a tolerance for residues of lasalocid in sheep liver. The regulations are further amended in § 556.347 to reflect these actions.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Animal drugs, Foods.

1. The authority citation for 21 CFR part 556 continues to read as follows:

2. Section 556.347 is revised to read as follows:

(a) Acceptable daily intake (ADI) . The ADI for total residues of lasalocid is 10 micrograms per kilogram of body weight per day.

(b) Tolerances —(1) Cattle. The tolerance for parent lasalocid (the marker residue) in liver (the target tissue) is 0.7 part per million (ppm).

(2) Chickens —(i) Skin with adhering fat (the target tissue) . The tolerance for parent lasalocid (the marker residue) is 1.2 ppm.

(ii) Liver. The tolerance for parent lasalocid (the marker residue) is 0.4 ppm.

(3) Turkeys —(i) Liver (the target tissue) . The tolerance for parent lasalocid (the marker residue) is 0.4 ppm.

(ii) Skin with adhering fat . The tolerance for parent lasalocid (the marker residue) is 0.4 ppm.

(4) Rabbits . The tolerance for parent lasalocid (the marker residue) in liver (the target tissue) is 0.7 ppm.

(5) Sheep . The tolerance for parent lasalocid (the marker residue) in liver (the target tissue) is 1.0 ppm.

An electronic copy of this document may be downloaded by using a computer, modem, and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at (202) 512-1661. Internet users may reach the Office of the Federal Register's home page at: http://www.nara.gov/fedreg and the Government Printing Office's web site at: http://www.access.gpo.gov/nara.

On January 8, 2001, at 66 FR 1446, the FHWA published a final regulation regarding 23 CFR Parts 655 and 940, Intelligent Transportation Systems Architecture and Standards. The effective date of that regulation was February 7, 2001. The FHWA published a supplemental regulation extending the effective date of that regulation to April 8, 2001, at 66 FR 9198 on February 7, 2001.

The original regulation contained two dates upon which some requirement of this regulation was based; specifically, in §§ 940.9 and 940.11. Those dates were originally based on the effective date of the regulation as published on January 8, 2001. The date specified in § 940.9(b) was intended to be four years from the effective date of the regulation. The date specified in § 940.11(g) was intended to be the effective date of the regulation. When the effective date of the regulation was changed by supplemental rulemaking to April 8, 2001, those two dates cited in the regulation were not adjusted accordingly. Therefore, the purpose of this rulemaking is to correct those two dates to reflect the intent of the original rulemaking.

The FHWA's implementation of this rule without opportunity for public comment, effective immediately upon publication today in the Federal Register , is based on the good cause exceptions in 5 U.S.C. sections 553(b)(3)(B) and 553(d)(3). Seeking public comment is impractical, unnecessary, and contrary to public interest. The 60 day delay in the effective date from February 7, 2001 to April 8, 2001, was necessary to give Department officials the opportunity for further review and consideration of the new regulations, consistent with the Assistant to the President's memorandum of January 20, 2001. Given the imminence of the effective date, seeking public comment on the changes of these two dates would have been impractical, as well as contrary to the public interest in the orderly promulgation and implementation of regulations. These dates were originally based on the effective date of the regulation as published on January 8, 2001. The dates must be changed to comply with the new effective date as published on February 7, 2001. The imminence of the effective date and the impact that date has on projects that have reached their final design by that date are also good causes for making this action effective immediately upon publication.

This final rule changes two dates in Part 940, Intelligent Transportation Systems Architecture and Standards. The date on which regions that are implementing ITS must develop a regional architecture will be changed from February 7, 2005, to April 8, 2005. The date by which projects that have reached final design are exempt from the project implementation requirements of § 940.9 will be changed from February 7, 2001, to April 8, 2001.

The FHWA's issuance of this rule without prior notice and opportunity for public comment, effective immediately upon publication today in the Federal Register , is based on the good cause exceptions in 5 U.S.C. sections 553(b)(3)(B) and 553(d)(3). Seeking public comment is impracticable and unnecessary. On February 7, the FHWA delayed the effective date of its final rule until April 8. Given the imminence of the new effective date, seeking public comment on the changes of the two implementation dates contained in the rule is impractical, as well as contrary to the orderly promulgation and implementation of regulations.

Because these two implementation dates were based on the original effective date of the regulation as published on January 8, 2001, these two implementation dates now should be changed to comply with the new effective date as published on February 7, 2001. Without this change, the final rule would be effective on April 8, and would have a retroactive impact on some projects based on the previous effective date of February 7.

Moreover, the FHWA believes that further opportunity for public comment on these two implementation dates is unnecessary, because in its NPRM the FHWA had proposed that these two implementation dates be calculated from the effective date of the final rule. Today's action merely conforms the final rule to the new effective date announced on February 7. In the NPRM, the FHWA proposed the requirement that any region currently implementing ITS projects shall develop a regional architecture within 2 years of the effective date of the final rule. Commenters recommended extending this time to 4 years. The effect of today's action is to make clear that, at the time the final rule goes into effect on April 8, any region that is currently implementing ITS projects shall develop a regional architecture within 4 years. Furthermore, any ITS project that has advanced to final design by April 8 (rather than February 7) is exempt from the requirement that all ITS projects conform to the regional ITS architecture.

For these same reasons discussed above, the FHWA believes good cause exists for making this action effective immediately upon publication.

The FHWA has determined that this action is not a significant regulatory action within the meaning of Executive Order 12866 or significant within the meaning of the Department of Transportation's regulatory policies and procedures. The economic impact, if any, anticipated as a result of this action is so minimal, a full regulatory evaluation is not required.

In compliance with the Regulatory Flexibility Act (5 U.S.C. 601-612), the FHWA has evaluated the effects of this action on small entities and has determined that this action will not have a significant economic impact on a substantial number of small entities. This action is merely to correct dates in the rule to comply with the delay in the effective date. For this reason, the FHWA certifies that this action will not have a significant impact on a substantial number of small entities.

This action does not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Public Law 104-4, March 22, 1995, 109 Stat. 48). This rule will not result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, dated August 4, 1999, and the FHWA has determined that this action does not have sufficient federalism implications to warrant the preparation of a federalism assessment. The FHWA has also determined that this action does not preempt any State law or State regulation or affect the State's ability to discharge traditional State governmental functions.

The FHWA has analyzed this action under Executive Order 13175, dated November 6, 2000, and believes that this technical correction will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal law. Therefore, a tribal impact statement is not required.

Catalog of Federal Domestic Assistance Program Number 20.205, Highway planning and construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.

This action does not contain information collection requirements for the purposes of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.

This action 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 action 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 concern an environmental risk to health or safety that may disproportionately affect children.

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

The agency has analyzed this action for the purposes of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321-4347), and has determined that this action will not have any effect on the quality of the environment.

A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document can be used to cross reference this action with the Unified Agenda.

On March 6, 2001, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations; Harlem River, New York, in the Federal Register (66 FR 13460). We received no comments in response to the notice of proposed rulemaking. No public hearing was requested and none was held.

The two Broadway bridges, at mile 6.8, across the Harlem River have a vertical clearance of 24 feet at mean high water and 29 feet at mean low water. The existing operating regulations at 33 CFR 117.789(c) require the two Broadway bridges to open on signal from 10 a.m. to 5 p.m. if at least a four-hour advance notice is given. From 5 p.m. to 10 a.m. the bridges need not open for vessel traffic.

The owner of the bridges, the New York City Department of Transportation (NYCDOT), requested a temporary change to the operating regulations for the bridges to allow the bridges to remain in the closed position from May 15, 2001 through August 15, 2001, to facilitate painting operations. Vessels that can pass under the bridges without openings may do so at all times.

The Coast Guard received no comments in response to the notice of proposed rulemaking and no changes will be made to this final rule.

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). This conclusion is based on the fact that keeping the bridges closed should have no significant impact on navigation because the bridges opened only one time from 1999 through 2001.

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. “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 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 conclusion is based on the fact that the closure of the bridges should have no significant impact on navigation because the bridges have opened only one time from 1999 through 2001.

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 and have determined that this rule does not have implications for federalism under that Order.

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 unfunded mandate costs. This rule will not impose an unfunded mandate.

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

The Coast Guard considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (32)(e) of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation because promulgation of changes to drawbridge regulations have been found to not have a significant effect on the environment. A written “Categorical Exclusion Determination” is not required for this final rule.

On June 27, 2000, VA published in the Federal Register (65 FR 39580-39581), a proposed regulation to amend VA adjudication regulations to allow VA to accept photocopies of service documents as proof of service if they are certified by a claimant's representative who has successfully completed VA-prescribed training on military records, to be true copies of the original documents acceptable to VA. We asked for comments by August 28, 2000 and we received written comments from the American Legion and the Veterans of Foreign Wars. The two commentors did not suggest any changes.

The American Legion stated that the proposed regulation would be helpful to veterans and their representatives in submitting more completely developed claims. They also stated that it will help streamline VA claims procedures and help speed up the overall adjudication process. The Veterans of Foreign Wars stated that they concur with the proposed regulation.

Based on the rationale set forth in the proposed rule and this document, we are adopting the provisions of the proposed rule as a final rule without any changes.

The certification referenced in this final rule is not “information” in a collection of information as defined under 5 CFR 1320.3(h)(1). Therefore, this final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

This final rule has been reviewed by the Office of Management and Budget under Executive Order 12866.

The Secretary hereby certifies that this regulatory amendment will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612. The reason for this certification is that these amendments would not directly affect any small entities. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), these amendments are exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance program numbers are 64.100, 64.101, 64.104, 64.105, 64.106, 64.109, 64.110, and 64.127.

On July 2, 1997, the Commonwealth of Pennsylvania (the Commonwealth) submitted revisions to its SIP to establish RACT for several major sources of VOC and NO X . In this rulemaking action, EPA is approving the Commonwealth's VOC and NO X RACT determinations for Merck's West Point facility in Montgomery County. EPA will address the remainder of the Commonwealth's July 2, 1997 submittal in separate rulemaking actions. The Commonwealth's submittal for Merck consists of an operating permit (#46-0005) which imposes VOC and NO X RACT requirements for this source. The operating permit was revised on June 23, 2000 to incorporate administrative amendments and was resubmitted to EPA on August 9, 2000. On February 1, 2001, the Commonwealth submitted a clarifying supplement to its August 9, 2000 submittal for Merck to indicate that its SIP revision request only pertains to the RACT-related provisions of Merck's operating permit. In accordance with Pennsylvania's SIP revision request, EPA is approving only the RACT-related requirements and conditions contained in Merck's operating permit.

Pursuant to sections 182(b)(2) and 182(f) of the Clean Air Act (CAA), Pennsylvania is required to implement RACT for all major VOC and NO X sources. The major source size is determined by its location, the classification of that area and whether it is located in the ozone transport region (OTR), which is established by the CAA. Under section 184 of the CAA, at a minimum, moderate ozone nonattainment area requirements, including RACT as specified in sections 182(b)(2) and 182(f), apply throughout the OTR. The entire Commonwealth of Pennsylvania is located within the OTR. Therefore, RACT is applicable statewide in Pennsylvania.

Merck's West Point plant is a biological and pharmaceutical, research and support facility located in Upper Gwynedd, Montgomery County, Pennsylvania. The facility generates its own power using a combination of oil or natural gas-fired boilers and a gas turbine. The facility's RACT-subject units also include a rotary kiln incinerator and a waste heat incinerator. These combustion sources account for the majority of the facility's NO X emissions. Merck's operations include site engineering, graphic arts services, and pharmaceutical and biological manufacturing. Merck formulates aqueous and solvent-based pharmaceutical products, in addition to live and attenuated vaccines and sterile pharmaceutical products. These operations account for the majority of the facility's VOC emissions.

The Commonwealth has imposed requirements including the use of low NO X burners on Merck's oil and natural gas fired boilers and a water injection system on its gas turbine to control NO X emissions. As of December 31, 1996, Merck permanently shut down the rotary kiln incinerator, but the Commonwealth did establish NO X RACT for the incinerator in its operating permit based upon the use of low NO X burners and a target tray wet scrubber. The Commonwealth also imposed, among other conditions, the use of low NO X burners as RACT for the waste heat incinerator.

The Commonwealth's RACT determinations for Merck's VOC emitting operations from pharmaceutical manufacturing include the use of tray area local ventilation systems and a catalytic oxidizer with a minimum 90% VOC destruction efficiency, as well as a condenser designed to control emissions from the drying process with a minimum 90% efficiency. The Commonwealth has imposed VOC RACT on Merck's biological manufacturing operations including the use of liquid nitrogen cooling coils and gasket-fitted access doors. The Commonwealth has imposed limitations on the VOC content of the inks, vanishes, coatings and adhesives of Merck's graphic arts operations as RACT.

The details of Merck's NO X and VOC emitting operations and the Commonwealth's RACT determinations are found in Operating Permit No. OP-46-0005 issued by PADEP on January 13, 1997 and revised on June 23, 2000. That permit is included in the docket for this rulemaking and copies may be obtained from the EPA Regional Office listed in the ADDRESSES section of this document.

EPA has reviewed that RACT-related provisions of operating permit No. OP-46-0005 issued by the Commonwealth of Pennsylvania to Merck for its West Point facility and concurs with PADEP's RACT determinations to control NO X and VOC from this facility.

EPA is approving the Commonwealth's SIP revision submittal of July 2, 1997, as amended August 9, 2000 and the February 1, 2001 supplementary information clarifying the RACT-related provisions of operating permit, No. OP-46-0005. The operating permit (OP-46-0005) was issued to Merck and Company, Inc., by the Pennsylvania Department of Environmental Protection on January 13, 1997, and was revised on June 23, 2000. EPA is publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This direct final rule will be effective on June 4, 2001 without further notice unless we receive adverse comment by May 18, 2001. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

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. 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 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), nor will it 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), because it 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 (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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings' issued under the executive order. 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. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability establishing source-specific requirements for one named source.

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 June 18, 2001. 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 Pennsylvania's source-specific RACT requirements to control VOCs and NO X from Merck and Company Inc.'s West Point facility in Montgomery County may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under 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-301118. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA issued a final rule, published in the Federal Register of March 10, 1999 (64 FR 11782) (FRL-6062-5), which announced that on its own initiative under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) it established time-limited tolerances for the combined residues of metolachlor and its metabolites determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound in or on tomatoes at 0.1 part per million (ppm), tomato puree at 0.3 ppm, and tomato paste at 0.6 ppm, with an expiration date of April 1, 2001. EPA established the tolerance because 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 the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Such tolerances can be established without providing notice or period for public comment.

EPA received a request to extend the use of metolachlor on tomatoes for this year's growing season due to continuation of the emergency situation with weeds infesting tomato fields and the lack of a registered alternative to control them. After having reviewed the submission, EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of metolachlor on tomatoes for control of weeds in Ohio, Pennsylvania, Michigan, Maryland, California, and Virginia.

EPA assessed the potential risks presented by residues of metolachlor in or on tomatoes. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rule of March 10, 1999 (FRL-6062-5). Based on that data and information considered, the Agency reaffirms that extension of the time-limited tolerances will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerances are extended for an additional 15-month period. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on June 30, 2002, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on tomatoes, tomato puree, and/or tomato paste after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerances. 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.

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-301118 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 June 18, 2001.

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 III.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301118, 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). 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 petition 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 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_40/40cfr_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-301115. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of December 6, 2000 (65 FR 235) (FRL-6537-7), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (8F3654 and 8F3674) for tolerances by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. This notice included a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.434 be amended by establishing tolerances for combined residues of the fungicide propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-dichlorobenzoic acid and expressed as parent, in or on corn, field, stover at 12 parts per million (ppm); corn, field, forage at 12 ppm; corn, field, grain at 0.1 ppm; corn, sweet, kernel plus cob with husks removed at 0.1 ppm; pineapple at 0.1 ppm; pineapple, fodder at 0.1 ppm (8F3674); peanut at 0.2 ppm; and peanut, hay at 20 ppm (8F3654). These proposed tolerances will expire on March 30, 2004 and will replace previously established tolerances which expired on December 31, 2000.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for combined residues of propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-dichlorobenzoic acid and expressed as parent compound on corn, field, stover at 12 parts per million (ppm); corn, field, forage at 12 ppm; corn, field, grain at 0.1 ppm; corn, sweet, kernel plus cob with husks removed at 0.1 ppm; pineapple at 0.1 ppm; pineapple, fodder at 0.1 ppm; peanut at 0.2 ppm; and peanut, hay at 20 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by propiconazole are discussed in the following section.

1. Acute toxicity data were as follows: acute oral LD 50 = 1,517 mg/kg (toxicity category III); acute dermal LD 50 > 4,000 mg/kg (toxicity category III); acute inhalation LC 50 1.26 mg/L; primary eye irritation - clear by 72 hours (toxicity category III); primary skin irritation - slight irritation (toxicity category IV); and dermal sensitization - negative.

2. A developmental toxicity study with rats which were gavaged with doses of 0, 30, 90 or 360/300 mg/kg/day. The developmental no observed adverse effects level (NOAEL) was 30 mg/kg/day. Evidence of developmental toxicity observed at 90 mg/kg/day, the lowest observed adverse effect level (LOAEL) included increased incidence of unossified sternebrae, rudimentary ribs, and shortened or absent renal papillae. The maternal NOAEL was 30 mg/kg/day and the maternal LOAEL was 90 mg/kg/day based on reduced body weight gain and occurrence of rales in 1/24 females.

3. A developmental toxicity study with rabbits which were gavaged with doses of 0, 30, 90, or 180 mg/kg/day with no evidence of maternal or developmental toxicity observed under the conditions of the study.

4. A developmental toxicity study with rabbits which were gavaged with doses of 0, 100, 250, or 400 mg/kg/day on gestation days 7 through 19 with no developmental toxicity observed under the conditions of the study. The maternal NOAEL was 100 mg/kg/day and the maternal LOAEL was 250 mg/kg/day based on decreased food consumption, weight gain, and an increase in the number of resorptions at the higher dose levels. The developmental NOAEL was 400 mg/kg/day.

5. A two-generation reproduction study with rats fed diets containing 0, 1, 100, 500 or 2,500 ppm showed no reproductive effects under the conditions of the study. The developmental NOAEL was 500 ppm (equivalent to 25 mg/kg/day), and the developmental LOAEL was 2,500 ppm (equivalent to 125 mg/kg/day) based on decreased offspring survival, body weight depression, and increased incidence of hepatic lesions in rats. The parental NOAEL was 100 ppm (equivalent to 5 mg/kg/day) and the parental LOAEL was 500 ppm (equivalent to 25 mg/kg/day) based on increased incidence of hepatic cell change.

6. A 1-year feeding study with dogs fed diets containing 0, 5, 50, or 250 ppm with a NOAEL of 50 ppm (equivalent to 1.25 mg/kg/day). The LOAEL was 250 ppm (equivalent to 6.25 mg/kg/day based on mild irritation of stomach mucosa.

7. A 2-year chronic feeding/carcinogenicity study with rats fed diets containing 0, 100, 500, or 2,500 ppm with a systemic NOAEL of 100 ppm (equivalent to 5 mg/kg/day) based on hepatocyte changes in males at the 500 ppm level and in both sexes at the 2,500 ppm level. There were no carcinogenic effects observed under the conditions of the study.

8. A 2-year chronic feeding/carcinogenicity study with mice fed diets containing 0, 100, 500, or 2,500 ppm with a systemic NOAEL of 100 ppm (equivalent to 15 mg/kg/day) based on decreased body weight, and increased liver lesions and liver weight in males. There was a statistically significant increase in combined adenomas and carcinomas of the liver in male mice at the 2,500 ppm level (equivalent to 375 mg/kg/day).

9. A battery of mutagenicity studies to determine the potential of propiconazole to induce gene mutation, chromosomal aberrations, and other genotoxic effects were all negative.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.

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

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

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

1. Acute toxicity . The acute RfD is 0.3 mg/kg/day based on the NOAEL of 30 mg/kg/day from a developmental toxicity study in rats and using an UF of 100.

2. Short- and intermediate-term toxicity. For short- and intermediate-term dermal margin of exposure (MOE) calculations, the developmental NOAEL of 30 mg/kg/day from a developmental toxicity study in rats was selected. For short- and intermediate-term inhalation MOE calculations, the NOAEL of 92.8 mg/kg/day (0.5 mg/L), the highest dose tested, from a 5-day inhalation toxicity study was selected. The level of concern is 100.

3. Chronic toxicity . EPA has established the RfD for propiconazole at 0.013 mg/kg/day. This RfD is based on a 1-year feeding study in dogs with a NOAEL of 1.25 mg/kg/day and an UF of 100. The LOAEL of 6.25 mg/kg/day was based on mild irritation of the gastric mucosa.

4. Carcinogenicity . Propiconazole has been classified as a Group C, “possible human carcinogen,” chemical. The RfD approach for quantification of human risk was used. Since the RfD approach used the same endpoint to assess chronic toxicity, the chronic risk assessment addresses both the cancer risk as well as chronic effects.

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.434) for the combined residues of propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-dichlorobenzoic acid and expressed as parent compound, in or on a variety of raw agricultural commodities. Among these tolerances are stone fruits, various grain crops, grass, bananas, celery, mushrooms and pecans. Tolerances have also been established for meat, milk, poultry and eggs. Risk assessments were conducted by EPA to assess dietary exposures from propiconazole 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 Risk Exposure System was used for calculating acute dietary exposure. This analysis evaluated the individual food consumption as reported by respondents in the USDA 1977-1978 Nationwide Food Consumption Survey (NFCS) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: The acute dietary (food only) risk assessment used the Theoretical Maximum Residue Contribution (TMRC). Percent Crop Treated (PCT) data and anticipated residue values were not used. This risk assessment used high-end exposure estimates and should be viewed as a conservative risk assessment which overestimates the risk. The acute dietary exposure for the only population subgroup of concern, females 13 years and older, used 3.3% of the acute RfD of 0.3 mg/kg/day. The acute dietary risk (food only) does not exceed the Agency's level of concern.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Risk Exposure System was used. This analysis evaluated the individual food consumption as reported by respondents in the USDA 1977-1978 NFSC and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Anticipated residues and percent crop treated data were used for various commodities.

The chronic dietary risk assessment used the RfD of 0.013 mg/kg/day. EPA used data from the USDA NFCS, and made partial refinements to the exposure assumptions. Tolerance level residues were used for corn, pineapples and peanuts. Anticipated residue levels were used for the following crops: pecans; bananas; plantains; barley; eggs; milk and milk-by-products; poultry, beef, goat, sheep, swine and by-products; rice, rye, wheat and by-products. Percent of crop treated estimates were made for corn (6%), pineapple (100%) and peanuts (1%). The existing propiconazole tolerances (published and pending, including tolerances for emergency exemptions) resulted in exposure estimates that are equivalent to the following percentages of the RfD: U.S. population (48 states), 7%; non-nursing infants less than 1 year old, 20%; children 1-6 years old, 13%; children 7-12 years old, 9%; all other subgroups, 6-9%. EPA generally has no concern for exposures below 100% of the chronic RfD (when the FQPA factor has been removed) because this RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Therefore, the chronic dietary risk (food only) does not exceed the Agency's level of concern.

iii. Cancer . A quantitative risk assessment using a cancer endpoint was not performed since the RfD approach was identical to the chronic assessement. The chronic risk assessment is adequately protective for cancer risk as well as other chronic effects.

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 follows: Percent crop treated data was used for the following crops: corn (6%), peanuts (1%), pecans (47%), fresh peaches (13%), barley (2%), rice (25%), rye and wheat (1%) and corn and peanut oil (1%). It was assumed that propiconazole was used on 100% of the pineapple crop.

The Agency believes that the three conditions previously discussed 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.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for propiconazole 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 propiconazole.

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 SCI-GROW (Screening concentration in ground water), 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 incorporates 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 propiconazole they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the estimated environmental concentrations (EECs) of propiconazole for acute exposures are estimated to be .11 parts per billion (ppb) for surface water and .0014 ppb for ground water. The EECs for chronic exposures are estimated to be .09 ppb for surface water and .0014 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).

Propiconazole is currently registered for use on the following residential non-dietary site: preservative for wood. The risk assessment was conducted using the following residential exposure assumptions: This use does not present an acute or chronic exposure scenario, but may constitute a short- and/or intermediate-term dermal and inhalation exposure scenario for applicators. The Agency calculated short- and intermediate-term dermal and inhalation margins of exposure (MOEs) of 200 and 200,000 respectively for the wood preservative use of propiconazole. MOEs above 100 do not exceed the Agency's level of concern. For post application exposure, the Agency determined that propiconazole is volatile and not readily aerosolized. Therefore, post-application exposure from contact with treated wood is expected to be minimal and the Agency determined that a risk assessment for post-application exposure is not needed.

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 propiconazole 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, propiconazole 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 propiconazole 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. Safety factor for infants and children —i. 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 database 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.

ii. Prenatal and postnatal sensitivity . The pre- and post-natal toxicology database for propiconazole is complete with respect to current FQPA-relevant toxicological data requirements. Propiconazole is not developmentally toxic in the rabbit. There is evidence that propiconazole is developmentally toxic in the rat at doses that are toxic to the parents. In the developmental toxicity study in rats, the toxicity noted at the maternal LOAEL of 90 mg/kg/day consisted of rales and decreased weight gain on gestation days 6-8 whereas the toxicity noted at the developmental LOAEL of 90 mg/kg/day consisted of statistically significant increased incidences of unossified sternebrae, and nominally increased incidences of rudimentary ribs and shortened or absent renal papillae.

iii. Conclusion . There is a complete toxicity database for propiconazole and exposure data are complete or are estimated based on data that reasonably account for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because, in cases, where fetotoxic effects occur at the maternally toxic dose levels, the effects generally are of less concern than those occurring at non-maternally toxic dose levels because of the influence of toxicity in the mothers on the fetal toxicity expressed. However, where the fetal effects are judged to be qualitatively more severe than the effects in the maternal animals, there may be greater sensitivity in the fetus and thus of greater concern. Here, the effects in the fetus (delayed development) were not judged to be more severe than the effects in the maternal animals (decreased weight gain).

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 + residential 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, EPA's Office of Pesticide Programs (OPP) concludes with reasonable certainty that exposures to the pesticide 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 residues of the pesticide in 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 propiconazole will occupy 3.3% of the aPAD for females 13 years and older, the only population subgroup of concern. In addition, there is potential for acute dietary exposure to propiconazole in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to propiconazole from food will utilize 7% of the cPAD for the U.S. population, 20% of the cPAD for non-nursing infants < 1 year old and 13% of the cPAD for children 1-6 years old. Based the use pattern, chronic residential exposure to residues of propiconazole is not expected. In addition, there is potential for chronic dietary exposure to propiconazole in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 1:

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

Propiconazole is currently registered for use that could result in short- and intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short- and intermediate-term exposures for propiconazole.

Using the exposure assumptions described in this unit for short- and intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in an aggregate MOE of 200. This aggregate MOE does 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 propiconazole in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short- and intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 2:

5. Aggregate cancer risk for U.S. population . EPA classified propiconazole as a Group C, possible human carcinogen and determined that the RfD approach be used to estimate the carcinogenic risk to humans. Risk concerns for carcinogenicity due to long-term consumption of propiconazole residues are adequately addressed by the aggregate chronic exposure analysis using the chronic RfD.

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 propiconazole residues.

Adequate enforcement methodology (example - gas chromotography) 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.

International CODEX values are established for almond, animal products, bananas, barley, coffee, eggs, grapes, mango, meat, milk, oat, peanut-whole, peanut grains, pecans, rape, rye, stone fruit, sugar cane, sugar beets, sugar beet tops, and wheat. The U.S. residue definition includes both propiconazole and metabolites determined as 2,4-dichlorobenzoic acid (DCBA), and the CODEX definition is for propiconazole, per se, i.e. parent only. This difference results in unique tolerance expressions (0.1 ppm for peanuts) with the U.S. definition resulting in the higher tolerance levels (0.2 ppm for peanuts). EPA includes the metabolite in its assessment because it also raises hazard concerns.

Soybeans may be planted as a double crop following a cereal crop which has been treated with propiconazole. Crops intended for food, grazing, or any component of animal feed or bedding may not be rotated within 105 days of propiconazole application unless the crop appears on the product label.

Therefore, tolerances are established for combined residues of propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-dichlorobenzoic acid and expressed as parent compound, in or on corn, field, stover at 12 ppm; corn, field, forage at 12 ppm; corn, field, grain at 0.1 ppm; corn, sweet, kernel plus cob with husks removed at 0.1 ppm; pineapple at 0.1 ppm; pineapple, fodder at 0.1 ppm; peanut at 0.2 ppm; and peanut, hay at 20 ppm. These tolerances will expire on March 30, 2004 and will replace previously established tolerances which expired on December 31, 2000. These tolerances are time-limited because the Agency requested a modified carcinogenicity study in mice conducted at a mid-dose level to confirm or supplement findings in an Agency reviewed carcinogenicity study in mice conducted at low and high dose levels. Although the Agency has completed the review of the mid-dose level carcinogenicity study, the Agency has not yet reevaluated the data as a whole and the cancer classification.

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-301115 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 June 18, 2001.

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 VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301115, 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 tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 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 by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.”“ Policies that have federalism implications” is defined in the Executive Order to include regulations that have“ substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

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

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

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under 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/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. 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-301116. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of February 14, 2001 (66 FR 10292) (FRL-6765-8), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of pesticide petitions (PP 7F4841 and OF6171) for tolerances by Valent U.S.A. Corporation, 1333 North California, Boulevard, Suite 600, Walnut Creek, CA 94596-8025. This notice included a summary of the petition prepared by Valent U.S.A. Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2 H -1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1 H -isoindole-1,3(2 H )-dione, in or on soybean seed and peanuts at 0.01 part per million (ppm). Valent U.S.A. Corporation subsequently amended the petition to request tolerances in or on soybean seed and peanut nutmeat at 0.02 ppm.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL--5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerances for residues of flumioxazin on soybean seed and peanut nutmeat at 0.02 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by flumioxazin are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10x to account for interspecies differences and 10x for intra species differences.

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for flumioxazin used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses . No previous tolerances have been established for the residues of flumioxazin. Risk assessments were conducted by EPA to assess dietary exposures from flumioxazin 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) 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: For this acute analysis the assumption was made that 100% of the crops with flumioxazin tolerances are treated with flumioxazin. In addition, the assumption was made that all commodities contain tolerance level residues when consumed, with the exception of those with default processing factors. Default processing factors were used for peanuts-butter (1.89x) and for soybeans-sprouted seeds (0.33x). As the exposure and risk estimates were low, no further refinements were made to this analysis.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the DEEM 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: For this chronic analysis the assumption was made that 100% of the crops with flumioxazin tolerances are treated with flumioxazin. In addition, the assumption was made that all commodities contain tolerance level residues when consumed, with the exception of those with default processing factors. Default processing factors were used for peanuts-butter (1.89x) and for soybeans-sprouted seeds (0.33x). As the exposure and risk estimates were low, no further refinements were made to this analysis.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for flumioxazin 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 flumioxazin.

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 flumioxazin they are further discussed in the aggregate risk sections below.

The hydrolysis study for flumioxazin indicates that flumioxazin forms the metabolite 482-HA, which can further hydrolyze to metabolites APF and THPA. The rates of the two hydrolytic reactions are very pH dependent, but the parent is not very stable at any likely environmental pH. Additional data indicated that THPA and APF are likely to be very mobile. Although THPA can comprise a major portion of the total residue in water, it does not possess the phenyl ring and is thus considered significantly less toxic than parent, APF, and 482-HA, thus THPA needs not be included in the residue of concern for drinking water. Therefore, parent flumioxazin and the metabolites 482-HA and APF are the residues of concern in drinking water.

Based on the GENEEC and SCI-GROW models the estimated environmental concentrations (EECs) of flumioxazin and its metabolites of concern in water for acute exposures are estimated to be 2.4 parts per billion (ppb) for surface water and 6.3 ppb for ground water. The EECs for chronic exposures are estimated to be 0.67 ppb for surface water and 6.3 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).

Flumioxazin is not registered for use on any sites that would result in residential exposure.

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 flumioxazin 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, flumioxazin 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 flumioxazin 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 data for flumioxazin indicate that there is both quantitative and qualitative evidence of increased susceptibility to flumioxazin from prenatal or postnatal exposures. Quantitative susceptibility is observed when the young respond more than the adults at a given dose, and qualitative susceptibility is observed when there is a unique biological target, such as the developing brain, that predisposes the individual.

The quantitative and qualitative evidence of increased susceptibility is observed with the rat fetuses to in utero exposure to flumioxazin in the oral and dermal developmental studies. In both studies, there was an increased incidence in fetal cardiovascular anomalies (especially ventricular septal defects). In the oral study, no maternal effects were seen at the highest dose tested (HDT) (30 milligrams/kilograms (mg/kg/day)); whereas, the effects in the fetuses were observed at 10 mg/kg/day. In the dermal study, no maternal effects were noted at the HDT (300 mg/kg/day); whereas, the effects in the fetuses were observed at 100 mg/kg/day. Regarding the 2-generation rat reproduction study, parental effects (red substance in vagina and increased mortality in females as well as decreases in male and female body weights, body weight gains, and food consumption) were noted at 18.9 mg/kg/day in males HDT and 22.7 mg/kg/day in females HDT. Based on the results of the study, no apparent reproduction effects were attributed to test article administration. The effects observed regarding the offspring were a decrease in both the number of liveborn and pup body weights at 12.7 mg/kg/day for males and 15.1 mg/kg/day for females. Therefore, it was considered that there was both a quantitative and qualitative increase in susceptibility.

3. Conclusion . There is a complete toxicity data base for flumioxazin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The FQPA safety factor (as required by the Food Quality Protection Act of August 3, 1996) has been retained at 10x for all population subgroups for all exposure durations (acute and chronic) in assessing the risk posed by this chemical. The reasons for retaining the 10x safety factor are as follows. First, there is evidence of increased susceptibility of the rat fetuses to in utero exposure to flumioxazin by the oral and dermal route in the prenatal developmental toxicity studies in rats. In addition, there is evidence of increased susceptibility of young animals exposed to flumioxazin in the 2-generation reproduction toxicity study in rats. Finally, there is concern for the severity of the effects observed in fetuses and young animals when compared to those observed in the maternal and parental animals (dose- and treatment-related increase in the incidence of cardiovascular abnormalities, particularly ventricular septal defect, in the developmental studies; and decreases in the number of live born pups and pup body weights in the absence of parental toxicity in the reproduction study).

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 + residential 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 the pesticide 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 residues of the pesticide in 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 to the subgroup of concern, the acute dietary exposure from food to flumioxazin will occupy 0.72% of the aPAD for females 13 years and older. In addition, there is potential for acute dietary exposure to flumioxazin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 3:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to flumioxazin from food will utilize 0.5% of the cPAD for the U.S. population, 2.3% of the cPAD for all infants ( < 1 year) and 1.2% of the cPAD for children (1-6 years). There are no residential uses for flumioxazin that result in chronic residential exposure to flumioxazin. In addition, there is potential for chronic dietary exposure to flumioxazin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 4:

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).

Flumioxazin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

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

Flumioxazin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

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 flumioxazin residues.

Adequate enforcement methodology (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 established on soybeans or peanuts.

Therefore, the tolerances are is established for residues of flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2 H -1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1 H -isoindole-1,3(2 H )-dione, in or on soybean seed and peanuts at 0.02 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-301116 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 June 18, 2001.

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 VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301116, 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 tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have“substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

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

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under 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/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

2. In person . The Agency has established an official record for this action under docket control number OPP-301117. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

Hexythiazox is the active ingredient in Savey Ovicide/Miticide 50 WP (EPA Reg. No. 10163-208). Permanent tolerances are established under 40 CFR 180.448(a) for residues of hexythiazox and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as parent) in/on apples at 0.50 parts per million (ppm), wet apple pommace at 0.80 ppm; hops at 2.0 ppm, and pears at 0.3 ppm; milk, fat, and meat by-products of cattle, goats, horses, sheep, and swine at 0.02 ppm; almonds at 0.30 ppm and almond hulls at 10 ppm; and strawberries at 3.0 ppm. Tolerances with regional registrations are established for cotton gin by-products (California only) at 3.0 ppm and undelinted cotton seed (California only) at 0.20 ppm.

In the Federal Register of July 31, 1996 (61 FR 39971) (FRL-5384-6); April 30, 1997 (62 FR 23455) (FRL-5600-8); January 28, 1998 (63 FR 4252) (FRL-5763-6); and December 28, 2000 (65 FR 82349) (FRL-6761-6), EPA issued notices pursuant to section 408 of the FFDCA, 21 U.S.C. 346a as amended by the FQPA of 1996 (Public Law 104-170) announcing the filing of pesticide petitions for tolerances by Gowan Company, P.O. Box 5569, Yuma, AZ 85366-5569, and the Interregional Research Project Number 4 (IR-4), Technology Centre of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ, 08902-3390. These notices included summaries of the petitions prepared by Gowan Company, the registrant. There were no comments received in response to the notice of filings.

The petition(s) requested that 40 CFR 180.448 be amended by establishing tolerances for residues of the insecticide hexythiazox, in or on various food commodities as follows:

1. IR-4 petition 0E6198 proposes the establishment of tolerances for mint at 2.0 ppm.

2. IR-4 petition 0E6215 proposes the establishment of tolerances for the caneberry subgroup at 1.0 ppm.

3. Gowan Company petition PP 6F4738 proposes the establishment of tolerances for stone fruits including plums at 1 ppm; prunes at 5 ppm; and all tree nuts at 0.2 ppm.

The existing tolerance for almonds is being deleted since it is covered under the tree nut group tolerance.

Hexythiazox is currently proposed for use on mint to control Twospotted spider mites; stone fruits (including plums) to control European red mites, Twospotted spider mites, McDaniel spider mite, Strawberry spider mites, Pacific spider mites, Pecan leaf scorch mites, and Willamette mites; Tree nuts and pistachios to control European red mites, Twospotted spider mites, McDaniel spider mites, Strawberry spider mites, Pacific spider mites, Pecan leaf scorch mites, and Willamette mites; and on caneberries to control Twospotted spider mites, McDaniel spider mite, Yellow spider mite and Pacific spider mites.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of hexythiazox on tree nut group at 0.30 ppm; plums at 0.10 ppm; fresh prunes at 0.10 ppm; dried prunes at 0.40 ppm; pistachio at 0.30 ppm; peppermint (tops) at 2.0 ppm; spearmint (tops) at 2.0 ppm; and caneberry crop group subgroup at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by hexythiazox are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.