Has FAA taken any related action on the Raytheon airplane ruddervator system to this point? On October 15, 2002, FAA issued AD 94-20-04 R1, Amendment 39-12919 (67 FR 64794, October 22, 2002), to require ruddervator inspections and modifications on certain Raytheon Aircraft Company (Raytheon) Beech Models C35, D35, E35, F35, G35, H35, J35, K35, M35, N35, P35, S35, V35, V35A, and V35B airplanes.

The intent of this AD was to maintain the inspection and modification requirements of AD 94-20-04, Amendment 39-9032 (59 FR 49785, September 30, 1994), but condense and clarify the information presented in AD 94-20-04.

What has happened since AD 94-20-04 R1 to initiate this action? Comments from the public since issuance of AD 94-20-04 R1 indicate a need for a revision to that AD. Specifically, the visual inspection of the empennage, aft fuselage, and ruddervator control system with any subsequent repair and the setting of the elevator controls, rudder and tab system controls, cable tensions, and rigging should all be a one time action. Currently, they are to be accomplished repetitively at 100-hour time-in-service (TIS) intervals.

In addition, we inadvertently did not include the 100-hour TIS interval repetitive inspections of the fuselage bulkheads that were required by AD 94-20-04.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD and incorporate the above-referenced comments. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on January 27, 2003 (68 FR 3829). The NPRM proposed to:

—maintain the actions of AD 94-20-04 R1, but would make the repetitive visual inspection of the empennage, aft fuselage, and ruddervator control system with any subsequent repair and the setting of the elevator controls, rudder and tab system controls, cable tensions, and rigging a one time action; and

—add repetitive inspections of the fuselage bulkheads that were required by AD 94-20-04.

What is the potential impact if FAA took no action? This condition, if not corrected, could result in structural failure of the V-tail. Such failure could result in loss of control of the airplane.

Was the public invited to comment? The FAA encouraged interested persons to participate in the making of this amendment. The following presents the comments received on the proposal and FAA's response to each comment:

What is the commenter's concern? A commenter points out that FAA left off the phrase “unless already accomplished” for the initial actions of the proposed AD. The commenter believes that this phrase should be added based on FAA's inclusion of the phrase in other ADs.

What is FAA's response to the concern? We concur that this phrase should be added to the initial actions of the proposed AD. We are changing the final rule AD action accordingly.

What is the commenter's concern? Raytheon recommends that the repetitive inspections of the empennage, aft fuselage, and ruddervator control system continue. This would include the setting of the elevator controls, rudder and tab system controls, cable tensions, and rigging. Raytheon states that “these items can change with wear and usage and need to be maintained at specification to prevent unsafe conditions from developing.”

What is FAA's response to the concern? The FAA does not concur. The intent of AD 94-20-04 R1 was to maintain the actions of AD 94-20-04 on the affected airplanes. The inspections of the empennage, aft fuselage, and ruddervator control system were a one-time action in AD 90-20-04. We inadvertently made them repetitive in AD 90-20-04 R1. This action will incorporate FAA's intent. We will continue to monitor the service history of these airplanes. If necessary, we will initiate future rulemaking to address this subject.

We are not changing the final rule AD action based on this comment.

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

—provide the intent that was proposed in the NPRM for correcting the unsafe condition; and

—do not add any additional burden upon the public than was already proposed in the NPRM.

How many airplanes does this AD impact? We estimate that this AD affects 10,200 airplanes in the U.S. registry.

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

The above figures are based only on the initial inspections and do not take into account the cost of repetitive inspections or adjustments, repairs, or replacements that may be necessary based on the results of the inspections. We have no way of determining the number of repetitive inspections each owner/operator of the affected airplanes will incur or what adjustments, repairs, or replacements may be necessary based on the results of the inspections.

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

Does this AD involve a significant rule or regulatory action? For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES .

1. The Federal Energy Regulatory Commission (Commission) is amending 18 CFR Parts 375 and 376 to duplicate certain existing delegations to two Commission office directors for a third office director and to make related changes in connection with changes in the Commission's internal structure. These changes came about as a result of the formation of the Office of Market Oversight and Investigations (OMOI). By this order, the Commission is not revising or expanding existing delegations of authority. 1

2. In order to better understand natural gas, oil and power markets and to swiftly remedy market rule violations and abuse of market power, the Commission created OMOI, which became a formal, functioning office within the Commission in August 2002. OMOI serves as an early warning system to alert the Commission when market problems develop, and allows the Commission to analyze and address any problems more quickly. OMOI has begun an aggressive program of outreach to a wide variety of entities including other federal, state and provincial regulatory agencies, state consumer advocates, industry participants, academic institutions and think tanks, financial institutions (such as rating agencies), and Market Monitoring Units at Regional Transmission Organizations and Independent System Operators.

3. The formation of the new office implicates certain functions currently being performed under delegated authority by the Office of Market, Tariffs and Rates (OMTR) or by the Office of General Counsel (OGC). For example, currently the Director of OMTR has delegated authority to sign non-financial audit reports of jurisdictional companies, a function which the Director of OMOI may also need so that OMOI employees are able to perform their market monitoring duties. Likewise, the General Counsel is currently authorized to terminate any informal non-public investigation, a function which the director of OMOI needs so that his enforcement staff may handle their workload efficiently. This rule duplicates those authorities by adding Section 314 to Part 375 of Title 18 of the Code of Federal Regulations, and, as noted, creates no new delegations. In addition, this rule corrects the structure of § 375.303(a), corrects a reference to paragraph numbers in § 375.307(f), changes the nomenclature of the Office of Finance and Accounting in § 375.312, and revises § 376.204(b)(2) to include the Director of OMOI on the list of Commission staff delegations of authority during an emergency.

4. Specifically, the existing delegations are being revised as follows:

Office of the Chief Accountant (existing § 375.303). The paragraph structure of this section is corrected.

Office of Markets, Tariffs and Rates (existing § 375.307). Delegations in paragraphs (a), (c), (d), (g)(4), (h)(1), (i)(8) and (n)(3) are duplicated in paragraphs (i), (j), (k), (g), (e), (f) and (h) of new § 375.314, respectively. A reference to paragraph numbers “(b)(1) or (b)(2)” is corrected to read “(f)(1) or (f)(2).”

Office of the General Counsel (existing § 375.309). Delegations in paragraphs (a), (b), (c) and (d) are duplicated in paragraphs (b), (c), (d), and (b) of new § 375.314, respectively.

Office of the Finance, Accounting and Operations (existing § 375.312). The nomenclature for this office is changed to the Office of the Executive Director.

Part 376 governs the Commission's organization and its operations during emergency conditions. This rule making amends the list of officials authorized to conduct operations during emergency conditions to include the position of Director, OMOI, and replaces references to the former position of Director, OFAO, with the Executive Director in § 376.204(b)(2).

5. The Commission is issuing this order as a final rule without a period for public comment or delay in the effective date. Under 5 U.S.C. 553(b), notice and comment procedures are unnecessary where a rulemaking concerns only agency procedure and practice, or where the agency finds that notice and comment is unnecessary. This rule concerns only matters of internal agency procedure and will not affect regulated entities or the general public. Therefore, the Commission finds notice and comment procedures to be unnecessary.

6. Office of Management and Budget (OMB) regulations require OMB to approve certain information collection requirements imposed by agency rule. 5 CFR 1320.12. This rule making contains no information collections and OMB review is therefore not required.

7. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment. 2 The Commission has categorically excluded certain actions from this requirement as not having a significant effect on the human environment. Among these are rules that are clarifying, corrective, or procedural, or that do not substantively change the effect of the regulations being amended. 18 CFR 380.4(a)(2)(ii). This rule is procedural in nature and therefore falls under this exception; consequently, no environmental consideration is necessary.

8. The Regulatory Flexibility Act of 1980 (RFA) generally requires a description and analysis of final rules that will have significant economic impact on a substantial number of small entities. 5 U.S.C. 601-612. The Commission is not required to make such analysis if a rule would not have such an effect. Because this rule concerns only matters of internal agency procedure, the Commission certifies that it will have no impact upon any entity other than the Commission.

9. In addition to publishing the full text of this document in the Federal Register , the Commission provides all interested persons an opportunity to view or print the contents of this document via the Internet through FERC's Home Page ( http://www.ferc.gov ) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.

10. From FERC's Home Page on the Internet, this information is available in the Federal Energy Regulatory Records Information System (FERRIS). The full text of this document is available on FERRIS in PDF and WordPerfect format for viewing, printing, or downloading. To access this document in FERRIS, type the docket number excluding the last three digits of this document in the docket number field.

11. User assistance is available for FERRIS and the FERC's Web site during normal business hours from FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at (866) 208-3676, or for TTY, contact (202) 502-8659.

12. These regulations are effective on issuance. The Commission has determined that a delayed effective date for this final rule is unnecessary pursuant to 5 U.S.C. 553(d). Because the rule concerns only matters of internal agency procedure, the immediate implementation of the rule imposes no consequences to regulated entities or the general public, and any further delay could compromise the effective operation of the new office. Therefore, the Commission finds good cause for waiving the 30-day delay before the effective date of this final rule.

13. The Small Business Regulatory Enforcement Fairness Act of 1996 requires agencies to report to Congress on the promulgation of certain final rules prior to their effective dates. 5 U.S.C. 801. Rules of agency procedure and practice are excluded from this notification requirement. 5 U.S.C. 804(3)(C). Therefore, this final rule will not be submitted to Congress.

In consideration of the foregoing, the Commission amends Parts 375 and 376, Chapter I, Title 18, Code of Federal Regulations, as follows:

It has been determined that Privacy Act rules for the Department of Defense are not significant rules. The rules do not (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order.

It has been determined that Privacy Act rules for the Department of Defense do not have significant economic impact on a substantial number of small entities because they are concerned only with the administration of Privacy Act systems of records within the Department of Defense.

It has been determined that Privacy Act rules for the Department of Defense impose no information requirements beyond the Department of Defense and that the information collected within the Department of Defense is necessary and consistent with 5 U.S.C. 552a, known as the Privacy Act of 1974.

It has been determined that the Privacy Act rulemaking for the Department of Defense does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.

It has been determined that the Privacy Act rules for the Department of Defense do not have federalism implications. The rules do not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This notice implements the permanent special local regulation governing the 2003 Harvard-Yale Regatta. A portion of the Thames River in New London, Connecticut will be closed during the effective period to all vessel traffic except participants, official regatta vessels, and patrol craft. The regulated area is that area of the river between the Penn Central drawbridge and Bartlett's Cove. Additional public notification will be made via the First Coast Guard District Local Notice to Mariners and marine safety broadcasts. The full text of this regulation is found in 33 CFR 100.101.

The U.S. Naval Academy will sponsor the Blue Angels Airshow over the waters of the Severn River at Annapolis, Maryland. The events will consist of low flying, high performance aircraft performing precision maneuvers and aerial stunts. A fleet of spectator vessels is expected to gather near the event site to view the event. In order to ensure the safety of participants, spectators and transiting vessels, 33 CFR 100.518 will be in effect for the duration of the event. Under provisions of 33 CFR 100.518, vessels may not enter the regulated area without permission from the Coast Guard Patrol Commander. Spectator vessels may anchor outside the regulated area but may not block a navigable channel. Because these restrictions will only be in effect for a limited period, they should not result in a significant disruption of maritime traffic.

The vertical clearance under the Conrail Railroad Bridge in the open position is 135 feet at mean high water and 139 feet at mean low water. The draw is normally in the fully open position except for the passage of rail traffic. The existing regulations are listed at 33 CFR 117.589.

The owner of the bridge, the U. S. Army Corps of Engineers (USACE), requested a temporary deviation from the Drawbridge Operation Regulations to facilitate scheduled maintenance, the replacement of the rail tracks, at the bridge. This work must be performed with the bridge in the closed position.

The mariners who normally use this waterway were advised about the necessary repairs at the bridge and the temporary closures that will be required in order to facilitate the repairs. No objections were received.

Under this temporary deviation the Conrail Railroad Bridge, mile 0.7, may remain in the closed position from 6 a.m. through 1 p.m. on May 22, 2003 and May 27, 2003.

Mariners may contact the U.S. Army Corps of Engineers Marine Traffic Controller 24-hour telephone line at (508) 759-4431 for the operational status of the bridge.

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

Pursuant to 5 U.S.C. 553, we did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553 (b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The Coast Guard operates under a three-tiered system of Maritime Security (MARSEC) conditions that are aligned with the color coded Homeland Security Advisory System Conditions (HSAS). The port of Valdez has been elevated to the second highest level of alert MARSEC II/HSAS ORANGE based on the conflict with Iraq and, as such, vessel control measures for the Coast Guard to establish heightened deterrence and detection of terrorist activities in the port are necessary.

Additionally, the Maritime Administration recently issued MARAD Advisory 03-01 (071900Z FEB 03) informing operators of maritime interests of increased threat possibilities to vessels and facilities and a higher risk of terrorist attack to the transportation community in the United States. Further, the heightened security posture of the country and U.S. maritime interests, described below, continues. The publication of an NPRM is contrary to the public interest insofar as urgent action is required to address the ongoing threat to U.S. maritime transportation interests.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . The measures contemplated by the rule are intended to prevent waterborne acts of sabotage or terrorism, which terrorists have demonstrated a capability to carry out. Immediate action is needed to defend against and deter these terrorist acts. Any delay in the effective date of this rule is impracticable and contrary to the public interest.

Terrorist attacks on September 11, 2001, inflicted catastrophic human casualties and property damage. These attacks highlighted the terrorists' ability and desire to utilize multiple means in different geographic areas to increase their opportunities to successfully carry out their mission, thereby maximizing destruction using multiple terrorist acts.

Since the September 11, 2001, terrorist attacks on the World Trade Center in New York, the Pentagon in Arlington, Virginia and Flight 93, the Federal Bureau of Investigation (FBI) has issued several warnings concerning the potential for additional terrorist attacks within the United States. The threat of maritime attacks is real as evidenced by the October 2002 attack on a tank vessel off the coast of Yemen and the prior attack on the USS Cole. These attacks manifest a continuing threat to U.S. assets as described in the President's finding in Executive Order 13273 of August 21, 2002 (67 FR 56215, September 3, 2002), that the security of the U.S. is endangered by the September 11, 2001, attacks and that such disturbances continue to endanger the international relations of the United States. See also Continuation of the National Emergency with Respect to Certain Terrorist Attacks, (67 FR 58317, September 13, 2002); Continuation of the National Emergency With Respect To Persons Who Commit, Threaten To Commit, Or Support Terrorism, (67 FR 59447, September 20, 2002). The U.S. Maritime Administration (MARAD) in Advisory 02-07 advised U.S. shipping interests to maintain a heightened state of alert against possible terrorist attacks. MARAD more recently issued Advisory 03-01 informing operators of maritime interests of increased threat possibilities to vessels and facilities and a higher risk of terrorist attack to the transportation community in the United States. The ongoing hostilities in Afghanistan and conflict in Iraq have made it prudent for U.S. ports and waterways to be on a higher state of alert because the al Qaeda organization and other similar organizations have declared an ongoing intention to conduct armed attacks on U.S. interests worldwide.

The conflict in Iraq has caused the Attorney General in consultation with the Secretary of the Department for Homeland Security to elevate the HSAS threat condition to High/Orange and accordingly the Coast Guard has established MARSEC II in the port of Valdez. The Coast Guard will follow the guidance for the Department of Homeland Security and implement the following general measures: Coordinate necessary security efforts with Federal, State, and local law enforcement agencies or any National Guard or other appropriate armed forces organizations; take additional precautions at public events and possibly considering alternative venues or even cancellation; and restrict threatened facility access to essential personnel only. The measures contemplated by this rule are intended to prevent future terrorist attacks against critical maritime infrastructure including the Trans-Alaska Pipeline System's Valdez Marine Terminal, and the shipping lanes leading to and from it. This terminal supplies approximately half of the crude oil needs of the U.S. West Coast.

To address the aforementioned security concerns and to take steps to prevent the catastrophic impact that a terrorist attack against a major crude oil loading terminal or other critical infrastructure in the port of Valdez would have on the public interest, the 17th Coast Guard District Commander is establishing vessel movement reporting requirements for all commercial and fishing vessels. These amendments to the existing rules for the Prince William Sound Regulated Navigation Area will help to prevent vessels or persons from engaging in terrorist actions against petroleum terminals, petroleum tankers, or other critical port facilities by providing the Coast Guard with the enhanced ability to track vessel movement in the Prince William Sound.

The Coast Guard is establishing these vessel movement reporting requirements within Prince William Sound, Alaska in order to safeguard vessels, ports and waterfront facilities from sabotage or terrorist acts or incidents. These requirements apply to commercial and fishing vessels operating within the boundaries of the Regulated Navigation Area defined in 33 CFR 165.1704. The Regulated Navigation Area is coextensive with the VTS Area and consists of the navigable waters of the United States north of a line drawn from Cape Hinchinbrook Light to Schooner Rock Light, comprising that portion of Prince William Sound between 146° 30′ W and 147° 20′ W and includes Valdez Arm, Valdez Narrows, and Port Valdez. In accordance with 33 CFR 161.19, at least 15 minutes before navigating in a VTS Area, a vessel must report its name and type, position, destination and ETA, intended route, time and point of entry, and dangerous cargo on board. In accordance with 33 CFR 161.20, vessels underway in the VTS Area must report their name and position upon entry, at designated reporting points, and upon direction from the Coast Guard Vessel Traffic Service. The designated reporting points for VTS Prince William Sound are set forth in 33 CFR Table 161.60(d) and in the VTS Prince William Sound User's Manual. We will issue Broadcast Notices to Mariners to further publicize the reporting requirements and any revisions to requirements. This regulation is issued under authority contained in 33 U.S.C. 1226 and 50 U.S.C. 191.

This rule temporarily requires all commercial and fishing vessels to participate in the Vessel Movement Reporting System. However, the COTP may, in his/her discretion grant waivers or exemptions to this rule, either on a case by case basis or categorically to a particular class of vessel or facility that otherwise is subject to adequate control measures. Vessels may be granted exemptions from the reporting requirements when, in the opinion of the Captain of the Port, position reporting would impede safe navigation of a vessel or would disclose sensitive information which requires protection in the interests of national security.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security. These operational restrictions are tailored to provide the minimal interruption of vessel operations necessary to provide immediate, improved security for the public, vessels, and the port of Valdez. Vessels may be exempted from the reporting requirements when, in the opinion of the Captain of the Port, reporting would impede safe navigation of a vessel or disclose information which requires protection in the interests of national security. Recreational vessels have been exempted in order to limit the burden on the public. However, recreational boaters are still highly encouraged to file float plans.

Additionally, these reporting requirements are temporary in nature and vessels and facilities can appeal to the Captain of the Port for a waiver of the reporting requirements. Any hardships experienced by persons or vessels are outweighed by the national interest in protecting the public, vessels, and vessel crews from the devastating consequences of acts of terrorism, and from sabotage or other subversive acts, accidents, or other causes of a similar nature.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of commercial and fishing vessels intending to operate or transit in the Prince William Sound Regulated Navigation Area. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: The short duration of the temporary rule does not coincide with major fishing openers in the Prince William Sound; further, a vessel's ability to transit the Prince William Sound will not be significantly impaired by the reporting requirements; finally, vessels with compelling interests that outweigh the port's security needs may be granted waivers from the reporting requirements.

Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), the Coast Guard wants to assist small entities in understanding this final rule so that they can better evaluate its effects on them and participate in the rulemaking. If your small business or organization would be affected by this final rule and you have questions concerning its provisions or options for compliance, please contact one of the points of contact listed under FOR FURTHER INFORMATION CONTACT.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comments on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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

The Secretary is waiving or modifying the following provisions of the HEA and regulations:

Under 34 CFR 674.33(d)(2) and section 464(e) of the HEA, there is a 3-year cumulative limit on the length of forbearances that a Perkins loan borrower can receive. To assist Perkins Loan borrowers described in the SUMMARY section of this notice, the Secretary is waiving these statutory and regulatory requirements so that any forbearance based on a borrower's military service is excluded from this 3-year cumulative limit.

Depending on the loan program, borrowers may qualify for loan cancellation if they are employed full-time in specified occupations, such as teachers, childcare providers, or law enforcement officers, pursuant to sections 428J(b)(1), 428K(d)(1), 460(b)(1), and 465(a)(2)(A)-(I) and (a)(3) of the HEA, 34 CFR 674.53(d), 674.55(a)(2), 674.55(b)(5), 674.55(c)(2), 674.56(d)(1), 674.57(b)(1), 674.58(b), 674.60(b), 34 CFR 682.215(d)(1), and 34 CFR 685.217(d)(1). Generally, borrowers must perform uninterrupted, otherwise qualifying service for a specified length of time (for example, one year) or for consecutive periods of time, such as 5 consecutive years, to be eligible for loan cancellation. For all borrowers described in the SUMMARY section of this notice, the Secretary is waiving the requirements in the various loan cancellation provisions that such periods of service be uninterrupted and/or consecutive. Loan holders should not consider the time that these borrowers are on active duty as an interruption in the required service for the borrower to receive a loan cancellation.

You may view this document, as well as all other Department of Education documents published in the Federal Register , in text or Adobe Portable Document Format (PDF) on the Internet at the following site: http://www.ed.gov/legislation/FedRegister.

To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.

You may also view this document in PDF at the following site: ifap.ed.gov.

On September 19, 2002, VA published in the Federal Register (67 FR 59033) a proposal to amend diagnostic code 6260 in 38 CFR 4.87, in order to codify current standard VA practice concerning the evaluation of tinnitus. It states that recurrent tinnitus will be assigned only a single ten-percent evaluation, whether it is perceived in one ear, both ears, or somewhere in the head. Interested persons were invited to submit written comments on or before November 18, 2002. We received two comments, one from the American Legion and one from a concerned individual.

One commenter felt that limiting tinnitus to a single ten-percent evaluation is arbitrary and inconsistent with other provisions of VA's Schedule for Rating Disabilities that deal with bilateral disabilities, such as those providing separate evaluations for each ear with hearing impairment. The same commenter felt that the proposed rule document offered no substantive rationale for maintaining the current assignment of a single evaluation for tinnitus, regardless of whether it is perceived in one or both ears.

We disagree. VA's Audiology and Speech Pathology Service recently wrote a booklet titled Hearing Impairment, an Independent Study Course for health care providers. The section on tinnitus states that the fact that most tinnitus appears to be coming from the ear led to a belief that tinnitus was generated in the inner ear, but this is not the case. It further states that damage in the inner ear may be a precursor for subjective tinnitus, but that subjective tinnitus is generated within the central auditory pathways. Comparing tinnitus, a central nervous condition, to hearing loss, a disability from damage to an organ of special sense (the ear) is not a valid comparison. We have made no change in response to this comment. Because over 200,000 veterans are currently rated for tinnitus under diagnostic code 6260 under Diseases of the Ear, for administrative efficiency, and because many are accustomed to looking in that section of the rating schedule, the current placement of tinnitus within the rating schedule will remain unchanged.

The SUPPLEMENTARY INFORMATION section of the proposed regulatory amendment explained that tinnitus is a single disability arising in the brain and that it consists of the perception of sound in the absence of an external stimulus. This definition applies whether the tinnitus is perceived in one ear, both ears, or somewhere undefined in the head. The commenter provided no information that would refute this medical explanation. The degree of disability, that is, the degree to which tinnitus impairs the veteran's earning capacity, is the same regardless of how the tinnitus is perceived. To rate each ear separately for this single disability would violate the prohibition on pyramiding, 38 CFR 4.14. Similarly, to rate each ear separately would be a violation of the principle of 38 CFR 4.25(b) that a “single disease entity” is to be given a single rating. A single evaluation for a single disability is appropriate. We have made no change based on this comment.

A second commenter suggested that we adopt measurable time and duration standards for the term “recurrent.” Because a substantive change to define the term “recurrent” is beyond the scope of this rulemaking, we have made no change based on this comment.

VA appreciates the comments submitted in response to the proposed rule. Based on the rationale stated in the proposed rule and in this document, the proposed rule is adopted without change.

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

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 this amendment would not directly affect any small entities. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

This regulatory amendment has been reviewed by the Office of Management and Budget under the provisions of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993.

The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in an expenditure by State, local, or tribal governments, in the aggregate, or by the private sector of $100 million or more in any given year. This rule would have no consequential effect on State, local, or tribal governments.

The Catalog of Federal Domestic Assistance program numbers are 64.104 and 64.109.

We stated in the direct final rule published at 68 FR 17741 (April 11, 2003) that if we received adverse comment on the amendment, by May 12, 2003, we would publish a timely withdrawal in the Federal Register . We have received adverse comments on the amendments to 40 CFR 89.2.

As a result of the adverse comments received, we are withdrawing the amendment to § 89.2. We intend to consider the issues raised by the comments in a final action based on the concurrent notice of proposed rulemaking (68 FR 17763).

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0173. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under 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.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of April 16, 2003 (68 FR 18582) (FRL-7302-3), EPA issued a proposed rule pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), EPA, in cooperation with university extension specialists, and DuPont Pont Crop Protection, pursuant to sections 408(e) and (r) of FFDCA, proposed to establish a tolerance for combined residues of the reduced risk pesticide, Indoxacarb in or on peaches. This temporary tolerance supports a non-crop destruct EUP under section 5 of FIFRA authorizing use of Indoxacarb on peaches in Georgia, Michigan, New Jersey, Pennsylvania, South Carolina, and West Virginia. Section 5 of FIFRA authorizes EPA to issue an experimental use permit for a pesticide. This provision was not amended by FQPA. EPA has established regulations governing such experimental use permits in 40 CFR part 172. Section 408(r) of FFDCA authorizes EPA to issue time-limited tolerances for pesticide residues from FIFRA experimental use permits.

The proposed rule requested that 40 CFR 180.564 be amended by establishing a tolerance for combined residues of the insecticide, Indoxacarb, (S)-methyl 7-chloro-2,5- dihydro-2- [[(methoxycarbonyl) [4-(trifluoromethoxy)phenyl]  amino]carbonyl] indeno[1,2-e] [1,3,4] oxadiazine-4a(3H)-carboxylate] + its R-enantiomer [(R)-methyl 7-chloro-2,5- dihydro-2- [[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino] carbonyl]indeno[1,2-e] [1,3,4] oxadiazine-4a(3H)-carboxylate, in or on peaches at 10.0 parts per million (ppm). The tolerance will expire on May 15, 2006.

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for combined residues of Indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl) [4- (trifluoromethoxy)phenyl] amino] carbonyl] indeno[1,2-e] [1,3,4]oxadiazine-4a(3H)- carboxylate] + its R-enantiomer [(R)-methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino] carbonyl] indeno[1,2-e] [1,3,4]oxadiazine-4a(3H)-carboxylate on peaches at 10 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 Indoxacarb are discussed in the proposed rule, as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

Refer to the April 16, 2003, Federal Register document (68 FR, 18582) for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon that risk assessment and the findings made in the Federal Register document in support of this action. Below is a brief summary of the aggregate risk assessment, including this use on peaches.

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.564) for the combined residues of Indoxacarb, in or on a variety of raw agricultural commodities. Including tolerances already established for: Apple at 1.0 ppm, apple, wet pomace at 3.0 ppm, brassica, head and stem, subgroup at 5.0 ppm, cattle, goat, horse, sheep, and hog fat at 0.75 ppm, cattle, goat, horse, sheep, and hog meat at 0.03 ppm, cattle, goat, horse, sheep, and hog meat byproducts at 0.02 ppm, corn, sweet, forage at 10 ppm, corn, sweet, kernel plus cob with husk removed at 0.02 ppm, corn, sweet stover at 15 ppm, cotton gin byproducts at 15 ppm, cotton, undelinted seed at 2.0 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 10.0 ppm, milk at 0.10 ppm, and milk, fat at 3.0 ppm, pear at 0.20 ppm, and vegetables, fruiting, group at 0.50 ppm. Risk assessments were conducted by EPA to assess dietary exposures from Indoxacarb in food as follows:

An acute dietary endpoint for females 13 years and older and for the general population, including infants and children has been identified. The acute population adjusted dose (aPAD) for females is 0.02 milligrams/kilogram/day (mg/kg/day). The acute dietary endpoint for the general population including infants and children is 0.12 mg/kg/day. The chronic population adjusted dose (cPAD) for all populations is 0.02 mg/kg/day. Indoxacarb has been classified as a “not likely” to be carcinogenic to humans. It has been determined that the FQPA safety factor could be reduced to 1X for Indoxacarb. There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure. Currently, indoxacarb is not registered for use in residential settings.

For the chronic exposure estimates, it was assumed that all commodities had tolerance level residues and 100% of all RACs were treated with indoxacarb. Refined processing factors were used in the chronic analysis for several commodities, in place of the Dietary Exposure Evaluation Model (DEEM®) default processing factors. The Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models provided the estimated environmental concentrations (EECs) of indoxacarb. The EECs for acute exposures are estimated to be 13.7 parts per billion (ppb) for surface water and 0.02 ppb for ground water. The EECs for chronic exposures are estimated to be 3.7 ppb for surface water and 0.02 ppb for ground water.

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The 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: An acute Tier II (partially refined analysis) dietary assessment was performed with use of anticipated residues (ARs) from field trial data, processing factors (where applicable), assumed 100% crop treated (CT) for all crops other than peaches, and 1% CT for the peach EUP (300 acres). ARs for meat, milk, poultry, and eggs (MMPE) raw agricultural commodities (RACs) were calculated also.

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: Chronic exposure estimates are expressed in mg/kg body weight (bw)/day and as a percent of the cPAD. The chronic dietary assessment assumed tolerance level residues, DEEM® default processing factors, assumed 100% CT for all crops other than peaches, and 1% CT for the peach EUP (300 acres) (Tier I).

iii. Cancer . There is no evidence for mutagenicity and there is no evidence of carcinogenicity in either the rat or mouse. Indoxacarb has been classified as “not likely to be carcinogenic in humans” by the Agency; therefore, no carcinogenic dietary risk analysis was performed.

Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must 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) of the FFDCA, EPA will issue a data call-in for information relating to ARs to be submitted no later than 5 years from the date of issuance of this tolerance.

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

Dietary exposure estimates were based on 1% PCT for peaches. This PCT of 1% was based on the fact that the 2-year experimental use permit was issued for only 300 acres of peaches to be treated annually, which amounts to 0.2% of the total peach acreage in the United States. The reason for using 1% instead of 0.2% is to allow for any uncertainties in the residue evaluation. Before making this tolerance permanent, reevaluation of dietary exposure will be performed using all available information. Other commodities were assumed to be 100% treated.

The Agency believes that the three conditions previously discussed have been met. With respect to Condition 1, EPA finds that the PCT information described 1% for Indoxacarb used on peaches is reliable and has a valid basis. A 2-year EUP has been issued for this use, which will allow for use of Indoxacarb on 300 acres of peaches in some eastern states. Before the use can be expanded for treatment of greater than 300 acres per year, permission from the Agency must be obtained. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which Indoxacarb may be applied in a particular area.

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

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the PRZM/EXAMS to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a Tier I model) before using PRZM/EXAMS (a Tier II 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 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 Indoxacarb they are further discussed in the aggregate risk sections below.

Based on the PRZM/EXAMS and SCI-GROW models the estimated EECs of Indoxacarb for acute exposures are estimated to be 13.7 parts per billion (ppb) for surface water and 0.02 ppb for ground water. The EECs for chronic exposures are estimated to be 3.7 ppb for surface water and 0.02 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). Indoxacarb 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) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether Indoxacarb 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, Indoxacarb 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 Indoxacarb 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) (FRL-5754-7).

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

2. Prenatal and postnatal sensitivity . There is no evidence for either qualitative or quantitative susceptibility. In all developmental studies, the developmental endpoint occurs at the maternal LOAEL or above. Although there is no rabbit developmental toxicity study with indoxacarb, a study is not required since:

i. Studies-both using methyl cellulose-comparing JW062 in the rabbit and rat demonstrate that the toxicity profiles for the rat and rabbit are similar and that the rat is the more sensitive species;

ii. Range finding studies in the rat comparing indoxacarb and JW062 indicate that the maternal and external developmental toxicity are comparable;

iii. A dietary developmental toxicity study in the rat with JW062 had comparable toxicity to the gavage indoxacarb rat developmental toxicity study. Developmental toxicity only occurred at levels at or above maternal toxicity.

iv. Systemic toxicity is at similar doses and of similar magnitude to that observed in subchronic feeding studies with both indoxacarb and JW062;

v. based on the data base, the HIARC determined that there was support for using data from dietary studies conducted with JW062 to satisfy the data requirements for indoxacarb.

The Agency has required a developmental neurotoxicity study as confirmatory data due to:

• Clinical signs of neurotoxicity in several studies, males and females, mice and rats, at some doses that do not cause mortality;

• Signs of neurotoxicity in the acute neurotoxicity study-rat with indoxacarb (males and females), no mortality in males at neurotoxic doses;

• Clinical signs of neurotoxicity in the 90-day toxicity study-rat indoxacarb (females), mortality;

• Clinical signs of neurotoxicity in the 90-day toxicity study-mouse with the racemic mixture, JW062 (males and females), no mortality in females at neurotoxic doses, mortality in males;

• Clinical signs of neurotoxicity in the 18 month carcinogenicity study-mouse with JW062 (males and females) high and mid dose, mortality at the high but no mortality at the mid dose; and

• Clinical signs of neurotoxicity in the developmental toxicity study-rat with JW062 (using methyl cellulose as the vehicle), at doses causing mortality.

3. Conclusion . The Agency concluded that the FQPA safety factor could be reducecd to 1X for Indoxacarb because:

• There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure;

• The requirement of a developmental neurotoxicity study is not based on the criteria reflecting special concern for the developing fetuses or young which are generally used for requiring a DNT study—and a safety factor (e.g.: neuropathy in adult animals; CNS malformations following prenatal exposure; brain weight or sexual maturation changes in offspring; and/or functional changes in offspring)—and therefore does not warrant an FQPA safety factor; and

• The dietary (food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children

• There are no registered residential uses at the current time.

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 EPAs Office of Water are used to calculate DWLOCs: 2 liter (L)/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 ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA 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, EPA 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 Indoxacarb will occupy 12% of the aPAD for the U.S. population, 64% of the aPAD for females 13 years and older, 67% of the aPAD for infants less than 1 year old and 79% of the aPAD for children 1 to 2 years old. In addition, there is potential for acute dietary exposure to Indoxacarb 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 Table 1 of this Unit:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to Indoxacarb from food will utilize 30% of the cPAD for the U.S. population, 29% of the cPAD for infants less than 1 year and 79% of the cPAD for children 1 to 2 years old. There are no residential uses for Indoxacarb that result in chronic residential exposure to Indoxacarb. Based on the use pattern, chronic residential exposure to residues of Indoxacarb is not expected. In addition, there is potential for chronic dietary exposure to Indoxacarb 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 Table 2 of this unit:

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). Indoxacarb 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). Indoxacarb 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. Aggregate cancer risk for U.S. population . There is no evidence for mutagenicity and there is no evidence of carcinogenicity in either rat or mouse. Indoxacarb has been classified as “not likely to be carcinogenic in humans” by the Agency; therefore Indoxacarb is is not expected to pose carcinogenic risk when used as directed.

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 Indoxacarb residues.

Adequate enforcement methodology (high performance liquid chromatography HPLC/UV Method AMR 2712-93) 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 Avenue., NW, Washington D.C. 20460; Telephone Number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no established or proposed Codex, Canadian, or Mexican maximum residue limits (MRLs) for residues of Indoxacarb; therefore, international harmonization is not an issue at this time.

Therefore, the time-limited tolerance is established for combined residues of Indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl) [4- (trifluoromethoxy)phenyl] amino]carbonyl] indeno[1,2-e][1,3,4]oxadiazine-4a(3H)- carboxylate] + its R-enantiomer [(R)-methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)- carboxylate, in or on peaches at 10 ppm. This tolerance will expire and is revoked on May 15, 2006.

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, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA 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 sections 408 and 409 of the FFDCA. 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 ID number OPP-2003-0173 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before July 14, 2003.

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 (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.

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 20460-0001.

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 20460-0001.

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.1. Mail your copies, identified by docket ID number OPP-2003-0173, 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 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. 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 section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

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

• Crop production (NAICS 111)

• Animal Production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0109. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under 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. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of March 7, 2003 (68 FR 11093) (FRL-7289-8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of pesticide petitions (PP) 2E6416, 2E6425, 2E6428, and 2E6436) by IR-4, 681 US Highway #1 South, North Brunswick, NJ 08902-3390. That notice included a summary of the petitions 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 180.510 be amended by establishing tolerances for residues of the insecticide pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine, in or on atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 0.20 ppm (PP 2E6416); avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla and star apple at 1.0 ppm (PP 2E6428); okra at 0.02 ppm (PP 2E6436); fig at 0.30 ppm (PP 2E6425); and fig, dried at 1.0 ppm (2E6425).

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for tolerances for residues of pyriproxyfen on atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 0.20 ppm (PP 2E6416); avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla and star apple at 1.0 ppm (PP 2E6428); okra at 0.02 ppm (PP 2E6436); fig at 0.30 ppm (PP 2E6425); and fig, dried at 1.0 ppm (2E6425). EPA's assessment of exposures and risks associated with establishing the tolerances 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 no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed as well as the nature of the toxic effects caused by pyriproxyfen are discussed in Unit III.A. of the Federal Registers of June 5, 2001 (66 FR 30065) (FRL-6782-5), August 28, 2002 (67 FR 55150) (FRL-7195-7), and March 7, 2003 (68 FR 10972) (FRL-7289-6).

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

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 pyriproxyfen used for human risk assessment is shown in Unit III.B. of the Federal Register of March 7, 2003 (68 FR 10972).

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.510) for the residues of pyriproxyfen, in or on a variety of raw agricultural commodities. There are no significant livestock feed items associated this action, thus the proposed uses will not result in the transfer of additional pyriproxyfen residues to livestock. Risk assessments were conducted by EPA to assess dietary exposures from pyriproxyfen 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. An acute dietary exposure analysis was not conducted since no acute doses or toxicological endpoints were selected for the general U.S. population (including infants and children) or the females 13-50 years old population subgroup.

ii. Chronic exposure . In conducting this chronic dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID®) which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The chronic dietary exposure assessment was performed using published and proposed tolerance levels, DEEM® default processing factors, and 100% crop treated (PCT) assumptions for all commodities. Some of the crops (atemoya, custard apple, ilama, birba, sapodilla, black and white sapote, star apple, and ugli fruit) considered in this risk assessment are not included in the present version of DEEM-FCID® due to their low consumption. In these cases, the DEEM-FCID® program underestimates the exposure to pyriproxyfen residues from these crops; however, because the consumption levels of these crops is so low (on a national basis), inclusion of these crops in a future version of DEEM-FCID® would likely make no difference in the overall predicted exposures to pyriproxyfen residues.

iii. Cancer . Pyriproxyfen was classified by the EPA (June, 1995) as a “Group E” chemical - no evidence of carcinogenicity to humans based on the absence of carcinogenicity in mice and rats.

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

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The screening concentration in ground water (SCI-GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a Tier I model) before using PRZM/EXAMS (a Tier II model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. FIRST and PRZM/EXAMS incorporate an index reservoir environment, and a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

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 percent reference dose (%RfD) or percent population adjusted dose (%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 pyriproxyfen they are further discussed in the aggregate risk sections in Unit III.E.

EPA determined that the residue of concern in water is pyriproxyfen per se . Drinking water estimates include surface water EECs based on the linked PRZM/EXAMS models and the SCI-GROW regression model, which was developed from studies with different hydrology and study conditions. Both models assumed a maximum seasonal application rate of 0.11 lb active ingredient per acre, applied 3 times per year. (The registered use for citrus). Based on the PRZM/EXAMS and SCI-GROW models the EECs of pyriproxyfen for acute exposures are estimated to be 2.15 parts per billion (ppb) for surface water and 0.006 ppb for ground water. The EECs for chronic exposures are estimated to be 0.40 ppb for surface water and 0.006 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).

Pyriproxyfen is currently registered for use on the following residential non-dietary sites: Residential sites for flea and tick control products (home environment and pet treatments) as well as products for ant and roach control (indoor and outdoor applications). Formulations include carpet powders, foggers, aerosol sprays, liquids (shampoos, sprays, and pipettes), granules, bait (indoor and outdoor), and impregnated materials (pet collars).

The risk assessment was conducted using the following residential exposure assumptions: There is a potential for short-term dermal and inhalation exposures to pet owners and homeowners who apply products containing pyriproxyfen (handlers); however, EPA did not identify any short-term dermal or inhalation endpoints. Because no short-term dermal or inhalation endpoints could be identified, EPA expects no short-term dermal or inhalation risks from exposure to pyriproxyfen. There is also a potential for non-dietary oral exposures (hand-to-mouth exposures) and dermal exposure following applications around the home and on pets for flea and tick control (carpet powder and pet shampoo). Short- and intermediate-term non-dietary oral and long-term dermal exposure assessments were included for toddlers since EPA selected toxicology endpoints for these exposures and toddlers are expected to have higher exposures than adults from treated home environments and pets due to their behavior patterns. Although EPA did not select a long-term non-dietary oral endpoint for pyriproxyfen, EPA used the chronic endpoint for the chronic (long-term) aggregate risk assessment.

Toddlers could potentially be exposed to pyriproxyfen residues on treated carpets, floors, furniture, and pets as follows: (i). Hand-to-Mouth: Short-, intermediate, and long-term hand-to-mouth exposures by toddlers from treated carpets, flooring (the efficacy of carpet powders is approximately 365 days); (ii). Hand-to-mouth: Short- and intermediate-term hand-to-mouth exposures by toddlers from petting treated animals (shampoos, sprays, spot-on treatments and collars). Long-term hand-to-mouth exposures by toddlers from petting treated animals (pet collars; efficacy of pet collars up to 395 days); (iii). Dermal: Long-term dermal exposures from treated carpets, flooring, and pets. (iv). Ingestion of granules or bait by toddlers (acute, episodic event): For the granular ingestion scenario, the Agency believes that if a toddler were to be exposed to a pellet/granular formulation (i.e., ant bait), the event is most likely to be “episodic,” that is, a one time occurrence and not likely to be repeated. It is not likely that a toddler would repeatedly locate and ingest very small, sand colored granules. For pyriproxyfen, EPA did not select an acute dietary endpoint, since an appropriate endpoint could not be attributed to a single oral dose; therefore, no granular assessment was performed.

Exposure and risk estimates from post-application exposure to indoor crack and crevice treatments are not presented in this assessment as indoor broadcast treatments (i.e., carpet powders and sprays) are anticipated to have a higher exposure potential. Additionally, the Agency acknowledges that pet owners could retreat the home environment and/or the pet near the end of the efficacy period identified on the product labels. However, there are no chemical-specific residue data for pyriproxyfen to determine the dissipation rate of residues or whether residues may be additive upon retreatment. Therefore, a Tier I assessment was performed based on Day 0 residues without accounting for daily residue dissipation. EPA anticipates that this assessment is protective as pyriproxyfen residues would be expected to dissipate from Day 0 residue values.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether [pyriproxyfen] has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to pyriproxyfen and any other substances and pyriproxyfen 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 pyriproxyfen has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/ .

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

2. Prenatal and postnatal sensitivity . Based on the available data, there is no quantitative and qualitative evidence of increased susceptibility observed following in utero pyriproxyfen exposure to rats and rabbits or following pre/post natal exposure in the 2-generation reproduction study.

3. Conclusion . There is a complete toxicity data base for pyriproxyfen and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be reduced to 1X because there was no evidence of prenatal or postnatal extra sensitivity or increased susceptibility in developmental studies in rats and rabbits, and in reproduction studies in rats. Likewise, there was no quantitative or qualitative evidence of increased susceptibility to rat or rabbit fetuses identified in the guideline prenatal developmental toxicity studies for rats and rabbits. Additionally, in the 2 non-guideline studies that evaluated perinatal and prenatal development, there was no evidence of quantitative or qualitative increased susceptibility. In 1-study, when pregnant rats were treated from gestation day 17 to lactation day 20, the resulting toxicity was comparable between adults (clinical signs, decreased body weight gain and food consumption) and offspring (decreased body weight and dilation of the renal pelvis) at the same dose. In the other study, when rats were exposed to pyriproxyfen prior to and in the early stages of pregnancy, no developmental toxicity was seen at the limit dose. Lastly, in the reproduction toxicity study, offspring toxicity (decreased body weight on pups during lactation days 14 to 21) occurred only in the presence of decreases in body weight in parental animals at the same dose level (i.e., comparable toxicity in adults and offspring).

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 milligrams/kilogram/day (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 EPAs Office of Water are used to calculate DWLOCs: 2 liter (L)/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 ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA 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, EPA 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 . An acute dietary RfD for females 13-50 and the general U.S. population, including infants and children, was not selected because an acute oral endpoint attributable to a single-dose exposure could not be identified; therefore, acute dietary risk is not expected.

2. Chronic aggregate risk . Using the exposure assumptions described in this unit for chronic (long-term) exposure, EPA has concluded that exposure to pyriproxyfen from food will utilize 1.1% of the cPAD for the U.S. population, 2% of the cPAD for all infants, less than 1 year old and 3.9% of the cPAD for children 1 to 2 years old, the subpopulation at greatest exposure. Pyriproxyfen is an active ingredient in pesticide products registered for residential use. Based on the use patterns, the residential risk assessment was performed for toddlers since they are anticipated to have the higher chronic residential exposure to residues of pyriproxyfen. EPA considered background chronic-dietary exposure (food + water), long-term, residential non-dietary oral exposures (hand-to-mouth exposures by toddlers following applications around the home and on pets for flea and tick control-carpet powder and pet shampoo), and long-term dermal exposure to toddlers. The total chronic food and residential aggregate MOEs were calculated. As these MOEs are greater than 100, the chronic aggregate risk does not exceed EPA's level of concern. In addition, there is potential for chronic dietary exposure to pyriproxyfen in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate chronic exposure to exceed the Agency's level of concern, as shown in Table 1 of this unit:

3. Short-term aggregate risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyriproxyfen is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for pyriproxyfen. EPA considered background chronic-dietary exposure (food + water) and short-term, residential non-dietary oral exposures (hand-to-mouth exposures by toddlers following applications around the home and on pets for flea and tick control-carpet powder and pet shampoo).

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs for toddlers ranging from 1,600 for children 1 to 2 years old to 1,800 for children less than 1 year old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of pyriproxyfen in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in Table 2 of this unit:

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

Pyriproxyfen is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for pyriproxyfen. EPA considered background chronic-dietary exposure (food + water) and intermediate-term, residential non-dietary oral exposures (hand-to-mouth exposures by toddlers following applications around the home and on pets for flea and tick control-carpet powder and pet shampoo).

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs for toddlers ranging from 580 for children 1 to 2 years old to 650 for infants less than 1 year old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of pyriproxyfen in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in Table 3 of this Unit:

5. Aggregate cancer risk for U.S. population . There is no evidence of carcinogenicity to humans based on carcinogenicity studies in male and female rats and mice. The Agency concludes that pesticidal uses of pyriproxyfen are not likely to pose a carcinogenic hazard to humans.

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 pyriproxyfen residues.

Adequate enforcement methodology (gas chromotography/nitrogen phosphorous detector method (RM-33P-1-3a)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no Codex, Canadian, or Mexican maximum residue limits established for residues of pyriproxyfen in or on the subject food commodities.

Therefore, the tolerance is established for residues of pyriproxyfen, [2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or on atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 0.20 parts per million (ppm); avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla and star apple at 1.0 ppm; okra at 0.02 ppm; fig at 0.30 ppm; and fig, dried at 1.0 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA 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) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 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 ID number OPP-2003-0109 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before July 14, 2003.

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 (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.

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 20460-0001.

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 20460-0001.

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.1. Mail your copies, identified by docket ID number OPP-2003-0109, 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 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. 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 section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-13, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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).

In 1987, the Department of Health and Human Services published regulations which addressed the issue of the increasing number of requests for the testimony of Department employees in litigation involving only private parties and not the United States. The regulation addresses this matter by generally prohibiting both voluntary appearances and compliance with subpoenas for testimony as part of an employee's official duties, except where the relevant agency head or his or her designee determines that the appearance would promote the objectives of the Department. In addition, the regulation provides that subpoenas for the production of documents would be processed under the Freedom of Information Act, 5 U.S.C. 552.

These amendments are designed to address cases in which a Federal court has jurisdiction to issue a subpoena for DHHS documents. In such cases, the current regulation may infringe on the power of the court by allowing greater authority to withhold a document under the FOIA than would be the case under the rules governing disclosure of documents in court. See FTC versus Grolier, Inc., 462 U.S. 19, 27-28 (1983). Because it is not the intention of the Department to create or broaden a Federal litigation privilege through this part, we are amending the regulation to limit the applicability of the FOIA to situations in which the issuing tribunal has no jurisdiction over the Department.

Accordingly, we are amending §§ 2.1, 2.3, and 2.5 to provide that when the Office of the General Counsel determines that a subpoena is “legally sufficient,” including when the issuing court has jurisdiction over the Department or its employee(s), the Department will follow the applicable procedural and substantive rules relating to the production of information and documents by a non-party. In cases of informal requests for documents, and where the tribunal issuing the subpoena does not have jurisdiction over the Department—such as is the case in most subpoenas issuing out of State, local and tribal courts, see, e.g., Boron Oil Co. versus Downie, 873 F.2d 67, 70 (4th Cir. 1989); Environmental Enterprises, Inc. versus EPA, 664 F. Supp. 585, 586 (D.D.C. 1987); Reynolds Metals Co. versus Crowther, 572 F. Supp. 288, 290-91 (D. Mass. 1982)—the regulation provides that we will continue to treat the request as a request made pursuant to the FOIA.

The amendments also include examples following the text of § 2.1 which illustrate the applicability of this regulation to situations in which the regulation may or may not apply.

The amendments also reflect changes in the organizational structure in the Department. The references in § 2.2 to the Assistant Secretary for Human Development Services and the Assistant Secretary for Family Support are deleted and replaced by references to the Assistant Secretary for Children and Families as the Agency Head for requests involving the Administration for Children and Families and by the Assistant Secretary for Aging for requests involving the Administration on Aging. In addition, reference to the Commissioner of Social Security is deleted, due to the March 31, 1995, independence of the Social Security Administration.

These amendments also modify § 2.6 to delete the reference to the Freedom of Information Act regulations, 45 CFR part 5, to reflect the policy that the Department will certify any disclosed documents upon request, not just those disclosed pursuant to part 5.

Public Participation: This rule is published as a final rule. It is exempt from public comment, pursuant to 5 U.S.C. 553(b)(A) as a rule of “agency organization, procedure, or practice.”

Paperwork Reduction Act: This regulation is not subject to the Paperwork Reduction Act because it deals solely with internal rules governing Department of Health and Human Services personnel.

Cost/Regulatory Analysis: In accordance with Executive Order 12291, the Secretary has determined that these amendments will not constitute a “major” rule and therefore are not subject to the regulatory impact and analysis requirements of the Order. Major rules are those which impose a cost on the economy of $100 million or more a year and have certain other economic impacts.

These amendments will not have a significant impact on small businesses; therefore, preparation of a regulatory flexibility analysis is not required.

This is a summary of the Commission's Order (Order), FCC 03-63, adopted on March 24, 2003, and released on March 28, 2003. The full text of this document is available for inspection and copying during normal business hours in the Consumer and Government Affairs Bureau's Reference Information Center, (Room CY-A257) of the Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. The document is also available for download over the Internet at http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-03-63A1.pdf. The complete text of this document also may be purchased from the Commission's copy contractor, Qualex, Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20054, telephone (202) 863-2893.

1. On January 30, 2002, the Commission released a Notice of Proposed Rulemaking (67 FR 10656, March 9, 2002) to review the Commission's international call-back enforcement policy. International call-back arrangements allow foreign callers to take advantage of low U.S. international services rates, many of which are significantly lower than the rates available in their home countries. Specifically, the Commission's international call-back policy extends to the uncompleted call signaling configuration of call-back. Uncompleted call signaling involves a foreign caller who dials the call-back provider's switch in the United States, waits a predetermined number of rings, and hangs up before the switch answers. The switch then automatically returns the call, and upon completion, provides the caller in the foreign country with a U.S. dialtone.

2. In a 1994 order, the Commission authorized U.S. carriers to provide call-back service. The Commission concluded that the provision of call-back does not violate U.S. law or international law or regulations. In 1995, the Commission reconsidered its decision in light of international comity. The Commission adopted a policy prohibiting U.S. carriers from offering international call-back using the completed call signaling configuration to countries where it has been expressly prohibited. Foreign governments were invited to notify the Commission of the legality of call-back within their territory, and the Commission maintains a public file containing the submitted material from foreign governments.

3. Since adopting its call-back policy in 1995, the Commission has taken significant steps to open the U.S. international market to competition and to enhance consumer benefits on U.S. international routes. In this Order, the Commission concluded that the policy is no longer necessary in today's pro-competitive environment. Thus, the Commission decided to eliminate its comity-based call-back policy and discontinue the policy that allows a foreign government or entity to make use of the enforcement mechanisms of the Commission to prohibit the U.S. carriers from offering one form of call-back abroad.

4. The Commission continues to maintain that its policy allowing the uncompleted call signaling configuration of call-back is consistent with international law.

5. Further, the Commission finds that this change to its policy on call-back services is also consistent with the ITU Plenipotentiary 2002 Resolution 21 and the 1994 Kyoto Declaration.

6. The Commission will continue to maintain a public file to inform call-back providers about the legality of call-back in foreign nations. Also, the FCC will continue to maintain its policies prohibiting call-back configurations that degrade the network or constitute fraudulent activity.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 6013612, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, Title II, 110 Stat. 957, requires a final regulatory flexibility analysis in notice-and-comment proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” The policy change adopted in this Order does not impose any additional compliance burden on small entities dealing with the Commission. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. Accordingly, we certify, pursuant to Section 605(b) of the RFA, that the policy change adopted in this Order does not have a significant economic impact on a substantial number of small business entities, as defined by the RFA. The Commission's Consumer and Government Affairs Bureau, Reference Information Center, shall send a copy of this Order, including the Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration in accordance with section 605(b) of the RFA. This final certification will also be published in the Federal Register .

In this Order, the Commission eliminated the comity-based prohibitions on call-back and the policy that allowed a foreign government or entity to make use of the enforcement mechanisms of the FCC to enforce foreign government prohibitions against U.S. carriers from offering call-signaling aboard. After careful consideration, the Commission concluded that eliminating the policy will foster competition for both small and large entities.

The Commission does not know the precise number of small entities that may be affected by this Order because it does not maintain statistical data on the size and scope of call-back providers. However, the Commission believes that most, if not all, of the call-back providers would not be considered small entities because many of these entities are wireline carriers with more than 1500 employees ( see NAICS Code 517110, 13 CFR parts 121-201). Thus, very few, if any, small entities would be affected by this Order. Elimination of the call-back policy will be beneficial for both large and small entities. The Commission's Order is pro-competitive and will provide, for both large and small entities, lower prices, new and better products and services, and greater consumer choices. In addition, the Commission will maintain an on-going public file to inform both large and small carriers about the legality of call-back in foreign countries. The public file will enable all entities to note which foreign governments have notified the Commission that call-back is illegal in their countries.

Therefore, we certify that eliminating the call-back policy will not have a significant economic effect on a substantial number of small entities.

7. Accordingly, pursuant to sections 1, 4 (j)(-j), 201(b), 214, 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i)(j), 201(b), 214, 303(r), and 403, this Order is hereby adopted.

8. The condition placed on international Section 214 authorizations regarding the provision of international call-back services through the use of uncompleted call-signaling, is hereby removed from all existing Section 214 authorizations.

9. The Commission's Consumer and Government Affairs Bureau's Reference Information Center, shall send a copy of this Order including the final regulatory flexibility certification, to the Chief Counsel for Advocacy of the Small Business Administration.

This is a summary of the FCC's Report and Order, FCC 03-79, adopted on April 9, 2003, and released on April 16, 2003. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the FCC's copy contractor, Qualex International, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text also may be downloaded at: http://www.fcc.gov. Alternative formats are available to persons with disabilities by contacting Brian Millin at (202) 418-7426 or TTY (202) 418-7365 or at bmillin@fcc.gov.

1. In this Report and Order, the FCC amends § 1.937 of its rules to prohibit the filing of any repetitious license application in the Wireless Radio Services within twelve months of the denial or dismissal with prejudice of a substantially similar application. It also streamlines rule barring repetitious applications by combining § 1.937(a) and (b). The amendment of § 1.937 will simplify and clarify prohibition against repetitious applications. The FCC believes that this action will promote the most efficient use of it's resources by preventing the filing of such applications and barring applicants from initiating reexamination of such matters within a short time after final decision.

2. The Commission's Rules have long prevented the filing of repetitious license applications. Prior to 1998, the rules barring repetitious license applications were set forth in separate rule parts pertaining to each of the Wireless Radio Services. These rules generally prohibited the filing of a repetitious application within twelve months of the denial or dismissal with prejudice of a substantially similar application. In 1998, the Commission consolidated its licensing rules for all Wireless Radio Services, and enacted § 1.937 to replace its prior service-specific rules on the filing of repetitious or conflicting applications. Section 1.937 provides,

(a) Where the Commission has, for any reason, dismissed an application for a new station or for any modification of services or facilities with prejudice, or revoked the license for a radio station in the Wireless Radio Services, the Commission will not consider a like or new application involving service of the same kind to substantially the same area by substantially the same applicant, its successor or assignee, or on behalf of or for the benefit of the original parties in interest, until after the lapse of 12 months from the effective date of final Commission action.

(b) If an applicant has been afforded an opportunity for a hearing with respect to an application for a new station or an enlargement of service area, and the Commission has, after hearing or default, denied the application or dismissed it with prejudice, the Commission will not consider a like application for service of the same type to the same area by that applicant, or by its successor or assignee, or on behalf of or for the benefit of the parties in interest to the original application, until after the lapse of 12 months from the effective date of final Commission action on the original application.

(c) If an appeal has been taken from the action of the Commission denying a particular application, a like application for service of the same type to the same area, in whole or in part, filed by that applicant or by its successor or assignee, or on behalf or for the benefit of the parties in interest to the original application, will not be considered until the final disposition of such appeal.

(d) While an application is pending, any subsequent inconsistent or conflicting application submitted by, on behalf of, or for the benefit of the same applicant, its successor or assignee will not be accepted for filing. Section 1.937 and its antecedents were adopted to achieve sound administrative process by barring applicants from immediately re-litigating matters already decided.

3. On March 20, 2002, the Commission released a Notice of Proposed Rule Making, 67 FR 34651, May 15, 2002, in which it proposed to amend § 1.937 to clarify that the prohibition on repetitive applications applies to all types of license applications ( i.e. , new applications and renewal applications), and applies equally to all dispositive actions, including dismissals with prejudice, denials, and revocations. Comments were filed by the American Mobile Telecommunications Association, Inc. (AMTA). AMTA supports the Commission's effort to simplify its rules, but cautions the Commission to do so carefully so as not to apply the sanction to applications dismissed without prejudice.

4. The FCC, pursuant to 5 U.S.C. 605(b) certifies that the rule will not have a significant economic impact on a substantial number of small entities. The purpose of this Report and Order is to prohibit the filing of applications for radio station licenses within twelve months of the denial of a substantially similar application. This change is made to promote the most efficient use of the FCC's resources by preventing the immediate filing of repetitious applications. The FCC has analyzed the information submitted during the comment period and the proposed rule change does not impose any additional compliance burden on small entities regulated by the FCC. Accordingly, we certify, pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), that the rule change established in this Report and Order will not have a significant economic impact upon a substantial number of small entities, as that term is defined by the RFA. The FCC's Office of Public Affairs, Reference Operations Division, shall send a copy of this Report and Order, including this certification, to the Chief Counsel for Advocacy of the Small Business Administration in accordance with the RFA. We shall also publish a copy of this certification in the Federal Register .

5. This Report and Order does not contain either a proposed or modified information collection.

6. Pursuant to sections 4(i), 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(r), 403, this Report and Order is hereby adopted.

7. The rules set forth in the rule changes will become effective June 13, 2003.

8. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Report and Order including the Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

On June 16, 2000, the Federal Communications Commission published in the Federal Register (65 FR 37703) a document amending section 52.15(f) of its rules to include new information collection requirements. Inadvertently, the number “360,” instead of “365,” was placed in section 52.15(f)(1)(ii) as the maximum amount of days that a number previously assigned to a business customer could be aged. This document corrects paragraph (f)(1)(ii) of that rule.