The Direction Generale De L'Aviation Civile (DGAC), the airworthiness authority for France, notified the FAA that an unsafe condition may exist on Eurocopter Model EC155B helicopters. The DGAC advises of the detection of operating anomalies affecting the red “GOV” warning lights and the need to check the engine governing warning system for correct operation before the next flight.

Eurocopter has issued Alert Service Bulletin EC155 No. 77A001, dated May 7, 2003, which specifies operational checks of the red “GOV” warning lights and the related electrical circuits. The DGAC classified the service bulletin as mandatory and issued AD No. 2003-196(A), dated May 28, 2003, to ensure the continued airworthiness of these helicopters in France.

This helicopter model is manufactured in France and is type certificated for operation in the United States under the provisions of 14 CFR 21.29 and the applicable bilateral agreement. Pursuant to the applicable bilateral agreement, the DGAC has kept the FAA informed of the situation described above. The FAA has examined the findings of the DGAC, reviewed all available information, and determined that AD action is necessary for products of these type designs that are certificated for operation in the United States.

The previously described unsafe condition is likely to exist or develop on other helicopters of the same type design. Therefore, this AD is being issued to prevent failure of the display to warn of an engine governor failure, resulting in an engine over speed, loss of an engine, and subsequent loss of control of the helicopter. This AD requires the following:

• Before further flight, determine if the display illuminates the “GOV” warning lights. If the display illuminates the “GOV” warning lights, no further action is required.

• If crosses illuminate instead of the “GOV” warning lights on the display, replace the front panel of the display with an airworthy part before further flight.

Replacing the front panel of the display with an airworthy part, part number 022TA0402, constitutes terminating action for the requirements of this AD.

An owner/operator (pilot) may perform the visual checks for an inoperative governing warning system display. Pilots may perform these checks because they require no tools and can be accomplished by observation and may be performed equally well by a pilot or a mechanic. However, the pilot must enter compliance with those requirements into the helicopter maintenance records in accordance with 14 CFR 43.11 and 91.417(a)(2)(v).

The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the controllability of the helicopter. Therefore, checking that the display illuminates the “GOV” warning lights and, if necessary, replacing the front panel of the display with an airworthy part before further flight is required.

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

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's AD system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. Because we have now included this material in part 39, we no longer need to include it in each individual AD.

The FAA estimates that this AD will affect 3 helicopters and will take approximately 15 minutes for an operational check of the engine governor warning system and 1 work hour to replace the front panel of the display at an average labor rate of $60 per work hour. Required parts will cost approximately $3500 per helicopter. Based on these figures, the estimated total cost impact of the AD on U.S. operators is $10,725.

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

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

Commenters wishing the FAA to acknowledge receipt of their mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2003-SW-22-AD.” The postcard will be date stamped and returned to the commenter.

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

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

The FAA published FR Document 03-20406 in the Federal Register on August 12, 2003, (68 FR 47846) to modify Class E airspace at Waimea-Kohala, HI. The latitude description of the Waimea-Kohala Airport and the wording of the 700' Class E airspace were described incorrectly.

The VHF Omnidirectional Range/Distance Measuring Equipment (VOR/DME) SIAP for Hassell Field Airport has been canceled. Therefore, the Class E5 airspace area must be removed. This rule will become effective on the date specified in the “DATE” section. Since this action eliminates the impact of controlled airspace on users of the airspace in the vicinity of the Hassell Field Airport, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Class E airspace designations for airspace ares extending upward form 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. The Class E designation listed in this document will be published subsequently in the Order.

This amendment to Part 71 of the Federal Aviation Regulations (14 CFR part 71) removes Class E5 airspace at Clifton, TN.

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

The temporary regulations that are the subject of these corrections are under section 6103(k)(6) of the Internal Revenue Code.

As published, the temporary regulations contains errors that may prove to be misleading and are in need of clarification.

On October 29, 1998, we published a notice of proposed rulemaking entitled “Handling of Class 1 (Explosive) Materials or Other Dangerous Cargoes within or Contiguous to Waterfront Facilities” in the Federal Register (63 FR 57964). On January 12, 1999, we published a notice in the Federal Register reopening the comment period for this rulemaking (64 FR 1770). We received eight letters commenting on the proposed rule. No public hearing was requested, and none was held.

The regulations in 33 CFR part 126 prescribing requirements for designated waterfront facilities that handle, store, and transfer hazardous materials to and from vessels were written in the 1950s and have never been significantly updated.

On September 4, 1990, the Coast Guard published a final rule (55 FR 36252) amending part 126 to exclude its application to bulk-liquid hazardous materials, other than certain liquefied gases. Moreover, on August 3, 1995, the Coast Guard published a final rule (60 FR 39788) further amending part 126 to exclude its application to the remaining liquefied gases and to transfer the requirements for the control of liquefied hazardous gas transfers from 33 CFR 126.15(o) to 33 CFR part 127. As amended, part 126 applies only to facilities handling packaged and dry-bulk hazardous materials.

On January 13, 1993, the Coast Guard published an advance notice of proposed rulemaking ((ANPRM)(58 FR 4127)) requesting comments on proposed changes to 33 CFR part 126. The Coast Guard received 11 comments in response to the ANPRM.

We are amending our regulations in 33 CFR part 126 concerning waterfront facilities handling certain dangerous cargo. These amendments are necessary to better address the hazards and precautions necessary for packaged cargo, which have changed significantly with the advent of containerization. We are also incorporating up-to-date industry standards and reorganizing the part for clarity.

All measurements in this rule are in Systéme International D'Unites (SI) units, with the English measurement following in parentheses. The Omnibus Trade and Competitive Act of 1988 (Pub. L. 100-418) designates the SI system as the preferred system of weights and measurements for United States trade and commerce. The American Society of Testing and Materials (ASTM) and the American Society of Mechanical Engineers (ASME) also support the conversion to metric standards.

A discussion of the comments received and changes made to the proposed rule follow.

1. Sections numbered under the outmoded system for numbering sections ( e.g. , § 126.01) are renumbered using the current system ( e.g. , § 126.1).

1. We added new § 126.1 to make it clear that this part has requirements not only for waterfront facilities but also for vessels at those facilities. For example, see new § 126.30 on welding and hotwork on facilities and vessels at those facilities.

1. One comment recommended that the definition of “container” be the same as in the Intermodal Safe Container Act (ISCA) and its implementing regulations at 49 CFR parts 450 through 453.

We do not agree. The ISCA and its regulations address the technical standards for the construction and structural integrity of containers. The proposed definition for “container” is the same as found in 49 CFR parts 170 through 176 for containers used in the transportation of hazardous materials.

2. We have added the definition of “facility operator” in this section. See the explanation for this under “hotwork” (§ 126.30) in this section of the preamble.

1. One comment asked whether the proposed changes to § 126.15(a) would continue to apply to facilities handling dry, bulk-solid dangerous cargo.

As stated in the preamble to the NPRM, proposed § 126.15 differentiates between container terminals and other designated waterfront facilities. Proposed § 126.15(a) would apply to those facilities not handling dangerous cargo in transport units and proposed § 126.15(b) would apply to container terminals. Proposed §§ 126.15(c) through 126.15(n) would apply to all designated waterfront facilities. We reorganized § 126.15 to make this differentiation clearer. New paragraph (a) contains requirements for all waterfront facilities subject to this part; new paragraph (b) contains additional requirements for facilities that handle dangerous cargo not in transport units; and new paragraph (c) contains additional requirements for facilities that handle dangerous cargo in transport units.

1. Two comments requested clarification as to whether these updated regulations would eliminate all restrictions on the physical arrangement of dry, bulk-solid dangerous cargoes.

The existing regulations for cargo spacing were designed to permit firefighting access to storage areas. Though we are revising § 126.15 by removing most of the requirements for the arrangement of cargo, freight, merchandise, or material, including dry, bulk-solid materials, we still require at least one main aisle, as indicated in the National Fire Protection Association (NFPA) Code 307, chapter 8-5. The only exception to having at least one main aisle is when cargo is transferred directly to or from railroad cars or vehicles. For that reason, it is unnecessary to use trucks within the structure. Therefore, an aisle must not be required. Additionally, you must segregate bulk-solid cargoes according to § 126.27(g) for product compatibility. We encourage facility owners and operators to coordinate with the Captain of the Port (COTP) and local fire-service officials to implement these new standards based on the structure of the facility and local fire-service practices.

1. One comment requested that we incorporate the standards in NFPA 307, chapters 3 and 4, for the construction of piers, wharves, and terminal buildings into these regulations.

We do not agree with this comment. While we recognize that the requirements of NFPA 307 represent generally accepted building practices, the standards for the design and construction of designated waterfront facilities are best established by State or local authorities. Additionally, we determined that, in many ports, the construction aspects of NFPA 307 are already enforced, usually by the local fire department, in conjunction with other building codes.

1. One comment noted that, by applying the NFPA standards to existing facilities, we would create a large financial burden on industry, particularly for facilities and terminals that were built many years ago.

Because NFPA 307 does not require refurbishment of existing facilities for this purpose, only those facilities that are rebuilding or remodeling existing structures and those building completely new structures will be affected. Paragraph 1-2 of NFPA 307 states: “Unless otherwise noted, it is not intended that the provisions of this document be applied to facilities, equipment, structures, or installations that were existing or approved for construction prior to the effective date of the document, except in those cases in which it is determined by the authority having jurisdiction that the existing situation involves a distinct hazard to life or property.” Additionally, in many ports, the construction aspects of NFPA 307 are already enforced by local authorities. Accordingly, we will not require owners to refurbish existing facilities unless there is a distinct safety hazard.

1. One comment requested clarification as to who, at each facility, is responsible for enforcing the regulations required by this section that are posted on the warning signs. This comment asked if we will cite a terminal owner if we find an individual smoking in a “No Smoking” area.

Generally, our enforcement actions will target the party subject to these regulations who can most effectively bring about compliance or a remedy for the deficiencies or alleged violations. The COTP is still responsible for identifying who is responsible for a violation and initiating appropriate enforcement actions.

1. One comment recommended that a designated waterfront facility, that conducts cargo operations with foreign-flag vessels, should be allowed to use an international shore connection provided by the local fire department rather than provide its own connection at that facility.

We conditionally agree with this comment. As stated in the NPRM, the international shore connection makes it possible to connect dissimilar U.S. facilities and fire main connections for foreign vessels in the event of an emergency. You must make available an international shore connection that meets ASTM F-1121 by providing it yourself or through your local emergency response department.

1. One comment asked if the COTP must be notified when containers with dangerous cargo in railroad or highway vehicles are being transported across or on the facility solely for transfer to or from a ferry.

We have clarified this paragraph by adding the words “transport units” to the exceptions listed in § 126.27(b). Transport units and railroad or highway vehicles carrying containers loaded with dangerous cargo across or on the facility solely for transfer to a ferry are not subject to these reporting requirements.

1. Three comments recommended that the quantity of explosives triggering a notification to the COTP under § 126.27(b)(1) should be revised to specify that the net explosive quantity is used. The net explosive quantity is the most commonly used indicator in the industry of the actual amount of explosives present.

We agree with this comment and have revised this paragraph.

1. Two comments recommended that the proposed amendments to § 126.27(b)(2) concerning the provisions for notification to the COTP for shipments of Class 2, Division 2.1 (Flammable Gas), apply to bulk packaging of this product.

We agree with these comments and have revised this paragraph. For the purposes of this section, the definition of “bulk packaging” is the same as that found in 49 CFR 171.8.

1. Two comments recommended that we allow the same exception from the segregation requirements for break-bulk dangerous cargo in limited quantity packaging in §§ 126.27(d) to 126.27(e) for limited quantity packaging in transport units. This was suggested for consistency with the International Maritime Dangerous Goods Code. One of these comments also suggested that we clarify the regulations regarding segregating transport units at a facility according to 49 CFR 176.83(f). The same requirements should apply for “on-deck” horizontal stowage.

We agree with these comments and have revised this paragraph accordingly.

2. Two comments objected to the proposed requirement that containers loaded with dangerous cargoes must be segregated according to 49 CFR 176.83. These comments described a local practice where containers loaded with dangerous cargo are required to be stored on a chassis rather than in grounded storage. These comments stated that, by removing the containers with dangerous cargo from grounded storage, the port would provide a safer environment by enabling easier access and identification in the event of an emergency. This, among other benefits, would reduce handling and provide greater accessibility for monitoring.

As stated in the preamble to the proposed rule, these rules will establish minimum safety standards for the operation of designated waterfront facilities. With approximately 485 facilities being subject to these regulations, we recognize that there are situations where the application of these regulations is not practical. This might arise because of local conditions or because the local port authorities or facility owners or operators have developed programs or operational practices to ensure safety, such as the one described by these comments. Existing § 126.11 allows the COTP to grant waivers of compliance; new § 126.12 allows the COTP to examine alternative methods of compliance. Both of these sections allow the minimum safety standards to be tailored to meet unique, local conditions and to provide for the development and implementation of alternative methods of ensuring safety. Facility owners and operators, who have developed alternative methods of ensuring safety, such as the one described in these comments, may request a waiver or alternative from the COTP under §§ 126.11 or 126.12.

1. One comment requested clarification of the requirements in § 126.27(h). This requires you to store water-soluble oxidizers (Division 5.1) in a manner that prevents them from coming into contact with water. This comment stated that industry takes every precaution to ensure these materials are kept dry but does not plan for abnormal situations, such as the vessel sinking or hurricanes.

This section applies to the storage of dangerous cargoes at designated waterfront facilities and not while they are on a vessel or in another mode of transportation. Therefore, we retain our proposed language.

1. One comment objected to the provisions in proposed § 126.27(i) that requires liquid oxidizers (Division 5.1) materials to be stored so that, in the event of a leak from their packaging, they would not come in contact with organic materials. This comment stated that industry was unaware of any incidents resulting from a leak of a liquid oxidizer coming in contact with organic material. It added that the current segregation standards under International Maritime Organization (IMO) and Research and Special Programs Administration (RSPA) for the transportation of dangerous goods are adequate.

We do not agree with this comment. While we agree that the IMO and RSPA segregation standards are adequate for transportation purposes, the requirements of this section apply to the storage of dangerous cargoes at designated waterfront facilities. We recognize that, although there are possible combinations of Division 5.1 products and organic materials that would not result in a hazardous reaction, there are many other possible combinations of these materials that could produce a dangerous chemical reaction. Therefore, we retain our proposed language.

1. One comment expressed concern that proposed § 126.27(j), which would require that dangerous cargo on the facility be stored in a manner that retards the spread of fire, could be interpreted to mean that explosives stored within an explosive storage magazine would have to be interspersed with fire-retardant material. This comment requested that we clarify this section by indicating that this does not apply to packages within an explosive storage magazine.

This section applies to the storage of dangerous cargo at a designated waterfront facility. If a designated waterfront facility has the capability to store explosive materials within an explosive storage magazine, this type of storage is already adequately addressed under other existing Federal, State, and local regulations and, therefore, would not be subject to this requirement.

1. One comment noted that the facility operator is responsible for welding or hotwork conducted at a facility. The comment also requested clarification regarding the definition of a “facility operator.” This comment asked if we would recognize a contractual delegation if a facility operator contractually makes another company, such as a vendor, responsible for compliance with these requirements.

We have noted this comment and have added a definition of “facility operator” to these regulations to help clarify their role. It is the responsibility of the facility owner or operator to ensure safety at their facility. The actions of any vendors or other contracted parties at a facility are subject to the control and oversight of the owner or operator while on the facility. Therefore, the owner or operator retains the ultimate responsibility for compliance with these regulations.

2. One comment requested that we change § 126.30(a) to allow welding or hotwork to be performed on a vessel when dangerous cargo is within the specified distances but stowed inside a container and the COTP is notified of the work before it begins.

We agree with this comment and have revised this paragraph.

1. You may notice some changes in the final rule that are not discussed in this section of the preamble. These are non-substantive changes intended simply to improve the clarity of our regulations.

1. Two comments addressed issues that are beyond the scope of this current rulemaking. They requested that we initiate a separate rulemaking to address concerns over the loading and unloading of Class 1 (Explosive) materials at waterfront facilities according to these regulations and Coast Guard policies.

The Director of the Federal Register has approved the material in § 126.5 for incorporation by reference under 5 U.S.C. 552 and 1 CFR part 51. Copies of the material are available from the sources listed in § 126.5.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). A summary of the Regulatory Evaluation follows:

This rule amends 33 CFR part 126 to better address the hazards and precautions necessary for packaged dangerous cargo, which have changed significantly with the advent of containerization. As amended, part 126 applies only to waterfront facilities handling packaged and bulk-solid dangerous cargo. This rule incorporates up-to-date industry standards.

According to the Marine Safety Management System, there are 485 waterfront facilities that handle, store, and transfer dangerous cargo to and from vessels. We estimate that the maximum implementation cost of the rule is $304 per affected facility. This cost includes 4 warning signs per facility at $50 per sign, 1 international shore connection at $100 per international shore connection, and $4 for posting warning signs per entity. Some facilities, however, may already meet the requirements, and will not incur additional cost. The present value of the total cost of this rule during 2002 through 2012 is $111,425. The cost calculation is based on the assumption that half of the facilities would already have warning signs and international shore connections. No documented marine casualties were found in our databases that could have been prevented by the regulations; however, the rule will contribute to a higher level of marine safety at waterfront facilities.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612) and Executive Order 13272, Proposed Consideration of Small Entities, we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

There are 485 waterfront facilities that will be affected by this rule. We estimate that some facilities will not incur additional cost, while others will incur minimal cost. The maximum cost per facility is approximately $300.

Because this cost is minimal, even for a small entity, the Coast Guard certifies, under 5 U.S.C. 605(b), that this final rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking. We provided opportunity for public comment in the notice of proposed rulemaking (NPRM) entitled “Handling of Class 1 (Explosive) Materials or Other Dangerous Cargoes within or Contiguous to Waterfront Facilities” published on October 29, 1998, in the Federal Register (63 FR 57964). On January 12, 1999, we published a notice in the Federal Register reopening the comment period for this rulemaking (64 FR 1770). Additionally, the NPRM provided small businesses, organizations, or governmental jurisdictions a Coast Guard contact to ask questions concerning this rule's provisions.

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

This rule calls for a new collection-of-information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection-of-information consists of posting warning signs at all designated waterfront facilities as required in § 126.15(a)(3). These signs must meet the requirements of the National Fire Protection Association (NFPA) 307.

No comments were received regarding the collection-of-information requirement.

This rule amends an existing Office of Management and Budget (OMB) approved collection, OMB control number 1625-0016 (formerly 2115-0054), that expires on November 30, 2004. As required by 44 U.S.C. 3507(d), we submitted a copy of this rule to OMB for its review of the collection-of-information. OMB has not yet completed its review of, or approved, the changes to this collection. Therefore, § 126.15(a)(3) in the final rule will not become effective until approved by OMB. We will publish a document in the Federal Register announcing OMB's approval and the effective date of that section.

You are not required to respond to a collection-of-information unless it displays a currently valid OMB control number.

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 Executive Order 13132 and have determined that it does not have implications for federalism under that Order.

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

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

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern 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, or 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. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph (34)(a), of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation. This rule concerns handling and storage procedures and will contribute to a higher level of marine safety at waterfront facilities. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES.

On February 28, 2003, we published a notice of proposed rulemaking (NPRM) entitled “Safety Zone for Outer Continental Shelf Facility in the Gulf of Mexico for Viasca Knoll 915” in the Federal Register (68 FR 9611). We received two comments on the proposed rule. No public hearing was requested, and none was held.

The Coast Guard is establishing a safety zone around Marlin Tension Leg Platform (Marlin TLP), Viasca Knoll 915 (VK 915), located at position 29°06′27.46″ N, 87°56′37.14″ W.

The safety zone established by this rule is in the deepwater area of the Gulf of Mexico. For the purposes of this rule the deepwater area is considered to include waters of 304.8 meters (1,000 feet) or greater in depth extending to the limits of the Exclusive Economic Zone (EEZ) contiguous to the territorial sea of the United States and up to a distance of 200 nautical miles from the baseline. Vessels navigating in the area of the safety zone consist of large commercial shipping vessels, fishing vessels, cruise ships, tugs with tows and the occasional recreational vessel. An extensive system of navigational fairways is within the deepwater area. The fairways include the Gulf of Mexico East-West Fairway, the entrance/exit route of the Mississippi River, and the Mobile Bay approaches. Significant amounts of vessel traffic occur in or near the various fairways in the deepwater area.

Chas R. Haven & Assoc., Inc., hereafter referred to as Haven Group requested that the Coast Guard establish a safety zone in the Gulf of Mexico around the tension leg platform, Marlin owned by B.P. Amoco.

The request for the safety zone was made due to the high level of shipping activity around the facility and the safety concerns for both the personnel on board the facility and the environment. The Haven Group indicated that the location, production level, and personnel levels on board the facility make it highly likely that any allision with the facility would result in a catastrophic event. The Marlin is a high production oil and gas drilling facility producing approximately 41,000 barrels of oil per day, 310 million cubic feet of gas per day and is manned with a crew of approximately 80 people.

The Coast Guard reviewed Group Haven's concerns and agreed that the risk of allision to the facility and the potential for loss of life and damage to the environment resulting from such an accident warrants the establishment of this safety zone. This rule significantly reduces the threat of allisions, oil spills and natural gas releases and increases the safety of life, property, and the environment in the Gulf of Mexico. This regulation is issued pursuant to 14 U.S.C. 85 and 43 U.S.C. 1333 as set out in the authority citation for 33 CFR part 147.

We received two comments on the proposed rule. One comment was received requesting that the owner of Marlin TLP, B.P. Amoco, be included in the rule.

The second comment expressed concerns over the Coast Guard establishing “security zones” around offshore platforms and the potential economic impact this type of zone may have on recreational and commercial fishing industries. Over the past several years the Coast Guard has established thirteen offshore safety zones in the Gulf of Mexico. Each zone, as well as this one, was requested in accordance with 33 CFR 147. The purpose of this offshore safety zone is clearly stated in the “Background and Purpose” section of this rule. The purpose of offshore safety zones is also described in 33 CFR 147.1, which clearly states that they are “to promote the safety of life and property on the facilities, their appurtenances and attending vessels, and on the adjacent waters within the safety zones.” The Coast Guard has not proposed an offshore security zone for the Marlin TLP or any other offshore facility.

Since the rule will allow vessels less than 100 feet not engaged in towing within the zone and any vessel may request permission from the Eighth Coast Guard District Commander to enter the zone, the Coast Guard has made no substantial changes to the provisions of the proposed rule.

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 (DHS).

The impacts on routine navigation are expected to be minimal because the safety zone does not encompass any nearby safety fairways.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. Few privately owned fishing vessels and recreational boats/yachts operate in the area of the Marlin TLP because it is located far offshore, and alternate routes are available for those that do. Use of alternate routes may cause a minimal loss of time (estimated loss of four to ten minutes) to their destination depending on how fast the vessel is traveling. The Coast Guard expects the impact of this rule on small entities to be minimal.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment ( see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1 paragraph (34)(g), of the instruction, from further environmental documentation because this rule is not expected to result in any significant environmental impact as described in NEPA. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available where indicated under ADDRESSES.

On February 27, 2003, we published a temporary final rule (TFR) for High Interest Vessels (HIVs) in San Francisco Bay and Delta ports entitled “Security Zones; San Francisco Bay, CA” in the Federal Register (68 FR 9003) under § 165.T11-077. It has been in effect since February 10, 2003. On May 30, 2003, we published a change in effective period in the Federal Register (68 FR 32368) that extended the effective period of the above temporary final rule (TFR) to September 30, 2003.

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. Additionally, 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 , for the following reasons. The threat of maritime attacks is real as evidenced by the October 2002 attack of a tank vessel off the coast of Yemen and the 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). Additionally, a Maritime Advisory was issued to: Operators of U.S. Flag and Effective U.S. controlled Vessels and other Maritime Interests , detailing the current threat of attack, MARAD 02-07 (October 10, 2002). As a result, a heightened level of security has been established around all HIVs in San Francisco Bay and Delta ports. Additionally, the measures contemplated by this rule are intended to prevent future terrorist attacks against individuals and facilities within or adjacent to HIVs. Any delay in the effective date of this TFR is impractical and contrary to the public interest.

The original temporary final rule was urgently required to prevent possible terrorist strikes against the United States and more specifically the people, waterways, and properties in and near the San Francisco and Delta ports. It was anticipated that we would assess the security environment at the end of the effective period to determine whether continuing security precautions were required and, if so, propose regulations responsive to existing conditions. We have determined that the need for continued security regulations exists. Therefore, delaying the effective date of this extension to the existing security zone would be contrary to the public interest since the safety and security of the people, ports, waterways, and properties of San Francisco Bay and Delta Ports areas would be jeopardized without the protection afforded by these security zones. The measures contemplated by this extension are intended to facilitate ongoing response efforts and prevent future terrorist attack. Any delay in implementing this rule would be contrary to the public interest since immediate action is necessary to ensure the protection of all HIVs, their crews, the public and national security.

We plan to publish a notice of proposed rulemaking (NPRM) for a permanent HIV security zone. In that NPRM, we will propose to amend 33 CFR 165.1183, which was added by a final rule [COTP San Francisco Bay 02-019] published in the Federal Register (67 FR 79854) on December 31, 2002. 33 CFR 165.1183, “Security Zones; Cruise Ships and Tank Vessels, San Francisco Bay and Delta ports, California”, establishes security zones around cruise ships and tank vessels, but does not address HIVs. The forthcoming NPRM will clarify the classes of vessels sought to be encompassed in the section and will allow for a public comment period and for a final rule to be put into effect without an interruption in the protection provided by the original temporary rule that established HIV security zones. Section 165.1183 will remain in effect until amended by a future rule.

The measures contemplated by this extension to the original temporary final rule are intended to facilitate ongoing response efforts and prevent future terrorist attack. The Coast Guard will utilize the extended effective period created by this TFR to engage in notice and comment rulemaking to develop permanent regulations tailored to the present and foreseeable security environment with the Captain of the Port (COTP) San Francisco Bay. Therefore, this revision preserves the status quo within the Ports while permanent regulations are developed.

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. In addition, the ongoing hostilities in Afghanistan and Iraq have made it prudent to U.S. ports 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.

In its effort to thwart terrorist activity, the Coast Guard has increased safety and security measures on U.S. ports and waterways. As part of the Diplomatic Security and Antiterrorism Act of 1986 (Pub. L. 99-399), Congress amended section 7 of the Ports and Waterways Safety Act (PWSA), 33 U.S.C. 1226, to allow the Coast Guard to take actions, including the establishment of security and safety zones, to prevent or respond to acts of terrorism against individuals, vessels, or public or commercial structures. The Coast Guard also has authority to establish security zones pursuant to the Act of June 15, 1917, as amended by the Magnuson Act of August 9, 1950 (50 U.S.C. 191 et seq. ) and implementing regulations promulgated by the President in subparts 6.01 and 6.04 of part 6 of title 33 of the Code of Federal Regulations.

In this particular rulemaking, to address the aforementioned security concerns, and to take steps to prevent the catastrophic impact that a terrorist attack against an HIV would have on the public interest, the Coast Guard is extending the effective period of security zones around and under HIVs entering, departing, moored or anchored within the San Francisco Bay and Delta ports. These security zones help the Coast Guard to prevent vessels or persons from engaging in terrorist actions against HIVs. Due to these heightened security concerns, and the catastrophic impact a terrorist attack on an HIV would have on the crew and passengers on board, and surrounding area and communities, security zones are prudent for these types of vessels.

As of today, the need for security zones around HIVs still exists. This temporary final rule will extend for 6 months the effective period of security zones that were set to expire September 30, 2003. The security zones will now expire on March 31, 2003. This will allow the Coast Guard time to publish a notice of proposed rulemaking in the Federal Register , which will include a public comment period, and for a final rule to be put into effect without there being an interruption in the protection provided by HIV security zones.

On December 31, 2002, we published the final rule [COTP San Francisco Bay 02-019] adding § 165.1183, “Security Zones; Cruise Ships and Tank Vessels, San Francisco Bay and Delta ports, California” in the Federal Register (67 FR 79854). That section set forth security zones for cruise ships and tank vessels. A forthcoming NPRM, under docket COTP San Francisco Bay 03-002 will propose to amend section 165.1183 to include HIVs as protected vessels in that section, along with cruise ships and tank vessels. The Coast Guard will utilize the extended effective period of the HIV security zones created by the TFR to engage in notice and comment rulemaking to develop permanent regulations tailored to the present and foreseeable security environment with the Captain of the Port (COTP) San Francisco Bay.

This TFR extends the effective period of the current security zones around all HIVs that are anchored, moored or underway within the San Francisco Bay and Delta ports. A security zone is automatically activated when any HIV passes shoreward of the line drawn between San Francisco Main Ship Channel buoys 7 and 8; LLNR 4190 & 4195, positions 37°46.9′ N, 122°35.4′ W and 37°46.5′ N, 122°35.2′ W, respectively, and remains in effect while the vessel is underway, anchored, or moored within the San Francisco Bay and Delta ports. When activated, this security zone will encompass all waters, extending from the surface to the sea floor, within 100 yards ahead, astern and extending 100 yards along either side of any HIV in the San Francisco Bay and Delta ports. This security zone is automatically deactivated when the HIV passes seaward of the line drawn between San Francisco Main Ship Channel buoys 7 and 8; LLNR 4190 & 4195, positions 37°46.9′ N, 122°35.4′ W and 37°46.5′ N, 122°35.2′ W, respectively, on its departure from port. Vessels and people may be allowed to enter an established security zone on a case-by-case basis with authorization from the Captain of the Port.

Vessels or persons violating this section will be subject to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192. Pursuant to 33 U.S.C. 1232, any violation of the security zone described herein, is punishable by civil penalties (not to exceed $27,500 per violation, where each day of a continuing violation is a separate violation), criminal penalties (imprisonment up to 6 years and a maximum fine of $250,000), and in rem liability against the offending vessel. Any person who violates this section, using a dangerous weapon, or who engages in conduct that causes bodily injury or fear of imminent bodily injury to any officer authorized to enforce this regulation, also faces imprisonment up to 12 years. Vessels or persons violating this section are also subject to the penalties set forth in 50 U.S.C. 192: seizure and forfeiture of the vessel to the United States, a maximum criminal fine of $10,000, and imprisonment up to 10 years, and a civil penalty of not more than $25,000 for each day of a continuing violation.

The Captain of the Port will enforce these zones and may enlist the aid and cooperation of any Federal, State, county, municipal, and private agency to assist in the enforcement of the regulation. This regulation is proposed under the authority of 33 U.S.C. 1226 in addition to the authority contained in 50 U.S.C. 191 and 33 U.S.C. 1231.

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 (DHS).

Although this regulation restricts access to the waters encompassed by the security zones, the effect of this regulation will not be significant because: (i) The zones will encompass only a small portion of the waterway; (ii) vessels will be able to pass safely around the zones; (iii) vessels may be allowed to enter these zones on a case-by-case basis with permission of the Captain of the Port, or his designated representative; and (iv) vessels are able to safely transit around the zones while a vessel is moored or at anchor in the San Francisco Bay and Delta ports.

The sizes of the zones are the minimum necessary to provide adequate protection for HIVs, their crews and passengers, other vessels operating in the vicinity of HIVs, their crews and passengers, adjoining areas, and the public. The entities most likely to be affected are commercial vessels transiting the main ship channel en route the San Francisco Bay and Delta ports and pleasure craft engaged in recreational activities and sightseeing. The security zones will prohibit any commercial vessels from meeting or overtaking an HIV in the main ship channels, effectively prohibiting use of the channels. However, the moving security zones will only be effective during HIV transits, which will last for approximately 30 minutes.

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. As discussed above, the security zones will affect the following entities some of which may be small entities: the owners and operators of vessels intending to transit or anchor in a portion of the waterways encompassed by the zones. The security zones will not have a significant economic impact on a substantial number of small entities for several reasons: small vessel traffic can pass safely around the area and vessels engaged in recreational activities, sightseeing and commercial fishing have ample space outside of the security zones to engage in these activities. When a HIV is at anchor, vessel traffic will have ample room to maneuver around the security zones. In addition, vessels may receive authorization to transit through these security zones on a case-by-case basis. Small entities and the maritime public will be advised of these security zones via public notice to mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding this rule.

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation because we are establishing a security zone.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

The NPS is granted broad statutory authority under various acts of Congress to manage and regulate water activities in areas of the National Park System. 16 U.S.C. 1, 1a-2(h) and 3. The NPS's Organic Act of 1916 (Organic Act) (16 U.S.C. 1 et seq. ) authorizes the NPS to “regulate the use of Federal areas known as national parks, monuments, and reservations * * * by such means and measures as conform to the fundamental purpose of the said parks * * * which purpose is to conserve the scenery and the natural and historic objects and the wildlife therein and to provide for the enjoyment of the same in such manner and by such means as will leave them unimpaired for the enjoyment of future generations.” Congress has also emphasized that the “authorization of activities shall be construed and the protection, management, and administration of these areas shall be conducted in light of the high public value and integrity of the national park system and shall not be exercised in derogation of the values and purposes for which these various areas have been established, except as may have been or shall be directly and specifically provided by Congress.” 16 U.S.C. 1a-1. The appropriateness of a visitor use or recreational activity will vary from park to park. NPS Management Policies states that “the laws do give the Service the management discretion to allow impacts to park resources and values when necessary and appropriate to fulfill the purposes of a park, so long as the impact does not constitute impairment of the affected resources and values.” (1.4.3). NPS Management Policies provide further that, “preserving park resources and values unimpaired is the core, or primary responsibility of NPS managers * * *. In cases of doubt as to impacts of activities on park natural resources, the Service will decide in favor of protecting the natural resources.” (4: 1).

The Organic Act and the other statutory authorities of the NPS vest the NPS with substantial discretion in determining how best to manage park resources and provide for park visitors. “Courts have noted that the Organic Act is silent as to the specifics of park management and that under such circumstances, the NPS has broad discretion in determining which avenues best achieve the Organic Act's mandate * * *. Further, the NPS is empowered with the authority to determine what uses of park resources are proper and what proportion of the park resources are available for each use” Bicycle Trail Council of Marin v. Babbitt, 82 F.3d 1445, 1454 (9th Cir. 1996), quoting National Wildlife Federation v. National Park Service, 669 F. Supp. 384, 390 (D. Wyo. 1987). In reviewing a challenge to NPS regulations at Everglades National Park, the court stated, “The task of weighing the competing uses of Federal property have been delegated by Congress to the Secretary of the Interior * * *. Consequently, the Secretary has broad discretion in determining how best to protect public land resources.” Organized Fisherman of Florida v. Hodel, 775 F.2d 1544, 1550 (11th Cir. 1985), cert. denied, 476 U.S. 1169 (1986).

Over the years, NPS areas have been impacted with new, and what often prove to be controversial, recreational activities. These activities tend to gain a foothold in NPS areas in their infancy, before a full evaluation of the possible impacts and ramifications that expanded use will have on the area can be initiated, completed, and considered. PWC use fits this category.

PWC use emerged and gained popularity in park units before the National Park Service could initiate and complete a full evaluation of the possible impacts and ramifications. Although PWC use remains a relatively new recreational activity, it has occurred in 32 of 87 park units that allow motorized boating.

The National Park Service first began to study PWC in Everglades National Park. The studies showed that PWC use over emergent vegetation, shallow grass flats, and mud flats commonly used by feeding shore birds damaged the vegetation, adversely impacted the shore birds, and disturbed the life cycles of other wildlife. Consequently, managers at Everglades National Park determined that PWC use was inconsistent with the resources, values, and purposes for which the park was established. In 1994, the National Park Service prohibited PWC at Everglades National Park by a special regulation 36 CFR 7.45(e)(8) (59 FR 58781, Nov. 15, 1994).

Other public entities have taken steps to limit, and even to ban, PWC use in certain waterways as national researchers study more about the effects of PWC use. At least 34 states have either implemented regulations or considered regulating the use and operation of PWC (63 FR 49314, Sept. 15, 1998). Several Federal agencies, including the U.S. Fish and Wildlife Service and the National Oceanic and Atmospheric Administration, have managed PWC differently than other classes of motorized watercraft.

When the National Oceanic and Atmospheric Administration regulated the use of PWC in most national marine sanctuaries, it was sued by the PWC Industry Association (PWIA). As a result, the Court of Appeals for the District of Columbia declared such PWC-specific management to be valid. In PWC Industry Association v. Department of Commerce, 48 F.3d 540 (D.C. Cir. 1995), the court ruled that an agency can discriminate and manage one type of vessel (specifically, PWC) differently than other vessels if the agency explains its reasons for the differentiation.

In February 1997, the Tahoe Regional Planning Agency, the governing body charged with ensuring no derogation of Lake Tahoe's water quality, voted unanimously to ban all vessels using two-stroke, internal combustion engines, including PWC, because of their adverse effects on water quality. Lake Tahoe's ban began in 2000.

Historically, the National Park Service grouped PWC with all other vessels. Thus, people could use PWC within a park service unit when the unit allowed the use of other vessels. However, by 1998 the National Park Service had closed seven units to PWC and other motorized vessels use through the implementation of horsepower restrictions and park-specific regulations such as those promulgated by Everglades National Park. At that time, the National Park Service was reevaluating its management of PWC use, based on its responsibilities under the Organic Act and increased concerns for public safety.

In May 1998, the Bluewater Network, a private, independent, non-profit organization, filed a petition urging the National Park Service to initiate a rulemaking process to prohibit PWC use throughout the national park system. In response to the petition the National Park Service proposed a specific PWC regulation premised on the notion that PWC differ from conventional watercraft in terms of design, use, safety record, controversy, visitor impacts, resource impacts, horsepower-to-vessel ratio, and thrust capacity (63 FR 49312, Sept. 15, 1998).

The National Park Service envisioned the servicewide regulation as an opportunity to evaluate impacts of PWC use before authorizing their use. The preamble to the servicewide regulation calls the regulation a “conservative approach to managing PWC use” that considered resource concerns, visitor conflicts, visitor enjoyment, and visitor safety. During a 60-day public comment period, the National Park Service received nearly 20,000 comments on the proposed regulation. As a result of public comments and further review, the National Park Service issued a final rule (36 CFR 3.24(a), 64 FR 15077, March 21, 2000) that prohibited PWC use in park units, unless authorized by a special regulation.

In the 2001 Management Policies, the NPS adopted its new servicewide policy for PWC. As stated in section 8.2.3.3, “PWC use is prohibited unless it has been identified as appropriate for a specific park.” PWC use can only be authorized based on “an evaluation of the park's enabling legislation, resources and values, other visitor uses, and overall management objectives [that] confirms that PWC use is appropriate and consistent” with other NPS management goals and objectives.

Motorboats and other watercraft such as houseboats, ski boats, fishing boats, and powerboats have been used in Glen Canyon National Recreation Area since its establishment in 1972. PWC use has emerged at the recreation area with the introduction of this type of vessel in the 1980s. Prior to 2000, PWC use was allowed throughout Glen Canyon National Recreation Area except in the waters designated closed in the Superintendent's Compendium, which included portions of the Colorado, Dirty Devil, Escalante, and San Juan rivers. These closures were for the protection of environmental values and the avoidance of conflict between users.

Glen Canyon National Recreation Area is located within the states of Arizona and Utah. Both states enforce their laws on Lake Powell within their respective state jurisdictions. The National Park Service adopts (36 CFR 3.1) and enforces these state regulations together with the NPS boating regulations in part 3 of Title 36 of the Code of Federal Regulations. The United States Coast Guard Regulations are also adopted in 36 CFR part 3.

On January 17, 2003, the National Park Service published a notice of proposed rulemaking for the operation of PWC at Glen Canyon National Recreation Area (68 FR 2466). The proposed rule for PWC use was based on alternative B (the preferred alternative) in the Glen Canyon National Recreation Area Draft Environment Impact Statement (DEIS). The DEIS was made available for public review on September 13, 2002 (67 FR 58071). The DEIS analyzed three alternatives for addressing PWC use at Glen Canyon National Recreation Area. Two of the alternatives would permit PWC use with certain restrictions through the development of special regulations. Alternative A would reestablish the limits on PWC use that existed prior to 2002 under the Superintendent's Compendium. Alternative B would impose additional restrictions on PWC use beyond what was proposed by alternative A. Alternative C would leave intact the existing 36 CFR 3.24 prohibition on PWC use within the recreation area. The 60-day public comment period for the proposed rule ended March 18, 2003.

A Final Environmental Impact Statement (FEIS) was made available to the public on May 16, 2003 (68 FR 26645). Some changes were made in the FEIS in response to the over 30,000 public and agency comments received on the DEIS. These changes are discussed below under “Changes to the Final Rule.” The FEIS includes a discussion of comments section that addresses all of the issues raised by commenters to the DEIS. A Record of Decision on the FEIS was signed by the National Park Service on June 27, 2003.

While Glen Canyon National Recreational Area was officially closed to PWC use on November 6, 2002, the closure was temporarily lifted for the summer season of May 10, 2003, through September 30, 2003 after an agreement between the Bluewater Network and the Superintendent of Glen Canyon National Recreational Area. The lifting of the closure will allow the use of PWC on the majority of Lake Powell. The agreement, however, retained the restrictions in the 2002 Superintendent's Compendium and added closures from the mouth of San Juan River to the NRA boundary and north or beyond mile marker 108 of the Colorado River as measured from the Glen Canyon Dam to the NRA boundary.

Some changes have been made in the FEIS and to the final rule. The alternatives presented in the DEIS were modified in the FEIS in response to comments received on the DEIS. The primary modifications to alternatives A and B in the FEIS include conducting a 3-year pilot study to identify and develop conflict resolution techniques and preparing a comprehensive lake management plan to address all uses of Lake Powell. Additionally, alternative B and the final rule were modified to include compliance with 2006 emission standards (described below) and to add an additional geographic restriction.

1. Alternative B includes strategies to better protect recreation area resources, improve visitor safety, and reduce conflicts. These strategies include conducting a 3-year pilot study to identify the techniques and area restrictions that would be most effective in reducing conflicts and preparing a comprehensive lake management plan addressing all uses. See the discussion below in the comments summary ( e.g. , comment numbers 20 and 60) and in appendix C of the Draft and Final Environmental Impact Statement.

2. Alternative B, as reflected in this final rule, requires that PWC in the recreation area meet the 2006 U.S. Environmental Protection Agency emissions standards by the end of 2012 and in subsequent years. PWC not meeting the standards would no longer be permitted to operate within Glen Canyon National Recreation Area beginning in 2013. See the discussion below under number 17 in the comments discussion.

3. In the DEIS and NPRM a PWC would have been allowed to operate at flat wake speed on the Dirty Devil River upstream of the Utah Highway 95 bridge to a point where measurable downstream current is encountered. In the FEIS and final rule, PWC use on the Dirty Devil River upstream of the Utah Highway 95 bridge is prohibited. In addition the reference to Coyote Gulch in the proposed rule has been changed in the final rule to reference Coyote Creek. Coyote Creek is the correct geographic name for the area discussed and this non-substantive change was made for clarification.

In the Economic Analysis, NPS estimates that the total impact of the proposed alternatives for regulating PWC use in Glen Canyon on Page, Arizona, output is $23.8 to $39.9 million for Alternatives A and B and $0 for Alternative C (because this alternative maintains baseline conditions) in the first year after the rule implementation. The increases in output under Alternatives A and B are substantial compared to the size of the regional economy, ranging from about 11 to 18 percent of regional personal income. Area businesses would be likely to experience large positive impacts under this final rule.

A proposed rule was published for public comment on January 17, 2003 (68 FR 2,466-76), with the comment period lasting until March 17, 2003. The National Park Service received 2,170 timely written responses regarding the proposed regulation. Of the responses, 1,973 were form letters in 5 separate formats and 197 were individual letters. Of the 197 individual letters received 180 were from individuals, 5 from businesses, 8 from organizations and 4 from public agencies. Within the analysis, the term “commenter” refers to an individual, business, or organization that responded. The term “comments” refers to statements made by a commenter.

1. Some commenters, including the PWC Industry Association (PWIA), advocate that any regulation or restriction on PWC by the National Park Service should be uniformly applied to all motorized recreational vessels. Allowing other motorized vessels to operate in some of the proposed restricted areas would undermine the purported goals of reducing user conflicts and allowing for solitude and quiet. Closing these river areas to PWC, and not other motorized vessels, would be discriminatory.

NPS Response: With this final rule the National Park Service is adopting special regulations to manage PWC use at Glen Canyon. The alternatives listed in the Final Environmental Impact Statement were based upon the best information available. As noted by the commenter, the management actions under modified preferred alternative B for the San Juan, Escalante, Colorado, and Dirty Devil Rivers will be implemented to reduce visitor conflicts with river rafters, fishermen, and backcountry hikers; promote opportunities for quiet and solitude; and ensure visitor safety. Following completion of the Final Environmental Impact Statement, it remains within National Park Service authority to prescribe similar use restrictions on all watercraft, if appropriate.

Glen Canyon expects to proceed with a Lake Management Plan in the near future, which will further examine vessel management as a whole on the waters of Lake Powell and its tributaries.

2. A number of commenters, including PWIA, proposed that the flat-wake zone should apply to all motorized vessels. Restricting only PWC to flat-wake speeds presents a safety hazard if other vessels are permitted to operate at significantly faster speeds.

NPS Response: Under a combination of NPS regulations and State laws and regulations all vessels are required to operate at flat wake speed in certain areas. In the case of the Escalante River, the NPS is requiring in this special regulation all PWCs to operate at flat wake speed because of the narrow waterways, blind corners and high use of the area, which would otherwise be a safety concern. The NPS has already adopted this requirement for all vessels in the Superintendent's Compendium for the same reasons.

3. Many commenters questioned why the focus of the analysis was on PWC alone when other motorized watercraft have similar or greater impacts on park resources.

NPS Response: The focus was on PWC because of the new management approach taken by the NPS. As a result, PWC use would be prohibited unless Glen Canyon NRA adopted a special regulation. The EIS and rulemaking were not designed to determine if PWC caused more environmental damage to park resources than other boats, but rather to determine if PWC use was consistent with Glen Canyon National Recreation Area's enabling legislation and management goals and objectives. As stated in the “Purpose of and Need for Action” chapter in the Draft and Final Environmental Impact Statements, the overall objective for the EIS and rulemaking is to evaluate a range of alternatives and strategies to manage PWC use, with the goal of ensuring protection of recreation and resource value. The impacts of other motorized watercraft could be considered in a future Lake Management Plan.

4. One commenter stated that the analysis should include examples of best management practices to avoid or reduce pollution to the recreation area. They encourage the National Park Service to “use all available practices to meet the intent of guidance issued by the Council on Environmental Quality (CEQ) integrating pollution prevention opportunities in National Environmental Policy Act (NEPA) planning, documents and decisions (Pollution Prevention and the National Environmental Policy Act, CEQ, January 1993).” Pertinent provisions of executive orders should be addressed in the Final Environmental Impact Statement and the future Lake Management Plan referenced in this rulemaking.

NPS Response: Each impact topic contains a summary of the applicable laws and regulations that were applied in the analysis of the effects of PWC on Glen Canyon National Recreation Area resources and values.

The NPS and the marina operators have developed a Spill Prevention, Control, and Countermeasure Plan (SPCC) that provides recommendations and requirements to prevent environmental damage resulting from the spills of oil and fuel. These plans are required by the Environmental Protection Agency (EPA) as stated in 40 CFR part 112. All marina operators and National Park Service must comply with these requirements and Best Management Practices contained within the Spill Prevention Plan. The CEQ requires NPS units to comply with the recommendations and requirements established by the NPS Hazardous Waste Management and Pollution Prevention Team and the EPA. An SPCC is required by EPA to protect the environment from oil spills. Glen Canyon NRA requires the current concessionaire (ARAMARK) to have a SPCC plan for each marina fueling operations. The SPCC plans comply with CEQ guidance the commenter mentions by following the EPA standards for spill protection and prevention. In addition, placards are displayed at marinas and educational materials are made available to recreation area visitors to inform boat operators about proper fueling of vessels and containers.

The National Park Service manages the water of Lake Powell in accordance with the water quality standards of Arizona and Utah. Water quality in Lake Powell is regulated by the Arizona and Utah Departments of Environmental Quality under water quality standards and regulations that are promulgated in the Arizona Administrative Code (R18-11-107) and Utah Administrative Code (R317-2), respectively. Consistent with Federal regulations, Arizona and Utah have established numerical and narrative standards that protect existing and designated uses of state waters and implement the antidegradation requirements. Compliance with the numerical standards for water quality is determined at control points that are specified in the regulations.

In the case of the Draft and Final Environmental Impact Statements, three alternatives for PWC management were analyzed. The alternatives also consider means to mitigate the effects of PWC on park resources and values, including limiting use in areas where management objectives strive to create a visitor experience without intrusion of these vessels or where important park resources must be protected. Alternative B (modified preferred alternative) in the Final Environmental Impact Statement includes mitigation measures to protect other park users from potential conflicts with PWC (refer to the modified preferred alternative section in the “Environmental Consequences” chapter), as well as other measures to protect species of special concern and water and air resources. Requiring that PWC used in the recreation area after 2012 be compliant with the EPA 2006 emission standards for gasoline marine engines under alternative B (modified preferred alternative) will further mitigate impacts of these vessels on recreation area resources. The National Park Service finds that the modified preferred alternative will not result in an impairment of park resources and values for which the Glen Canyon National Recreation Area was established.

5. Several commenters stated that limiting access to PWC users is against the intent which Glen Canyon National Recreation Area was created.

NPS Response: The authorizing legislation for Glen Canyon National Recreation Area was considered when developing alternatives to be analyzed in the Draft and Final Environmental Impact Statements. The “Introduction” section in the “Purpose of and Need for Action” chapter in the Draft and Final Environmental Impact Statements states that the overall objective for the regulation and EIS is to evaluate a range of alternatives and strategies to manage PWC use, to protect recreation and resource values. This objective was derived from the enabling legislation for Glen Canyon National Recreation Area. As further stated in this section, a thorough analysis for the management of PWC was also provided under each alternative following the guidance of the National Park Service Management Policies (2001).

Both the servicewide regulation and the National Park Service Management Policies acknowledge that park units proposing to continue PWC use must complete an analysis of impacts from PWC use. This analysis includes a thorough review of the enabling legislation of the unit and its management objectives, and the resources and values potentially affected by continued PWC use.

In the case of the Draft and Final Environmental Impact Statements, three alternatives were analyzed under various PWC scenarios. The alternatives consider various ways of mitigating the effects of PWC on park resources and values, including limiting use in areas where management objectives strive to create a visitor experience without intrusion of these vessels or where important park resources must be protected. Alternative B (modified preferred alternative) in the Final Environmental Impact Statement includes mitigation measures to protect other park users from potential conflicts with PWC (refer to the discussion for alternative B in the “Environmental Consequences” chapter), as well as other measures to protect species of special concern and water and air resources.

As a result, the alternatives presented in the Draft and Final Environmental Impact Statements protect resources and values while providing for a number of different recreational opportunities for park visitors to enjoy at Glen Canyon National Recreation Area. The NPS concluded that limiting PWC access in certain areas is necessary and appropriate for achieving management objectives in those areas of Glen Canyon NRA.

6. Several comments were received citing the Organic Act and the mission of the National Park Service to leave the resources and wildlife “unimpaired for future generations.” A number of letters were received stating Federal law clearly prohibits activities that impair or derogate the recreation area resources.

NPS Response: We agree. The “Summary of Laws and Policies” section in the “Environmental Consequences” chapter summarizes the three overarching laws that guide the National Park Service in making decisions concerning protection of park resources. These laws, as well as others, are also reflected in the NPS Management Policies. An explanation of how the Park Service applied these laws and policies to analyze the effects of PWC on Lake Powell resources and values can be found under “Impairment Analysis” in the “Methodology” section of the “Environmental Consequences” chapter. For each resource topic, the Final Environmental Impact Statement established thresholds or indicators of magnitude of impact. An impact approaching a “major” level of intensity is one indication that impairment could result. For each impact topic, when the intensity approached “major,” the interdisciplinary planning team would consider mitigation measures to reduce the potential for “major” impacts, thus reducing the potential for impairment.

The National Park Service finds that alternative B (modified preferred alternative) presented in the Final Environmental Impact Statement will not result in an impairment of park resources and values for which the Glen Canyon National Recreation Area was established.

7. Several commenters questioned how a proposed rule supporting a preferred alternative can be issued before a Final Environmental Impact Statement and a Record of Decision have been issued.

NPS Response: In January of 2003, the National Park Service published a proposed rule that proposed the preferred alternative in the Draft Environmental Impact Statement. The National Park Service approach was to allow the public an opportunity to view the preferred alternative in a regulatory form and comment on that proposed rule similar to the comment period for the Draft Environmental Impact Statement. Upon review and consideration of those comments, and in conjunction with the comments received on the Draft Environmental Impact Statement, the National Park Service has modified the final rule and the Final Environmental Impact Statement. Publishing the proposed rule after the DEIS allowed the National Park Service to maintain flexibility in the regulatory options in contrast to if it had waited until after the Record of Decision was issued, since that would have been a final decision document.

8. One commenter stated that until the NEPA process is complete, the rulemaking does not perform the minimal duty of informing the agency or the public about the environmental effects of the proposed rule.

NPS Response: Federal rulemaking requires that the National Environmental Policy Act be addressed, along with various other laws and Executive Orders, in the proposed and final rules. Again, the National Park Service approach was to allow the public to comment on the preferred alternative identified in the Draft Environmental Impact Statement in a regulatory form. This is the purpose of issuing proposed rules; to give the public a preliminary review of a proposed action with opportunity to comment on that proposal, provide additional or new information, and point out elements which the commenter feels are accurate or inaccurate. To that end, the agency considers those comments and modifies the final rule as necessary or even re-proposes a new rule if significant changes need to be made. The National Park Service cannot issue a final rule until a Record of Decision is issued under the NEPA portion of the Compliance section of the rule. The final rule is the National Park Service's final conclusion and must be consistent with the Record of Decision.

9. One commenter stated that there is a problem with publishing a final rule prior to completing the NEPA process and that this would tend to nullify the intent of NEPA by revealing that the National Park Service has already reached a conclusion prior to actually performing the required analysis.

NPS Response: We agree, but the commenter may misunderstand what was published in the Federal Register . The National Park Service has only published and taken comment on a proposed rule. This document is the final rule and it is being published now that the NEPA process is complete and a Record of Decision has been issued.

10. One commenter stated that the statement “The National Park Service has analyzed this rule in accordance with the criteria of the National Environmental Policy Act * * *” is clearly not true since the environmental analysis has not been completed. There has only been a Draft Environmental Impact Statement with no response to the concerns raised by the public.

NPS Response: NEPA and CEQ guidelines require that agencies publish a Draft Environmental Impact Statement as indicated by the commenter. Because the issuance of a Draft Environmental Impact Statement is consistent with these guidelines, and neither NEPA nor CEQ address the timing related to issuance of a proposed rule, the National Park Service is in accordance with NEPA.

11. One commenter is concerned that earlier public comments on the Draft Environmental Impact Statement were not taken into consideration in the rulemaking process and cites that the current discussion in the final rulemaking does not address any of the public concerns.

NPS Response: Again, the commenter seems to be under the impression that the National Park Service had previously issued a final rule on PWC management at Lake Powell. The National Park Service has issued a proposed rule which solicits comments on the proposed action (implementation of the preferred alternative identified in the Draft Environmental Impact Statement). The National Park Service did not take any comments received on the Draft Environmental Impact Statement into consideration when writing the proposed rule. Comments on the Draft Environmental Impact Statement and the proposed rule were incorporated in the Final Environmental Impact Statement, which was released on May 12, 2003, and were considered and are discussed in this final rule.

12. One commenter questioned the process by which the public is informed of the availability of the proposed rule stating that they had not received notice of the publication of the rule and that it was not available in the press. The commenter further states that organizations or individuals who participate in the NEPA process should be kept informed of the progression of the process through the Draft Environmental Impact Statement, Environmental Impact Statement, Decision Notice, opportunities for appeal, and the opportunity to pursue a legal remedy.

NPS Response: On January 17, 2003, Glen Canyon issued a press release informing the public of the publication of the proposed rule in the Federal Register (68 FR 2466). In addition, the Federal Register is available to all members of the public online at any time and in libraries throughout the country. The National Park Service does not routinely notify individuals personally about stages in the rulemaking process. The National Park Service has many parties interested in the issue of PWC and relies on local and national media and the National Recreation Area's website to provide notification of various milestones included in planning, environmental compliance, and rulemaking to interested parties.

13. One commenter requested that the National Park Service include all of Bluewater Network's previous letters and correspondences sent to Glen Canyon concerning PWC activity in the administrative record for the rule.

NPS Response: The “Methodology and Purpose” section at the beginning of volume 2 of the Final Environmental Impact Statement provides a detailed explanation of how public comments were received, reviewed, and ultimately responded to in the document. The criteria for determination of substantive comments is found in CEQ regulations (40 CFR 1503.4) and amplified in Director's Order 12: Conservation Planning, Environmental Impact Analysis, and Decision Making (section 4.6 (B)). Public comments, as well as other factors, were used by Glen Canyon National Recreation Area to modify the “preferred alternative” (alternative B) that was analyzed in the Draft Environmental Impact Statement. A description of the modified preferred alternative B is found in the “Alternatives” chapter of the Final Environmental Impact Statement and in this document.

The National Park Service acknowledges the 30,000 citizen comments submitted on the National Park Service PWC rulemaking. The administrative record for this rulemaking includes all comments and most documents received from the public, including those comments submitted by the Bluewater Network.

14. A number of commenters disagreed with the restrictions on the Escalante River presented in the analysis.

NPS Response: Under current PWC management as described in the Superintendent's Compendium 2002, PWC travel upstream in the San Juan, Escalante, Colorado, and Dirty Devil Rivers is restricted. The management actions under the modified preferred alternative B, for the San Juan, Escalante, Colorado, and Dirty Devil Rivers, will additionally restrict travel downstream on the same stretches of river. Access will also be restricted in both directions on 10 additional miles of the Dirty Devil River and 23 miles on the Colorado River. We understand the disagreement with the restrictions, but based on the best available information developed in the EIS process, the NPS has determined these restrictions are necessary on the rivers to reduce visitor conflicts with river rafters, fishermen, and backcountry hikers; promote visitor enjoyment; and ensure visitor safety.

15. Many commenters stated that the selection of alternative B provides no significant benefit, except to areas at the extreme ends of the tributaries where there is no significant visitation (and now no access). Additional alternatives are available that allow PWC's access to enjoy Lake Powell without destroying the experience of other users.

NPS Response: The NPS Director's Order 12: Conservation Planning, Environment Impact Analysis and Decision-Making (NPS 2001b) states that a full range of alternatives must be examined, and that “the alternatives carried forward for analysis must meet project objectives to a large degree, although not necessarily completely.” The National Park Service believes the Draft and Final Environmental Impact Statements contain a reasonable range of alternatives under this definition.

In addition, the modified preferred alternative B provides for a three-year pilot study to further evaluate PWC use areas. Potential restrictions of PWC use in other locations of the recreation area will be evaluated during the pilot study. The purpose of the pilot study and a description of how it will be implemented are provided in appendix C of the Final Environmental Impact Statement.

16. Several commenters suggested that the alternative selected should incorporate increased education, strict enforcement, and testing and licensing of PWC operators and that they would support increased fees for these improvements or institution of a permit system.

NPS Response: The states of Arizona and Utah establish the current operational age of PWC users. The licensing of boat or PWC operators rests with the State governments and is not an appropriate administrative activity for the Federal government. Currently, the State of Utah provides an extensive and nationally recognized mandatory education program for PWC users between the ages of 12 and 17. The National Park Service will continue to support this existing program. In addition, the modified preferred alternative B will provide enhanced educational materials and programs highlighting PWC issues to distribute to the public familiar with the State of Utah education program and for those from out of state and will seek funding to increase visitor protection staff.

17. Several commenters suggested that the alternative selected should ban the use of conventional two-stroke technology and only allow clean technology engines that would meet 2006 EPA standards.

NPS Response: The NPS considered an immediate ban of conventional two-stroke technology but, based upon the findings of the EIS process, determined it was not necessary to protect the resource and would impose an unreasonable economic burden on PWC users. Instead, the modified preferred alternative B of the Final Environmental Impact Statement requires that PWC used at Glen Canyon NRA must meet the EPA 2006 emission standards by the end of 2012. PWC not meeting the standards would no longer be allowed to operate in Glen Canyon National Recreation Area beginning in 2013.

The National Park Service expects that by 2012, most PWC owners would already be in compliance with the 2006 EPA marine engine standards. The economic impact on visitors as a result of the 2012 engine type restrictions is expected to be small. PWC manufacturers currently offer models that are compliant with the EPA 2006 standards, and new PWC purchased after 2006 will all meet the EPA emission standards. The average operating life of a PWC is 5 to 10 years, depending upon the source (see the “General Methodology” section in the “Environmental Consequences” chapter of the Final Environmental Impact Statement). As a result, it is expected that the majority of noncompliant PWC would no longer be in operation when the engine restrictions proposed under the modified preferred alternative B take effect at the end of 2012.

18. Several commenters suggested restricting speed in narrow canyons or making major canyons flat-wake zones to reduce visitor conflicts and to improve visitor safety.

NPS Response: NPS considered these measures, but concluded they were not necessary because of existing restriction under state law. Under Utah State law, all boaters must operate at flat-wake speeds or idle speed within 150 feet of another boat, a person in or floating on the water, a waterskier (except those being towed), a shore fisherman, a launching ramp, a dock, or a designated swimming area. Arizona State law requires all boaters to operate at flat-wake speeds within 60 feet of another vessel. The modified preferred alternative B addresses signing, buoys, and boater education that will enhance other watercraft operators' observance of safe boating practices.

In addition, the modified preferred alternative B currently provides for a three-year pilot study to further evaluate PWC-use areas. Potential restrictions of PWC use in other locations of the recreation area will be evaluated during the pilot study. The purpose of the pilot study and a description of how it will be implemented are provided in appendix C of the Final Environmental Impact Statement.

19. Many commenters suggested additional alternatives to restrict PWC to specific areas such as: Wahweap Bay, Warm Creek Bay, the areas near Hall's Crossing and Bullfrog Bay, and the Colorado River from Warm Creek to the Dam. At a minimum, restrict their usage to the less remote areas of the lake, e.g. , the main channel and certain large bays.

NPS Response: The alternatives in the Draft and Final Environmental Impact Statements were developed based upon the best information available. The area restrictions under the modified preferred alternative B on PWC use were identified because of the levels of non-motorized and passive uses that pose present or potential conflicts. Alternative B currently provides for a three-year pilot study to further evaluate PWC use areas. Potential restrictions of PWC use in other locations of the recreation area will be evaluated during the pilot study. The pilot study will provide the recreation area managers with additional information to evaluate reasonable measures to manage all lake uses and activity until a lake management plan is developed for Glen Canyon NRA. The purpose of the pilot study and a description of how it will be implemented are provided in appendix C of the Draft and Final Environmental Impact Statements.

20. One commenter was opposed to implementing a pilot study because it would result in PWC users avoiding areas zoned as flat-wake and would concentrate their use in other areas of the lake thereby reducing the ability of the study to adequately assess conflict between PWC and other users.

NPS Response: The National Park Service must manage Glen Canyon National Recreation Area to protect the recreational opportunities available at the park, as well as the natural resources found in the lake and surrounding lands. To accomplish this, a lake management plan will be developed which will provide the tools necessary to analyze activities that take place on the lake and determine if unacceptable impacts are occurring. Even though there is rationale and need to consider management of PWC under a separate decision-making framework, there remains the need to examine all uses of the lake collectively. As identified in the cumulative effects analysis under each impact topic, there are many management issues involving the mix of lake uses that will require additional planning in a lake management plan.

Modified alternative B provides for a three-year pilot study to further evaluate PWC-use areas. Potential restrictions of PWC use in other locations of the recreation area will be evaluated during the pilot study. The pilot study will provide recreation area managers the best available data to manage all lake uses and activity until a lake management plan is developed. There are no guarantees or predictable outcome for what open areas PWC users will or will not utilize during the initial implementation of this regulation. The data collected will be analyzed based on the best information available to National Park Service managers at that time. The purpose of the pilot study and a description of how it will be implemented are provided in appendix C of the Draft and Final Environmental Impact Statement.

21. One commenter stated that children under the age of 16 that operate PWC is a safety issue that should be addressed.

NPS Response: The National Park Service does not currently have regulations which set a minimum vessel operator age. The States of Arizona and Utah do have current operational age requirements for PWC users and those requirements are enforced by Park Rangers at Glen Canyon as NPS requirements pursuant to 36 CFR 3.1. Arizona regulations require children younger than 12 years of age to be accompanied by an adult when operating a PWC. Children older than 12 years can operate a PWC alone. Utah laws and regulations state that children between 12 and 15 can operate PWC after completing a mandatory boating education course if they remain within visual parental supervision. Children ages 16 to 17 must complete a mandatory boating education course to operate a PWC without supervision. The NPS thinks the current age requirements are acceptable and do not pose a safety issue on Lake Powell.

22. A number of commenters stated that the problem with PWC is that there are sufficient laws in place to protect visitors, however these laws are not being enforced and that there needs to be more enforcement of these laws.

NPS Response: We disagree that the existing laws are not being enforced. NPS agrees that there is a need for more enforcement and an element of the modified preferred alternative B is to seek increased funding to provide additional law enforcement at Glen Canyon National Recreation Area to enforce the existing regulations. An increased number of law enforcement officers on the lake would have the added advantage of increasing the number of visitor contacts on the lake to prevent unsafe behavior. In addition, an active information and education program, also an element of the modified preferred alternative B, will help to reduce the need for enforcement actions. However, the NPS is working with law enforcement officers from Arizona and Utah to provide a proper level of enforcement of the existing laws.

23. One commenter asked how the Federal noise standard which states “Operating a vessel in or upon inland waters so as to exceed a noise level of 82 decibels measured at a distance of 82 feet (25 meters) from the vessel is prohibited,” would be enforced in the areas such as confined canyons and rivers where there is no point 25 meters from the shore.

NPS Response: Federal and State law enforcement staff within Glen Canyon NRA enforce the Federal sound standard in areas where a distance of 82 feet (25 meters) occurs such as marina launch areas and large open bays. In confined canyons and river areas where 82 feet is not obtainable, a stationary sound level test can determine if a motorboat engine is exceeding acceptable sound levels. Federal and State protection staff have the ability to enforce excessive or unusual noise within confined areas utilizing the SAE J2005 and SAE J1970 as stated within the State of Utah Boating Laws and Rules.

24. Based on the analysis of water quality in the Draft Environmental Impact Statement which stated that some hydrocarbons can adsorb onto suspended soil particles and settle out, one commenter requested that any monitoring plan should therefore include sediment chemistry monitoring in marinas and sediment deposition areas down current for the constituents most likely to settle, including poly-aromatic hydrocarbons (PAH). Additionally, to understand whether current sediment conditions and aquatic health of the benthic community is altered from the historical baseline, the monitoring plan should include benthic population sampling, and bioassay of these sediments. The Final Environmental Impact Statement should identify whether there is potential for these sediment deposition areas to be dredged. If so, it may merit implementing management practices to reduce or eliminate release of toxic constituents from PWC use.

NPS Response: Text has been added to the Final Environmental Impact Statement in the “Alternatives” section to describe the monitoring plan that was added to the modified preferred alternative B. A report is presently being completed for a study that was done to determine the chemical content of sediment at the main inflow area of the Colorado River. Funding is currently being sought for another study to do the same evaluation in the San Juan and Escalante inflow/sediment deposition areas. These studies will identify the hydrocarbon content of these sediments. In addition, another study is currently being conducted that examines the dynamics of sediment re-suspension and reworking in the Colorado River inflow. The monitoring plan that will be developed for the lake will include PAHs, as well as other gasoline constituents that may become re-suspended when there is down-cutting of the sediment deposits as a result of lowering lake level. The monitoring program that will be developed will also consider the most likely places for contamination, such as marina areas and areas downstream from major sediment depositional zones, if appropriate. The data from a study examining visitor effects (including hydrocarbon contamination) in three canyons will be used to develop water quality baselines for Glen Canyon National Recreation Area. A lake-wide monitoring plan will then be developed using the data gathered and the methods tested in these three studies (sediment, three canyons, and synoptic). Plan development will be guided by the Technical Advisory Committee that was formed in 1996 by the National Park Service, the Departments of Environmental Quality Water Divisions of Utah and Arizona, and other interested organizations and agencies (including the EPA) to protect Lake Powell water quality. The Technical Advisory Committee provides an excellent vehicle for establishing standards and protocols for Lake Powell that are acceptable to the EPA and states and that conform to the states' regulations developed under authority of the Clean Water Act. Benthic population sampling and bioassay may be included in the monitoring plan as determined to be appropriate by the Technical Advisory Committee. Dredging to remove sediment is not contemplated by the National Park Service.

25. One commenter stated that the water quality assessment uses assumptions that result in overestimation of potential PWC hydrocarbon emissions to the water in Lake Powell, amounting to the “most extreme adverse conditions.” For example, benzo(a)pyrene concentrations in gasoline range from 0.19 to 2.8 mg/kg, and the highest value was used. Similarly, MTBE concentrations in gasoline were range from 0 to 15%, but only the highest figure was used.

NPS Response: In an effort to determine “what could happen,” a conservative methodology was constructed using the highest concentration of known pollutants commonly found in gasoline. The values referenced by the commenter were incorporated into the analysis to determine if the mixing layers of Lake Powell have adequate volume to mitigate the effects of carbureted two-stroke PWC engines, as well as all other two-stroke watercraft. Using this conservative approach, it was determined that the water quality impacts generated by PWC use would be negligible to minor, and that no water quality criteria for designated uses of the lake would be violated. The National Park Service is satisfied that incorporation of the given component concentration in gasoline has served this approach. Table 10 in the Final Environmental Impact Statement shows the benchmarks used in the evaluation for each pollutant.

In addition the modified preferred alternative B in the Final Environmental Impact Statement will provide an important step toward substantially reducing petroleum-related pollution by requiring PWC used in the recreation area after 2012 be 100% compliant with the EPA 2006 emission standards for gasoline marine engines. Based on the analysis presented, the National Park Service finds that the modified preferred alternative B (including the provision for continued PWC use) will not result in an impairment of park water quality.

26. One commenter stated that the assessment represents an outdated look at potential emissions from an overstated PWC population of conventional two-stroke vessels, and underestimates the accelerating changeover to four-stroke and newer technology two-stroke models. Sales of these newer models have already overtaken conventional two-stroke PWC. The commenter estimates that the changeover to PWC engines that meet the requirements of the EPA 2006 and California Air Resources Board (CARB) 2008 emission standards is occurring much more rapidly than EPA and the National Park Service have estimated. The commenter believes that the amounts of unburned fuel released at Lake Powell will decline rapidly, achieving a reduction from the 1998 baseline levels of more than 50% by 2006 and approximately 80% by 2012. The Draft Environmental Impact Statement, in contrast, only estimated a 25% reduction in hydrocarbon emissions from PWC in the Glen Canyon National Recreation Area by 2006, and only a 50% reduction by 2012.

NPS Response: In the water quality analysis, the assumption made by the commenter was that clean technology engines (any engine not using carbureted two-stroke technology) would be 90% cleaner than the carbureted two-stroke engines. This is based on two assumptions made by the commenter. The first is based on confidential, proprietary PWC sales and forecast data prepared by PWC manufacturers. No supporting data was supplied with the comment.

The commenter states that the data indicates that the conversion of PWC models to cleaner engines is occurring more rapidly than anticipated in the 1996 EPA analysis of the effects of the conversion rule. While the National Park Service has no reason to doubt that PWC conversions are proceeding at a greater rate than forecast by the EPA, there is no survey or similar data available at this time indicating the engine conversion at Glen Canyon is proceeding at a faster or slower rate than the EPA forecast. Therefore, use of the EPA rates is considered appropriate. The second assumption by the commenter is that 75% of the PWC at Glen Canyon would have engines that comply with the CARB conversion rule that requires marine engine manufacturers implement the EPA emission targets sooner than those outlined by the Federal rule. The commenter assumes that 50% of PWC users at Glen Canyon will be from California, and will have CARB-compliant watercraft. And that an additional 20% will have CARB-compliant vessels. The National Park Service concurs that many watercraft users at Glen Canyon have California registered PWC, and they will meet CARB standards. However, there is no data relative to PWC at Glen Canyon to confirm the 75% figure assumed by the commenter.

The National Park Service emissions calculations are conservative only in the sense that they do not specifically account for watercraft that have already been or will be converted to meet EPA or CARB standards. Under the modified preferred alternative B, PWC used in the recreation area after 2012 would be 100% compliant with the EPA 2006 emissions standards for the manufacturing of gasoline marine engines.

27. One commenter stated that the Draft Environmental Impact Statement acknowledges that hydrocarbon compounds evaporate rapidly from water and are subject to chemical breakdown, but then states that attenuating factors such as evaporation and photodegradation are not included in the calculations. In addition, the EPA has confirmed that studies show most unburned gasoline and gasoline additives emitted from two-stroke marine engines evaporate rapidly from water (The Effects of Marine Engine Exhaust Emissions on Water Quality, Summary of Findings of Various Research Studies, EPA 1994).

NPS Response: In 1994, the EPA released a public memorandum entitled “The Effects of Marine Engine Exhaust on Water Quality: Summary of Findings of Various Research Studies.” This document summarized 11 research papers and presents volatilization rates and dilution ratios for observable effects such as taste, odor, and generation of oil film. At temperatures commonly found in Lake Powell during the summer boating season, the majority of gasoline and oil components would be volatilized within 1.2 hours. Although a portion of the gas/oil mixture may accumulate in the water column, water quality testing at Lake Powell did not reveal detectable levels of most PAH components. Given that the contaminants were largely undetectable, specific cumulative analysis of the PWC contribution is not possible at this time. The text has been changed in the Final Environmental Impact Statement to include information on volatility consistent with the above-referenced EPA memorandum.

28. One commenter requested that the Final Environmental Impact Statement list all designated uses for the water in Lake Powell.

NPS Response: Designated uses for the water of Lake Powell, as defined by Arizona and Utah, include drinking, recreation, agricultural, and aquatic life. The complete list of designated uses of the water as defined by Arizona and Utah are listed in the “Water Quality” section of the “Affected Environment” chapter of the Draft and Final Environmental Impact Statements.

29. One commenter wanted the presence and location of drinking water intakes addressed in the analysis.

NPS Response: There are two drinking water intakes within the lake, one near Hite, Utah and one at Glen Canyon Dam that serves the town of Page, Arizona. The intake near Hite is approximately 1/2 mile north (upstream) of the marina when the lake level is above 3,630 feet above sea level. The Glen Canyon Dam intake is under the jurisdiction of the Bureau of Reclamation. The National Park Service has no access to the site, and it is not responsible for monitoring at this location. The locations of the drinking water intakes near Hite Marina and at Glen Canyon Dam has been added to the “Affected Environment” chapter in the “Water Quality” section in the Final Environmental Impact Statement.

30. One commenter stated that presenting average values for water quality testing samples infers complete mixing of lake waters.

NPS Response: Inclusion of average values was not intended to infer that lake waters are mixed, but rather to show the reader a mean value for relative comparison to measured maximum and minimum values. The “average values” have been removed from Table 8 in the Final Environmental Impact Statement.

31. One commenter stated that the need to sample Wahweap Marina is called to attention based on the results of the Bullfrog Marina sample where benzene concentrations were elevated.

NPS Response: Under the modified preferred alternative B, the National Park Service would implement a water quality monitoring program at Lake Powell. This program will be guided by the Technical Advisory Committee, and is detailed in the Final Environmental Impact Statement description of the modified preferred alternative B in the “Alternatives” chapter. Locations selected for ongoing testing will be chosen to maximize use of data in making appropriate management decisions.

32. The EPA requested that monitoring should also be done in drinking water intakes to assure that drinking water standards are met for Arizona and Utah.

NPS Response: Water quality monitoring at the Hite drinking water intake would take place under all alternatives addressed in the Final Environmental Impact Statement. The water quality monitoring program would be directed by the Technical Advisory Committee, formed in 1996 to protect Lake Powell's water quality. The plan would ensure that water quality complies with State regulations and criteria and is consistent with requirements of the Clean Water Act.

The drinking water intake at Glen Canyon Dam, which serves the town of Page, Arizona, is under the jurisdiction of the Bureau of Reclamation. The National Park Service has no authority to access this site to obtain water quality samples. Potable water obtained from Lake Powell is tested after treatment at both the Hite and Page water treatment plants. The localities are responsible for the final quality of the drinking water, in addition to the State requirements for the quality of the drinking water source. The “Water Quality” section in the “Affected Environment” chapter of the Final Environmental Impact Statement has been revised to include additional information regarding the drinking water intakes at Hite and Page.

33. The EPA questioned the presence of a “rainbow sheen” in the marinas and whether this was a violation of Utah Water Quality Standards (R317-2, Utah Administrative Code).

NPS Response: The Utah Department of Environmental Protection, Water Quality Division, was contacted for interpretation of Water Quality Standard R317-2. The term “oil scum” is not intended to equate to the “rainbow sheen” commonly seen on water surfaces at fueling stations and marinas. Although these sheens could be considered minor violations, they are generally localized and transient and therefore not considered a significant enough concern to warrant pursuit of a violation by either state. The sheen itself was not tested during water quality sampling for this assessment. Suggestions regarding sampling locations and techniques would be incorporated into the water quality monitoring program proposed under the modified preferred alternative B in the Final Environmental Impact Statement. Recognizing that the presence of the sheen does indicate degraded water quality, the text in the Final Environmental Impact Statement has been changed to acknowledge temporary, localized degradation of water quality. Because the sheen results from combined marina and fueling activities, it was not possible to determine the specific PWC related contribution to this transient water quality issue.

The modified preferred alternative B in the Final Environmental Impact Statement includes mitigation measures to further protect park waters. Under the modified preferred alternative, PWC used in the recreation area after 2012 will be 100% compliant with the EPA 2006 emission standards for the manufacturing of gasoline marine engines, further reducing petroleum-related pollution. Based on the analysis presented, the National Park Service finds that the modified preferred alternative B will not result in an impairment of park water quality.

34. The EPA suggests that the analysis should address whether PWC use and fueling of vessels in marinas that result in a visible sheen or numeric concentrations would be in violation of Arizona water quality standards. If so, the water quality effects should be designated “major” rather than “negligible to minor”.

NPS Response: Lake Powell is an Arizona Tier II water body, and existing water quality “shall be maintained and protected. Water quality shall not be lowered to a level that does not comply with applicable water quality standards” (Arizona Administrative Code R18-11-107; see the “Water Quality” section, “Affected Environment” chapter). The National Park Service water quality sampling performed at Lake Powell did not show that any Arizona water quality criteria were exceeded. As shown in Table 9 in the “Affected Environment” chapter, Arizona standards are not as stringent as those for Utah, with the exception of naphthalene and these standards are not violated. There would be no violation of Arizona water quality standards set for the designated uses of Lake Powell under any of the alternatives analyzed in this assessment. The EIS text has been edited in the “Water Quality” section of the “Environmental Consequenses” chapter to clearly state this finding.

The modified preferred alternative B in the Final Environmental Impact Statement includes mitigation measures to further protect water quality in the recreation area. The modified preferred alternative will provide an important step toward substantially reducing petroleum-related pollution by requiring all PWC used in the recreation area after 2012 to be 100% compliant with the EPA 2006 emissions standards for the manufacturing of gasoline marine engines.

35. One commenter stated that cumulative effects of the build up of oil and gasoline in the lake over time were ignored. The estimated emission into the lake assumed that on a daily basis, 100% of hydrocarbon emissions volatilized daily. The emissions from PWC contain oil, and oil does not volatilize completely.

NPS Response: The commenter has misinterpreted the DEIS. NPS never stated that 100% of the hydrocarbon emissions volatized daily. Although most polycyclic aromatic hydrocarbon components are volatile, some of these hydro pollutants do accumulate in the water column. The text has been changed and is included in the Final Environmental Impact Statement to provide more information on volatility and on the evaporation and half-life rates applicable to the waters of Lake Powell. Detailed discussions on this issue can be found in the Final Environmental Impact.

36. One commenter stated that the analysis lacks a description of a detailed long-term monitoring plan to ensure evaluation of impacts on the aquatic system.

NPS Response: Modified alternatives A and B addressed in the Final Environmental Impact Statement include implementation of a water quality monitoring project. The project will be directed at developing a detailed long-term monitoring plan by the Technical Advisory Committee, formed in 1996 to protect Lake Powell's water quality. The plan will ensure that water quality complies with State regulations and criteria and is consistent with requirements of the Clean Water Act. The monitoring project will benefit from the findings of two recently completed studies on the chemical content of lake waters and sediment in the Colorado River inflow area and three side canyons. An additional study on the dynamics of sediment re-suspension in the Colorado River inflow is currently underway. Funding is also being sought for additional studies in the San Juan and Escalante River inflow areas. The monitoring project will include hydrocarbon content of sediments and PAH content of lake waters. Benthic population studies may be included, if deemed necessary by the Technical Advisory Committee. The results of the monitoring project will be used to guide management decisions for any impacts on the aquatic system on Lake Powell.

37. One commenter requested that the water quality section of the Final Environmental Impact Statement should clearly state whether activities regulated by the National Park Service are violating, or have the potential to violate, State-adopted, EPA-approved water quality standards under the Federal Clean Water Act.

NPS Response: We agree with the comment and the FEIS was revised to show that there are no violations or potential violations of State or Federal standards. The Utah Department of Environmental Quality, Water Quality Division, was contacted for clarification of the State's assessment of Lake Powell water quality. The division reported that the State has no concerns with regard to the 1.7 μg/L and 3.43 μg/L benzene concentration obtained near Bullfrog Marina during water quality testing. The drinking water intake near Hite Marina is approximately 0.25 mile upstream of the marina, and it is unlikely that gasoline components from the marina would migrate in this direction. Hite is also a smaller marina than Bullfrog, with much less boat traffic and fueling activities. Because of current water levels, Hite Marina is not currently operating. Water levels will need to increase significantly in Lake Powell before Hite Marina can return to full operation. In addition, the intake floats at approximately 12 feet below the water surface. Benzene is lighter than water, highly volatile, and has a half-life of approximately five hours. There are no water quality concerns by the State of Arizona since no drinking water is extracted from Lake Powell in Arizona.

The Final Environmental Impact Statement proposes a water quality monitoring program for modified alternatives A and B. This plan is outlined in responses to “General Comments” above.

The “Water Quality” section in the “Affected Environment” chapter has been changed in the Final Environmental Impact Statement to include new information on the drinking water intakes and on the jurisdiction over the two sites.

38. One commenter stated that the assessment of water quality is based on water column samples taken at 0.5 and 3 meter depths. Given that most constituents from watercraft exhaust or refueling spills will float on the water's surface, it would seem logical to collect water samples at the water's surface rather than 0.5 meters below to determine compliance with standards.

NPS Response: The objective of the sampling effort was to collect representative data that would be most useful for comparison to Clean Water Act water-quality criteria and standards, especially those promulgated for the protection of drinking water supplies and aquatic life. To meet these objectives, sample locations that represented mixed and homogeneous conditions after considering watercraft propeller and wake affects and naturally occurring wave action would yield date representative for these purposes. To determine appropriate sampling depths that would meet these criteria, the most recent body of literature on water pollution caused by motorized watercraft was reviewed and researchers in the field were sought and interviewed.

Through that review and those interviews the NPS determined that there is evidence that, for motorized vessel-expelled PAHs, completely mixed conditions occur at 3m depth. PAH concentrations that are found in completely mixed conditions are more representative of bioavailable concentrations for aquatic life and therefore more comparable to water quality criteria.

Additionally, concentrations of BTEX in particular were assumed to be much more variable at the surface than 0.5m below it and, therefore, concentrations at the water surface would be less representative. The assumption here was that due to vessel and wave action, mixing would be greater just below the surface rather than right at it. Previous research found that, at least at near- shore locations, the 0.5m depth was a representative depth when taking this into consideration.

Lastly, most studies and long-term monitoring efforts conducted elsewhere were designed with sampling stations at 3m and/or 0.5 depths, thus allowing the Lake Powell results to be compared to results in these other water bodies.

39. One commenter stated that the numbers used to predict loading on the lake for future years assume a zero growth condition. A zero growth assumption is not realistic for the boating industry or Glen Canyon National Recreation Area. Glen Canyon National Recreation Area has plans to continue to develop projects that support the boating industry.

NPS Response: New estimates for changes in boat uses at Glen Canyon have been generated for the Final Environmental Impact Statement based on trends for National Park Service units with PWC usage throughout the United States. Over the last 10 years Glen Canyon NRA has experienced a decrease in boating use at about −2.6%. In order to give a variety of growth scenarios for the future, the effects of three differing growth scenarios are now described in the analysis: (1) Annual increase in use of 2% per year, (2) no change (flat rate), and (3) annual decrease in use of 2% per year. For a complete explanation of the change in use, see the “Visitor Use and Experience” section in the “Affected Environment” chapter in the Final Environmental Impact Statement.

40. One commenter stated that there was no conclusion as to how much of the water pollution could be attributed to PWC.

NPS Response: The conclusion on PWC hydrocarbon contribution relative to all watercraft is presented in the “Environmental Consequences” chapter of the Draft and Final Environmental Impact Statements. Using the methodology developed by the National Park Service Division of Environmental Quality (Bransom) and assumptions of the relative polluting capabilities of PWCs and other motorized vessels, PWC were estimated to contribute 50% of all hydrocarbon pollution to the lake.

41. One commenter performed calculations to determine the PWC contribution to lake pollution. Assuming PWC engines have four times the emission displacement into the water of other boats, a total contribution of 21% was obtained versus the NPS assumption of 50%.

NPS Response: Commenter's assumptions about engine sizes do not reflect the boating distribution data gathered for Lake Mead which was used as an estimate of use by engine type on Lake Powell. The “Methodology and Assumptions” section in the “Environmental Consequences” chapter of the Draft and Final Environmental Impact Statements explains the boat distribution and clearly shows the greatest percent of boat hours are generated by “stern-drive” or inboard/outboard engines. These engines are often comparable in size to automobile engines, not one-quarter the size of the typical PWC engine. Because the commenter did not consider the distribution of engine types in the recreation area, we believe that their conclusion that PWC contribute only 21% of the pollution into the lake is incorrect. Furthermore, the methodology used in the EIS analysis differed from the commenter's calculation in that the EIS methodology considered the pollution contribution to the lake by engine type (carbureted, two-stroke direct-injected, and four-stroke). The assumptions in the EIS methodology are that four-stroke and clean technology two-stroke engines deliver to the water 10% of the hydrocarbons of carbureted two-stroke engines.

42. One commenter suggested calculating two-stroke engine pollution contribution using fuel and engine oil purchases made at the lake's marinas.

NPS Response: Many boaters buy fuel and oil at locations other than the marina, and using the marina sales would not capture the total amount of petroleum products used on the lake by two-stroke or other engine types.

43. Commenters stated that the National Park Service did not consider that the changeover to four-stroke and two-stroke direct injection PWC engines to meet the requirements of the EPA 2006 and CARB 2008 emission standards is occurring much more rapidly than EPA and National Park Service has estimated. Amounts of emissions at Glen Canyon will accordingly continue to decline rapidly, achieving a reduction of approximately 90% by 2012.

NPS Response: All alternatives use the rate of conversion of the engines from carbureted two-stroke to clean engines consistent with the EPA rule, “Final Rule for New Gasoline Spark-Ignition Marine Engines” (EPA 1996). The National Park Service used the EPA data where it was assumed that 21.6% of the carbureted two-stroke engines in use in 1998 would be replaced by 2004 and that 58.4% would be replaced by 2012. The commenter's opinion is principally based on confidential, proprietary PWC sales and forecast data prepared by PWC manufacturers. This proprietary data was not supplied with the comment and, therefore, was not available to the National Park Service.

The commenter states that the data indicates that the conversion of two-stoke carbureted PWC models to cleaner direct-injection engines is occurring more rapidly than anticipated in the 1996 EPA analysis of the effects of the conversion rule. While the National Park Service has no reason to doubt that PWC conversions and sales may be proceeding at a greater rate than forecast by the EPA, there is no survey or similar data available at this time that indicates that the engine mix at Glen Canyon is proceeding at a faster or slower rate than the EPA forecast. Therefore, use of the EPA rates is considered appropriate in disclosing potential impacts on air quality. Under the modified preferred alternative B, PWC used in the recreation area after 2012 would be 100% compliant with the EPA 2006 emissions standards for the manufacturing of gasoline marine engines versus 58.4 percent estimated by EPA in 1996. The concessionaire is currently replacing any discontinued PWC with a new model that meets or exceeds the EPA 2006 standards. It is estimated that the concessionaire fleet would consist of PWCs meeting the EPA 2006 standards within the next three years.

PWCs rented outside the recreation area for use in the recreation area will also have to meet the EPA emission standards after 2012. Entrance to the recreation area will require all PWC to have EPA 2006 emission certification prior to entering the park.

44. One commenter expressed concern that PWC emissions are declining faster than forecasted by the EPA. The existing fleet of PWC has achieved a 25% reduction compared to hydrocarbon plus nitrogen oxides (HC + NO X ) emission levels before the EPA regulation became effective, and will achieve reductions greater than 80% by 2012.

NPS Response: The comment is principally based on two assumptions made by the commenter. The first is based on confidential, proprietary information regarding PWC sales and forecast data prepared by PWC manufacturers. No supporting data was supplied with the comment. The commenter states that the data indicates that the conversion of PWC models to cleaner engines is occurring more rapidly than anticipated in the 1996 EPA analysis of the effects of the conversion rule. While the National Park Service has seen that local rentals of PWC have exceeded estimates for conversions and are proceeding at a greater rate than forecast by the EPA, there is no sales data available at this time indicating the engine conversion at Glen Canyon is proceeding at a faster or slower rate than the EPA forecast. Therefore, use of the EPA rates is considered appropriate, and use of an accelerated rate may be considered speculative without additional supporting data.

The second assumption by the commenter is that 75% of the non-rental PWC at Glen Canyon will have engines that comply with the CARB conversion rule for all years, which requires that marine engine emission reductions targeted by the EPA for 2006 be achieved in California by 2001. The California rule then requires further emission reductions by 2004 and 2008 (Title 13, California Code of Regulations, sections 2440-2448). The commenter assumes that 50% of the PWC users at Glen Canyon will be from California and all will have CARB-compliant watercraft, and that, because of manufacturing and sales efficiencies outside of California, an additional 25% of the Glen Canyon PWC users will have CARB-compliant watercraft. The National Park Service concurs that many watercraft users at Glen Canyon have California-registered PWC, and that they will meet the CARB standards. However, there is no data relative to PWC at Glen Canyon to confirm the 75% figure assumed by the commenter. The National Park Service emission calculations are conservative only in the sense that they do not specifically account for watercraft that have already been or will be converted to meet CARB standards. Under the modified preferred alternative B, PWC used in the recreation area after 2012 would be 100% compliant with the EPA 2006 emissions standards for the manufacturing of gasoline marine engines.

45. Continued PWC use on Lake Powell under the proposed rule will not pose any adverse health risks for park visitors under even the “worst case” airborne PAH concentrations that could theoretically be generated by the vessels.

NPS Response: The commenter submitted an analysis of PAH emissions at Glen Canyon to support the comment. The commenter's analysis uses many conservative assumptions and a pollutant dispersion model to conclude that PAH exposure to PWC users from PWC PAH emissions would be less than one thousandth of one percent (<0.001%) of an Occupational Safety & Health Administration (OSHA) limit for PAH exposure. Shoreline exposure would be even lower. OSHA published the limit as part of a discussion of safety and health related to coal tar pitch volatiles. The limit is for total PAH, and the comment in reference to OSHA for limits of coal tar volatiles does not apply in the context of the Glen Canyon PWC rule-making discussion. In addition, another relevant study concluded that there are some health effects associated with PAH emissions (see Environmental and Occupational Exposure to Toxic Air Pollutants from Winter Snowmobile Use in Yellowstone National Park, Kado et al. 2001). Therefore, the National Park Service cannot support a conclusion, as the commenter suggests, that PWC use at Glen Canyon would pose no adverse health risks from toxic air pollutant emissions.

46. One commenter believes that the analysis reference to moderate levels of air quality impacts from HC, NO X , and carbon monoxide (CO) emissions associated with PWC use is incorrect and potentially misleading. The commenter believes that these emissions, even under the “worst case” scenario, would not pose a health risk for park visitors.

NPS Response: Emission levels shown in the Air Quality analysis tables in the “Environmental Consequences” chapter are not directly comparable with the emission levels submitted by the commenter, because the National Park Service Air Quality Division calculates emissions on an annual basis, and the commenter's calculations are for an average boating day during the boating season. Some assumptions made for National Park Service calculations are more conservative than those used for the commenter's calculations. The National Park Service assumed that the conversions from carbureted two-stroke engines to cleaner engines would occur at the rate forecast by the EPA. Based on the National Park Service model (presented in the tables as tons per year of estimated hydrocarbon and nitrogen oxide emissions for all alternatives), a 21.6% conversion is assumed from 1998 levels by 2004 and a 58.4% conversion by 2012. The commenter assumes a faster conversion. The commenter assumes that emissions would be reduced because a significant portion of PWC would be cleaner than EPA requirements due to compliance with the more restrictive California requirements. There is no data relative to PWC at Glen Canyon to confirm the 75% figure that is assumed by the commenter. The National Park Service emission calculations are conservative only in the sense that they do not specifically account for watercraft that have already been or will be converted to meet either CARB or EPA standards. Under the modified preferred alternative B, PWC used in the recreation area after 2012 would be 100% compliant with the EPA 2006 emissions standards for the manufacturing of gasoline marine engines, which would result in a substantial reduction in emissions. Using the EPA forecast rate of emission reductions in the National Park Service air quality emissions model, and assuming a 2% annual visitor growth rate, the PWC emissions associated with the modified preferred alternative would be up to 365 tons per year of HC + NO X by 2012 and 2,955 tons per year of CO, which is considered by the National Park Service to be a moderate adverse effect.

47. One commenter stated the National Park Service analysis does not reflect the increase in nitrogen oxides emissions that are likely with the conversion to more four-stroke engines.

NPS Response: The Draft and Final Environmental Impact Statements do note in the “Air Quality” section of the “Environmental Consequences” chapter that nitrogen oxide emissions will increase with implementation of the EPA 1996 rule and the conversion to 4-strokes. However, there would be sizeable reductions in emissions such as VOC, HC, PM and CO and overall air quality in the recreation area would continue to be below national ambient air quality standards.

48. One commenter stated the National Park Service analysis does not reflect CARB research which found that four-stroke PWC emit more carbon monoxide (CO) pollution than do conventional two-stroke machines. The commenter states that the National Park Service should be concerned with any technology that emits large amounts of this pollution given the recent spike in carbon monoxide-related deaths at Glen Canyon National Recreation Area.

NPS Response: The CARB 2001 study, Outboard Engines and PWC Emissions to Air and Water: A Laboratory Study found that CO emissions from four-stroke outboard and PWC engines tested were lower than conventional two-stroke engines. The CARB results indicate that the carbureted two-stroke PWC engine tested emitted nearly three times the amount of carbon monoxide than did the four-stroke engine. Results also indicated that the four-stroke outboard engine emitted lower levels of carbon monoxide than two-stroke carbureted outboard engines with exception of the two-stroke 90 hp direct-injected engine, which emitted lower levels than the four-stroke engine. In addition, the EPA emission test data from outboard marine engines indicates that carbon monoxide emissions from four-stroke engines are lower than conventional two-stroke technology engines (EPA 1996). Although the EPA final regulation on emission standards does not contain standards for carbon monoxide, it is expected that the engine technology changes which would be used to meet the EPA standards would result in some modest carbon monoxide reductions (EPA 1996). Under the modified preferred alternative B, PWC used in the recreation area after 2012 will be required to be 100% compliant with the EPA 2006 emission standards for the manufacturing of gasoline marine engines, which would result in a substantial reduction in total emissions. Although there would not be a significant reduction in carbon monoxide emissions over the next ten years, based on the National Park Service model, they would be reduced from 3,168 to 2,955 tons per year assuming a 2% annual increase in visitor use.

Carbon monoxide related fatalities that have occurred in the recreation area have been a result of exposure to extremely high levels of carbon monoxide in confined, poorly ventilated spaces such as under a boat swimming platform or near exhaust ports. The levels of carbon monoxide presented in the analysis represent carbon monoxide levels over the entire recreation area, dispersed in a large volume of air, and are based on year-long boating activity. There has only been one reported fatality caused by carbon monoxide poisoning at the recreation area involving a PWC. This individual died while being towed on his broken PWC behind a motorboat. Nationally, of the 701 boating fatalities reported in 2000, five deaths were attributed to carbon monoxide. None of these deaths involved PWC.

The National Park Service is concerned about fatalities at Glen Canyon National Recreation Area related to carbon monoxide poisoning. The park has an active and aggressive campaign to inform visitors to the recreation area of the risk of carbon monoxide poisoning from exposure to boat generators, engines, and gas appliances. This safety information is provided to visitors at entrance gates, visitor centers, recreation area headquarters, and on the recreation area Web site.

49. One commenter asked the National Park Service to disclose the derivation of the 21% average engine load as an assumption in the methodology of the air quality analysis.

NPS Response: The assumption of an average engine load of 21% for PWC was based on the activity data used in the EPA NONROAD model.

50. One commenter expressed concern over the inconsistencies in the Draft Environmental Impact Statement regarding the volatilization of pollutants to the air and water. This commenter stated that the text should use the same percentage for how much and which pollutants volatize in both the air and water quality impacts sections. No estimate of the percent that volatilizes is given in the water quality section. In the air quality section it is stated that up to 30% of the fuel from PWC is unburned and is discharged as gaseous hydrocarbons (Draft Environmental Impact Statement, p. 181). The numbers should be consistent for the analysis.

NPS Response: The Draft Environmental Impact Statement incorrectly stated that 30% of the fuel is exhausted into the air. However, the Final Environmental Impact Statement correctly states that up to one-third of the fuel delivered to the two-stroke carbureted PWC engine is unburned and discharged into the water instead of exhausted into the air. It is difficult to determine how much of the fuel is volatilized into the atmosphere. As stated in “Methodology and Assumptions” section under “Air Quality,” many organic pollutants that are initially dissolved in the water volatilize to the atmosphere, especially if they have high vapor pressures, are lighter than water, and mixing occurs at the air/water interface. It is difficult to assess the specific evaporation rates of exhaust pollutants from PWC because the rates will differ according to the ratio of gas to oil used, by fuel brand, by engine, and operating conditions such as temperature and water aeration.

In 1994, the EPA released a public memorandum entitled “The Effects of Marine Engine Exhaust on Water Quality: Summary of Findings of Various Research Studies.” This document summarizes 11 research papers and presents volatilization rates and dilution ratios for observable effects such as taste, odor, and generation of oil film.

At temperatures commonly found in Lake Powell during the summer boating season (77°F-86°F), 78-84% of the gasoline/oil mixture (50:1) for carbureted two-stroke engines would be evaporated from the water to the air in 1.2 hours. This EPA review also cites a study by the Boating Industrial Association (1974) that describes the two-stroke gas/oil mixture as having an 11-day half-life in still water (such as a laboratory tank) and a half-life of less than one day in open, aerated water (such as a lake). A description of the volatile nature of five gasoline constituents has been provided in the “Water Quality” section of the “Affected Environment” chapter.

51. One commenter requested that the Final Environmental Impact Statement include updated information on the July 2002 EPA proposed cleaner evaporative standards for PWC.

NPS Response: The text in the “Air Quality Methodology and Assumption” section of the “Environmental Consequences”chapter has been changed to include the proposed EPA evaporative standards.

52. One commenter argued that the National Park Service based its findings on recent studies suggesting that changing from two-stroke carbureted to two stroke direct injection PWC engines might increase PAH emissions. A study by Norman Y. Kado et al, Airborne Particle Emissions from two- and four-stroke Outboard Marine Engines: Polycyclic Aromatic Hydrocarbon and Bioassay Analysis , (hereinafter referred to as “Kado Study”) quantified PAH concentrations in airborne particulate emissions. The Kado Study showed that the PAH emissions from the direct-injection two-stroke engines tested were greater than from carbureted two-stroke engines. The direct-injection two-stroke outboard engine used in that study was a 1999 model and represented very early technology, and the results of the study are not applicable to newer model direct-injection outboard engines, much less PWC engines.

NPS Response: The NPS disagrees with the commenters conclusions. In addition, because many older engines would still be allowed to operate at Lake Powell through 2012, the National Park Service assumes that there would be increased PAH emissions and the Kado Study is relevant. Also, a recent study dated 2003 by the Tahoe Regional Planning Agency (hereinafter referred to as “TRPA Study”) compared the concentrations of PAH compounds released into the water and found that the two-stroke carbureted outboard engine emitted lower PAH levels into the water than did the two-stroke direct-injected engine. The four-stroke carbureted outboard engine emitted the lowest PAH levels, as well as other gasoline-related contaminants into the water (TRPA Study dated 2003; CARB). So, while conversion of some carbureted two-stroke engines to direct-injection two-stroke engines would result in increased PAH emissions, the concurrent conversion to four-stroke engines would result in reduced PAH emissions. However, the two-stroke carbureted outboard engine emitted higher levels of benzene than the two-stroke direct-injected engine model (CARB). PWC engines follow the same patterns of emission rates as outboard engines (CARB). The TRPA Study confirms other findings regarding emissions into the water and does not substantially change National Park Service conclusions regarding water quality impacts.

According to the Kado Study the higher levels of PAHs from two-stroke direct-injection engines may be due to differences in the characteristics of combustion such as temperature, spray location or spray pattern of the fuel and oil, timing of fuel delivery, and high levels of unburned fuel and oil in the two-stroke direct inject engines.

As shown by the commenter, using Kado data, the combined PAH emissions of one direct-injection two-stroke engine and one four-stroke engine would be slightly less than the PAH emissions of the two carbureted two-stroke engines that would be replaced. Therefore, the increase or decrease of PAH emissions as carbureted two-stroke engines are converted to cleaner engine types would depend on the relative numbers of the types of cleaner engines. In addition, in speaking with local PWC businesses, the majority of newer PWC models being sold are four-stroke engines, not two-stroke direct-injection engines, but no specific data is available. The speculation of the mix of engine types would not appreciably change National Park Service conclusions concerning PAH emissions made in the Final Environmental Impact Statement.

53. One commenter stated that the National Park Service identifies a potential concern that the ability of PWC operators to access remote areas of Glen Canyon National Recreation Area unit could intrude on traditional tribal activities and make certain cultural sites vulnerable to trampling, looting, and vandalism. The analysis does not document any instances where these problems have occurred. Nor is there any reason to believe that PWC users are more likely to pose these concerns than canoeists, kayakers, hikers, or others who might access these same areas. Even so, alternative B proposes to prohibit PWC use in several areas to protect against potential adverse impacts on these resources.

NPS Response: Navajo practitioners conduct traditional activities as individuals, and generally do not share this information with others. Almost universally, American Indians are extremely reticent to share sensitive information about personal religious activities with the public. Out of respect for these traditional beliefs, and in keeping with various laws and mandates, the National Park Service does not include descriptions of specific traditional activities or their locations in a public document. For these reasons, Glen Canyon National Recreation Area does not have documentation of specific instances where PWC users have intruded on traditional activities by tribal practitioners. However, the National Park Service is aware of the potential for conflicts with visitor use along the shorelines, particularly in more isolated areas. The effects on cultural resources, including sacred sites within the recreation area used by Native Americans, as a result of nonmotorized use as well as other uses of the lake will be assessed under the lake management plan. Even though the lake management plan is an element of alternative B, a separate NEPA assessment will be prepared to evaluate its effects.

54. One commenter stated that there is no legitimate reason for National Park Service to impose restrictions on PWC users only to protect cultural resources and activities from intrusion.

NPS Response: The plan was not designed to determine if PWC caused more damage to park resources than other boats or users, but rather, to determine if PWC use was consistent with Glen Canyon National Recreation Area's enabling legislation and management goals and objectives. An analysis was done on the management of PWC and with completion of the Final Environmental Impact Statement, the National Park Service is taking action to adopt special regulations to manage PWC use at Glen Canyon.

55. One commenter requested that the Final Environmental Impact Statement include a map that identifies the Natural Zone and the Recreation and Resource Utilization Zone in the analysis area, and include additional detail regarding the purposes and objectives for these two zones. The impact of each alternative on whether the Natural Zone qualifies for wilderness designation, as recommended in the last Management Plan, should be described in the document.

NPS Response: A map of Glen Canyon National Recreation Area's management zones has been added to the “Affected Environment” chapter of Final Environmental Impact Statement, along with an additional description of the zones' objectives. All of the Federal lands in the natural zone were proposed as wilderness in the General Management Plan in 1972.

56. Some commenters cited user conflicts. Specific incidents included conflicts between PWC users and kayakers, fishermen, and hikers. A few PWC supporters said these conflicts resulted from a minority of inconsiderate PWC operators and that we should regulate inappropriate behavior or enforce existing regulations rather than prohibit PWC use.

NPS Response: The modified preferred alternative B will restrict PWC use on portions of the Escalante, Colorado, Dirty Devil, and San Juan Rivers and implement a flat-wake zone for PWC on a portion of the Escalante River. Based on the best available information, the National Park Service will implement these restrictions on the rivers to reduce visitor conflicts with river rafters, fishermen, and backcountry hikers; promote visitor enjoyment; and ensure visitor safety.

The modified preferred alternative B also provides for a three-year pilot study to further evaluate PWC use areas. Potential restrictions of PWC use in other locations of the recreation area will be evaluated at that time. The purpose of the pilot study and a description of how it will be implemented are provided in appendix C in the Draft and Final Environmental Impact Statements.

57. One commenter stated that the overall conclusions in the Draft Environmental Impact Statement and in the proposed rule regarding visitor perceptions of PWC were inconsistent with the data presented in the University of Minnesota study used in the analysis.

NPS Response: Conclusions of the Minnesota study (James 2000) were based on their professional analysis and statistical limitation of the data they collected. During the summer of 2000, the University of Minnesota conducted three on-site visitor surveys at Glen Canyon National Recreation Area. This survey was followed by a mail-back questionnaire sent to visitors after their trip to the recreation area. The study focused on visitors using the resources, as well as looking specifically at the population of visitors who used and also those who did not use PWC during their visit to the area. The analysis of impacts on visitor use and experience presented in the Draft and Final Environmental Impact Statements was based on the Minnesota study visitor's perceptions of problems or conflicts with PWC.

58. One commenter stated that PWC use and human activities associated with their use may not be any more disturbing to wildlife species than any other type of motorized or non-motorized watercraft. The commenter cites research by Dr. Rodgers whose studies have shown that PWC are no more likely to disturb wildlife than any other form of human interaction. PWC posed less of a disturbance than other vessel types. Dr. Rodgers' research clearly shows that there is no reason to differentiate PWC from motorized boating based on claims on wildlife disturbance.

NPS Response: The wildlife impact analysis completed for the Glen Canyon NRA considered a large body of technical information, including research findings of Dr. Rodgers, that addressed, observed and tested effects of PWC and other motorized watercraft use on various fish and wildlife species and to wildlife in general. Some of the available literature discussed effects to some wildlife species and not to other groups. Some of the available literature noted that PWC use was less or no more disruptive than other types of motorized or man-powered watercraft. A common theme in many of the research findings was that much of the wildlife effect depended on a complex of other environmental variables not just the type of watercraft. The NPS considered all these findings in conducting an objective and balanced impact analysis. The literature results were used as appropriate within the physical and ecological conditions that prevail at Glen Canyon. It was concluded in the final EIS that alternatives A and B would have negligible to minor adverse affects on wildlife and wildlife habitat from noise, high-speed operations, habitat disturbance and exposure to fuel constituents. Continued PWC operation under these alternatives would not result in an impairment of wildlife, fish, or supporting habitat resources. These conclusions regarding wildlife impacts that were based on scientific literature and based on the environmental conditions present in Glen Canyon NRA are believed to be accurate and complete.

59. One commenter noted that the EIS identified the issue of potential concern that the beaching and landing of PWC could result in the trampling of shoreline vegetation. The comment refers to several other phrases in the text that discuss the affected environment and the indistinguishable cumulative effects of PWC use and other watercraft on shoreline or submerged aquatic vegetation.

NPS Response : Shoreline vegetation has been historically subjected to many sources of disturbance since the recreation area was created. The most important has been repeated inundation and desiccation as the reservoir level rises and falls. Other sources that have affected and would continue to affect shoreline vegetation include PWC operators, other watercraft operators and passengers, general visitors and livestock in some areas. The NPS believes that the incremental effect from PWC users on shoreline vegetation conditions would be indistinguishable from other visitor-induced effects. Foot traffic from all visitor activities would occur on shorelines and lake beaches in accessible shoreline areas. Past, current and future PWC use would not produce any noticeable effect on submerged aquatic, riparian and wetland vegetation. Therefore, cumulative effects would be negligible.

60. Several commenters noted that PWC were being singled out for restrictions without regard to other sources of noise, including “muscle” boats, other motorboats, loud music, parties, and illegal fireworks.

NPS Response : The Final Environmental Impact Statement and final rule were not designed to determine if PWC caused more environmental damage to park resources than other boats, but rather, to determine if PWC use was consistent with Glen Canyon National Recreation Area's enabling legislation and management goals and objectives of the park. Depending upon the results of the Final Environmental Impact Statement, the National Park Service could, as it has in this rulemaking, take action to adopt special regulations to manage PWC use at Glen Canyon, or could have chosen to discontinue PWC use. The alternatives listed were based upon the best information available. Other resource impacts and issues will be addressed through other planning documents and regulations.

61. Several commenters expressed a concern that the analysis did not address the fluctuations of sound that PWC make compared to other motorized watercraft. Specifically, the distinctive pitch variation may have different effects on humans and other species and is more annoying or irritating than the more constant sounds associated with other boats.

NPS Response : The pitch variations associated with PWC and the noise differences between PWC and motorboats are acknowledged under the “Soundscapes” section in the “Affected Environment” chapter of the Draft and Final Environmental Impact Statements. PWC noise does fluctuate as a result of typical operation, but the noise intensity levels are not typically in violation of the National Park Service noise standard. The suggestion that pitch variations may have different effects on humans and other species, and that the variation is more annoying or irritating, was incorporated in the analysis and contributes to the “minor to moderate” adverse impact determination.

62. One commenter stated that wilderness management in the Natural Zone is ignored even though it is stated as a goal in Glen Canyon National Recreation Area's general management plan. They further state that only alternative C which bans PWC correlates satisfactorily with the values of wilderness management.

NPS Response : The noise impacts on the Natural Zone were determined to be adverse and ranged from minor to moderate within a mile of the shoreline (refer to the noise analysis in the “Soundscapes” section of the “Environmental Consequences” chapter).

The Final Environmental Impact Statement states that PWC sound impacts wilderness values of solitude and natural quiet because sound carries beyond the shoreline and is heard at some distance within the Natural Zone. The sound is heard up to a maximum of 2 miles from the source over a flat surface, but the topography surrounding Lake Powell is not flat. Assuming that a natural barrier to the sound would exist where there is an elevation change of 50 feet (approximate height of a five-story building), approximately 16,000 acres would be affected (between 3,700 feet to 3,750 feet in elevation). This equals 2.3% of the Natural Zone (668,670 acres). Time of day and season of use would also reduce the level of noise in the Natural Zone because the noise would not be continuous, would be encountered only during daylight hours, and would be minimal between October and May.

Although noise does intrude on desired wilderness and Natural Zone soundscape values, the inescapable juxtaposition of the Natural Zone and the Recreation and Resource Utilization Zone make it impossible to avoid all adverse impacts on the Natural Zone/ wilderness soundscape. As shown above, only 2.3% of the Natural Zone's area would be affected, and those soundscape effects would be offset even further by diurnal/nocturnal and seasonal reductions in watercraft noise.

There is a potential conflict in the management objectives between the Recreation and Resource Utilization Zone and the Natural Zone that is extremely difficult to avoid because the zones are adjacent to each other. However, the percentage of the Natural Zone that is adversely affected by PWC noise, as shown in the preceding paragraph, is small. The noise generated by watercraft in the Recreation and Resource Utilization Zone, including PWC, is consistent with Glen Canyon National Recreation Area's enabling legislation “to provide for public outdoor recreation use and enjoyment of Lake Powell and the lands adjacent thereto.”

The modified preferred alternative B provides for a three-year pilot study to further evaluate PWC use areas. Potential restrictions of PWC use in other locations of the recreation area will be evaluated during the pilot study. The purpose of the pilot study and a description of how it will be implemented are provided in appendix C of the Final EIS. In addition, the preparation of a lake management plan, which was included in all alternatives in the Final Environmental Impact Statement, will provide an opportunity for the National Park Service to further evaluate impacts of all lake users on all resources, including the soundscape.

63. One commenter asked why if noise generated by watercraft is consistent with the park purposes is soundscape being addressed as a reason to manage PWC.

NPS Response: The “Purpose of and Need for Action” chapter in the Draft and Final Environmental Impact Statements states that the overall objective for EIS and rulemaking is to evaluate a range of alternatives and strategies to determine the appropriateness of PWC use at Glen Canyon NRA with the goal of ensuring protection of recreational and resource values. This objective was derived from the enabling legislation for Glen Canyon National Recreation Area. Soundscape was one of the issues that was evaluated in order to determine appropriateness of PWC use. As a result of the evaluation, the NPS determined that no additional measures are required, beyond exist NPS noise regulations, to manage noise from PWC.

64. One commenter stated that since 1998, the PWC companies have reduced engine sound levels by up to 70% and have introduced design changes to not only reduce engine sound intensity, but to reduce the sound pitch that some claim to be annoying.

NPS Response: The National Park Service appreciates the information regarding new noise suppression designs being used by some PWC manufacturers. The Final Environmental Impact Statement refers to the potential noise abatement factors and acknowledges that future designs may mitigate sound impacts (see the “Affected Environment” chapter).

65. One commenter stated that the “promise” of quieter PWC by the PWC companies is no reason to approve PWC use at the recreation area.

NPS Response : The National Park Service has recognized that some PWC manufacturers are developing new noise suppression designs for new PWC. The industry's conversion to the four-stroke technology and the use of resonators is reducing the noise. Manufacturers are using noise absorbing foam and rubber padding in the construction of PWC. Consequently, the newer technology used in PWC construction is addressing noise concerns. The Final Environmental Impact Statement refers to the potential noise abatement factors and acknowledges that future designs may mitigate sound impacts (see the “Affected Environment” chapter).

The Final Environmental Impact Statement and final rule were designed to determine if PWC use was consistent with Glen Canyon National Recreation Area's enabling legislation and management goals and objectives. With completion of the Final Environmental Impact Statement, the National Park Service could, as it has in this rulemaking, take action to adopt special regulations to manage PWC use at Glen Canyon, or could have chosen to discontinue PWC use.

The primary authors of this regulation were Suzy Schulman, Environmental Specialist, Glen Canyon NRA; Brian Wright, Outdoor Recreation Planner, Glen Canyon NRA; Sarah Bransom, Environmental Quality Division, National Park Service; Kym Hall, Regulations Program Manager, National Park Service, and Michael Tiernan, DOI Solicitor's Office.

This document is a significant rule and has been reviewed by the Office of Management and Budget under Executive Order 12866.

(1) This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, environment, public health or safety, or State, local, or tribal governments or communities. This determination is based upon the findings in a report prepared by the National Park Service entitled “Economic Analysis of PWC Regulations in Glen Canyon National Recreation Area” (Law Engineering and Environmental Services, Inc., 2002). The focus of this study was to document the impact of this rule on a variety of small entities including PWC dealerships and repair shops, PWC rental business, and other local businesses that provide services to PWC users. The Economic Analysis may be viewed on the Glen Canyon Web site at http://www.nps.gov/glca .

This rule will continue PWC use with restrictions in some narrow canyon areas and other management restrictions. Some localized ecosystem protection and noise reduction benefits are anticipated. However, because the vast majority of Lake Powell, including the most popular areas for PWC use, will remain open to PWC use under this rule, the NPS anticipates no significant effects on the visiting public or local businesses.

If this rule was not instituted, PWC use would be completely banned under the no-action alternative, affecting the approximately 40 percent of visitors that use PWC. Maintaining PWC use in GLCA under this rule will result in an estimated increase in producer surplus (a measure closely related to business profit) in the local community of between $1,232,800 and $12,304,300 annually relative to baseline conditions (where PWC would be banned). The economic effect on the members of the visiting public that do not use PWC was not quantified due to limited data availability; however, the 40 percent of visitors that currently use PWC will regain all the consumer surplus value they receive from PWC use in GLCA. Consumer surplus gains to PWC users of continued access to GLCA are estimated to be between $9,806,600 and $20,166,400 annually. Beneficiaries of the no-action alternative would include the remaining portion of visitors that do not use PWC. Additionally, “nonusers” may significantly benefit from knowing that resources in the National Recreation Area will be better protected into the future.

Over a ten-year horizon, the present value of the gains is estimated to be $86.9 million to $155.3 million in consumer surplus and $10.9 million to $94.7 million in producer surplus using a 3 percent discount rate. This suggests the total gain in consumer and producer surplus from this rule relative to the baseline is $97.8 million to $250.0 million using a 3 percent discount rate. Losses to non-PWC users have not been quantified due to insufficient data. A 3 percent discount rate is widely recognized in the economics literature and Federal rulemakings as an appropriate discount rate for valuing natural amenities and other non-market resources and services. When discounted at 7 percent per year (OMB Circular A-94), the present value of the gain in consumer surplus is estimated to be $68.5 million to $122.5 million and the present value of the gain in producer surplus is estimated to be $8.6 million to $74.7 million. In this case, the total gain in consumer and producer surplus relative to baseline conditions is $77.1 million to $197.2 million, not including unquantified losses to non-PWC users.

This analysis clearly indicates that this rule is expected to avoid significant losses to local business. However, the net effect of this rule on the visiting public and nonusers has not been quantitatively determined.

(2) This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. Actions taken under this rule will not interfere with other agencies or local government plans, policies, or controls. This is an agency specific rule.

(3) This rule does not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients. This rule will have no effects on entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients. No grants or other forms of monetary supplements are involved.

(4) This rule raises novel legal or policy issues. This rule is among the first of its kind for managing PWC use in National Park Units. The National Park Service published general regulations (36 CFR 3.24) in March 2000, requiring individual park areas to adopt special regulations to authorize PWC use. The implementation of the requirements of the general regulation continues to generate interest and discussion from the public concerning the overall effect of authorizing PWC use and National Park Service policy and park management.

The Department of the Interior certifies that this document will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) based on a report entitled Economic Analysis of PWC Regulations in Glen Canyon National Recreation Area (Law Engineering and Environmental Services, Inc. 2002). The focus of this study was to document the impact of this rule on two types of small entities, PWC dealerships and PWC rental outlets. This report found that there was no potential loss for these types of businesses as a result of this rule since PWC use would remain substantially the same as it has been over the last several years.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. The National Park Service has completed an economic analysis to make this determination. This rule:

a. Does not have an annual effect on the economy of $100 million or more.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

c. Does not have a significant adverse effect on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. This rule is an agency specific rule and imposes no other requirements on other agencies, governments, or the private sector.

In accordance with Executive Order 12630, the rule does not have significant takings implications. A taking implication assessment is not required. No taking of personal property will occur as a result of this rule.

In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. This proposed rule only affects use of NPS administered lands and waters. It has no outside effects on other areas by allowing PWC use in specific areas of the park.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.

This regulation does not require an information collection from 10 or more parties and a submission under the Paperwork Reduction Act is not required. An OMB form 83-I is not required.

The National Park Service has analyzed this rule in accordance with the criteria of the National Environmental Policy Act and has prepared an Environmental Impact Statement (EIS). The draft EIS was made available for public review and comment on September 13, 2002, (67 FR 58071), and the Final Environmental Impact Statement (FEIS) was made available to the public on May 16, 2003 (68 FR 26645). A copy of the FEIS is available on the Glen Canyon National Recreation Area Web page at http://www.nps.gov/glca/plan.htm, at regional libraries, or a copy may be obtained by contacting the Superintendent, Glen Canyon National Recreation Area.

In accordance with the President's memorandum of April 29, 1994, “Government to Government Relations with Native American Tribal Governments” (59 FR 22951) and 512 DM 2, the National Park Service has evaluated potential effects on federally recognized Indian tribes and have determined that there are no potential effects.

During May 2002, the NPS consulted with tribes in the surrounding area in writing and/or in person about the development of this rule and the supporting Environmental Impact Statement. Those tribes include the Hopi, Navajo, San Juan Southern Paiute, and Kaibab Paiute Tribes as well as several tribal historic preservation programs and cultural and natural resources divisions of the tribes. None of the tribes have expressed concern or dissent with the planning process or development of the alternatives for the EIS or this rule.

This final rule is effective upon publication in the Federal Register . In accordance with the Administrative Procedure Act, specifically, 5 U.S.C. 553(d)(1), this rule, 36 CFR 7.70(g), is exempt from the requirement of publication of a substantive rule not less than 30 days before its effective date.

As discussed in this preamble, the final rule is a part 7 special regulation for Glen Canyon National Recreation Area that relieves the restrictions imposed by the general regulation, 36 CFR 3.24. The general regulation, 36 CFR 3.24, prohibits the use of PWC in units of the national park system unless an individual park area has designated the use of PWC by adopting a part 7 special regulation. The proposed rule was published in the Federal Register (68 FR 2466) on January 17, 2003, with a 60-day period for notice and comment consistent with the requirements of 5 U.S.C. 553(b). The Administrative Procedure Act, pursuant to the exception in paragraph (d)(1), waives the section 553(d) 30-day waiting period when the published rule “grants or recognizes an exemption or relieves a restriction.” In this rule the NPS is authorizing the use of PWCs, which is otherwise prohibited by 36 CFR 3.24. As a result, the 30-day waiting period before the effective date does not apply to the Glen Canyon National Recreation Area final rule.

The Attorney General's Manual on the Administrative Procedure Act explained that the “reason for this exception would appear to be that the persons affected by such rules are benefited by them and therefore need no time to conform their conduct so as to avoid the legal consequences of violation. The fact that an interested person may object to such issuance, amendment, or repeal of a rule does not change the character of the rule as being one “granting or recognizing exemption or relieving restriction,” thereby exempting it from the thirty-day requirement.” This rule is within the scope of the exception as described by the Attorney General's Manual and the 30-day waiting period should be waived. See also, Independent U.S. Tanker Owners Committee v. Skinner, 884 F.2d 587 (DC Cir. 1989). In this case, the court found that paragraph (d)(1) is a statutory exception that applies automatically for substantive rules that relieves a restriction and does not require any justification to be made by the agency. “In sum, the good cause exception must be invoked and justified; the paragraph (d)(1) exception applies automatically” (884 F.2d at 591). The facts are that Glen Canyon National Recreation Area is promulgating this special regulation for the purpose of relieving the restriction, prohibition of PWC use, imposed by 36 CFR 3.24 and therefore, the paragraph (d)(1) exception applies to this rule.

In accordance with the Administrative Procedure Act, this rule is also excepted from the 30-day waiting period by the “good cause” exception in 5 U.S.C. 553(d)(3) and is effective upon publication in the Federal Register . As discussed above, the purpose of this rule is to comply with 36 CFR 3.24 requirement for authorizing PWC use in park areas by promulgating a special regulation. “The legislative history of the APA reveals that the purpose for deferring the effectiveness of a rule under section 553(d) was “to afford persons affected a reasonable time to prepare for the effective date of a rule or rules or to take other action which the issuance may prompt.” S. Rep. No. 752, 79th Cong., 1st Sess. 15 (1946); H.R. Rep. No. 1980, 79th Cong., 2d Sess. 25 (1946).” United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977). The persons affected by this rule are PWC users and delaying the implementation of this rule for 30 days will not benefit them; but instead will be counterproductive by denying them, for an additional 30 days, the benefits of the rule.

The rule has been developed in full compliance with section 553(b) and (c) rulemaking requirements. The proposed rule was published in the Federal Register and provided 60 days for public comments. The public comments received are summarized and analyzed in this document. Also as part of this process, the park prepared a Draft Environmental Impact Statement (DEIS) that was made available to the public on September 13, 2002, for comment. The DEIS evaluated the various alternatives for managing PWC use at Glen Canyon, including an alternative with no PWC use. After reviewing the comments to the DEIS the NPS modified the proposed alternatives and responded to comments in a Final Environmental Impact Statement that was made available to the public on May 16, 2003. This rule will now implement the preferred alternative B with certain modifications as a result of the public comments received in response to the proposed rule and the DEIS.

“In determining whether to invoke the exception, the agency is ‘required to balance the necessity for immediate implementation against principles of fundamental fairness which require that all affected persons be afforded a reasonable time to prepare for the effective date of its ruling.”’ The Northern Arapahoe Tribe v. Hodel, 808 F.2d 741, 752 (10th Cir. 1987). The primary purpose of the 30-day waiting period is to provide the public with time to prepare for the changes caused by the new rule. This rule authorizes the continued use of PWCs at Glen Canyon National Recreation Area. Because of the two-year grace period established by the March 2000 Final Rule and the temporary lifting of the PWC ban for the summer of 2003, PWC use has been allowed to continue at Glen Canyon despite the prohibition in 36 CFR 3.24. Providing a 30-day waiting period would not benefit the parties affected by this rule, instead there is good cause for making this rule effective upon publication so that affected parties can continue using PWCs.

On December 6, 2002, the Veterans Benefits Act of 2002, Pub. L. 107-330 (the Act), was enacted. Certain provisions of the Act directly affect the payment of VA compensation or pension benefits. These provisions concern special monthly compensation for loss of breast tissue in a woman and the amount of pension payable to Medal of Honor recipients.

Section 102 of the Act amended 38 U.S.C. 1114(k) to authorize special monthly compensation to women veterans for loss of 25% or more of tissue from a single breast or both breasts in combination, including loss by mastectomy or partial mastectomy, or following receipt of radiation treatment of breast tissue. In this document we are amending 38 CFR 3.350(a) to reflect that change. We are deleting 38 CFR 3.350(a)(7) because the change to 38 CFR 3.350(a) makes it no longer necessary to define the term “anatomical loss of one or both breasts.”

Section 304 of the Act amended 38 U.S.C. 1562 to provide for an annual increase in the Medal of Honor pension effective December 1 of each year, beginning December 1, 2004, by a percentage equal to the cost of living adjustment of benefits paid under Title II of the Social Security Act. This document amends 38 CFR 3.27 to reflect that change. Section 304 also provides for a retroactive lump sum payment of the Medal of Honor pension from the first day of the month after the date of the event for which the veteran earned the Medal of Honor for current as well as future recipients of the special pension. This document amends 38 CFR 3.802 to reflect that change. In accordance with the Act, no retroactive lump sum payment can be made prior to October 1, 2003.

When Congress does not specify an effective date for a statutory provision, the effective date is the date of enactment. In section 102 of the Act, because Congress did not specify an effective date for the amendment to 38 U.S.C. 1114(k), that amendment was effective December 6, 2002, the date of enactment of the Act. Similarly, in section 304 of the Act, Congress did not specify an effective date for the amendment to 38 U.S.C. 1562 authorizing a retroactive lump sum payment for the Medal of Honor pension, and the amendment was effective December 6, 2002. For certain provisions of the Act, however, Congress specifically provided effective dates that are different from the date of enactment of the Act. In paragraph (d)(1) of section 304 of the Act, Congress specified that the amendment to 38 U.S.C. 1562 authorizing an annual increase in the Medal of Honor pension would be effective September 1, 2003.

For certain provisions in the Act, the effective date of the provision governs the date on which benefit eligibility can arise. For instance, section 102 of the Act authorizes, as of December 6, 2002, special monthly compensation for women veterans who suffered the “loss of 25 percent or more of tissue from a single breast or both breasts in combination (including loss by mastectomy or partial mastectomy) or has received radiation treatment of breast tissue.” For certain other provisions, Congress provided that, although the amendment was effective immediately, benefit eligibility would not arise until a later date. In paragraph (d)(2) of section 304 of the Act, Congress specified that VA would not make any annual adjustment to the monthly Medal of Honor pension in 2003. Therefore, the first annual adjustment would be made on December 1, 2004. Also, in paragraph (d)(1) of section 304, Congress specifically noted that no retroactive lump sum payment of the Medal of Honor pension would be made prior to October 1, 2003. These effective dates and rules governing eligibility are reflected in the effective-date and substantive provisions of this notice.

Changes made by this final rule merely reflect new statutory provisions. Accordingly, there is a basis for dispensing with prior notice and comment and delayed effective date provisions of 5 U.S.C. 552 and 553.

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 will have no such effect on State, local, or tribal governments, or the private sector.

The Office of Management and Budget has reviewed this document under Executive Order 12866.

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 the adoption of this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The final rule does not affect any small entities. Only individuals could be directly affected. Therefore, pursuant to 5 U.S.C. 605(B), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance program number for this rule is 64.109.

In a document published in the Federal Register on March 19, 2003 at 68 FR 13590, we promulgated an interim final rule that revised the regulations concerning the VA Homeless Providers Grant and Per Diem Program as explained in the SUMMARY portion of this document.

We provided a 60-day comment period that ended May 19, 2003. We did not receive any comments. Based on the rationale set forth in the interim final rule, we are adopting the provisions of the interim final rule as a final rule without any changes, except for the addition of OMB's information collection requirements approval number for the affected sections.

This final rule is issued under authority of 38 U.S.C. 501, 2002, 2011, 2012, 2061, 2064, and 7721 note.

This final rule contains new collections of information under the Paperwork Reduction at §§ 61.11, 61.15, 61.17, 61.20, 61.31, 61.41, 61.51, 61.55 and 61.80. We described the new information collections in the preamble of the interim final rule and provided comment periods on both emergency and non-emergency bases. We did not receive any comments concerning the new information collections. The Office of Management and Budget has assigned control number 2900-0554 to the new information collections. VA may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays this currently valid OMB control number.

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

The Secretary hereby certifies that the final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-602. In all likelihood, only similar entities that are small entities will participate in the Homeless Providers Grant and Per Diem Program. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirement of sections 603 and 604.

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 such effect on State, local, or tribal governments, or the private sector.

The Catalog of Federal Domestic Assistance program number is 64.024.

Please see the information provided in the direct final action published in the Federal Register on June 26, 2003 (68 FR 37973) and in the companion proposed rule which was also published on June 26, 2003 (68 FR 37993).

The use of “we,” “us,” or “our” in this document refers to EPA.

In a Federal Register notice published on December 11, 2001, (66 FR 63972) EPA proposed to approve the 1-hour ozone attainment demonstration for the Atlanta 1-hour ozone nonattainment area which was submitted by the GAEPD on July 17, 2001, and extend the attainment date to November 15, 2004. Additionally, in the alternative, EPA proposed to find that the Atlanta area had failed to attain the 1-hour ozone NAAQS by November 15, 1999, the date set forth in the CAA for serious nonattainment areas. Subsequently, in a Federal Register notice published on May 7, 2002, (67 FR 30574) EPA granted final approval to the 1-hour ozone attainment demonstration for the Atlanta area as submitted on July 17, 2001, the Reasonably Available Control Measures (RACM) analysis, commitment to perform an early attainment assessment, contingency measures, the 2004 motor vehicle emissions budget (MVEB), and the Partnership for a Smog Free Georgia (PSG) program, and EPA extended the area's attainment date to November 15, 2004. At that time, EPA did not finalize the finding of failure to attain and the Atlanta area remained classified as a serious nonattainment area.

EPA cited its July 16, 1998, guidance memorandum entitled “Extension of Attainment Dates for Downwind Areas” which was published in a notice of interpretation on March 25, 1999, (64 FR 14441) as justification for the extension of the attainment date without reclassification. On July 2, 2002, the D.C. Circuit Court, Sierra Club v. EPA, 294 F.3d 155, determined that the CAA precluded the attainment date extension policy as a matter of law. The Seventh Circuit, Sierra Club v. EPA, , 311 F.3d 853 (7th Cir. Nov. 25, 2002), and the Fifth Circuit, Sierra Club v. EPA, 314 F.3d 735 (5th Cir. Dec. 11, 2002) subsequently issued opinions that reached the same conclusion with respect to extensions granted to St. Louis, MO and Beaumont, TX  1 . In light of the decisions of these circuits, on February 20, 2003, the EPA filed a motion for voluntary vacatur of its extension of the attainment date deadline for the Atlanta 1-hour ozone nonattainment area and its approval of the Atlanta area 1-hour ozone attainment demonstration SIP. The Eleventh Circuit Court of Appeals granted EPA's request on June 16, 2003, and the Court remanded the matter to EPA for further proceedings consistent with the court's order.

The Atlanta 1-hour ozone nonattainment area consists of the following counties: Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Henry, Paulding, and Rockdale.

Section 110 of the CAA requires states to develop air pollution regulations and control strategies to ensure that state air quality meets the NAAQS established by EPA. These ambient standards are established under section 109 of the CAA, and they currently address six criteria pollutants: carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each state must submit these regulations and control strategies to us for approval and incorporation into the Federally-enforceable SIP. Each Federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin. These SIPs can be extensive. They may contain state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations.

The 1-hour ozone standard of 0.12 parts per million (ppm) was promulgated in 1979. The 1-hour ozone standard continues to apply to the Atlanta area, and it is the classification of the Atlanta area with respect to the 1-hour ozone standard that is addressed in this document.

On December 11, 2001, EPA proposed its finding that the Atlanta area did not attain the 1-hour ozone standard by the applicable date (66 FR 63972). In that notice of proposed rulemaking we discussed how we believed the provisions of section 181(b)(2), the relevant sections of the CAA regarding determinations of attainment and reclassifications for failure to attain, would apply to the Atlanta area. The proposed finding was based upon ambient ozone concentration data for the period 1997 through 1999, from the monitoring sites in the Atlanta area, several of which recorded an average of more than one exceedance per year.

Section 181(b)(2)(A) of the CAA requires that when EPA determines that an area has not attained the standard by its statutorily required date the area shall be reclassified by operation of law to the higher of:

(1) The next higher classification for the area, or

(2) The classification applicable to the area's design value as determined at the time EPA publishes its notice that the area failed to attain.

Even if a serious area's design value at the time of reclassification is lower than the design value for serious areas that serious area cannot be reclassified to a lower classification because the minimum statutory classification resulting from a failure to attain is severe. No area can be reclassified to a category higher than severe. Extreme is the only classification higher than severe, but the statute does not permit reclassification to this level.

The air quality data upon which we made the proposed finding of failure to attain the ozone NAAQS were available for comment in our December 11, 2001, notice of proposed rulemaking. We received no adverse comments pertaining to that air quality data and the proposed determination of nonattainment.

EPA has determined that the relevant air quality data for the period of 1997 through 1999, inclusive, for the Atlanta area shows that the Atlanta area contained at least one monitor with an average annual number of expected exceedances that was greater than the 1.0 allowed by the 1-hour ozone NAAQS. Therefore, we make the determination pursuant to section 181(b)(2)(B) of the CAA that the Atlanta area did not attain the 1-hour ozone standard by the November 15, 1999, attainment date, and that the area is reclassified by operation of law to severe nonattainment on the effective date of this rule.

On May 7, 2002, EPA granted final approval to the 1-hour ozone attainment demonstration for the Atlanta area and extended the attainment date to November 15, 2004. Subsequently, the Southern Organizing Committee for Economic and Social Justice, the Georgia Coalition for the People's Agenda and the Sierra Club petitioned for review of the agency's action to the 11th Circuit Court of Appeals. Due to a series of prior rulings in other circuits that EPA's attainment date extension policy was invalid as a matter of law, EPA filed a motion for voluntary vacatur with the 11th Circuit Court of Appeals on February 20, 2003. The 11th Circuit granted the request for voluntary vacatur on June 16, 2003, and remanded the matter to the agency for further proceedings consistent with the court's order.

In this action, EPA is issuing a final determination pursuant to section 181(b)(2) of the CAA, that the Atlanta area did not attain the 1-hour ozone NAAQS by November 15, 1999. In doing so, EPA is fulfilling our nondiscretionary duty pursuant to the CAA. As a result of this final determination, the Atlanta area is reclassified by operation of law to severe ozone nonattainment pursuant to section 181(b)(2) of the CAA. In addition, this action sets the dates by which the Atlanta area must submit a SIP revision addressing the CAA's pollution control requirements for severe ozone nonattainment areas (the “severe area SIP”) and to attain the 1-hour NAAQS for ozone.

Section 182(i) states that the Administrator may adjust applicable deadlines (other than attainment dates) to the extent such adjustment is necessary or appropriate to assure consistency for submission of the requirements applicable to the reclassified area. An area reclassified to severe is required to submit SIP revisions addressing the severe area requirements for the 1-hour ozone NAAQS in section 182(d) and the penalty requirement in section 185.

In the December 11, 2001, (66 FR 63972) supplemental proposed rule EPA requested comment on the time frame for the State to submit the severe area SIP requirements. The proposal requested comment on two potential time frames of 12 months and 18 months. No comments were received by EPA on this issue. Due to the short time frames, GAEPD in a letter dated September 8, 2003, agreed to submit all SIPs, with one exception, by July 1, 2004, which is less than the proposed time frames. The one exception is the section 185 penalty rule. This SIP is due 18 months after the effective date of this action, July 1, 2005, because the State will need the full 18 months to acquire the necessary statutory authority to implement this rule.

Section 181(b)(2)(A) of the CAA requires that, when an area is reclassified for failure to attain, its reclassification be the higher of the next higher classification or the classification applicable to the area's ozone design value at the time the notice of reclassification is published in the Federal Register . Section 181(b)(2)(A)(ii) provides that no area shall be reclassified as Extreme. The Atlanta area is a serious nonattainment area with a design value of 0.156 ppm based on monitoring data for the years 1997 to 1999. Therefore, the Atlanta area is reclassified, by operation of law, as a severe nonattainment area.

EPA is setting the effective date of this action as January 1, 2004, because the GAEPD has calendar year contracts for sampling for the Georgia fuel rule, as well as, calendar year reporting requirements. The same suppliers and importers for the Georgia fuel rule will be impacted by the requirement, beginning one year after the effective date of the reclassification, to supply gasoline that complies with the federal reformulated gasoline standards. Therefore, this effective date will minimize complications regarding reporting and compliance with both the State and federal fuel requirements.

Under section 181(a)(1) of the CAA, the new severe area attainment deadline for the Atlanta area as reclassified pursuant to section 181(b)(2) is as expeditiously as practicable but no later than November 15, 2005. The expeditiously as practicable attainment date will be determined as part of the approval of the severe area attainment demonstration.

Under section 181(a)(1) of the CAA, the attainment deadline for serious ozone nonattainment areas reclassified to severe under section 181(b)(2) is as expeditiously as practicable but no later than November 15, 2005. Under section 182(i), such areas are required to submit SIP revisions addressing the severe area requirements for the 1-hour ozone NAAQS. Under section 182(d), severe area plans are required to meet all the requirements for serious area plans plus the requirements for severe areas, including, but not limited to: (1) A 25 ton per year major stationary source threshold; (2) additional reasonably available control technology (RACT) rules for sources subject to the new lower major applicability cutoff; (3) a new source review (NSR) offset requirement of at least 1.3 to 1; (4) a post-1999 rate-of-progress plan containing emission reductions of ozone precursors of at least 3 percent per year from November 15, 1999, until the attainment date; and (5) additional transportation control measures (TCMs) needed to offset growth in emissions due to growth in vehicle miles traveled (VMT); and (6) a fee requirement for major sources of volatile organic compounds (VOC) and nitrogen oxides (NO X ) should the area fail to attain by 2005. Additionally, section 211 “Reformulated Gasoline and Oxygenated Gasoline” of CAA requires any area reclassified from “serious” to “severe” to implement reformulated gasoline. We have issued a “General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990” that sets forth our preliminary views on these section 182 requirements and how we will act on SIPs submitted under Title I. See 57 FR 13498 (April 16, 1992) and 57 FR 18070 (April 28, 1992). Further, Georgia is required to submit a revision to the SIP containing contingency measures under sections 172(c)(9) and 182(c)(9) for its severe area SIP to meet ROP requirements and for failure to attain.

The GAEPD's severe SIP for the Atlanta area must also contain adopted regulations, and/or enforceable commitments to adopt and implement control measures in regulatory form by specified dates, sufficient to make the required rate-of-progress and to attain the 1-hour ozone NAAQS as expeditiously as practicable but no later than November 15, 2005. These adopted regulations must include, at a minimum, the regulations to meet the specific requirements listed above and any other emission reductions necessary to achieve attainment.

The section 182(c)(2)(B) reasonable further progress requirement requires volatile organic compounds (VOC) or nitrogen oxides (NO X ) reductions of 3 percent per year, averaged over a 3-year period, until the attainment date, for serious and above ozone nonattainment areas designated and classified under the 1-hour ozone NAAQS. The EPA refers to these reductions as the ROP requirement.

The first required post-1999 ROP 9 percent reduction originally was required by November 15, 2002 under the CAA. However, that date has elapsed prior to the time Atlanta was redesignated and first became subject to the requirement. Therefore, in this action EPA is allowing the Atlanta area to demonstrate that the first required post-1999 9 percent ROP is achieved as expeditiously as practicable after November 15, 2002, but in any case no later than November 15, 2005. EPA is also allowing the Atlanta area to link contingency measures for the 2002 ROP milestone to this new date.

In light of the fact that the statutory deadline has passed, it is impossible for the State to demonstrate any progress by a date that passed before the time the area became classified as a severe area and thus first became subject to the requirement to demonstrate post-1999 ROP. EPA agrees that the Atlanta area must now demonstrate such progress, but reasonably concludes that the State must have some time in which to actually develop and implement the measures to achieve such ROP. EPA has addressed similar issues on several occasions in the past when areas for various reasons have not timely submitted progress SIPs, and when the date for achieving progress had passed prior to EPA action on a progress SIP. EPA has routinely concluded in these circumstances that the area should demonstrate the required ROP as expeditiously as practicable once the statutory date for achieving such ROP had passed. See, e.g. , 65 FR 31485 (May 18, 2000), 63 FR 28898 (May 27, 1998), 62 FR 31343 (June 9, 1997). Even though there is no provision in the statute expressly addressing the situation where an area has failed to timely submit a progress SIP, EPA must fill the statutory gap where such SIPs are submitted after the date for achieving progress, and EPA has reasonably done so in this case by following its past practice of requiring such SIPs to demonstrate ROP as expeditiously as practicable. Although no court has directly addressed the issue of the propriety of this “as expeditious as practicable” standard, courts have addressed other issues concerning ROP plans submitted after the statutory date for achieving ROP, which have demonstrated ROP as expeditiously as practicable, without expressing any concern with that standard. See, e.g., Sierra Club v. EPA , 252 F.3d 943 (8th Cir. 2001) (Court upheld calculation methods used in 15 percent ROP plan submitted three years after statutory date demonstrating achievement of ROP seven years after statutory date).

For the reasons set forth in this final rulemaking notice and pursuant to section 182(i) of the CAA, EPA is allowing the Atlanta area to demonstrate the first required post-1999 9 percent ROP, due under the CAA by November 15, 2002, as expeditiously as practicable after that date (but in any case no later than November 15, 2005) in the event that control measures currently in the Atlanta area SIP or already promulgated by EPA did not achieve the required 9 percent reduction by November 15, 2002.

The severe area SIP will have to provide for a total of a 3 percent per year reduction from base line emissions between November 15, 1999, and the attainment year. Because the 2002 ROP deadline is now past, the ROP reduction requirement for the period 1999 to 2002 will have to be achieved as expeditiously as practicable after November 15, 2002. EPA understands that the GAEPD would likely submit one ROP plan which includes all the ROP required until the attainment date, and will demonstrate that the 1999-2002 increment is achieved as expeditiously as practicable. The State must submit by July 1, 2004, an ROP plan to achieve a three percent reduction in the precursor emissions per year until the as expeditiously as practicable attainment year. Additionally, the area must submit adequate on-road mobile source emission budgets consistent with that plan.

Because EPA is allowing the GAEPD to demonstrate the first required post-1999 9 percent ROP, due under the CAA by November 15, 2002, as expeditiously as practicable after that date (but in any case no later than November 15, 2005), EPA is also allowing the GAEPD to adopt contingency measures keyed to this new date. Thus, the GAEPD must submit contingency measures to take effect if the area fails to achieve the first post 1999 9 percent ROP by the as expeditiously as practicable date.

The January 18, 2002, memorandum from John S. Seitz and Margo Tsirigotis Oge “Policy Guidance for the Use of MOBILE6 in SIP Development and Transportation Conformity” indicates, among other things, that newly developed SIPS, including the motor vehicle emissions budgets in the post-1999 rate-of-progress plans, will have to be developed using MOBILE6. Using MOBILE6 may require a revision to the 1990 base year inventory and ROP targets.

Upon reclassification to severe, the major stationary source threshold will be lowered. Consequently, the State's Title V operating permits program regulations need to cover existing sources that will become subject to the appropriate lower major stationary source threshold. Any new major stationary sources must submit a timely Title V permit application. “A timely application for a source applying for a part 70 permit for the first time is one that is submitted within 12 months after the source becomes subject to the permit program or on or before such earlier date as the permitting authority may establish.” See 40 CFR 70.5(a)(1). The 12 month (or earlier date set by the applicable permitting authority) time period to submit a timely application will commence on the effective date of the reclassification.

On May 7, 2002, EPA granted final approval to the 1-hour ozone attainment demonstration for the Atlanta area and extended the attainment date to November 15, 2004, (see 67 FR 30574). Subsequently, the Southern Organizing Committee for Economic and Social Justice, the Georgia Coalition for the People's Agenda and the Sierra Club petitioned for review of the agency's action to the 11th Circuit Court of Appeals alleging that EPA exceeded its authority because the CAA precludes extension of attainment dates. Due to a series of prior rulings, in other cases, which held that EPA's attainment date extension policy was an invalid exercise of EPA's authority, on February 20, 2003, EPA filed, with the 11th Circuit, a motion for voluntary vacatur of the attainment date extension for the Atlanta area and of EPA's approval of the attainment demonstration. On June 16, 2003, the 11th Circuit granted the request for voluntary vacatur and remanded the matter to the agency for further proceedings consistent with this order.

One result of vacating the attainment demonstration for the Atlanta area is that the MVEBs contained in that approval were vacated as well. The vacatur of the MVEB resulted in reverting to the previously approved MVEBs for the purposes of transportation conformity. These budgets can be found in the approval of the 15 Percent Rate of Progress plan and the Post 1996 Rate of Progress Plan. These plans were granted final approval on April 26, 1999, ( see 64 FR 20186) and March 18, 1999, ( see 64 FR 13348), respectively.

In the December 11, 2001, notice of supplemental proposed rulemaking (66 FR 63972) for this action, EPA proposed to find that the Atlanta area had failed to attain the 1-hour ozone NAAQS by November 15, 1999, the date set forth in the CAA for serious nonattainment areas and that if EPA finalized this finding, the Atlanta area would be reclassified, by operation of law, as a severe nonattainment area. EPA also solicited comment on the schedule for submittal of the SIP revisions required for severe areas should the area be reclassified.

In this document, EPA is responding to adverse comments that are germane to this final action and which were submitted in response to the December 11, 2001 (66 FR 63972), supplemental proposed rulemaking. EPA received no adverse comments pertaining to the data used for our nonattainment determination, and therefore we are making the determination that the Atlanta area did not attain by its attainment deadline.

Comment: Reclassification to severe nonattainment would not shorten the time for meeting Atlanta's air quality goals. In fact, it would extend the time for compliance to at least 2005. Regardless of whether EPA grants an extension pursuant to the downwind extension policy, EPA is prohibited from reclassifying the Atlanta area under Subpart 2 of the federal CAA. Under 42 U.S.C. 7509(c), an area can be reclassified only if EPA makes a formal finding “[w]ithin 6 months following the applicable attainment date” that the area failed to attain the ozone NAAQS. EPA did not make such a determination within six months of the nominal 1999 attainment deadline for the Atlanta area, and thus is now prohibited from doing so.

Response: EPA agrees that reclassification must be based on a notice and comment rulemaking. See D.C. Circuit Slip opinion Sierra Club v. Whitman No. 01-5123 and 015299 April 5, 2002, Slip Opinion (D.C. Cir). EPA does not agree, however, that missing a mandatory deadline means that EPA loses the power to act to discharge the duty to which the deadline applied. EPA retains the power to act to discharge the duty after the deadline has passed. Southwestern Pennsylvania Growth Alliance v. Browner , 121 F.3d 106, 113-114 (3d Cir. 1997). (EPA does not lose power to perform mandatory duty to act on redesignation request after 18-month statutory period has elapsed).

For the reasons set forth in the notice of proposed rulemaking and in this final rulemaking notice, EPA has determined that the Atlanta 1-hour ozone nonattainment area failed to attain the 1-hour ozone NAAQS by November 15, 1999, as required by section 181(a) of the CAA, and the Atlanta 1-hour ozone nonattainment area is reclassified by operation of law to severe ozone nonattainment pursuant to section 181(b)(2) of the CAA.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA is required to determine whether regulatory actions are significant and therefore should be subject to Office of Management and Budget (OMB) review, economic analysis, and the requirements of the Executive Order. The Executive Order defines a “significant regulatory action” as one that is likely to result in a rule that may meet at least one of the four criteria identified in section 3(f), including, under paragraph (1), that the rule may “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.”

The Agency has determined that the finding of nonattainment would result in none of the effects identified in section 3(f) of the Executive Order. Under section 181(b)(2) of the CAA, determinations of nonattainment are based upon air quality considerations and the resulting reclassifications must occur by operation of law. They do not, in and of themselves, impose any new requirements on any sectors of the economy. In addition, because the statutory requirements are clearly defined with respect to the differently classified areas, and because those requirements are automatically triggered by classifications that, in turn, are triggered by air quality values, determinations of nonattainment and reclassification cannot be said to impose a materially adverse impact on state, local, or tribal governments or communities.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This final action to reclassify the Atlanta area as a severe ozone nonattainment area and to adjust applicable deadlines does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

This final action to reclassify the Atlanta area as a severe ozone nonattainment area and to adjust applicable deadlines does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

Determinations of nonattainment and the resulting reclassification of nonattainment areas by operation of law under section 181(b)(2) of the CAA do not in and of themselves create any new requirements. Instead, this rulemaking only makes a factual determination, and does not directly regulate any entities. See 62 FR 60001, 60007-8, and 60010 (November 6, 1997) for additional analysis of the RFA implications of attainment determinations. Therefore, pursuant to 5 U.S.C. 605(b), I certify that this final action does not have a significant impact on a substantial number of small entities within the meaning of those terms for RFA purposes.

Under section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated annual costs to state, local, or tribal governments in the aggregate, or to the private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA believes, as discussed previously in this document, that the finding of nonattainment is a factual determination based upon air quality considerations and that the resulting reclassification of the area must occur by operation of law. Thus, EPA believes that the proposed finding does not constitute a Federal mandate, as defined in section 101 of the UMRA, because it does not impose an enforceable duty on any entity.

Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be economically significant as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. This final action is not subject to Executive Order 13045 because this is not an economically significant regulatory action as defined by Executive Order 12866.

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by state and local officials in the development of regulatory policies that have Federalism implications.” “Policies that have federalism implications” 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.” Under Executive Order 13132, EPA may not issue a regulation that has Federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal Government provides the funds necessary to pay the direct compliance costs incurred by state and local governments, or EPA consults with state and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has Federalism implications and that preempts state law unless the Agency consults with state and local officials early in the process of developing the proposed regulation. This determination of nonattainment and the resulting reclassification of a nonattainment area by operation of law will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because this action does not, in and of itself, impose any new requirements on any sectors of the economy, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. Thus, the requirements of section 6 of the Executive Order do not apply to these actions.

This final rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

Under Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), EPA must prepare for those matters identified as significant energy actions. A “Significant energy action” is any action by an agency (normally published in the Federal Register ) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking that is a significant regulatory action under Executive Order 12866 and is likely to have a significant adverse effect on the supply, distribution, or use of energy. Under Executive Order 12866, this action is not a “significant regulatory action”. For this reason, the proposed finding of nonattainment and reclassification is also not subject to Executive Order 13211.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 25, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action to reclassify the Atlanta area as a severe ozone nonattainment area and to adjust applicable deadlines may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in FOR FURTHER INFORMATION CONTACT . 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-2003-0264. 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 August 13, 2003 (68 FR 48362) (FRL-7321-7), 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 a pesticide petition (PP 0F6166) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709-3528. That notice included a summary of the petition prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.500 be amended by establishing a tolerance for residues of the herbicide imazapyr, in or on grass, forage at 100 parts per million (ppm); grass, hay at 30 ppm; fish at 1.0 ppm; shellfish at 0.10 ppm; fats of cattle, sheep, goats, and horses 0.05 ppm; kidney of cattle, sheep, goats, and horses at 0.20 ppm; meat byproducts (except kidney) of cattle, sheep, goats, and horses at 0.05 ppm; meat of cattle, sheep, goats, and horses at 0.05 ppm; and milk at 0.01 ppm.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) 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 residues of imazapyr on grass, forage at 100 ppm; grass, hay at 30 ppm; fish at 1.0 ppm; shellfish at 0.10 ppm; fats of cattle, sheep, goats, and horses 0.05 ppm; kidney of cattle, sheep, goats, and horses at 0.20 ppm; meat byproducts (except kidney) of cattle, sheep, goats, and horses at 0.05 ppm; meat of cattle, sheep, goats, and horses at 0.05 ppm; and milk at 0.01 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 imazapyr are discussed in Tables 1 and 2 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the margin of exposure (MOE). A UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (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.

A summary of the toxicological endpoints for imazapyr used for human risk assessment is shown in Table 3 of this unit:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.500) for the residues of imazapyr, in or on corn, field, forage; corn, field, grain; and corn field, stover at 0.05 ppm. Risk assessments were conducted by EPA to assess dietary exposures from imazapyr in food as follows:

i. Acute exposure . Quantitative 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. No appropriate endpoint attributable to a single exposure was identified for imazapyr.

ii. Chronic exposure .In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The dietary exposure analysis assumed 100% crop treated tolerances and residues. Based on total food exposure for imazapyr, all population subgroups are below 1% cPAD (Chronic Population Adjusted Dose).

iii. Cancer . Imazapyr showed no evidence of carcinogenicity in at least 2 adequate animal tests in different species, and therefore, a quantitative cancer risk assessment was not performed.

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

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow groundwater. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

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

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

Based on the FIRST and SCI-GROW models the estimated environmental concentrations (EECs) of imazapyr for acute exposures are estimated to be 137 parts per billion (ppb) for surface water and 1,700 ppb for ground water. The EECs for chronic exposures are estimated to be 81 ppb for surface water and 1,700 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). Imazapyr is currently registered for use on the following residential sites that could result in non-occupational, non-dietary exposure: Driveways, parking areas, brick and gravel pathways, patios, and along sidewalks and bare ground. In addition to residential sites on which imazapyr is registered, there is the possibility of recreational exposure for post application exposure from the registered use on golf courses and fairgrounds and exposure from incidental ingestion and dermal exposure from swimming in treated water from the proposed aquatic weed control use. The risk assessment was conducted using the following exposure assumptions:

i. Residential handler . Short-term (1 to 30 days) dermal and inhalation exposure from mixing, loading and application via sprinkler can could occur. For the Outdoor Residential Exposure Task Force study reviewed, the Health Effects Division (HED) used a hose-end sprayer as surrogate data for the sprinkler can scenario. The registered label states that the product offers long-term weed control and prevents re-growth for up to one year with a single application; therefore only short-term handler exposures are anticipated.

ii. Residential post-application . Adults and children are anticipated to have short-term dermal exposures; however, given that the product is not intended for lawn use, dermal exposures by adults and children are considered to be negligible as compared to recreational post-application exposures. (See fairground post-application). However, toddlers could potentially ingest soil from treated bare ground in the residential use scenario. The assumptions used to assess the soil ingestion scenario were: Day of treatment residues are assumed to be available for short-term exposure, toddler body weight is estimated at 15 kg, 100 % of application rate is available in the top 1 cm of soil for soil ingestion exposures, and a toddler can possibly ingest 100 mg soil/day.

iii. Golfer post-application . Golfer exposure assumptions are: One round of golf (18 holes) takes 4 hours and an average golfer plays 18 times per year, so short-term dermal exposures are anticipated. Inhalation exposures are considered to be negligible since the vapor pressure of imazapyr was reported by the registrant to be < 2x 10 - 7 mm Hg (vs. HED ExpoSAC vapor pressure threshold of 1 x 10 - 5 mm Hg). 5% of the maximum application rate is available as turf transferrable residues (TTR) available on Day 0 (assumes no dissipation). The transfer coefficient (TC) for dermal exposure is assumed to be 500 cm2/hr based on golfers wearing short pants and short-sleeved shirts. The exposure estimate for child golfers is 1.7 times the adult exposure estimate to account for differences in body weight and surface area. Maximum labeled application rate is 0.0041 lb ae/A broadcast liquid formulation applications.

iv. Fairground post-application .—a. The following assumptions were used to assess dermal exposures to adults and toddlers after contact with treated lawns: Adult and toddler body weights are 70 kg and 15 kg respectively, 5% of the maximum application rate represents fraction of imazapyr available as dislodgeable foliar reside (DFR) on the day of treatment. Dermal TC for adults is 14,500 cm2/hr, and for toddlers, 5,200 cm2/hr with an exposure duration of 2 hours.

b. To assess hand-to-mouth exposures for toddlers after contact with treated turf, the following assumptions were used: residues are assumed to be available for the short-term and intermediate-term exposure durations. Toddler body weight is 15 kg, hand surface area is 20 cm2, and a toddler performs 20 hand-to-mouth events per hour for short-term exposures. 5% of application rate represents fraction of imazapyr available for transfer to hands on the day of treatment with a 50% saliva extraction factor. 100% of the application rate is available in the top 1 cm of soil for soil ingestion exposures, and a toddler can ingest 100 mg of soil a day. The exposure duration is 2 hours per day.

c. To assess object-to-mouth exposures for toddlers after contact with treated turf, the following assumptions were used: Residues are assumed to be available for the short-term and intermediate-term exposure durations, the toddlers' body weight is 15 kg, 20% of the application rate is available as dislodgeable residues on the day of treatment, the object area is 25 cm2, 100% of the application rate is available in the top 1 cm of soil for soil ingestion exposures,a toddler can ingest 100 mg of soil a day, and the exposure duration is 2 hours per day.

v. Swimmer post-application . For incidental ingestion and dermal exposure, the following assumptions are made: The worst-case estimate of imazapyr in the top one-foot of the water column in a treated waterbody is 550 ppb. 100% of this concentration is assumed available for ingestion at a rate of 0.05 L/hr. The exposure duration is 2 hours a day for non-competitive adult and child swimmers. Body weights of 70 kg for adults, 29 kg for children, and 15 kg for toddlers are assumed. For dermal exposure, the body surface area of an adult is 20,670 cm2 and 14,580 cm2 for toddlers and children. The permeability coefficient is assumed at 5.85 x 10 - 5 cm/hr.

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 imazapyr 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, imazapyr 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 imazapyr has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. In general . Section 408 of the FFDCA provides that EPA shall apply an additional ten-fold 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 . No prenatal or postnatal sensitivity was found.

3. Conclusion . There is a complete toxicity data base for imazapyr and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency has determined that the Special FQPA SF of 10x can be reduced to 1x because:

i. Lack of concern for pre- and post-natal toxicity.

ii. No qualitative/quantitative evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure was reported in the developmental studies at doses up to 1,000 mg/kg/day (limit dose) in the rat and 400 mg/kg/day (HDT) in the rabbit.

iii. There is no concern for developmental neurotoxicity resulting from exposure to imazapyr. While there were no neurotoxicity studies available from the published literature, there was no evidence of neurotoxicity/neuropathology in adult animals in the available studies.

iv. The toxicology database is complete based on the developmental studies in the rat and rabbit and the 2-generation reproduction study in the rat

v. No developmental neurotoxicity (DNT) study was required.

vi. No residual uncertainties were identified in the exposure database.

vii. The chronic dietary food exposure assessment utilizes tolerance level residues and 100% CT information for all commodities. By using these screening level assumptions, actual exposures/risks will not be underestimated.

viii. The dietary drinking water assessment utilizes water concentration values generated by models and associated modeling parameters which are designed to provide conservative, health-protective, high-end estimates of water concentrations which will not likely be exceeded.

ix. Residential exposure and risk were assessed using standard assumptions from Science Advisory Council on Exposure (Expo SAC) Standard Operating Procedure (SOP). These assumptions are not expected to underestimate risk.

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

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 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 groundwater are less than the calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . No acute risk from exposure to imazapyr is expected because there were no toxic effects of concern attributable to a single dose identified in available data.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to imazapyr from food will utilize < 1% of the cPAD for the U.S. population, < 1% of the cPAD for all infants ( < 1 year old) and < 1% of the cPAD for children ages 1-2 years old. Based the use pattern, chronic residential exposure to residues of imazapyr is not expected. In addition, there is potential for chronic dietary exposure to imazapyr 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 4 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).

Imazapyr 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 imazapyr. Short-term aggregate risk assessments are required for adults as there is potential for both dermal and inhalation handler exposure, and dermal post-application exposure from the residential and recreational uses of imazapyr on turf and swimmer exposure. In addition, short-term aggregate risk assessments are required for children and toddlers because there is a potential for oral and dermal post-application exposure resulting from the residential uses of imazapyr on turf and from swimming. The short-term residential handler scenario results in the highest exposure for adults. Therefore, for adults, the homeowner handler scenario was aggregated with the chronic dietaryfood exposure for the U.S. General population. The swimmer scenario resulted in the highest exposure for toddlers and children. Therefore, the swimmer scenario exposure estimates were aggregated with the chronic dietary (food) to provide a worst-case estimate of short-term aggregate risk for children 1-2 years old.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 75,000 for the United States population, and 55,000 for children 1-2 years old. These aggregate MOEs do not exceed the Agency's level of concern, an MOE of 100, for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of imazapyr in ground 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 5 of this unit:

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). Though residential exposure could occur with the use of imazapyr, the short-term and intermediate-term endpoints are the same and thus the short-term assessment is conservative for the intermediate-term. 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 . Imazapyr is not expected to pose a cancer risk because no evidence of carcinogenicity was found in at least 2 adequate animal tests in different species.

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 imazapyr residues.

Two methods are currently listed in the Pesticide Analytical Manual (PAM) Vol. II for enforcing tolerances of imazapyr in or on corn commodities; Method M 2468 is a gas chromatography/mass spectrometry (GC/MS) methods with a limit of quantitation (LOQ) of -0.01 ppm for imazapyr in or on corn grain, forage and fodder, and Method M 2657 is a capillary electrophoresis (CE) method with ultraviolet (UV) detection that has a LOQ of 0.05 ppm for imazapyr in or on corn grain, forage and fodder.

CE/UV methods were proposed for determining imazapyr in or on grass forage and hay (M 3023), in livestock tissues (M 3184), in milk and milk fat (M 3075 and M 3223), and in fish and shellfish tissues (M 3066). These methods are similar to the current enforcement method M 2657, and based on the concurrent method recovery data submitted, are adequate for collecting data on residues of imazapyr in grass forage and hay, cattle tissues and milk, and fish and shellfish.

The CE/UV Methods M 3023, M 3184, M 3075, and M 3066 have been forwarded to the Analytical Chemistry (ACB) for petition method validation (PMV) trials. Conclusions regarding the suitability of the proposed enforcement methods will be deferred until completion of the PMV trials.

There are no Codex, Canadian, or Mexican maximum residue limits (MRLs) for residues of imazapyr in or on any of the crops involved in the proposed new uses.

Prior to granting unconditional registration, the registrant will be required to address the following issues:

1. Fish metabolism study

2. Corn or grass storage stability information or study

3. Additional spray additive information supporting the grass field trials.

Therefore, the tolerance is established for residues of imazapyr in or on grass, forage at 100 ppm; grass, hay at 30 ppm; fish at 1.0 ppm; shellfish at 0.10 ppm; fats of cattle, sheep, goats, and horses 0.05 ppm; kidney of cattle, sheep, goats, and horses at 0.20 ppm; meat byproducts (except kidney) of cattle, sheep, goats, and horses at 0.05 ppm; meat of cattle, sheep, goats, and horses at 0.05 ppm; and milk at 0.01 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-2003-0264 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 November 25, 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-2003-0264, 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-2003-0289. 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 August 13, 2003 (68 FR 48377) (FRL-7322-6), 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 a pesticide petition (PP 2F6420) by Valent U.S.A. Corporation, 1333 North California Blvd., Suite 600, Walnut Creek, CA 94596. That notice included a summary of the petition prepared by Valent U.S.A. Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole, in or on cottonseed at 0.05 parts per million (ppm); cotton, gin byproducts (gin trash) at 1.0 ppm, pome fruit (Crop Group 11) at 0.2 ppm, apple, wet pomace at 1.0 ppm, strawberry at 0.5 ppm, and oranges at 0.10 ppm (to support the importation of mandarin oranges into the U.S.). As residues in processed commodities fed to animals may be transferred to milk and edible tissue of ruminants, tolerances were also proposed for animal fat at 0.03 ppm and milk fat at 0.04 ppm.

Based on EPA's review, the petition was revised by the petitioner to propose tolerances for residues of etoxazole on cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 1.0 ppm; fruit, pome, group 11 at 0.20 ppm; apple, wet pomace at 0.50 ppm; strawberry at 0.50 ppm; tangerine at 0.10 ppm; liver of cattle, goat, horse, and sheep at 0.01 ppm; fat of cattle, goat, horse, and sheep at 0.02 ppm; and milk, fat at 0.01 ppm. Although EPA requested a number of changes to the initial petition, the nature of the changes (i.e., clarification and correction of commodity terms and adjustments in tolerance levels) are not considered significant. Therefore, EPA is issuing this as a final action.

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 etoxazole on cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 1.0 ppm; fruit, pome, group 11 at 0.20 ppm; apple, wet pomace at 0.50 ppm; strawberry at 0.50 ppm; tangerine at 0.10 ppm; liver of cattle, goat, horse, and sheep at 0.01 ppm; fat of cattle, goat, horse, and sheep at 0.02 ppm; and milk, fat at 0.01 ppm. 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 nature of the toxic effects caused by etoxazole are discussed in Table 1 of this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The dose at which 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 factors (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 etoxazole used for human risk assessment is shown in Table 2 of this unit:

1. Dietary exposure from food and feed uses . There are currently no food/feed uses or tolerances for etoxazole. Risk assessments were conducted by EPA to assess dietary exposures from etoxazole in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. An endpoint of concern attributable to a single oral dose was not selected for either the general U.S. population (including infants and children) or the females 13-50 years old population subgroup for etoxazole; therefore, an acute dietary exposure analysis was not performed. EPA evaluated the suitability of the developmental toxicity study in rabbits in which the developmental NOAEL of 200 mg/kg/day is based upon increased incidences of 27 presacral vertebrae and 27 presacral vertebrae with 13th ribs (skeletal variations) in the fetuses at the LOAEL of 1,000 mg/kg/day (limit dose). Although these developmental effects may be attributed to a single dose, EPA concluded that these effects are minor in magnitude and were observed only at the limit dose (1,000 mg/kg/day). Therefore, quantitation of the acute risk was not performed.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM ® ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The assessment assumed that 100% of the proposed crops were treated and that all treated crops and livestock had residues of concern at the tolerance level. The general U.S. population and all population subgroups have exposure and risk estimates which are below EPA's LOC (i.e., the cPADs are all below 100%). The most highly exposed subgroup is children 1 to 2 years of age, which utilizes 5% of the cPAD.

iii. Cancer . EPA has determined that etoxazole is not likely to be a human carcinogen and EPA therefore, does not expect it to pose a cancer risk. As a result, a quantitative cancer dietary exposure analysis was not performed.

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

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The 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. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, 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 LOC.

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

Based on the FIRST and SCI-GROW models, the EECs of etoxazole for chronic exposures are estimated to be 1.77 parts per billion (ppb) for surface water and 0.242 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). Etoxazole is not registered for use on any sites that would result in residential exposure.

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

EPA does not have, at this time, available data to determine whether etoxazole 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 etoxazole and any other substances and etoxazole 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 etoxazole 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 . There is qualitative evidence of increased susceptibility following exposure to etoxazole in the rat reproduction study. Therefore, EPA performed a Degree of Concern Analysis to determine the LOC for the effects observed when considered in the context of all available toxicity data, and to identify any residual uncertainties after establishing toxicity endpoints and traditional UF to be used in the risk assessment of this chemical. If residual uncertainties are identified, EPA examines whether these residual uncertainties can be addressed by a special FQPA safety factor and, if so, the size of the factor needed.

In performing the Degree of Concern Analysis, EPA noted that the effects in the pups in the rat reproduction study are well-characterized with a clear NOAEL. In addition, the pup effects occur at the same dose as maternal toxicity. Furthermore, the doses selected for various risk assessment scenarios are lower than the doses that caused off spring toxicity. There are no residual uncertainties for prenatal/postnatal toxicity in this study. Therefore, although there is evidence of increased qualitative susceptibility in the rat reproduction study, the concern is low.

For the reasons stated above, EPA has concluded that there is low concern for prenatal and/or postnatal toxicity resulting from exposure to etoxazole.

3. Conclusion . There is a complete toxicity data base for etoxazole and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be removed. The FQPA factor is removed for the following reasons. The toxicological data base is complete for FQPA assessment and there is low concern for prenatal and/or postnatal toxicity resulting from exposure to etoxazole. The chronic dietary food exposure assessment assumed that 100% of the proposed crops were treated and that all treated crops and livestock had residues of concern at the tolerance level. By using these screening-level assumptions, actual exposures/risks will not be underestimated. In addition, the dietary drinking water assessment utilized modeling results which included conservative assumptions for the parent and all degradates of concern. Since conservative assumptions were used in the water models where environmental fate data are lacking, the water exposure assessment will not underestimate the potential risks for infant, and children. Finally, there are no registered or proposed residential uses for etoxazole.

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

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 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 . As stated above, an endpoint of concern attributable to a single oral dose was not identified in the hazard data base for either the general U.S. population (including infants and children) or the females 13-50 years old population subgroup. Therefore, no acute risk is expected.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to etoxazole from food will utilize 1% of the cPAD for the U.S. population, 3% of the cPAD for all infants less than 1-year old and 5% of the cPAD for children 1 to 2 years old. There are no residential uses for etoxazole that result in chronic residential exposure to etoxazole. In addition, there is potential for chronic dietary exposure to etoxazole in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 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). Etoxazole 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 LOC.

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). Etoxazole 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 LOC.

5. Aggregate cancer risk for U.S. population . Etoxazole has been classified as a “not likely human carcinogen.” Therefore, etoxazole is not expected to pose a cancer risk.

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

Adequate enforcement methodology (example—gas chromotography) 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 .

No Codex, Canadian or Mexican maximum residue limits have been established for residues of etoxazole.

Therefore, the tolerances are established for residues of etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole, in or on cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 1.0 ppm; fruit, pome, group 11 at 0.20 ppm; apple, wet pomace at 0.50 ppm; strawberry at 0.50 ppm; tangerine at 0.10 ppm; liver of cattle, goat, horse, and sheep at 0.01 ppm; fat of cattle, goat, horse, and sheep at 0.02 ppm; and milk, fat at 0.01 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-2003-0289 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 November 25, 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-2003-0289, 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, and pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Industry (NAISC 111, 112, 311, 32532), e.g., Crop production, Animal production, Food manufacturing, and Pesticide manufacturing.

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-2003-0297. 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 January 15, 2003 (68 FR 2032) (FRL-7286-4), 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 petition (PP 2E6517) by IR-4, 681 US Highway 1 South, New Brunswick, NJ 08902-3390. That notice included a summary of the petition prepared by Crompton Manufacturing Company, Inc. (formerly Uniroyal Chemical Company), Middlebury, CT 06749, the registrant.

The petition requested that 40 CFR 180.572 be amended by establishing tolerances for combined residues of the miticide, bifenazate, (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate), in or on the following commodities: Nut, tree, group 14 at 0.20 ppm; okra at 2.0 ppm; peppermint, tops at 25 ppm; pistachio at 0.20 ppm; spearmint, tops at 25 ppm; vegetable, cucurbit, group 9 at 0.75 ppm; and vegetable, fruiting, group 8 at 2.0 ppm. The petition was subsequently amended by IR-4 to also propose tolerances for combined residues of bifenazate and diazinecarboxylic acid in or on almond hulls at 15 ppm; and to propose increases to the established bifenazate meat, meat byproducts and milk tolerances; and to change the tolerance expression for meat, meat byproducts and milk. IR-4 proposes tolerances for combined residues of bifenazate, (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl) hydrazinecarboxylate); diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate); 1,1'-biphenyl, 4-ol; and 1,1'-biphenyl, 4-oxysulfonic acid (expressed as 1,1'-biphenyl, 4-ol) in or on meat and meat byproducts of cattle, goat, hog, horse, and sheep at 0.02 ppm and milk at 0.02 ppm. There were no comments received on these petitions.

EPA has received objections to tolerances it established for residues of bifenazate on a variety of food commodities in a final rule published in the Federal Register of February 1, 2002 (67 FR 4913) (FRL-6818-3). The objections were filed by the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA has initiated a public comment period on them in the Federal Register of June 19, 2002 (67 FR 41628) (FRL-7167-7), which ended on October 16, 2002. Although that proceeding remains ongoing, prior to acting on this current tolerance action, EPA reviewed the bifenazate-specific objections raised by NRDC and has addressed them at relevant points throughout this preamble.

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 combined residues of bifenazate and diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate) on almond, hulls at 15 ppm; nut, tree, group 14 at 0.20 ppm; okra at 2.0 ppm; peppermint, tops at 25 ppm; pistachio at 0.20 ppm; spearmint, tops at 25 ppm; vegetable, cucurbit, group 9 at 0.75 ppm; and vegetable, fruiting, group 8 at 2.0 ppm, and combined residues of bifenazate; diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate); 1,1'-biphenyl, 4-ol; and 1,1'-biphenyl, 4-oxysulfonic acid (expressed as 1,1'-biphenyl, 4-ol) in meat and meat byproducts of cattle, goat, hog, horse, and sheep at 0.02 ppm and milk at 0.02 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follow.

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 bifenazate are discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

In its objection to a separate bifenazate tolerance action, NRDC, asserts that developmental toxicity is a data gap for bifenzate. NRDC appears to be referring to language in the Table 1, Unit III.A. of the Federal Register final rule of February 1, 2002, that states that a clear assessment of developmental toxicity was not possible in the range finding study used to choose the dose levels for the developmental toxicity study in rabbits. The Agency concludes there are acceptable developmental toxicity studies conducted with bifenazate in rats and in rabbits, and an acceptable 2-generation reproduction study in rats, which are described in Table 1. of this unit.

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

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (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 bifenazate used for human risk assessment is shown is shown in Table 2 of this unit:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.572) for the combined residues of bifenazate, and D3598 expressed as bifenazate (diazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-methylethylester), in or on a variety of food commodities.

Risk assessments were conducted by EPA to assess dietary exposures from bifenazate in food as follows:

i. Acute exposure . An acute dietary reference dose (RfD) for the females 13-50 years of age and the general population, including infants and children, was not selected because an acute oral endpoint attributed to a single-dose exposure could not be identified in any of the studies in the toxicology data base, including developmental and maternal toxicity in the developmental toxicity studies.

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 TM ) 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 was made for the chronic exposure assessment: The chronic dietary exposure analysis assumed tolerance level residues and 100% crop treated for all registered and proposed crops excluding tomato where average field trial residues were used. DEEM (ver 7.73) default processing factors were assumed for all commodities excluding apple juice, grape juice, wine/sherry, tomato paste, and tomato puree. The processing factors for these commodities were reduced to 0.23, 0.17, 0.17, 5.0, and 5.0, respectively, based on data from processing studies.

In its objections to the earlier bifenazate tolerance action, NRDC claims that EPA relied upon unsupported and apparently arbitrary processing factors to reduce estimates of dietary exposure to bifenazate on apples and grapes. NRDC was incorrect to assert that the processing factors for apples and grapes were unsupported and arbitrary. The DEEM processing factors for apple juice and grape juice used for this action and the earlier bifenazate tolerance action are based on data from processing studies. In this action, the Agency used DEEM (ver 7.73) default processing factors when processing studies were not available. These default factors are worst case assumptions regarding pesticide partitioning into component commodity fractions. DEEM (ver 7.73) default processing factors assume that 100 percent of the pesticide that was originally present in the commodity is present in the processed fractions. This is a worst case theoretical concentration factor since it assumes that processing does not result in any reduction in pesticide content.

iii. Cancer . EPA has classified bifenazate as a not likely human carcinogen. Therefore, a quantitative cancer dietary exposure and risk assessment was not performed.

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

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 SCI-GROW model is used to predict pesticide concentrations in shallow groundwater. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 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.

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 screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern.

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

Parent bifenazate degrades rapidly in aerobic soil conditions with a half-life of approximately 30 minutes. The first degradate formed (D3598 (diazinecarboxylic acid, 2-(4-methoxy-1,1'- biphenyl-3-yl) (half-life of 7 hours)) was reported in a concentration of 95% of the applied radioactivity. D3598 degrades to D1989 (4-methylethylester) (reported at a maximum of 26% of the applied radioactivity), which is moderately persistent with an EPA-calculated half-life of approximately 96 days. Photodegradation and other routes of dissipation of parent bifenazate do not appear to be significant.

The Agency concluded that the residue of concern in drinking water is D1989. Parent and D3598 were not included as a residue of concern in drinking water due to the short half-lives of these compounds and the lack of an acute dietary endpoint (toxicity of D3598 is assumed to be equivalent to bifenazate). Since ground or surface water monitoring data to calculate a quantitative aggregate exposure are not available, EPA provided Tier I ground (SCI-GROW) and surface water (FIRST) EECs for D1989. Both models were conducted using the strawberry application scenario (one application at 0.75 lbs ai/acre; highest registered/proposed application rate). The resulting ground and surface water chronic EECs are < 0.001 ppb and 6.4 ppb, respectively.

In its objections to a separate bifenazate tolerance action, NRDC asserts that EPA failed to complete an assessment of drinking water exposure to bifenazate degradates. As stated in the Federal Register final rule of February 1, 2002, and restated in this document, EPA considered the environmental persistence of bifenazate and its two major metabolites D3598 and D1989. Aqueous photolysis and soil metabolism studies demonstrated that the parent bifenazate and the D3598 degradate quickly metabolize under aerobic soil conditions. Noting the lack of persistence of these two compounds and the absence of any acute dietary endpoint, EPA focused its drinking water exposure assessment for bifenazate on the degradate (D1989) that had a possibility of being present in drinking water. Accordingly, NRDC is incorrect to assert that potential exposure to bifenazate degredates in drinking water was not assessed by EPA.

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). In its objections to a separate bifenazate tolerance action, NRDC asserts that EPA failed to assess and incorporate residential uses as a source of aggregate exposure. In the current risk assessment, EPA calculated short-term residential risks to homeowner applicators. However, the Agency concluded that no significant post-application exposure is aniticipated from landscape ornamentals; therefore, no residential post-application assessment was conducted.

Bifenazate is currently registered for use on the following residential non-dietary sites: Commercial application to ornamental plants (including bedding plants, flowering plants, foliage plants, bulb crops, perennials, trees and shrubs; not turf) and all fruit trees which will not bear fruit for a minimum of 12 months. The registrant has proposed an amendment to the Floramite (EPA Reg. No. 400-508) label to permit application to home ornamental plants and fruit trees that will not bear fruit within 12 months by residents/homeowners. The risk assessment was conducted using the following residential exposure assumptions: EPA anticipates only short-term dermal and short-term inhalation exposure for the residential handler (applicator). The proposed formulation is appropriate for application via pump up sprayers, garden hose-end sprayers or similar homeowner pesticide devices. A larger area per day may be treated with a hose-end sprayer than with a pump up compressed air sprayer, which in turn results in possibly greater contact with the active ingredient per day. Therefore, exposure from a hose-end sprayer is assessed rather than that of a compressed air sprayer. For the treatment of shrubs and ornamentals, EPA assume 100 gallons of finish spray are applied per day. The unit exposure value for a residential handler using open pour mixing/loading for a garden hose-end sprayer is 11 mg/lb handled (dermal) and 0.013 mg/lb handled (inhalation). Exposures were calculated using the Agency's draft Residential Standard Operating Procedures.

The highest label rate of application is 8 fl oz product/100 gal water.

i. Dermal Exposure Assessment and MOE .

ii. Inhalation Exposure Assessment and MOE .

MOEs are combined for the dermal and inhalation routes of exposure since the short term toxicological effects are the same (reduced body weight gain and food consumption).

iii. Combined MOE .

An MOE of 100 is adequate to protect a residential handler under the circumstances described. The estimated MOE is > 100 therefore this use is not of concern.

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

EPA does not have, at this time, available data to determine whether bifenazate 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 bifenazate and any other substances and bifenazate 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 bifenazate 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 . There is no indication of qualitative or quantitative increased susceptibility of rats and rabbits during in utero exposure or post-natal exposure based on developmental toxicity and reproductive toxicity studies performed with bifenazate.

3. Conclusion . There is a complete toxicity data base for bifenazate and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be reduced to 1X for the following reasons:

Acceptable developmental toxicity studies in the rat and the rabbit are available, as is an acceptable 2-generation reproduction study in the rat and there is no indication of qualitative or quantitative increased susceptibility of rats and rabbits to in utero or postnatal exposure. A developmental neurotoxicity study is not required for bifenazate. The dietary (food and water) and non-dietary (residential) exposure assessments are not expected to underestimate the potential exposures for infants and children from the use of bifenazate.

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

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 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 groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute 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. Bifenazate is not expected to pose an acute risk to humans.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to bifenazate from food will utilize 24% of the cPAD for the U.S. population, 59% of the cPAD for all infants < 1 year old, 85% of the cPAD for children 1-2 years old (the most highly exposed population subgroup), and 17% of the cPAD for females 13-49 years old. Based on the use pattern, chronic residential exposure to residues of bifenazate is not expected. In addition, there is potential for chronic dietary exposure to bifenazate 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 3 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). In its objections to a separate bifenazate tolerance action, NRDC claims that residential short- and intermediate-term risk assessments are data gaps for bifenazate. In the current risk assessment, EPA calculated short-term residential risks to homeowner applicators. However, the Agency concluded that no significant post-application exposure is aniticipated from landscape ornamentals; therefore, no residential post-application assessment was conducted. In addition, intermediate-term aggregate exposure (30 days to 6 months) is not expected since homeowner exposure is not expected to exceed 1 to 30 days.

Bifenazate 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 bifenazate.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 2,069 for the U.S. population; 2,418 for youth 13-19 years old; 2,429 for adults 20-49 years old; 2,467 for females 13-49 years old; and 2,377 for adults 50+ years 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 bifenazate in ground 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 4 of this unit:

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-2003-0304. 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 May 7, 2003 (68 FR 24458) (FRL-7303-7), 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 a pesticide petition (PP 9F6060) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. That notice included a summary of the petition prepared by Bayer CropScience, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide, thiacloprid, in or on apple, wet pomace; cattle, meat and meat byproducts; cotton, gin byproducts; cotton, undelinted seed; fruit, pome, group 11; and milk at 0.6; 0.2; 11.0; 1.0; 0.3; and 0.1 parts per million (ppm), respectively. Upon review and evaluation of the data submitted in support of the petition, the Agency determined that the residues of concern are thiacloprid plus metabolites retaining the thiazolidine ring intact. Excluded from the residues of concern are metabolites such as 6-nicotinic acid (6-CNA) for which the thiazolidine ring is broken. These metabolites are excluded based on the finding that the toxic effects of thiacloprid are considered to be associated with the entire thiacloprid molecule (with both the thiazolidine ring and the chloropyridine ring intact). Because metabolism and degradation studies have shown that the thiazolidine ring is less stable than the chloropyridine ring, it is understood that metabolites retaining the thiazolidine ring also retain the chloropyridine ring intact. Metabolites retaining the thiazolidine ring generally constitute most of the residue in foods and feeds. The petition was subsequently revised to:

1. Request that 40 CFR part 180 be amended by establishing tolerances for the insecticide thiacloprid in or on the commodities: Meat, meat byproducts, liver, fat, and kidney of sheep, goat and horse; liver; fat and kidney of cattle; and

2. Lowering the previously proposed tolerance levels for the food commodities, cattle, meat from 0.2 ppm to 0.03 ppm; cattle, meat byproducts from 0.2 ppm to 0.05 ppm; cotton, undelinted seed from 1.0 ppm to 0.02 ppm and milk from 0.1 ppm to 0.03 ppm based on measurement of thiacloprid per se rather than measurement of the common moiety, 6-nicotinic acid (6-CNA) upon which the original proposed tolerances were based; as summarized in Table 1 of this unit.

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 combined residues of thiacloprid and metabolites retaining the thiazolidine ring intact, measured and expressed in terms of thiacloprid, per se on apple, wet pomace; cattle, sheep, goat and horse meat; meat byproducts; liver; kidney; and fat; cotton, undelinted seed; cotton, gin byproducts; fruit, pome, group 11; and milk at 0.6; 0.03; 0.05; 0.15; 0.05; 0.02; 0.02; 11.0; 0.3; and 0.03 ppm, respectively. 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 thiacloprid are discussed in Table 2 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. As explained in Unit III.D.3., EPA determined that the FQPA SF be reduced to 3X.

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 factors (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 thiacloprid used for human risk assessment is shown in Table 3 of this unit:

1. Dietary exposure from food and feed uses . There are no tolerances established for residues of thiacloprid. Risk assessments were conducted by EPA to assess dietary exposures from thiacloprid in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: A moderately refined, Tier 3 acute dietary exposure assessment, which incorporated field trial data, estimates of % market share, and empirical processing factors, was conducted for the general U.S. population and various population subgroups. Monitoring data are not available for thiacloprid as it is a new chemical. EPA estimated exposure at the 99.9th exposure percentile.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A partially refined, Tier 3 chronic dietary exposure assessment, which incorporated field trial data, empirical processing factors, and projected percent crop treated estimates, was conducted for the general U.S. population and various population subgroups. Monitoring data are not available for thiacloprid as it is a new chemical.

iii. Cancer . A cancer assessment was performed using the same assumptions as the chronic assessment in Unit III.C.1. ii. The cancer dietary exposure estimate for the general U.S. population is 1.3 x 10 - 6 .

iv. Anticipated residue and percent crop treated (PCT) information . 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 anticipated residues 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 PCT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on PCT.

The Agency used PCT information for both the acute and chronic dietary risk assessment as follows:

A routine acute and chronic dietary exposure analysis for thiacloprid was based on 61% of apple crop treated, 51% of pear crop treated and 1% of cotton crop 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 in the preceding paragraph for thiacloprid used on these crops is reliable and has a valid basis. The PCT estimates are based on use of existing alternate insecticides against insects that thiacloprid will control. As per Agency practice, the PCT estimates are what the Agency expects to be likely upper bound market penetrations for various crop/pest niches. Maximal percent crop treated estimates were projected for apples, pears, and cotton. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which thiacloprid 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 thiacloprid 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 thiacloprid.

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow groundwater. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, 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.

The Tier II screening model, PRZM/EXAMS, was used to estimate residues of thiacloprid and one of its major degradates, YRC 2984 amide in surface water. The SCI-GROW model was used to estimate the ground water residues.

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

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

Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of thiacloprid and one of its major degratates, YRC 2894 amide for acute exposures are estimated to be 10.2 parts per billion (ppb) for surface water and 0.06 ppb for ground water. The EECs for chronic exposures are estimated to be 2.36 ppb for surface water and 0.06 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).

Thiacloprid is not registered or proposed for use on any sites that would result in residential exposure.

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

EPA does not have, at this time, available data to determine whether thiacloprid 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 thiacloprid and any other substances and thiacloprid does not appear to produce a toxic metabolite produced by other substances. Thiacloprid does produce 6-CNA, a metabolite also produced by another registered chloronicotinoid pesticide. However, the limiting toxic endpoints used in this assessment for thiacloprid are not based upon the toxicity of 6-CNA. For the purposes of this tolerance action, therefore, EPA has not assumed that thiacloprid 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 . Developmental studies did not show either qualitative or quantitative susceptibility. There is no increase in quantitative susceptibility demonstrated in the rat developmental neurotoxicity, rabbit developmental or rat reproduction studies. There is an apparent qualitative increase in susceptibility in the rat developmental toxicity study as indicated by increases in resorptions, increases in skeletal variations and retardations and malformations, and decreases in fetal body weight that occurred at the same dose showing a decrease in maternal body weight, but the concern is low since:

i. There is a well characterized dose response with a clear NOAEL and LOAEL;

ii. The fetal effects were noted in the presence of maternal toxicity; and

iii. There are no residual uncertainties.

3. Conclusion . In evaluating whether to retain the 10X SF to protect infants and children or to select a different safety factor, EPA considered the following factors:

i. There are no special concerns regarding pre- or post-natal toxicity exposure;

ii. The exposure databases ( food and drinking water) are complete and/or employ conservative assumptions;

iii. There is no residential exposure;

iv. The risk assessments cover or approximate all the metabolites and degradates of concern;

v. The assessments do not underestimate the potential risk for infants and children; and

vi. The toxicity database is complete except that there is a lack of morphometric assessments for the low- and mid-dose group animals in the developmental neurotoxicity study (DNT).

Although the lack of morphometric assessments in the DNT raised some uncertainty, EPA determined that there were sufficient reliable data to select an additional safety factor of 3X instead of 10X. The FQPA safety factor of 3X is in the form of a database uncertainty factor of 3X. A 3X factor was judged to be adequate because the dose selected for overall risk assessments is already based on the most sensitive end points for acute (i.e. clinical signs indicative of neurotoxicity) and chronic (i.e. liver and thyroid effects) dietary and non-dietary exposure scenarios, and the available data indicate that the full characterization of brain morphometrics from the DNT study would not be expected to lower the dose used for risk assessments by more than 3-fold.

To elaborate, since the magnitude (4-14%) of the morphometric histopathology changes seen in the offspring at the highest dose (40.8 mg/kg/day) in the developmental neurotoxicity study were considered to be at or near the limit of detection for differences in morphometric measurements, it is unlikely that measurable morphometric changes will be seen at lower doses. Any possible slight effects at lower doses are highly unlikely to change the regulatory level. The actual doses used to establish the acute RfD (3.1 mg/kg/day) and the chronic RfD (1.2 mg/kg/day) are 13 and 34 fold lower, respectively, than the 40.8 mg/kg/day dose where the effects of minimal magnitude were seen. Applying the 3 X factor further renders the adjusted doses 39 and 102-fold lower than the dose level where the effects of minimal magnitude were seen. Morever, even if the slight morphometric changes are seen at the mid, and even the low, dose of the DNT, a RfD calculated on such findings is highly unlikely to be lower than current acute and chronic RfDs adjusted by 3X given that the effects seen at the high dose were marginal. Therefore it is concluded that 3X is adequate to account for any possible morphometric effects that may be noted in the lower doses for which the additional readings are being sought.

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

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 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 groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to thiacloprid will occupy 20% of the aPAD for the U.S. population, 8.5 % of the aPAD for females 13 years and older, 51 % of the aPAD for all infants and 47 % of the aPAD for children 1-2 years old. In addition, there is potential for acute dietary exposure to thiacloprid 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 4 of this unit:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to thiacloprid from food will utilize < 1.0 % of the cPAD for the U.S. population, 4.4 % of the cPAD for all infants and 4.2% of the cPAD for children 1-2 years old . There are no residential uses for thiacloprid that result in chronic residential exposure to thiacloprid. In addition, there is potential for chronic dietary exposure to thiacloprid 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 5 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).

Thiacloprid is not registered or proposed 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).

Thiacloprid is not registered or proposed 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 . In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment: (July 1999), thiacloprid was classified into the category Likely to be Carcinogenic to Humans. A linear low-dose extrapolation approach is applied to the quantifications of risk to be estimated, based upon male rat thyroid, rat uterine, and mouse ovarian tumors. The data did not support a mode of action. The Q1* is 4.06 x 10 - 2 in human equivalents based on the rat uterine adenoma, adenocarcinoma and/or adenosquamous carcinoma combined tumor rates.

The dietary cancer risk from residues in food is 1.3X 10 - 6 . A cancer DWLOC is calculated only for the general U.S. Population. For this population the calculated DWLOC of 1.5ug/L is the same as the calculated EEC of 1.5 ug/L.

DWLOC = 3 X 10 - 6 /Q 1 * - average food exposure (mg/kg/day)]*bwt* 1,000 ug/mg÷Water consumption (liter/day)

DWLOC (US Pop.) = 1.5 ug/L. Since the surface water EEC for cancer is 1.5 ug/L the risk cup is exactly filled to 3 X 10 - 6 .

For risk management purposes, EPA considers a cancer risk to be greater than negligible when it exceeds the range of 1 in 1 million. EPA has generally treated cancer risks up to 3 in 1 million as within the range of 1 in 1 million.

EPA believes that the lifetime exposure will be result in negligible cancer risk for the following reason:

The cancer risk from the food uses alone is 1.3 x 10 - 6 .The dietary risk is based on residue data derived from the average of field trials. It is not unusual in the Agency's experience for field trial data to be an order of magnitude above actual monitoring. Since thiacloprid is a new chemical, actual monitoring data are not yet available. It is likely that the actual risk contribution from food will be much lower than current data indicate, which would result in a larger DWLOCcancer.

Thus, EPA does not expect that the general population would be exposed to levels that would exceed a neglible cancer risk over a lifetime.

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 thiacloprid residues.

The petitioner proposed a high performance liquid chromatography mass spectrometry (HPLC/MS/MS) method for determining thiacloprid, YRC-2894 amide and 4-hydroxy-YRC2894 amide in plants which has been found to be appropriate for use in the enforcement of the plant tolerances associated with this petition. The available radiovalidation and metabolism data supports this method. An adequate Independent Lab Validation (ILV) has been provided for the method and adequate confirmatory ions were also identified in the ILV.

The petitioner has proposed a HPLC/MS/MS method for determining thiacloprid in livestock tissues which has been found to be appropriate for use in the enforcement of the animal tissue tolerances associated with this petition. Existing radiovalidation and metabolism data supports this method as well as does an ILV. Mass spectrometry provides an adequate confirmatory method. This conclusion is based upon the successful use of mass spectrometry as a confirmatory method for thiacloprid in plants, the similarity between the HPLC/MS/MS methods for thiacloprid in plants and animals, and the Agency's familiarity with mass spectrometry in general. As a condition of registration, the registrant will be required to submit a description of the procedures for the use of mass spectrometry for thiacloprid in animals.

Thiacloprid, parent only, has been tested through the FDA PAM I multi-residue protocol. Upon request, the methods will be available prior to the harvest 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 established Codex, Canadian or Mexican maximum residue limits (MRLs) for thiacloprid.

The following information must be submitted as a condition for product registrations related to these tolerances: The registrant will be required to submit a description of the procedures for the use of mass spectrometry for thiacloprid in animals.

Therefore, tolerances are established for combined residues of thiacloprid and metabolites retaining the thiazolidine ring intact, measured and expressed as thiacloprid, per se , in or on apple, wet pomace at 0.6 ppm; cattle, sheep, goat, and horse meat at 0.03 ppm; cattle, sheep, goat and horse meat byproducts at 0.05 ppm; cattle, sheep, goat, and horse liver at 0.15 ppm; cattle, sheep, goat, and horse kidney at 0.05 ppm; and cattle sheep, goat, and horse fat at 0.02 ppm; cotton, undelinted seed at 0.02 ppm; cotton, gin byproducts at 11.0 ppm; fruit, pome, group 11 at 0.3 ppm; and milk at 0.03 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-2003-0304 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 November 25, 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-2003-0304, 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:

• Industry (NAICS 111), e.g., Crop production.

• Industry (NAICS 112), e.g., Animal production.

• Industry (NAICS 311), e.g., Food manufacturing.

• Industry (NAICS 32532), e.g., Pesticide manufacturing.

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-2003-0301. 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 May 21, 2003 (68 FR 27799) (FRL-7308-4), 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 a pesticide petition (PP 2E6463, 2E6496, 3E6532, and 3E6541) by IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. That notice included a summary of the petitions prepared by Arvesta Corporation, 100 First Street, Suite 1700, San Francisco, CA 94105, the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.553 be amended by establishing tolerances for residues of the fungicide fenhexamid, N -(2,3-dichloro-4-hydroxyphenyl)-1-methyl-cyclohexane carboxamide, in or on food commodities as follows: cucumber at 2.0 parts per million (ppm) (PP 2E6496); fruit, stone, group 12, postharvest at 10.0 ppm (PP 3E6541); kiwifruit, postharvest at 15.0 ppm (PP 2E6463); leafy greens, subgroup 4A, except spinach at 30.0 ppm (PP 3E6532); vegetable, fruiting, group 8, at 2.0 ppm (PP2E6496). IR-4 subsequently amended PP 3E6541 to propose tolerances for fruit, stone, group 12, except plum, prune, fresh, postharvest at 10.0 ppm and separate tolerances for plum, prune, dried at 2.5 ppm and plum, prune, fresh at 1.5 ppm. IR-4 also amended PP 2E6496 to propose tolerances for vegetable, fruiting, group 8, except nonbell pepper at 2.0 ppm. EPA is deleting the established fenhexamid tolerance for fruit, stone, except plum, prune, fresh at 6.0 ppm. This tolerance is no longer needed since this action establishes a higher tolerance at 10.0 ppm to cover both pre- and postharvest application to stone fruit, except plum, prune, fresh.

EPA has received objections to tolerances it established for residues of fenhexamid on a variety of berry crops and pistachio (67 FR 19114) (FRL-6829-9). The objections were filed by the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA has initiated a public comment period on them in the Federal Register of June 19, 2002 (67 FR 41628) (FRL-7167-7), which ended on October 16, 2002. Although that proceeding remains ongoing, prior to acting on this current tolerance action, EPA reviewed the fenhexamid-specific objections raised by NRDC and has addressed them at relevant points throughout this preamble.

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 fenhexamid on cucumber at 2.0 ppm; fruit, stone, group 12, except plum, prune, fresh, postharvest at 10.0 ppm; kiwifruit, postharvest at 15.0 ppm; leafy greens subgroup 4A, except spinach at 30.0 ppm; plum, prune, dried at 2.5 ppm; plum, prune, fresh at 1.5 ppm; vegetable, fruiting, group 8, except nonbell pepper at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by fenhexamid are discussed in Unit II.A. of the final rule on Fenhexamid; Pesticide Tolerance published in the Federal Register of April 13, 2000 (65 FR 19842) (FRL-6553-7).

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

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (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 fenhexamid used for human risk assessment is shown in Table 1 of this unit:

You may be potentially affected by this action if you grow fruiting vegetables in commercial greenhouses, consume vegetables that were raised in commercial greenhouses, or provide pest control services to commercial greenhouses. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS 111)

• Pesticide manufacturing (NAICS 32532)

• Other food crops grown under cover (NAICS 111419)

• Entomological services, agricultural; insect control for crops (NAICS 115112)

• Agricultural production or harvesting crews (NAICS 115115)

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-2003-0146. 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 September 13, 2000 (65 FR 55236) (FRL-6742-3), 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 an amended pesticide petition (PP 6F4716) by BASF Agro Research, now BASF Corporation, P.O. Box 400, Princeton, NJ 08543-0400, now P.O. Box 13528, Research Triangle Park, NC 27709-3528. (The original pesticide petition PP 6F4716 was filed by American Cyanamid (now BASF Agro Research) in 1996). The 2000 notice included a summary of the petition prepared by BASF Agro Research, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.513 be amended by establishing a tolerance for residues of the insecticide chlorfenapyr, [4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile], in or on vegetables, fruiting, group 8 at 1.0 parts per million (ppm).

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) 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 residues of chlorfenapyr on vegetables, fruiting, group 8 at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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

The dose at which 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. An additional safety factor (SF) may be required if the data base is incomplete. For chlorfenapyr EPA concluded that a developmental neurotoxicity (DNT) study is required based on the presence of neuropathology (CNS lesions) and neurotoxic signs seen in adult rats (males) and mice (both sexes). EPA further concluded that a UF of 10X is required until the data are received and evaluated. EPA does not have sufficient reliable data justifying the selection of a factor lower than the default 10X value for the additional SF for the protection or infants and children for this data gap.

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 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.

A summary of the toxicological endpoints for chlorfenapyr used for human risk assessment is shown in Table 2 of this unit:

1. Dietary exposure from food and feed uses . Risk assessments were conducted by EPA to assess dietary exposures from chlorfenapyr in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Tolerance-level residues (not anticipated residues); 100% crop treated for all registered and proposed commodities; and default DEEM® Version 7.76 processing factors for all commodities. EPA selected separate acute dietary endpoints for females 13-50 years old and the general U.S. population (including infants and children). Therefore, two separate acute dietary exposure assessments were performed for females 13-49 years old and for the general U.S. population and various population subgroups. These assessments conclude that the acute dietary exposure estimates are below EPA's LOC ( < 100% aPAD) at the 95th exposure percentile for females 13-49 years old (15% aPAD), and the general U.S. population (6% of the aPAD) and all other population subgroups. The most highly exposed population subgroup (other than females 13-49 years old) is children 1-2 years old, at 12% of the aPAD.

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 1994-1996, and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance-level residues (not anticipated residues); 100% crop treated for all registered and proposed commodities; and default DEEM® Version 7.76 processing factors for all commodities. An assessment of the general U.S. population and various population subgroups was conducted. This assessment concludes that the chronic dietary exposure estimates are below EPA's LOC ( < 100% cPAD) for the general U.S. population (24% of the cPAD) and all population subgroups. The most highly exposed population subgroup is children 1-2 years old, at 47% of the cPAD.

2. Dietary exposure from drinking water . The registered uses of chlorfenapyr include: Termiticide use, crack and crevice use, and use on ornamental plants grown in greenhouses. The proposed use is for vegetable crops grown in greenhouses. When used according to label directions, these uses are not expected to result in contamination of drinking water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Chlorfenapyr is registered for residential crack and crevice use and in-ground termite use. EPA has addressed the issues of possible residential exposures to chlorfenapyr when used according to label directions, either as a termiticide or as a crack and crevice treatment. EPA concluded that there is essentially no incidental-oral or dermal exposures. Further, the low vapor pressure of chlorfenapyr makes inhalation exposure negligible.

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

EPA does not have, at this time, available data to determine whether chlorfenapyr 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 chlorfenapyr and any other substances and chlorfenapyr 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 chlorfenapyr 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 . There is no evidence (qualitative or quantitative) for increased susceptibility following in utero exposure in the developmental toxicity studies in rats and rabbits or prenatal/postnatal exposure in the 2-generation reproduction study in rats. In both the rat and rabbit developmental toxicity studies maternal toxicity included decreased body weight gain. No developmental toxicity was noted in rats up to the highest dose tested of 225 mg/kg/day). Developmental toxicity in rabbits (increased post implantation loss) occurred at a higher dose than maternal toxicity. In the 2-generation reproduction study in rats, parental and offspring toxicity included body weight decrements at similar doses. No reproductive effects were noted up to the highest dose tested.

3. Conclusion . EPA evaluated the potential for increased susceptibility of infants and children from exposure to chlorfenapyr. EPA concluded that the toxicology data base was incomplete for FQPA purposes because a required DNT has not been submitted. The DNT was required due to the presence of neuropathology (central nervous system lesions) and neurotoxic signs seen in adult rats (males) and mice (both sexes). Other than lacking the DNT study, EPA identified no residual uncertainties for prenatal/postnatal toxicity. This decision is based on the following:

• There is no evidence (qualitative or quantitative) of increased susceptibility of rat or rabbit fetuses to in utero exposure in developmental toxicity studies. There is no evidence (qualitative or quantitative) of increased susceptibility of rat offspring in the multi-generation reproduction toxicity study.

• There are no concerns or residual uncertainties for prenatal and postnatal toxicity in the available developmental and 2-generation reproduction toxicity studies.

• The conservative residue assumptions used in the dietary exposure risk assessments, and the completeness of the residue chemistry database.

EPA concluded that a FQPA SF in the form of UFDB of 10X is required until the data from the DNT study are received and evaluated. EPA does not have sufficient reliable data justifying the selection of a factor lower than the default 10X value for this data gap.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to chlorfenapyr will occupy 6% of the aPAD for the U.S. population, 15% of the aPAD for females 13 years and older, 12% of the aPAD for children 1-2 years old and 3% of the aPAD for infants < 1 year old. As explained in Unit III.C.2., there is no potential for acute dietary exposure to chlorfenapyr in drinking water. EPA does not expect the aggregate exposure to exceed 100% of the aPAD.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to chlorfenapyr from food will utilize 24% of the cPAD for the U.S. population, 10% of the cPAD for infants < 1 year old and 47% of the cPAD for children 1-2 years old. Based on the use pattern, chronic residential exposure to residues of chlorfenapyr is not expected. There is no potential for chronic dietary exposure to chlorfenapyr in drinking water. EPA does not expect the aggregate exposure to exceed 100% of the cPAD.

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Chlorfenapyr is registered for use on sites that would result in negligible residential exposure and no exposure from drinking water. Therefore, the aggregate risk is equal to the risk from food, and does not exceed the Agency's LOC.

1. Residue analytical methods. The proposed enforcement method is M2427, a gas chromatography/electron capture detection (GC/ECD) method with an limit of quantitation (LOQ) of 0.05 ppm. Method M2427 has been subjected to a successful independent laboratory validation (ILV) as well as an acceptable radiovalidation using samples obtained from lettuce and tomato metabolism studies. A version of this method, M2284 was sent to EPA's Analytical Chemistry Branch (ACB) in Beltsville, MD for a petition method validation (PMV) on oranges and citrus oil. Although the PMV was successful, minor revisions were required. A new version of analytical method M2284 with the recommended revisions has not been submitted. The Agency's review of PP 6F4716 concluded that method M2427 is adequate for data collection and tolerance enforcement purposes pending submission of the rewritten method M2284. Since M2427 is similar to M2284, the petitioner was directed to rewrite Method M2427 following the ACB comments regarding M2284. The petitioner has submitted Method 2427.02, which contains the requested revisions.

2. Multiresidue method (MRM). The data requirement for MRM is satisfied pending U.S. Food and Drug Administration (FDA) review and acceptance of the MRM results. The petitioner previously submitted MRM recovery data for chlorfenapyr through FDA Protocols A through E. Protocols A and B were not applicable to chlorfenapyr. In Protocol C, chlorfenapyr gave a good response with the electron capture detector on three different GC columns. In Protocol D, using pears as a non-fatty food representative, the 5% OV-101 column gave the greatest sensitivity at 0.05 and 0.50 ppm. In Protocol E, chlorfenapyr eluted well on Florisil in both the ethyl ether/petroleum ether system and the alternate hexane/acetonitrile/methylene chloride system and gave acceptable recovery.

Adequate enforcement methodology 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 established Codex, Canadian, or Mexican maximum residue levels (MRLs) for chlorfenapyr on fruiting vegetables; therefore, harmonization of MRLs and U.S. tolerances is not an issue at this time.

The following data are required as a condition of registration: A developmental neurotoxicity study to determine the cause/relationship of potential central nervous system/myelinopathic alterations to neurotoxicity in the developing young.

Therefore, the tolerance is established for residues of chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile, in or on vegetables, fruiting, group 8 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-2003-0146 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 November 25, 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-2003-0146, 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).

On August 29, 2003, we published in the Federal Register a final rule with comment period entitled, “Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program.” The rule establishes requirements for recordkeeping and time limits on price recalculations. The effective date of these requirements as stated in the August 2003 rule is October 1, 2003.

The Office of Management and Budget (OMB) declared that the August 2003 final rule is a major rule. Thus, we should have given January 1, 2004 as the effective date in accordance with 5 U.S.C. 801(a)(4). However, we erroneously incorporated an incorrect effective date of October 1, 2003. We have identified and corrected that error in the “Correction of Errors” section below.

In FR Doc. 03-21548 of August 29, 2003 (68 FR 51917), make the following correction:

• On page 51912, in column one, in the “Dates” section, remove “October 1, 2003” and replace it with “January 1, 2004.”

We ordinarily publish a general notice of proposed rulemaking in the Federal Register and invite prior public comment on a proposed rule. Final rules generally have a 30-day or longer prospective effective date. However, this document merely provides a correction to the effective date of the final rule with comment published on August 29, 2003. This correction is being made based on OMB's decision that the August 2003 final rule is a major rule. Thus, we should have given January 1, 2004 as the effective date in accordance with 5 U.S.C. 801(a)(4). However, we erroneously incorporated an incorrect effective date of October 1, 2003. It would be impracticable, unnecessary and contrary to the public interest to publish a proposed rule and solicit comments since this document is technical in nature and does not impose new limits on the substantive rights of the industry or the public. Similarly, given the imminence of the effective date, it would serve no useful purpose to further delay the effective date of this technical correction. Therefore, to the extent that 5 U.S.C. 553 applies to this action, we find good cause to waive notice and comment procedures and our usual delay in the effective date.

Copies: This Federal Register document is also available from the Federal Register online database through GPO access, a service of the U.S. Government Printing Office. The Web site address is http://www.access.gpo.gov/nara/index.html.

Sections 1819(a) through (e) and 1919(a) through (e) of the Social Security Act (the Act) set forth the requirements that long term care facilities must meet to participate in the Medicare and Medicaid programs, respectively. Sections 1819(f)(2) and 1919(f)(2) of the Act contain requirements for nurse aide training and competency evaluation programs (NATCEP). Sections 1819(g) and 1919(g) of the Act contain the criteria that we use to assess a facility's compliance with the requirements. These statutory provisions were mandated by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) (Pub. L. 100-203, enacted December 22, 1987). The requirements for long term care facilities are codified at 42 CFR part 483, subpart B; the nurse aide training and competency evaluation program requirements are codified at 42 CFR part 483, subpart D; and the survey, certification and enforcement procedures are codified at 42 CFR part 488, subparts E and F.

Sections 1819(b)(5)(F) and 1919(b)(5)(F) of the Act and regulations at § 483.75(e) define a nurse aide as any individual furnishing nursing or nursing-related services to residents in a facility, who is not a licensed health professional, a registered dietitian, or someone who volunteers to provide services without pay. Sections 1819(f)(2) and 1919(f)(2) of the Act set forth the requirements for approval of a nurse aide training and competency evaluation program, but do not define “nursing” or “nursing related” skills. Section 483.152 of the regulations specifies nurse aide training requirements. These include, for example, basic nursing skills, personal care skills, communication and interpersonal skills, infection control, safety and emergency procedures, mental health and social service needs, residents' rights, care of cognitively impaired residents, and basic restorative services.

On March 29, 2002, we published in the Federal Register a proposed rule, “Requirements for Paid Feeding Assistants in Long Term Care Facilities” (67 FR 15149), that offered long-term care facilities the option to use paid feeding assistants, if consistent with State law.

Currently, there is no provision in the regulations for the use of single-task workers, such as paid feeding assistants, in nursing homes. To ensure the safety of facility residents, we require that qualified nursing staff provide assistance with eating and drinking, although there is some question whether or not all residents need medical supervision. This group of personnel includes registered nurses, licensed practical nurses, and certified nurse aides who have completed 75 hours of training. However, volunteers, who are usually family members, may also feed residents, because the law and regulations exclude volunteers from the definition of certified nurse aide.

Nursing homes in many States report a continuing shortage of certified nurse aides. 1 , 2 , 3 . Nursing homes are finding it increasingly difficult to train and retain sufficient numbers of qualified nursing staff, especially certified nurse aides. Certified nurse aides perform the majority of resident care tasks. Other employers often pay similar wages for less physically and emotionally demanding jobs. This makes it harder for nursing homes to employ enough nursing staff to perform routine nursing care and to feed residents who need minimal help or just encouragement at mealtimes. Feeding residents is often a slow process and competes with more complex tasks, such as bathing, toileting, and dressing changes, as well as urgent medical care.

For many elderly nursing home residents, physical and psychological changes often interfere with eating ability and meal consumption. Residents may need assistance with feeding if they have, for example, cognitive impairment, impaired swallowing due to muscular weakness or paralysis, a tendency to aspirate or choke, poor teeth, ill-fitting dentures or partial plates, or poor muscular or neurological control of their arms or hands, as with Parkinson's disease.

Nursing homes are caring for an aging population that has more acute clinical conditions than in the past. The result is a higher percentage of nursing home residents who need higher levels of care, which takes more staff time and leaves less time for routine tasks, such as ensuring that residents eat their meals and drink enough fluids.

In addition, evidence suggests that there has been a recent increase in assisted living facilities that house many individuals with minimal medical needs who previously would have been cared for in nursing homes. Both of these trends have resulted in a frailer nursing home population than previously, with residents who are more dependent on nursing staff for basic needs, such as feeding and personal care. A critical shortage of certified nurse aides in many parts of the country has resulted in a need for staff who are specially trained to help residents eat at mealtimes, to supplement, not replace certified nurse aides.

Some residents only need encouragement or minimal assistance, which does not require nursing training. Properly trained non-nursing personnel could provide this type of assistance. Nurse aides and other nursing staff receive training so that they are able to feed residents with all kinds of feeding problems. A higher level of training is required of nurse aides because nurse aides need to be able to deal with complicated feeding problems. However, when there is a nurse aide shortage, it is often the case that residents without complicated feeding problems receive little or no assistance at mealtimes with eating or drinking, while the nursing staff focuses on feeding residents with complicated problems. We believe there is a place in nursing homes for the use of feeding assistants who, after proper basic training in feeding techniques and working with the elderly, are able to feed residents who do not have complicated feeding problems. It is reasonable to require that feeding assistants receive a lower level of training than a nurse aide because feeding assistants would not handle complicated feeding cases. This would allow facilities, if they choose, to train other facility employees as feeding assistants so that available staff can feed residents at mealtimes.

Because of the shortage of certified nurse aides and the increasingly complex medical needs of residents, facilities in some States have used paid feeding assistants to supplement certified nurse aides to ensure that residents take in adequate food and fluids. Generally, feeding assistants used by these facilities are part-time workers, often retired individuals, or homemakers who are available for a few hours a day. They may also be older students who come into the facility between 1 and 2 hours either at the noon or evening meal. In other facilities, staff shortages are so acute that all nonmedical employees, including the administrator of the facility, are required to complete training and help feed residents at mealtimes. Training facility personnel for functions other than their primary position is known as cross-training. There is anecdotal evidence that cross-training of personnel in nursing homes increases coordination and continuity of care. 1 It also contributes to increased morale and lower staff turnover.

There is no provision in Federal regulations for the employment of nursing home workers who perform only a single task without completing 75 hours of nurse aide training. Currently, residents must be fed by a registered nurse, licensed practical nurse, or a nurse aide who has completed 75 hours of training and who has been certified as competent to perform all nurse aide tasks. Volunteers may also feed residents. The reason for this existing policy is to ensure that residents who cannot, or do not, feed themselves are fed by trained nursing staff. This is intended to protect residents from unskilled workers who might injure a resident by not recognizing serious medical complications associated with eating.

Wisconsin and North Dakota are two States in which nursing homes have had serious difficulty hiring enough certified nurse aides and have used feeding assistants as a supplement to certified nurse aides. Other States have expressed interest in using paid feeding assistants, including Ohio, Minnesota, Florida, California, and Illinois. Florida and Illinois have both passed laws that permit the use of single task workers in their States, but they have not yet implemented the provisions.

Wisconsin nursing homes have been using single-task feeding assistants for more than 7 years. Wisconsin uses a structured, formal program that requires a facility wanting to implement a feeding assistant program to submit an application for approval by the State. The classes are taught by a registered nurse, with a registered dietitian teaching the dietary elements of the program. A facility's approved program must include the following core areas: Interpersonal communication and social interaction; Basic nursing skills (including infection control); Personal care skills (assisting with eating, hydration); Basic restorative services (assistive devices for eating); Resident rights; and special problems associated with Dementia (specialized feeding and intake problems). Participants who complete the training must demonstrate skills and pass a written test with a score of 80 percent or better. Feeding assistants are used solely for feeding residents who have no feeding complications. They are permitted to feed residents only in the dining room and operate under the direction of a registered nurse or licensed practical nurse. Feeding assistants serve to supplement care delivered by certified nurse aides, which frees up more extensively trained aides to perform more complex resident care tasks.

North Dakota has used paid feeding assistants for a number of years and has a slightly less formal program than that of Wisconsin. The residents to be fed are selected by the dietary and nursing staff. If a facility has a nurse aide training program, the training coordinator and dietitian work together to train new feeding assistants individually. After training and orientation, a new feeding assistant is assigned to one resident who needs minimal assistance. As the assistant gains skill and confidence, he or she is assigned to more residents at a meal or to a resident who requires a higher level of skill to feed. Typically, feeding assistants work only about 1 1/2 hours per day, providing assistance at either the noon or evening meal.

We are committed to ensuring that long term care residents receive the best possible care. We recognize that a shortage of certified nurse aides may adversely affect resident care and prevent many residents from receiving adequate help with eating and drinking. Further, we are persuaded by the experience of States that have used paid feeding assistants, that proper training and medical direction of these feeding assistants minimizes the risk to residents, while providing substantial benefits to residents. After thoroughly considering this issue, we believe that the benefits to residents outweigh the potential risks. We believe that a policy change to allow the use of feeding assistants can be accommodated under existing statute. There is nothing in the statute governing requirements for long term care facilities (sections 1819 and 1919 of the Act) that would preclude the use of these workers and we believe that there is no conflict with other statutory requirements.

We proposed that feeding assistants must complete successfully a State-approved training course that meets minimum Federal requirements specified in proposed § 483.160. These course requirements would consist of relevant items from the nurse aide training curriculum and would include feeding techniques; assistance with feeding and hydration; communication and interpersonal skills; appropriate responses to resident behavior; safety and emergency procedures, including the Heimlich Maneuver; infection control; resident rights; and recognizing changes in residents that are inconsistent with their normal behavior, and the importance of reporting those changes to the supervisory nurse. Facilities or States may want to add items to these minimum requirements.

We proposed that each facility that uses feeding assistants maintain a record of the individuals who have successfully completed the feeding assistance training. Facilities would be required to report to the State any incidents in which a feeding assistant has been found to neglect or abuse a resident, or misappropriate a resident's property. The State must then maintain a record of all reported incidents.

We proposed that a facility may use a paid feeding assistant to feed residents who do not have a clinical condition that would require the training of a nurse or nurse aide. Selection of residents to be fed would be made by the professional nursing staff, using the comprehensive assessment. Nurses or nurse aides would continue to feed residents who require the assistance of staff with more specialized training, such as those residents with recurrent lung aspirations, difficulty swallowing, or those residents on feeding tubes or parenteral/IV feedings. Feeding assistants would work under the direct supervision of registered nurses (RN) or licensed practical nurses (LPN), who are in the unit or on the floor where the feeding assistance is furnished. In proposed § 483.75(e), we revised the definition of “nurse aide” to clarify that paid feeding assistants are not performing nursing or nursing-related tasks.

Feeding assistants could be paid by the facility or paid under an arrangement with another agency or organization (§ 488.301). Facilities would be able to use staff who are not health care personnel as feeding assistants if they successfully complete the training program. This might include the administrator, activity staff, clerical, laundry, housekeeping staff, or others who see residents on a daily basis. However, feeding assistants are intended to supplement certified nurse aides, not substitute for certified or licensed nursing staff.

We proposed that these requirements would not apply to volunteers and family members.

We received over 6,000 public comments on the proposed rule. About 99 percent of commenters were overwhelmingly supportive of the proposal, but raised a large number of issues and offered many suggestions for clarifications and revisions to the final regulation. Commenters supporting the proposal included for-profit and not-for-profit nursing homes, national and State nursing home associations, national and State health care associations, State health and human services agencies, United States Congresspersons, and private citizens. Many beneficiary advocates and employee unions opposed giving facilities the option to use paid feeding assistants. A summary of the major issues and our responses follow.

Comment: One commenter recommended that we conduct a pilot study or do further research before finalizing the proposal because there is a lack of data that would support the proposal. Another commenter suggested that we implement the proposal, but reevaluate the policy in 3 years to see if the objective is being met.

Response: We believe that the experience of Wisconsin and North Dakota has provided a demonstration of the merits of the use of paid feeding assistants. Both States have reported that in facilities that use feeding assistants, the benefits to residents include fewer cases of unexplained weight loss and dehydration than in facilities that do not use feeding assistants, with no reported ill effects.

Comment: Some commenters believed that the proposal is illegal, that is, there is no basis in the law to support the use of paid feeding assistants.

Response: Our review of the law indicates that there is nothing that would prohibit the use of feeding assistants and we believe that we have the authority and discretion under the law to implement this practice. Although commenters have focused on the language of the statute, at sections 1819(b)(5)(F) and 1919(b)(5)(F) of the Act that requires persons engaged in nursing or nursing related care to be trained either as a nurse or nurse aide, we do not consider the kinds of tasks facilities may ask feeding assistants to provide as either nursing or nursing related. While feeding has been part of the nurse aide training curriculum, that requirement was predicated on the nurse aide having to tend to persons with pronounced eating complications (such as swallowing disorders) for which specialized training is essential. What facilities would be free to do as a result of this rule, however, is to use persons who have had a lesser level of training to assist residents who have no feeding issues that require any specialized attention. Thus, we do not consider feeding assistants who may be used by facilities under this rule to be engaged in nursing or nursing related activities.

Comment: Several commenters cited the lack of Federal oversight built into the proposal.

Response: The survey process will provide the Federal oversight of facilities' use of feeding assistants, as it does for other participation requirements. During surveys of nursing homes, surveyors will observe the meal or snack service to note if any of the residents receiving feeding assistance are having trouble, such as coughing or choking. If this is observed, surveyors will investigate to determine if this is an unusual occurrence or a chronic problem and whether feeding assistants have successfully completed the 8-hour training course. Surveyors will also determine if the resident receiving the feeding assistance is one who has no complicated feeding problems. This will be done by a review of medical charts and discussion with the professional nursing staff. Similarly, surveyors will note concerns about supervision of paid feeding assistants and investigate how the facility provides supervision by interviewing staff during meal or snack times and drawing their own conclusions from observations. Deficiencies will be cited by surveyors when they identify problems. By retaining training and employment records of feeding assistants, a facility will help document its compliance with Federal requirements, and have a record that surveyors may review when they survey the facility.

Comment: Some commenters were convinced that the use of feeding assistants will not improve the quality of care and may, in fact, lower it. One commenter contended that Wisconsin's use of feeding assistants did not lead to a documented improvement in quality of care. Others commented that use of feeding assistants would disrupt the continuity of care and reduce quality by creating an assembly line atmosphere.

Response: We are not aware of any data that would suggest that there is an improvement in the quality of care when residents are helped to eat by feeding assistants, nor are we aware of any data that would suggest a decline in quality of care. We are relying on support for the use of paid feeding assistants that has been provided by the Wisconsin and North Dakota survey agencies. Neither agency has indicated that use of feeding assistants has resulted in diminished quality of care.

Comment: A few commenters recommended that we prohibit a facility from training feeding assistants when it has certain deficiencies, in the same way we currently prohibit a facility from training nurse aides. For example, commenters suggested that we prohibit facilities from training feeding assistants if the facility has (1) any deficiency at level F or above; (2) a deficiency at any level in the area of nutrition, staffing, and residents' rights; (3) imposed against it a per instance civil money penalty (CMP) of $5,000 or more, a per day CMP of $5,000 or more cumulatively, a State monitor, or temporary manager; (4) an approved nurse-staffing waiver.

Several consumer advocacy groups recommended that we limit the authority for a facility to use feeding assistants to facilities that are authorized to conduct nurse aide training programs. In other words, if a facility loses the right to train nurse aides, it should also lose the right to train feeding assistants. Many providers took the opposite position, that a facility that loses nurse aide training rights should retain the right to train feeding assistants.

Response: The prohibition to which commenters refer is a statutory requirement that causes a facility to lose the right to train nurse aides when the facility has certain deficiencies specified in the law. We disagree with commenters and believe that each State needs the flexibility to respond to specific situations and make its own decision whether or not to permit a facility to train and use feeding assistants.

Facilities that have an approved nurse-staffing waiver, which waives requirements in § 483.30 to have a RN on staff 8 hours per day, 7 days per week, are still required to have adequate numbers of LPNs on staff at all times. Thus, even if RNs are unavailable, the supervision requirement for feeding assistants would be met by having LPNs on duty.

Comment: Many commenters said that they did not want us to limit hours worked by feeding assistants to mealtimes and advocated permitting feeding assistants to work whenever needed by a facility. Some facilities thought that feeding assistants could be used full time to provide snacks and liquids to residents, particularly those who cannot leave their room. These commenters believed that this would be a good way to reduce the potential for dehydration since assistants would have time to deliver liquids, provide social stimulation, and encourage bedfast residents to drink more fluids.

Response: The text of the regulations does not limit working hours to mealtimes. According to § 483.35(h), facilities may use feeding assistants at any time that the supervision requirements are met.

Comment: Many providers and individuals expressed strong support for the use of existing staff as feeding assistants, after proper training. A large number of providers reported that they favor this because existing staff, such as clerical, dietary, and housekeeping staff, are already trained in facility policies, are usually well acquainted with residents, and have time available to devote to feeding residents.

A number of other commenters were opposed to using existing staff as feeding assistants, citing their full-time responsibilities and concern about added burden.

Response: The text of the proposed regulations permits any individual to act as a feeding assistant if he or she meets the training and supervision requirements (§ 483.35(h)). Each facility's administrator is responsible for allocating available staff to necessary tasks and we believe that it is reasonable to leave the decision to the administrator whether to use as feeding assistants staff who are not health care personnel.

Comment: Some commenters suggested requiring that facilities assign feeding assistants to certain residents to ensure continuity of care.

Response: We believe that this decision is best left to each facility and the supervisory nurses.

Comment: Consumer advocates were concerned that insufficiently trained feeding assistants would endanger residents. Other commenters were concerned that feeding assistants might make clinical judgments and take actions that are beyond their scope of training or be unable to handle emergency situations.

Response: The purpose of the training is to ensure that feeding assistants are properly prepared to feed residents and recognize emergency situations that need the immediate help of a supervisory nurse. We believe that a training program that meets the requirements listed in § 483.160 will ensure that a feeding assistant receives proper training.

Comment: One commenter suggested that we consider expanding the role and training of feeding assistants so that they can eventually assist in feeding residents with complex feeding problems.

Response: Individuals who have complex feeding problems, such as the need for IV or parenteral feedings, swallowing problems, and those with recurrent lung aspirations, need the assistance of professional nurses or certified nurses aides who have been trained to work with residents who have these needs. We do not believe that it is appropriate for feeding assistants to feed any residents other than those who are low risk and whose eating problems are uncomplicated.

Comment: Two senators and one congressman wrote in support of the proposal, noting the success of one state that used feeding assistants and experienced reduced weight loss and dehydration among nursing home residents. These commenters also reported that the Board of Nursing of one state had defined feeding as a nursing task and was concerned that this might prevent the state from using feeding assistants. (In the proposal, we indicated that feeding assistants would not be performing nursing or nursing-related tasks.) Another commenter believed that feeding is a nursing-related service and should not be performed by an individual with minimal training.

Response: The definition of the term, “nursing and nursing-related tasks,” is frequently prescribed by State law and, therefore, we are declining to impose a Federal definition of this term on all States. We believe the matter should be left with the State in those situations in which State law or standards-setting organizations have established a definition that is more restrictive than the Federal definition permitting the use of feeding assistants. We suggest that the State investigate whether a revision to State law would resolve this issue.

Comment: One consumer advocacy group suggested that we require state survey agencies to use the investigative protocol for staffing from the State Operations Manual in all facilities that request to use or use feeding assistants. This protocol, used to identify problems that may be associated with insufficient nursing staff, would ensure that a facility has an appropriate number of RNs and LPNs to supervise feeding assistants.

Response: We believe that facilities that request to use or use feeding assistants should be surveyed in the same way as any other facility. Surveyors should use the investigative protocol for staffing only when systemic problems relate to insufficient nursing staff.

Comment: A consumer advocate asked that we require facilities to post information about the numbers of feeding assistants, in addition to the current requirement to post the number of licensed and unlicensed staff employed per shift. The commenter also suggested that we require that feeding assistants wear badges or name tags so that they will be clearly recognized by other staff.

Response: A provision in the Medicare, Medicaid & State Child Health Insurance Program (SCHIP) Benefits Improvement & Protection Act of 2000 (BIPA) requires facilities to post daily for each shift the current number of licensed and unlicensed nursing staff directly responsible for resident care in the facility. This provision is effective January 1, 2003. Because paid feeding assistants do not qualify as licensed or unlicensed nursing staff, facilities do not need to post the numbers of feeding assistants used by the facility. However, we will consider at a later date whether this might be useful and what additional burden it may impose on facilities.

With regard to name tags, we believe it is probably a good idea, but leave that decision to each facility and do not see the need for us to make this a requirement.

Comment: Several commenters suggested that we require volunteers to complete the training requirements for feeding residents, pointing out that it is inconsistent not to do so.

Response: While we believe that it is a good idea for family members and volunteers to take the training, and we encourage it, we are not making this a requirement. Many volunteers in facilities are family members who are only there to feed a relative. Often, family members have been feeding the ailing resident for years, both at home and in the facility. We are leaving it to each facility to determine whether or not to require volunteers and family members to complete feeding assistance training. Ultimately, facilities are responsible for the care and safety of residents, even if the resident is fed by a relative or friend.

Comment: Some providers were concerned about how they would be paid for the training and services of feeding assistants. A few commenters recommended that we allocate payment for feeding assistants to the nursing cost center.

Response: Skilled nursing facilities will not receive additional Medicare payment for the costs of using feeding assistants. Medicare payment for residents in skilled nursing facilities is made through a prospective payment system, which covers all costs (routine, ancillary, and capital) of covered skilled nursing facility services furnished to beneficiaries under Part A of the Medicare program. For Medicare payment, the term and concept, “nursing cost center,” is outdated, but still may be used in some State Medicaid programs. The Medicare SNF PPS per diem payment rate is based, in part, on levels of care and resources required and received by residents, established by the resident assessment instrument specified in § 483.20. The system does not require that tasks performed by a staff person fit within a direct care or indirect care category (such as a nursing cost center).

Medicaid payments for nursing facilities are established by each State. Therefore, it would be up to individual States to determine whether they would need to change their payment rates for those facilities that use feeding assistants and how the rates would be changed. However, because feeding assistants will likely be paid at a minimum wage, which is less than the wage paid to certified nurse aides, facilities participating in Medicare and Medicaid may incur less cost than if they had hired additional certified nurse aides to perform feeding and hydration duties.

Comment: One provider reported using workers who pass out trays, provide beverages and condiments, talk to and encourage residents, record food intake, and perform routine dining room tasks. The commenter asked if the facility would be able to continue to use these workers.

Response: A facility may continue to use workers who perform the dietary service functions described by the commenter. They need not be trained as feeding assistants if they do not feed residents. Facilities are required to employ sufficient support personnel to carry out the functions of the dietary service. If these workers successfully complete the feeding assistant training course, the facility may also use them to feed residents. However, as we indicated in the last response, the Medicare program pays skilled nursing facilities a prospectively determined per diem rate, which does not require that tasks performed by personnel fit into a direct or indirect care category. For Medicaid payment, payment is determined by each Medicaid state agency.

Comment: One state commented that it is cumbersome to rely on the comprehensive assessment to determine which residents may be safely fed by a feeding assistant. Instead, the decision should be left entirely up to the professional judgment of the licensed nurse. A consumer advocacy group also indicated that the comprehensive assessment/annual evaluation is not an effective tool for the assessment of residents to be fed because the information may not be current. Several organizations suggested that we emphasize the importance of the RN or LPN's professional judgment along with input from the interdisciplinary team, as reflected in the comprehensive assessment, when selecting residents for feeding assistance.

Response: We agree with commenters and are revising § 483.35(h)(1)(ii) to say that the decision about whether a resident is to be fed by a feeding assistant is based on the charge nurse's assessment and the resident's latest assessment and plan of care. We note that facilities that choose to use paid feeding assistants remain responsible for any adverse actions resulting from the use of these assistants, as with any other employee.

Comment: An organization representing licensed professionals suggested that the RN or LPN should consult with a speech-language pathologist when a resident is suspected to have, or is at risk for, swallowing difficulties.

Response: We have no objection to this and facilities may use this approach if they choose.

Comment: Several commenters indicated that the criteria for selecting residents to be fed is inadequate and suggested that we define the clinical conditions that would require feeding by an RN or LPN or nurse aide. Another commenter suggested that we prohibit feeding assistants from feeding residents with swallowing problems.

Response: We believe that the clinical decisions as to which residents may be fed by feeding assistants are best left to the professional judgment and experience of RNs and LPNs who work in the facility and have personal knowledge of a resident's day-to-day condition. If we were to define clinical conditions, we would only be substituting the judgment of professional nurses employed by the Federal government for the judgment of nurses working in facilities. We believe that professional nurses conclude that certain clinical conditions relating to eating and drinking would require the skills and knowledge of an RN or LPN. These conditions include, but are not limited to, recurrent lung aspirations, difficulty swallowing, and tube or parenteral/IV feedings.

Comment: One commenter suggested a number of more stringent requirements for facilities, including (1) obtaining informed consent from the resident or resident's representative that the resident agrees to be fed by a feeding assistant and accepts the risks and benefits; (2) an individualized feeding plan; and (3) a certification by a licensed nurse in a resident's medical record that the resident can be safely fed by a feeding assistant prior to each instance of feeding.

Response: We understand that the commenter intends the proposed provisions to be in the best interest of residents, but we believe that, for the most part, they are unduly burdensome for facilities to implement. To require consent before a resident can receive help from a feeding assistant implies that this is a high risk procedure, which we believe it is not. We believe that the Wisconsin and North Dakota experience indicates that it is safe to use well-trained feeding assistants who are properly supervised. It would be inconsistent to require residents to give informed consent for feeding assistance when they need not do so for any other services provided by a facility. Further, a feeding plan would very likely duplicate part of the care planning process. Consequently, we are not revising the rule to accommodate the commenter's suggestions.

Comment: Commenters, concerned about lack of supervision, pointed out that the proposed requirement, in § 483.35(h)(2)(ii), that a nurse is in the unit or on the floor, exceeds the licensed nursing requirements in most states. Other commenters worried that the shortage and high turnover rates of licensed and unlicensed nursing staff could mean that fewer staff are familiar with residents and could result in inadequate monitoring.

Response: Facilities are required by § 483.30, Nursing services, to have sufficient qualified nursing staff available on a daily basis to meet residents' needs for nursing care. The requirement in § 483.30, Nursing services, is that, unless waived, a facility must have a RN on duty 8 consecutive hours per day, 7 days a week. A facility must also have a sufficient number of licensed nurses and other nursing personnel on a 24-hour basis to provide nursing and related services to residents. The proposed requirement that a feeding assistant work under the direct supervision of a RN or LPN builds on the requirement that sufficient licensed nursing staff are on duty 24 hours a day. We believe that, if a facility chooses to use feeding assistants, it is the facility's responsibility, and in its best interest, to ensure that adequate supervisory nursing staff is available.

However, we recognize that the supervision requirement is unclear and subject to a variety of interpretations. Therefore, we are revising § 483.35(h)(2) by removing the word, “direct” from the phrase, “direct supervision,” because it may unintentionally imply visual contact between a feeding assistant and a supervisory nurse. This is not possible in most facilities, especially if assistants are feeding residents in their rooms. Next, we are removing the requirement that a nurse be in the unit or on the floor where the feeding assistance is furnished and immediately available to give help. As commenters noted, this sentence is unclear. While we are not prescribing the precise means by which facility RNs or LPNs assert their supervisory responsibilities, we will expect that facilities do so in a way that avoids negative outcomes for their residents. Additionally, we are requiring that a feeding assistant call a supervisory nurse on the resident call system when there is an emergency or a need for help. All facilities are currently required to have a resident call system.

Comment: Consumer advocates expressed concern about a potential lack of supervision and suggested that all residents who are fed by feeding assistants be fed in the dining room or other congregate area to ensure that a licensed nurse is physically present. Other commenters supported allowing feeding assistants to feed residents in their rooms, citing the fact that many of the most frail residents do not go to the dining room and are least likely to get adequate assistance with eating. Numerous commenters cited examples of bedfast residents, unable to feed themselves or reach the food, receiving no help at mealtime, after which the tray is removed, untouched by the resident.

Response: We share commenters' concerns about adequate supervision of feeding assistants to ensure the safety of residents. We are equally concerned, however, that those residents who are unable or unwilling to go to a congregate dining area receive needed feeding assistance in their rooms. We are confident that the nurse in charge, using his or her professional judgment in assessing residents who are appropriate for feeding assistance, will be able to select residents who can safely be fed in their own rooms.

Comment: An organization representing nursing home employees noted that nursing staff is already overworked and supervising feeding assistants would only add to the burden. Another commenter indicated that the proposed supervision requirement would further burden RNs and LPNs because they would have to stay in the dining room during mealtimes and this would limit their availability elsewhere in the facility.

Response: Adequate supervisory staff is just one factor that a facility needs to consider when deciding whether or not to use feeding assistants. If a facility chooses to use paid feeding assistants, it would be the facility's responsibility to ensure that it has sufficient RNs and LPNs available to adequately supervise feeding assistants without adding undue burden on the staff. When using feeding assistants, there will be a need for a facility to balance the increase in staff available to meet resident needs with the increased need to supervise these assistants.

Comment: Several providers asked whether facilities would be able to hire paid feeding assistants if the State does not approve a training program for feeding assistants. Many providers supported giving facilities maximum flexibility to implement the proposal without lengthy state approval requirements. One commenter suggested that we require all states to mandate feeding assistant programs in all facilities.

Other commenters believed that, before facilities may opt to use feeding assistants, States should be able to decide whether implementing feeding assistant programs is in the best interest of the State or consistent with State law.

Several providers, provider organizations, and States asked that we remove the requirement that a training course for feeding assistants be State approved, citing potential burden on States, cost, and delays in implementing feeding programs. One State with a large number of facilities and a shortage of resources was concerned about the potential burden of approving a large number of feeding programs. Commenters, instead, suggested that we require that an individual complete a training course that meets the requirements of § 483.160. In this case, the facility would maintain documentation of compliance with the requirements and surveyors would review the training records at annual surveys.

Many states and providers asked for clarification on our expectations in terms of state approval. They wondered whether other entities, such as community colleges, would be permitted to offer the training. One commenter noted that travel to community colleges and cost would discourage individuals from taking the training. There was also a question about the frequency with which a state would need to review or reapprove a feeding assistant program. Another commenter suggested that we offer more specific guidance to states to assist them in establishing criteria for training programs and others suggested using established models from Wisconsin and North Dakota.

Response: We have chosen to retain the requirement that States approve training programs for feeding assistants. We believe that this will give States the necessary control and flexibility to structure approval processes for training programs to fit the needs of each State. States that have large numbers of facilities and resources that are stretched to the limit may want to minimize any burden associated with State approval of training programs, while States with fewer facilities may structure approval in a very different way.

However, States also have the flexibility not to implement a program for approval of feeding assistant training programs. If a State does not implement an approval program, the result is that facilities in that State will not be able to hire any paid feeding assistants.

Comment: We received a variety of comments on training, including requests for additional requirements, removal of requirements, and clarifying changes. Many commenters asked that we provide more specificity on training requirements and establish a minimum number of hours of training. Suggestions for hours of training ranged from 5 to 75.

Response: We believe that being overly prescriptive on the content of training is unnecessary, would reduce flexibility to offer these training programs, and would unnecessarily limit the ability of States and providers to develop these programs within the scope of their considerable knowledge. However, to ensure that training is not conducted in a superficial manner, we are revising § 483.160(a) to require that a training course for feeding assistants include, at a minimum, 8 hours of training.

Comment: A few commenters suggested that we specify in the text of the regulation that a feeding assistant must “successfully” complete the entire training course before he or she is qualified to work with residents in the facility.

Response: We agree with the commenters that successful completion of the training course is essential and are revising § 483.35(h)(2)(i) by adding the word “successful.” We believe that it is reasonable to expect that a feeding assistant will successfully complete the training course before working directly with residents. This is a basic safety precaution to ensure that residents are protected. After completion of training, a facility may want to slowly ease a feeding assistant into the work by feeding a resident who needs minimal assistance, as North Dakota does.

Comment: Many commenters advocated requiring a competency test before feeding assistants are permitted to work with residents.

Response: We are not including a requirement for a competency test in the final rule. We believe that the instructor or supervisory nurse will be able to assess the competency of trained feeding assistants.

Comment: Several commenters objected to the inclusion of the Heimlich Maneuver in the training course and its use by feeding assistants. They were concerned that its use by a robust feeding assistant on a frail resident might result in rib fractures or other injuries. Commenters emphasized that only nursing staff should determine the need for, and administer, the Heimlich Maneuver. Instead, they suggested that the training course emphasize the need for feeding assistants to recognize symptoms that should be immediately reported to licensed supervisory staff for further action.

Response: The Heimlich Maneuver is an emergency procedure that is taught to the public, as well as medical personnel. It seems reasonable to retain this training requirement in view of the fact that nurse aides are trained to use this procedure and they may also be strong individuals. Proper training is essential and feeding assistants will receive the same training on the Heimlich Maneuver as nurse aides. Also, experienced RNs tell us that training in handling emergencies will emphasize the need for a feeding assistant to call for help immediately, and then, if necessary, begin a procedure like the Heimlich.

Comment: One commenter suggested that, if a facility uses a feeding assistant under an arrangement with another organization, the facility must verify that the feeding assistant has successfully completed the training.

Response: Section 483.35(h)(2) already provides for this. It says that, if a facility uses a paid feeding assistant, the facility must ensure that the individual has completed a State-approved training course. The burden of proof is on the facility to ensure that any feeding assistant it uses is properly trained.

Comment: Commenters suggested a number of additions to the general training requirements. One suggestion was to require that training programs explicitly include feeding problems of the cognitively impaired, since 60-70 percent of nursing home residents are cognitively impaired. Other suggestions included training in dementia, food and drug interactions, diet consistencies, how much and how to feed, resident preferences, difficulty swallowing, and emphasis on performing only feeding tasks for which training has been provided. A consistent concern of commenters was a need for a training emphasis on recognition and prevention of emergency situations associated with feeding, such as dysfunctional swallowing, tracheal aspiration, esophageal obstruction, and other potentially severe emergency situations.

Response: It is important to note that the training course requirements proposed in § 483.160 are minimum requirements. States and facilities are free to add to those requirements. However, many of the training additions suggested by commenters appear to be more useful in the training of nurse aides than feeding assistants, who will feed residents without any significant eating problems.

Comment: Several commenters suggested that we address payment for training in the same way that we do in the regulations for nurse aides. One commenter asked that we prohibit facilities from charging potential feeding assistants for training. Another asked if a facility may require that a trained feeding assistant repay the facility for training if he or she leaves? A commenter asked if a facility can require that a trained feeding assistant work for a set period of time.

Response : Judging from provider comments received, there will be a strong demand for feeding assistants and it is unlikely that facilities will want to charge for training. Generally, these positions will be part time and will not require extensive training that would be costly for the facility. We think it is unnecessary to amend the regulations to provide for payment provisions similar to those for nurse aides. With regard to a facility entering into a contract with a feeding assistant that would require that individual to work for a certain period of time, there is nothing in our regulations that would prohibit this practice. This is strictly between the facility and the feeding assistant.

Comment: Many individual commenters and professional organizations asked that we establish standards or qualifications for instructors of the training program. Commenters suggested numerous licensed or certified health care professionals who could conduct the training, including RNs, registered dietitians, licensed physical therapists, licensed speech therapists, and occupational therapists. Dietitians argued that they have the expertise in food and nutrition issues in long-term care settings, are trained to teach self-help feeding devices, and basic restorative feeding services, citing established manuals and materials that would support this practice. Occupational therapists argued that they are trained to match an analysis of disabilities with effective interventions, resources and adaptations.

Several commenters strongly recommended that we prohibit feeding assistants from teaching each other on-the-job.

Response : It is apparent that a number of options are available in terms of the variety of licensed or certified health care professionals that may be qualified to conduct training for feeding assistants. Some, RNs and LPNs, are employed full time in facilities and would be available without additional cost to conduct the training. Dietitians may be employed by a facility full time, part time, or on a consultant basis. Other health care professionals may be available at additional cost; however we believe that it would be inappropriate to permit a feeding assistant to train another. Consistent with the flexibility for States to develop a State-approved training program, we are deferring to States the decision as to which individuals would be qualified to teach the feeding assistant training.

Comment : Several commenters pointed out that there is no requirement for states to maintain a formal registry of feeding assistants or to check with other states for background information. One commenter suggested that states report information on feeding assistants to the nurse aide registry and provide this information to facilities for hiring purposes. Others suggested that we require facilities to check with the nurse aide registry before employing individuals as feeding assistants in case the individual had worked as a nurse aide previously.

Response : We have decided to include only nurse aides in the nurse aide registry, largely because the law is so specific about the requirements. Also, we believe it is not necessary to further burden States by requiring them to establish and maintain a separate registry for feeding assistants. As we explain later in the preamble, states are already required by § 488.335 to review and investigate all allegations of abuse, neglect, and misappropriation of resident property. This information can be accessed by any hiring facility. Facilities need to screen feeding assistants, as any other employee, to try to ensure that individuals have no history that would preclude their interaction with frail elderly residents.

Comment : Several commenters reported that there is no provision for feeding assistants trained in one facility, city, or state to carry that training forward so that it does not have to be repeated. There is no requirement for a facility to request a copy of an individual's training record before he or she is hired as a feeding assistant. A commenter suggested that we establish a requirement for states to have reciprocity agreements within each state or between states.

Response : It is not our intent that individuals repeat training when moving to another facility. However, we believe that it is unnecessary to establish extensive regulatory provisions for requesting records or for state reciprocity agreements in this case. As with any other job applicant, a feeding assistant should indicate where he or she was last employed and a hiring facility may contact the former employer to verify employment and training. States are currently required to review allegations of abuse, neglect, or misappropriation of resident property. A hiring facility should be able to contact the state for that information.

Comment : Commenters had a number of suggestions concerning proposed § 483.160(c), which requires a facility to report to the state all incidents of a paid feeding assistant who has been found to neglect or abuse a resident, or misappropriate a resident's property. That section also requires a state to maintain a record of all reported incidents. One state reported that it already has a requirement for criminal background checks and a law requiring that facilities report allegations of abuse and neglect. Other commenters suggested language changes to the text. One commenter noted that § 483.160(c) is inconsistent with § 488.335, which requires a state to review all allegations of resident neglect, abuse, and misappropriation of property, and follow procedures in § 488.332. Section 488.332 requires a state to establish procedures to investigate complaints of participation requirements.

Response : We agree with the commenter regarding requirements in proposed § 483.160(c). Paragraph (c) is unnecessary because it repeats certain provisions of existing § 488.335. Since § 488.335 already establishes state requirements for review of allegations of neglect, abuse, misappropriation of property, and procedures for investigation of complaints and hearings, we are removing proposed paragraph (c) in § 483.160.

Comment: Many commenters objected to the term, feeding assistant, saying that it has a pejorative connotation and it lacks sensitivity to the elderly. Others thought that the term failed to include the importance of fluid intake. Commenters suggested a variety of alternatives, including the following: meal assistant; food and hydration aide or assistant; nourishment aide, nutrition assistant, nutritional aide, nutrition-hydration assistant; dining assistant; and resident assistant.

Response: The commenters make a good point, which we had not recognized when drafting the proposal. However, the term, feeding assistant, was widely used by states and organizations before our proposal. Rather than change the term in the regulations, we suggest that facilities and states use whatever term they prefer.

For the most part, this final rule incorporates the provisions of the proposed rule. The following provisions of this final rule differ from the proposed rule:

• We are reorganizing and revising § 483.35(h) so that paragraph (h)(1) applies to State approval of training courses for feeding assistants. We are adding the requirement that a feeding assistant must successfully complete a State-approved training course, and do so before feeding residents.

• Also, in revised § 483.35(h)(1), we are clarifying that a facility may use a paid feeding assistant if it is consistent with State law.

• In revised § 483.35(h)(2), we are revising the supervision requirement to remove the word, “direct,” from the phrase, “direct supervision.”

• Also, in revised § 483.35(h)(2), we are removing the requirement that a supervisory nurse be in the unit or on the floor where the feeding assistance is furnished and is immediately available to give help, if necessary. In place of that sentence, we are adding the requirement that a feeding assistant call a supervisory nurse for help during an emergency on the resident call system.

• In revised § 483.35(h), we are adding a new paragraph (3) concerning resident selection criteria to replace proposed § 483.35(h)(1)(ii). In new paragraph (3), we are replacing the term, “clinical condition” with the phrase, “complicated feeding problem.”

• In § 483.35, we also specify that a complicated feeding problem includes, but is not limited to, difficulty swallowing, recurrent lung aspirations, and tube or parenteral/IV feedings.

• Also, in § 483.35, we provide that a facility must base resident selection on the charge nurse's assessment and the resident's latest assessment and plan of care.

• In § 483.160(a), we are adding a requirement that the State-approved training course include a minimum of 8 hours of training covering the topics listed in § 483.160(a).

• In § 483.160(c), we are removing the requirement that a facility report to the State all incidents of a paid feeding assistant who has been found to neglect or abuse a resident, or misappropriate a resident's property, and that a State must maintain a record of all reported incidents. This paragraph unnecessarily duplicates existing requirements in § 488.335, Action on complaints of resident neglect and abuse, and misappropriation of resident property.

Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether OMB should approve an information collection, section 3506(c)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

Nursing homes in two States currently use feeding assistants and eight other States have expressed an interest in implementing this policy. While public comments from nursing homes and provider organizations indicated strong support for the use of feeding assistants, only 13 States responded to the proposal. Some States indicated interest and others had concerns about the cost of implementation and other issues, so we do not now have a better idea of how many States will choose to approve the use of feeding assistants in nursing homes. In addition, it remains a facility option, so we still do not know how many facilities in which States will choose this option, nor do we know how many feeding assistants would be used by each facility. There are approximately 17,000 nursing homes in the nation, and they are not evenly distributed within States. Wisconsin reported that about 25 percent of nursing homes in the State used feeding assistants. On a nationwide basis, we believe that it is reasonable to project that 20 percent of facilities will use feeding assistants. We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements:

Section 483.160(b)

A facility must maintain a record of all individuals, used by the facility as feeding assistants, who have successfully completed the training course for paid feeding assistants.

We estimate that 20 percent of nursing homes may implement this policy (20 percent of 17,000 = 3,400 facilities/respondents). If we assume that each facility will hire two feeding assistants, this results in a total of 6,800 feeding assistants. Depending on the method chosen by a facility to collect this information, we believe that each facility (respondent) would spend no more than 30 minutes per month (6 hours per year) entering feeding assistant information into its record- keeping system. Some months, facilities may have no information to add. With 3,400 facilities at 6 hours/year, the total would be 20,400 hours for facilities. Using a clerical wage cost of $10 per hour, the total facility burden is estimated to be $204,000.

We are submitting a copy of regulation § 483.160 to OMB for its review of the information collection requirements. The revision is not effective until OMB has approved it.

If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following addresses:

Comments submitted to OMB may also be emailed to the following address: email: baguilar@omb.eop.gov; or faxed to OMB at (202) 395-6974.

We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule is not a major rule. The costs of using feeding assistants will be covered by existing Medicare payment and, most likely Medicaid payment, depending on how a State establishes payment rates. Skilled nursing facilities receive an all-inclusive per diem Medicare payment rate for each resident's care. This includes all costs (routine, ancillary, and capital) of covered skilled nursing facility services furnished to beneficiaries under Part A of the Medicare program. Skilled nursing facilities will not receive additional Medicare payment for the costs of using feeding assistants.

Medicaid payments for nursing facilities are established by each State. Therefore, it would be up to individual States to determine whether they would need to change their payment rates for those facilities that use feeding assistants and how the rates would be changed. However, because feeding assistants will likely be paid at a minimum wage, which is less than the wage paid to certified nurse aides, facilities participating in Medicare and Medicaid that use feeding assistants may incur less cost than if they had hired additional certified nurse aides to perform feeding and hydration duties.

State costs associated with feeding assistant training programs are considered administrative expenses and are funded under Medicaid with matching funds at 50 percent Federal financial participation. Any information we have on potential State costs of implementing feeding assistant programs comes from States that have used such programs in the past. One State, Wisconsin, has a well-structured program and has experienced relatively minimal costs. One registered nurse spends approximately 10 percent of her time reviewing and approving facility feeding assistant training programs. This represents 10 percent of a full-time equivalent position (FTE), which is reported by Wisconsin to be a cost of about $7,000 per year. At a time when the use of feeding assistants was highest, a quarter of Wisconsin's 420 nursing homes, or 100 to 110 facilities, used feeding assistants. The number of feeding assistants used by each facility varies according to the size of the home, with the maximum number estimated to be 5 for a large, 200- to 250-bed home. Feeding assistants are typically paid at the same minimum wage. The number of hours each feeding assistant works at a facility is also variable and different for each worker and facility. Further, some facilities use only existing staff as trained feeding assistants. Because of the number of hours worked by each feeding assistant is variable, we do not have an exact estimate of the total cost to Wisconsin for using feeding assistants. However, this summary of Wisconsin's program may be helpful to other States, which are interested in establishing feeding assistant programs.

The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small government jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 to $29 million in any 1 year. For purposes of the RFA, all long-term care facilities are considered to be small entities. Individuals and States are not included in the definition of a small entity. The Small Business Administration considers 62 percent of long term care facilities to meet their definition of small entity (those facilities with total revenues of $11.5 million or less in any 1 year. We have determined that this rule will affect these entities, but, in general, we expect any cost to be covered by Medicare and Medicaid program payments.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. This final rule does not affect small rural hospitals.

For these reasons, we are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined that this rule will not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This final rule will not have a cost greater than $110 million on the governments mentioned or on the private sector. In general, we believe that existing Medicare and Medicaid payments will cover the facility costs of using feeding assistants. Costs associated with surveys of long term care facilities are Federally funded, as are costs of State approval of training programs.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We believe that this rule contributes to State flexibility by giving States the option to allow the use of feeding assistants, control over how to structure the process of the approval of facility feeding assistant programs, and over elements of training, including instructor qualifications. In this way, States can establish policies that fit their unique circumstances. We believe that this rule will not have a substantial effect on State or local governments.

These provisions will affect long term care facilities. We expect the provisions to be a substantial benefit both to facilities that are short-staffed and to residents who need help with eating and drinking. By using feeding assistants to help residents with eating and drinking, facilities can use trained, certified nurse aides to perform other, more complex resident care tasks.

Based on the large number of comments we received from nursing homes in a variety of States, we now believe that there is widespread support for the proposal and widespread intent to implement the provisions. However, because this is an optional provision, and some States may have legal barriers to implementation, we do not know how many States or facilities may implement these provisions, or how many feeding assistants will be used by facilities. Based on public comments, we anticipate that some facilities may hire no additional staff as feeding assistants, opting instead to use existing staff whose primary function is not direct care of residents, such as administrative or activities staff. We believe that feeding assistant training most likely will be conducted by existing facility staff and that there will be some nominal training costs to the facility since training requires time away from other duties that other staff may have to perform.

We require that a feeding assistant successfully complete an 8-hour State-approved training course, which meets the Federal requirements in § 483.160(a). We have established no requirements on how States are to approve these programs, thereby giving each State the flexibility to decide what method makes the most sense in terms of use of its resources. There are several ways in which States may approach approval of training programs. States might choose to develop a model training program that complies with Federal requirements and require that any facility that trains and uses feeding assistants use that specific program. One model might be based on an existing training program already established, such as those conducted in Wisconsin or North Dakota. A State might choose to do a paper review of each facility's training program, or the State might insist on a site visit to review a facility's program. Lastly, a State might initially deem each facility's training program approved and then review the program when the facility is next surveyed. For some of these options, a State may need additional staff hours to review and approve training programs. However, States already review and approve training programs for nurse aides, so there is an existing administrative structure in place. There is the potential for increased State costs associated with review and approval of facility feeding assistant programs. However, any cost will depend on the approval method that is chosen by each State.

1. Effects on the Medicare and Medicaid programs.

There are approximately 17,000 facilities nationally. Long term care facilities that participate in the Medicare and Medicaid programs must provide the necessary care and services to residents so that they attain or maintain the highest practicable physical, mental, and psychosocial well being. To do this, facilities must employ sufficient staff on a 24-hour basis, including nursing staff, administrative, medically-related social services, dietary, housekeeping, and maintenance staff.

The Medicare program pays for skilled nursing facility services to eligible beneficiaries through a prospective payment system that covers all costs of covered services furnished to residents on a per diem basis. This Medicare SNF PPS per diem payment rate is based, in part, on levels of care and resources required and received by residents. The payment rate covers all care required and received by a resident and does not require that tasks performed by a staff person fit within a direct or indirect care category. Therefore, the Medicare program would not pay a skilled nursing facility any additional funds if the facility chooses to use feeding assistants.

Medicaid payments for nursing facilities are established by each State. Therefore, it would be up to individual States to determine whether they would need to change their payment rates for those facilities that use feeding assistants and how the rates would be changed.

There has been a continuing shortage of certified nurse aides in recent years, along with a shortage of RNs and LPNs willing to work in nursing homes. Certified nurse aides perform the majority of resident care in a long term care facility and are the lowest paid workers, while RNs and LPNs receive higher wages commensurate with their advanced training, experience, and supervisory responsibilities.

One alterative to the use of paid feeding assistants is to broaden the hours during which meals are served so that everyone is not fed at the same time within a one-hour mealtime. Expanded meal service, covering perhaps a 3-hour mealtime, or a restaurant model, where meals are available most of the time, would allow existing staff more time to help feed residents. However, this option already exists in regulations, and other than a few innovative facilities, nursing homes have chosen not to use this method. The current preference of most nursing homes is for an institutional approach in which meals are served to all residents early morning, noon, and evening at fixed hours. As a result, the nursing home industry prefers the use of feeding assistants rather than an expanded meal service. The other alternative is not to publish a regulation on the use of feeding assistants and, instead, make greater use of volunteers to assist with feeding. The use of volunteers to assist with feeding assistance is permitted in the current regulations. However, it is questionable whether facilities could find sufficient numbers of volunteers to meet their needs.

We believe that both residents and providers will benefit from these provisions. Residents will receive more assistance with eating and drinking, both at meals and at snack time. Facilities will be able to use existing staff to assist at mealtimes and hire additional staff to meet the needs of residents, freeing certified nurse aides to perform more complex tasks that require their training.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

As used in this subpart—

Recipients of Legal Services Corporation (“Corporation”) funds are permitted by law to provide legal assistance only to U.S. citizens and certain legal aliens. Recipients are required to verify the eligibility of non-U.S. citizen applicants for legal assistance by seeing documentary proof of the applicant's status. This appendix sets forth a listing of documents upon which recipients may rely to verify the eligibility of non-U.S. citizens applicants for legal assistance from LSC-funded programs.

On August 8, 2002, the Research and Special Programs Administration (RSPA, we) published a final rule under Docket No. RSPA-01-10373 (HM-220D) (67 FR 51625) amending the requirements of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the maintenance, requalification, repair, and use of DOT specification cylinders. The revisions were made to simplify the regulations, respond to petitions for rulemaking, address recommendations of the National Transportation Safety Board, and enhance the safe transportation of hazardous materials in cylinders. The effective date of the final rule was October 1, 2002.

The August 8, 2002 final rule extended current approval requirements for persons who requalify DOT specification cylinders to persons who requalify certain cylinders by performing a complete external visual inspection. The rule requires each person who performs a visual inspection in accordance with § 180.209(g) to obtain an approval from us and to mark the requalifier identification number assigned by RSPA on a cylinder that successfully passes a visual requalification after September 30, 2003. The approval requirements are contained in § 107.805(f). The approval requirements do not apply to a person who does prefill cylinder inspections such as prescribed in § 173.301(a)(2) or annual inspection of self-contained breathing apparatus (SCUBA) cylinders and who does no visual requalifications under § 180.209(g). After publication of the final rule, we received more than 2,300 applications and many telephone calls from persons asking about the approval requirements.

Because of the number of applications that we continue to receive, we are not able to complete processing and assigning requalifier identification numbers by the October 1, 2003 compliance date and we are concerned that many affected persons may not get their applications in by that date. Therefore, in this interim final rule, we are extending the compliance date after which persons who perform visual cylinder requalifications under § 180.209(g) must obtain approval from us and mark their assigned requalifier identification number on cylinders that have been successfully requalified to May 31, 2004.

Because October 1, 2003 is the mandatory compliance date currently prescribed in the HMR for marking cylinders with a requalifier identification number, we are issuing this interim final rule without prior notice and public comments. For this same reason, we are making these amendments effective without the customary 30-day delay following publication. Although an opportunity for public comment has not been provided prior to the issuance of this interim final rule, we are seeking public comments to this action. We may further amend the compliance date if warranted, based on the merits of comments.

This interim final rule is not considered a significant regulatory action under section 3(f) of Executive Order 12866 and was not reviewed by the Office of Management and Budget. The interim final rule is not considered significant under the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034).

This interim final rule amends an August 8, 2002 final rule that made revisions to requirements applicable to the maintenance, requalification, repair and use of DOT specification cylinders. A regulatory evaluation prepared for the August 8, 2002 final rule is available for review in the docket.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires an agency to review regulations to assess their impact on small entities unless the agency determines a rule is not expected to have a significant economic impact on a substantial number of small entities. This interim final rule imposes no new costs of compliance on the regulated industry. Based on the assessment in the original regulatory evaluation, I hereby certify that while this interim final rule applies to a substantial number of small entities, there will not be a significant economic impact on those small entities. A detailed regulatory flexibility analysis for the August 8, 2002 final rule is available for review in the docket.

This interim final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). This interim final rule preempts state, local, and Indian tribe requirements but does not propose any regulation with substantial direct effects on the states, the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.

Federal hazardous materials transportation law, 49 U.S.C. 5101-5127, contains an express preemption provision (49 U.S.C. 5125(b)) preempting state, local, and Indian tribe requirements on certain covered subjects. Covered subjects are:

(1) The designation, description, and classification of hazardous materials;

(2) The packing, repacking, handling, labeling, marking, and placarding of hazardous materials;

(3) The preparation, execution, and use of shipping documents related to hazardous materials and requirements related to the number, contents, and placement of those documents;

(4) The written notification, recording, and reporting of the unintentional release in transportation of hazardous material; or

(5) The design, manufacture, fabrication, marking, maintenance, recondition, repair, or testing of a packaging or container represented, marked, certified, or sold as qualified for use in transporting hazardous material.

This interim final rule addresses covered subject item 5 above and preempts state, local, and Indian tribe requirements not meeting the “substantively the same” standard.

Federal hazardous materials transportation law provides at section 5125(b)(2) that, if DOT issues a regulation concerning any of the covered subjects, DOT must determine and publish in the Federal Register the effective date of federal preemption. The effective date may not be earlier than the 90th day following the date of issuance of the final rule and not later than two years after the date of issuance. The effective date of federal preemption of this final rule is 90 days from publication of this final rule in the Federal Register .

This interim final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this interim final rule does not significantly or uniquely affect the communities of the Indian tribal governments and does not impose substantial direct compliance costs, the funding and consultation requirements of Executive Order 13175 do not apply.

This interim final rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $100 million or more, in the aggregate, to any of the following: State, local, or Indian tribal governments, or the private sector.

Under the Paperwork Reduction Act of 1995, no person is required to respond to an information collection unless it displays a valid OMB control number. The amendments contained in this interim final rule impose no changes to the information collection and recordkeeping requirements contained in the August 8, 2002 final rule, which were approved by the Office of Management and Budget under the provisions of 44 U.S.C. chapter 35 and assigned control numbers 2137-0022 (approved through 09/30/2005) and 2137-0557 (approved through 12/31/2005).

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

This interim final rule extends the mandatory compliance date for certain persons who requalify cylinders to obtain approval from us and mark their assigned requalifier identification number on successfully requalified cylinders. The approval requirements were adopted in an August 8, 2002 final rule. The regulatory evaluation prepared for the August 8, 2002 final rule contains an environmental assessment and is in the public docket for this rulemaking. The August 8, 2002 final rule incorporates new cylinder technologies through new and updated incorporations by reference of consensus standards developed by CGA; increases flexibility for cylinder requalifiers, and users; and facilitates compliance with the HMR by clarifying and reorganizing regulatory requirements applicable to cylinders. In addition, the August 8, 2002 final rule improves the overall safety performance of DOT specification cylinders by addressing several identified safety problems. The August 8, 2002 final rule contains revisions to reduce unintentional releases of hazardous materials from cylinders during transportation and, therefore, will reduce environmental damage associated with such releases. To the extent that the revisions in this interim final rule maintain safety for transportation of hazardous materials in cylinders, we find that there are no significant environmental impacts associated with this final rule.

The standards that are the subject of these corrections are Federal Motor Vehicle Safety Standard (FMVSS) No. 205, “Glazing materials,” and FMVSS No. 500, “Low-speed vehicles.” A final rule amending these standards was published on July 25, 2003 (68 FR 43964). The rule updates FMVSS No. 205 so that it incorporates by reference the 1996 version of the industry standard, American National Standard for Safety Glazing Materials for Glazing Motor Vehicles and Motor Vehicle Equipment Operating on Land Highways (“ANSI/SAE Z26.1-1996”), on motor vehicle glazing. Currently, the Federal standard references the 1977 version of the industry standard and the 1980 supplement to that standard. The July 2003 final rule also simplifies understanding of the Federal glazing performance requirements. The amendments of the past 20 years to the standard resulted in a patchwork of requirements in the Federal standard that needed to be read alongside the industry standard in order to gain a comprehensive understanding of the overall requirements of the Federal standard.

As published, the July 2003 final rule contained errors that need correction. First, this document corrects the effective date of the final rule to provide the 180-day lead-time discussed in the preamble. The Dates section of the document incorrectly cited that the rule would become effective on September 23, 2003. This has been corrected in the Dates section of this document to state that the effective date for the July 2003 final rule is January 22, 2004, which is 180 days after the publication date of the July 2003 final rule.

Second, this document corrects an inadvertent omission of a location restriction for Item 4A glazing. In the current FMVSS No. 205 (S5.1.2.11), NHTSA only permits Item 4A glazing—Rigid Plastic for Use in Side Windows Rearward of the “C” pillar—to be used in side windows rearward of the “C” pillar. As stated in the final rule permitting the installation of Item 4A glazing published on August 12, 1996 (61 FR 41739) and subsequent letters of interpretation, NHTSA does not permit Item 4A glazing near rear-facing seats or side-facing seats in any motor vehicle because of the concern that occupants riding in those seating locations may be able to contact their heads against Item 4A glazing in a crash. The breaking of rigid plastic windows in a crash could leave sharp, pointed shards in the window frame which could easily be contacted by an occupant's head. There is also concern about occupant injury resulting from large shards of rigid plastic glazing being propelled inward by vehicle impacts with trees, poles, or other vehicles. 1

In the July 2003 final rule, NHTSA incorporated by reference the ANSI/SAE Z26.1-1996 provision for Item 4A glazing that closely mirrors the requirements contained in the current FMVSS No. 205. It has come to our attention, however, that the ANSI/SAE Z26.1-1996 provision for Item 4A glazing does not contain the restriction that this Item of glazing only be permitted for use in side windows rearward of the “C” pillar. It would also permit Item 4A glazing in the rear windows of vehicles that previously were not allowed to have Item 4A glazing in any windows other than some rear side windows. The omission of this restriction was inadvertent and, as such, was not discussed or considered in either the Notice of Proposed Rulemaking published on August 4, 1999 proposing to amend FMVSS No. 205 by incorporating by reference ANSI/SAE Z26.1-1996 or in the July 2003 final rule. As such, the agency is taking this opportunity to correct the regulatory text of FMVSS No. 205 to make clear that Item 4A glazing is only permitted for use in side windows rearward of the “C” pillar.

Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable Federal motor vehicle safety standards shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable Federal motor vehicle safety standards. Where there is no substantially similar U.S.-certified motor vehicle, 49 U.S.C. 30141(a)(1)(B) permits a nonconforming motor vehicle to be admitted into the United States if its safety features comply with, or are capable of being altered to comply with, all applicable Federal motor vehicle safety standards based on destructive test data or such other evidence as the Secretary of Transportation decides to be adequate.

Under 49 U.S.C. 30141(a)(1), import eligibility decisions may be made “on the initiative of the Secretary of Transportation or on petition of a manufacturer or importer registered under [49 U.S.C. 30141(c)].” The Secretary's authority to make these decisions has been delegated to NHTSA. The agency publishes notice of eligibility decisions as they are made.

Under 49 U.S.C. 30141(b)(2), a list of all vehicles for which import eligibility decisions have been made must be published annually in the Federal Register . On October 1, 1996, NHTSA added the list as an appendix to 49 CFR part 593, the regulations that establish procedures for import eligibility decisions (61 FR 51242). As described in the notice, NHTSA took that action to ensure that the list is more widely disseminated to government personnel who oversee vehicle imports and to interested members of the public. See 61 FR 51242-43. In the notice, NHTSA expressed its intention to annually revise the list as published in the appendix to include any additional vehicles decided by the agency to be eligible for importation since the list was last published. See 61 FR 51243. The agency stated that issuance of the document announcing these revisions will fulfill the annual publication requirements of 49 U.S.C. 30141(b)(2). Ibid .

This rulemaking action was not reviewed under E.O. 12866. NHTSA has analyzed this rulemaking action and determined that it is not “significant” within the meaning of the Department of Transportation's regulatory policies and procedures.

In accordance with the Regulatory Flexibility Act, NHTSA has evaluated the effects of this action on small entities. Based upon this evaluation, I certify that the revisions resulting from this rulemaking will not have a significant economic impact on a substantial number of small entities. Accordingly, the agency has not prepared a regulatory flexibility analysis.

Because this rulemaking does not impose any regulatory requirements, but merely furnishes information by revising the list in the Code of Federal Regulations of vehicles for which import eligibility decisions have been made, it has no economic impact.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this rule does not have sufficient Federalism implications to warrant preparation of a Federalism Assessment. No State laws will be affected.

The agency has considered the environmental implications of this rule in accordance with the National Environmental Policy Act of 1969 and determined that it will not significantly affect the human environment.

In accordance with the Paperwork Reduction Act of 1980, Public Law 96-511, the agency notes that there are no information collection requirements associated with this rulemaking action.

This rule does not have any retroactive effect. It does not repeal or modify any existing Federal regulations. A petition for reconsideration or other administrative proceeding will not be a prerequisite to an action seeking judicial review of this rule. This rule does not preempt the states from adopting laws or regulations on the same subject, except that it will preempt a state regulation that is in actual conflict with the Federal regulation or makes compliance with the Federal regulation impossible or interferes with the implementation of the Federal statute.

NHTSA finds that prior notice and opportunity for comment are unnecessary under 5 U.S.C. 553(b)(3)(B) because this action does not impose any regulatory requirements, but merely revises the list of vehicles not originally manufactured to conform to the Federal motor vehicle safety standards that NHTSA has decided to be eligible for importation into the United States to include all vehicles for which such decisions have been made since October 1, 2001.

In addition, so that the list of vehicles for which import eligibility decisions have been made may be included in the next edition of 49 CFR parts 400 to 999, which is due for revision on October 1, 2002, good cause exists to dispense with the requirement in 5 U.S.C. 553(d) for the effective date of the rule to be delayed for at least 30 days following its publication.