The Egg Products Inspection Act (EPIA) authorizes the mandatory inspection of egg products operations and the mandatory surveillance of the disposition of shell eggs that are undesirable for human consumption. From its enactment in 1970, AMS administered the EPIA and its regulations in 7 CFR part 59.

Congress amended the EPIA as part of the Food, Agriculture, Conservation and Trade Act Amendments of 1991 (Pub. L. 102-237) (hereafter referred to as “the 1991 amendments”). To implement the 1991 EPIA amendments, AMS proposed changes to 7 CFR parts 56 and 59 (57 FR 48569, October 27, 1992) so that both regulations would contain the changes authorized by the 1991 amendments. Before AMS published a final rule, however, the Department consolidated food safety issues into the Food Safety and Inspection Service (FSIS) following enactment of the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994 (Pub.L. 103-354). This included delegating responsibility to administer the EPIA egg products inspection functions to FSIS, while the shell egg surveillance functions remained with AMS. FSIS promulgated a final rule that implemented the 1991 amendments by revising 7 CFR part 59 (63 FR 45663, August 27, 1998).

AMS then promulgated a final rule to duplicate and redesignate those portions of 7 CFR part 59 pertinent to shell egg surveillance as a new 7 CFR part 57 (63 FR 69968, December 17, 1998). FSIS promulgated a final rule to redesignate the remaining portions of 7 CFR part 59 and transfer them to 9 CFR part 590 (63 FR 72351, December 31, 1998). AMS is now revising the regulations in 7 CFR part 57 to clarify and simplify them following the duplication and redesignation of the regulations from 7 CFR part 59 to 7 CFR part 57.

To facilitate and simplify the duplication and re-designation effort, the regulations were promulgated with as few editorial changes as possible. However, that action subsequently required AMS to review the regulations that were duplicated and redesignated as 7 CFR part 57 and revise them to clarify the shell egg surveillance functions of the EPIA administrated by AMS.

This action will complete that requirement. In addition, AMS is including in this rulemaking effort other non-substantive editorial revisions that were identified during the review. The amendments will update the regulations to comply with the current department organizational structure and add non-technical, grammatical, non-substantive revisions.

The amendments would not change how the requirements are administered, how specific requirements are implemented, or the responsibilities of program users. The amendments would make the requirements more accurate and simplify interpretation and implementation.

For example:

This rule has been determined to be not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget (OMB).

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA), AMS has considered the economic impact of this action on small entities as defined in the RFA (5 U.S.C. 601). This rule is non-technical in nature. It does not change regulatory requirements or the responsibilities of any party. Accordingly, AMS has determined that provisions of this rule would not have any economic impact on small entities.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This action is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this rule.

The information collection requirements in §§ 57.13, 57.28(a), 57.110(a), 57.112, 57.200(a), 57.200(b), 57.320, 57.690, 57.720(a)(2), 57.720(a)(3), 57.720(a)(4), 57.800, 57.905(a), 57.915(b), 57.920, 57.930(f), 57.960, and 57.965 amended by this rule have been previously approved by OMB and assigned OMB control number 0581-0128 under the Paperwork Reduction Act of 1995.

AMS is committed to compliance with the Government Paperwork Elimination Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.

This amendment to 14 CFR part 71 modifies the Class D airspace area, the Class E airspace area designated as a surface area, the Class E airspace area designated as an extension to the Class D airspace area and the Class E airspace area extending upward from 700 feet above the surface at Salina, KS. An examination of controlled airspace for Salina, KS revealed that the Salina Municipal Airport ARP used in the legal descriptions for all airspace areas is incorrect. The location of the Salina collocated very high frequency omni-directional radio range and tactical air nagivational aid (VORTAC) used in the Class E airspace area designated as an extension to the Class D airspace area legal description is incorrect. The examination also revealed that the airspace areas do not comply with airspace requirements for diverse departures as set forth in FAA Order 7400.2E, Procedures for Handling Airspace Matters, and that the dimensions of extensions to the airspace areas do not comply with FAA Order 8260.19C, Flight Procedures and Airspace.

This action expands the Salina, KS Class D and Class E airspace area designated as a surface area from a 4.9-mile to a 5.4-mile radius of Salina Municipal Airport. It also expands the Class E airspace area extending upward from 700 feet above the surface from a 7.4-mile radius to an 8.4-mile radius of the airport and corrects the ARP and location of the Salina VORTAC in the legal descriptions. Additionally, this action modifies the Class E airspace area designated as an extension to the Class D airspace area reducing its width from 2 to 1.5 miles each side of centerline and decreasing its length by 2 miles. Extensions to the Class E airspace area extending upward from 700 feet above the surface are no longer required and are deleted from the legal description.

These modifications provide controlled airspace of appropriate dimensions to protect aircraft departing from and executing SIAPs to Salina Municipal Airport and bring the legal descriptions of the Salina, KS Class D and Class E airspace areas into compliance with FAA Orders 7400.2E and 8260.19C. Class D airspace areas are published in Paragraph 5000 of FAA Order 7400.9M, dated August 30, 2004, and effective September 16, 2004, which is incorporated by reference in 14 CFR 71.1. Class E airspace areas designated as surface areas, Class E airspace areas designated as an extension to a Class D airspace area and Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraphs 6002, 6004 and 6005, respectively, of the same FAA Order. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulelmaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2004-18822/Airspace Docket No. 04-ACE-48.” The postcard will be date/time 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 noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This amendment to 14 CFR 71 modifies the Class E airspace area extending upward from 700 feet above the surface at St. Francis, KS. An examination of controlled airspace for Cheyenne County Municipal Airport revealed it does not meet the criteria for 700 feet AGL airspace required for diverse departures as specified in FAA Order 7400.2E, Procedures for Handling Airspace Matters. The criteria in FAA Order 7400.2E for an aircraft to reach 1200 feet AGL, taking into consideration rising terrain, is based on a standard climb gradient of 200 feet per mile plus the distance from the airport reference point to the end of the outermost runway. Any fractional part of a mile is converted to the next higher tenth of a mile. Additionally, the examination revealed the dimensions of the extension to the airspace area were not in compliance with FAA Order 8260.19C, Flight Procedures and Airspace. This amendment expands the airspace area from a 6-mile radius to a 7.3-mile radius of Cheyenne County Municipal Airport, decreases the length of the extension ot the Class E airspace area from 7.4 to 7 miles from the St. Francis nondirectional radio beacon (NDB), decreases the width of the extension from 2.6 to 1.9 miles each side of the centerline and brings the legal description of the St. Francis, KS Class E airspace area into compliance with FAA OPrders 7400.2E and 8260.19C. This area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9M, Airspace Designations and Reporting Points, dated August 30, 2004, and effective September 16, 2004, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2004-18821/Airspace Docket No. 04-ACE-47.” The postcard will be date/time 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 noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This amendment to 14 CFR 71 modifies the Class E airspace area extending upward from 700 feet above the surface at Burwell, NE. An examination of controlled airspace for Cram Field revealed it does not meet the criteria for 700 feet AGL airspace required for diverse departures as specified in FAA Order 7400.2E, Procedures for Handling Airspace Matters. The criteria in FAA Order 7400.2E for an aircraft to reach 1200 feet AGL, taking into consideration rising terrain, is based on a standard climb gradient of 200 feet per mile plus the distance from the airport reference point (ARP) to the end of the outermost runway. Any fractional part of a mile is converted to the next higher tenth of a mile. This amendment expands the airspace area from a 6-mile radius to an 8.3-mile radius of Cram Field, eliminates the extension to the airspace area, deletes reference to the Burwell nondirectional radio beacon (NDB) in the legal description and brings the legal description of the Burwell, NE Class E airspace area into compliance with FAA Order 7400.2E. This area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9M, Airspace Designations and Reporting Points, dated August 30, 2004, and effective September 16, 2004, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register, and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2004-18823/Airspace Docket No. 04-ACE-49.” The postcard will be date/time 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 noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, filed a supplement to NADA 140-439 for EQVALAN (ivermectin) Oral Liquid for Horses. The supplemental application provides for revisions to the labeled indications. Specifically, the supplement provides for the use of ivermectin oral liquid for the treatment and control of Craterostomum acuticaudatum , Petrovinema poculatum , and Coronocyclus spp., including Coronocyclus coronatus and Coronocyclus labratus . The label descriptions of some currently approved parasite genera are also being revised to add included species for which data already exists in the NADA file and to reflect changes in scientific nomenclature. In addition, under the sub-heading “Small Strongyles,” the labeling has been revised to separate the listing of adult species from the fourth-stage larvae. The supplemental NADA is approved as of August 9, 2004, and 21 CFR 520.1195 is amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning August 9, 2004. This marketing exclusivity only applies to the parasites for which new data were required.

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

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

The Virginia Beach Neptune Festival will sponsor the fireworks display on September 25, 2004 over the coastal waters in the vicinity of the Virginia Beach Fishing Pier, Virginia Beach, Virginia. The pyrotechnic display will be launched from the fishing pier located within the regulated area. A fleet of spectator vessels is expected to gather nearby to view the event. Therefore, to ensure the safety of spectators and transiting vessels, 33 CFR 100.522 will be enforced for the duration of the event. Under provisions of 33 CFR 100.522, a vessel may not enter the regulated area unless it receives permission from the Coast Guard Patrol Commander. Spectator vessels may anchor outside the regulated area but may not block a navigable channel.

In addition to this notice, the maritime community will be provided extensive advance notification via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

New Jersey Transit, who operates their trains and controls the signaling system at the Delair Railroad Bridge, has requested a temporary deviation from the operating regulation to facilitate needed replacement of bridge timbers.

To facilitate this replacement, the vertical lift-span will be locked in the closed-to-navigation position from 8 a.m. to 4 p.m. on nine consecutive Mondays: on September 27; on October 4, 11, 18, and 25; and on November 1, 8, 15, and 22, 2004. During these stages, the work requires completely immobilizing the operation of the vertical-lift span in the closed-to-navigation position. At all other times, the bridge will operate in accordance with the current operating regulations outlined in 33 CFR 117.716.

The Coast Guard has informed the known users of the waterway of the closure periods for the bridge so that these vessels can arrange their transits to minimize any impact caused by the temporary deviation.

The District Commander has granted temporary deviation from the operating requirements listed in 33 CFR 117.35 for the purpose of repair completion of the drawbridge. The temporary deviation allows the Delair Railroad Bridge across the Delaware River mile 104.5, between Philadelphia, PA and Delair, NJ, to remain closed to navigation from 8 a.m. to 4 p.m. on nine consecutive Mondays: on September 27; on October 4, 11, 18, and 25; and on November 1, 8, 15, and 22, 2004.

On March 14, 1983, the Commonwealth of Pennsylvania transferred ownership of approximately 21 miles of U.S. Route 209 within the boundaries of Delaware Water Gap National Recreation Area to the National Park Service. This portion of road was a heavily traveled commercial vehicle route between Interstates 80 and 84, primarily because it is shorter and flatter and more direct than the alternate routes, and therefore was preferred by the commercial vehicle operators. Since § 5.6 of Title 36 Code of Federal Regulations (36 CFR 5.6), prohibits the use of roads within National park areas by commercial through traffic, the National Park Service announced that U.S. Route 209 would be closed to commercial vehicles on April 25, 1983. Due to negative comments from the trucking industry concerning the announced closure, the NPS Director, on April 23, 1983, announced a 180-day delay in the implementation of the closure.

On July 30, 1983, Congress enacted Public Law 98-63, closing U.S. Route 209 to commercial vehicle use, with certain exceptions, and directed the National Park Service to establish a commercial operation fee for certain commercial vehicles excepted from the closure. In order to implement the statute, Delaware Water Gap National Recreation Area began operation of two commercial vehicle check stations, one each near the North and South entrances to the recreation area on U.S. Route 209. The check stations were operated 24 hours a day.

Public Law 98-63, as amended by Public Law 98-151 and Public Law 99-88, closed U.S. Route 209 to all commercial vehicles except:

(1) Those vehicles operated by businesses based within the recreation area;

(2) Those vehicles operated by businesses that as of July 30, 1983, operated a commercial vehicular facility in Monroe, Pike, or Northampton Counties, PA, if the vehicle operation originates or terminates at such facility;

(3) Those vehicles operated in order to provide services to businesses and persons located in or contiguous to the boundaries of the recreation area, that area determined to be composed of Lehman, Delaware, Milford, Dingman, Stroud, Westfall, Smithfield, Middle Smithfield and Upper Mount Bethel townships in Pennsylvania;

(4) Up to 125 northbound, and 125 southbound, commercial vehicles serving businesses and persons in Orange, Ulster, Rockland and Sullivan Counties, New York.

The exceptions to the closure of U.S. Route 209 were to remain in effect unless further action was taken by Congress.

Under the Omnibus Parks and Public Lands Management Act of 1996, Public Law 104-333, enacted on November 12, 1996, U.S. Route 209 will be closed to commercial vehicle traffic on September 30, 2005. Commercial vehicles connected with the operation of the recreation area, or serving “businesses within or in the vicinity of the recreation area” will be permitted to use the highway. The Act directs the Secretary of the Interior to define the term “businesses within or in the vicinity of the recreation area”.

Public Law 98-63, as amended by Public Law 99-88, directed the Secretary of the Interior to establish a fee for the use of U.S. Route 209 by commercial vehicles. The law directed the National Park Service to set aside all fees in a special account, the funds to be available for the management, operation, construction, and maintenance of U.S. Route 209 within the boundary of the recreation area. The fee schedule was not to exceed $7 per trip. Those commercial vehicles serving businesses within, or contiguous to the boundaries of, the recreation area were exempted from the fee.

In accordance with Public Law 98-63, the National Park Service published in the Federal Register (48 FR 46779, October 14, 1983), a fee schedule based on the number of axles of lightweight and heavy commercial vehicles. The fees ranged from $0.50 for two axle cars, vans or pickups, to $5.00 for a five or more axle vehicle. The full 1983 fee schedule can be found in Table 1.

On August 23, 1985, the National Park Service revised the fee schedule, publishing a final rule in the Federal Register (50 FR 34128), revising the fee schedule. The rule was based on the revised estimates of costs for management, operation, construction and maintenance of U.S. Route 209. The raised fees ranged from $1.00 for two axle cars, vans or pickups, to $7.00 for a five or more axle vehicle. The full 1985 fee schedule can be found in Table 1.

Authority to collect fees for those commercial vehicles permitted to use U.S. Route 209 terminated on July 30, 1993. The NPS stopped collecting fees on that date, but was required to continue to enforce the statutory closure and exceptions to the commercial use of the highway. The commercial vehicle check stations were operated as before July 30, 1993, but no fees were collected.

On November 12, 1996, Congress enacted Public Law 104-333, which reinstated the National Park Service's authority to collect commercial vehicle fees on U.S. Route 209. Public Law 104-333 specified that fees could not exceed $25 per trip. The NPS resumed the collection of fees, using the 1985 fee schedule, on November 26, 1996.

Congress specified that the fees collected from commercial vehicles excepted from the closure of U.S. Route 209 be made available, “without further appropriation, for the management, operation, construction, and maintenance of highway 209 within the boundaries of the recreation area”. Congress intended the income from the commercial vehicle fee program to equal or exceed the cost of operating the program, and to fund the program without further appropriation or use of other operating funds.

Initially, fee collection revenues from U.S. Route 209 provided enough revenue to operate the commercial use program, purchase equipment related to the operation of U.S. Route 209, and do some maintenance. The amount of revenue generated has decreased over time as several large commercial vehicle facilities closed their local terminals, and stopped traveling on U.S. Route 209. Fluctuations in the local economy have also had an effect. A comparison of revenue generated through the fee operation from fiscal years 1984 to 2002 is illustrated in Figure 1.

Large 5-axle tractor-trailers have been the most important permitted commercial vehicles to use U.S. Route 209, both in total number of commercial vehicles, and in fees generated. Trucks paying the maximum fee of $7.00 for a five-axle vehicle account for approximately 75 percent of the total number of fee-paying vehicles, and nearly 90 percent of the total revenue received. A comparison of the percent of total fee vehicles, by number of vehicles and revenue collected, for each class of vehicle may be found in Figure 2.

In recent years the cost of operating the commercial operation program has largely exceeded the income generated by fees. The trends of fee revenue remaining relatively steady and increasing expenses is expected to continue. The operating deficit is made up with funds appropriated for normal park operations (ONPS funds). A year by year comparison of income and expenditures may be found in Figure 3.

When the current commercial vehicle policy on U.S. Route 209 was begun in 1983, closing the highway and charging a fee for permitted uses were very controversial issues. Under the circumstances, promulgating special regulations implementing the closure and fees was an appropriate action. The revenue generated was much greater than the cost of operating the fee program at that time, and there was a carry-over balance that was available for other uses related to the operation and maintenance of U.S. Route 209. As documented above, in recent years the cost of managing commercial operations has been more than the revenue collected. The collection of fees for commercial vehicle use of U.S. Route 209 is authorized by Federal statute, and Congress's intent is that the commercial vehicle fees collected fund the commercial traffic management program. The National Park Service has set the fees to attempt to provide an amount of revenue approximately equal to or slightly over the cost of collection, and to fund the commercial traffic management program with the collected revenue. There is no plan to set fees at a level that would provide funds for maintenance of the highway, though any surplus could be used for repairs. The new fee schedule is provided in Table 2.

Prior to the partial closure of U.S. Route 209 to commercial vehicles in 1983, more than 2,000 tractor-trailers per day traveled through the recreation area. That number has been reduced to fewer than 200 per day in 2001, including fee-paying and fee-exempt trucks. The 5-axle, fee-paying tractor-trailers using U.S. Route 209 use the highway because it is the most convenient route between their points of origin and destination. A majority of these trucks are making trips between points within one hundred miles north or south of the recreation area. Generally, these trucks are either based in Monroe or Northampton Counties, PA, or are serving businesses in the four-county New York area. Relatively few trucks originating more than a hundred miles from Delaware Water Gap National Recreation Area use the highway, even if they would be permitted to use the highway based on their destination. The trucks using U.S. Route 209 do so because it is the most convenient, and economically feasible, alternative.

There are two potential alternate routes available to the majority of trucks currently using U.S. Route 209. The first is to bypass the highway through the recreation area by traveling between Interstates 80 and 84 via Route 402. This route is not usable because there is a weight limit of 20,000 lbs.; an average weight for a loaded tractor trailer is 80,000 lbs. The second alternative is to use Interstate 380 between Routes 80 and 84. This route adds approximately 46 miles to each one-way trip. Using a 2003 estimate of $1.45 per mile for shipping freight via tractor trailers, travel via Interstate 380 adds an additional $66. Other alternatives, such as using Route 94 or Interstate 287, are unlikely to be chosen because of traffic congestion, additional miles, and tolls. Therefore, NPS expects the large 5-axle, fee-paying traffic to remain relatively constant.

NPS has identified the six most common companies using U.S. Route 209 on a fee basis. These six companies paid approximately 45 percent of all the 5-axle fees paid in fiscal year 2001. NPS received approximately $46,277 from these companies in calendar year 2001, out of a total of $103,838 paid by all 5-axle vehicles in fiscal year 2001. This compares a calendar year to a fiscal year, so therefore these are estimates, but they should be approximately correct because the traffic from these six companies is relatively constant. These companies will be the most affected by a fee increase. Increasing the fees by 155% will proportionally increase the cost of using U.S. Route 209 to these companies. Table 3 summarizes the total number of paid trips by these companies and the revenue received from them in calendar year 2001.

NPS anticipates fee revenue will increase by about 155% the when the proposed rule becomes final and the fee schedule is increased. Revenue from commercial vehicles decreased over the years of the program, but NPS does not have enough years of data since the resumption of fee collection in 1996 to predict future collections. A small percentage of commercial vehicles may elect to use an alternate route, rather than using U.S. Route 209. However, the larger 5-axle trucks are still expected to use the highway, as $18 per trip will still be less expensive than driving the additional miles on alternate routes. If those assumptions are correct, the revenue collected will be affected mostly by economic conditions.

The NPS estimates the fee revenue will be $270,300 in the first fiscal year following implementation of the revised fee schedule. NPS believes the fee increase will be implemented on or shortly before the beginning of fiscal year 2005 on October 1, 2004. NPS anticipates spending an average additional 3.3 percent per year to operate the commercial vehicle fee program, based on increases in personnel costs. Figure 4 illustrates expected revenue collected, expenses, and carryover until the end of fiscal year 2005. This projection is based on the current hours of operation, which target about 90 percent of the commercial traffic. If the fee collection operation were extended beyond the end of fiscal year 2005, and revenue remained constant, the operation would be operating at a deficit during fiscal year 2007.

The National Park Service published a proposed rule on July 6, 2004, (69 FR 40562). Two comments were received on the rule during the 30-day comment period.

Comment: A private citizen from New Jersey commented that the increase in fees was not sufficient, and that the National Park Service should charge each commercial vehicle the maximum of $25.00 as allowed by the 1995 law. In addition, the comment included the statement that the fees should be $25.00 per axle.

Response: The National Park Service fee structure was originally designed to be consistent to those used by governmental entities that collect fees or tolls for roadway or bridge use; i.e., the amount of the fee is based on the number of axles the vehicle has. For example smaller, lighter vehicles such as pickup trucks are charged a fee at the lower end of the schedule, while the largest, heaviest vehicles such as tractor-trailers pay the highest fees.

The National Park Service wishes to retain that accepted fee structure. It has adjusted fees to a level that, given no decrease in present use, will make the commercial vehicle regulation program self-sustaining as directed by Public Law 98-63; increasing fees to $25.00 per vehicle would likely result in an excess of funds above the cost of managing the program. Though Congress has also authorized the use of funds to perform maintenance on the highway, no maintenance/construction on U.S. Route 209 is expected during fiscal year 2005. Thus collecting funds in excess of operating costs would therefore be inappropriate. In addition, the suggestion of charging $25.00 per axle would exceed the maximum fee authorized by Congress.

Comment: The second comment received was from the management of a truck terminal in the local area. The terminal is a branch facility of a large multinational corporation. The comment received was to suggest a 6-year phase-in of the increase in fees.

Response: P.L. 104-333 ends the National Park Service authority to collect fees on September 30, 2005, so any collections beyond that time would not be authorized, and a phase-in therefore not possible. As mentioned before, the Service established the fee schedule to cover costs; any lesser amounts would prevent the program from becoming self-sufficient.

This document is not a significant rule and has not 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, the environment, public health or safety, or State, local, or tribal governments or communities. The NPS has prepared an Initial Cost-Benefit analysis to support this statement. That analysis can be viewed at http://www.nps.gov/dewa.

(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 does not raise novel policy issues.

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. ). This certification is based on a Regulatory Flexibility threshold analysis performed by NPS economists in October 2003. That document can be viewed at http://www.nps.gov/dewa.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. 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 significant adverse effects 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 taking implications. A taking implication assessment is not required. No takings 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.

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.

A Final Environmental Impact Statement for the management of U.S. Route 209 was issued in September 1983. The Department has determined that further compliance under this Act is not required for any of these proposed actions.

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:

We have evaluated potential effects on federally recognized Indian tribes and have determined that there are no potential effects.

Executive Order 12866 requires each agency to write regulations that are easy to understand. We invite your comments on how to make this rule easier to understand, including answers to questions such as the following: (1) Are the requirements in the rule clearly stated? (2) Does the rule contain technical language or jargon that interferes with its clarity? (3) Does the format of the rule (grouping and order of sections, use of headings, paragraphing, etc .) aid or reduce its clarity? (4) Would the rule be easier to read if it were divided into more (but shorter) sections? (A “section” appears in bold type and is preceded by the symbol “§ ” and a numbered heading; for example § 7.71 Delaware Water Gap National Recreation Area. (5) Is the description of the rule in the “Supplementary Information” section of the preamble helpful in understanding the proposed rule? What else could we do to make the rule easier to understand?

Send a copy of any comments that concern how we could make this rule easier to understand to: Office of Regulatory Affairs, Department of the Interior, Room 7229, 1849 C Street, NW., Washington, DC 20240.

The principal contributors to this proposed rulemaking are Joel Schwartz, Fee Collection Program Manager, and Brian McDonnell, Park Ranger, and Philip A. Selleck, Chief Ranger, Delaware Water Gap NRA.

The Office's Trademark Operation, as well as its Trademark Trial and Appeal Board, are currently housed at 2900 Crystal Drive in Arlington, Virginia, and § 2.190 requires that all trademark-related correspondence filed on paper, except for requests to record documents in the Assignment Services Division and requests for copies of trademark documents, be sent to that location.

The Trademark Operation and the Trademark Trial and Appeal Board are moving to a new facility in Alexandria, Virginia. It is expected that this move will commence on or about October 4, 2004, and will be completed on or about November 9, 2004. The Office is therefore amending § 2.190 to provide for new mailing addresses for all paper-filed trademark-related correspondence, except for requests to record documents in the Assignment Services Division and requests for copies of trademark documents.

The Office continues to encourage trademark applicants and registrants to file documents with the Trademark Operation via the Trademark Electronic Application System (“TEAS”), available at http://www.uspto.gov , and to file documents with the Trademark Trial and Appeal Board via the Electronic System for Trademark Trials and Appeals (“ESTTA”), available at http://estta.uspto.gov .

The Madrid Protocol is an international treaty that allows a trademark owner to seek registration in any of the countries and organizations that have joined the Protocol (“Contracting Parties”), by submitting a single international application. The international application must be based on a trademark application filed in or registration issued by the trademark office of one of the Contracting Parties (“basic application” or “basic registration”), and must be submitted to the IB through the trademark office of the Contracting Party in which the basic application or registration is held (“Office of Origin”). Before forwarding the international application to the IB, the Office of Origin must certify that the information in the international application corresponds to the information in the basic application or registration.

The Madrid Protocol became effective in the United States on November 2, 2003. The Madrid Protocol Implementation Act of 2002, Public Law 107-273, 116 Stat. 1758, 1913-1921 (“MPIA”) amended the Trademark Act to provide that: (1) The owner of a U.S. application or registration may seek protection of its mark in any of the countries and organizations party to the Madrid Protocol by submitting a single international application to the IB through the Office; and (2) the holder of an international registration may request an extension of protection of the international registration to the United States. A notice of final rule making amending the Trademark Rules of Practice to incorporate the MPIA was published at 68 FR 55748 (Sept. 26, 2003).

The rules required: (1) That filers use TEAS to submit international applications, subsequent designations, responses to notices of irregularity, requests to record changes in the International Register, and requests for transformation; and (2) that international fees required by the IB for international applications, subsequent designations and requests to record changes in the International Register be paid through TEAS at the time of submission. Due to unforeseen technical difficulties, the deployment of Madrid-related TEAS forms has been delayed. Therefore, these requirements of the rules were temporarily waived in a notice published at 68 FR 74479 (Dec. 24, 2003). The Office is amending its rules to incorporate these changes.

The Madrid Protocol, Common Regulations Under the Madrid Agreement Concerning the International Registration of Marks and the Protocol Relating to That Agreement (April 1, 2004) (“Common Regs.”), and Guide to International Registration (2004) (“Guide”), are available on the IB's Web site, at http://www.wipo.int/madrid . The Common Regs. are the procedures agreed to by the Contracting Parties, pursuant to Madrid Protocol Article 10(2)(iii).

References below to “the Act,” “the Trademark Act,” or “the statute” refer to the Trademark Act of 1946, 15 U.S.C. 1051, et seq. , as amended.

The Office is amending rules 2.190, 2.195, 2.197, 7.4, 7.7, 7.11, 7.14, 7.21, 7.23, 7.25, and 7.31.

The Office is revising § 2.190(a) to set forth a new mailing address for all paper-filed trademark-related correspondence (except requests to record documents in the Assignment Services Division, requests for copies of trademark documents, and certain documents filed pursuant to the Madrid Protocol), and adding a new § 2.190(e) to set forth a new mailing address for the following Madrid-related paper-filed documents: international applications under § 7.11; subsequent designations under § 7.21; responses to notices of irregularity under § 7.14; requests to record changes in the International Register under § 7.23 and § 7.24; requests for transformation under § 7.31; and petitions to the Director to review an action of the MPU.

The Office is amending § 2.195(d)(3) to delete the word “and” after the semi-colon, and amending § 2.195(d)(4) to replace the period with a semi-colon and to add the word “and” after the semi-colon.

The Office is adding a new § 2.195(d)(5), to prohibit the use of facsimile transmission to file international applications, subsequent designations, responses to notices of irregularity, requests for transformation, and requests to record changes in the International Register.

The Office is revising § 2.197(a)(2) to provide that the certificate of mailing or transmission procedure described in § 2.197(a)(1) does not apply to international applications, subsequent designations, responses to notices of irregularity, requests for transformation, and requests to record changes in the International Register.

The Office is redesignating the current § 7.4 as § 7.4(a).

The Office is adding a new § 7.4(b) to designate a new mailing address for paper-filed international applications, subsequent designations, responses to notices of irregularity, requests to record changes in the International Register, requests for transformation, and petitions to the Director to review an action of the MPU.

The Office is adding a new § 7.4(b)(1), to provide that international applications, subsequent designations, requests to record changes in the International Register, and petitions to the Director to review an action of the MPU, when filed by mail, will be accorded the date of receipt in the Office, unless they are sent by Express Mail pursuant to § 2.198, in which case they will be accorded the date of deposit with the United States Postal Service.

The Office is adding a new § 7.4(b)(2), to provide that requests for transformation and responses to notices of irregularity, when filed by mail, will be accorded the date of receipt in the Office. International applicants are advised that a response to a notice of irregularity under § 7.14 must be received at the IB before the end of the response period set forth in the IB's notice. Receipt in the Office does not satisfy this requirement. See § 7.14(e); IB's Guide at B.I.05.01.

The Office is adding a new § 7.4(c) to designate a location for hand delivery of international applications, subsequent designations, responses to notices of irregularity, requests to record changes in the International Register, requests for transformation, and petitions to the Director to review an action of the MPU.

The Office is adding a new § 7.4(d), to prohibit the use of facsimile transmission to file international applications, subsequent designations, responses to notices of irregularity, requests for transformation, and requests to record changes in the International Register.

The Office is adding a new § 7.4(e), to provide that the certificate of mailing or transmission procedure described in § 2.197(a)(1) does not apply to international applications, subsequent designations, responses to notices of irregularity, requests for transformation, and requests to record changes in the International Register. This is consistent with the revision to § 2.197(a)(2), discussed above.

The Office is revising § 7.7(a) to provide that fees for international applications, subsequent designations, and requests to record changes of ownership may be paid to the IB through the Office only when the documents are filed through TEAS. At present, the Office is unable to process international fees for paper filings.

The Office is adding a new § 7.7(c) to provide that all fees for paper filings must be paid directly to the IB. These fees can be paid to the IB either before or after submission of the document to the Office. However, fees paid after the document is received by the IB could result in a notice of irregularity.

The Office is redesignating § 7.7(c) as § 7.7(d).

The Office is revising § 7.11(a) to remove the requirement that an international application be filed through TEAS and to permit the filing of an international application either through TEAS, or on the official paper form issued by the IB, currently available on the IB's Web site at http://www.wipo.int/madrid . Inasmuch as deployment of the TEAS form has been delayed due to unforeseen technical difficulties, international applications must be filed on paper until the TEAS form is posted on the Office's Web site. When the TEAS form is posted, applicants will have the option to file international applications either on paper or through TEAS.

Revised § 7.11(a) requires that an international application filed on paper be presented on the official paper form issued by the IB, currently available on the IB's Web site at http:// www.wipo.int/madrid . MM2 is the official IB form for an application for international registration under the Madrid Protocol. The IB does not accept paper applications that are not presented on the official IB form. The form cannot be hand-written. Madrid Protocol Article 3(1); Common Regs. 9(2)(a) and 11(4)(a)(i). When submitting an international application on paper, applicants should complete the official form online, print the completed form, and submit it to the Office. For instructions on completing the IB's official international application form, see the IB's Guide at B.II.07.01-20.11.

The Office is revising § 7.11(a)(3) by breaking it into subsections 7.11(a)(3)(i) through 7.11(a)(3)(iii), for purposes of clarity.

The Office is adding a new § 7.11(a)(3)(iv), to require, for international applications filed on paper, that the depiction of the mark appear no larger than 3.15 inches (8 cm) high by 3.15 inches (8 cm) wide, and that the mark be placed in the box designated by the IB on the IB's official form. This is required by Common Reg. 9(4)(a)(v). The size requirement is consistent with the size requirement of § 2.54(b).

The Office is revising § 7.11(a)(9) to delete reference to fees payable to the IB for international applications. These fees are provided for in new § 7.11(a)(10).

The Office is redesignating § 7.11(a)(10) as § 7.11(a)(11) and revising it to provide that if an international application is filed through TEAS, in order to be accorded a date of receipt in the Office it must include the international application fees for all classes, and the fees for all designated Contracting Parties identified in the application. This requirement does not apply to international applications filed on paper. Under new § 7.7(c), international fees for paper applications must be paid directly to the IB, and may be paid either before or after submission of the international application to the Office. However, fees paid after the international application is received by the IB could result in a notice of irregularity. The requirement in § 7.11(a)(9) that the U.S. certification fee required by § 7.6 be paid at the time of submission in order to obtain a date of receipt applies to both TEAS and paper applications.

The Office is redesignating § 7.11(a)(11) as § 7.11(a)(12), and revising it to provide that an e-mail address for correspondence is required only when the international application is filed through TEAS. The inclusion of an e-mail address in paper applications is encouraged, but not mandatory.

The Office is revising § 7.14(e) to remove the requirement that a response to a notice of irregularity issued by the IB be filed through TEAS. Deployment of the TEAS form has been delayed due to unforeseen technical difficulties. Until the TEAS form is available, responses to notices of irregularity must be filed on paper. When the TEAS form is operational, applicants will have the option to file responses either on paper or through TEAS.

The Office is revising § 7.21(b) to remove the requirement that a subsequent designation be submitted through TEAS, and permit the submission of a subsequent designation either through TEAS or on the official paper form issued by the IB. Deployment of the TEAS form has been delayed due to unforeseen technical difficulties. Until the TEAS form is available, subsequent designations must be filed on paper. When the TEAS form is posted, holders will have the option to file subsequent designations either on paper or through TEAS.

Revised § 7.21(b) requires that a subsequent designation filed on paper be presented on the official paper form issued by the IB, currently available on the IB's Web site at http://www.wipo.int/madrid . MM4 is the official IB form for a designation subsequent to the international registration under the Madrid Protocol. The IB does not accept paper subsequent designations that are not presented on the official IB form. The form cannot be hand-written. Madrid Protocol Article 3 ter (2); Common Reg. 24(2)(b). When submitting a subsequent designation on paper, the holder should complete the official form online, print the completed form, and submit it to the Office. Completed subsequent designations may also be filed directly at the IB. The IB's Guide contains instructions for completing the subsequent designation form, at B.II.43.01-44.03.

The Office is revising § 7.21(b)(7) to delete reference to subsequent designation fees payable to the IB. These fees are provided for in new § 7.21(a)(8).

The Office is revising § 7.21(a)(8) to provide that a subsequent designation filed through TEAS must include the subsequent designation fees payable to the IB in order to obtain a date of receipt in the Office. This requirement does not apply to subsequent designations filed on paper. Under new § 7.7(c), fees for paper subsequent designations must be paid directly to the IB, and may be paid either before or after submission of the subsequent designation to the Office. However, fees paid after the subsequent designation is received by the IB could result in a notice of irregularity. The requirement that the U.S. transmittal fee required by § 7.6 be paid at the time of submission in order to obtain a date of receipt remains unchanged for paper subsequent designations.

The Office is redesignating § 7.21(b)(8) as § 7.21(b)(9), and revising it to provide that an e-mail address for correspondence is required only if the subsequent designation is filed through TEAS. The inclusion of an e-mail address in a paper subsequent designation is encouraged, but not mandatory.

The Office is revising § 7.23(a)(8) to remove the requirement that a request to record a change of ownership include the recording fee required by the IB. The Office currently does not have an electronic form available for requests to record changes of ownership, and cannot process the international fees for paper filings. Therefore, under § 7.7(c), if a request to record a change of ownership is submitted on paper, the fee must be paid directly to the IB, and may be paid either before or after submission of the request to the Office. However, fees paid after the request is received by the IB could result in a notice of irregularity. The requirement that the U.S. transmittal fee required by § 7.6 be paid at the time the request is submitted remains unchanged.

The Office is revising § 7.25(a) to delete the designation of § 2.172 as a section of part 2 of this chapter that does not apply to registered extensions of protection of international registrations to the United States. This will allow parties to file requests to surrender registered extensions of protection of an international registration to the United States either directly with the IB or with the Office. If the request to surrender is filed through the Office, the Office will notify the IB of the surrender.

The Office is amending § 7.31(a) to delete the requirement that a request for transformation be filed through TEAS. The Office currently does not have a TEAS form available for requests for transformation. Until the TEAS form is available on the Office's Web site, requests for transformation must be filed on paper. When the TEAS form is operational, holders will be able to file requests for transformation either on paper or through TEAS.

This final rule merely involves rules of agency practice and procedure within the meaning of 5 U.S.C. 553(b)(A), as it merely provides new mailing addresses for certain trademark-related correspondence and eliminates certain existing procedural requirements related to filings under the Madrid Protocol that were waived pursuant to a notice published at 68 FR 74479 (Dec. 24, 2003) and incorporates agency procedure and practice to implement the changes therein. Therefore, this final rule may be adopted without prior notice and opportunity for public comment under 5 U.S.C. 553(b) and (c), or thirty-day advance publication under 5 U.S.C. 553(d).

The changes in this final rule merely: (1) Set forth the mailing addresses that should be used for mailing certain trademark-related correspondence to the Office; and (2) incorporate agency procedures and practice put in place to ensure compliance with a notice published at 68 FR 74479 (Dec. 24, 2003) eliminating certain existing requirements for trademark-related filings under the Madrid Protocol. This final rule package does not impose any new fees on members of the public, and places no additional economic burden on large or small entities.

This final rule change is a rule of agency practice and procedure under 5 U.S.C. 553(b)(A), and prior notice and an opportunity for public comment therefore is not required pursuant to 5 U.S.C. 553(b)(A) (or any other law). See Bachow Communications Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application process are “rules of agency organization, procedure, or practice” and exempt from the Administrative Procedure Act's notice and comment requirement); Merck & Co., Inc. v. Kessler, 80 F.3d 1543, 1549-50, 38 USPQ2d 1347, 1351 (Fed. Cir. 1996) (the rules of practice promulgated under the authority of former 35 U.S.C. 6(a) (now in 35 U.S.C. 2(b)(2)) are not substantive rules (to which the notice and comment requirements of the Administrative Procedure Act apply)); Fressola v. Manbeck, 36 USPQ2d 1211, 1215 (D.D.C. 1995) (“it is doubtful whether any of the rules formulated to govern patent and trade-mark practice are other than ‘interpretative rules, general statements of policy, * * * procedure, or practice’ ” (quoting C.W. Ooms, The United States Patent Office and the Administrative Procedure Act , 38 Trademark Rep. 149, 153 (1948). Thus, the provisions of the Regulatory Flexibility Act are not applicable to this rule making.

This rule making does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

This rule making has been determined not to be significant for purposes of Executive Order 12866.

The final rules are in conformity with the requirements of the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501 et seq. ).

An information collection package supporting the information requirements set forth in this rule was approved by the Office of Management and Budget under 0651-0051. That information collection package included a requirement that the following documents be submitted electronically: international applications under § 7.11, subsequent designations under § 7.21, responses to notices of irregularity under § 7.14, and requests for transformation under § 7.31. This final rule removes the requirement that these forms be filed electronically, and instead permits filing either electronically or on paper. The information to be provided on paper is the same information as that collected by the electronic forms described in the information collection package that was approved under 0651-0051.

These final rules require that international applications and subsequent designations, when submitted on paper, be presented on the official forms provided by the IB. The IB will not accept paper international applications and subsequent designations that are not presented on the official IB form. Madrid Protocol Article 3(1) and 3 ter (2); Common Regs. 9(2)(a), 11(4)(a)(i), and 24(2)(b). The IB's paper forms collect the same information required in the electronic forms approved under 0651-0051.

Neither the Office nor the IB provides a paper form for responses to notices of irregularity or requests for transformation. The applicant/holder must provide the same information required in the electronic forms approved under 0651-0051, using the form of their choice.

There are no other new information collection requirements in this final rule.

The public reporting burden is estimated to average as follows: Fifteen minutes for international trademark applications; three minutes for subsequent designations; ten minutes for responses to notices of irregularities issued by the IB; and five minutes for requests to transform cancelled extensions of protection into applications for registration under section 1 or 44 of the Trademark Act. These time estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Comments are invited on: (1) Whether the collection of information is necessary for proper performance of the functions of the agency, (2) the accuracy of the agency's estimate of the burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) ways to minimize the burden of the collection of information to respondents.

Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to the Commissioner for Trademarks, 2900 Crystal Drive, Arlington, VA 22202-3514 (Attn: Ari Leifman), and to the Office of Information and Regulatory Affairs, OMB, 725 17th Street, NW., Washington, DC 20503 (Attn: USPTO Desk Officer).

Notwithstanding any other provision of law, no person is required to respond to nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number.

The following table of contents describes the format for the SUPPLEMENTARY INFORMATION section:

The EPA is approving a negative declaration submitted by the State of New Jersey dated March 4, 2004. This negative declaration finds that there are no existing facilities subject to regulation as commercial and industrial solid waste incinerators (CISWI) in the State of New Jersey. The negative declaration satisfies the federal Emission Guidelines requirements of EPA's promulgated regulation entitled “Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units'' (65 FR 75338, December 1, 2000; and corrected at 66 FR 16605, March 27, 2001). The negative declaration officially certifies to EPA that, to the best of the State's knowledge, there are no CISWI sources in operation in the State of New Jersey.

In its March 4, 2004 letter, New Jersey further stated that its negative declaration was consistent with the EPA's database of CISWI units which shows only one potential CISWI incinerator located at the Hoffman LaRoche (HLR) facility in Nutley, New Jersey. However, New Jersey stated that the HLR incinerator is regulated as a co-fired combustor under EPA's Hospital/Medical/Infectious Waste Incinerator (HMIWI) Federal Plan (title 40, part 62, subpart HHH of the Code of Federal Regulations (40 CFR 62, subpart HHH), promulgated on August 15, 2000) and therefore, exempt from the CISWI Emission Guidelines. EPA agrees with New Jersey that the HLR incinerator is considered a co-fired combustor under EPA's HMIWI Federal Plan and, due to the nature of the waste combusted in the incinerator, is exempt from the CISWI Emission Guidelines.

EPA has evaluated the negative declaration submitted by New Jersey for consistency with the Clean Air Act (Act), EPA guidelines and policy. EPA has determined that New Jersey's negative declaration meets all applicable requirements and, therefore, EPA is approving the State's certification that there are no existing CISWI units in operation throughout the State. For additional details, see EPA's proposed approval published in the Federal Register on July 16, 2004 (69 FR 42641).

Section 60.2530 of 40 CFR 60, subpart DDDD (page 75363 @ 65 FR 75338, December 1, 2001) requires that if, after the effective date of EPA's final action on New Jersey's negative declaration, an existing CISWI unit is found in the State, the Federal Plan (40 CFR 62, subpart III, promulgated on October 3, 2003) implementing the Emission Guidelines would automatically apply to that CISWI unit until a State Plan is approved by EPA.

The public comment period on EPA's proposed approval ended on August 16, 2004. There were no comments received on EPA's proposed approval of New Jersey's negative declaration. Therefore, EPA is approving New Jersey's negative declaration.

EPA has determined that New Jersey's negative declaration meets all applicable requirements and, therefore, EPA is approving New Jersey's certification that no CISWI units are in operation within the State of New Jersey. If any existing CISWI sources are discovered in the future, the Federal Plan implementing the Emission Guidelines would automatically apply to that CISWI unit until the State Plan is approved by EPA.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

Under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , OMB must approve all “collections of information” by EPA. The Act defines “collection of information” as a requirement for “answers to * * * identical reporting or recordkeeping requirements imposed on ten or more persons * * * “ 44 U.S.C. 3502(3)(A). Because the final rule applies to New Jersey's negative declaration letter for CISWI units, there are no companies affected by this approval and therefore, the Paper Reduction Act does not apply.

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.

This rule will not have a significant impact on a substantial number of small entities because as a negative declaration no sources in the state are subject to the CISWI Emission Guidelines requirements. Therefore, because the Federal approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), 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 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 has determined that the approval action does not include a Federal mandate that may result in estimated costs of $100 million or more to either state, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under state or local law, and imposes no new requirements. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, result from this action.

Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). 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.” 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.

EPA has concluded that this rule may have federalism implications. The only reason why this rule may have federalism implications is if in the future a CISWI unit is found within the State of New Jersey the unit will become subject to the Federal Plan until a State Plan is approved by EPA. However, it will not impose substantial direct compliance costs on state or local governments, nor will it preempt state law. Thus, the requirements of sections 6(b) and 6(c) of the Executive Order do not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination With Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, Executive Order 13175 does not apply to this rule.

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 rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

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) because it is not a significant regulatory action under Executive Order 12866.

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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 .

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

In the Federal Register of August 6, 2003 (68 FR 46609) (FRL-7320-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3F6542) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the herbicide penoxsulam, 2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide, in or on rice, grain at 0.01 parts per million (ppm), rice, straw at 0.5 ppm, rice, hulls at 0.01 ppm, rice, bran at 0.01 ppm, and rice, polished rice at 0.01 ppm. That notice included a summary of the petition prepared by Dow AgroSciences LLC, the registrant. There were no comments received in response to the notice of filing. The tolerance for rice grain was increased to 0.02 ppm to reflect the submitted field residue data. Residues of penoxsulam do not concentrate in the processed commodities, rice hull, bran, or polished rice, therefore any residues of penoxsulam on these commodities will be covered by the tolerance on rice, grain.

Section 408(b)(2)(A)(i) of 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 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 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 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 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 FFDCA, for a tolerance for residues of penoxsulam on rice, grain at 0.02 ppm and rice, straw at 0.5 ppm. No tolerances were necessary for the rice process commodities, rice hulls, bran, or polished rice, because residues will not exceed the established tolerance in rice, grain. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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 .

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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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 .

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), 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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/ .

In the Federal Register of January 29, 2003 (68 FR 4475) (FRL-7287-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 8F3591 and 9F3798) by Valent U.S.A. Corporation, 1333 North California Blvd., Suite 600, Walnut Creek, CA 94596-8025. The petitions requested that 40 CFR 180.432 be amended by establishing tolerances for residues of the herbicide lactofen, 1-(carboethoxy)ethyl 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate, in or on cottonseed at 0.01 part per million (ppm), cotton gin byproducts at 0.02 ppm (PP 9F3798), and peanut nutmeats at 0.01 ppm (PP 8F3591). That notice included a summary of the petitions prepared by Valent U.S.A. Corporation, the registrant. There were no comments received in response to the notice of filing.

The proposed and established tolerances are corrected to conform to the Food and Feed Commodity Vocabulary Database ( http://www.epa.gov/pesticides/foodfeed/ ) and to lower the established tolerances for snap bean and soybean to 0.01 ppm as required by the Lactofen Tolerance Reassessment ( http://www.epa.gov/pesticides/reregistration/lactofen/ ) to read as follows: Tolerances for residues of the herbicide lactofen, 1-(carboethoxy)ethyl 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate, in or on beans, snap, succulent (excluding limas) at 0.01 ppm; cotton, undelinted seed at 0.01 ppm; cotton, gin byproducts at 0.02 ppm; peanut at 0.01 ppm; and soybean, seed at 0.01 ppm.

Section 408(b)(2)(A)(i) of 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 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 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 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 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 FFDCA, for tolerances for residues of lactofen on cotton, undelinted seed at 0.01 ppm; cotton, gin byproducts at 0.02 ppm; and peanut at 0.01 ppm 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 lactofen 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.

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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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 .

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), 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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

In the Federal Register of March 19, 2001 (66 FR 15443-15459) (FRL-6766-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F6176) by Rohm and Haas, 100 Independence Mall West, Philadelphia, PA 19106, which has been subsequently purchased by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268. The petition requested that 40 CFR 180.482 be amended by establishing a tolerance for residues of the insecticide tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, in or on citrus (crop group 10) and citrus oil at 0.80 and 10 parts per million (ppm), respectively. That notice included a summary of the petition prepared by Rohm and Haas, the registrant at the time. There were no comments received in response to the notice of filing.

In the Federal Register of March 12, 2003 (68 FR 11846-11850) (FRL-7295-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 2E6397 and PP 2E 6413), by Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1, South Brunswick, NJ 08902. The petitions requested that 40 CFR 180.482 be amended by establishing tolerances for residues of the insecticide, tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, in or on grape at 3.0 ppm (PP 2E6413) and vegetable, tuberous and corm (except potato) subgroup 1D at 0.01 ppm (PP 2E6397). That notice included a summary of the petition prepared by IR-4. There were no comments received in response to the notice of filing.

In the Federal Register of January 28, 2004 (69 FR 4147-4151) (FRL-7335-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7F4824), by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268. The petition requested that 40 CFR 180.482 be amended by establishing tolerances for indirect or inadvertent combined residues of tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1-(1,1dimethylethyl)-2-[4-(1-hydroxyethyl)benzoyl]hydrazide in or on forage, fodder, hay and straw of cereal grain; forage, fodder, straw and hay of non-grass animal feed; forage, fodder and hay of grass and foliage of legume vegetables at 0.5, 0.5, 0.5, and 0.1 ppm, respectively. That notice included a summary of the petition prepared by Dow AgroSciences, the registrant. One comment was received in response to this notice. The commentator stated that there should be a zero tolerance since the data supporting the tolerance was too old. EPA, however, believes that the data submitted in 1999 are still relevant and reliable. The submitted studies were conducted pursuant to EPA regulations and guidelines and the commentor has offered no reason as to why the data from these studies is unreliable.

Section 408(b)(2)(A)(i) of 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 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 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 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 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 FFDCA, for a tolerance for residues of tebufenozide on tuberous and corm vegetables (except potato) subgroup 1D, grape, citrus (crop group 10), and citrus oil at 0.015, 3.0, 0.80, and 15.0 ppm and indirect or inadvertent combined residues of tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1-(1,1dimethylethyl)-2-[4-(1-hydroxyethyl)benzoyl]hydrazide in or on forage, fodder, hay and straw of ceral grain; forage, fodder, straw and hay of non-grass animal feed; forage, fodder and hay of grass and foliage of legume vegetables at 1.0, 1.0, 1.0, and 0.20 ppm. EPA'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 tebufenozide as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of October 21, 1999 (64 FR 56690-56697) (FRL-6382-6).

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 intraspecies differences.

Three other types of safety or uncertainty factors may be used: “Traditional uncertainty factors;” the “special FQPA safety factor;” and the “default FQPA safety factor.” By the term “traditional uncertainty factor,” EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term “special FQPA safety factor” refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The “default FQPA safety factor” is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).

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 an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, 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 safety factor.

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10 - 5 ), one in a million (1 X 10 - 6 ), or one in ten million (1 X 10 - 7 ). 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 tebufenozide used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of October 21, 1999 ( 64 FR 56690-56697) (FRL-6382-6).

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.482) for the residues of tebufenozide, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from tebufenozide 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 appropriate endpoint attributable to a single dose was not identified. This risk is considered to be negligible.

ii. Chronic exposure . In conducting the 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 U.S. Department of Agriculture 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: For the tolerances established in this action it was assumed that 100% of the crops would be treated with tebufenozide. Percent crop treated (PCT) estimates were used for some already existing tolerances. No anticipated residues were used.

iii. Cancer . Tebufenozide has been classified as a Group E “No evidence of carcinogenicity for humans.” Thus, tebufenozide is considered to pose at most a negligible risk of cancer and a quantitative exposure assessment for assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information . Section 408(b)(2)(F) of 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.

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.

The Agency used PCT information in Table 1 of this unit as follows:

Estimates of PTC were used for the following crops. In all cases the maximum estimate was used.

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

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

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a 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), which are the model estimates of a pesticide's concentration in water. EECs derived from these models are used 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 tebufenozide they are further discussed in the aggregate risk sections in Unit III.E.

Based on the PRZM/EXAMS and SCI-GROW models, the EECs of tebufenozide for acute exposures are estimated to be 15 parts per billion (ppb) for surface water and 1.19 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).

Tebufenozide 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 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.”

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 tebufenozide and any other substances and tebufenozide 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 tebufenozide 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 OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/ .

1. In general . Section 408 of 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 database on toxicity and exposure unless EPA determines based on reliable data 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. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . EPA evaluated the potential for increased susceptibility of infants and children from exposure to tebufenozide. EPA concluded that there are no concerns or residual uncertainties for prenatal and postnatal toxicity.

3. Conclusion . There is a complete toxicity database for tebufenozide and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Based on these data, EPA determined that the 10X SF to protect infants and children should be removed. The FQPA factor is removed because:

i. The toxicology database is complete.

ii. There is no indication of increased susceptibility of rats or rabbit fetuses to in utero and/or postnatal exposure in the developmental and reproductive toxicity data.

iii. Dietary exposure estimates are only partially refined by use of PCT information and therefore provide a very conservative (health-protective) estimate of dietary exposure through food.

iv. Modeling is used for the ground and surface source drinking water exposure assessments, resulting in estimates that are conservative upper-bound concentrations.

v. There are currently no registered residential uses for tebufenozide and therefore, non-dietary exposure to infants and children is not expected.

vi. No evidence of neurotoxicity was reported.

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 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 EPA's 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, 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 . An acute exposure risk assessment was not performed since no toxicity endpoint for tebufenozide attributable to a single dose was identified. Acute risk from exposure to tebufenozide is expected to be negligible.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to tebufenozide from food will utilize 25% of the cPAD for the U.S. population, 27% of the cPAD for all infants (1 year), and 92% of the cPAD for children 1-2 years. There are no residential uses for tebufenozide that result in chronic residential exposure to tebufenozide. In addition, there is potential for chronic dietary exposure to tebufenozide in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit:

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

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

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

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

5. Aggregate cancer risk for U.S. population . Tebufenozide is classified as “no evidence of carcinogenic for humans;” therefore, tebufenozide is expected to pose no greater than a negligible 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 tebufenozide residues.

The analytical method used for analysis of tebufenozide residues in/on oranges, lemons, and grapefruit was Preliminary Residue Method for RH-5992 in Citrus (Orange, Grapefruit, Lemon and Mandarin Orange) , Y.Meng and D.W.Chu, Rohm and Haas Analytical Method TR 34-96-184, 12/4/96. This (high performance liquid chromatography using ultraviolet (HPLC-UV) detection) method is very similar to the proposed food tolerance enforcement method for plant commodities (TR 34-94-38) and thus is adequate for collection of residue data, ergo, the method is suitable for the quantitation of tebufenozide in/on citrus commodities. The Agency has previously requested that the petitioner revise the analytical method submitted for enforcement purposes on directly treated crops (TR 34-94-38) to correct deficiencies noted during Agency method validation. Adequate recovery data for citrus samples (fortified with tebufenozide) were provided. The limit of detection (LOD) for tebufenozide in/on citrus was 0.006 ppm. The limit of quantitation (LOQ) for tebufenozide in/on citrus was 0.020 ppm.

Grape samples were analyzed for tebufenozide, via HPLC/UV, using the Del Monte Research Center Tebufenozide Working Method. This working method was based on Tolerance Enforcement Method for RH-5992 in Vegetables (Cabbage, Lettuce, Mustard Greens, Spinach, Broccoli and Celery), Rohm and Haas Analytical Method TR 34-94-41, 11/3/94. Minor modifications were made that would not negatively affect the performance of the method. Adequate recovery data for grape samples (fortified with tebufenozide) were provided. Method TR 34-94-41 has been conditionally approved by the Agency as an analytical enforcement method, pending incorporation of the corrections noted during the Analytical Chemistry Branch/BEAD's petition method validation (PMV) trial. This method is considered adequate for the enforcement of tebufenozide residues in/on grapes. The LOD for tebufenozide in/on grape was 0.004 ppm. The LOQ for tebufenozide in/on grape was 0.013 ppm.

Sweet potato root samples were analyzed for tebufenozide, via HPLC/UV, using the Del Monte Research Center Tebufenozide Working Method. This working method was based on Tolerance Enforcement Method for RH-5992 in Vegetables (Cabbage, Lettuce, Mustard Greens, Spinach, Broccoli and Celery), Rohm and Haas Analytical Method TR 34-94-41, 11/3/94. Minor modifications were made that would not negatively affect the performance of the method. Adequate recovery data for sweet potato root samples (fortified with tebufenozide) were provided. Method TR 34-94-41 has been conditionally approved by the Agency as an analytical enforcement method, pending incorporation of the corrections noted during the Analytical Chemistry Branch/BEAD's PMV trial. This method is considered adequate for the enforcement of tebufenozide residues in/on sweet potato roots. The LOD for tebufenozide in/on sweet potato was 0.005 ppm. The LOQ for tebufenozide in/on sweet potato was 0.015 ppm.

Quantitative analysis of tebufenozide and RH-1788 residues in/on foliage of cereal grains and foliage of legumes (as well as cereal grain and legume seeds) was performed via the (HPLC/mass spectroscopy (MS)/MS) method, Determination of Residues of Tebufenozide and Metabolite in Low Moisture Rotational Crops by Liquid Chromatography with Tandem Mass Spectrometry , Dow AgroSciences Analytical Method GRM 02.20, 2002. As stated in the Dow AgroSciences method validation report, the LOD was 0.006 ppm (for both tebufenozide and RH-1788) in low-moisture foliage samples and the LOQ, as demonstrated by the lowest acceptable recovery level, was 0.020 ppm. Fortified samples were analyzed over a validation range of 0.020 ppm (LOQ) to 1.00 ppm. The recovery results from these samples indicate the method's acceptability as a data-gathering method, at minimum. The original proposed analytical method for the enforcement of tebufenozide residues in/on rotated crops is Rohm and Haas Analytical Method TR 34-99-10. This HPLC/MS method has been validated with LOQs for tebufenozide and its metabolite in low moisture plant commodities at 0.02 ppm; the reported LODs for the analytes were 0.002 ppm. The results of the PMV trial demonstrated that, although the third validation attempt was successful for the parent compound, the method trial was unsuccessful for the metabolite, RH-1788, due to excessive interferences in the chromatograms. EPA recommended that the method be returned to the petitioner for modifications to improve the cleanup step and recovery of the metabolite. As EPA considers DAS Method GRM 02.20 to be the superior technique for quantitation of tebufenozide and RH-1788 residues in low-moisture rotational crops, the registrant has proposed it as the tolerance enforcement method, rather than Rohm and Haas Method TR 34-99-10. EPA will review the method; an independent method validation (ILV) or PMV or possibly both could be required before DAS Method GRM 02.20 is deemed acceptable for tolerance enforcement purposes.

These methods 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 Canadian or Mexican maximum residue limits (MRL) have been established for tebufenozide residues. Codex MRLs have been established for grapes at 2.0 ppm. The Codex MRL for grapes was based on data from France and Australia. No U.S. data was submitted to Codex.

Therefore, the tolerance is established for residues of tebufenozide on tuberous and corm vegetables (except potato) subgroup 1D, grape, citrus (crop group 10), and citrus oil at 0.015, 3.0, 0.80, and 15.0 ppm and indirect or inadvertent combined residues of tebufenozide , benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1-(1,1dimethylethyl)-2-[4-(1-hydroxyethyl)benzoyl]hydrazide in or on forage, fodder, hay and straw of ceral grain; forage, fodder, straw and hay of non-grass animal feed; forage, fodder and hay of grass and foliage of legume vegetables at 1.0, 1.0, 1.0, and 0.20 ppm.

Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of 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 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-2004-0209 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 23, 2004.

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 (1900L), 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 Suite 350, 1099 14 th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564-6255.

2. 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 ADDRESSES . Mail your copies, identified by docket ID number OPP-2004-0209, 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 ADDRESSES . 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 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, entitled 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 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 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).

This correction is necessary to reinstate the regulation text for § 411.370 through § 411.389 (regarding the physician self-referral advisory opinion process), which was inadvertently deleted from Part 411 in the March 26, 2004 interim final rule. We note that we are updating an incorrect address to be used in submitting advisory opinions.

The requirements in § 411.370 through § 411.389 are subject to the Paperwork Reduction Act; however, these requirements are currently approved under OMB control #0938-0714 with a current expiration date of October 31, 2004. Note that the information collection package containing these approved requirements is currently at OMB awaiting re-approval.

We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect. We can waive this procedure, however, if we find good cause that notice and comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporate a statement of the finding and the reasons for it into the rule issued.

We find it unnecessary, impracticable, and contrary to the public interest to offer an opportunity to comment on this rule before it becomes effective. This rule merely corrects the inadvertent removal of certain regulatory provisions regarding the physician self-referral advisory opinion process. The deleted advisory opinion regulations have been in effect since they were first published on January 9, 1998 in an interim final rule with comment period. We never proposed to remove or revise these regulations, and they were not the subject of the March 26, 2004 interim final rule. Nothing in the preamble to the March 26, 2004 interim final rule indicated any intent to remove or revise the advisory opinion regulations. In fact, the preamble referred several times to the existence of the advisory opinion process. But for the omission of an ellipsis at the end of the regulatory text for Part 411 at 69 FR 16142 of the March 26, 2004 interim final rule, these regulations would not have been removed. Reinstatement of these regulations does not impose any additional burden on the public. Delaying the effective date of this rule pending prior notice and an opportunity for public comment would be impracticable because it would create uncertainty as to the appropriate procedures and standards that the agency would apply in receiving and processing requests for advisory opinions. The absence of these regulations in the CFR could increase the burden on both the agency and the public. For these reasons, we find it unnecessary and impracticable to provide an opportunity to comment on the technical correction made by this rule. Moreover, it would be contrary to the public interest for us to require members of the public to draft and submit advisory opinion requests, and for us to issue advisory opinions, in the absence of any rules to guide the process. We believe that the comment period established by this interim final rule will protect the public's interest in this rulemaking. Therefore, we find good cause to waive the opportunity to receive public comments on this rule prior to its effective date.

We ordinarily designate an interim final rule to be effective at least 30 days from the date of publication. Under 5 U.S.C. 553(d), a rule may have a retroactive effective date if the agency finds good cause and incorporates a statement of the finding and the reasons for it into the rule issued. Section 1871 of the Social Security Act, as amended by section 903(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), provides that a substantive change in regulations may be applied retroactively if the Secretary determines that “failure to apply the change retroactively would be contrary to the public interest.”

We believe that there is good cause to reinstate § 411.370 through § 411.389 retroactively and that failure to reinstate these regulations retroactively would be contrary to the public interest. We have issued two advisory opinions since July 26, 2004, and we are currently reviewing approximately 30 advisory opinion requests that were submitted under an MMA mandate related to an 18-month moratorium on physician referrals to specialty hospitals in which they have an ownership interest. We need to issue all advisory opinions related to the moratorium well before the moratorium expires in June 2005. We believe that it would be contrary to the public interest for us to require members of the public to draft and submit advisory opinion requests, and for us to issue advisory opinions, in the absence of any rules to guide the process and to increase its efficiency. In addition, retroactive reinstatement of the rules removes any uncertainty regarding whether appropriate procedures and standards were followed with respect to advisory opinions issued after July 26, 2004.

In FR Doc 04-10661, in the Federal Register of Monday, May 17, 2004, the following corrections are made.

The Federal Communications Commission published a document amending 47 CFR 64.604 in the Federal Register of August 25, 2003, (68 FR 50973). The amended rules are intended to improve the overall effectiveness of TRS to ensure that persons with hearing and speech disabilities have access to telecommunications networks that is consistent with the goal of functional equivalency mandated by Congress.

As published, the final regulations contain errors which may prove to be misleading and need to be clarified.

This is a synopsis of the Commission's Report and Order, MM Docket No. 00-127, adopted September 9, 2004, and released September 17, 2004. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC, 20554, telephone 301-816-2820, facsimile 301-816-0169, or via-e-mail joshir@erols.com.

This document does not contain [new or modified] information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

The Commission will send a copy of this Report & Order in a report to be sent to Congress and the General Accounting Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).