The Office of Personnel Management (OPM) is issuing an interim regulation to incorporate the Occupational Safety and Health Administration (OSHA) permissible exposure limits (PELs) standard for concentrations of airborne asbestos in the Federal Wage System (FWS) environmental differential pay (EDP) category for asbestos, as required by section 1122 of the National Defense Authorization Act for 2004 (Public Law 108-136, November 24, 2003).

OPM establishes EDP categories under section 5343(c)(4) of title 5, United States Code, which provides that EDP may be paid for “duty involving unusually severe working conditions or unusually severe hazards.” Section 1122 of Public Law 108-136 amended section 5343(c)(4) by adding “and for any hardship or hazard related to asbestos, such differentials shall be determined by applying occupational safety and health standards consistent with the permissible exposure limit promulgated by the Secretary of Labor under the Occupational Safety and Health Act of 1970.” This change in law became effective on November 24, 2003.

The FWS EDP categories are contained in appendix A to subpart E of part 532 of title 5, Code of Federal Regulations. The current rule covering asbestos exposure for FWS employees provides that Federal agencies may pay their prevailing rate employees a differential for “[w]orking in an area where airborne concentrations of asbestos fibers may expose employees to potential illness or injury and protective devices or safety measures have not practically eliminated the potential for such personal illness or injury.” This interim regulation would revise part 532 to implement section 1122 for prevailing rate employees and require Federal agencies to apply occupational safety and health standards consistent with the permissible exposure limit (PEL) promulgated by the Secretary of Labor under the Occupational Safety and Health Act of 1970 as published in title 29, Code of Federal Regulations, §§ 1910.1001 or 1926.1101 (construction work only). Any OSHA regulatory change in the PELs for asbestos will be applied automatically to OPM's regulations effective on the first day of the first pay period beginning on or after the effective date of the change in the PELs.

Pursuant to section 553(b)(3)(B) and (d)(3) of title 5, United States Code, I find that good cause exists to waive the general notice of proposed rulemaking to comply with the change in law required by Public Law 108-136, which was enacted on November 24, 2003. The waiver of the requirements for proposed rulemaking and of the delay in the effective date are necessary to comply with the change in law in a timely manner.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities because it affects only Federal agencies and employees.

This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.

This rule is issued under Marketing Agreement No. 148 and Order No. 932, both as amended (7 CFR part 932), regulating the handling of olives grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California olive handlers are subject to assessments. Funds to administer the order are derived from such assessments. The assessment rate issued herein will be effective beginning on January 1, 2005, apply to all first handled assessable olives from the current crop year, and will continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule increases the assessment rate established for the committee for the 2005 and subsequent fiscal years from $12.18 per ton to $15.68 per ton of olives first handled from the applicable crop years.

The California olive marketing order provides authority for the committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The fiscal year, which is the 12-month period between January 1 and December 31, begins after the corresponding crop year, which is the 12-month period beginning August 1 and ending July 31 of the subsequent year. Fiscal year budget and assessment recommendations are made after the corresponding crop year olive tonnage is reported. The members of the committee are producers and handlers of California olives. They are familiar with the committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2004 and subsequent fiscal years, the committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal year to fiscal year unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the committee or other information available to USDA.

The committee met on December 13, 2004, and unanimously recommended fiscal year 2005 expenditures of $1,217,014 and an assessment rate of $15.68 per ton of olives first handled during the 2004-05 crop year. In comparison, the expenditures for fiscal year 2004 were originally budgeted at $1,269,063. In July of 2004, the committee voted unanimously to increase the budget by $117,535 to fund a research project. The committee's reserves were used to fund the revised budget. The revised budget for 2004 totaled $1,386,598.

The assessment rate of $15.68 is $3.50 higher than the $12.18 rate currently in effect. Expenditures recommended by the committee for the 2005 fiscal year include $680,000 for marketing activities, $337,014 for administration, and $200,000 for research. Budgeted expenses for these items in 2004 were originally $633,500 for marketing activities, $360,563 for administration, and $225,000 for research. The revised 2004 budget provided $342,535 for research.

The assessment rate recommended by the committee was derived by considering anticipated fiscal year expenses (including restoration of the reserve funds allocated to the 2004 emergency research project), actual olive tonnage received by handlers during the 2004-05 crop year, and additional pertinent factors. The California Agricultural Statistics Service (CASS) reported olive receipts for the 2004-05 crop year at 85,862 tons, which compares to 102,703 for the 2003-04 crop year. The reduction in the crop size for the 2004-05 crop year, due in large part to the alternate-bearing characteristics of olives, has made it necessary for the committee to recommend an increase in the assessment rate from the current $12.18 per assessable ton to $15.68 per assessable ton, an increase of $3.50 per ton. Income derived from handler assessments, interest, and utilization of reserve funds will be adequate to cover budgeted expenses. Funds in the reserve will be kept within the maximum permitted by the order of approximately one fiscal period's expenses (§ 932.40).

The assessable tonnage for the 2005 fiscal year is expected to be less than the 2004-05 crop year receipts of 85,862 tons reported by CASS, because some olives may be diverted by handlers to uses that are exempt from marketing order requirements.

The assessment rate will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate will be in effect for an indefinite period, the committee will continue to meet prior to or during each fiscal year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of committee meetings are available from the committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The committee's 2005 budget and those for subsequent fiscal years will be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 910 producers of olives in the production area and 3 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $6,000,000.

Based upon information from the committee, the majority of olive producers may be classified as small entities. One of the handlers may be classified as a small entity, but the majority of the handlers may be classified as large entities.

This rule increases the assessment rate established for the committee and collected from handlers for the 2005 and subsequent fiscal years from $12.18 per ton to $15.68 per ton of first handled olives from the applicable crop years. The committee unanimously recommended 2005 expenditures of $1,217,014 and an assessment rate of $15.68 per ton. The assessment rate of $15.68 per ton is $3.50 per ton higher than the 2004 rate.

The quantity of olive receipts for the 2004-05 crop year was reported by CASS to be 85,862 tons, but the actual assessable tonnage for the 2005 fiscal year is expected to be lower. This is because some of the receipts are expected to be diverted by handlers to exempt outlets on which assessments are not paid.

The $15.68 per ton assessment rate should be adequate to meet this year's expenses. Funds in the reserve will be kept within the maximum permitted by the order of about one fiscal period's expenses (§ 932.40).

Expenditures recommended by the committee for the 2005 fiscal year include $680,000 for marketing development, $337,014 for administration, and $200,000 for research. Budgeted expenses for these items in 2004 were originally $633,500 for marketing development, $360,563 for administration, and $225,000 for research. The research budget was increased to $342,535 in July 2004 to fund an additional project unanimously recommended by the committee.

In 2003-04, olive receipts totaled 102,703 tons compared to the 2004-05 crop year's tonnage of 85,862. Although the committee decreased 2005 budgeted expenses, the significant decrease in olive production makes the higher assessment rate necessary.

The research expenditures will fund studies to develop chemical, biological, and cultural controls of the olive fruit fly in the California production area. The budget for market development expenditures has been increased because the committee's marketing program for 2005 has been expanded to include nutrition and education outreach activities for wider audiences. Some of the outreach activities include cookbook contributions, school activities, and website development. The committee reviewed and unanimously recommended 2005 expenditures of $1,217,014, which reflect an increase in the market development budget and decreases in the research and administrative budgets.

Prior to arriving at this budget, the committee considered information from various sources, such as the committee's Executive Subcommittee and the Market Development Subcommittee. Alternate spending levels were discussed by these groups, based upon the relative value of various research and marketing projects to the olive industry and the anticipated olive production. The assessment rate of $15.68 per ton of assessable olives was derived by considering anticipated expenses, the volume of assessable olives first handled from the 2004-05 crop year, and additional pertinent factors.

A review of historical and preliminary information pertaining to the upcoming fiscal year indicates that the grower price for the 2004-05 crop year is estimated to be approximately $720 per ton for canning fruit and $276 per ton for limited-use size fruit. Approximately 85 percent of a ton of olives are canning fruit sizes and 10 percent are limited-use sizes, leaving the balance as unusable cull fruit. Total grower revenue on 85,862 tons would then be $54,917,335 given the percentage of canning and limited-use sizes and current grower prices for those sizes. Therefore, with a $15.68 per ton assessment rate, the estimated assessment revenue is expected to be approximately 2.33 percent of grower revenue.

This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, these costs are offset by the benefits derived by the operation of the marketing order. In addition, the committee's meeting was widely publicized throughout the California olive industry and all interested persons were invited to attend the meeting and participate in committee deliberations on all issues. Like all committee meetings, the December 13, 2004, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

This rule imposes no additional reporting or recordkeeping requirements on California olive handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

A proposed rule concerning this action was published in the Federal Register on February 22, 2005 (70 FR 8545). Copies of the rule were mailed or sent via facsimile to all committee members and olive handlers. Finally, the rule was made available through the Internet by USDA and the Office of the Federal Register. A 30-day comment period was provided to allow interested persons to respond to the proposal. One comment was received, but that comment was not relevant to this rulemaking action.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

Pursuant to 5 U.S.C. 553, it is also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) The 2005 fiscal year began on January 1, 2005, and the marketing order requires that the rate of assessment for each fiscal year apply to all assessable olives handled; (2) the committee needs sufficient funds to pay its expenses which are incurred on a continuous basis; (3) handlers are aware of this action, which was unanimously recommended by the committee at a public meeting and is similar to other assessment rate actions issued in past years; and (4) a 30-day comment period was provided for in the proposed rule and no relevant comments were received.

The FAA proposed to amend 14 CFR Part 39 with an AD for certain Raytheon Model Hawker 800XP airplanes. That action, published in the Federal Register on February 2, 2005 (70 FR 5387), proposed to require inspecting to detect damage of certain wiring in the flight compartment, performing corrective actions if necessary, modifying certain wiring connections, and revising the airplane flight manual.

We provided the public the opportunity to participate in the development of this AD. No comments have been submitted on the proposed AD or on the determination of the cost to the public.

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

There are about 45 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866;

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

The final rule, request for comment, was published in response to several requests that the FAA eliminate the requirement that aircraft that operate for hire, over water, and beyond power off gliding distance from shore, carry one pyrotechnic signaling device in addition to those signaling devices required as part of each required life raft. The FAA considered petitioners arguments that the requirement of an additional pyrotechnic device, or flare gun, was unnecessary because other requirements, such as air traffic control, dispatch/flight following systems, and advanced communications provide an equivalent, if not greater, level of safety as that provided by the pyrotechnic signaling device. This requirement was limited to those operators conducting operations under Part 121 because all of the additional safety redundancies, such as dispatch/flight following, do not exist to the same extent in other operations.

The FAA received seven comments on the pyrotechnic signaling device final rule. Three were from individuals, three were from air carriers (Southwest Airlines, American Airlines, and Net Jets), and one was from a trade association (the Regional Airline Association). Most comments favor the change. One individual commenter did not reflect support or opposition to the change. None of the comments reflect an adverse position to this final rule. The FAA's response to the comments follows:

All but one commenter expressed concerns about the safety and security of pyrotechnic signaling devices. One individual commenter stated that the devices were a high-pilferage item and pose a hazard of becoming a potential terrorist weapon. Another individual commenter expressed a general concern about a security hazard to the flight crew. Southwest Airlines and Net Jets inferred that pyrotechnic signaling devices are lethal weapons and constitute hazardous materials on the flight deck.

Three commenters, including American Airlines, inferred that these devices do not enhance safety. Southwest Airlines stated that the device would provide minimal value in locating an aircraft following a ditching at sea, assuming that a pilot could find it.

The FAA does not agree that pyrotechnic signaling devices are unsafe if stored and maintained in accordance with the manufacturer's instructions and personnel are properly trained in their use. Pyrotechnic signaling devices are still required whenever life rafts are required to be onboard. The FAA does not agree that a pyrotechnic signaling device might be hard to locate in a ditching emergency. FAA regulations require a passenger briefing composed of instructions to use in preparation for a ditching. Part of this preparation includes use of emergency equipment, including life rafts and associated equipment (such as pyrotechnic signaling devices), before the actual ditching occurs. Crewmembers are required to be trained in the proper use of emergency equipment. Moreover, when pyrotechnic signaling devices are required as part of a life raft's survival equipment, they are generally inaccessible without removing the raft itself. In cases where the life raft's survival kit is stored separately from the raft, locations are typically not readily available for passenger access until actually needed.

An individual commenter, Net Jets, and the Regional Airline Association stated they are in favor of including relief for part 135 operations. An individual commenter stated that all of the justification for part 121 operations is true for part 135 operations, as well. Net Jets stated that similarly situated part 135 operators should be provided with the same relief as part 121 operators, and noted the similarities between part 121 dispatch/flight following systems and the flight locating requirements of part 135. Net Jets also stated that the Part 125/135 Aviation Rulemaking Committee (ARC) is addressing the issue as it applies to part 135 operations. Net Jets stated that a complete power loss of a part 25 certificated turbojet airplane is extremely low.

Although the requirements differ, the FAA agrees that similarities may exist between part 121 flight following requirements and part 135 flight locating requirements. Also, while some 135 operators conduct operations very similar to part 121 operators, many do not so it would not be appropriate to provide the same blanket relief to all 135 operators. However, if a particular part 135 operator's flight locating system meets all of the requirements of a part 121 flight following system, relief provided in this rule change may be sought by that operator and evaluated by the FAA through the exemption process.

The FAA agrees that complete engine failure of a part 25-certificated airplane is extremely low. However, engine failure is not the only precursor to a forced ditching. Onboard fires, flight control malfunctions, and fuel exhaustion have also resulted in ditching incidents.

The FAA looks forward to receiving recommendations from the Part 125/135 ARC when they are complete.

An individual commenter stated that the rule should contain a requirement for positive proof that a pyrotechnic device required as part of a life raft is, in fact, onboard and goes on to question how an operator would determine that the device is installed in the life raft.

It is incumbent upon an operator to demonstrate compliance with any applicable requirements for a particular operation. For example, an operator may maintain an inventory of life raft-related equipment to satisfy this requirement when the equipment must be carried onboard for over-water operations.

After consideration of the comments submitted in response to the final rule, the FAA has determined that no further rulemaking action is necessary. Amendment 91-285 remains in effect as adopted.

FDA published notices in the Federal Register on February 10, 1998 (63 FR 6762), and February 8, 1999 (64 FR 6100), announcing the filing of food additive petitions, FAP 8A4580 and FAP 9A4643, respectively, by Monsanto Co. to amend the food additive regulations in Part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption (21 CFR part 172) to provide for the safe use of neotame as a nonnutritive sweetener for tabletop use (FAP 8A4580) and for general-purpose use in food (FAP 9A4643) where standards of identity do not preclude such use. The rights to these petitions were subsequently sold to the NutraSweet Co. In the Federal Register of July 9, 2002 (67 FR 45300), FDA issued a final rule permitting the safe use of neotame as a sweetening agent and flavor enhancer in foods generally, except in meat and poultry. The preamble to the final rule advised that objections to the final rule and requests for a hearing were due within 30 days of the publication date (i.e., by August 8, 2002).

Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(f)) provides that, within 30 days after publication of an order relating to a food additive regulation, any person adversely affected by such order may file objections, specifying with particularity the provisions of the order “deemed objectionable, stating reasonable grounds therefore, and requesting a public hearing based upon such objections.” FDA may deny a hearing request if the objections to the regulation do not raise genuine and substantial issues of fact that can be resolved at a hearing.

Under 21 CFR 171.110 of the food additive regulations, objections and requests for a hearing are governed by part 12 (21 CFR part 12) of FDA's regulations. Under § 12.22(a), each objection must meet the following conditions: (1) Must be submitted on or before the 30th day after the date of publication of the final rule; (2) must be separately numbered; (3) must specify with particularity the provision of the regulation or proposed order objected to; (4) must specifically state the provision of the regulation or proposed order on which a hearing is requested; failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection; and (5) must include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested; failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection.

Following publication of the neotame final rule, FDA received three submissions, within the 30-day objection period, objecting to the agency's safety evaluation of neotame as a general-purpose sweetener. Two of the submissions are essentially identical in content and assert that all of the studies that were discussed in the neotame final rule are meaningless because they are based on aspartame, which they claim has never been proven to be safe for use in food. Both of these submissions requested a hearing. The third submission questions the validity of the agency's exposure estimate for neotame and its metabolites. This same submission also asks a number of questions regarding the clinical studies that were conducted on human tolerance to neotame. The submission requested a hearing on both of these issues.

Specific criteria for deciding whether to grant or deny a request for a hearing are set out in § 12.24(b). Under that regulation, a hearing will be granted if the material submitted by the requester shows, among other things, the following: (1) There is a genuine and substantial factual issue for resolution at a hearing; a hearing will not be granted on issues of policy or law; (2) the factual issue can be resolved by available and specifically identified reliable evidence; a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions; (3) the data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the requestor; a hearing will be denied if the data and information submitted are insufficient to justify the factual determination urged, even if accurate; and (4) resolution of the factual issue in the way sought by the person is adequate to justify the action requested; a hearing will not be granted on factual issues that are not determinative with respect to the action requested (e.g., if the action would be the same even if the factual issue were resolved in the way sought).

A party seeking a hearing is required to meet a “threshold burden of tendering evidence suggesting the need for a hearing” (Costle v. Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980), reh. denied, 446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-621 (1973)). An allegation that a hearing is necessary to “sharpen the issues” or to “fully develop the facts” does not meet this test (Georgia Pacific Corp. v. EPA, 671 F.2d 1235, 1241 (9th Cir. 1982)). If a hearing request fails to identify any factual evidence that would be the subject of a hearing, there is no point in holding one. In judicial proceedings, a court is authorized to issue summary judgment without an evidentiary hearing whenever it finds that there are no genuine issues of material fact in dispute and a party is entitled to judgment as a matter of law (see Rule 56, Federal Rules of Civil Procedure). The same principle applies in administrative proceedings (see § 12.28).

A hearing request must not only contain evidence, but that evidence should raise a material issue of fact concerning which a meaningful hearing might be held (Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 1085 (9th Cir. 1982)). Where the issues raised in the objection are, even if true, legally insufficient to alter the decision, the agency need not grant a hearing (see Dyestuffs and Chemicals, Inc. v. Flemming, 271 F.2d 281 (8th Cir. 1959), cert. denied, 362 U.S. 911 (1960)). FDA need not grant a hearing in each case where an objector submits additional information or posits a novel interpretation of existing information (see United States v. Consolidated Mines & Smelting Co., 455 F.2d 432 (9th Cir. 1971)). In other words, a hearing is justified only if the objections are made in good faith and if they “draw in question in a material way the underpinnings of the regulation at issue” (Pactra Industries v. CPSC, 555 F.2d 677 (9th Cir. 1977)). Finally, courts have uniformly recognized that a hearing need not be held to resolve questions of law or policy (see Citizens for Allegan County, Inc. v. FPC, 414 F.2d 1125 (D.C. Cir. 1969); Sun Oil Co. v. FPC, 256 F.2d 233, 240 (5th Cir.), cert. denied, 358 U.S. 872 (1958)).

Even if the objections raise material issues of fact, FDA need not grant a hearing if those same issues were adequately raised and considered in an earlier proceeding. Once an issue has been so raised and considered, a party is estopped from raising that same issue in a later proceeding without new evidence. The various judicial doctrines dealing with finality can be validly applied to the administrative process. In explaining why these principles “self-evidently” ought to apply to an agency proceeding, the U.S. Court of Appeals for the District of Columbia Circuit wrote:

In summary, a hearing request must present sufficient credible evidence to raise a material issue of fact and the evidence must be adequate to resolve the issue as requested and to justify the action requested.

FDA addresses each of the three objections in the following paragraphs, as well as the evidence and information filed in support of each, comparing each objection and the information submitted in support of it to the standards for granting a hearing in § 12.24.

Two submissions objected to the final rule asserting that all of the safety studies on neotame are meaningless because they are based on aspartame. Both submissions requested hearings on this point. As stated in the neotame final rule, to support the safety of neotame, the petitioner submitted, within the two petitions, a combined total of 113 preclinical, clinical, and special studies, plus an additional 32 exploratory and screening studies in a food master file on the safety of neotame and its metabolites, not aspartame. The objectors did not specifically address any of these studies. Further, the assertion that the safety evaluation of neotame is based on aspartame is baseless and completely false. FDA is denying the requests for a hearing on this point because there is no genuine and substantial issue of fact for resolution at a hearing, and a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(1) and (b)(2)).

The third objection questioned the agency's exposure estimate for neotame and the clinical studies that were conducted and requested a hearing on these issues. However, the submission provided no information that would support a reevaluation of the agency's exposure estimate or the clinical studies that were conducted. Therefore, this submission provides no basis for FDA to reconsider its decision to issue the final rule on neotame. Moreover, this submission provides no basis for granting a hearing because a hearing request must include specifically identified reliable evidence that can lead to resolution of a factual issue in dispute. A hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)). Therefore, FDA is denying the hearing requested by this submission.

Section 409 of the act requires that a food additive be shown to be safe prior to marketing. Under 21 CFR 170.3(i), a food additive is “safe” if there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. In the final rule approving neotame, FDA concluded that the data presented by the petitioner to establish safety of the additive demonstrate that neotame is safe for its intended use as a general-purpose sweetener and flavor enhancer in foods. The final rule did not authorize the use of neotame in meat and poultry.

The petitioner has the burden to demonstrate the safety of the additive in order to gain FDA approval. Once FDA makes a finding of safety, the burden shifts to an objector, who must come forward with evidence that calls into question FDA's conclusion (American Cyanamid Co. v. FDA, 606 F2d. 1307, 1314-1315 (DC Cir. 1979)).

None of the three objections received contained evidence to support a genuine and substantial issue of fact. Nor has any objector established that the agency overlooked significant information in reaching its conclusion. Therefore, the agency has determined that the objections that requested a hearing do not raise any substantial issue of fact that would justify an evidentiary hearing (§ 12.24(b)). Accordingly, FDA is not making any changes in response to the objections and is denying the requests for a hearing.

Prior to the establishment of the 8-hour ozone nonattainment areas, EPA developed a program to allow these potential nonattainment areas to voluntarily adopt local emission control programs to avoid air quality violations and mandated nonattainment area controls. Areas with air quality meeting the 1-hour ozone standard were eligible to participate. In order to participate, state and local governments and EPA developed and signed a memorandum of agreement that describes the local control measures the state or local community intends to adopt and implement to reduce ozone emissions in advance of air quality violations. In this agreement, also known as an Early Action Compact (EAC), the state or local communities agree to prepare emission inventories and conduct air quality modeling and monitoring to support its selection of emission controls. Areas that participate in the EAC program have the flexibility to institute their own approach in maintaining clean air and protecting public health. For a period of time (generally not to exceed 5 years), participating areas can avoid a nonattainment designation.

Several localities in the Winchester and Roanoke areas have elected to participate in the EAC program. The areas that signed an EAC are the City of Winchester and Frederick County, which comprise the Northern Shenandoah Valley EAC; and the cities of Roanoke and Salem, and the counties of Roanoke and Botetourt, which comprise the Roanoke EAC. Virginia's strategy for enabling these localities to participate in the EAC program is to have them be subject to volatile organic compound (VOC) and NOX control measures from which they had, until this time, been exempt. In order to enable the affected localities to implement these VOC and NOX controls, the Virginia Regulations for the Control of Abatement of Air Pollution were revised to include these affected localities. In a separate rulemaking action, the list of VOC and NOX emission control areas (9 VAC 5-20-206) was expanded to include the EAC areas as the Western Virginia Emissions Control Area. With this expansion, the VOC and NOX control rules of Chapter 40 became applicable in these areas.

In order to implement the NOX control measures, VADEQ adopted a regulation (Rule 4-4) which provides that VADEQ must, on case-by-case basis, determine whether there is RACT to reduce NOX emissions from major sources for which EPA has not issued control techniques guideline (CTG). EPA has approved the regulation (Rule 4-4) in a separate rulemaking action. A major source in the Western Virginia Emissions Control Area subject to Rule 4-4, emits or has the potential to emit 100 tons per year of NOX. CTGs are documents issued to define RACT for a particular source category. EPA has defined RACT as the lowest emission limit that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility.

The following sources in the Western Virginia Emissions Control Area have been identified as sources subject to the RACT requirements: (1) Roanoke Electric Steel Corporation Steel Mini-Mill located in the City of Roanoke, (2) Roanoke Cement Company Portland Manufacturing Plant located in Troutville, County of Botetourt; (3) Norfolk Southern Railway Company—East End Shops located in the City of Roanoke; and (4) Global Stone Chemstone Corporation located in Frederick County.

On January 31, February 3, 7, and 14, 2005, VADEQ submitted revisions to the Virginia SIP which establish and impose RACT for four sources of NOX. The Commonwealth's submittals consist of permits to operate which impose NOX RACT requirements for each source.

Copies of the actual permits to operate imposing RACT and VADEQ's evaluation memoranda are included in the electronic and hard copy docket for this final rule. As previously stated, all documents in the electronic docket are listed in the RME index at http://www.docket.epa.gov/rmepub/. Publicly available docket materials are available either electronically in RME or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Virginia Department of Environmental Quality, 629 East Main Street, Richmond, Virginia 23219.

The table below identifies the sources and the individual permits to operate which are the subject of this rulemaking.

EPA is approving these RACT SIP submittals because VADEQ established and imposed requirements in accordance with the criteria set forth in SIP-approved regulations for imposing RACT. The Commonwealth has also imposed record-keeping, monitoring and testing requirements on these sources sufficient to determine compliance with the applicable RACT determinations.

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information (1) that are generated or developed before the commencement of a voluntary environmental assessment; (2) that are prepared independently of the assessment process; (3) that demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts. * * * ” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the Clean Air Act, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the Clean Air Act is likewise unaffected by this, or any, state audit privilege or immunity law.

EPA is approving the revisions to the Virginia SIP submitted by VADEQ to establish and require NOX RACT for four major sources. These SIP revisions are necessary to implement the Early Action Compact Plan for the Roanoke and the Northern Shenandoah Valley Ozone Early Action Compact Plan. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on June 27, 2005, without further notice unless EPA receives adverse comment by May 27, 2005. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability establishing source-specific requirements for four named sources.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 27, 2005. Filing a petition for reconsideration by the Administrator of this final rule approving source-specific RACT requirements for four sources in the Commonwealth of Virginia does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Prior to the final establishment of the 8-hour ozone nonattainment areas, EPA developed a program to allow potential nonattainment areas to voluntarily adopt local emission control programs to avoid air quality violations and mandated nonattainment area controls. Areas with air quality meeting the one-hour ozone standard were eligible to participate. In order to participate, state and local governments and EPA had to develop and sign an Early Action Compact (EAC) agreement with EPA. This agreement outlined the implementation procedures for the EAC program. As part of the EAC process, state and local communities are required to adopt and implement measures to reduce ozone precursor pollutants. In addition, the EAC program requires the preparation of an attainment demonstration.

Several localities in the Winchester and Roanoke areas of Virginia were eligible to participate in the EAC program. The areas that signed an EAC are the City of Winchester and Frederick County, which comprise the Northern Shenandoah Valley EAC, and the cities of Roanoke and Salem, and the counties of Roanoke and Botetourt, which comprise the Roanoke EAC.

In order to support this effort, the Commonwealth has elected to expand its pre-existing list of emission control areas to include the EAC participating localities and to expand its NOX RACT regulation to the new emission control area.

On December 22, 2004, and supplemented on February 24, 2005, the Commonwealth of Virginia submitted a formal revision to its SIP. The SIP revision amends the Virginia Code at 9 VAC 5-20-206 to expand the VOC and NOX emission control areas to include the Western Virginia Emissions Control Area. This area includes the counties of Botetourt, Frederick, and Roanoke, and the cities of Roanoke, Salem, and Winchester. The revision also authorizes the implementation of NOX RACT in the Western Virginia Emissions Control Area.

This SIP revision also includes several amendments to various regulations in 9 VAC 5-40 which are intended to clarify certain provisions. A more detailed summary of the changes may be found in the technical support document (TSD) prepared for this rulemaking.

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information (1) that are generated or developed before the commencement of a voluntary environmental assessment; (2) that are prepared independently of the assessment process; (3) that demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law,Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts * * *.” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its [*] program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the Clean Air Act, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the Clean Air Act is likewise unaffected by this, or any, state audit privilege or immunity law.

EPA is approving a revision to the Commonwealth of Virginia SIP consisting of a regulation establishing the Western Virginia Emissions Control Area, and providing the enabling authority for NOX RACT determinations in the affected areas. The regulations are necessary in order to implement the control measures and achieve the emission reductions in the plans for the Roanoke and Northern Shenandoah Valley EAC areas.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on June 27, 2005 without further notice unless EPA receives adverse comment by May 27, 2005. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 27, 2005. Filing a petition for reconsideration by the Administrator of this final rule approving the expansion of the VOC emission standards to the Western Virginia Emissions Control Area, and providing the enabling authority for NOX RACT determinations in the affected areas, does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

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

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/.

In the Federal Register of August 6, 2003 (68 FR 46620) (FRL-7317-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petition (7E3489) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that the tolerance expression for the inert ingredient benoxacor (safener) in 40 CFR 180.460 be amended to remove the references to metolachlor and replace it with references to S-metolachlor. Currently, the benoxacor tolerance permits residues of benoxacor in or on raw agricultural commodities for which tolerances have been established for the herbicide metolachlor when benoxacor is used in pesticide formulations containing metolachlor. Syngenta's petition seeks this amendment because it has voluntarily canceled all its metolachlor product registrations, including its metolachlor registrations containing the safener benoxacor, and has registered products containing S-metolachlor in their place. Some or all of these new registrations contain not only S-metolachlor but benoxacor as well.

The notice of filing included a summary of Syngenta's petition. EPA received one comment, which is discussed further in Unit IV.

This final rule is issued pursuant to section 408(d) of FFDCA, as amended by the FQPA (21 U.S.C. 346a(d)). Section 408 of FFDCA authorizes the establishment of tolerances, exemptions from the requirement of a tolerance, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or tolerance exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under section 402(a) of the FFDCA. If food containing pesticide residues is found to be adulterated, the food may not be distributed in interstate commerce (21 U.S.C. 331(a) and 342 (a)).

In this action, EPA is ruling on a petition (7E3489) filed by Syngenta Crop Protection pursuant to FFDCA section 408(d) to amend a tolerance regulation. Section 408(d)(4) authorizes EPA to act on a petition by issuing a final rule adopting the amendment sought by the petition, issuing a final rule that varies from the amendment sought by the petition, or completely denying the petition. For the reasons described below, EPA has chosen the middle course with regard to Syngenta's petition - granting it only in part and denying the remainder.

The Agency is granting Syngenta's petition in part. The Agency has determined that the tolerance for benoxacor at 40 CFR 180.460 should be amended to include a reference to both metolachlor and S-metolachlor. EPA agrees there are sufficient grounds to amend the tolerance expression for benoxacor to include a reference to S-metolachlor, the product Syngenta is now marketing in place of the metolachlor registrations it has voluntarily canceled. EPA has previously determined that the existing benoxacor tolerances meet the safety standard of FFDCA section 408(b)(2)(A)(i). See the Federal Register of February 13, 1998, (63 FR 7299) (FRL-5771-1).

A chronic dietary exposure and risk assessment was conducted using Dietary Exposure Evaluation Model-Food Commodity Intake Database (DEEM-FCIDTM), which uses food consumption data from the United States Department of Agriculture's (USDA's) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. The chronic analysis assumes tolerance-level residues on all crops with established, pending, or proposed tolerances for metolachlor and/or S-metolachlor. The analysis also assumes that 100% of the crops included in the assessment were treated with metolachlor and/or S-metolachlor and its safener, benoxacor. These assumptions result in over estimates of exposure and are, therefore, highly conservative with respect to dietary risk assessment. Even with these assumptions, the dietary risk estimates for all population subgroups are less than 15% of the chronic Population-Adjusted Dose (cPAD). Generally EPA is concerned when risk estimates exceed 100% of the cPAD. Therefore, the dietary risk estimates are below EPA's level of concern for all population subgroups, including those of infants and children. There are no acute toxicological or cancer concerns for benoxacor.

Accordingly, EPA finds for the reasons set forth in the Federal Register notice of February 13, 1998 (63 FR 7299), establishing the existing benoxacor tolerances, that these tolerances, as amended today, are safe for the general population, including infants and children, within the meaning of FFDCA section 408(b)(2)(A)(i).

EPA does not agree, however, that grounds exist to remove the reference to metolachlor in 40 CFR 180.460 as requested by the petition. As noted, EPA has found previously that residues of benoxacor resulting from its use with metolachlor, are safe and will be safe under the regulation when amended to also reference S-metolachlor. Further, while Syngenta may have canceled its metolachlor registrations, there are existing metolachlor registrations currently held by other persons. The fact that one registrant of several has chosen to stop marketing the pesticide does not constitute the “abandonment” of a pesticide as contemplated by 40 CFR 180.32(b) that would justify the administrative amendment or repeal of a tolerance. Further, as the commenter has made clear, existing metolachlor registrants are interested in retaining the reference to metolachlor in the benoxacor tolerance expression. For these reasons, EPA is denying Syngenta's request to remove metolachlor from the existing tolerance expression.

Based on its decision to grant, in part, and deny, in part, Syngenta's petition, EPA is today amending the tolerance expression for benoxacor at 40 CFR 180.460(a) as found in the regulatory section of this document.

As noted in Unit.II. of this document, EPA received a comment objecting to Syngenta's petition to replace the references to metolachlor in 40 CFR 180.460 with references to S-metolachlor. Specifically, the commenter argues that the proposed amendment is unnecessary to protect public health; that it would establish an inappropriate precedent prior to the adoption of an isomer active ingredient policy; and that the rationale for action that Syngenta has offered is materially incomplete and inadequate. Because EPA has decided for reasons set forth in Unit.III. of this document to retain the references to metolachlor in 40 CFR 180.460, EPA need not reach the commenter's arguments objecting to Syngenta's proposed deletion of metolachlor from that regulation. The commenter also argues, however, that as a general matter Syngenta's petition provides no pertinent new “data, information and arguments” or “reasonable grounds” in support of the petition. EPA disagrees with this comment to the extent it suggests there are inadequate grounds for adding references to S-metolachlor to the tolerance expression at 40 CFR 180.460. As discussed above, the petition noted that EPA has previously found that benoxacor residues are safe and has determined that this action will not alter the assumptions upon which that determination relied. Accordingly, EPA believes reasonable grounds exist to add references to S-metolachlor to 40 CFR 180.460.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2005-0080 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before June 27, 2005.

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 14th 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 VIII.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-2005-0080, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in 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 an exemption from the tolerance requirement under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

You may be 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 athttp://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 July 28, 2004 (69 FR 45047) (FRL-7366-2), 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 3F6537) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for the combined residues of the insecticide/miticide:

1. Spiromesifen; butanoic acid, 3,3-dimethyl-, 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl ester [subsequently referred to as (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one)] in or on strawberry at 2.0 parts per million (ppm); vegetable, tuberous and corm, crop subgroup 1C, at 0.01 ppm (subsequently revised to 0.02 ppm); vegetable, leafy greens (except Brassica), crop subgroup 4A at 10 ppm (subsequently revised to vegetable, leafy greens, subgroup 4A at 12 ppm); vegetable, Brassica, head and stem, crop subgroup 5A, at 2.0 ppm; vegetable, Brassica, leafy, crop subgroup 5B at 12 ppm; vegetable, fruiting, crop group 8, at 0.30 ppm; tomato, paste at 0.60 ppm; vegetable, cucurbit, crop group 9, at 0.10 ppm; corn, field, grain, at 0.01 ppm (subsequently revised to 0.02 ppm); corn, field, forage, at 3.0 ppm; corn, field, stover, at 5.0 ppm; cotton (subsequently defined as cotton, undelinted seed) at 0.50 ppm; and cotton, gin byproducts, at 15 ppm.

2. Spiromesifen; butanoic acid, 3,3-dimethyl-, 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl ester [subsequently referred to as (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), and its metabolites containing the 4-hydroxymethyl moiety (4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one)] in or on the rotational crop commodities alfalfa, forage, at 1.5 ppm; alfalfa, hay, at 3.0 ppm; wheat, grain, at 0.01 ppm (subsequently revised to 0.03 ppm); wheat, forage, at 0.20 ppm; wheat, hay, at 0.15 ppm; wheat, straw, at 0.25 ppm; wheat, bran, at 0.05 ppm (subsequently combined with wheat, shorts and defined together as “wheat milled byproducts” with no tolerance required); wheat, shorts, at 0.03 ppm (subsequently combined with wheat, bran and defined together as “wheat milled byproducts” with no tolerance required); barley, grain, at 0.02 ppm (subsequently revised to 0.03 ppm); barley, hay, at 0.25 ppm; barley, straw, at 0.25 ppm (subsequently revised to 0.15 ppm); beet, sugar, tops, at 0.20 ppm; beet, sugar, roots, at 0.02 ppm (subsequently revised to 0.03 ppm); and beet, sugar, molasses, at 0.05 ppm (tolerance subsequently not required).

3. Spiromesifen; butanoic acid, 3,3-dimethyl-, 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl ester [subsequently referred to as 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), and its metabolites containing the enol (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one) and 4-hydroxymethyl (4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one) moieties)] in or on the raw agricultural commodities cattle, fat, at 0.05 ppm; cattle, meat byproducts, at 0.05 ppm; milk at 0.01 ppm (tolerance subsequently not required); and milk, fat, at 0.03 ppm (subsequently revised to 0.10 ppm).

Following the review of all data, tolerances are also required for the following commodities: Goat, fat at 0.05 ppm; goat meat byproducts at 0.05 ppm; sheep, fat at 0.05 ppm; sheep, meat byproducts at 0.05 ppm; horse, fat at 0.05 ppm; and horse, meat byproducts at 0.05 ppm.

That notice included a summary of the petition prepared by Bayer CropScience, the registrant. A comment was received from a private citizen who challenged the value of using animal testing for evaluating pesticide toxicity and questioned the data gaps related to the tolerance proposal process. This commenter's objections have been addressed in prior rulemaking documents. See (69 FR 63083, 63096) (October 29, 2004).

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 the combined residues of spiromesifen on the crops and animal commodities listed above.

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

The dose at which 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 (MOEcancer = point of departure/exposures) is calculated.

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

1. Dietary exposure from food and feed uses. No tolerances have previously been established for spiromesifen. Risk assessments were conducted by EPA to assess dietary exposures from spiromesifen 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. Acute dietary exposure limits for all populations, including infants and children, were not performed because an endpoint of concern attributable to a single exposure (dose) was not identified from the oral toxicity studies.

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-FCIDTM) and the LifelineTM model version 2.0, which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. Percent crop treated and anticipated residues were not used.

An unrefined, Tier 1 chronic dietary exposure assessment was conducted using the following:

a. Recommended tolerances for all plant and livestock except the leafy-green and leafy-Brassica vegetable subgroups;

b. EPA calculated residues of concern (parent and metabolites) for the leafy-green and leafy-Brassica vegetable subgroups;

c. 100% crop treated (CT) information for all proposed uses; and

d. Default processing factors for all commodities.

1.3 = Metabolites in Risk Assessment (ppm)/Metabolites in Tolerance Expression (ppm).

The dietary-exposure assessment was conducted for the general U.S. population and various population subgroups. This assessment concludes that the chronic dietary exposure estimates are below EPA's level of concern (<100% cPAD) for the general U.S. population (27% cPAD and 29% cPAD, based on the LifelineTM and DEEM-FCIDTM analyses, respectively) and all population subgroups. Both LifelineTM and DEEM-FCIDTM estimate that children 3 to 5 years old are the most highly-exposed subpopulation with risks of 30% cPAD and 37% cPAD, respectively.

iii. Cancer. A cancer exposure assessment was not performed because spiromesifen is classified as “not likely to be carcinogenic to humans.”

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

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentrations in Groundwater (SCI-GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include 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 spiromesifen they are further discussed in the aggregate risk sections in Unit E.

Based on the PRZM/EXAMS and SCI-GROW models, the EECs of spiromesifen for acute exposures are estimated to be 7.1 parts per billion (ppb) for surface water and 0.005 ppb for ground water. The EECs for chronic exposures are estimated to be 0.70 ppb for surface water and 0.005 ppb for ground water.

EECs of spiromesifen and its metabolites for acute exposures are estimated to be 26 ppb for surface water and 28 ppb for ground water. The EECs for chronic exposures are estimated to be 11 ppb for surface water and 28 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).

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

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

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 spiromesifen and any other substances and spiromesifen 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 spiromesifen has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

1. In general. Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines 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. There was no evidence of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to spiromesifen. In a rat developmental toxicity study, no developmental toxicity was observed at doses up to 500 mg/kg/day (the highest dose tested) in the presence of maternal toxicity. The rat maternal LOAEL was determined to be 70 mg/kg/day based on decreased body-weight gain and reduced food consumption. In the rabbit developmental toxicity study, there was no developmental toxicity observed at doses up to 250 mg/kg/day (the highest dose tested), but the maternal LOAEL was determined to be 35 mg/kg/day based on body weight loss and reduced food consumption. There is no qualitative and/or quantitative evidence of increased susceptibility to spiromesifen following pre/postnatal exposure in a 2-generation reproduction study in rats.

There is no concern for developmental neurotoxicity resulting from exposure to spiromesifen. Neurotoxic effects such as reduced motility, spastic gait, increased reactivity, tremors, clonic-tonic convulsions, reduced activity, labored breathing, vocalization, avoidance reaction, piloerection, limp, cyanosis, squatted posture, and salivation were observed in two studies (5-day inhalation and subchronic oral rat). However, these effects were considered as secondary, not neurotoxic, effects due to the high dosage. There was no evidence of neurotoxicity in the acute or subchronic neurotoxicity or any other studies.

3. Conclusion. For spiromesifen, EPA determined that the 10X safety factor to protect infants and children should be removed. A 1X safety factor is appropriate because:

• There is a complete toxicity data base for spiromesifen.

• There is no evidence of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to spiromesifen. In the prenatal developmental toxicity studies in rats and rabbits and in the 2-generation reproduction study in rats, developmental toxicity to the offspring occurred at equivalent or higher doses than maternal toxicity.

• There are no neurotoxicity concerns based on acute and subchronic neurotoxicity studies.

• The dietary food exposure assessment uses proposed tolerance levels or higher residues and assumed 100% crop-treated (CT) information for all commodities. By using these screening-level assessments, chronic exposures and risks will not be underestimated. The “higher residues” are those that were calculated using a modifying factor to account for the lack of spiromesifen-4-hydroxymethyl residue data.

• The dietary drinking water assessment (Tier 2 estimates) uses values generated by model and associated modeling parameters which are designed to provide conservative, health protective, and high-end estimates of water concentrations.

• Residential exposure is not expected--spiromesifen will be registered for agricultural and greenhouse/ornamental uses only.

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. Spiromesifen is not expected to pose an acute risk because an endpoint of concern attributable to a single exposure (dose) was not identified from the oral toxicity studies.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure and the EECs from DEEM-FCIDTM as these were slightly higher, and thus are more conservative, than the LifelineTM estimates, EPA has concluded that exposure to spiromesifen from food will utilize 29% of the cPAD for the U.S. population, 15% of the cPAD for all infants less than 1 year old, and 37% of the cPAD for children 3-5 years old. There are no residential uses for spiromesifen that result in chronic residential exposure to spiromesifen. There is no concern regarding spiromesifen in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of this unit:

3. Spiromesifen 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. Spiromesifen 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. Spiromesifen is not expected to pose a cancer risk.

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

Adequate analytical enforcement methodologies, liquid chromatography LC)/mass spectrometry (MS)/MS, exist and have been successfully validated by independent laboratories.

There are no international residue limits for spiromesifen listed in CODEX.

Therefore, the tolerance is established for:

1. Primary crops for the combined residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), calculated as the parent compound equivalents in or on strawberries at 2.0 parts per million (ppm); vegetable, tuberous and corm, subgroup 1C at 0.02 ppm; vegetable, leafy greens, subgroup 4A at 12 ppm; vegetable, Brassica, head and stem, subgroup 5A at 2.0 ppm; vegetable, Brassica, leafy greens, subgroup 5B at 12 ppm; vegetable, fruiting, group 8 at 0.30 ppm; tomato, paste at 0.60 ppm; vegetable, cucurbit, group 9 at 0.10 ppm; corn, field, grain at 0.02 ppm; corn, field, forage at 3.0 ppm; corn, field, stover at 5.0 ppm; cotton, undelinted seed at 0.50 ppm; and cotton, gin byproducts at 15 ppm.

2. Rotational crops for the inadvertent or indirect combined residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), and its metabolites containing the 4-hydroxymethyl moiety (4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one), calculated as the parent compound equivalents in or on alfalfa, forage at 1.5 ppm; alfalfa, hay at 3.0 ppm; wheat, grain at 0.03 ppm; wheat, forage at 0.20 ppm; wheat, hay at 0.15 ppm; wheat, straw at 0.25 ppm; barley, grain at 0.03 ppm; barley, hay at 0.25 ppm; barley, straw at 0.15 ppm; beet, sugar, tops at 0.20 ppm; and beet, sugar, roots at 0.03 ppm.

3. Livestock commodities for the combined residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), and its metabolites containing the enol (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one) and 4-hydroxymethyl (4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one) moieties, calculated as the parent compound equivalents in or on cattle, fat at 0.05 ppm; cattle, meat byproducts at 0.05 ppm; milk, fat at 0.10 ppm; goat, fat at 0.05 ppm; goat, meat byproducts at 0.05 ppm; sheep, fat at 0.05 ppm; sheep, meat byproducts at 0.05 ppm; horse, fat at 0.05 ppm; and horse, meat byproducts at 0.05 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-2005-0046 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before June 27, 2005.

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 14th 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-2005-0046, 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, 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).

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/.

In the Federal Register of November 24, 2004 (69 FR 68287) (FRL-7686-4), EPA on its own initiative, under section 408(e) of FFDCA, 21 U.S.C. 346a(e), announced a proposal to establish a permanent tolerance for residues of the herbicide trifluralin in spearmint and peppermint oil at 2.0 parts per million (ppm). The proposal included a summary of the exposure assessment prepared by the Agency. The Agency received three submissions for comment; two from private citizens and one from Dow AgroSciences, the registrant.

Comments received from the registrant address the following areas: evidence of errors and inconsistencies/miscalculations, belief that potential risks are significantly overstated, belief that unrealistic assumptions have been made, and the position that relevant information has been omitted and not incorporated into the Agency's decision(s). Additionally, the registrant has asked for clarification on labeling requirements. However, in general, the registrant does agree with the assessments that have been conducted for the human health and residue chemistry risk studies available for trifluralin. Furthermore, the registrant does not state any objections to the establishment of a permanent tolerance for residues of the herbicide trifluralin in peppermint and spearmint oil at 2.0 ppm.

One of the private citizen's comments raised objections to any establishment of a tolerance for trifluralin. The citizen's comments and EPA's response to those comments follow:

1. Comment. Both 28-day dermal and developmental toxicity tests on rabbits as well as a 1-year oral capsule study on dogs have no validity and are abusive to the test animals.

EPA response. This commenter's objections to animal testing have been addressed in prior rulemaking documents. See 69 FR 63083, 63096 (October 29, 2004).

2. Comment. 1994 surveys of food intake are out of date.

EPA response. Consumption survey data is used in part to determine acute and chronic exposure. In assessing exposure to trifluralin, EPA relied on food consumption data as reported by respondents in the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). These surveys are generally updated every 10 years or so. The commenter claims the USDA surveys are out of date. The basis for this assertion is the commenter's observation that Americans are obese. This type of unsupported allegation is insufficient to call into question EPA's reliance on scientifically-designed studies. In any event, EPA's experience has been that while eating patterns change over time, these changes are generally marginal between surveys.

3. Comment. The DEEM software is not suitable for evaluating exposure/risk

EPA response. The commenter provides no basis for claiming that the DEEM is unsuitable for risk assessment. For this reason alone, the comment is insignificant. EPA would note, however, that the DEEM software has been thoroughly tested by the Agency and has been reviewed by an independent body of technical experts, the FIFRA Scientific Advisory Panel, and found to be suitable for evaluating risks of pesticide residues on food. The results of that review may be found at http://www.epa.gov/scipoly/sap/2000/february/partialfinalreport06292000.pdf.

4. Comment. Exposure to residential handlers makes the product too dangerous to be sold.

EPA response. The commenter states that if there are any exposures to residential handlers, then the product is far too dangerous to use or be sold. In response, EPA would first note that this tolerance rulemaking is being conducted under the FFDCA, and EPA does not regulate the sale or use of pesticides in residential settings under the FFDCA, although EPA does consider exposure from residential uses of pesticides in determining whether pesticide tolerances are safe. Decisions on whether a pesticide may be sold and distributed for residential uses is made pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Based on its uses, trifluralin has been assessed under the FFDCA for the residential applicator as well as other potential contact sources. Residential exposure scenarios were developed based on the use sites, formulations, application rates, and the various other equipment that could be used during applications. Residential risk estimates are also based on estimates (and assumptions) regarding the body weight of a typical homeowner/applicator, the area treated per application, and the seasonal duration (in days) of exposure. It is also assumed that residential applicators complete all elements of an application (mix/load/apply) without use of protective equipment (assessments are based on an assumption that individuals will be wearing short-sleeved shirts and short pants). For short-term non-cancer risks to residential handlers, a margin of exposure (MOE) of less than 100 exceeds the Agency's level of concern. For residential handlers, calculations of short-term inhalation non-cancer risk indicate that the MOEs are greater than 100 for all residential handler scenarios. Likewise, residential handler cancer risk indicates that all scenarios are below the Agency's level of concern. Therefore, the Agency is confident that no unreasonable risk exists (excluding any misuse) based on the assumptions made, likely scenarios, and the conservative approach used in determining any potential risk problem for residential handlers.

Another private citizen objected to allowing this genetically-modified crop to become a legal use in the United States or anywhere else. The commenter argued that genetic modification of plants is an unknown danger to humans as well as a wide variety of other species. In response, EPA would note that the commenter is mistaken in concluding that the production of trifluralin involves genetic modification of plants.

Based on the information, analysis, and conclusions in the November 24, 2004 (69 FR 68287) proposal, a tolerance is established for residues of trifluralin, alpha, alpha, alpha-trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine, in or on spearmint and peppermint oil at 2.0 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-2004-0142 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before June 27, 2005.

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 14th 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 V.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-2004-0142, 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 on EPA's own initiaive. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that this rule will not have significant negative economic impact on a substantial number of small entities. 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).

In 1980, Congress enacted the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601-9675 (“CERCLA” or “the Act”), in response to the dangers of uncontrolled releases or threatened releases of hazardous substances, and releases or substantial threats of releases into the environment of any pollutant or contaminant which may present an imminent or substantial danger to the public health or welfare. CERCLA was amended on October 17, 1986, by the Superfund Amendments and Reauthorization Act (“SARA”), Public Law 99-499, 100 Stat. 1613 et seq.

To implement CERCLA, EPA promulgated the revised National Oil and Hazardous Substances Pollution Contingency Plan (“NCP”), 40 CFR part 300, on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets guidelines and procedures for responding to releases and threatened releases of hazardous substances, or releases or substantial threats of releases into the environment of any pollutant or contaminant which may present an imminent or substantial danger to the public health or welfare. EPA has revised the NCP on several occasions. The most recent comprehensive revision was on March 8, 1990 (55 FR 8666).

As required under section 105(a)(8)(A) of CERCLA, the NCP also includes “criteria for determining priorities among releases or threatened releases throughout the United States for the purpose of taking remedial action and, to the extent practicable, taking into account the potential urgency of such action for the purpose of taking removal action.” “Removal” actions are defined broadly and include a wide range of actions taken to study, clean up, prevent or otherwise address releases and threatened releases of hazardous substances, pollutants or contaminants (42 U.S.C. 9601(23)).

The NPL is a list of national priorities among the known or threatened releases of hazardous substances, pollutants, or contaminants throughout the United States. The list, which is appendix B of the NCP (40 CFR part 300), was required under section 105(a)(8)(B) of CERCLA, as amended by SARA. Section 105(a)(8)(B) defines the NPL as a list of “releases” and the highest priority “facilities” and requires that the NPL be revised at least annually. The NPL is intended primarily to guide EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is only of limited significance, however, as it does not assign liability to any party or to the owner of any specific property. Neither does placing a site on the NPL mean that any remedial or removal action necessarily need be taken.

For purposes of listing, the NPL includes two sections, one of sites that are generally evaluated and cleaned up by EPA (the “General Superfund Section”), and one of sites that are owned or operated by other Federal agencies (the “Federal Facilities Section”). With respect to sites in the Federal Facilities Section, these sites are generally being addressed by other Federal agencies. Under Executive Order 12580 (52 FR 2923, January 29, 1987) and CERCLA section 120, each Federal agency is responsible for carrying out most response actions at facilities under its own jurisdiction, custody, or control, although EPA is responsible for preparing a Hazard Ranking System (HRS) score and determining whether the facility is placed on the NPL. EPA's role is less extensive than at other sites.

There are three mechanisms for placing sites on the NPL for possible remedial action (see 40 CFR 300.425(c) of the NCP): (1) A site may be included on the NPL if it scores sufficiently high on the Hazard Ranking System (“HRS”), which EPA promulgated as appendix A of the NCP (40 CFR part 300). The HRS serves as a screening device to evaluate the relative potential of uncontrolled hazardous substances, pollutant or contaminants to pose a threat to human health or the environment. On December 14, 1990 (55 FR 51532), EPA promulgated revisions to the HRS partly in response to CERCLA section 105(c), added by SARA. The revised HRS evaluates four pathways: Ground water, surface water, soil exposure, and air. As a matter of Agency policy, those sites that score 28.50 or greater on the HRS are eligible for the NPL; (2) Pursuant to 42 U.S.C 9605(a)(8)(B), each State may designate a single site as its top priority to be listed on the NPL, without any HRS score. This provision of CERCLA requires that, to the extent practicable, the NPL include one facility designated by each State as the greatest danger to public health, welfare, or the environment among known facilities in the State. This mechanism for listing is set out in the NCP at 40 CFR 300.425(c)(2); (3) The third mechanism for listing, included in the NCP at 40 CFR 300.425(c)(3), allows certain sites to be listed without any HRS score, if all of the following conditions are met:

• The Agency for Toxic Substances and Disease Registry (ATSDR) of the U.S. Public Health Service has issued a health advisory that recommends dissociation of individuals from the release.

• EPA determines that the release poses a significant threat to public health.

• EPA anticipates that it will be more cost-effective to use its remedial authority than to use its removal authority to respond to the release.

EPA promulgated an original NPL of 406 sites on September 8, 1983 (48 FR 40658) and generally has updated it at least annually.

A site may undergo remedial action financed by the Trust Fund established under CERCLA (commonly referred to as the “Superfund”) only after it is placed on the NPL, as provided in the NCP at 40 CFR 300.425(b)(1). (“Remedial actions” are those “consistent with permanent remedy, taken instead of or in addition to removal actions * * *.” 42 U.S.C. 9601(24).) However, under 40 CFR 300.425(b)(2) placing a site on the NPL “does not imply that monies will be expended.” EPA may pursue other appropriate authorities to respond to the releases, including enforcement action under CERCLA and other laws.

The NPL does not describe releases in precise geographical terms; it would be neither feasible nor consistent with the limited purpose of the NPL (to identify releases that are priorities for further evaluation), for it to do so.

Although a CERCLA “facility” is broadly defined to include any area where a hazardous substance release has “come to be located” (CERCLA section 101(9)), the listing process itself is not intended to define or reflect the boundaries of such facilities or releases. Of course, HRS data (if the HRS is used to list a site) upon which the NPL placement was based will, to some extent, describe the release(s) at issue. That is, the NPL site would include all releases evaluated as part of that HRS analysis.

When a site is listed, the approach generally used to describe the relevant release(s) is to delineate a geographical area (usually the area within an installation or plant boundaries) and identify the site by reference to that area. As a legal matter, the site is not coextensive with that area, and the boundaries of the installation or plant are not the “boundaries” of the site. Rather, the site consists of all contaminated areas within the area used to identify the site, as well as any other location to which that contamination has come to be located, or from which that contamination came.

In other words, while geographic terms are often used to designate the site (e.g., the “Jones Co. plant site”) in terms of the property owned by a particular party, the site properly understood is not limited to that property (e.g., it may extend beyond the property due to contaminant migration), and conversely may not occupy the full extent of the property (e.g., where there are uncontaminated parts of the identified property, they may not be, strictly speaking, part of the “site”). The “site” is thus neither equal to nor confined by the boundaries of any specific property that may give the site its name, and the name itself should not be read to imply that this site is coextensive with the entire area within the property boundary of the installation or plant. The precise nature and extent of the site are typically not known at the time of listing. Also, the site name is merely used to help identify the geographic location of the contamination. For example, the name “Jones Co. plant site,” does not imply that the Jones company is responsible for the contamination located on the plant site.

EPA regulations provide that the “nature and extent of the problem presented by the release” will be determined by a Remedial Investigation/Feasibility Study (RI/FS) as more information is developed on site contamination (40 CFR 300.5). During the RI/FS process, the release may be found to be larger or smaller than was originally thought, as more is learned about the source(s) and the migration of the contamination. However, this inquiry focuses on an evaluation of the threat posed; the boundaries of the release need not be exactly defined. Moreover, it generally is impossible to discover the full extent of where the contamination “has come to be located” before all necessary studies and remedial work are completed at a site. Indeed, the known boundaries of the contamination can be expected to change over time. Thus, in most cases, it may be impossible to describe the boundaries of a release with absolute certainty.

Further, as noted above, NPL listing does not assign liability to any party or to the owner of any specific property. Thus, if a party does not believe it is liable for releases on discrete parcels of property, supporting information can be submitted to the Agency at any time after a party receives notice it is a potentially responsible party.

For these reasons, the NPL need not be amended as further research reveals more information about the location of the contamination or release.

EPA may delete sites from the NPL where no further response is appropriate under Superfund, as explained in the NCP at 40 CFR 300.425(e). This section also provides that EPA shall consult with states on proposed deletions and shall consider whether any of the following criteria have been met:

(i) Responsible parties or other persons have implemented all appropriate response actions required;

(ii) All appropriate Superfund-financed response has been implemented and no further response action is required; or

(iii)The remedial investigation has shown the release poses no significant threat to public health or the environment, and taking of remedial measures is not appropriate.

In November 1995, EPA initiated a new policy to delete portions of NPL sites where cleanup is complete (60 FR 55465, November 1, 1995). Total site cleanup may take many years, while portions of the site may have been cleaned up and available for productive use.

EPA also has developed an NPL construction completion list (“CCL”) to simplify its system of categorizing sites and to better communicate the successful completion of cleanup activities (58 FR 12142, March 2, 1993). Inclusion of a site on the CCL has no legal significance.

Sites qualify for the CCL when: (1) Any necessary physical construction is complete, whether or not final cleanup levels or other requirements have been achieved; (2) EPA has determined that the response action should be limited to measures that do not involve construction (e.g., institutional controls); or (3) the site qualifies for deletion from the NPL. For the most up-to-date information on the CCL, see EPA's Internet site at http://www.epa.gov/superfund.

Yes, documents relating to the evaluation and scoring of the sites in this final rule are contained in dockets located both at EPA Headquarters and in the Regional offices.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “Quick Search,” then key in the appropriate docket identification number; SFUND-2005-0002. (Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facilities identified below in section II D.)

The Headquarters docket for this rule contains, for each site, the HRS score sheets, the Documentation Record describing the information used to compute the score, pertinent information regarding statutory requirements or EPA listing policies that affect the site, and a list of documents referenced in the Documentation Record. The Headquarters docket also contains comments received, and the Agency's responses to those comments. The Agency's responses are contained in the “Support Document for the Revised National Priorities List Final Rule—April 2005.” An electronic version is available at http://www.epa.gov/edocket/ using the docket identification number SFUND-2005-0002.

The Regional dockets contain all the information in the Headquarters docket, plus the actual reference documents containing the data principally relied upon by EPA in calculating or evaluating the HRS score for the sites located in their Region. These reference documents are available only in the Regional dockets.

You may view the documents, by appointment only, after the publication of this document. The hours of operation for the Headquarters docket are from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. Please contact the Regional dockets for hours.

Following is the contact information for the EPA Headquarters: Docket Coordinator, Headquarters; U.S. Environmental Protection Agency; CERCLA Docket Office; 1301 Constitution Avenue; EPA West, Room B102, Washington, DC 20004, 202/566-0276.

The contact information for the Regional dockets is as follows:

Ellen Culhane, Region 1 (CT, ME, MA, NH, RI, VT), U.S. EPA, Superfund Records and Information Center, Mailcode HSC, One Congress Street, Suite 1100, Boston, MA 02114-2023; 617/918-1225.

Dennis Munhall, Region 2 (NJ, NY, PR, VI), U.S. EPA, 290 Broadway, New York, NY 10007-1866; 212/637-4343.

Dawn Shellenberger (ASRC), Region 3 (DE, DC, MD, PA, VA, WV), U.S. EPA, Library, 1650 Arch Street, Mailcode 3PM52, Philadelphia, PA 19103; 215/814-5364.

John Wright, Region 4 (AL, FL, GA, KY, MS, NC, SC, TN), U.S. EPA, 61 Forsyth Street, SW., 9th floor, Atlanta, GA 30303; 404/562-8123.

Janet Pfundheller, Region 5 (IL, IN, MI, MN, OH, WI), U.S. EPA, Records Center, Superfund Division SRC-7J, Metcalfe Federal Building, 77 West Jackson Boulevard, Chicago, IL 60604; 312/353-5821.

Brenda Cook, Region 6 (AR, LA, NM, OK, TX), U.S. EPA, 1445 Ross Avenue, Mailcode 6S-RA, Dallas, TX 75202-2733; 214/665-7436.

Michelle Quick, Region 7 (IA, KS, MO, NE), U.S. EPA, 901 North 5th Street, Kansas City, KS 66101; 913/551-7335.

Gwen Christiansen, Region 8 (CO, MT, ND, SD, UT, WY), U.S. EPA, 999 18th Street, Suite 500, Mailcode 8EPR-B, Denver, CO 80202-2466; 303/312-6463.

Jerelean Johnson, Region 9 (AZ, CA, HI, NV, AS, GU), U.S. EPA, 75 Hawthorne Street, San Francisco, CA 94105; 415/972-3094.

Sylvia Kawabata, Region 10 (AK, ID, OR, WA), U.S. EPA, 1200 6th Avenue, Mail Stop ECL-115, Seattle, WA 98101; 206/553-1078.

You may obtain a current list of NPL sites via the Internet at http://www.epa.gov/superfund/ (look under the Superfund sites category) or by contacting the Superfund Docket (see contact information above).

This final rule adds the following ten sites to the NPL; all to the General Superfund Section:

Three of the sites in this final rule received comments supporting listing, Safety Light Corporation, Price Battery and Brewer Gold. These sites were all proposed September 23, 2004 (69 FR 56970) with a 60-day comment period which ended on November 22, 2004. None of the comments affect the HRS score, and all support listing on the NPL. Additional contamination information and a request for a removal action were provided in comments for Safety Light Corporation and Brewer Gold Mine. The comment for Price Battery requested that the buildings be removed and asked about the impact of a listing on the sale of properties within the site. EPA will evaluate what, if any, remediation is needed, and the most appropriate response for the properties within the Price Battery site.

In addition to these comments supporting listing, one site in this rule received negative comments, Crown Vantage Landfill. The Agency's responses are contained in the “Support Document for the Revised National Priorities List Final Rule—April 2005.” All other sites in this rule received no comments.

Out of the ten sites included in this final rule, EPA only received comments on the Crown Vantage Landfill site in Alexandria Township, NJ. EPA responded to all relevant comments received on this site and EPA's responses to the site-specific comments are addressed in the “Support Document for the Revised National Priorities List Final Rule—April 2005.” The comments and the support document are contained in the Headquarters Docket and are also listed in EPA's electronic public docket and comment system at http://www.epa.gov/edocket/ using the SFUND-2005-0002 identification number.

Under Executive Order 12866, (58 FR 51735 (October 4, 1993)) the Agency must determine whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

No. The listing of sites on the NPL does not impose any obligations on any entities. The listing does not set standards or a regulatory regime and imposes no liability or costs. Any liability under CERCLA exists irrespective of whether a site is listed. It has been determined that this action is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to OMB review.

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the preamble of the final rules, are listed in 40 CFR part 9.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. EPA has determined that the PRA does not apply because this rule does not contain any information collection requirements that require approval of the OMB.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996) whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities.

This rule listing sites on the NPL does not impose any obligations on any group, including small entities. This rule also does not establish standards or requirements that any small entity must meet, and imposes no direct costs on any small entity. Whether an entity, small or otherwise, is liable for response costs for a release of a hazardous substance depends on whether that entity is liable under CERCLA 107(a). Any such liability exists regardless of whether the site is listed on the NPL through this rulemaking. Thus, this rule does not impose any requirements on any small entities. For the foregoing reasons, I certify that this rule will not have a significant economic impact on a substantial number of small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal Agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. Before EPA promulgates a rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

No, EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments in the aggregate, or by the private sector in any one year. This rule will not impose any federal intergovernmental mandate because it imposes no enforceable duty upon State, tribal or local governments. Listing a site on the NPL does not itself impose any costs. Listing does not mean that EPA necessarily will undertake remedial action. Nor does listing require any action by a private party or determine liability for response costs. Costs that arise out of site responses result from site-specific decisions regarding what actions to take, not directly from the act of listing a site on the NPL.

For the same reasons, EPA also has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. In addition, as discussed above, the private sector is not expected to incur costs exceeding $100 million. EPA has fulfilled the requirement for analysis under the Unfunded Mandates Reform Act.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

Under section 6 of Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law, unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Thus, the requirements of section 6 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 6, 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.” “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 final rule does not have tribal implications. 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this final rule.

Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to Executive Order 13045 because it is not an economically significant rule as defined by Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this section present a disproportionate risk to children.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001), requires EPA to prepare and submit a Statement of Energy Effects to the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, for certain actions identified as “significant energy actions.” Section 4(b) of Executive Order 13211 defines “significant energy actions” as “any action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking: (1)(i) That is a significant regulatory action under Executive Order 12866 or any successor order, and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (2) that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action.”

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 (See discussion of Executive Order 12866 above.)

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

No. This rulemaking does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

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 has submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A “major rule” cannot take effect until 60 days after it is published in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Provisions of the Congressional Review Act (CRA) or section 305 of CERCLA may alter the effective date of this regulation.

Under the CRA, 5 U.S.C. 801(a), before a rule can take effect the federal agency promulgating the rule must submit a report to each House of the Congress and to the Comptroller General. This report must contain a copy of the rule, a concise general statement relating to the rule (including whether it is a major rule), a copy of the cost-benefit analysis of the rule (if any), the agency's actions relevant to provisions of the Regulatory Flexibility Act (affecting small businesses) and the Unfunded Mandates Reform Act of 1995 (describing unfunded federal requirements imposed on state and local governments and the private sector), and any other relevant information or requirements and any relevant Executive Orders.

EPA has submitted a report under the CRA for this rule. The rule will take effect, as provided by law, within 30 days of publication of this document, since it is not a major rule. Section 804(2) defines a major rule as any rule that the Administrator of the Office of Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB) finds has resulted in or is likely to result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. NPL listing is not a major rule because, as explained above, the listing, itself, imposes no monetary costs on any person. It establishes no enforceable duties, does not establish that EPA necessarily will undertake remedial action, nor does it require any action by any party or determine its liability for site response costs. Costs that arise out of site responses result from site-by-site decisions about what actions to take, not directly from the act of listing itself. Section 801(a)(3) provides for a delay in the effective date of major rules after this report is submitted.

Under 5 U.S.C. 801(b)(1) a rule shall not take effect, or continue in effect, if Congress enacts (and the President signs) a joint resolution of disapproval, described under section 802.

Another statutory provision that may affect this rule is CERCLA section 305, which provides for a legislative veto of regulations promulgated under CERCLA. Although INS v. Chadha, 462 U.S. 919,103 S. Ct. 2764 (1983) and Bd. of Regents of the University of Washington v. EPA, 86 F.3d 1214,1222 (D.C. Cir. 1996) cast the validity of the legislative veto into question, EPA has transmitted a copy of this regulation to the Secretary of the Senate and the Clerk of the House of Representatives.

If action by Congress under either the CRA or CERCLA section 305 calls the effective date of this regulation into question, EPA will publish a document of clarification in the Federal Register.

In the matter of the Commission's financial management matters and its administration of the issuance of FCC Registration Numbers. Amendment of sections 0.11, 0.231, and 1.8002 of the Commissions rules Adopted: July 2, 2004, Released: January 7, 2005.

The Commission will not send a copy of this Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted rules relate to agency organization, procedure or practice that do not “substantially affect the rights or obligations of non-agency parties. Pursuant to sections 4(i), 4(j), 5(c), 303(r), 47 U.S.C. 154(i), 154(j), 155(c), 251(e), 303(r) of the Communications Act of 1934, as amended, 47 CFR. parts 0 and 1 are amended as set forth below, effective upon publication in the Federal Register.

The FCC published a document in the Federal Register 69 FR 29459, May 24, 2004, that sets forth an effective date of June 23, 2004, except for amendment to § 15.240, which contained an information collection requirement that had not been approved by the Office of Management and Budget. The document stated that the Commission will publish a document in the Federal Register announcing the effective date for § 15.240 and the information collection contained therein. On March 18, 2005, the Office of Management and Budget (OMB) approved the information collection requirements contained 47 CFR 15.240 pursuant to OMB Control No. 3060-1079. Accordingly, the information collection requirement contained in this rule became effective on March 18, 2005. The expiration date for the information collection requirement will be March 31, 2008.

This is a summary of the Commission's Report and Order, ET Docket No. 04-243, FCC 05-69, adopted on March 10, 2005, and released on March 11, 2005. The full text of this document is available on the Commission's Internet site at http://www.fcc.gov. It is also available for inspection and copying during regular business hours in the FCC Reference Center (Room CY-A257), 445 12th Street., SW., Washington, DC 20554. The full text of this document also may be purchased from the Commission's duplication contractor, Best Copy and Printing Inc., Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20554; telephone (202) 488-5300; fax (202) 488-5563; e-mail FCC@BCPIWEB.COM.

1. The Commission amended parts 2 and 90 of its rules to revise our transition plan for primary and secondary PLMR operations in certain Federal bands. The Commission concluded that these actions will provide for an orderly transition from wideband (25 kHz channels) to narrowband (12.5 kHz channels) operations, increase spectrum efficiency, maintain compatibility with Federal operations, permit PLMR licensees to operate using existing equipment with greater confidence that their critical operations will not be suddenly required to cease transmissions, and significantly reduce the probability that wideband PLMR operations will interfere with new Federal operations. Specifically, the Commission narrowbanded 25 Hydrological and Meteorological (Hydro) channels, nine Forest Firefighting and Conservation channels (two of these channels are available to conservation agencies, while all nine are available for firefighting use), two Public Safety channels, three medical radiocommunication system channels (MED channels), and one channel for Stolen Vehicle Recovery System (SVRS). In addition, the Commission added 23 Hydro channels to the rules, removed six Hydro channels (only four of which are currently licensed) from our rules, and will no longer license two MED channels.

2. The transition plan that was adopted today refines certain aspects of the Commission's larger narrowbanding policies, most recently modified in the Narrowbanding Third MO&O in the Refarming Proceeding, FCC 04-292, 19 FCC Rcd 25045 (2004), in the following ways:

• As of the effective date of the Report and Order, the Commission limited new MED channel stations that use the frequencies 150.775 MHz and 150.790 MHz to a transmitter output power of 100 watts Effective Radiated Power (ERP). New wideband systems on these frequencies will be authorized on a primary basis until January 1, 2008. Wideband systems licensed prior to January 1, 2008, may be expanded until January 1, 2011, and may continue to operate on a primary basis until January 1, 2013, at which time wideband transmissions must cease;

• As of the effective date of the Report and Order, the Commission will not accept applications or issue licenses for new wideband systems that use the MED channel frequency 163.250 MHz. Existing wideband systems on this frequency may be expanded until January 1, 2011, and may continue to operate on a primary basis until January 1, 2013, at which time wideband transmissions must cease. The Commission will not narrowband the non-Federal MED channel paging frequency 152.0075 MHz;

• On a going-forward basis, new non-Federal operations on the three MED channel frequencies in the Federal band (150.775 MHz, 150.790 MHz, and 163.250 MHz) will be limited to medical radiocommunication systems;

• As of the effective date of the Report and Order, the Commission will no longer issue new licenses for the frequencies 150.7825 MHz and 150.7975 MHz. However, the Commission will continue to renew existing licenses on these channels indefinitely; and

• The existing SVRS system operated by the LoJack Corporation (LoJack) and police licensees may continue wideband operations until 14 years after the effective date of the Report and Order, at which time wideband transmissions must cease. Any new SVRS licensee that begins service after the effective date of the Report and Order must operate a narrowband system.

• The Commission revised its Hydro channel plan by adding 23 channels and by deleting six channels in order to make it consistent with NTIA's plan, and the Commission included the Hydro channels in the 406.1-420 MHz band in our transition plan to 12.5 kHz channels;

• Existing Hydro channel licensees, which operate on frequencies that are being removed from the Hydro Plan (171.975 MHz, 409.675 MHz, 409.725 MHz, and 412.625 MHz), must migrate to a center frequency that is available under the new Hydro channel plan on a timetable that is recommended by the Hydro Committee, agreed to by NTIA, and approved by the FCC;

• As of the effective date of the Report and Order, the Commission will not accept applications or issue licenses for new wideband stations for channels whose operation is permitted on a secondary basis (Hydro, Forest Firefighting and Conservation, and the Public Safety channels) in the 162-174 MHz band.

• New wideband Hydro stations in the 406.1-420 MHz band will be authorized on a secondary basis until January 1, 2008.

• Existing wideband systems in the 162-174 MHz band that operate on a secondary basis may be expanded until January 1, 2011, and may continue to operate until January 1, 2013, at which time wideband operations must cease. However, these licensees must modify or discontinue their operations if, at any time, their operations cause interference to new Federal operations,

• Existing wideband Hydro systems in the 406.1-420 MHz band may be expanded until January 1, 2011, and may continue to operate until January 1, 2013, at which time wideband operations must cease. However, these licensees must modify or discontinue their operations if, at any time after January 1, 2008, their operations cause interference to new Federal operations; and

• The Commission revised the list of radio astronomy observatories and the associated areas where prior coordination for fixed operations is required, and modified the power limit for stations in the fixed and mobile services in order to better protect the radio astronomy service (RAS) in the 406.1-410 MHz band.

3. Refining the Commission's Narrowbanding Proceedures for the Federal Bands. The Commission adopted proposals, as modified to reflect the narrowbanding dates as modified by the Narrowbanding Third MO&O. As an initial matter, the Commission included the 406.1-420 MHz band in our transition plan to narrowband channels. No commenters addressed this proposal. The Commission concluded that action is necessary to address the federal narrowbanding matters in a complete and comprehensive manner, and because secondary users in these bands will be directly affected by the Federal narrowbanding efforts and Hydro channel plan modifications. Also, by providing a narrowbanding procedure for existing non-Federal Hydro operations in the band, the Commission will aid the Hydro Committee in its efforts to make the most efficient use of the new channel plan. Those actions that we proposed to take effect on January 1, 2005, will necessarily instead be tied to the effective date of the Report and Order.

4. For new stations in the Federal bands the Commission adopted deadlines, as proposed in this proceeding, Notice of Proposed Rule Making (NPRM), FCC 04-156, 69 FR 46462, August 3, 2004, that align with Federal narrowbanding requirements: As of the effective date of this Report and Order, the Commission will not accept applications or issue licenses for new wideband Hydro, Forest Firefighting and Conservation, Public Safety, and MED channel systems in the 162-174 MHz band. The Commission will authorize new wideband operations for the MED channel frequencies 150.775 MHz and 150.790 MHz and Hydro channels in the 406.1-420 MHz band only until January 1, 2008. Although, the Commission does not believe that NTIA will generally agree to waiver requests for wideband operations in the Federal bands, we will consider granting wideband applications after these dates, if accompanied by a waiver request, in the following circumstances: for Forest Firefighting and Conservation channels, if a waiver has been recommended by a sponsoring Federal agency and if NTIA agrees with the recommendation; and for public safety use of the frequency 166.25 MHz and 170.15 MHz, if NTIA agrees to the grant of the waiver application. In addition, the Commission recognizes the role of the Hydro Committee in promoting efficient use of the Hydro channels by both Federal agencies and non-Federal licensees, and realizes that the Hydro Committee is in the best position to recommend the narrowband transition cycle for specific Hydro channel users. As such, the Commission intend to support applications for new wideband channels after the Federal wideband cut-off dates, if such a grant is recommended by the Hydro Committee and is accompanied by NTIA's concurrence.

5. The Commission concluded that the deadlines are necessary and appropriate for the class of Commission licensees that maintain operations on these Federal bands, particularly in light of NTIA's policy to no longer authorize wideband assignments. Although the International Municipal Signal Association and the International Association of Fire Chiefs, Inc. (IMSA/IAFC) request that the Commission employ a 2018 cut-off date for new wideband applications in the two primary MED channels might have short-term financial benefits for budget-constrained agencies, doing so would compromise NTIA's efforts to expand the band by adding efficient new narrowband channels, would create even greater disparities between Federal and non-Federal operations in the band, and would not change the ultimate transition to narrowband channels. Moreover, the 2008 cut-off for new wideband stations still allows applicants for Commission licenses in the band to take account of the narrowbanding requirement adopted today prior to deciding whether to seek use of those two channels for new facilities.

6. For existing wideband systems operating in the Federal bands, the Commission will maintain the January 1, 2011 deadline for system expansions and the January 1, 2013 as the date by which all licensees must migrate completely to 12.5 kHz narrowband technology. This action reflects the deadlines recently adopted in the Narrowbanding Third MO&O.

7. The Commission will continue to recognize primary status for MED channels in the Federal bands that are listed in footnote US216 (150.775 MHz, 150.790 MHz and 163.250 MHz) and it will continue to treat these MED channels in a similar manner to all other primary land mobile licensees under the Commission's jurisdiction. Users of these channels still must narrowband their operations by the same January 1, 2013 deadline the Commission has established for all other licensees in the Federal bands. Our approach preserves our traditional first-in-time policy by which the first licensed entity does not have to modify its operations but instead maintains a primary status in relation to subsequently licensed entities. Under this policy, an existing wideband MED channel operation is entitled to protection from interference from new Federal operations and non-Federal licensees that subsequently begin operations in the band, and will not need to modify existing operations to prevent interference to these new entrants. The Commission expects that NTIA will protect these wideband operations from harmful interference from new or modified Federal operations in the band until the January 1, 2013, narrowbanding date.

8. For existing licensees operating in the Federal bands on a secondary basis “ specifically, users of the Hydro, Forest Firefighting and Conservation, and the Public Safety channels—the Commission notes that NTIA may now authorize new Federal operations in the 162-174 MHz band on channels that are only 12.5 kHz away from the center frequencies of non-Federal licenses. After January 1, 2008, NTIA may authorize new Federal operations in the 406.1-420 MHz bands that are only 12.5 kHz away from the center frequencies of non-Federal Hydro stations that operate on a secondary basis. Thus, while the Commission will permit these licensees to continue to operate on wideband channels on a non-interference basis until as late as 2013, it emphasize that they must modify or discontinue wideband operations if, at any time (for the 162-174 MHz band), and at any time after January 1, 2008 (for the 406-416 MHz band), they cause interference to new Federal operations. Once a Federal agency begins narrowband operations, these non-Federal licensees must be prepared to accept harmful interference, and will be subject to termination if harmful interference is caused to Federal operations. Termination of operations will be required regardless of the length of advance notice, as well as in cases where we are unable to provide advance notice. The Commission will, of course, closely work with NTIA under the auspices of the FAS of the IRAC to provide as much advance notice as possible to non-Federal licensees that a proposed Federal assignment has been filed with NTIA.

9. Consistent with the Commission's decision in the Narrowbanding Third MO&O, we will not narrowband the MED channel at 152.0075 MHz, which is used for paging. This channel is within a band that is allocated primarily for non-Federal use, is not subject to NTIA's narrowbanding efforts, and thus will continue to follow the Commission's Rules regarding paging operations. In the Narrowbanding Third MO&O, the Commission stated that paging channels are neither congested nor do they typically create interference problems given, for example, their relatively short duty cycle. The Commission agree with the 152 MHz Paging Commenters that there are benefits to retaining wideband operations on this channel, and conclude that such benefits outweigh any benefits that would be realized from narrowbanding all frequencies used by medical radiocommunication systems.

10. The Commission will, include the MED channel at 163.250 MHz in its narrowbanding requirements. The Commission distinguished this channel from other paging channels because it operates within the Federal bands, and note that NTIA did not grant Federal agencies a paging exemption in its narrowbanding plan. The Department of Veterans Affairs (VA) is currently moving to narrowband its paging operations to meet NTIA's mandated narrowbanding schedule. Given our desire to limit the potential for interference between existing licensees and new NTIA-approved operations on a channel used for important medical paging applications, the Commission concluded that it is appropriate for us to apply the January 1, 2013 narrowbanding deadlines to this channel. The Commission noted, however, that any wideband operations on this channel are subject to termination if harmful interference is caused to Federal operations.

11. Lastly, the Commission found that it is unnecessary and potentially detrimental to our narrowbanding efforts to require that non-Federal licensees to use 6.25 kHz channels in the Federal bands in advance of Federal agencies at this time, and will modify our rules accordingly. The Commission see no advantage to this requirement in the Federal bands, given the uncertainty as to if or when Federal entities will begin using 6.25 kHz channels.

12. MED Channels (US216). The Commission will no longer license non-Federal stations on the frequencies 150.7825 MHz and 150.7975 MHz. These frequencies, which were never incorporated into footnote US216, lie within the Federal military band and additional authorizations would limit the future deployment of vital military systems. IMSA/IAFC objects to this proposal, noting that these channels have been used by public safety licensees in many large cities and concluding that such use “far outweighs” the public gain in limiting use of the channels. The Commission disagree. Because these channels were not part of the original 1974 agreement with NTIA, but were instead only recently licensed to non-Federal applicants as part of the Refarming Proceeding, and because of NTIA's interest in making the band available for narrowband Federal systems—including those used by the military—the Commission conclude that the discontinuance of new licensing of these frequencies will benefit the public good by allowing vital new Federal systems to deploy. The Commission will permit the existing mobile stations that are authorized as of effective date of this Report and Order to use the frequencies 150.7825 MHz and 150.7975 MHz indefinitely with their current usage designation.

13. The Commission adopted its proposal to revise footnote US216 to list the available frequencies (152.0075 MHz and 163.250 MHz) in lieu of the 152-152.0150 MHz and 163.2375-163.2625 MHz bands. No party commented on this proposal. It also revised, in concurrence with NTIA, the two non-Federal bands at 460 MHz in footnote US216 in order to align the non-Federal 460 MHz bands in footnote US216 with the Commission's revised Rules and to formally provide Federal agencies access to all 30 of the new MED channels in the 463 MHz and 468 MHz bands. These revisions to footnote US216 are included in the final rules.

14. With respect to new licenses on the mobile channels 150.775 MHz and 150.790 MHz and the paging channel 163.250 in the Federal band, the Commission adopted its proposal to implement, on a going forward basis, the footnote US216 requirement that the use of these channels be limited to medical radiocommunications systems. This action will support Federal users that have made and implemented spectrum usage plans based on the text of the footnote, and will have the added benefit of harmonizing use of these channels with the concept of medical radiocommunications systems as it was first adopted in 1974. The Commission notes that several commenters opposed this change. While it recognizes that the current usage practice is beneficial in that it permits a broad range of medical and public safety uses of the frequencies, the Commission cannot reconcile an expansion of such use with our obligation to Federal users that it license these frequencies in the Federal bands on a limited basis for medical radiocommunications systems, as reflected in footnote US216. The Commission will, with the concurrence of NTIA, permit existing licensees to continue even if such operations are not restricted to medical radiocommunications systems operations. Also, the Commission will not change the existing frequency coordinator for the paging channel frequencies, as proposed in the NPRM.

15. The Commission is limiting all operations on the mobile channels for licenses issued after the effective date of this Report and Order to a maximum output power of 100 watts ERP. IMSA/IAFC objected to the Commission's proposal to limit the transmitter output power of the mobile channels to 2.5 watts, arguing that these channels provide needed frequency separation from the primary Public Safety allocation for two-frequency repeater operations. A general review of our licensing data indicates that mobile stations operating on these frequencies have been authorized an output power between 2.5 and 200 watts ERP, but with the majority in the range of 30 to 100 watts. The Commission continues to believe that we must take steps to harmonize non-Federal use of the mobile channels, and that it should work to complement rather than frustrate NTIA's narrowbanding efforts in the Federal bands. However, the Commission is also cognizant of the difficult funding challenges faced by public safety users of these frequencies, recognize the important work these entities routinely undertake, and appreciate the intensive use of these bands as described in IMSA/IAFC's comments. The 100 watt limit established for new licenses caps these channels at a lower power level than other channels in the 150-174 MHz band, and will promote wider availability of these channels for both new Federal and non-Federal users. However, the 100 watt limit that was set is substantially larger than the 2.5 watt proposal, and is consistent with the majority of current use in the band. The Commission will allow licensees to continue existing operations under their existing authorizations, subject only to the more general narrowbanding requirements it adopted. The Commission, explicitly prohibit airborne operations by both existing and future mobile channel licensees. Such operations have the potential to cause wide-area interference, and adoption of the prohibition will promote continued cooperative use of the band by both Federal and non-Federal entities and is consistent with § 4.3.11 of the NTIA Manual.

16. Finally, with respect to the non-Federal paging channel 150.0075 MHz—the Commission is not narrowbanding—it is removing limitation 19. The Commission concludes that this limitation, which reserved the frequency 150.0075 MHz for assignment to stations for intersystem operations only and which required that these operations be primarily base-mobile communications, overly limits widespread use of the band. In addition, because this paging channel is within a non-Federal band, the Commission will continue to make it available for a full range of medical and public safety uses and will not restrict its future use to medical radiocommunications systems exclusively.

17. Stolen Vehicle Recovery Systems (US312). LoJack, the only commenter to address this issue, supports creation of a narrowbanding plan for SVRS systems. In order to preserve the substantial utility of the existing wideband SVRS for consumers and law enforcement agencies, LoJack requests that the Commission provide at least a 14 year transition period from the effective date of final rules in this proceeding. LoJack states that this schedule would give it four years to develop and deploy a narrowband system and would give ten years for police departments and consumers relying on the installed base of wideband equipment to continue to receive service once the narrowband system is deployed.

18. The Commission finds LoJack's proposal persuasive. Given the need to develop and test new equipment, as well as the scope of the transition, a fourteen-year transition provides sufficient time for SVRS to adopt narrowband technology in a manner that does not jeopardize the public benefits associated with the service. The Commission notes LoJack's claims that it will not be able to continue serving its wideband customers during the transition period if Federal agencies begin operating on the new adjacent narrowband frequencies of 173.0625 MHz and 173.0875 MHz. The Commission will work with NTIA to prevent Federal entities from being assigned new narrowband channels that are spaced only 12.5 kHz away from the SVRS center frequency until after the end of the transition period (i.e., approximately 2019), and will use our role as a voting member of the FAS to ensure that the primary status afforded to SVRS continues to be recognized during the Federal frequency assignment process. As previously noted, LoJack is currently the only SVRS licensee. Because subsequent SVRS licensees will have to deploy equipment to begin service, all new licensees will be required to employ narrowband operations without the benefit of a transition period. To reflect these new narrowband requirements in the SVRS, the Commission amended—in concurrence with NTIA—footnote US312, which is shown in the final rules. Accordingly, the Commission amended § 90.20 by revising paragraph (e)(6) to reflect the 12.5 kHz maximum authorized bandwidth for SVRS and associated transition plan.

19. Hydro Channels and Protection for Radio Astronomy (US13 and US117). The Commission did not receive any comments that addressed our proposals for the Hydro channels. The Commission adopted it proposals and revised its Rules to reflect an updated Hydro channel plan that is consistent with the channel plan shown in the NTIA Manual. Consistency between Federal and non-Federal band plans furthers the public interest and safety by maintaining a ready flow of hydrologic and metrological data between non-Federal and Federal entities. This decision also recognizes the fact that non-Federal Hydro stations operation is closely coordinated the Hydro Committee. The Commission note, for example, that the Hydro Committee has begun encouraging the use of narrowband equipment by non-Federal applicants, and a review of our licensing database indicates that while many non-Federal Hydro operations still use wideband channels, some narrowband use is prevalent among the more newly licensed channels.

20. The Commission discussed the process for Commission licensees to narrowband the existing Hydro channels that are to be retained by NTIA. It now also require licensees operating on the Hydro channels that are being removed from the Hydro channel plan to modify their equipment and station licenses and migrate to a center frequency under the new Hydro channel plan on a timetable as advised by the Hydro Committee and approved by NTIA and the Commission. As of January 1, 2005, licensees of stations transmitting on the frequency 169.575 MHz should be prepared to cease or relocate operations, if their wideband operations cause harmful interference to Federal operations. As of January 1, 2008, licensees of stations transmitting on the frequencies 409.675 MHz, 409.725 MHz, or 412.625 MHz should be prepared to cease or relocate operations, if their wideband operations cause harmful interference to Federal operations. Finally, all licensees must cease operating on these channels after January 1, 2013.

21. To implement these proposals, the Commission revised its Rules to reflect the new Hydro channel plan and our plan for transitioning to narrowband channels, as well as to make other necessary modifications to reflect the Hydro operations. Also, in concurrence with NTIA, the Commission revised footnote US117 to provide more effective protection of RAS reception in the 406.1-410 MHz band. These revisions are included in the final rules.

22. Forest Firefighting and Conservation Channels (US8). The Commission did not receive any comments that addressed our proposals. The Commission has adopted a requirement that applications for use of these channels be accompanied by a letter of concurrence. Based on our experience with past applications that included such a letter, the Commission believes that this practice aids the coordination of assignments between NTIA and the Commission. The Commission is also moving the existing limitations that are contained in § 90.20 of the Commission's rules into a new subsection of § 90.265. Section 90.265 of the rules already describes procedures by which the Commission license two services permitted on Federal bands pursuant to United States footnotes—Hydro operations and wireless microphones. The Commission concludes it would be convenient and consistent to expand this section to include similarly situated services including, inter alia, the Forest Firefighting and Conservation channels.

23. Public Safety Channels (US11). IMSA/IAFC is the only party to address the proposals dealing with the two Public Safety channels. IMSA/IAFC states that these Public Safety channels are widely assigned to agencies in the New York City metropolitan area and nearby environs that are expected to provide critical support to homeland security operations. IMSA/IAFC states that the current coordination procedures between Public Safety and Federal agencies are sufficient to address any concerns regarding possible interference, and urges us to “tread cautiously” to implement a policy so that Federal agencies would implement narrowband operations on the new channels adjacent to the Public Safety channels only as an absolute last resort when other acceptable channels are not available, and to work to expedite timely frequency coordination procedures for these channels.

24. The Commission recognizes the unique needs and critical nature of public safety communications in the New York City metropolitan area and the funding difficulties that many of these licensees face, and have worked with NTIA to limit the possibility that it will assign the new narrowband channels that are immediately adjacent to the two Public Safety channels in the New York City area until the conclusion of our transition period to mandatory narrowband operations. The Commission will continue to work in cooperation with NTIA, and within the Federal frequency coordination process, to be sure this remains the case.

25. The Commission created a new paragraph in § 90.265 of the rules to describe these public safety channels, revising the existing limitation contained in § 90.20(d)(47) of the Commission's rules to serve as a cross-reference, and updated footnote US11 in concurrence with NTIA to remove an outdated reference to wideband operations and to simplify the description of public safety and remote pickup broadcast operations in the band. The Commission stated in its rules that these operations are on a secondary basis to any Federal station, in order to give effect to the restriction embodied in footnote US11 that non-Federal operations on 166.250 MHz and 170.150 MHz operate on the condition that no harmful interference is caused to “present or future” Federal stations. Finally, the Commission will not require a letter of concurrence by a sponsoring Federal agency in conjunction with an application for use of these channels. The Commission is persuaded by IMSA/IAFC's claims that such a requirement would “entail an unneeded and time consuming step” in a coordination process that it describes as “more than sufficient.”

26. Public Coast Station Channels (US223). Footnote US223 makes a channel available for public coast station use in limited areas near the Canadian border. Because ship and public coast operations do not fall under the same rules as PLMR operations, footnote US223 does not need to be modified to support NTIA's narrowbanding timetable, and therefore the Commission proposed no changes to these frequencies as part of this proceeding.

27. Wireless Microphone Channels (US300). Footnote US300 specifies eight frequencies that are available for wireless microphone operations on a secondary basis to Federal and non-Federal operations. Because wireless microphones operate at very low power (50 mW output power), there is a minimal likelihood that they will cause interference to high-power land mobile operations. Thus, the Commission proposed no changes to the frequencies allocated for wireless microphones as part of footnote US300. No comments were received on these proposals. Accordingly, the Commission will not narrowband these operations.

28. As required by the Regulatory Flexibility Act of 1980, as amended (RFA),1 an Initial Regulatory Flexibility Analysis (“IRFA”) was incorporated in the Notice of Proposed Rule Making (“NPRM”) 2 in ET Docket No. 04-243. The Commission sought written public comment on the proposals in the NPRM, including comment on the IRFA. No written public comments were received concerning the initial regulatory flexibility analysis. This present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.3

29. In the 150.05-150.8 MHz, 162-174 MHz, and 406.1-420 MHz bands, the National Telecommunications and Information Administration (NTIA) is transitioning Federal operations in the fixed and land mobile services from wideband (25 kHz) to narrowband (12.5 kHz) channels at a more rapid schedule than the Commission has adopted for Private Land Mobile Radio (PLMR) operations in these bands. Because there could be extended periods during which existing PLMR wideband operations may not be compatible with narrowband Federal operations, the Commission has revised its current narrowbanding plan for these bands to take into account that many PLMR operations in the above Federal bands are authorized on the condition that they not cause interference to Federal operations.

30. The Commission's objectives are to provide for a more orderly transition from wideband to narrowband operations, increase spectrum efficiency, maintain compatibility with Federal operations, permit licensees to operate using existing equipment for the maximum amount of time possible, and significantly reduce the probability that wideband operations will interfere with new Federal operations.

31. There were no comments filed that specifically addressed the rules and policies addressed in the IRFA.

32. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the rules adopted herein.4 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act, unless the Commission has developed one or more definitions that are appropriate for its activities.5 Under the Small Business Act, a “small business concern” is one that: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).6

33. A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” 7 Nationwide, there are approximately 1.6 million small organizations.8 “Small governmental jurisdiction” generally means “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than 50,000.” 9 As of 1997, there were approximately 87,453 governmental entities in the United States.10 This number includes 39,044 county governments, municipalities, and townships, of which 37,546 (approximately 96.2%) have populations of fewer then 50,000 and 1,498 have populations of 500,000 or more. Thus, we estimate the number of small governmental jurisdictions overall to be approximately 84,098 or fewer.

34. PLMR systems serve an essential role in a range of industrial, business, land transportation, and public safety activities. These radios are used by companies of all sizes operating in all U.S. business categories, and are often used in support of the licensee's primary (non-telecommunications) business operations. For the purpose of determining whether a licensee of a PLMR system is a small business as defined by the SBA, we could use the definition for “Cellular and Other Wireless Telecommunications.” This definition provides that a small entity is any such entity employing no more than 1,500 persons.11 The Commission does not require PLMR licensees to disclose information about number of employees, so the Commission does not have information that could be used to determine how many PLMR licensees constitute small entities under this definition. Moreover, because PMLR licensees generally are not in the business of providing cellular or other wireless telecommunications services but instead use the licensed facilities in support of other business activities, we are not certain that the Cellular and Other Wireless Telecommunications category is appropriate for determining how many PLMR licensees are small entities for this analysis. Rather, it may be more appropriate to assess PLMR licensees under the standards applied to the particular industry subsector to which the licensee belongs.12

35. The final rules adopted in the R&O affect the following PLMR licensees: (1) Industrial/Business Pool and state and local government licensees that are authorized to make hydrological and meteorological (Hydro) measurements under footnote US13; (2) forest firefighting agencies, which are primarily state government licensees, and forest conservation agencies that are authorized under footnote US8; (3) Public Safety Pool licensees that are authorized under footnote US11; and (4) hospital, medical centers, nursing homes, etc. that operate medical radiocommunication systems, which are authorized under footnote US216. These United States footnotes are fully discussed in the R&O.

36. Hydro Channel Users. The Commission has authorized 9 licensees to operate 219 fixed stations on the six channels that would be removed from the Hydro channel plan: (1) One licensee (the State of California) is authorized to operate 15 fixed stations on the frequency 169.575 MHz; (2) five licensees are authorized to operate 83 fixed stations at 409.675 MHz; (3) three licensees are authorized to operate ten fixed stations at 409.725 MHz; (4) four licensees are authorized to operate 97 fixed stations at 412.625 MHz; and (5) there are no licensees authorized to operate on the frequencies 170.375 MHz and 171.975 MHz. The Commission has issued 1053 licenses (there is at least one station per license) for the remaining Hydro channels that are being narrowbanded. We believe that some of the Hydro channel licensees are small businesses or small governmental entities.

37. Forest Firefighting and Conservation Agencies. The Commission has authorized 21 licensees to operate 414 fixed stations and 45,630 mobile stations on the nine channels that are available to forest firefighting agencies; two of these frequencies are also available for use by conservation agencies. By Commission Rule, these frequencies are reserved primarily for assignment to state licensees. Assignments to other licensees may be made only where the frequencies are required for coordinated operation with the state system to which the frequency is assigned. The 21 licensees consist of 19 states and state agencies, the County of Los Angeles, and a non-profit organization. This small organization may be impacted by our actions.

38. Public Safety Licensees. The Commission has granted 27 licensees authorization to operate wideband equipment on the frequencies 166.25 MHz and 170.15 MHz. By Commission Rule, these frequencies are to be assigned to stations in the Public Safety Pool that are at points within 240 kilometers of New York City. Specifically, the Commission has granted 15 licensees authorization to operate 1295 mobile stations, 95 pagers, and 30 fixed stations using the frequency 166.25 MHz. The Commission has granted 12 licensees authorization to operate 899 mobile stations, 165 pagers, and 22 fixed stations on the frequency 170.15 MHz. We believe that many of these public safety licensees are small governmental entities.

39. Medical Radiocommunication Systems. The Commission has issued 510 licenses for the frequency 150.775 MHz and 424 licenses for the frequency 150.790 MHz. By Commission Rule, these 150 MHz channels are used only by mobile stations. For example, these frequencies may be used for voice transmissions from a portable (hand-held) unit to an ambulance. The Commission has issued 524 licenses for the frequency 163.250 MHz. By Commission Rule, the frequency 163.250 MHz can be assigned only for one-way paging. We believe that most of the hospitals, medical centers, and nursing homes that operate medical radiocommunication systems are small businesses or small governmental entities.

40. The final rules require that:

• PLMR licensees employing wideband channels for Hydro, Forest Firefighting and Conservation, and public safety operations modify or discontinue operations if, after May 27, 2005, these wideband operations cause interference to new Federal operations in the 162-174 MHz band, or if, after January 1, 2008, these wideband operations cause interference to new Federal operations in the 150.05-150.8 MHz and 406.1-420 MHz bands;

• Hydro channel licensees operating on the center frequencies 169.575 MHz, 409.675 MHz, 409.725 MHz, and 412.625 MHz cease operations not later than January 1, 2013;

• PLMR applicants requesting authority to operate Hydro, Forest Firefighting and Conservation, public safety, and medical radiocommunication stations in the 162-174 MHz band use narrowband channels after January 1, 2005; and that these applicants use narrowband channels after January 1, 2008 in the 150.05-150.8 MHz and 406-416 MHz bands; and

• New Hydro stations that would operate on the center frequencies 406.125 MHz and 406.175 MHz be limited to a transmitter output power of 125 watts and required to coordinate with the Radio Astronomy Observatory at Socorro, New Mexico.

41. If a licensee is required to modify its operations, we believe that the licensee would either buy new narrowband equipment or that the licensee would hire a vendor to modify some or all of its wideband equipment. We are uncertain of the exact costs relating to the narrowbanding requirements.

42. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.13

43. So long as incompatibilities are not created with Federal narrowband operations, we are permitting incumbent licensees to use existing equipment until January 1, 2013. We are requiring that the 9 licensees of the six Hydro channels being deleted from the Hydro channel plan modify their equipment and station licenses and migrate to a center frequency listed in the new Hydro channel plan on a timetable as advised by the Hydro Committee and approved by NTIA and the Commission.

44. We are grandfathering those incumbent stations that operate on the frequencies 150.7825 MHz and 150.7975 MHz indefinitely. We are exempting equipment designed for use in the Federal bands from our current 6.25 kHz equipment certification requirement.

45. Report to Congress: The Commission will send a copy of the Report and Order, including this FRFA, in a report to Congress pursuant to the Congressional Review Act.14 In addition, the Commission will send a copy of the Report and Order, including the FRFA, to the Chief Counsel for Advocacy of the SBA.

46. Pursuant to sections 1, 4(i), 7(a), 301, 302(a), 303(a)-(c), 303(f), 303(g), 303(r), 307, 308, and 332 of the Communications Act of 1934, as amended, 47 U.S.C. Sections 151, 154(i), 157(a), 301, 302(a)-(c), 303(f), 303(g), 303(r), 307, 308, and 332, this report and order is hereby adopted.

47. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this report and order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

This is a correction to the Commission's Report and Order portion (Report and Order) of the Commission's Report and Order and Notice of Proposed Rulemaking, FCC 04-287, in WT Docket Nos. 03-103 and 05-42, adopted December 15, 2004, and released February 22, 2005, as summarized and published at 70 FR 19293, April 13, 2005.

This is summary of the Federal Communications Commission's Sixth Report and Order, FCC 05-9, adopted January 5, 2005 and released on January 7, 2005. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at http://www.fc.gov. Alternative formats are available to persons with disabilities by contacting Brian Millin at (202) 418-7426 or TTY (202) 418-7365 or at Brian.Millin@fcc.gov.

1. In the Sixth Report and Order, the Commission takes the following actions:

• Changes the terminology used in Sections 90.543 and 27.53 of the Commission's rules from Adjacent Channel Coupled Power (ACCP) to Adjacent Channel Power (ACP); and

• Adopts recommended changes to the ACP limits in § 90.543 and 27.53 of the Commission's rules.

2. The order does not contain any new or modified information collection.

3. A Final Regulatory Flexibility Analysis has been prepared with respect to the Sixth Report and Order and is set forth below.

4. The Commission will send a copy of this Sixth Report and 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).

5. As required by the Regulatory Flexibility Act (RFA), a Final Regulatory Flexibility Analysis (FRFA) was incorporated in the Fifth Report and Order in WT Docket 96-86. The Commission sought written public comment on the proposals in the Fifth Notice of Proposed Rulemaking.

6. The Regulatory Flexibility Act (RFA) requires that an agency prepare a regulatory flexibility analysis for notice-and-comment rulemaking proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” The RFA generally defines “small entity” as having the same meaning as the terms “small business,” “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

7. In this Sixth Report and Order, we:

• Revise values in the emission limit tables set forth at 47 CFR 90.543 to ensure technological feasibility;

• Delete the column entitled “Maximum ACCP (dbm)” from the table governing ACCP requirements for mobile transmitter set forth at 47 CFR 90.543 because these values are inconsistent with the Commission's decision not to require mobile transmitters to utilize Automatic Power Control;

• Change the terminology “Adjacent Channel Coupled Power” to “adjacent Channel Power” in our Rules to align our rules with industry standards.

8. These changes, which are intended to ensure that the Commission's rules reflect the latest technical and industry standards, and to correct typographical or ministerial errors in the Commission's Rules, are exclusively of an administrative nature. The changes will not have a significant economic impact on small entities because they are technologically neutral and will affect all entities equally.

9. The Commission therefore certifies, pursuant to the RFA, that the rule changes contained proposals in this Sixth Report and Order will not have a significant economic impact on a substantial number of small entities.

10. The Commission will send a copy of the Final Analysis including a copy of this Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the SBA. This certification will also be published in the Federal Register.

11. Pursuant to Sections 4(i), 303(f), 332, 337 and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(f), 332, 337 and 405 this Sixth Report and Order is hereby adopted.

12. It is further ordered that the amendments of the Commission's Rules as set forth in Rule Changes are adopted May 27, 2005.

13. It is further ordered, that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Sixth Report and Order including the Final Regulatory Flexibility Analysis to the Chief Counsel for Advocacy of the Small Business Administration.

Communications.

This is a synopsis of the Commission's Report and Order, MB Docket No. 04-316, adopted April 6, 2005, and released April 8, 2005. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision also may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC, 20554, (800) 378-3160, or via the company's Web site, http://www.bcpiweb.com. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see U.S.C. 801(a)(1)(A).

This is a synopsis of the Commission's Report and Order, MB Docket No. 02-387, adopted April 6, 2005, and released April 8, 2005. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or www.BCPIWEB.com. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a summary of the Commission's Report and Order, MB Docket No. 04-240, adopted April 6, 2005, and released April 8, 2005. The full text of this Commission decision is available for inspection and copying during normal business hours in the Commission's Reference Center 445 Twelfth Street, SW., Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20054, telephone 1-800-378-3160 or www.BCPIWEB.com. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This document contains new information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public to comment on the information collection requirements contained in this Order as required by the Paperwork Reduction Act of 1995, Public Law 104-13. Public and agency comments are due May 27, 2005, except for sections 76.66(d)(2) and 76.66(d)(5) which contain Paperwork Reduction Act requirements that are not effective until approved by the Office of Management and Budget. The Commission will publish a document in the Federal Register announcing the effective date for those sections. In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we have not previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees. However, this information collection does not affect businesses with fewer than 25 employees. Accordingly, there is no impact pursuant to the Small Business Paperwork Relief Act of 2002.

This is a synopsis of the Media Bureau's Order in FCC 05-81, adopted March 28, 2005, and released on March 30, 2005. The full text of this Order is available for inspection and copying during regular business hours in the FCC Reference Center, 445 Twelfth Street, SW., Room CY-A257, Portals II, Washington, DC 20554, and may also be purchased from the Commission's copy contractor, BCPI, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. Customers may contact BCPI, Inc. via their Web site, http://www.bcpi.com, or call 1-800-378-3160.

1. The Commission, in this Order, adopts procedural rules in compliance with requirements in the Satellite Home Viewer Extension and Reauthorization Act of 2004 (SHVERA).1 The SHVERA amends the 1988 copyright laws (17 U.S.C. 119 and 122) and the Communications Act of 1934, as amended (Act) to further aid competition in the multichannel video programming distribution market and provide more video programming options for satellite subscribers. The Order is one of several actions the Commission is taking to implement SHVERA. The other proceedings will follow according to timeframes set forth in the SHVERA, to be undertaken and largely completed in 2005.

2. The Order first implements procedural rule revisions required by section 340(h) of the Act. Section 202 of the SHVERA requires the Commission to add new section 340 of the Act, which provides for satellite carriage of “significantly viewed” broadcast signals.2 Accordingly, in February 2005, the Commission adopted a Notice of Proposed Rulemaking to implement new section 340 of the Act. This decision may be found at 70 FR 11313, March 8, 2005. Section 340(h) prescribes rules for carriage elections on a county basis, unified retransmission consent negotiations, and notifications by satellite carriers to local broadcasters concerning carriage of significantly viewed signals.

3. Additionally, section 205 of the SHVERA amends section 338(h)(2) of the Act to add subsection 338(h) which instructs the Commission to amend § 76.66(d)(2) of the Commission's rules concerning satellite carrier notification to television broadcast stations in new local-into-local markets. The Order, as required by the SHVERA, mandates that the carrier's notice be sent to each station in a local market in which the carrier proposes to commence local-into-local service not later than 60 days before the local-into-local service will begin and also specifies the information that must be included in the notice and that the notice be sent via certified mail to the television station licensee's address listed in the Commission's consolidated database. The purpose is to ensure that notices clearly indicate to local broadcasters the rights and responsibilities that they have under the carry-one, carry-all provisions of the Act and Commission regulations.

4. Finally, section 209 of the SHVERA creates new section 339(c)(4)(D) of the Act, which requires that the Commission exempt satellite carriers from the signal testing requirements of section 339(c)(4)(A) of the Commission's rules when the request comes from a satellite subscriber in a market in which local-into-local service is offered. The Order implements this change.

5. The Commission adopts these rule amendments without providing prior public notice and comment because these amendments merely implement the provisions of the SHVERA that direct the Commission to revise its rules as specified in the legislation. The Commission's action involves no discretion. Accordingly, notice and comment would serve no purpose and is thus unnecessary, and this action falls within the “good cause” exception of the Administrative Procedure Act.

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

7. Accordingly, it is ordered that pursuant to section 202 of the Satellite Home Viewer Extension and Reauthorization Act of 2004, codified as section 340(h) of the Communications Act of 1934, as amended, 47 U.S.C. 340(h), part 76.66(d)(5) is added as reflected in the rule changes portion of this document.

8. It is further ordered that pursuant to section 205 of the Satellite Home Viewer Extension and Reauthorization Act of 2004, codified as section 338(h) of the Communications Act of 1934, as amended, 47 U.S.C. 338(h), part 76.66(d)(2) is amended as set forth in the rule changes portion of this document.

9. It is further ordered that pursuant to section 209 of the Satellite Home Viewer Extension and Reauthorization Act of 2004, codified as section 339(c)(4)(D) of the Communications Act of 1934, as amended, 47 U.S.C. 339(c)(4)(D), section 73.683(f) is added as set forth in the rule changes portion of this document.

This is a summary of the Federal Communications Commission's Fifth Memorandum Opinion and Order, FCC 05-9, adopted January 5, 2005 and released on January 7, 2005. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at http://www.fcc.gov. Alternative formats are available to persons with disabilities by contacting Brian Millin at (202) 418-7426 or TTY (202) 418-7365 or at Brian.Millin@fcc.gov.

1. In the Fifth Memorandum Opinion and Order, the Commission takes the following actions:

• defers the ban on the marketing, manufacture and importation of equipment soley capable of utilizing 12.5 kHz bandwidth when operating in the voice mode in the 700 MHz Public Safety Band (12.5 kHz equipment) from December 31, 2006 until December 31, 2014; and

• defers the prohibition on filing applications for new systems that operate utilizing 12.5 kHz voice channels from December 31, 2006 until December 31, 2014.

2. The order does not contain any new or modified information collection.

3. A Supplemental Final Regulatory Flexibility Analysis with respect to the Fifth Memorandum Opinion and Order has been prepared and is set forth below.

4. The Commission will send a copy of this Fifth Memorandum Opinion and 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).

5. In view of the fact that the Commission has adopted further rule amendments in the Fifth Memorandum Opinion and Order, the Commission has included this Supplemental Final Regulatory Flexibility Analysis (SFRFA). This SFRFA conforms to the RFA. Need for, and Objectives of the Fifth Memorandum Opinion and Order:

6. The Fifth Memorandum Opinion and Order adopts rules to promote the transition to dual mode equipment and 6.25 kHz equipment in the 700 MHz Public Safety band operating in the General Use and State License channels. Specifically, we amend our rules to delay the ban on the marketing, manufacture, and importation of 12.5 kHz equipment until December 31, 2014. In addition, we amend our rules to delay until December 31, 2014, the cut-off for accepting applications for new systems operating in the General Use and State License channels that use 12.5 kHz equipment. These actions will effect a transition to a narrowband channel plan. The resulting gain in efficiency will ease congestion on the General Use and State License channels in these bands. Delaying this transition, however, will ease the economic burden on small businesses by allowing them to make this transition over a longer period of time.

Summary of Significant Issues Raised by Public Comments in Response to the FRFA:

7. No comments or reply comments were filed in direct response to the FRFA. The Commission has, however, reviewed the general comments that may impact small businesses. Much of the potential impact on small businesses arises form the mandatory migration to 6.25 kHz or dual mode technology beginning on December 31, 2014; the ban on marketing, importation and manufacture of 12.5 kHz equipment after December 31, 2014; and the freeze on new 12.5 kHz applications. The costs associated with replacement of current systems were cited in opposition to mandatory conversion proposals.

Description and Estimate of the Number of Small Entities to Which the Rules Apply:

8. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the rules adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of 1992, there were approximately 275,801 small organizations. Below, we further describe and estimate the number of small entity licensees and regulates that may be effected by the proposed rules, if adopted.

9. Governmental Entities. The term “small governmental jurisdiction” is defined as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” As of 1997, there were approximately 87,453 governmental jurisdictions in the United States. This number includes 39,044 county governments, municipalities, and townships, of which 37,546 (approximately 96.2%) have populations of fewer than 50,000, and of which 1,498 have populations of 50,000 or more. Thus, we estimate the number of small governmental jurisdictions overall to be 84,098 or fewer.

10. Public Safety Radio Licensees. As a general matter, Public Safety Radio Pool licensees include police, fire, local government, forestry conservation, highway maintenance, and emergency medical services. The SBA rules contain a definition for cellular and other wireless telecommunications companies which encompass business entities engage in radiotelephone communications employing no more that 1,500 persons. There are a total of approximately 127,540 licensees within these services. With respect to local governments, in particular, since many governmental entities as well as private businesses comprise the licensees for these services, we include under public safety services, we include under public safety services the number of government entities affected.

11. Wireless Communications Equipment Manufacturers. The SBA has established a small business size standard for radio and television broadcasting and wireless communications equipment manufacturing. Under the standard, firms are considered small if they have 750 or fewer employees. Census Bureau data for 1997 indicates that, for that year, there were a total of 1,215 establishments in this category. Of those, there were 1,150 that had employment under 500, and an additional 37 that had employment of 500 to 999. The Commission estimates that the majority of wireless communications equipment manufacturers are small business.

Description of Projected Reporting, Recordkeeping and Other Compliance Requirements:

12. This Fifth Memorandum Opinion and Order adopts rules to promote the transition to dual mode equipment and 6.25 kHz equipment in the 700 MHz Public Safety band operating in the General Use and State License channels. Further, this Fifth Memorandum Opinion and Order amends our current rules to prohibit the marketing, importation or manufacture of 12.5 kHz-only equipment beginning on December 31, 2014. All equipment utilized in the 700 MHz Public Safety band on or after December 31, 2014 must utilize a maximum channel bandwidth of 6.25 kHz. These rules do not impose new reporting or recordkeeping requirements on licensees, but will require licensees to transition to new equipment. We have this transition as long as possible.

Steps Taken To Minimize Significant Economic Impact on Small Entities and Significant Alternatives Considered:

13. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.

14. The Commission considered the economic burden on small businesses when it adopted the rules set forth in the Fifth Memorandum Opinion and Order. For instance, in consideration of the amortization and life-space of current equipment and the resources available to small entities, we amend our Rules to delay until December 31, 2014 the cut-off for accepting applications for new systems operating in the General Use and State License channels that use 12.5 kHz equipment. In addition we amend our rules to delay until December 31, 2014 the prohibition on the marketing, manufacture and importation of 12.5 kHz equipment.

15. Exemption from coverage of the rule changes for small businesses would frustrate the purpose of the rule, i.e., migration to more efficient spectrum use, and facilitate continued inefficient use of spectrum.

16. Report to Congress: The Commission will send a copy of this Fifth Memorandum Opinion and Order, including this SFRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the Fifth Memorandum Opinion and SFRFA (or summaries thereof) will also be published in the Federal Register. See 5 U.S.C. 604(b).

17. Pursuant to Sections 4(i), 303(f), 332, 337 and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(f), 332, 337 and 405 this Fifth Memorandum Opinion and Order is hereby adopted.

18. Pursuant to Sections 1, 4(i), 303(f) and (r), 332, and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 1, 154(i), 303(f) and (r), 332, and 405 the Petition for Reconsideration filed by Motorola, Inc. on January 13, 2003, is granted to the extent described herein.

19. It is further order that the amendments of the Commission's Rules as set forth in Rule Changes are adopted May 27, 2005.

20. It is further ordered, that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Fifth Memorandum Opinion and Order including the Supplemental Final Regulatory Flexibility Analysis to the Chief Counsel for Advocacy of the Small Business Administration.

The Atlantic shark fishery is managed under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The Fisheries Management Plan for Atlantic Tunas, Swordfish, and Sharks (HMS FMP), finalized in 1999, and Amendment 1 to the HMS FMP, finalized in 2003, are implemented by regulations at 50 CFR part 635.

On December 24, 2003, NMFS published a final rule (68 FR 74746) for Amendment 1 to the HMS FMP that established, among other things, the 2004 annual landings quota for LCS at 1,017 metric tons (mt) dressed weight (dw) and the 2004 annual landings quota for SCS at 454 mt dw. The final rule also established regional LCS and SCS quotas for the commercial shark fishery in the Gulf of Mexico (Texas to the west coast of Florida), South Atlantic (east coast of Florida to North Carolina and the Caribbean), and North Atlantic (Virginia to Maine). The LCS and SCS quotas were split among the three regions based upon historic landings.

On November 30, 2004, NMFS published a final rule (69 FR 69537) that adjusted the 2005 regional quotas for LCS and SCS based on updated landings information, divided the quotas among the three trimester seasons, established a method of accounting for over- or underharvests in the transition from semi-annual to trimester seasons, and implemented a new process for notifying participants of season opening and closing dates and quotas.

The 2004 final rule divided the LCS quota among the three regions as follows: 52 percent to the Gulf of Mexico, 41 percent to the South Atlantic, and 7 percent to the North Atlantic. The SCS quota was split among the three regions as follows: 10 percent to the Gulf of Mexico, 88 percent to the South Atlantic, and 2 percent to the North Atlantic. The regional quotas for LCS and SCS were divided equally between the trimester seasons in the South Atlantic and the Gulf of Mexico, and according to historical landings in the North Atlantic. The quotas were divided in this manner because sharks are available throughout much of the year in the Gulf of Mexico and South Atlantic regions, but primarily during the summer months in the North Atlantic region. Dividing the quota according to historical landings in the North Atlantic provided that region with a better opportunity to harvest its regional quota.

The final rule also established a method of dividing any over- or underharvests from the 2004 first semi-annual season equally between the 2005 first and second trimester seasons, and any over- or underharvest from the 2004 second semi-annual season equally between the 2005 second and third trimester seasons. This was done, in part, to make a larger portion of the quota available to fishermen during the second and third trimester seasons when the time/area closure off North Carolina will no longer be in effect.

The 2004 final rule established a process of issuing proposed and final rules for notification of season lengths and quotas to facilitate public comment. This final rule serves as notification of season lengths and quotas pursuant to 50 CFR 635.27(b)(1)(iii). This action does not change the 2005 base landings quota or the 2005 regional quotas established in the November 30, 2004, final rule (69 FR 69537).

NMFS issued a proposed rule on March 10, 2005 (70 FR 11922), to adjust regional quotas based on over- or underharvests from the 2004 season and to establish the second and third trimester season opening and closing dates.

Comments on the March 2005 proposed rule received during the public comment period are summarized below, together with NMFS' responses.

Comment 1: NMFS received several comments regarding the proposed second trimester season opening dates. Commenters indicated a preference for a number of different opening dates including May 1, July 1, and July 6. All of the commenters expressed a preference for a particular date due to a combination of potential shark availability, marketing concerns, other fishery openings and closings such as lobster and grouper, and other economic considerations.

Response: NMFS has selected July 6 as the opening date for the second trimester LCS season in the Gulf of Mexico and South Atlantic regions, and July 21 as the opening date for the North Atlantic region. The LCS season was postponed from the May 1 start date in order to protect sharks during the pupping season and to ensure availability of quota for North Carolina fishermen after the reopening of the time/area closure on August 1, 2005. The shark pupping season occurs from March through September in the Atlantic Ocean and the Gulf of Mexico with a peak from May through June. The LCS fishery has usually been closed for at least some of the time during these peak pupping months to reduce the likelihood of interactions with juvenile and reproductive female sharks. Additionally, if NMFS were to open the season on May 1, it is likely that the South Atlantic regional quota would have been harvested prior to the reopening of the time/area closure off North Carolina. Although July 1 has historically been the start of the second semi-annual season, NMFS received several comments that a season opening date of July 6 would improve marketing opportunities because it does not conflict with the Fourth of July holiday. Commenters pointed out that a July 6 season start date would prevent a glut of shark product on the market prior to the Fourth of July holiday when the market for sharks has historically been low. Thus, NMFS believes that the July 6 start date for the second trimester LCS season in the South Atlantic and Gulf of Mexico regions strikes a balance between the various competing interests based on shark availability, pupping concerns, and equitable distribution of the quota. The start date of July 21 for the North Atlantic region will allow that region's second and third trimester seasons to run consecutively.

Comment 2: The proposed opening date of September 1 for the third trimester season in the Gulf of Mexico will allow fishing when there are virtually no sharks to catch, with the exception of migrating dusky sharks. This is a prohibited species that will no doubt be caught and discarded if there is any fishing effort in the Gulf of Mexico during this time.

Response: NMFS does not anticipate that there will be excessive catch and discard of prohibited shark species. However the likelihood of catching prohibited species always exists, and NMFS will monitor landings and discards closely in order to determine whether the discard of prohibited shark species is excessive. Vessels will be selected for observer coverage, and through the observers, NMFS will be able to determine during the season if the third trimester season is resulting in excessive prohibited species interactions. Before the 2006 third season, NMFS will also use logbook reports to further verify whether or not opening at that time caused excessive prohibited species interactions.

Comment 3: Catching sharks should be totally banned. If not totally banned, then shark quotas should be cut by 50 percent this year, and by 10 percent every year after that.

Response: NMFS does not believe that banning all shark fishing is warranted for the following reasons: a number of businesses, including fishermen, processors, suppliers, and dealers could be forced out of business and a number of communities, including recreational fishing communities, would be adversely affected. In addition, the current rebuilding plan implemented in 2003 reduced the LCS quotas by 41 percent from 1,714 to 1,017 mt dw, to ensure a sustainable fishery and viable Atlantic shark populations in compliance with the requirements of the Magnuson-Stevens Act and other domestic laws.

Comment 4: NMFS should implement a more frequent reporting system for Atlantic shark landings. Reporting every week, as opposed to the current two-week reporting period, would help improve monitoring catch rates during the season.

Response: NMFS may consider shortening the reporting period in the future. However, prior to taking such an action, NMFS would need to conduct additional analyses, including an opportunity for public notice and comment as required by the Paperwork Reduction Act (PRA). Since shortening the reporting period would increase the reporting burden on seafood dealers, NMFS would need to amend the current regulations as well as the information collection approved by the Office of Management and Budget pursuant to the PRA. Even if the reporting period were shortened, NMFS would likely continue to establish the commercial shark fishing seasons in advance of the season to avoid overharvests.

Comment 5: NMFS should shorten the third trimester season in the South Atlantic by approximately one month to avoid an overharvest.

Response: NMFS agrees that there is the possibility that catch rates in late October or early November could increase, potentially resulting in an overharvest. As a result, NMFS will take the precautionary step of closing the third trimester season in the South Atlantic on November 15. Any over- or underharvest will be counted against or added to the South Atlantic quota during the third season of 2006.

Comment 6: NMFS should consider opening the first trimester season in February rather than January, because sharks are typically not available until that time.

Response: NMFS will consider postponing the opening date in all regions for the 2006 first trimester season in a proposed rule to be published later this year in the Federal Register.

Comment 7: There are enormous numbers of spiny dogfish and something must be done to manage them.

Response: Spiny dogfish are currently managed jointly by the Mid-Atlantic and New England Fishery Management Councils. Any comments on that FMP should be submitted to those Councils.

In the proposed rule, NMFS considered opening the LCS second trimester season in the Gulf of Mexico on August 1, in the South Atlantic on July 1, and in the North Atlantic on July 15. NMFS considered delaying the start of the second season from May 1 in order to reduce the likelihood of interactions during shark pupping periods, and to allow the available quota to be harvested by the beginning of the third trimester season. Delaying the start of the second trimester season would have allowed the second and third trimester seasons to run consecutively. This would have prevented the need for a closure of the LCS fishery between the second and third trimester seasons and could have helped minimize disruption to fishery participants in the transition from semi-annual to trimester seasons. After considering public comments, NMFS has decided to change the season opening date for the Gulf of Mexico from August 1 to July 6, and the South Atlantic season opening date from July 1 to July 6. NMFS received several comments that a July 6 opening date in both regions would improve marketing opportunities because it does not conflict with the Fourth of July holiday. Many fishermen indicated that sharks are available in July, but not in August, and that an opening date of August 1 would have had negative economic impacts on fishermen in the Gulf of Mexico as a result. Fishermen also noted that the lobster fishery opens on August 1, and that opening the shark season on the same date would have prevented them from participating in either the shark or the lobster fishery, thus creating further economic hardship on fishermen who rely on revenues from both fisheries. Since the fishery has historically opened on July 1, NMFS does not believe there will be any negative ecological or economic impacts as a result of this change. Since the season will now begin on July 6, and catch rates have historically been higher in July than August however, the season in the Gulf of Mexico will need to be shortened. Consequently, the second and third trimester seasons in the Gulf of Mexico will not run consecutively.

For the North Atlantic region, recent updates to landings information indicated higher landings that required delaying the start of the second trimester season one week from July 15 to July 21. This will allow the second and third trimester seasons to run consecutively from July 21 to August 31, 2005, and from September 1 to September 15, 2005, respectively, without overharvesting the quota.

In the proposed rule, NMFS considered a closing date of December 15 for the South Atlantic region. After considering public comments, NMFS has decided to establish a closing date of November 15. There has historically been no commercial shark fishery in October or November, and NMFS thus estimated the closing date in the proposed rule based on the available quota and historic catch rates during August and September. Fishermen indicated that there is a likelihood of an increased harvest of LCS during October and November, and that leaving the fishery open until December 15 could have resulted in an overharvest. Thus, NMFS opted for a precautionary approach of an earlier closing date. In the event that the quota is not caught during this period, NMFS may consider a longer season in the future.

The calculations and details for establishing the regional quotas are described in the proposed rule (March 10, 2005, 70 FR 11922) and are not repeated here. For the Gulf of Mexico, the final LCS quotas for the second and third trimester seasons are 147.8 and 167.7 mt dw, respectively, and the final SCS quotas for the second and third trimester seasons are 30.5 and 31.7 mt dw, respectively.

For the South Atlantic, the final LCS quotas for the second and third trimester seasons are 182.0 and 187.5 mt dw, respectively, and the final SCS quotas for the second and third trimester seasons are 281.3 and 201.0 mt dw, respectively.

For the North Atlantic, the final LCS quotas for the second and third trimester seasons are 65.2 and 4.8 mt dw, respectively, and the final SCS quotas for the second and third trimester seasons are 23.0 and 15.9 mt dw, respectively.

The 2005 second and third trimester quotas for pelagic (other than blue and porbeagle), blue, and porbeagle sharks are established at 162.7 mt dw (358,688 lb dw), 91.0 mt dw (200,619 lb dw), and 30.7 mt dw (67,681 lb dw), respectively.

The second trimester fishing season of the 2005 fishing year for LCS will open on July 6, 2005, in the South Atlantic and Gulf of Mexico regions, and on July 21, 2005, in the North Atlantic region. The second trimester season LCS fishery will close on July 23, 2005, at 11:30 p.m. local time in the Gulf of Mexico, and on August 31, 2005, at 11:59 p.m. local time in the South Atlantic and North Atlantic regions.

The second trimester fishing season of the 2005 fishing year for SCS, pelagic sharks, blue sharks, and porbeagle sharks in the northwestern Atlantic Ocean, including the Gulf of Mexico and the Caribbean Sea, will open on May 1, 2005. When quotas are projected to be reached for the SCS, pelagic, blue, or porbeagle shark fisheries, the Assistant Administrator (AA) will file notification of closures at the Office of Federal Register at least 14 days before the effective date, as consistent with 50 CFR 635.28(b)(2).

To estimate the LCS fishery opening and closing dates for the second season, NMFS calculated the average reported catch rates for each region from the second semi-annual season in recent years (2000-2004). These catch rates were used to estimate the amount of available quota that would likely be taken by the end of each dealer reporting period.

Consistent with 50 CFR 635.27(b)(1)(vi), any over- or underharvests in one region will result in an equivalent increase or decrease in the following year's quota for that region.

Because state landings during a Federal closure are counted against the quota, NMFS also calculated the average amount of quota reported received during the Federal closure dates of the years used to estimate catch rates.

Pursuant to 50 CFR 635.5(b)(1)(iii), shark dealers must report any sharks received twice a month. More specifically, sharks received between the first and 15th of every month must be reported to NMFS by the 25th of that same month and those received between the 16th and the end of the month must be reported to NMFS by the 10th of the following month. Thus, in order to simplify dealer reporting and aid in managing the fishery, in recent years NMFS has opened and closed the Federal LCS fishery on either the 15th or the end of any given month. However, based on available quota, historic catch rates, and the recent change counting state landings against the quota, NMFS has decided to allow the Gulf of Mexico LCS fishery to remain open for 18 days during the second trimester season, rather than the usual two or four weeks. An 18-day season will allow the quota to be harvested without exceeding the quota. A two-week season would only have allowed 75 percent of the quota to be harvested.

Based on average LCS catch rates in recent years (2000-2004) for the Gulf of Mexico region, approximately 92 percent of the available second trimester LCS quota (148.0 mt dw) would likely be taken in 18 days and 108 percent of the available LCS quota would likely be taken in three weeks. Dealer data also indicate that, on average, approximately 6.5 mt dw of LCS has been reported received by dealers during a Federal closure. This is approximately 4 percent of the available quota. If catch rates in 2005 are similar to the average catch rates from 2000 to 2004, 96 percent (92 + 4 percent) of the second trimester quota could be caught if the season were open for 18 days, and 112 percent (108 + 4) of the quota could be caught if the season were open for three weeks. If the fishery were to remain open for three weeks, the quota would likely be exceeded. Thus, the LCS fishery in the Gulf of Mexico region will open on July 6, 2005, and close at 11:30 p.m. on July 23, 2005.

Based on average LCS catch rates in recent years (2000-2004) for the South Atlantic region, and accounting for reduction in effort due to the time/area closure off North Carolina, approximately 89 percent of the available second trimester LCS quota (182.0 mt dw) would likely be taken in eight weeks and 107 percent of the available LCS quota would likely be taken in nine weeks. Dealer data also indicate that, on average, approximately 17 mt dw of LCS has been reported received by dealers during a Federal closure. This is approximately 9 percent of the available quota. Thus, if catch rates in 2005 are similar to the average catch rates from 2000 to 2004, 98 percent (89 percent + 9 percent) of the quota could be caught in eight weeks, and 116 percent (107 percent + 9 percent) of the quota could be caught in nine weeks. Thus, in order for the second and third trimester seasons to run consecutively without exceeding the quota during the second trimester season, the LCS fishery in the South Atlantic will open on July 6, 2005, and close at 11:59 p.m. on August 31, 2005.

Based on average LCS catch rates in recent years (2000-2004) for the North Atlantic region, approximately 80 percent of the available second trimester LCS quota (65.2 mt dw) would likely be taken in five weeks and 89 percent of the available LCS quota would likely be taken in six weeks. Dealer data also indicate that, on average, approximately 12 mt dw of LCS has been reported received by dealers during a Federal closure. This is approximately 18 percent of the available quota. Thus, if catch rates in 2005 are similar to the average catch rates from 2000 to 2004, 98 percent (80 + 18 percent) of the quota could be caught in five weeks, and 107 percent (89 percent + 18 percent) in six weeks. Thus, allowing the fishery to stay open for six weeks could result in an overharvest. In order for the second and third trimester seasons to run consecutively without exceeding the quota during the second trimester season, the North Atlantic will open on July 21, 2005 and close at 11:59 p.m. on August 31, 2005.

The third trimester fishing season of the 2005 fishing year for LCS, SCS, pelagic sharks, blue sharks, and porbeagle sharks in all regions in the northwestern Atlantic Ocean, including the Gulf of Mexico and the Caribbean Sea, will open on September 1, 2005. When quotas are projected to be reached for the SCS, pelagic, blue, or porbeagle shark fisheries, the AA will file notification of closures at the Office of Federal Register at least 14 days before the effective date, as consistent with 50 CFR 635.28(b)(2).

NMFS will close the third trimester season LCS fishery in the North Atlantic on September 15, 2005, at 11:30 p.m. local time, in the Gulf of Mexico on October 31, 2005, at 11:30 p.m. local time, and in the South Atlantic on November 15, 2005, at 11:30 p.m. local time.

Since the LCS fishery has historically been closed during much of the third trimester period, NMFS used average LCS catch rates from August and September in recent years (2000-2004) to estimate the third trimester season catch rates and closure dates for each of the regions. NMFS used this precautionary approach of averaging catch rates from August and September because of the potential for higher effort in September than has been observed in the past, and to reduce the likelihood of an overharvest. Using catch rates from August alone may not be appropriate because catch rates during that month have been higher historically than during September, and because it does not fall within the third trimester season. However, using catch rates from September alone may also not be appropriate because of the lack of data during that month. Hence, NMFS used the average of the two-month catch rates.

In the Gulf of Mexico, approximately 79 percent of the available third trimester LCS quota (167.8 mt dw) would likely be taken by the end of October and 99 percent of the available LCS quota would likely be taken by the second week of November. Dealer data also indicate that, on average, approximately 6.5 mt dw of LCS has been reported received by dealers after a Federal closure. This is approximately 4 percent of the available quota. Thus, if catch rates in 2005 are similar to the average catch rates from 2000 to 2004, 82 percent (79 percent + 4 percent) of the quota could be caught by the end of October. If the fishery were to remain open until the second week of November, the quota would likely be exceeded (99 percent + 4 percent = 103 percent). Accordingly, NMFS will close the Gulf of Mexico LCS fishery on October 31, 2005, at 11:30 p.m. local time.

In the South Atlantic, approximately 86 percent of the available third trimester LCS quota (187.5 mt dw) would likely be taken by the second week of December and 98 percent of the available LCS quota would likely be taken by the end of December. Dealer data also indicate that, on average, approximately 18 mt dw of LCS has been reported received by dealers after a Federal closure. This is approximately 10 percent of the available quota. Thus, if catch rates in 2005 are similar to the average catch rates from 2000 to 2004, 96 percent (86 percent + 10 percent) of the quota could be caught by the second week of December. If the fishery were to remain open until the end of December, the quota would likely be exceeded (98 percent + 10 percent = 108 percent). However, since publishing the proposed rule (March 10, 2005, 70 FR 11922), NMFS has received comments from fishermen with historical knowledge of the fishery that landings may actually increase in late October or early November. As a precautionary step to avoid an overharvest, NMFS will close the South Atlantic LCS fishery on November 15, 2005, at 11:30 p.m. local time.

In the North Atlantic region, approximately 70 percent of the available third trimester LCS quota (4.8 mt dw) would likely be taken by the second week of September and 140 percent of the available LCS quota would likely be taken by the end of September. Dealer data also indicate that, on average, approximately 7 mt dw of LCS has been reported received by dealers after a Federal closure. This is approximately 138 percent of the available quota. Thus, if catch rates in 2005 are similar to the average catch rates from 2000 to 2004, 210 percent (70 percent + 140 percent) of the quota could be caught by the second week of September. Accordingly, NMFS will close the North Atlantic LCS fishery on September 15, 2005, at 11:30 p.m. local time. This is the shortest season duration that NMFS believes is reasonable to ensure harvest of the 4.8 mt dw quota. Although the percentage overharvest ms high, the actual landings during a Federal closure in the North Atlantic (7 mt dw) are low compared to the overall LCS quota (<1 percent), and NMFS does not believe that this would have a negative ecological impact on the LCS rebuilding plan.

The Chief Counsel for Regulation at the Department of Commerce certified to the Chief Counsel for Advocacy at the Small Business Administration that this action would not have a significant economic impact on a substantial number of small entities.

The factual basis for this certification was published in the proposed rule. No comments were received regarding the economic impact of this rule. As a result, no Final Regulatory Flexibility Act analysis was prepared. This final rule will not increase overall quotas, landings or regional percentages for LCS or SCS, implement any new management measures not previously considered, and is not expected to increase fishing effort or protected species interactions.

The AA finds that good cause exists to waive the 30-day delay in effective date for the May 1, 2005, start of the second trimester fishing season for SCS, pelagic, blue, and porbeagle shark fisheries. NMFS received updated landings reports for the first and second 2004 fishing seasons on February 17, 2005. These data were necessary for making over- or underharvest adjustments to the quotas consistent with 50 CFR 635.27(b)(1)(vi). Although preliminary reports from earlier reporting periods were available, NMFS needed to obtain the most recent landings data available to establish appropriate quotas and season lengths based on the best available information for the 2005 second and third trimester seasons. The February 17, 2005, report on commercial shark landings was the first report received from dealers since the end of the 2004 second semi-annual season, as well as the first report received for the 2005 first trimester season. If the 30-day delay in effective date is not waived, then commercial fishermen in the SCS, pelagic, blue, and porbeagle shark fisheries will not be able to fish on May 1, 2005. Not allowing them to fish for these species, which are not overfished and are not at risk of an overharvest, would have negative economic impacts. Negative economic impacts would include elimination of all shark landings during a time in which fishermen have historically been allowed to fish, loss of anticipated revenues, marketing opportunities, predictability in the supply and availability of shark products, and general disruption to the Atlantic commercial shark fishery. Since the LCS commercial fishing season has been shortened in recent years to adjust for lower LCS landings quotas, fishermen have come to rely on landings of SCS, pelagic, blue, and porbeagle sharks during times when the LCS fishery is closed. Not allowing the fishery to remain open during this period would likely result in fishermen having to target other species, switch to new gears, or leave the fishery entirely. Other provisions of this final rule, including the opening dates for LCS, would have a 30-day delay in effectiveness from the date of publication of this rule. Accordingly, pursuant to 5 U.S.C. 553(d)(1), a delay in effective date is waived for the above-referenced May 1, 2005, start date.

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

NMFS determined that this rule will be implemented in a manner that is consistent, to the maximum extent practicable, with the enforceable policies of the approved coastal zone management (CZM) programs of coastal states in the Atlantic, Gulf of Mexico, and Caribbean. NMFS asked for states concurrence with this determination during the proposed rule stage. Three states replied affirmatively regarding the consistency determination, and one state (Texas) indicated that its CZM program no longer issues consistency determinations for federally managed fishing activities. NMFS presumes that the remaining states that have not yet responded concur with the determination.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

NMFS closed directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the GOA under § 679.21(d)(7)(i) on April 8, 2005 (70 FR 19338, April 13, 2005).

NMFS has determined that approximately 60 metric tons of halibut remain in the second seasonal apportionment of the 2005 Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA. Therefore, in accordance with §§ 679.25(a)(2)(i)(C) and (a)(2)(iii)(D), and to allow the deep-water species fisheries by vessels using trawl gear in the GOA to resume, NMFS is terminating the previous closure and is reopening directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the GOA. The reopening is effective 1200 hrs, Alaska local time (A.l.t.), April 24, 2005, through 1200 hrs, A.l.t., July 5, 2005. The species and species groups that comprise the deep-water species fishery are all rockfish of the genera Sebastes and Sebastolobus, deep-water flatfish, rex sole, arrowtooth flounder, and sablefish.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the delay the opening of the fishery, not allow the full utilization of the species and species groups that comprise the deep-water species fisheries, and therefore reduce the public's ability to use and enjoy the fishery resource.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.21 and is exempt from review under Executive Order 12866.